[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Rules and Regulations]
[Pages 24714-24759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9865]
[[Page 24713]]
Vol. 76
Monday,
No. 84
May 2, 2011
Part III
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 321, 332, and 381
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Product; Final Rule
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and
Regulations
[[Page 24714]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 321, 332, and 381
[Docket No. FSIS-2008-0039]
RIN 0583-AD37
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to establish a
new voluntary cooperative program under which State-inspected
establishments with 25 or fewer employees will be eligible to ship meat
and poultry products in interstate commerce. In participating States,
State-inspected establishments selected to take part in this program
will be required to comply with all Federal standards under the Federal
Meat Inspection Act (FMIA) and the Poultry Products Inspection Act
(PPIA). These establishments will receive inspection services from
State inspection personnel that have been trained in the enforcement of
the FMIA and PPIA. Meat and poultry products produced under the program
that have been inspected and passed by designated State personnel will
bear an official Federal mark of inspection and will be permitted to be
distributed in interstate commerce. FSIS will provide oversight and
enforcement of the program.
DATES: Effective Date: July 1, 2011.
FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant
Administrator, Office of Policy and Program Development, Room 350-E,
Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington,
DC 20250; Telephone (202) 720-2709, Fax (202) 720-2025.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.)
(``the Acts'') require that FSIS protect the public by ensuring that
meat and poultry products are safe, wholesome, and accurately labeled.
The Acts require Federal inspection and provide for Federal regulation
of meat and poultry products prepared for distribution in commerce for
use as human food.
Cooperative State inspection programs. Section 661 of the FMIA and
454 of the PPIA authorize FSIS to cooperate with State agencies in
developing and administering their own meat or poultry products
inspection programs for the inspection and regulation of products that
are produced and sold solely within the State (21 U.S.C. 661 & 454).
These cooperative State inspection programs are required to operate in
a manner and with authorities ``at least equal to,'' but not
necessarily identical to, the provisions set out in the FMIA and PPIA
(21 U.S.C. 661 (a)(1) & 454 (a)(1)). The ``at least equal to'' standard
is a concept that requires that State MPI Programs operate in a manner
that is at least as effective as those standards adopted for the
Federal inspection program. The Acts provide for FSIS to contribute up
to 50 percent of the cost of the cooperative State inspection programs,
as long as the State programs are effectively enforcing requirements
that are ``at least equal to'' the Federal program (21 U.S.C. 661
(a)(3) & 454 (a)(3)).
Section 11015 of Title XI of The Food, Conservation, and Energy Act
of 2008 (``the 2008 Farm Bill''), enacted on June 18, 2008, amended the
Acts to establish a new cooperative inspection program under which
certain State-inspected establishments will be eligible to ship meat
and poultry products in interstate commerce (Pub. L. 110-246, 112 Stat.
1651; 21 U.S.C. 683 and 472). The amendments to the Acts provide that
the Secretary of Agriculture (FSIS by delegation), ``in coordination
with the appropriate State agency of the State in which the
establishment is located,'' may select State-inspected establishments
with 25 or fewer employees to ship meat and poultry products in
interstate commerce (21 U.S.C. 683 (b) and 472(b)). Inspection services
for these establishments must be provided by State inspection personnel
that have ``undergone all necessary inspection training and
certification to assist the Secretary with the administration and
enforcement of [the Acts]'' (21 U.S.C. 683(a)(2) and 472(a)(2)). Meat
and poultry products inspected and passed by the State inspection
personnel would bear a ``Federal mark, stamp, tag, or label of
inspection'' and would be permitted to be shipped in interstate
commerce (21 U.S.C. 683(b)(1) and 472(b)(1)).
The law provides for the Secretary to ``designate an employee of
the Federal government'' to ``provide oversight and enforcement'' of
the program (21 U.S.C. 683(d)(1) and 472 (d)(1)). If the Federal
employee finds that an establishment selected for the program is in
violation of the Acts, he or she is required to ``deselect the selected
establishment or suspend inspection at the selected establishment'' (21
U.S.C. 683(d)(3)(c) and 472(d)(3)(c)). The law requires that any
selected establishment that FSIS ``determines to be in violation of any
requirement of the Act, be transitioned to be a Federal establishment''
(21 U.S.C. 683(h) and 472(g)).
The law provides that FSIS is to reimburse a State for costs
related to the inspection of establishments in the State selected for
the program ``in an amount of not less than 60 percent of eligible
State costs'' (21 U.S.C. 683(c) and 472(c)). The law also states that
FSIS ``may provide grants to appropriate State agencies to assist the
appropriate State agencies in helping establishments covered by this
Act to transition to selected establishments'' (21 U.S.C. 683(g) and
472(f)). The law is to take effect ``on the date on which the
Secretary, after providing a period of public comment (including
through the conduct of public meetings or hearings), promulgates final
regulations to carry out [section 11015]'' (21 U.S.C. 683 (j)(1) and
472((i)(1)).
Proposed rule. On September 16, 2009, FSIS published proposed
regulations to implement the new cooperative interstate shipment
program (``Cooperative Inspection Programs: Interstate Shipment of Meat
and Poultry Products,'' 74 FR 47648).
FSIS held two public meetings by teleconference on October 27,
2009, and November 4, 2009, to solicit comments on the proposed
regulations (74 FR 54493). The comment period for the proposed rule was
scheduled to close on November 16, 2009, but, in response to comments,
was extended to December 16, 2009.
In developing this final rule, FSIS considered all comments
submitted in response to the September 2009 proposed rule, as well as
those provided at the two teleconferences held in October and November
2009. Based on its analysis of the issues, and on information provided
by the comments, FSIS made certain changes to the proposed regulations.
Those changes are summarized below and are discussed in detail in the
Agency's responses to comments.
For a more detailed discussion of section 11015 of the 2008 Farm
Bill and FSIS's proposed implementing regulations, refer to the
September 16, 2009, proposed rule.
[[Page 24715]]
II. Summary of Amendments to the Proposed Rule To Implement the
Cooperative Interstate Shipment Program
In this rulemaking, FSIS is finalizing, with some changes, the
provisions in the September 2009 proposed rule. Specifically, the
Agency is amending the proposal to:
Revise the standards for determining an establishment's
average number of employees for purposes of the cooperative interstate
shipment program to exclude employees whose duties do not involve
handling the meat or poultry products produced by the establishment (9
CFR 332.3(b)(1) and (2) and 9 CFR 318.513(b)(1) and (2));
Revise the standards for determining the average number of
employees for purposes of the cooperative interstate shipment program
to include uncompensated volunteers who are involved in handling the
meat or poultry products produced by the establishment (9 CFR
332.3(b)(6) and 381.515(b)(6));
Allow States that have existing cooperative agreements for
a State MPI program to submit a request to enter into an agreement with
FSIS for a cooperative interstate shipment program before the States
have identified establishments to recommend for the cooperative
interstate shipment program (9 CFR 332.4(b)(1) and 381.514(b)(1));
Identify factors that will be considered to determine the
frequency with which the FSIS selected establishment coordinator (SEC)
will visit selected establishments under his or her jurisdiction (9 CFR
332.7(a) and 381.517(a));
Give establishments that were deselected from the
cooperative interstate shipment program because they are located in a
State whose agreement for the program was terminated the option to
either revert back to operating under the cooperative State MPI program
or obtain a Federal grant of inspection (9 CFR 332.11(a) and
381.521(a));
Allow establishments that were deselected from the
cooperative interstate shipment and successfully transitioned to become
Federal establishments to revert back to the State MPI program after
successfully operating as a Federal establishment for a year (9 CFR
332.11(b) and 381.521(b));
Allow establishments selected to participate in the
cooperative interstate shipment program to operate under both the State
MPI program for the State where the establishment is located and the
new cooperative interstate shipment program. State-inspected
establishments that operate under both programs must maintain an
appropriate separation of time or space between operations (9 CFR
332.13 and 381.523);
Allow selected establishments that are in full compliance
with the requirements of the cooperative interstate shipment program to
voluntarily end their participation in the program and revert back to
the State MPI program (9 CFR 332.14 and 381.514);
Codify the definition of ``eligible State costs'' to
include those costs that a State has justified and FSIS has approved as
necessary for the State to provide inspection services to selected
establishments in the State (9 CFR 321.3(b) and 381.187(b)).
III. Comments and Responses
FSIS received approximately 90 separate comment letters in response
to the September 2009 proposed regulations and approximately 5000
identical comment letters submitted by a consumer advocacy organization
on behalf of private citizens. Comments submitted by consumer advocacy
organizations, private citizens, State farm bureaus, trade associations
representing meat processors, and a labor union representing food and
commercial workers expressed general support for the proposed
regulations. Comments submitted by an association of State meat and
food inspection directors, an association of State Departments of
Agriculture, several State Departments of Agriculture and other State
agencies, farm and agriculture advocacy organizations, Congress members
providing comments on behalf of the State of Wisconsin, and private
citizens expressed support for the concept of a cooperative interstate
shipment program but objected to several provisions in FSIS's proposed
implementing regulations. Other comments submitted by FSIS inspection
personnel, small federally-inspected establishments, and one consumer
advocacy organization opposed any program that would permit State-
inspected meat and poultry products in interstate commerce.
Following is a discussion of these comments and FSIS's responses.
A. Development of the proposed rule
Comment: Several comments criticized FSIS for not consulting with
State officials during the development of the proposed regulations. The
comments stated that several States and organizations of State
officials had offered to form an advisory committee to assist FSIS in
developing the proposed regulations to implement the cooperative
interstate shipment program. As noted by the comments, FSIS determined
that such a request was not practical due to the regulatory constraints
and the statutory time-line for implementing this program. The comments
encouraged FSIS to work closely with State inspection officials to
develop final regulations to make the program as workable as possible.
One comment said that creating an environment where state regulators
and federal regulators work together consistently will provide the
stability the program needs to be successful for all involved.
Some comments suggested that FSIS use this rulemaking as an
opportunity to encourage more State involvement in addressing the
nation's food safety problem. The comments encouraged FSIS to accord
considerable weight to comments submitted by States with exemplary food
safety inspection histories and State-inspected establishments that
likewise have exemplary histories when the Agency finalizes the
proposed rule.
Response: FSIS appreciates the States' willingness to participate
in the development and implementation of the new cooperative interstate
shipment program. In developing this final rule, FSIS carefully
considered the comments and suggestions submitted by the States and, as
a result, the Agency made certain revisions to the proposed
regulations. FSIS will work closely with the States as the Agency moves
forward to implement the cooperative interstate shipment program
established in this final rule.
Comment: A few comments stated that the teleconference format for
the two public meetings that were held in October and November of 2009
was not an appropriate way to generate comments on the proposed
cooperative interstate shipment program. One comment noted that there
were few comments presented during the teleconferences, which the
commenter believed may be related to the format of the public meeting.
One comment said that both teleconferences occurred on the same dates
and times when FSIS was offering webinars for small and very small
plant operators, which presented a conflict for those interested in
participating in both meetings. Another comment complained that,
although the commenter had registered for the teleconference and has a
confirmation passcode to participate, the commenter was not allowed to
speak during the meeting.
Response: FSIS chose the teleconference format for the public
meetings to provide individuals with
[[Page 24716]]
easier access to the meeting, particularly those who may lack the
resources or time to attend a meeting in person. FSIS will consider the
comments submitted on this issue to determine how it can improve its
use of the teleconference format to conduct public meetings in the
future.
B. General Support for and General Opposition to the Proposed Rule
1. Support for the Proposed Regulations
Comment: Comments submitted by consumer advocacy organizations,
private citizens, State farm bureaus, trade associations representing
meat processors, and a labor union representing food and commercial
workers expressed general support for FSIS's proposed regulations to
implement the cooperative interstate shipment program. Some of these
comments said that the language in Section 11015 of the 2008 Farm Bill
reflects an agreement reached through negotiations between various
national consumer organizations, the National Association of State
Departments of Agriculture, the National Farmers Union, the American
Federation of Government Employees, and the United Food and Commercial
Workers Union. According to these comments, the language in section
11015 was carefully crafted to meet the desire of some State-inspected
meat plants to enlarge their area of sales while assuring that all meat
and poultry sold across state lines meet federal inspection standards.
The comments commended FSIS for writing proposed regulations that
closely adhere to both the intent and specific language of the
legislation.
One comment noted that the program established in the proposed
regulations builds on existing State inspection programs and includes
important enhancements that can lead to stronger State inspection
programs. The comment approved of the fact that, like the statute, the
proposed regulations would not permit ``regulatory forum shopping.''
Response: FSIS agrees that the proposed regulations are consistent
with both the intent and language of the enabling legislation. The
Agency also agrees that the program established in the proposed
regulations will complement the existing State inspection programs.
2. Support Interstate Shipment but not the Program Proposed by FSIS
Comment: Comments submitted by an organization of State Agriculture
Departments, an organization of State meat inspection program
Directors, several State Departments of Agriculture, State agencies,
farm and agriculture advocacy organizations, and private citizens
expressed support for the concept of a cooperative interstate shipment
program but had concerns about FSIS's proposed regulations to implement
the program. Many of these comments stated that, instead of allowing
for the interstate shipment of state inspected products, FSIS's
proposed regulations essentially set up another Federal inspection
system under more stringent and inflexible provisions than the current
Federal system. According to the comments, FSIS's proposed program
fails to remove unnecessary barriers for small establishments to sell
their specialty products across State lines. The comments asserted that
the proposed regulations will create a regulatory system that is too
burdensome for either establishments or State inspection programs,
which likely means that few will take advantage of the program.
To support these assertions, the comments noted that, when FSIS
issued the proposed rule, the Agency estimated that approximately 60%
(16 of 27) of the States with existing State MPI programs and
approximately 200-600 establishments were interested in participating
in the new cooperative interstate shipment program. The comments stated
that after FSIS issued the proposed rule, an internal poll conducted by
an organization of State official indicates that only 2 of these 27
States, each with only a handful of establishments, now find the
cooperative interstate shipment proposed by FSIS to be even potentially
viable. According to the comments, without a drastic revision of the
proposed regulations and active FSIS participation in cooperation with
the State partners, the program is unlikely to succeed.
Response: After careful consideration of all comments submitted in
response to the 2009 proposed rule, FSIS modified the proposed
regulations to provide some added flexibility for establishments
selected to participate in the cooperative interstate shipment program.
For example, under this final rule, selected establishments that are in
full compliance with the program will be permitted to voluntarily end
their participation in the program. This final rule will also permit
selected establishments to operate under both the cooperative
interstate shipment program and the State's MPI program if they
maintain an appropriate separation of time or space between operations.
The Agency believes that these modifications, which are discussed in
more detail in the Agency's response to comments, will provide
additional incentive for some establishments to participate in the
program.
3. Oppose any Program That Would Allow Interstate Shipment of State-
Inspected Product
Comment: Comments submitted by FSIS inspection personnel, small
federally-inspected meat and poultry processing establishments, and a
consumer advocacy organization objected to any program that would
permit state-inspected meat and poultry products to be shipped in
interstate commerce. According to many of these comments, meat and
poultry products produced in State-inspected establishments do not
undergo the same level of inspection as products produced in Federal-
inspected facilities, and many State MPI programs are not truly ``at
least equal to'' the Federal inspection program. A few comments
referenced a 2006 Office of Inspector General Audit Report of State-
inspected meat and poultry programs that the comments said found that
some State-inspected facilities had failed to operate in a sanitary
manner and that FSIS had not provided consistent oversight of existing
State MPI programs.
Response: As required by law, the cooperative interstate shipment
program established under this final rule will operate under the same
standards imposed under the Federal inspection program. Thus, meat and
poultry products produced in State-inspected establishments selected
for the cooperative interstate shipment program will undergo the same
level of inspection as products produced in federally-inspected
facilities.
With respect to the comment that many State MPI programs are not
truly ``equal to'' the Federal inspection program, each year the FSIS
OPEER Federal State Audit Branch reviews the State cooperative MPI
programs and their requirements to verify that each State program ``at
least equal to'' the Federal program. These comprehensive reviews
consist of an annual review of the State MPI program's self assessment
submission and an on-site review to verify the State's self-assessment
submission. The onsite reviews are scheduled at a minimum, once every
three years.
Based on the self assessment documents received during FY 2009,
FSIS determined that all of the 27 State MPI programs provided adequate
documentation to support that they have implemented and can maintain
MPI programs ``at least equal to'' the Federal program. FSIS determined
that
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all of the 11 State MPI programs reviewed on-site were enforcing
requirements ``at least equal to'' those imposed under the Federal
Acts.
In its 2006 audit of the FSIS's cooperative State MPI programs, the
OIG provided recommendations to strengthen FSIS's review of these
programs. FSIS provided management decisions in response to the 2006
OIG audit recommendations, which were accepted by OIG. The Agency has
implemented the 2006 management decisions.
Comment: One comment stated that State-inspected establishments
should not be allowed to ship products interstate because the States do
not have the money or staff to provide the inspection that the Federal
government does. Another comment maintained that Federal inspectors
undergo more extensive training than State inspection personnel and,
therefore, unlike State inspectors, are continuously expanding their
knowledge bases.
Response: As discussed in greater detail below, to qualify for the
cooperative interstate shipment program, States with cooperative State
MPI programs will need to demonstrate that they have staffing
sufficient to conduct the same inspection activities in establishments
operating under the cooperative interstate shipment program that FSIS
conducts in official Federal establishments. The States will also need
to demonstrate that the designated State personnel have been properly
trained in Federal inspection methodology. FSIS will not enter into an
agreement for a cooperative interstate shipment program with States
that are unable to meet these conditions.
Comment: One comment submitted by a consumer advocacy organization
said that while the commenter does not support State-inspected meat and
poultry for either intrastate or interstate commerce, it understands
that Congress amended the FMIA and PPIA to establish the cooperative
interstate shipment program, and that FSIS is required to develop
regulations to implement the law. The comment urged the Agency to put
into place a system whereby establishments that participate in the
program are held to the identical Federal standards and practices as
those establishments under Federal inspection and that the Agency
maintain strict oversight of such a program.
Response: The cooperative interstate shipment program established
in these final regulations will be a State inspection program under
which designated State-personnel enforce Federal food safety standards.
As required by law, FSIS will provide oversight and enforcement of the
program.
Comment: Several comments submitted by FSIS inspection personnel
and small federally-inspected meat and poultry processors maintained
that instead of establishing cooperative interstate shipment program,
FSIS should require that State-inspected establishments that desire to
ship their meat and poultry products in interstate commerce come under
Federal inspection.
One comment submitted by a small federally-inspected establishment
explained that as a small company, it decided to obtain a Federal grant
of inspection as an investment for the future of its business. The
comment noted that the establishment did this to allow for interstate
sales of its products and that the same option is available today for
any company willing to make a similar investment. The comment asserted
that to provide for a level playing field, all small companies that
want to sell their products across state lines should be required to go
through the same process and obtain a Federal grant of inspection.
Response: Section 11015 of the 2008 Farm Bill amended the FMIA and
PPIA to establish the cooperative interstate shipment program. The
amendments require that FSIS issue final regulations to implement the
new program. Once the new program becomes effective, small State-
inspected establishments that are interested in selling meat or poultry
products across State lines will have the option to operate as a
selected establishment under the cooperative interstate shipment
program or as an official Federal establishment. An establishment that
ships products across States lines must comply with all Federal
standards regardless of the inspection program that it chooses to
operate under.
Comment: One comment said that the cooperative interstate shipment
program is not necessary because the Talmadge/Aiken program serves the
same purpose.
Response: The Talmadge-Aiken program and the cooperative interstate
shipment program serve different purposes. Under the Talmadge-Aiken
program, FSIS enters into a separate agreement with a State agency for
the State program to conduct meat, poultry, or egg products inspection
or other regulatory activities on behalf of FSIS. Establishments that
participate in the Talmadge-Aiken program operate under a Federal grant
of inspection. Under the cooperative interstate shipment program, FSIS
enters into a separate agreement with a State agency to enforce Federal
food safety standards at State-inspected establishments. Establishments
that participate in the cooperative interstate shipment program are not
Federal establishments operating under a Federal grant of inspection.
Comment: Comments submitted by a few FSIS inspection personnel
opposed the proposed cooperative interstate shipment stated because the
commenters believe that the program will result in a reduction in the
Federal inspection force. The comments stated that under such a
program, small federally-inspected establishments will want to drop
their Federal grant of inspection and produce products under State-
inspection, thereby taking jobs that would otherwise belong to Federal
employees and giving them to State employees.
Response: Under the law and implementing regulations,
establishments that operate under the Federal inspection program are
ineligible to participate in the cooperative interstate shipment
program. The new program is limited to certain small and very small
State-inspected establishments. Thus, the cooperative interstate
shipment program will have little effect on Federal inspection
personnel.
Comment: One comment objected to allowing the interstate shipment
of state-inspected products because, according to the comment, FSIS
will no longer have control or jurisdiction over some meat and poultry
products in interstate commerce. The comment noted that a State's
jurisdiction is limited to the State's borders. The comment asked what
would happen if product produced by a State-inspected establishment is
implicated in a food safety issue resulting in a recall.
Response: Under the law, FSIS is responsible for providing
oversight and enforcement of the cooperative interstate shipment
program. Therefore, if an establishment operating under the cooperative
interstate shipment program distributes meat or poultry products that
present a food safety hazard or that need to be recalled for other
reasons, FSIS will coordinate with the State MPI program to ensure that
such product is removed from commerce. FSIS will be responsible for the
overall coordination of the recall and for verifying that recalled
product that has been shipped interstate has been removed from
commerce.
C. Establishment Participation--Conditions for Eligibility and
Standards for Determining Average Number of Employees
The proposed rule prescribed conditions that State-inspected
[[Page 24718]]
establishments would be required to meet to become eligible to
participate in the cooperative interstate shipment program. Consistent
with the law, among these proposed conditions were that an
establishment be in compliance with all Federal inspection requirements
under the FMIA, PPIA, and their implementing regulations, and that the
establishment employ, on average, no more than 25 individuals. The
proposed rule also included proposed standards for determining the
average number of employees, which, for the most part, reflect
applicable methods used by the Small Business Administration (SBA) to
calculate the number of employees for a small business concern. FSIS
received several comments on the proposed conditions for establishment
eligibility and the proposed standards for determining the average
number of employees.
1. Compliance With Federal Standards
Comment: Some comments agreed that State-inspected establishments
should be required to comply with Federal standards to be eligible for
the cooperative interstate shipment program. The comments stated that
many small and very small establishments have managed to conform to,
and operate successfully under, the requirements of the Federal
inspection system. Two comments noted that data obtained from FSIS's
PBIS in 2007 show that 51 percent (2,878 of 5,603) of all federally-
inspected establishments have 10 or fewer employees and 80% have 50 or
fewer employees.
The comments also noted that all establishments that prepare or
process meat and poultry products have always had the opportunity to
ship their products in interstate commerce provided that they apply for
and receive a Federal grant of inspection. The comments stated that
small and very small establishments now under Federal inspection have
invested time and money to comply with all Federal regulations and to
operate under Federal standards. The comments asserted that while the
new cooperative interstate shipment program is intended to offer
establishments operating under their State inspection program an
opportunity to broaden their distribution, any establishment that ships
meat or poultry products in interstate commerce can and should meet
Federal food safety standards.
Other comments stated that requiring that State-inspected
establishments comply with Federal food safety standards in order to be
eligible for the cooperative interstate shipment program will establish
unfair barriers for small plants to participate in the program. The
comments urged FSIS to provide small State-inspected establishments
with greater flexibility in achieving food safety standards. One
comment from a small State-inspected establishment stated that it
cannot afford Federal inspection. The comment noted that establishments
operating under the State MPI system are required to adhere to very
strict food safety standards but, unlike the Federal system, State
inspection personnel are also available to help the small and very
small establishments with education and training.
Response: The amendments to the Acts in section 11015 of the 2008
Farm Bill require that State-inspected establishments be in compliance
with all Federal standards in order to be eligible for the cooperative
interstate shipment program. The provisions in the Acts that establish
the cooperative interstate shipment program define an ``eligible
establishment'' as an establishment that is in compliance with both ``*
* * the State inspection program of the State in which the
establishment is located'' and ``[the FMIA or PPIA], including the
rules and regulations issued under [the FMIA or PPIA]'' (21 U.S.C.
472(a)(3) and 683(a)(3)).
The Senate Conference Committee report on the bill that established
the cooperative interstate shipment program also makes clear that
establishments selected for the program ``* * * must fully follow [the
FMIA or PPIA], its regulations, notices, directives and policies just
as would be required of a Federal establishment'' (S. Rep. No. 220,
110th Cong., 1st Sess. (2007), pp. 211-214). Thus, requiring that
State-inspected establishments comply with Federal food safety
standards to become eligible to participate in the cooperative
interstate shipment program is consistent with both the language and
intent of section 11015 of the 2008 Farm Bill.
FSIS's Office of Outreach, Employee Education, and Training (OOEET)
will provide technical resources, information, and guidance to small
and very-small State establishments that are interested in becoming
eligible to participate in the cooperative interstate shipment program.
2. Determining Average Number of Employees
a. Proposed standard: All individuals, both supervisory and non-
supervisory, employed by the establishment on a full-time, part-time,
or temporary basis are to be counted when calculating the total number
of employees.
Comment: Several comments stated that for purposes of the
cooperative interstate shipment program, an establishment's average
number of employees should be based only on those directly involved in
the preparation or processing of meat and poultry products. The
comments noted that many small and very small establishments conduct
operations other than the processing of meat or poultry products, such
as grocery stores, convenience stores, or other retail outlets.
According to the comments, employees that do not perform duties related
to the meat or poultry processing operations of the business should not
be included when calculating the average number of employees.
One comment suggested that FSIS consider basing the ``value''
associated with the employee on the workers compensation code that the
employer designates. The commenter said that it could give FSIS a
simple way of determining which workers are associated with the meat
processing part of the business and which employees offer other roles
for the company, such as administrative workers or retail clerks.
Other comments said that all establishment personnel, including
those not involved in the actual production of meat and poultry
products, should be counted when calculating the average number of
employees. One comment noted that the law specifically states that
supervisory and nonsupervisory employees are to be counted when
calculating the average number of employees. The comment maintained
that this indicates that if Congress had intended to exclude certain
employees from the calculation, it would have expressly stated so in
the law. The comment urged FSIS to require that temporary and part-time
employees, regardless of their position in the establishment, be
counted when determining the average number of employees.
Response: Although the law limits participation in the cooperative
interstate shipment program to State-inspected establishments that
employ, on average, 25 or fewer employees, it does not distinguish
between employees involved in an establishment's meat or poultry
processing operations from those that are not. Counting all individuals
employed by the establishment would ensure that participation in the
cooperative interstate shipment program is limited to very small and
certain small establishments. Counting only
[[Page 24719]]
employees directly involved in the preparation or processing of meat
and poultry products would create a more flexible standard that would
expand the number of potentially eligible establishments to include
those that have a small number of employees that work in meat or
poultry processing but a larger number of employees that work in other
areas of their business.
The 2008 amendments to the Acts give FSIS the authority to define
``average number of employees'' for purposes of the cooperative
interstate shipment program, but they also make clear that the program
is intended for State-inspected establishments that employ a limited
number of individuals. Therefore, FSIS is adopting a standard for
calculating the average number of employees that provides some
flexibility for establishments that conduct operations other than meat
or poultry processing, but that also clearly distinguishes those
employees that are to be counted for purposes of the interstate
shipment program from those that are not.
Therefore, instead of counting all individuals employed by the
establishment as proposed, under this final rule, an establishment's
average number of employees will be calculated by counting all
individuals employed by the establishment, excluding the employees that
do not come into contact with the meat or poultry products produced by
the establishment. For example, if the owner of a gas station produces
beef jerky and sells it at the gas station, the employees that are
involved in producing the jerky, as well as those that work as cashiers
and sell the product, will be counted. The mechanics that work on the
cars, however, will not be. Employees that perform solely
administrative functions and that do not handle meat or poultry
products will also not be counted.
When an establishment conducts multiple operations, it is sometimes
difficult to distinguish employees associated with the meat or poultry
operations from those that are not. For example, an individual employed
as a cashier at an establishment's deli operations may also slice and
package meat or poultry products produced by the establishment. The
standard adopted in this final rule clearly distinguishes employees
whose duties are associated with the meat or poultry products produced
by an establishment from those that are not. It also ensures that the
cooperative interstate shipment program will remain limited to certain
small and very small establishments, as intended.
b. Proposed standard: Part-time and temporary employees are to be
counted the same as full-time employees.
Comment: Several comments, most submitted by consumer advocacy
organizations and one submitted by a food and commercial workers union,
agreed with the proposed standard to count part-time and temporary
workers as full-time workers for purposes of qualifying for the
cooperative interstate shipment program. The comments noted that most
very small establishments have few full-time employees, and many do not
operate every day. The comments maintained that counting part-time and
temporary employees the same as full time employees is an effective
means to assure the cooperative interstate shipment program serves the
entities it was intended to serve. According to the comment, failing to
count part-time and temporary employees in the average number of
employees would permit substantially larger entities to participate in
a program that was designed to serve very small local establishments.
Some of these comments noted that during negotiations with the
States, consumer advocacy groups reluctantly agreed to the States'
request for a program with a 25 employee limit. According to the
comment, none of the groups involved in the negotiations ever agreed to
anything larger than 25 employees. The comments said that the primary
reason that many consumer advocacy organizations had opposed the House
interstate shipment bill was because the bill contained a 50 employee
limit, which, according to the comment, would have expanded the number
of establishments in the new cooperative program far beyond what was
intended. One comment stated that, although the program's 25 employee
limit is reasonable, the commenter would have preferred a limit of 10
employees, which is similar to the current FSIS definition for very
small establishments.
Several other comments, most submitted by State Departments of
Agriculture and other State agencies, disagreed with the proposed
standard to count part-time and temporary workers as full time
employees. The comments stated that such a standard seems excessive and
does not provide an accurate depiction of an establishment's actual
number of employees.
The comments noted that many small establishments in small towns
hire part-time employees who work as little as a few hours a week.
According to the comments, to count such employees as full-time would
contradict and undercut the rural development intentions of the
enabling legislation. One comment stated that in some rural areas,
especially those with small and very small establishments, meat
processing has a seasonal component that provides part-time seasonal
work for rural residents. The comments noted that during each part of
the day, an establishment may have only 25 employees on site, even if
the total number of part-time and fulltime employees employed overall
during the day exceeds 25.
The comments suggested that part-time and temporary workers be
counted on the basis of ``full-time equivalents'' or ``FTEs,'' i.e.,
based on the ratio of their work-hours to those of a full-time year-
round employee. The comments said that part-time and temporary
employees should be grouped together and counted based on the number of
hours they work each week during the year, with 40 hours per week being
considered an FTE. Several comments suggested formulas for calculating
the number of employees based on FTEs.
Response: After considering the comments, FSIS has decided to adopt
the proposed standard to count temporary and part time employees the
same as full-time employees. For purposes of its regulatory programs,
FSIS defines small and very small establishments based on SBA criteria.
A standard that counts part-time and temporary workers the same as
full-time workers reflects the SBA methods for calculating the average
number of employees for a small business concern and is thus consistent
with FSIS's overall approach for defining small and very small
establishments.\1\
---------------------------------------------------------------------------
\1\ See 13 CFR 121.105 and 121.106 for SBA methods to calculate
the number of employees of a business concern where the size
standard in number of employees.
---------------------------------------------------------------------------
As noted by the comments, several very small establishments have
few full-time employees, and many do not operate every day. A standard
that is based on the SBA criteria that counts part-time and temporary
employees the same as full time employees allows these establishments
to hire seasonal workers while ensuring that only very small and
certain small establishments are eligible to participate in the
program.
Comment: Several comments stated that the standards for determining
the average number of employees need to allow for more flexibility in
counting temporary seasonal workers. The comments noted that small and
very small establishments often have fluctuation in their employees
during certain parts of the year, such as during
[[Page 24720]]
holiday and hunting seasons, and that the term ``seasonal'' will have
different meanings in different areas of the country. Some comments
noted some establishments hire extra employees to help with seasonal
activities that are not related to the processing of amenable species,
such as processing game meat or for busy times in their retail shops
around holidays.
The comments suggested that seasonal employees be counted based on
FTE. As an example, the comments explained that a seasonal employee who
works full-time for 3 months would be a 25% FTE and should be counted
as one quarter of an employee.
One comment asserted that seasonal employees should not be counted
at all when calculating the average number of employees. The comment
suggested that the final rule define a seasonal employee as an employee
that works for the establishment ninety or fewer days in a calendar
year.
Response: When Congress amended the FMIA and PPIA to establish the
cooperative interstate shipment program, it intended for FSIS to
interpret the term average ``[hellip]to provide some flexibility to
these selected plants that require seasonal employees for certain parts
of the year, as long as the increase in employees are [sic] manageable
by the establishment and the increase in employees does not undermine
food safety standards'' (S. Rep. No. 220, 110th Cong., 1st Sess., pp.
211-214 (2007)).
As discussed below, under the proposed rule, selected
establishments may temporarily employ more than 25 employees during
busy seasons, as long as the average number of employees continues to
be 25 and the number of employees does not exceed 35. Thus, a standard
that counts temporary seasonal employees the same as full-time
employees will allow selected establishments to hire seasonal employees
while ensuring that the number of employees remains manageable by the
establishment, as Congress intended.
FSIS disagrees with the comment that stated that seasonal employees
should not be counted at all. Such an approach would be inconsistent
with the language and intent of the statute.
c. Proposed standard: The total number of employees cannot exceed
35 at any given time, regardless of the average number of employees.
Comment: Some comments stated that the proposed standard that
provides that the total number of employees can never exceed 35
individuals at any given time, regardless of the average number of
employees, is a reasonable upper limit for selected establishments to
remain eligible to participate in the program. One comment stated that
such a limit is reasonable if FSIS does not count part-time and
temporary employees the same as full time.
Other comments asserted that FSIS should not limit the number of
employees working at a selected establishment at any given time if the
establishment maintains an average of 25 employees or fewer. The
comments stated that while section 11015 of the 2008 Farm Bill requires
that the average number of employees not exceed 25, the law does not
prohibit a selected establishment from ever, over the course of a year,
having more than 35 employees.
The comments stated that in many small establishments there may be
``spikes'' in employee numbers during busy periods, but the overall
average number of employees is under 25. The comments asserted that, as
written, the proposed rule excludes such establishments from
participating in the interstate shipment program. According to the
comments, section 11015 was not intended to exclude these
establishments. The comments suggested that FSIS revise the proposed
rule to ensure that these establishments remain eligible for the
program.
One comment disagreed with the proposed 35 employees limit because,
according to the comment, allowing selected establishment to have 35
employees during seasonal shifts represents, at minimum, a 40% increase
in establishment personnel. The comment argued that the higher number
of employees represents a huge increase in production that could
overwhelm a very small establishment's production systems, which could
result in contaminated food entering commerce. The comment noted that
if an establishment routinely employs 5 people and then increases this
number to 10 or 20 during a certain timeframe, it will have a 100% or
400% increase in employees. The comment maintained that this level of
increase is not manageable and is not what Congress intended.
The comment suggested that instead of limiting the total number of
employees to 35 at any given time, FSIS should cap at 20% the increase
in the number of employees that an establishment may use during a
seasonal shift. The comment acknowledged that the commenter does not
have data to support this number, but stated that it stands to reason
that a sudden increase in production could significantly affect the
dynamics within an establishment and overwhelm the system. According to
the comment, small and very small establishments have HACCP plans for a
production process at a certain level that would not necessarily
support a significantly higher level of production. The comment pointed
out that FSIS did not provide any data to support the proposed 35
employee cap.
One comment stated that FSIS should not allow more than 25
employees in selected establishments at any given time. The comment
noted that section 11015 requires that establishments that consistently
employ more than 25 employees but fewer than 35 employees transition to
Federal establishments within three years of the enactment date. The
comment stated that this provision indicates that Congress recognized
that establishments that ship product in interstate commerce and that
have more than 25 employees should be under Federal inspection.
Response: While the 2008 amendments to the Acts do not specifically
prohibit selected establishments from ever having more than 35
employees, the Senate report described above indicates that Congress
intended that there be some limits on the number of employees working
at a selected establishment at any given time.
As explained in the preamble to the proposed rule, FSIS proposed
that the number of employees working in a selected establishment never
exceed 35 at any given time because the law allows FSIS to select for
the cooperative interstate shipment program establishments that
employed more than 25 but fewer than 35 employees as of June 18, 2008,
the date the law was enacted (21 U.S.C. 683(b)(3)(B) and 472(b)(3)(B)).
To remain in the program, these establishments must employ fewer than
25 employees on average 3 years after the effective date of this final
rule. Thus, while Congress did not intend to ``* * * routinely allow
selected establishments to employ above 25 or more employees,'' the
fact that the law provides for some selected establishments to
initially employ up to 35 individuals demonstrates that a temporary
increase in the number of employees of up to 35 individuals, as long as
the average number of employees remains 25 or fewer, is consistent with
the language and intent of the Acts.
As noted above, when Congress established the cooperative
interstate shipment program, it intended to provide some flexibility to
establishments that require seasonal employees to meet consumer demands
for certain parts of the year. The 20%
[[Page 24721]]
cap on the increase in the number of employees suggested by one of the
comments would greatly restrict the number of temporary workers that a
selected establishment would be allowed to hire during busy seasons.
For example, an establishment that regularly employs five employees on
average would be permitted to hire only one temporary employee during
its busy seasons. Many small and very small establishments operate on
an intermittent or seasonal basis and are accustomed to adjusting their
operations to temporarily increase production without undermining food
safety standards. FSIS has concluded that restricting the increase in
employees to 20% is unlikely to provide the flexibility that many very
small selected establishments will need to meet seasonal demands for
their products.
d. Proposed standards: Volunteers who receive no compensation are
not considered employees.
Comment: One comment disagreed with the proposed standard that
provides that volunteers are not considered employees. The comment
stated as a food safety measure, uncompensated volunteers who are
engaged in meat or poultry product processing should be considered
employees for the purpose of the cooperative interstate shipment
program.
Response: FSIS agrees with this comment and has revised the
standards for counting employees to include as employees, volunteers
that perform duties that involve handling the meat or poultry products
produced by the establishment.
D. State Participation: ``The Same as'' Standard for Inspection
Services Provided to Selected Establishments
The proposed regulations provide that States interested in
establishing an agreement for a cooperative interstate shipment program
are required to submit a request for such an agreement to FSIS through
the FSIS district office that covers the State. The proposed rule also
provided that, in their requests, States are required to include
documentation to demonstrate that they are able to provide the
necessary inspection services to selected establishments in the State
and conduct any related activities that would be required under a
cooperative interstate shipment program. The preamble to the proposed
rule explained that to meet this requirement, the statute requires that
States demonstrate that the inspection service that they provide to
selected establishments in the State will be ``the same as,'' rather
than ``at least equal to'' those provided under the Federal inspection
program. FSIS received a significant number of comments on the proposed
``same as'' standard.
1. Support for ``the same as'' Standard
Comments submitted by consumer advocacy organizations, meat
processor trade associations whose members mainly operate under the
Federal inspection system, a union representing food and commercial
workers, two pork producer trade associations, and some private
citizens expressed support for the proposed ``same as'' standard.
Comment: The comments that supported the proposed ``same as''
standard agreed that the language and intent of the enabling statute
require that the cooperative interstate shipment program operate under
standards that are the ``same as'' the Federal inspection system and
not the ``at least equal to'' standard that applies to State MPI
programs. The comments believed that all meat and poultry products
shipped in interstate commerce should be required to comply with
uniform Federal food safety standards rather then multiple State
standards. The comments stated that it is especially important for
State-inspected establishments that participate in the new program to
be in compliance with all Federal standards because the meat and
poultry products produced by these establishments will bear a Federal
mark of inspection.
One comment stated that requiring that selected establishments that
voluntarily request the opportunity to participate in a cooperative
interstate shipment program operate in a manner that is the ``same as''
federally-inspected establishments is not only consistent with the
provisions and intent of the law, but also ensures that the food safety
standards established in the FMIA, PPIA, and their implementing
regulations are applied uniformly to all meat and poultry products that
are distributed in interstate commerce. The comment encouraged FSIS to
retain the proposed ``same as'' standard to first and foremost ensure
the safety of meat and poultry products distributed in interstate
commerce, but also to ensure equity in the marketplace. The comment
added that this fundamental proposition, that the playing field be
level for all companies engaging in interstate commerce, was a critical
element in securing passage of the statutory provisions that authorized
the cooperative interstate shipment program. The comment asserted that
the program must not provide an unfair advantage to small companies
that will not, or cannot, make the commitments necessary to comply with
Federal food safety requirements.
Two comments stated that requiring that State-inspected products
produced under the cooperative interstate shipment program comply with
all Federal requirements is essential for maintaining domestic and
international markets for U.S. meat and poultry products. Other
comments said that consumers expect that products carrying the Federal
mark of inspection comply with Federal standards for meat and poultry
inspection. The comments stated that establishments that are not held
to all aspects of the Federal requirements should not be entitled to
apply the Federal mark of inspection on their products.
One comment that supported the ``same as'' standard noted that
although establishments operating under a State MPI inspection program
receive inspection services that are ``at least equal to'' the Federal
inspection program, the methodology employed by FSIS is a critical part
of the effectiveness of the Federal food safety system. The comment
asserted that, as such, it is essential for States that participate in
the cooperative interstate shipment program to follow Federal
inspection methodology when providing inspection services to selected
establishments.
Response: FSIS agrees that the ``same as'' standard is consistent
with the language and intent of the statutes. The issues raised by the
comments demonstrate why it is important for the cooperative interstate
shipment program to operate under standards that are ``the same as''
those imposed under the Federal meat and poultry products inspection
programs.
2. Opposed to ``same as'' standard
Several comments submitted by State Departments of Agriculture and
other State agencies, as well as organizations representing these
entities, objected to the proposed ``same as'' standard. Some farm and
rural community advocacy organizations, cattle producer organizations,
a trade association representing small meat processors, and an animal
welfare advocacy organization also opposed the proposed standard.
Comment: Several comments that objected to the proposed ``same as''
standard claimed that such a standard is not authorized by law. These
comments asserted that the Acts, as amended by the 2008 Farm Bill, do
not contain any language that would require that the inspection
services that States provide to selected establishments be ``the same
[[Page 24722]]
as'' or ``identical to'' the inspection services provided under the
Federal program. The comments maintained that such an interpretation is
an extrapolation of the language that does not exist in the statute.
The comments noted that under the 2008 Farm Bill amendments, the
term ``eligible establishment'' refers to an establishment that is ``in
compliance with'' the Acts. The comments also noted that these
amendments authorize the SEC to ``ensure that selected establishments
are operating in a manner that is consistent with * * *'' the Acts (21
U.S.C. 472(d)(3)(A), 683(d)(3)(A)). The comments argued that these
provisions indicate that if Congress had intended to require that the
State program be ``the same as'' or ``identical to'' to the Federal
program, it would have specifically said so in the statute.
The comments also noted that the 2008 Farm Bill did not amend the
provisions in the FMIA and PPIA that provide for cooperative State MPI
programs that are ``at least equal'' to the Federal program. According
to the comments, the fact that Congress did not amend these provisions
demonstrates that State programs that are ``at least equal to'' the
Federal program are in compliance with the Acts.
Response: The language in the FMIA and PPIA, as amended by the 2008
Farm Bill, is clear: Congress provided that the cooperative interstate
shipment program would operate under standards that are ``the same as''
those imposed under the Federal program.
The 2008 amendments to the FMIA and PPIA provide that to be
eligible for the cooperative interstate shipment, State-inspected
establishments must be in compliance with both the State's MPI program
and ``* * * the requirements of this chapter, including the rules and
regulations issued under this chapter'' (21 U.S.C. 472(a)(3) and
683(a)(3)). As used in the statutes, the term ``this chapter'' refers
to the FMIA at 21 U.S.C Chapter 12, and the PPIA at 21 U.S.C. Chapter
10. The 2008 amendments also require that the State personnel
designated to provide inspection services under the program undergo ``*
* * all necessary training and certification to assist * * * in the
administration and enforcement of this chapter, including the rules and
regulations issued under this chapter'' (21 U.S.C. 472(a)(2) and
683(a)(2)). The 2008 amendments allow a meat or poultry product
inspected by designated State personnel to bear a Federal mark of
inspection and be shipped in interstate commerce if the product ``* * *
qualifies for the mark * * * under the requirements of this chapter''
(21 U.S.C. 472(b)(1)(A) and 683(b)(1)(A)).
The Senate Conference Committee report on the bill that established
the cooperative interstate shipment program provides that ``* * *
establishments selected for the [cooperative interstate shipment]
program * * * must fully follow [the FMIA or PPIA], its regulations,
notices, directives and policies just as would be required of a Federal
establishment'' (S. Rep. No. 220, 110th Cong., 1st Sess. (2007), pp.
211-214). The report also provides that ``* * * [t]he inspection
personnel of the State that will inspect the selected establishment
must have undergone all the necessary training to carry out the
requirement of [the Acts], [their] regulations, notices directives and
policies, just as required of a Federal inspector.''
Thus, both the statute and the Committee report make clear that
Congress intended for the cooperative interstate shipment program to
operate under standards that are ``the same as'' those imposed under
the Federal inspection program.
FSIS agrees with the comments that stated that the 2008 Farm Bill
did not amend the provisions in the FMIA and PPIA that provide for
cooperative State MPI programs that are ``at least equal'' to the
Federal program. However, FSIS disagrees that this means that State
programs that are ``at least equal to'' the Federal program are in
compliance with all requirements of the Acts for purposes of the
cooperative interstate shipment program. Under the FMIA and PPIA,
establishments operating under an ``at least equal to'' State MPI
program are permitted to produce meat or poultry products solely for
distribution within the State where the establishment is located (21
U.S.C. 454(a)(1) and 661(a)(1)). Thus, State programs that are ``at
least equal to'' the Federal program are in compliance with the Acts
only if the establishments operating under these programs prepare and
ship products solely for use within the State where they are located.
Comment: One comment asked whether the proposed rule requires that
a State's entire MPI program must be ``identical to'' the Federal
program for the State to qualify for the cooperative interstate
shipment program.
Response: No, a State's entire MPI program does not need to be
identical to the Federal program for the State to qualify for the
cooperative interstate shipment program. To qualify for the program, a
State must demonstrate that the inspection services that it will
provide to selected establishments in the State will be ``the same as''
those provided under the Federal inspection program. States that
participate in the cooperative interstate shipment program may continue
to operate an ``at least equal to'' State MPI program for
establishments that produce meat and poultry products solely for
distribution within the State.
Comment: Several comments stated that the interstate shipment
program's legislative history demonstrates that Congress intended for
the program to operate under the ``at least equal'' standard required
for the existing cooperative State MPI programs. According to the
comments, the conference reports for the House and Senate versions of
interstate shipment legislation indicate that Congress adopted the
Senate version of the bill because the House version would have
required that States implement meat and poultry inspection programs
``identical to'' the Federal inspection system. The comments maintained
that the legislative intent was to provide current State facilities
with a viable route to ship State product interstate. The comments said
that the requirement for State plants to be ``identical to'' or ``same
as'' a federal plant radically deviates from this.
Response: The comments are correct in that Congress did adopt the
Senate version of the legislation that established the cooperative
interstate shipment program. However, FSIS disagrees that the Senate
version was adopted to permit State-inspected establishments operating
under an ``at least equal to'' standard to ship meat and poultry
products in interstate commerce.
Section 11103 of the House version of the 2008 Farm Bill would have
amended the FMIA and PPIA to replace the existing ``at least equal to''
cooperative State MPI program with a new program that would have
authorized FSIS to approve, and enter into cooperative agreement with,
only those State MPI programs that adopt standards identical to those
imposed under the Federal program (H. Rep. 110-256, 110th Cong., 1st
Session, pp. 184-191). Under the House version, all State-inspected
establishments would have been required to comply with Federal
standards, the State mark of inspection would have been deemed an
official mark, and all State-inspected establishments would have been
allowed to ship meat or poultry products in interstate commerce.
The Senate bill, which was the version adopted in the 2008 Farm
Bill, supplements, but does not replace, the
[[Page 24723]]
existing State MPI programs. The Senate version provides an option
under which State-inspected establishments that have, on average, 25 or
fewer employees, will be permitted to ship their meat or poultry
products in interstate commerce. Under the Senate version, State-
inspected establishments are required to comply with all Federal
standards to be eligible to participate in the cooperative interstate
shipment program, and designated State personnel must be trained to
enforce Federal food safety standards. Under the Senate version, State-
inspected establishments that choose not to participate in the
cooperative interstate shipment program may continue to operate under
the ``at least equal to'' State MPI program and ship their products
within the States where they are located.
Comment: Some comments claimed that in the past, FSIS itself
concluded that it was unrealistic for States to maintain MPI programs
that are ``the same as'' or ``identical to'' FSIS's program. The
comments noted that in 2003, the Agency provided an option for the
States to claim that their meat and poultry inspection programs were
``same as'' or ``identical to'' FSIS inspection as part of the Agency's
annual review in which it verifies that State MPI programs are ``equal
to'' the Federal program. The comments said that in 2006, FSIS reached
the conclusion that it was logistically impossible for State programs
to maintain a true ``same as'' or ``identical to'' status, so the
Agency removed this option from the State Self Assessment Manual forms.
The comments asserted that if only a few years ago FSIS acknowledged
that it is impossible for State MPI programs to be the ``same as''
Federal programs, proposing such a standard now will effectively
prevent States from qualifying for a cooperative interstate shipment
program.
Response: FSIS has stated that ``at least equal to'' does not
require that States operate their cooperative MPI programs in a manner
that is ``the same as'' or ``identical to'' the FSIS program or does
not prohibit States from establishing safeguards that the States
believe to be more effective than those employed by FSIS. The law does
not require that the cooperative State MPI programs operate under
standards ``identical to'' the Federal program.
As noted above, the cooperative interstate shipment program will
supplement the existing State MPI programs, not replace them. Thus,
while States that participate in the cooperative interstate shipment
program will need to provide the same inspection services to selected
establishments that FSIS provides to federally-inspected
establishments, States may also continue to operate their cooperative
State MPI programs in a manner that is ``at least equal to'' the
Federal program.
Comment: Several comments noted that a foreign country must
demonstrate that its inspection system is ``equivalent'' to the U.S.
inspection system before FSIS will permit establishments located in the
foreign country to import meat and poultry products into the United
States. These comments asserted that requiring that States operate
their cooperative interstate shipment programs under standards that are
the ``same as'' those required under the Federal program subjects the
States to a stricter and less flexible standard than the standard
applied to foreign countries. One comment maintained that while the
commenter does not support the equivalent standard for foreign
facilities, there is no justification for discriminating against
domestic establishments under the jurisdiction of State inspection
programs by requiring that they meet more rigid standards than those
imposed on foreign establishments.
Response: The equivalence standard applied to imported meat and
poultry products and the ``same as'' standard applied to meat and
poultry products produced under the cooperative interstate shipment
program reflect the relevant provision in the FMIA and PPIA. The FMIA
and PPIA require that FSIS treat as equivalent to a U.S. requirement
alternative measures proposed by an exporting country if the country
provides scientific evidence or other information, in accordance with
risk assessment methodologies agreed to by FSIS and the exporting
country, to demonstrate that the alternative measure achieves the level
of protection that is appropriate for the United States (21 U.S.C.
620(e)(1)(B), 466(d)(2)(A)). These provisions reflect the U.S.
Government's obligation under the World Trade Organization (WTO)
Agreement on the Application of Sanitary and Phytosanitary Measures
(the SPS Agreement) to accept the sanitary measures of an exporting
Member country as equivalent if the exporting member demonstrates that
its sanitary measures attain the same level of protection (Article 4.1,
``Agreement on the Application of Sanitary and Phytosanitary Measures).
FSIS evaluates foreign food regulatory systems for equivalence through
document reviews, on-site audits, and port-of-entry reinspection of
products at the time of importation (9 CFR part 327 and 381 subpart T).
Comment: Several comments asserted that it is unnecessary to
require that the inspection services that States provide to selected
establishments be the ``same as'' inspection services provided under
the Federal program because most States have incorporated the Federal
requirements into their State MPI programs. The comments stated that,
according to FSIS's 2008 report on its review of the State MPI
programs, these State programs have demonstrated that they can
implement the Federal laws and regulations in a manner that is ``at
least equal to,'' and thus, ``in compliance with'' the Federal
standards without operating under a program that is ``the same as'' the
Federal inspection program because of the smaller staff size and other
administrative aspects of the State programs.
Response: As noted throughout this document, the 2008 amendments to
the Acts require that the inspection services that States provide to
selected establishments be ``the same as'' those provided under the
Federal inspection program. The Senate report also makes clear that
State inspection personnel are ``* * * to carry out the Federal
requirements of the [the Acts], [their] regulations, notices directives
and policies, just as required of a Federal inspector'' (S. Rep. No.
110-220, 110th Cong., 1st Sess. (2007), pp 211-214). Thus, FSIS
disagrees that State programs that have implemented the Federal laws
and regulations in a manner that is ``at least equal to'' the Federal
inspection program are ``in compliance with'' the Federal standard for
purposes of the cooperative interstate shipment program. The law
clearly requires that the inspection services that designated State
personnel provide to selected establishments in States participating in
the cooperative interstate shipment program be ``the same as'' those
provided under the Federal program.
Comment: Several comments claimed that under the ``at least equal
to'' standard, some States have implemented requirements for food
safety and consumer protection that are stricter than those provided
for under the Federal Acts. According to these comments, many States
have processes for the review and evaluation of product labels that do
more than FSIS's generic label process to ensure that the labels of
meat and poultry products properly inform consumers about the product,
its weight and its ingredients. The comments also noted that while FSIS
currently does not have the authority to levy civil penalties for
violations of the
[[Page 24724]]
Federal Acts, many States have the authority to impose civil penalties
against violators of State meat and poultry inspection laws. Some
comments stated that while FSIS allows the slaughter and sale of up to
20,000 farm raised chickens annually to restaurants and retail markets
without benefit of inspection, many State programs do not permit this
activity. The comment claimed that requiring States to operate their
MPI programs in a manner that is ``identical to'' the Federal program
could force the States to lower their standards.
One comment stated that some states impose humane handling and
slaughter requirements that go above and beyond those required by
Federal law. Another comment said that some States have stricter cold
storage requirements than FSIS.
Response: As discussed above, the cooperative interstate shipment
program established in this final rule supplements rather than replaces
the existing State MPI programs. States that participate in the
cooperative interstate shipment program may continue to operate their
``at least equal to'' State MPI programs for meat and poultry products
produced and sold solely within the State. Thus, this final rule does
not affect requirements for labeling, civil fines, poultry inspection,
humane handling, or cold storage that States have adopted as part of
their cooperative State MPI programs.
Comment: In the preamble to the proposed rule, FSIS explained that
to qualify for a cooperative interstate shipment program, States will
need to demonstrate that they have the authority under State law to
provide the necessary inspection services to selected establishments in
the State (74 FR 47652). Some comments noted that if the final
regulations require that inspection services provided to selected
establishments be the ``the same as'' those provided under the Federal
inspection system, many States will not be able to immediately change
their laws to make them identical to the Federal inspection laws.
One comment noted that the ability of States interested in the new
program to change their rules and adopt FSIS regulations will depend on
the process the State program must follow in order to make those
changes. Other comments noted that each State has its own legislative
process and some State legislatures do not meet every year. One comment
noted that, although the State programs are ``equal to'' the Federal
inspection system, the terminology and precise phrasing in the laws and
regulations differ, and that State administrative systems vary.
Response: As discussed above, the cooperative interstate shipment
program supplements the existing State MPI programs. Therefore, States
are not required to amend all State inspection laws to make them
identical to the Federal requirements. States interested in
participating in the cooperative interstate shipment program will need
to demonstrate that they have the necessary legal authority to enforce
Federal food safety standards in selected establishments in the State.
As noted by the comments, State laws and regulations differ, and
each State has its own legislative process. Some States may already
have the necessary legal authority to participate in the cooperative
interstate shipment program, while others may need to make legislative
changes to provide for any additional authority that they may need.
Comment: Some comments asserted that the main focus of any program
that provides for the interstate shipment of State-inspected products
should be on the safety of the products produced in the selected
establishments, not on administrative procedures for the inspection
program. According to the comments, if States are required to operate
their cooperative interstate shipment programs in a manner that is the
``same as'' the Federal program, the focus of these programs will be on
the administrative procedures of the State instead of food safety. The
comments stated that regulatory requirements can be met through
different means and that it is not practical or effective for a State
program to operate under the exact same procedures prescribed in the
Federal system.
The comments suggested that an effective alternative would be to
allow States to work within the existing ``equal to'' framework to
develop food safety activities focused on problems specific to their
establishments. The comments stated that the ``at least equal to''
standard is well accepted and has been effective in ensuring that State
MPI inspection programs are comparable to the Federal program.
Response: As explained above, the law does not provide for the
cooperative interstate shipment program to operate within the existing
``at least equal to'' framework. Under the 2008 amendments to the Acts,
meat or poultry produced in selected establishments are permitted to
bear a Federal mark of inspection and be shipped in interstate commerce
only if designated State personnel find that such product qualify for a
Federal mark (21 U.S.C. 683(b)(1)(a) and 472(b)(1)(a)). While products
that are inspected and passed under a State's ``at least equal'' MPI
program qualify for a State mark, these products are not eligible for a
Federal mark.
Comment: Some comments complained that FSIS's proposed regulations
would require that States maintain two separate inspection systems, one
that is ``identical to'' the Federal program and one that is ``equal
to'' the Federal program. The comments said that adding an entirely new
State inspection system to comply with the ``same as'' standard will
add an extra layer of cost for the States. According to the comments,
many States would need to hire additional laboratory staff to perform
different methodology and complete documentation the same as FSIS. The
comments also said that States would need funds to train inspectors and
purchase Federal computers, and that overall State administrative costs
would increase because office staff, accountants, supervisors, and
managers would need to manage two systems. One comment urged FSIS to
fully consider the impact that the ``same as'' standard will have on
the administrative aspects of the State inspection programs.
Response: In the Preliminary Regulatory Impact Analysis (PRIA) to
the proposed interstate shipment rule, FSIS acknowledged that States
that choose to participate in the cooperative interstate shipment
program may need to make certain modifications to their inspection
program to provide inspection services to selected establishments in
the State (74 FR 47657). The Agency also acknowledged that the
inspection costs under the new program may differ from the costs of the
existing State MPI program. As required by law, if Congress provides
the necessary funding for the cooperative interstate shipment program,
FSIS will reimburse States for costs related to the inspection of
selected establishments in the State in an amount not less than 60
percent of eligible State cost. FSIS has updated its analysis of the
State costs in the Final Regulatory Impact Analysis (FRIA) for this
final rule.
As noted by the comments, the cooperative interstate shipment
program established in the proposed rule may require that States
maintain two separate inspection programs, one that is ``the same as''
the Federal program and one that is ``equal to'' the Federal program.
States that enter into cooperative agreements under the Talmadge-Aiken
program to provide Federal inspection services to Federal
establishments on behalf of FSIS are
[[Page 24725]]
also required to maintain two separate inspection systems--one under
the cooperative State ``at least equal to'' MPI program and the other
under the cooperative Talmadge-Aiken program. Thus, FSIS does not
believe that the cost to administer two separate cooperative inspection
programs will prevent States that are interested in participating in
the cooperative interstate shipment program from doing so.
3. ``Same as'' Computer Systems and Forms
In the preamble to the proposed rule, FSIS explained that to
qualify for a cooperative interstate shipment program, the Agency
expects States to demonstrate that they can provide the necessary
equipment for State personnel to provide the same inspection services
to selected establishment that FSIS provides to official
establishments, including computers and supplies for collecting
regulatory product samples (74 FR 47652).
Comment: A number of comments said that this statement could be
interpreted to mean that State programs must obtain and use the same
computers and computer programs that are used by FSIS personnel. The
comments requested that FSIS clarify its expectations with regard to
the type of computers and information systems the States will need to
have in place to qualify for a cooperative interstate shipment program.
Some of these comments noted that many States currently use State-
issued laptops computers and have developed systems that have been
determined ``equal to'' FSIS to track and report inspection activities
and other required data. One comment noted that some States have
developed their own data-driven systems that mimic the Federal System,
but that also allow State program personnel access to State licensing
information and to view and conduct other inspection activities in
facilities that are not related to meat and poultry. According to the
comment, States with their own information systems are able to tailor
FSIS inspection activities, which are geared towards use in larger
establishments, to be effective in very small establishments.
Response: To qualify for the cooperative interstate shipment
program, States will need to have computer programs and information
systems that are ``the same as'' those used by FSIS to administer the
Federal inspection program. Assuming that Congress provides the
necessary funding, FSIS will allow States that do not have the
necessary information systems to purchase from the Agency federally-
procured computers and the necessary computer programs. FSIS will
reimburse the States for 60% of their eligible costs to obtain the
necessary computers and software. FSIS does not intend to reimburse
more than 60% of the States' costs unless Congress directs it, and
provides the money for it to do so.
Comment: Some comments stated that if FSIS expects States to have
information systems that are identical to those used under the Federal
system, some States will need to maintain two computer systems to
participate in the program because the Federal computer system does not
allow any State program loads, and the Federal systems cannot be
operated on a computer other than a federally-sourced computer. One
comment noted that federally-procured computers generally cost more
than State-procured ones, and the Federal computers would only be used
on a limited basis by State personnel that work in selected
establishments.
Response: As noted above, to provide the necessary inspection
services under the cooperative interstate shipment program, States that
participate in the program will need to use computer programs that are
``the same as'' those used by FSIS to administer the Federal inspection
program. Thus, if the Federal computer programs cannot be operated on
State-sourced computers, the State may need to purchase new computers
from FSIS. As a result, some States will need to maintain two computer
systems to participate in the cooperative interstate shipment program.
Comment: One comment asked if states participating in the
cooperative interstate shipment program will have access to all of the
Federal data programs, like eADRS, Assurance Net and FSIS intranet.
Another comment stated that FSIS did not explain how requiring that
States have identical computer systems in order to participate in the
cooperative interstate shipment program will further food safety and
compliance with the Acts.
Response: States that participate in the cooperative interstate
shipment program will have access to the computer programs that are
necessary to provide inspection services that are ``the same as'' those
provided under the Federal program. The computer systems used by States
to administer the cooperative interstate shipment program need to be
``the same as'' those used under the Federal program to ensure that
selected establishments are meeting all food safety standards that are
``the same as'' rather than ``at least equal to'' standards imposed
under the Federal program.
Comment: Some comments asked whether the forms used by States
operating under a cooperative interstate shipment need to be identical
to the Federal forms that FSIS uses under its inspection program.
According to one comment, State inspection programs frequently do not
have access to Federal forms and, therefore, most have developed their
own forms. The comment stated that, if States are required to maintain
forms that are identical to the Federal forms, many States will need to
manage two different sets of documentation to participate in the
cooperative interstate shipment program.
Response: To provide the necessary inspection services to selected
establishments participating in the cooperative interstate shipment
program, States will need to use forms that are the same as those used
under the Federal inspection program. FSIS's OOEET will assist the
States to obtain the necessary forms.
4. ``Same as'' Training for Designated State Personnel
The preamble to the proposed rule stated that to qualify for a
cooperative interstate shipment program, States will need to
demonstrate that designated State personnel have been properly trained
in Federal inspection methodology (74 FR 7652). The preamble also
explained that FSIS offers training courses in Federal inspection
methodology to State inspection personnel and that States that are
interested in participating in a cooperative interstate shipment
program will be responsible for making arrangements for their
inspection personnel to attend these courses.
Comment: Several comments stated that FSIS-sponsored training is
costly, lengthy, and almost always requires travel out of State for
extended periods of time. The comments suggested that, instead of
requiring designated State personnel to attend FSIS training, the
Agency should allow States to provide training that is ``equal to''
FSIS's training program. The comments explained that such training
would include equivalent content as FSIS training but could be
administered by the individual States, other State programs, FSIS or
other qualified entities.
Response: The law does not provide for training that is ``equal
to'' FSIS's training program or that includes equivalent content. The
2008 amendments to the Acts require that designated State personnel
under go ``* * * all necessary inspection training
[[Page 24726]]
and certification to assist the [FSIS Administrator] in the
administration and enforcement of [the Acts], including rules and
regulations issued under [the Acts]'' (21 U.S.C. 683(a)(2)and
472(a)(2)). As stated in the Senate Committee report, this means that
the designated State personnel ``* * * must have undergone all the
necessary training to carry out the requirements of [the Acts], [their]
regulations, notices, directives and policies, just as required of a
Federal inspector'' (S. Rep. No. 220, 110th Cong., 1st Sess. (2007),
pp. 211-214) Thus, the law clearly requires that the training in
Federal inspection methodology provided to designated State personnel
be ``the same as'' the training provided to FSIS inspection personnel.
As noted in the preamble to the proposed cooperative interstate
shipment rule, FSIS offers training courses in Federal inspection
methodology to State inspection personnel. FSIS's OOEET will coordinate
with States participating in the cooperative interstate shipment
program to provide the necessary training for designated State
personnel.
Comment: Some comments stated that many States conduct their own
training courses, which are subject to oversight by FSIS. The
commenters noted that these State courses often present the identical
material that FSIS presents in its training courses. The comments
suggested that FSIS consider these State courses as acceptable training
for designated State personnel.
Response: Although some States may be providing training that
includes the same content as the training provided by FSIS, designated
State personnel will need to complete FSIS-sponsored training for the
State to qualify for the cooperative interstate shipment program. FSIS-
sponsored training courses will ensure that designated State personnel
receive the necessary training to carryout the requirements of the
Federal Acts, ``just as required of a Federal inspector,'' as intended
by Congress.
Comment: One comment asked whether State personnel will need to
complete their training before the State begins its cooperative
interstate shipment program. Some comments stated that State programs
cannot afford the travel costs associated with sending already trained
state inspectors to additional training. One comment suggested that
FSIS make any required training for State inspectors available through
on-line courses at no charge to the States. Two comments asked whether
FSIS would be covering training and training-related expenses.
Response: As noted above, the preamble to the proposed rule
explained that to qualify for the program, States would need to
demonstrate, among other things, that designated State personnel have
been properly trained in Federal inspection methodology. This means
that when a State submits a request to FSIS for a cooperative
interstate shipment program, the State must demonstrate either that its
designated State personnel have completed the necessary training in
Federal inspection methodology or that such personnel will have
completed such training before they begin to provide inspection
services to selected establishments in the State.
As previously noted, FSIS currently offers courses in Federal
inspection methodology to State inspection personnel. States that are
interested in participating in a cooperative interstate shipment
program will be responsible for making arrangements for their
inspection personnel to attend these courses. FSIS's OOEET will
coordinate with the States to help make the necessary training
available to designated personnel in the State. For example, if a State
has a significant number of designated personnel that need to be
trained Federal inspection methodology, FSIS could arrange to conduct
training courses at a location within the State so that all designated
State personnel can attend.
As it does for training costs associated with the State MPI
program, FSIS will reimburse States for any eligible training costs
associated with the cooperative interstate shipment program, including
necessary travel costs. However, instead of reimbursing the State for
50% of the eligible costs, FSIS will reimburse 60% of a State's
eligible costs associated with training designated State personnel.
As discussed above, for a State to qualify for the cooperative
interstate shipment program, its designated State personnel will need
to attend FSIS-sponsored training in person. Thus, FSIS will not be
providing the required training through on-line courses as suggested by
the comment. The Agency may, however, make supplemental training
materials available on-line.
5. ``Same as'' Laboratory Testing and Analysis
The preamble to the proposed rule explained that to qualify for an
interstate shipment program, States will need to demonstrate that the
laboratory services that they intend to use to analyze regulatory
product samples from selected establishments are capable of conducting
the same chemical, microbiological, physical, and pathology testing as
are required under the Federal meat and poultry products inspection
programs (74 FR 47652). The preamble also explains that FSIS's Office
of Public Health Science (OPHS) will provide laboratory audit
assistance to the State to verify that the methodologies used by a
State's laboratory services to analyze samples from selected
establishments are capable of producing the same results as the
methodologies used by FSIS laboratories.
Comment: Some comments agreed that State-inspected establishments
participating in the cooperative interstate shipment program should be
subject to the same regulatory sampling programs as those established
in the Federal inspection program. One comment stated that positive
results on pathogen and residue testing on products produced in
selected establishments should lead to the same regulatory actions that
federally-inspected establishments are subjected to.
Two comments stated that they were encouraged by the requirements
for regulatory sampling and laboratory analysis described in the
proposed rule. The comments stated that a robust residue,
microbiological, and pathological analysis capability will assure
accuracy of these test results, which, according to the comments, is
essential for maintaining foreign markets.
Response: The comments present valid reasons for requiring that the
selected establishments participating in the cooperative interstate
shipment program be subject to the same regulatory sampling required
under the Federal program.
Comment: Several comments requested that FSIS clarify its
expectations with regard to the laboratory services used by States to
analyze samples under the cooperative interstate shipment program. Many
comments specifically asked whether FSIS expects these laboratories to
be (International Organization for Standards) ISO accredited. Several
comments expressed concern that if FSIS requires laboratories that
analyze samples for the cooperative interstate shipment program to be
ISO accredited, some laboratories will have to abandon perfectly
acceptable procedures, or possibly more up-to-date procedures, to
perform the methodology executed at the FSIS laboratories. The comments
also said that some states would need to hire additional personnel to
perform the increased paperwork with no additional benefit in the
quality or quantity of tests performed.
[[Page 24727]]
Response: The laboratory services that States use to analyze
samples collected under the cooperative interstate shipment must be
capable of producing the same results as FSIS's laboratories.
Therefore, to demonstrate that the laboratory services used by a State
are sufficient for the State to qualify for the cooperative interstate
shipment program, the State will need to show that the laboratory is
accredited by an internationally recognized organization that accredits
food testing laboratories against the ISO 17025 ``General Requirements
for the Competence of Testing and Calibration Laboratories'' and AOAC
``Guidelines for Laboratories Performing Food Microbiological and
Chemical Analyses of Food and Pharmaceuticals Testing'' written by the
Analytical Laboratory Accreditation Criteria Committee (ALACC). The
assessment body that FSIS uses, the American Association for Laboratory
Accreditation (A2LA), is the sole organization that incorporates ALACC
into their program requirements. State labs would need to use A2LA or
another accrediting body that incorporates ALACC and is a signatory and
in good standing to the Mutual Recognition Arrangements of the
International Laboratory Accreditation Cooperation (ILAC).
The laboratory will also need to use the protocols for analytical
tests required for FSIS regulatory activities on meat and poultry
products described in the FSIS Chemistry, Microbiological, and
Pathology Laboratory Guidebooks. However, if the laboratory that a
State intends to use to analyze samples for the cooperative interstate
shipment program is unable to follow an FSIS method as written, the
State may submit a justification to FSIS that: (1) Explains why the
laboratory is unable to follow the FSIS methodology and (2) describes
the modifications that the laboratory intends to make to the FSIS
methodology. FSIS will evaluate the State's justification to determine
whether the modification of FSIS methodology is minimal and supportable
through validation or other evidence. FSIS will allow a State to use
the modified method if the Agency determines that methodology is
consistent with the original FSIS protocol and the State's method is
capable of achieving results that are consistent with the corresponding
FSIS method.
To assist the States in developing laboratory services that are
``the same as'' those provided under the Federal inspection program,
FSIS is adopting a ``phased in'' approach for the States to become ISO
17025 accredited. OPHS has developed a Quality Assurance (QA) checklist
based on ISO 17025 and ALACC criteria. It is not as extensive as ISO
17025, but contains minimum QA practices that laboratories should
follow to be able to defend their results. The checklist is included as
an appendix in FSIS's guidance for ``at least equal to'' State MPI
programs. States that use services from laboratories that are not ISO
17025 accredited but that can demonstrate that the laboratories meet
the laboratory criteria in the FSIS QA checklist will be permitted to
participate in the cooperative interstate shipment program if they
agree to actively seek and obtain ISO accreditation within two years.
However, if the laboratory fails to actively seek or does not obtain
the necessary accreditation, FSIS will terminate the State's
cooperative agreement for the interstate shipment program.
FSIS is developing materials to assist States whose laboratory
services are pursuing ISO accreditation to meet the requirements to
become accredited. States may also use an outside laboratory to analyze
samples collected under the cooperative interstate shipment program if
the outside laboratory has the necessary accreditation.
States that currently use laboratories with active ISO 17025
accreditations will need to submit the necessary documentation for FSIS
to verify that the laboratories are ISO accredited and meet ALACC food
laboratory requirements as assessed by an appropriate accreditation
body. To remain eligible for the programs, States will need to
demonstrate, through documented third-party audits or other appropriate
documentation, that their laboratories are maintaining their
accreditation and are continuing to use methods described in FSIS
Laboratory Guidebooks.
Comment: One comment asserted that instead of conducting the same
number and type of sampling that is conducted under FSIS's sampling
programs, the Agency should allow States to develop sampling programs
that reflect the same number of samples over the broad spectrum of meat
products produced under the cooperative interstate shipment program.
According to the comment, States may very well conduct more sampling or
more comprehensive sampling than Federal programs. The comment also
suggested that FSIS provide States with production data to guide them
in selecting the same number or more samples based on the same volumes
under FSIS inspection programs.
Response: To qualify for the cooperative interstate shipment
program States must, at a minimum, collect and analyze the same number
and type of regulatory product samples from selected establishments as
are collected and analyzed under FSIS's inspection sampling program. If
they have met the sampling requirements provided for in FSIS's
regulatory sampling programs, States may collect additional samples or
conduct additional analyses if they choose to do so. FSIS will provide
guidance to States in determining the appropriate number of samples
that they will need to collect to be the same as the Federal regulatory
sampling program.
Comment: Some comments noted that establishing a national
laboratory program to analyze samples collected under the cooperative
interstate shipment program would be more economically viable than
requiring that each State program conduct a laboratory program that is
``the same as'' FSIS's. According to the comments, it is economically
unreasonable for States to set up and maintain equipment necessary for
running extremely rare samples.
Response: States that do not have the laboratory capability to
conduct the necessary sampling and analyses required under the
cooperative interstate shipment program are permitted to submit samples
collected under the cooperative interstate shipment program to an
outside laboratory that does. The States may rely on the sample results
obtained from an outside laboratory if the State, in coordination with
FSIS's OPHS, has verified that the laboratory has the necessary
accreditation and is capable of producing the same results obtained by
FSIS's laboratories.
Comment: One comment stated that the level of oversight that FSIS
intends to have over State laboratories under the cooperative
interstate shipment program is unnecessary. The comment suggested that,
if FSIS intends to oversee the analysis of samples collected from
selected establishments, it should offer to analyze all samples from
eligible establishments at FSIS laboratories at no cost to the State
program.
Response: FSIS does not intend to oversee the analysis of samples
collected from selected establishments. The Agency intends to consult
with the States to verify that the laboratories that States use to
analyze samples from selected establishments are capable of producing
the same results as FSIS's laboratories.
Comment: One comment included a number of questions that the
commenter requested FSIS address before the
[[Page 24728]]
Agency issues the final rule to implement the cooperative interstate
shipment program. The questions are as follows:
Will the kidney inhibition swab (KIS) test for detecting
antimicrobial drug residues be required in establishments selected for
the program, or will other tests be acceptable?
If KIS is necessary, will every facility be required to
have an incubator, or can samples be sent to the state laboratory,
requiring only one incubator?
If an establishment decides to participate in both the
cooperative program and the state inspection program, would the
sampling program required by FSIS be sufficient, or would they also
have to participate in the State's sampling program?
Could the selected establishments be put into the FSIS
sampling program, with FSIS sending sample requests and supplies, and
the samples analyzed at Federal labs?
What process must be followed if a state's laboratory
wants to request audit help?
Will the recommendations of the auditor be the official
required adjustments the lab must make to allow the state to
participate in the program?
Response: As noted above, the laboratory services that a State uses
to analyze samples under the cooperative interstate shipment program
must use methods that are capable of producing results that are ``the
same as'' those obtained from the methods used by FSIS's laboratories.
Therefore, the KIS test for detecting antimicrobial drug residues used
by FSIS is the acceptable test. Samples may be sent to and analyzed by
the State laboratory if FSIS has evaluated and approved any minor
modifications to the procedures described in the FSIS Laboratory
Guidebooks.
If an establishment participates in both the cooperative interstate
shipment program and the cooperative State MPI program, the sampling
conducted under the cooperative interstate shipment program must be
``the same as'' the sampling conducted under the Federal program, while
the samples collected under the State MPI program must meet standards
that are ``at least equal to'' the Federal program.
States that participate in the cooperative interstate shipment
program are responsible for scheduling, collecting and analyzing
samples required under the program. FSIS will not collect or analyze
regulatory samples for the cooperative interstate shipment program.
The SEC assigned to the State will facilitate the process for the
State to obtain the necessary audit assistance from FSIS's OPHS. As
noted above, OPHS will provide guidance and advice on laboratory
accreditation requirements. However, the laboratories themselves will
be responsible for obtaining the necessary ISO accreditation.
6. Related Activities
Comment: Some comments requested that FSIS clarify what States need
to do to demonstrate they are able to ``conduct any related activities
that would be required under a cooperative interstate shipment
program,'' as required under the proposed regulations. The comments
said that the final rule must specifically describe the ``related
activities'' required under the cooperative agreement or else the
Agency should remove this statement.
One comment said that requiring that States conduct ``related
activities'' adds requirements for a State program that are outside of
what is authorized by the enabling statute, and is both unclear and
unnecessary. The comment said that FSIS should not be attempting to
impose ancillary requirements on the States through the cooperative
agreement process. According to the comment, the State's ability to
provide inspection service to selected establishments in accordance
with the statute is all that is authorized and, therefore, all that is
necessary.
Response: The term ``related activities'' refers to any activities
that are necessary to ensure that the inspection services provided to
selected establishments are ``the same as'' the inspection services
provided to Federal establishments. Such activities include, but are
not limited to, scheduling, collecting and analyzing regulatory
samples, issuing export certificates for establishments that will be
exporting products to foreign countries, and verifying that selected
establishments are humanely handling livestock in connection with
slaughter.
E. Additional Conditions for State Participation
In addition to requiring that a State's requests for an interstate
shipment program include documentation to demonstrate that it is
capable of providing the necessary inspection services to selected
establishments in the State, the proposed regulations also require
that, in its request, the State must agree to: (1) Provide FSIS with
access to the results of all laboratory analyses conducted on product
samples from selected establishments in the State; (2) inform the SEC
for the State of any laboratory results that indicate that a product
produced in a selected establishment may be adulterated or may
otherwise present a food safety concern; and (3) if necessary,
cooperate with FSIS to transition selected establishments in the State
that have been deselected from a cooperative interstate shipment
program to become official establishments (proposed 9 CFR 332.4(b)(3)
and 381.187(b)(3)).
The proposed regulations also provide that when States submit their
requests for an interstate shipment program, they must include a list
of establishments that have requested to participate in the program and
that the State recommends for initial selection into the program
(proposed 9 CFR 332.4(b)(1) and 381.187(b)(1)).
Comment: Two comments suggested that FSIS remove the provision in
the proposed regulations that requires that States give FSIS access to
the results of all laboratories analyses conducted at selected
establishments. The comments stated that such a requirement is
unnecessary because the States are also required to notify the SEC of
results that indicate that a product produced in a selected
establishment may be adulterated or may otherwise present a food safety
hazard.
Response: Although the States are required to notify the SEC of
laboratory results that indicate that a product produced in a selected
establishment may be adulterated or present a food safety hazard, the
SEC or other FSIS personnel also need to have access to the results of
the laboratory analyses conducted on products produced in selected
establishments to verify that these establishments are operating in a
manner that complies with the Acts.
Comment: One comment stated that, as written, the proposed
requirement that States give FSIS ``access'' to all laboratory results
could be interpreted as requiring that FSIS have electronic access, via
a particular system, to the results of testing conducted by State
programs. According to the comment, when an integrated electronic
system for data sharing is developed, funded, and implemented, State
programs will share laboratory results with FSIS electronically. The
comment maintained that the cooperative interstate shipment program
should not unintentionally limit the methods by which analytical
results are shared with FSIS before an electronic system is fully
operational.
Response: The regulations do not prescribe the methods by which
States are required to share their analytical results with FSIS. States
may share analytical results with FSIS
[[Page 24729]]
electronically or they may provide hard copies. The only requirement is
that they give FSIS access to these results upon request.
Comment: One comment said that the proposed requirement that the
State notify the SEC when laboratory results indicate that a product
from a selected establishment may be ``adulterated or may otherwise
present a food safety concern'' is overly broad and redundant. The
comment asserted that any product that presents a food safety concern
is, by definition, adulterated. The comment suggested that FSIS delete
the phrase ``may otherwise present a food safety concern'' in the final
regulations.
Response: There may be instances in which a product presents a food
safety concern but it is unclear as to whether the product is
adulterated under the FMIA or PPIA. For example, a preliminary
laboratory result may indicate that a product that has been distributed
in commerce is contaminated with a pathogen but the laboratory needs to
complete the analysis to confirm these results. The SEC needs to be
made aware of these situations to verify that the establishment and
States have responded to the preliminary result in a manner that
complies with the Federal Acts and implementing regulations.
Comment: One comment stated that, instead of requiring that a
State's request for a cooperative interstate shipment program include a
list of establishments that have submitted requests to participate in
the program and that the State recommends for the program, the final
regulations should permit States to submit a request for a cooperative
interstate shipment program before they have identified establishments
interested in being selected for the program. According to the comment,
this would allow the State and Federal programs to work out any issues
with their relationship before offering the program to establishments.
Response: FSIS agrees with this comment. The Agency has modified
the regulations to require that a State's request for a cooperative
interstate shipment program include a list of establishments that have
submitted a request to participate in the program, if any. This will
allow States to request an agreement for a cooperative interstate
shipment program before they have identified establishments interested
in participating in the program. However, FSIS will only reimburse
States for 60% of their eligible costs to administer the program if,
after entering into a cooperative agreement, establishments in the
State are selected for, and participate in, the program.
Comment: A few comments stated that, in addition to verifying that
States have sufficient authority, resources, personnel, training,
sampling capability and laboratory capacity to provide the necessary
inspection services to selected establishments in the State, FSIS will
also need to monitor budget issues in participating States on an
ongoing basis to ensure that States continue to have sufficient
resources to participate in the program. The comments noted that many
State governments are under financial duress and have had to make
budget cuts in their State inspection programs. One comment said that
even though FSIS is required to reimburse States for at least 60% of
their eligible costs associated with the cooperative interstate
shipment program, the Agency will need to verify that States interested
in participating in the new program will be able to meet Federal
inspection regulatory requirements during these hard economic times.
Response: States that enter into an agreement with FSIS for a
cooperative interstate shipment program will be required to prepare
annual budgets to cover the costs for the cooperative interstate
shipment program, maintain complete accounting records, and conduct all
other financial accountability activities just as they do for the State
MPI program. FSIS will terminate a State's agreement for a cooperative
interstate shipment program if the State does not have sufficient
finances to comply with all aspects of the cooperative interstate
shipment program.
F. Selection Process
Under the proposed regulations, State-inspected establishments that
are interested in participating in the cooperative interstate shipment
program must apply for the program through their State (proposed 9 CFR
332.5(a)(1) and 381.515(a)(1)). If a State determines that an
establishment operating under the State's meat or poultry products
inspection program qualifies for selection into a cooperative
interstate shipment program, and the State is able and willing to
provide the necessary inspection services to the establishment, the
State is to submit its evaluation of the establishment through the FSIS
District Office that covers the State (74 FR 47653). The proposed rule
provides that the FSIS Administrator, in coordination with the State,
will decide whether to select the establishment for the program
(proposed 9 CFR 332.5(b) and 381.151(b)).
Comment: Some comments said that the State inspection program is
the government entity best suited to begin the process of selecting
establishments for the cooperative interstate shipment program.
According to the comments the States, not the FSIS Administrator,
should be responsible for selecting establishments to participate in
the program. The comments suggested that after initiating the selection
process, the State program could collaborate with the FSIS SEC, who can
visit the establishments that are under consideration for selection
into the cooperative interstate shipment program.
Response: FSIS agrees that the States are best suited to begin the
process of determining which establishments in the State are eligible
for selection to the cooperative interstate shipment program.
Therefore, the proposed rule requires that establishments interested in
participating in the cooperative interstate shipment program apply for
the program through the State in which they are located (proposed 9 CFR
332.5(a) and 381.515(a). After the State recommends establishments for
the program, the law requires that the FSIS Administrator coordinate
with the State to select establishments for the program (21 U.S.C.
683(b)(1) and 472(b)(1)).
Comment: One comment argued that the regulations do not need to
include a process for selecting establishments to participate in the
cooperative interstate shipment program because establishments
operating under the State MPI programs are already under an inspection
system that provides for food safety in a manner that is ``at least
equal to'' the Federal inspection program. According to the comment,
there is no need for selection because the entire State program has
already been approved.
Response: The law requires that the FSIS Administrator, in
coordination with the State, select establishments to participate in
the new cooperative interstate shipment program (21 U.S.C. 683(b) and
472(b)). There is nothing in the law to indicate that establishments
operating under the existing State MPI programs have already been
approved for the cooperative interstate shipment program. Therefore,
these final regulations include procedures for selecting establishments
for the program.
Comment: One comment suggested that the final rule require that
selected establishments undergo an on-site review by FSIS at least 30
days before they become eligible to participate in the cooperative
interstate shipment program. The comment noted that such a review would
help to guarantee that selected establishments that wish to ship their
meat products in interstate
[[Page 24730]]
commerce are in compliance with Federal law.
Response: The preamble to the proposed rule explained that, as part
of the selection process, the SEC assigned to a State, in coordination
with the State, will verify that each establishment in the State that
has applied to participate in a cooperative interstate shipment program
is in compliance with all Federal standards (74 FR 47653). To verify
such compliance, the SEC will coordinate with the State to conduct on-
site reviews of each establishment that has applied, and that the State
recommends, for selection into the program.
Comment: One comment said that FSIS should better explain how
establishments may be selected for the cooperative interstate shipment
program.
Response: The preamble to the proposed rule provides a detailed
description of the proposed selection process. FSIS is adopting that
process in this final rule.
As proposed, State-inspected establishments that are interested in
participating in a cooperative interstate shipment program will be
required to apply for the program through the State agency that
administers the State MPI program. States are responsible for
establishing their own application procedures. The State will then
evaluate the establishment to determine whether it qualifies for
selection. To qualify for selection to the cooperative interstate
shipment program, an establishment must:
Have the appropriate number of employees;
Not be ineligible for a cooperative interstate shipment
program \2\;
---------------------------------------------------------------------------
\2\ Examples of establishments that are ineligible for the
cooperative interstate shipment program include official Federal
establishments, establishments located in a State that has a State
MPI program, establishments in violation of the FMIA or PPIA,
establishments that are the subject of a transition to become a
Federal plant, and establishments located in a State without a State
MPI program.
---------------------------------------------------------------------------
Be in compliance with all requirements under the State
inspection program; and
Be in compliance with all Federal meat or poultry products
inspection requirements.
If a State determines that an establishment operating under the
State's MPI program qualifies for selection into a cooperative
interstate shipment program, and the State is able and willing to
provide the necessary inspection services to the establishment, the
State is to submit its evaluation of the establishment through the FSIS
District Office that covers the State. The FSIS Administrator, in
coordination with the State, will then decide whether to select the
establishment for the program.
In deciding whether to select an establishment that the State has
recommended for the cooperative interstate shipment program, the
Administrator will consider whether the establishment qualifies for the
program and whether the Agency has the resources that it needs to
provide the required oversight of the establishment if it is selected
for the program. Before an establishment can be selected, the SEC, in
coordination with the State, must verify, through record reviews and
on-site visits, that the establishment is in compliance with all
Federal inspection requirements under the FMIA, PPIA, and their
implementing regulations in title 9, chapter III, of the CFR.
G. Mark of Inspection and Official Number
The proposed regulations require that inspection services for
selected establishments be provided by designated State personnel, and
that articles prepared or processed in a selected establishment that
have been inspected and passed by designated personnel bear an official
Federal mark of inspection (proposed 9 CFR 332.6(c) and 381.516(c)).
The proposed regulations also require that the Federal mark contain a
selected establishment number assigned to the establishment by the
State. The proposal provides that the number must include, as a suffix,
the abbreviation for the State in which the establishment is located,
as well as the abbreviation ``SE'' for selected establishment (e.g.
``38SETX'' as a number for a selected establishment in Texas). If the
establishment processes poultry products, the suffix must also contain
a ``P,'' (e.g., 38 SEPND for a selected poultry establishment in North
Dakota) (proposed 9 CFR 332.5(c) and 381.515(c)). The proposed
regulations also state that States that fail to assign an establishment
number to selected establishments in the State and report the number to
the SEC for the State will not qualify to participate in the program
(proposed 9 CFR 332.5(d) and 381.515(d)).
Comment: Some comments expressed concern that allowing State-
inspected meat and poultry products to bear a Federal mark of
inspection will make it difficult to maintain the integrity of the
Federal mark. One comment stated that the integrity of the Federal mark
will be diminished if a State-inspected product distributed in
interstate commerce is recalled or found to be adulterated. Another
comment said that allowing State-inspected products to bear a Federal
mark of inspection is misleading because consumers that see a Federal
mark of inspection on the label of a meat or poultry product will think
that the product is the same as all other federally-inspected products.
The comment noted that the FMIA and PPIA both prohibit labeling that is
false or misleading.
Response: Under the 2008 amendments to the Acts, meat and poultry
products produced under the cooperative interstate shipment that
designated State personnel have determined are in compliance with all
Federal standards are required to bear a ``Federal mark, stamp, tag, or
label of inspection'' (21 U.S.C. 472(b)(1) and 683(b)(1)). Thus,
requiring that articles prepared or processed in a selected
establishment that have been inspected and passed by designated
personnel bear an official Federal mark is consistent with the law.
Such a requirement will not diminish the integrity of the Federal mark
or be misleading to consumers, as suggested by the comments, because
all meat and poultry products that bear the Federal mark will have been
produced under Federal standards.
Comment: Some comments maintained that it is not necessary to
require that the meat and poultry products produced under the
cooperative interstate shipment program bear a Federal mark of
inspection because States that have MPI cooperative agreements already
provide State marks. A State Department of Agriculture and a State
agency commented that many State-inspected establishments prefer that
their products bear the State mark of inspection. The comments claimed
that requiring that selected establishments apply a Federal mark and
identify the State in the establishment number is unacceptable to most
plant owners. Another comment argued that requiring that a Federal mark
of inspection be applied to products that have been inspected by a
State inspector under a cooperative State meat inspection program is
counterintuitive and does not accomplish the goal of providing for
interstate shipment of State-inspected products.
Response: The 2008 amendments to the Acts require that meat and
poultry products produced under the cooperative interstate shipment
program bear a Federal mark of inspection.
As noted above, under the proposed regulations, the Federal mark is
required to contain a selected establishment
[[Page 24731]]
number assigned to the establishment by the State. The selected
establishment number is required to include, as a suffix, the
abbreviation for the State in which the establishment is located, as
well as the abbreviation ``SE'' for selected establishment (e.g.
``38SETX'' as a number for a selected establishment in Texas). If the
establishment processes poultry products, the suffix must also include
a ``P'' before State abbreviation (e.g., 38 SEPND for a selected
poultry establishment in North Dakota). Thus, although meat and poultry
products produced in selected establishments will not bear a State mark
of inspection, the State in which the product was produced can be
readily identified by referencing the selected establishment number
that is required to appear inside the Federal mark.
Comment: Some comments agreed that products produced in selected
establishments should bear a Federal mark of inspection but also
suggested that such products be allowed to bear a State mark if the
establishment so chooses. According to the comments, many State-
inspected establishments believe that compliance with their State
inspection program requirements along with the Federal standards
provides a marketing advantage and that appearance of the State mark
may add value to State-inspected products sold in interstate commerce.
One comment noted that because their State mark of inspection is an
outline of the State, selected establishments in the State could use
the State mark to promote their products interstate.
Response: It is not necessary for meat or poultry products that
have been processed or prepared in selected establishments to bear both
a State and Federal mark because the product's State-of-origin can be
identified by the selected establishment number that is required to
appear in the Federal mark. Moreover, allowing products produced under
Federal standards to bear both a Federal and State mark of inspection
may be misleading to consumers and foreign trade partners because the
law prohibits interstate shipment of products produced under State MPI
programs. Allowing both Federal and State marks could also be confusing
to consumers and make it difficult for them to identify products
potentially implicated in outbreaks or subject to recall.
Selected establishments that were interested in using the State
mark to market meat or poultry products produced under the cooperative
interstate shipment program could use labeling statements information
to identify where the product was produced instead, provided that the
statement is truthful and not misleading. For example, the label of a
meat product produced in a selected establishment in Texas, could
contain the statement ``prepared in Texas,'' if the statement is
presented in a manner that is truthful and not misleading to consumers.
Comment: Some comments suggested that instead of requiring that
States assign a new official State establishment number to selected
establishment, FSIS should allow establishments that participate in the
cooperative interstate shipment program to retain their official State
number in conjunction with the suffix ``SE.''
Response: There is nothing in the proposed rule that would prevent
a State from allowing establishments selected for the cooperative
interstate shipment program to retain their official State number,
provided that the suffix ``SE'' is added to original State
establishment number. The ``SE'' suffix is necessary to make clear that
the establishment associated with the number is a selected
establishment.
Comment: One comment noted that the proposed regulations identify
the ``SE'' that is required to appear as part of a selected
establishment's official State number as a suffix. The comment stated
that the ``SE'' designation is, in fact, a prefix.
Response: FSIS refers to the ``SE'' along with the State
abbreviation as a ``suffix'' because these abbreviations follow the
number assigned to the selected establishment.
Comment: One comment objected to the provision in the proposed
regulations that provide that a State that fails to assign an official
State number to the selected establishments in the State and inform the
SEC will be disqualified from participating in the cooperative
interstate shipment program. The comment believed that disqualification
is an overly harsh penalty for what may be a simple omission. The
comment suggested that in the final rule, FSIS replace the statement
that failure to assign an official number ``will disqualify the State''
to ``may disqualify the State.''
Response: As explained in the preamble to the proposed rule, full
compliance by a State with the requirements for assigning official
establishment numbers to establishments selected for the cooperative
interstate shipment program is essential if the program is to succeed
(74 FR 57654). FSIS will give States that inadvertently fail to assign
a proper establishment number to a selected establishment an
opportunity to take corrective actions to comply with the regulations.
However, failure to comply with the establishment number requirements
in this final rule will disqualify a State from participating in the
cooperative interstate shipment program.
Comment: Several comments submitted by State Departments of
Agriculture and State agencies requested that in the final rule FSIS
make clear that it will permit selected establishments to produce
products under both the cooperative interstate shipment program and the
State MPI program. The comments noted that FSIS allows establishments
with both a Federal grant and State grant of inspection to operate as
both a Federal plant and a State plant if they maintain an appropriate
separation by time or space between the State and Federal operations
and that the products are appropriately marked. The comments noted that
in a letter to the National Association of State Departments of
Agriculture (NASDA) dated September 15, 2009, the Deputy Secretary of
Agriculture said that FSIS expects to apply a similar policy to
selected establishments that are interested in continuing to produce
certain products solely for distribution in the State under the State
MPI program. The comments maintained that allowing for this type of
flexibility will benefit rural America and is necessary for the success
of the new program.
One comment said that if the final rule permits selected
establishments to produce products under both the State MPI program and
the cooperative interstate shipment program, FSIS should allow these
establishments to continue to apply the State mark to products that are
not produced under the cooperative interstate shipment program.
Response: FSIS has considered these comments and has decided to
revise the proposed regulations to allow selected establishments to
conduct operations under both the cooperative interstate shipment
program and the State MPI program if those establishments implement and
maintain written procedures for complete physical separation of product
and process for each operation by time or space. An establishment may
provide for separation by space by conducting its State MPI operations
in an area that is physically separate from the area in which it
conducts operations under the cooperative interstate shipment program.
Alternatively, an establishment may conduct each operation in the same
area provided that the separation in space is sufficient to
[[Page 24732]]
ensure that potential food safety hazards, such as microbiological
pathogens, if present, are not likely spread from one area to another
through aerosolization, air ducts, air currents, employees, or other
means and that there is no co-mingling of product. Establishments that
chose to conduct both operations in the same area must clearly identify
and distinguish the State MPI operation from the cooperative interstate
shipment operation. For example, the establishment might designate
certain employees on a given day to work exclusively on the State MPI
operations and have these employees wear white clothing, and designate
other employees to work exclusively on the cooperative interstate
shipment operations and have these employees wear yellow clothing. The
establishment could also color-code knives and other equipment
associated with each operation.
In addition to separation by space, an establishment may conduct
the State MPI operations and cooperative interstate shipment operations
at separate times if the establishment's procedures for separation
address clean-up between operations. Establishments that conduct both
operations in the same facility and on the same equipment, and that
separate the operations by time, will need to fully clean and sanitize
the facilities and equipment in between operations as set out in their
Sanitation SOPs.
Establishments that conduct operations under both the State MPI
program and the cooperative interstate shipment program will also need
to establish written procedures to ensure that product produced under
the State MPI program will not become co-mingled with product produced
under the cooperative interstate shipment program. The procedures will
need to ensure that products produced under each program are
appropriately identified as State MPI product or cooperative interstate
shipment products, and that each product bears the appropriate mark of
inspection.
Establishment will also need to maintain physical separation of
product produced under the State MPI program from products produced
under the cooperative interstate shipment program throughout the
process, either through the use of separate facilities or by designated
areas for holding or storing products produced under separate
operations.
The meat or poultry products produced when the establishment is
operating under the State MPI program will be required to bear the
State mark of inspection and will only be permitted to be distributed
within the State. Meat or poultry products produced when the
establishment is operating under the cooperative interstate shipment
program will be required to bear a Federal mark and may be shipped in
interstate commerce.
H. Oversight and Enforcement--Selected Establishment Coordinator
The preamble to the proposed rule explained that the statute
requires that FSIS appoint a ``state coordinator'' to ``provide
oversight and enforcement'' of the cooperative interstate shipment
program and ``to oversee the training and inspection activities'' of
State personnel designated to provide inspection services to selected
establishments (74 FR 47654). When FSIS issued the proposed rule, the
Agency explained that the ``state coordinator'' required by statute
would be referred to as the ``selected establishment coordinator''
(SEC) in the proposed regulations to avoid confusion with the ``State
coordinator'' under the Talmadge-Aiken program, which is a State
employee. In the preamble to the proposed rule, FSIS also explained
that the Agency had tentatively decided that the SEC would be an
employee of the FSIS Office of Field Operations (OFO) and would be
assigned to an FSIS district office.
1. SEC Definition and FSIS Program Area
Comment: One comment stated that the codified text in the final
rule should clarify that the term ``selected establishment
coordinator'' as used in the implementing regulations is synonymous
with the term ``state coordinator'' under the statute. The comment said
that there should not be both a State coordinator and an SEC.
Response: As noted in the preamble to the proposed rule, the term
``State coordinator'' is often used to refer to a State employee under
the Talmadge-Aiken program. Therefore, to make clear that the ``State
coordinator'' for the cooperative interstate shipment program is an
FSIS employee, this final rule identifies that employee as the FSIS
``selected establishment coordinator'' in the codified text. The
codified text in the final rule does not provide for both a State
coordinator and an SEC.
Comment: Some comments stated that, instead of being under the
direct supervision of an FSIS District Manager, as FSIS tentatively
decided in the proposed rule, the SEC should be under the direct
supervision of the Secretary of Agriculture as provided under the
statute.
Other comments agreed with FSIS's tentative determination that the
SECs operate out of the district offices. One comment noted that the
SEC is a Federal employee. The comment stated that, as such, it is
appropriate that the SEC be stationed at the district office and report
to a District Manager and ultimately, FSIS headquarters. The comment
asserted that the SEC should not be stationed at the State meat and
poultry inspection agency, but should maintain frequent communication
with State agency officials.
Response: The Secretary of Agriculture has delegated the
administration and enforcement of the cooperative interstate shipment
program to FSIS. Since the SEC will be an FSIS employee that operates
out of the FSIS district office, it is appropriate for the SEC to be
under the direct supervision of the FSIS District Manager.
Comment: Several comments were concerned about the Agency's
tentative decision to assign the SEC to an FSIS district office.
According to the comments, FSIS district offices are not always
consistent in their interpretation and enforcement of the Agency's
policies. The comments stated that administering the cooperative
interstate shipment program from different district offices will make
it difficult for FSIS to implement and enforce the program in a
consistent manner. The comment suggested that, instead of assigning
SECs to multiple district offices, FSIS should designate a single
entity within the Agency to implement and enforce the cooperative
interstate shipment program.
Some comments suggested that FSIS create a branch in OPEER, similar
to the Federal/State Audit Branch (FSAB), or assign the FSAB to
administer, review, and enforce the cooperative interstate shipment
program. The comments noted that the OPEER/FSAB is already responsible
for verifying that the State MPI programs are operating in a manner
that is ``equal to'' the Federal standards, and States now spend a
considerable amount of time providing information to OPEER/FSAB. The
comments stated that allowing a centralized Agency branch, such as the
OPEER/FSAB, to administer and enforce the cooperative interstate
shipment program will promote consistency in the program by providing
the FSIS SECs, the State programs, and selected establishments with a
single point of contact for guidance, policy implementation, and
enforcement.
Response: The FSIS SEC is required to provide ``oversight and
enforcement'' of the cooperative interstate shipment program and ``to
oversee the training
[[Page 24733]]
and inspection activities'' of State personnel designated to provide
inspection services to selected establishments (21 U.S.C. 683(d)(1) and
472(d)(1)). As noted above, when FSIS issued the proposed rule, it had
tentatively decided that the SEC would be an employee of the FSIS
Office of Field Operations (OFO) assigned to an FSIS District Office.
Because OFO has expertise in management and enforcement of Federal
inspection standards, FSIS is affirming that decision. The SEC will be
an OFO employee assigned to an FSIS district office as proposed.
As noted by the comments, the OPEER/FSAB is responsible for
conducting comprehensive audits of Federal and State MPI programs.
OPEER/FSAB verifies that State MPI programs are operating in a manner
that is ``at least equal to'' the Federal program. Although OPEER/FSAB
will not have direct oversight and enforcement of the cooperative
interstate shipment program, once the cooperative interstate shipment
program is fully implemented, the OPEER/FSAB will be responsible for
auditing that program to verify that it is operating in a manner that
is ``the same as'' the Federal inspection program.
2. Number of SECs per State
In the preamble to the proposed rule, FSIS explained that the
number of States in an FSIS district assigned to an SEC will likely
depend on several factors, including, but not limited to: (1) The
number of States and selected establishments, if any, that participate
in the cooperative interstate shipment program; (2) the location of
each selected establishment; (3) the number of State inspection
personnel providing inspection services to selected establishments in a
State; (4) the complexity of the operations conducted at each selected
establishment; and (5) the schedule of operations for each selected
establishment (74 FR 47654). The preamble also noted that the number of
States assigned to an SEC would also need to be based on consideration
of the most effective allocation of available Agency resources.
In the PRIA to the proposed rule, FSIS also estimated that 13 full-
time equivalent FSIS employees would be needed to perform the SEC
functions for the 16 States expected to participate in the cooperative
interstate shipment program (74 FR 47660). If 400 establishments
participate in the new program, the Agency estimated each SEC will be
responsible for 31 establishments in a geographically-limited area.
Comment: Several comments, most submitted by consumer advocacy
organizations, stated that 13 SECs to oversee cooperative interstate
shipment programs in 16 States is not sufficient to provide adequate
oversight of the new program. The comments urged FSIS to assign a
separate SEC to each State that participates in the program. The
comments asserted that to effectively verify that selected
establishments operating in a manner consistent with the Acts, the SECs
need to be spending most of their time in these establishments rather
than driving from state-to-state. One comment said that when the
provisions of the law were negotiated, the parties understood that
there was to be one SEC per State.
Other comments questioned whether the Agency's estimate of one SEC
for 31 establishments is adequate to ensure that these establishments
are operating in a manner that complies with the Acts. The comments
stated that FSIS must provide enough flexibility to reduce the number
of establishments covered by an SEC if circumstances warrant.
One comment expressed concern over the statement in the proposed
rule that ``[t]he number of States assigned to an SEC would also need
to be based on consideration of the most effective allocation of
available Agency resources.'' The comment stated this sentence
demonstrates that there is reason to be concerned that the new program
may not receive adequate resources to best protect public health and
safety. The comment maintained that there should be at minimum one SEC
per participating State and that the SEC's sole function should be
oversight and enforcement of the program, unless the State has so few
participating establishments that a full-time SEC is not warranted.
Response: As noted in the preamble to the proposed rule, the number
of SECs needed to provide effective oversight of the cooperative
interstate shipment program will depend on several factors, all of
which are intended to ensure that there is sufficient Federal oversight
of the program. FSIS agrees with the comments that stated that the SECs
should be spending most of their time overseeing activities in selected
establishments, and the Agency intends to structure the SEC's
assignment in a manner that will, to the greatest extent possible,
limit the time spent traveling between selected establishments. In some
instances, this will require that an SEC cover selected establishments
located in different States, particularly in States with selected
establishments located near the State borders.
As noted above, FSIS estimated that there would be one SEC for 31
establishments in a geographically-limited area. This number is an
estimate and assumes a certain level of participation by State-
inspected establishments that employed fewer than 35 employees when the
2008 Farm Bill was enacted. The actual number of establishments
assigned to an SEC will depend on a number of factors, including the
complexity of the operations conducted at the selected establishments
and the schedule of operations for each selected establishment.
3. Frequency of SEC Visits
As required under the statute, the proposed regulation provided
that the FSIS SEC is to visit each selected establishment in the State
on a regular basis to verify that these establishments are operating in
a manner that is consistent with the Acts and the implementing
regulations (proposed 9 CFR 332.7(a) and 318.517(a)). In the preamble
to the proposed rule, FSIS noted that the SEC's frequency of visits and
oversight activities for each selected establishment will need to
reflect the type of operations conducted by a selected establishment,
as well as the establishment's production processes (74 FR 47654). The
Agency requested comments on how frequently the SEC should visit each
establishment under his or her jurisdiction.
Comment: Several comments said that, since the law requires that
the SECs file quarterly reports on the status of the selected
establishment under their jurisdiction, they should visit each selected
establishment at least quarterly. Some comments stated that requiring
that the SEC visit selected establishments more often than once a
quarter would seem overly burdensome and ineffective. One comment
suggested that FSIS modify the proposed regulation to read that the SEC
will visit, ``each selected establishment in the State on a regular
basis, but no less frequently than quarterly, to verify that the
establishment is operating in a manner that is consistent with the
Act.''
One comment stated that requiring quarterly or bi-annual visits
will allow the SECs to both cover their assigned establishments and
conduct the day-to-day operations of managing the program for their
region. The comment said that if a problem arises, the SEC can visit
the establishment more frequently. The comment suggested that SECs also
rely on State inspection personnel to advise them if additional visits
are needed.
[[Page 24734]]
Many comments stated that the frequency of the SEC's visits should
be based on the performance of the establishment. The comments noted
that the number of visits may need to be higher when the program is
first implemented while the State inspection personnel gain experience
with the program's regulatory requirements. Two comments suggested that
initially, the visits should be weekly and that subsequent visits
should be based on the establishment's performance.
One comment said that the final regulations should clearly state
that the frequency of the SEC's visits shall be based on the
performance of the establishment's food safety control systems. The
comment maintained that such a statement will ensure judicious use of
FSIS resources and create an additional incentive for the establishment
to effectively operate their food safety control systems.
One comment stated that the SEC should visit selected
establishments no more frequently than FSIS front line supervisors
typically visit federally-inspected establishments in their circuit.
Another comment said that the SECs will need to visit selected
establishments quite frequently to ensure that they are in compliance
with Federal standards. One comment stated the goal in determining how
frequently SECs should visit establishments under their jurisdiction
should be to provide a statistically relevant sample to check on the
level of compliance and performance of inspections by state inspectors.
One comment suggested that in addition to prescribing the frequency
of SEC visits, the final regulations should specify that the SEC's
visits to selected establishments are to occur at different times and
be unannounced.
Response: The comments submitted on this issue indicate that there
is a general lack of consensus on how frequently the SEC should visit
selected establishments in the States. As noted above, some comments
suggested that the SEC conduct quarterly or even bi-annual visits,
while others suggested that the SEC visit each selected establishment
at least weekly.
The 2008 amendments to the Acts do not specify how frequently the
SECs are to visit selected establishments, but they do provide that the
SEC ``* * *shall visit selected establishments with a frequency that is
appropriate to ensure that selected establishments are operating in a
manner that is consistent with this Chapter (including regulations and
policies under this Chapter (21 U.S.C. 683(d)(3)(a) and 472(d)(3)(a)).
The Senate Committee report that explains this provision states that
``[i]t is the Committee's intent that the [SEC] inspect selected
establishments frequently each month'' (S. Rep. No. 110-20, 110th
Cong., 1st Sess. (2007), pp 211-214)).
Therefore, after considering the comments on this issue, as well as
the language in both the statute and the Senate Committee report, FSIS
has decided not to prescribe how frequently SECs are to visit selected
establishments under their jurisdiction. Instead, the Agency is
revising the proposed rule to clarify that the frequency with which the
SEC will visit selected establishments under the SEC's jurisdiction
will be based on a number of factors, including the complexity of the
operations conducted at the selected establishment, the establishment's
schedule of operations, and the establishment's performance under the
cooperative interstate shipment program. The Agency has concluded that
such an approach will ensure that the number of SEC visits reflects the
appropriate level of oversight needed for each selected establishment.
FSIS agrees with the comments that noted that the number of SEC
visits may need to be higher when the program is first implemented in
order for the State personnel to gain experience in enforcing Federal
food safety standards. FSIS also intends to schedule some unannounced
SEC visits to selected establishments, as suggested by the comments.
However, the SEC will also conduct scheduled visits to selected
establishments to give State personnel the opportunity to prepare to
discuss issues related to their role in enforcing Federal standards.
Although FSIS is not prescribing a specific minimum number of SEC
visits, based on the statement in the Senate Committee report, FSIS has
concluded that bi-annual or quarterly visits to selected
establishments, as suggested by some comments, are most likely not
frequent enough to carry out the intent of the statutes.
Comment: One comment stated that the provision in the proposed rule
that allows the SEC, in consultation with the District Manager, to
designate qualified FSIS personnel to visit a selected establishment on
behalf of the SEC is an appropriate use of Agency resources. The
comment said that assigning other designated FSIS personnel to visit
establishments on behalf of the SEC makes sense from a practical and
financial standpoint. The comment stated that FSIS could use inspection
personnel who are already out in the field to conduct visitations to
check compliance on a more frequent basis than sending the SEC into the
field.
Response: FSIS agrees that providing for qualified FSIS personnel
to visit selected establishment on behalf of the SEC is an appropriate
use of Agency resources.
4. SEC Duties--Oversight
Comment: Some comments supported the level of Federal oversight
provided for in the proposed regulations as necessary to maintain the
safety and security of all meat and poultry products distributed in
interstate commerce. One of the comments stated that any cooperative
interstate shipment program must be federally driven and that FSIS must
be in charge.
Other comments complained that the proposed rule would give the SEC
an excessive and unnecessary level of Federal oversight over the
cooperative interstate shipment program. The comments stated that FSIS
currently evaluates ``at least equal to'' State MPI programs through
reviews of State self-assessment and through an on-site evaluation of
the State's program every three years. The comments asserted that this
evaluation methodology has proven effective for assuring that State
programs are in compliance with Federal requirements. The comments said
that FSIS should, to the extent allowed by statute, consider using this
same method for evaluating a State's performance under the new
cooperative interstate shipment program.
Response: FSIS disagrees with the comments that stated that the
proposed rule would give the SEC an excessive and unnecessary level of
Federal oversight over the cooperative interstate shipment program. As
noted throughout this document, under the Acts, as amended by the 2008
Farm Bill, the FSIS Administrator is required to designate an FSIS
employee as an SEC for each State to ``provide oversight and
enforcement of the program'' and to ``oversee the training and
inspection activities'' of the designated State personnel providing
inspection services to a selected establishment. (21 U.S.C. 683(d)(1)
and 472(d)(1)). The Acts also require that the SEC visit selected
establishments as frequently as necessary to ensure that these
establishments are operating in a manner consistent with the Federal
Acts (21 U.S.C. 683(d)(3) and 472(d)(3)). Thus, the level of Federal
oversight that the proposed rule provides for the cooperative
interstate shipment program reflects the level of oversight that is
required by law.
FSIS disagrees with the comments that suggested that the Agency use
[[Page 24735]]
OPEER/FSAB's evaluation methodology to oversee a State's performance
under the new cooperative interstate shipment program. As noted by the
comments, the OPEER/FSAB conducts comprehensive audits of the State MPI
programs to verify that States are enforcing laws and regulations that
``are at least equal to'' to requirements of the Federal Acts. The
evaluation methodology used by the OPEER/FSAB is designed to provide a
comprehensive annual assessment of the State MPI programs rather than
continuous Federal oversight and enforcement of these programs. Thus,
this methodology would not provide the necessary level of oversight
that the Acts require for the cooperative interstate shipment program.
Comment: Some comments expressed concern that the proposed rule
would give ``de facto constant regulatory oversight authority'' to the
FSIS SEC. The comments stated that this would basically give State
personnel working in selected establishments two supervisors. According
to the comments, this chain-of-command will create confusion and
needless redundancy.
One comment said that the SEC needs to work with the States to
coordinate Federal oversight of the program to reduce the burden on the
selected establishments to the extent possible. The comments stated
that the program should not become one in which both Federal and State
officials are routinely inspecting the same facilities.
Another comment agreed with the provision in the proposed rule that
stated that the SEC's role is limited to oversight and enforcement of
the program. The comment also agreed that the State program should
continue to be responsible for the direct supervision of designated
State personnel.
Response: The proposed rule makes clear that inspection services
for selected establishments participating in the cooperative interstate
shipment program must be provided by designated personnel, who will be
under the direct supervision of a State employee (proposed 9 CFR
332.6(b) and 381.516(b)). Although the SEC will be responsible for
overseeing the inspection activities of the designated personnel, the
State program will continue to be responsible for the direct
supervision of all designated State personnel. Thus, the comment that
stated that the proposed rule would give State personnel working in
selected establishments two supervisors is inaccurate.
5. SEC Duties--Enforcement
The proposed regulation gave the SEC the authority to initiate any
appropriate enforcement action provided for in the FSIS rules of
practice in 9 CFR part 500 if the SEC determines that a selected
establishment under his or her jurisdiction is operating in a manner
that is inconsistent with the Acts (proposed 9 CFR 332.9(b) and
381.189(b)). As noted in the preamble, such actions include regulatory
control actions, withholding actions, and suspensions (74 FR 47655).
Comment: Some comments supported the proposed enforcement
provisions. One comment stated that it is appropriate for the SECs to
have the same authority to initiate enforcement actions with respect to
selected establishments as FSIS inspection personnel are authorized to
do with federally-inspected establishment. The comment also supported
the proposed requirement that selected establishments provide FSIS
officials with ``access to all establishment records required under the
Act and the implementing regulations in this chapter.''
Some comments said that the proposed rule's enforcement provisions
go beyond what is authorized under the statute and will result in
duplicative efforts. The comments asserted that the designated State
personnel, not the SEC, should be responsible for initiating
enforcement action in selected establishments.
Response: Under the proposed rule, designated State personnel are
responsible for providing the necessary inspection services to selected
establishments in the State. The SEC is responsible for verifying that
the designated personnel are providing inspection services in
compliance with the Acts.
In the preamble to the proposed rules, FSIS explained that to
verify that designated personnel are providing the necessary inspection
services, the SEC for the establishment, in coordination with the
State, will verify that the designated personnel are correctly applying
Federal inspection methodology, making decisions based upon the correct
application of this methodology, accurately documenting their findings,
and, when authorized to do so, implementing enforcement actions in
accordance with the FSIS Rules of Practice in 9 CFR part 500 (74 FR
47655). Thus, the proposed rule makes clear that, as part of their
inspection activities, designated State personnel are responsible for
initiating enforcement actions in selected establishments if such
personnel determine that an enforcement action is authorized under 9
CFR part 500.
The 2008 amendments to the Acts provide that if the SEC determines
that any selected establishment is in violation of any requirement of
the Acts, the SEC is required to: (1) Immediately notify the
Administrator and (2) ``deselect'' the establishment or suspend
inspection at the establishment (21 U.S.C. 683(d)(3)(C) and
472(d)(3)(C)). As explained in the preamble to the proposed rule, in
adopting this language, Congress intended that the SEC ``* * * shall be
provided all the tools necessary * * * to prevent or control any food
safety issue that would harm human health'' (S. Rep. No. 220, 110th
Cong., 1st Sess., at 211 (2007)). Therefore, to ensure that the SEC has
the appropriate authority to address any food safety issues as required
by the statutes, the proposed rule authorizes the SEC to initiate any
appropriate enforcement action provided for in 9 CFR part 500 if he or
she determines that a selected establishment under his or her
jurisdiction is operating in a manner that is inconsistent with the
Acts or their implementing regulations.
Thus, under the proposed rule, designated State personnel are
responsible for taking appropriate enforcement action for violations of
Federal food safety standards in selected establishments when such
actions are authorized under 9 CFR part 500. The SEC covering a
selected establishment is also authorized to take any necessary
enforcement actions if the SEC identifies the need to take such action
when conducting oversight activities at a selected establishment.
Comment: One comment agreed with the proposed enforcement
provisions and stated that selected establishments should be subject to
Food Safety Assessments (FSAs) just as federally-inspected
establishments are. The comment also maintained that NRs issued to
selected establishments and other enforcement action should be made
available through the Freedom of information Act (FOIA).
Response: States that participate in the cooperative interstate
shipment program will need to conduct comprehensive FSAs in order to
properly enforce Federal food safety standards. As discussed in the
preamble to the proposed rule, the SEC will also be authorized to
conduct an FSA, or to request that an FSIS Enforcement, Investigation,
and Analysis Officer (EIAO) conduct an FSA, if the SEC in consultation
with the District Manager determines that such action would help
[[Page 24736]]
determine whether the establishment is operating in compliance with the
Acts.
Any records that the States and selected establishment are required
to provide to FSIS to allow the Agency to provide the necessary
oversight and enforcement of the cooperative interstate shipment
program, including NRs issued to selected establishments, will be made
available to the public through the FOIA if the records are not subject
to an exemption under the FOIA.
Comment: One comment stated that the final rule needs to specify an
appeals process for non-compliances to ensure that all establishments
that participate in the program understand the process and their
rights.
Response: The proposed rule provided that selected establishments
participating in the cooperative interstate shipment program would be
subject to the notification and appeal procedures set out in 9 CFR part
500 (proposed 9 CFR 332.9(b) and 381.519(b)). Thus, the proposed rule
did provide for an appeals process for non-compliances.
6. SEC Duties--Quarterly Reports
As provided for in the law, the proposed rule provides that the SEC
is to prepare a report on a quarterly basis that describes the status
of each selected establishment under the SEC's jurisdiction (proposed 9
CFR 332.8 and 381.518).
Comment: Some comments requested clarification on the type of
information the SECs will be required to include in their quarterly
reports. One comment asked whether the quarterly reports will include
the SEC's assessment of the performance of the designated State
personnel or of the selected establishments. One comment stated that
the quarterly report should include the SEC's assessment of the State
program's performance in providing inspection services to selected
establishments and not be limited to the performance of the designated
personnel.
Response: The proposed rule provided that the SEC quarterly report
will: (1) Include the SEC's assessment of the performance of the
designated personnel in conducting inspection activities at selected
establishments and (2) identify the selected establishments that the
SEC has verified are in compliance with all Federal requirements, those
that have been deselected, and those that are transitioning to become
Federal establishments (proposed 9 CFR 332.8(b) and 381.518(b). Thus,
the quarterly report includes the SEC's assessment of the performance
of both the selected establishments and the designated State personnel.
The designated personnel's ability to provide inspection services
to selected establishments in a manner that complies with Federal
standards reflects the State's ability to administer the cooperative
interstate shipment program. Thus, the quarterly report will reflect
the SEC's assessment of the State program's performance in providing
inspection services to selected establishments.
Comment: One comment asserted that the SEC's do not need to visit
selected establishments on a quarterly basis to complete the quarterly
report. The comment stated that SECs will be able to determine the
status of selected establishments based on routine reports and other
documentation submitted by designated State personnel. Another comment
stated that requiring an assessment on a quarterly basis would
establish a burdensome Federal oversight process for States that
participate in the program.
Response: As discussed above, the 2008 amendments to the Acts
require that SECs visit selected establishments with a frequency that
is appropriate to ensure that selected establishments are operating in
a manner that is consistent with the Federal Act. There is nothing in
the law to indicate that the SEC is to determine the status of selected
establishments based on routine reports and other documentation
submitted by designated State personnel, as suggested by the comments.
FSIS disagrees with the comment that stated that requiring an
assessment on a quarterly basis would establish a burdensome Federal
oversight process for States that participate in the program. As noted
above, the 2008 amendments to the Acts require that the SECs prepare a
quarterly report.
Comment: Some comments asked whether the State MPI programs would
have a role in preparing the quarterly reports. One comment asked
whether the States will receive copies of the quarterly reports from
the SECs.
Response: The proposed rule provides that the SEC, in coordination
with the State, will verify that selected establishments in the State
are receiving the necessary inspection services from designated State
personnel and that these establishments are eligible, and remain
eligible, to participate in the cooperative interstate shipment program
(proposed 9 CFR 332.8(b) and 381.517(b)). Although the SEC is
responsible for preparing the quarterly reports, the SEC will
coordinate with the State to assess the status of selected
establishments under the SEC's jurisdiction. FSIS will provide the
State copies of the SEC's quarterly reports on the status of selected
establishments in the State upon request.
I. Deselection and Transition To Become Federal Establishment
The proposed regulations provide that the FSIS Administrator will
``deselect'' a selected establishment that becomes ineligible to
participate in the cooperative interstate shipment program (proposed 9
CFR 332.10(a) and 381.520(a)). The preamble to the proposed rule
explained that an establishment could become ineligible for the program
for various reasons, such as hiring additional employees or for
violating the Federal Acts (74 FR 47656). The preamble also noted that
establishments located in a State whose cooperative interstate shipment
program was terminated would also be ineligible for the program.
Consistent with the statute, the proposed regulations require that a
deselected establishment be transitioned to become a Federal
establishment (proposed 9 CFR 332.11 and 381.521).
1. Establishment Deselection
Comment: One comment requested that FSIS provide more specific
information on the circumstances in which an establishment will be
deselected for non-compliance with the Acts. The comment asked whether
a non-compliance report (NR) or a Notice of Intended Enforcement (NOIE)
could result in deselection. According to the comment, NRs and NOIEs
can sometimes be subjective depending on the inspection program
personnel writing them. The comment encouraged FSIS and State
inspection program directors to work with selected establishments that
have non-compliances or enforcement actions against them to help those
establishments come back into compliance and successfully continue
within the program. The comment also asked FSIS to provide proper
oversight and training to the SECs to ensure that the standards for
non-compliances and enforcement actions are applied consistently across
the country.
Response: As noted above, under the proposed rule, the SEC is
authorized to initiate any appropriate enforcement actions authorized
under the Agency's Rules of Practice in 9 CFR part 500, which include,
among others, regulatory control actions, withholding actions, and
suspensions (proposed 332.9(b) and 381.189(b)). The proposed
regulations provide that if inspection at a selected establishment is
suspended for any of
[[Page 24737]]
the reasons specified in 9 CFR 500.3 or 500.4, the Agency will provide
an opportunity for the establishment to implement corrective actions
and remain in the cooperative interstate shipment program or the Agency
will move to deselect the establishment (proposed 9 CFR 332.9(c) and
381.519(c)).
The proposed rule provides that the decision to deselect a selected
establishment under a suspension will be made on a case-by-case basis
(proposed 9 CFR 332.9(d) and 381.519(d)). The proposed rule also states
that in making this decision the FSIS Administrator, in consultation
with the State, will consider, among other factors: (1) The non-
compliance that led to the suspension; (2) the selected establishment's
compliance history; and (3) the corrective actions proposed by the
establishment (proposed 9 CFR 332.9(d) and 381.519(d)). Thus, under
certain conditions, the proposed rule does authorize the FSIS
Administrator to coordinate with the States to help selected
establishments with non-compliances come back into compliance and
successfully continue within the program.
FSIS will provide the SECs with the training they need to oversee
and enforce the cooperative interstate shipment program in a manner
that is consistent with the law and these implementing regulations.
Comment: One comment asserted that the State, not the SEC, should
initiate deselection of a selected establishment. The comment noted
that some States have not incorporated 9 CFR part 500 into their State
laws or regulations. The comment suggested that instead of referencing
9 CFR part 500, the final regulations should give States the authority
to take ``appropriate enforcement action'' against selected
establishments when necessary.
Response: Consistent with the law, under the proposed regulations,
designated State personnel are required to provide inspection services
in compliance with the Federal Acts and implementing regulations. Part
of the designated personnel's inspection duties involves taking
appropriate enforcement actions when authorized to do so. The FSIS
Rules of Practice in 9 CFR part 500 identify the conditions under which
inspection personnel are authorized to take enforcement actions and
include the criteria for when those actions are warranted. Thus, unless
they follow the procedures prescribed in the FSIS Rules of Practice,
designated State personnel will be unable to properly enforce Federal
standards in selected establishments.
Because States are responsible for providing inspection services to
selected establishments participating in the cooperative interstate
shipment program, the States may recommend that an establishment be
deselected from the program if the State determines that the
establishment is not complying with the requirements of the program.
FSIS is likely to accept the State's recommendation.
2. Deselected Establishments To Become Official Establishment
Comment: Some comments supported the provisions in the proposed
rule that require that establishments that become ineligible for the
cooperative interstate shipment program be transitioned to become
Federal establishments. These comments said that such a requirement is
necessary to prevent establishments from attempting to move into and
out of the program with no long-term commitment.
Several comments stated that requiring that a deselected
establishment transition to become a Federal establishment is a
disincentive for establishments to participate in the program and could
force deselected establishments that choose not to come under Federal
regulation out of business. One comment suggested that instead of
requiring that deselected establishments transition to become Federal
establishments, FSIS should allow them to implement corrective actions
and revert back to State inspection.
Response: The 2008 amendments to the Acts authorize the Agency to
establish a procedure to transition selected establishments that
employ, on average, more than 25 employees to become Federal
establishments (21 U.S.C. 683(b)(3)(A) and 472(b)(3)(A)). The 2008
amendments also require that selected establishments that the
Administrator determines to be in violation of any provision of the
Acts be transitioned to become Federal establishments in accordance
with the procedure developed to transition selected establishments that
employ more than 25 employees (21 U.S.C. 683(h) and 472(g)). Thus,
requiring that deselected establishments be transitioned to become
Federal establishments is necessary to implement the law. The law does
not authorize FSIS to allow deselected establishments to revert back to
the State MPI program without transitioning to become a Federal
establishment, even if such establishments implement corrective
actions.
Comment: Many comments stated that FSIS should allow establishments
that have been deselected and successfully transitioned to become
Federal establishments to revert back to the State MPI program if they
choose. The comments stated that if FSIS is concerned that
establishments might find it advantageous to periodically switch from
under one jurisdiction to under another, the Agency could establish a
reasonable time period, such as one-year, before an establishment that
has transitioned to become a Federal establishment could revert back to
a State's jurisdiction. One comment suggested that FSIS give
establishments that have successfully transitioned to become Federal
establishments the option to either revert to the State MPI program or
be reselected for the cooperative interstate shipment program.
Response: After considering these comments, FSIS has decided to
amend the proposed regulations to allow establishments that were
deselected from the cooperative interstate shipment and that have
successfully transitioned to become Federal establishments to revert
back to the cooperative State MPI program after operating as a Federal
establishment for one year.
As noted above, the 2008 amendments to the Acts require that
establishments that are in violation of the Acts be transitioned to
Federal establishments. The amendments also authorize FSIS to deselect
and transition to Federal establishments selected establishments that
consistently employ more than 25 employees on average. However, the
statutes are silent on whether establishments that have successfully
transitioned to become Federal establishments must remain in the
Federal program or whether they can later revert back to the State
program. Therefore, FSIS has determined that the law does not prohibit
such an action.
Allowing deselected establishments that have successfully
transitioned to become Federal establishments to revert back to the
State MPI program will provide flexibility for establishments to
determine which inspection system (Federal or State) best meets their
needs. In addition, requiring that deselected establishments operate
under Federal inspection for a year will promote food safety by
ensuring that these establishments can perform in accordance with
Federal standards before reverting back to the State program.
The statutes provide that the Administrator, in coordination with
the States, shall not select for the
[[Page 24738]]
cooperative interstate shipment program, an establishment that is a
Federal establishment (21 U.S.C. 683 (b)(2)(C)(i), 683(b)(2)(F)). Thus,
FSIS does not believe that the law would allow establishments that have
been deselected from the cooperative interstate shipment program and
transitioned to become a Federal establishment to be re-selected for
the program at a later date.
3. Establishments Deselected for Exceeding Employee Threshold
Comment: A few comments suggested that FSIS allow selected
establishments that were deselected and transitioned to become Federal
establishments because they now have more than 25 employees on average
to revert back to the State MPI program at a later date if they reduce
their average number of employees to fewer than 25. One of these
comments noted that it is not inconceivable that a selected
establishment could quickly exceed its employee-based eligibility
threshold, forcing it to transition to an official Federal
establishment, only to later discover that it does not desire to
maintain the larger operation. The comment stated that in such case,
the establishment should not be prohibited from reverting back to State
jurisdiction or from participating in the cooperative interstate
shipment program if it reduces its average number of employees to fewer
than 25.
One comment stated that selected establishments that have more than
25 employees on average should be required to transition to become
Federal establishments, and that once they have transitioned, they
should not be permitted to revert back to the State MPI program. The
comment stated that selected establishments should anticipate that as
they grow and add additional employees beyond the 25 employee limit,
they will be transitioned to the Federal inspection system. The comment
stated that it is essential that establishments not be permitted to
``forum shop'' for regulatory oversight. According to the comment, if
establishments are meeting the requirements of the new program and are
succeeding, there should be no reason why the establishments that
outgrow this special program should not operate under Federal
inspection.
One comment asked whether an establishment that was deselected
because its average number of employees exceeded 25 rather than for
food safety violations will remain ineligible to participate in the
program in the future.
Response: As discussed above, FSIS has decided to amend the
proposed rule to allow deselected establishments that have been
transitioned to become Federal establishments to revert back to the
State MPI program after successfully operating as a Federal
establishment for one year. This amendment will apply to establishments
that have been deselected for exceeding the average number of employees
limit regardless of whether they reduce their average number of
employees to fewer than 25 or not.
As noted above, because the law prohibits Federal establishments
from being selected for the cooperative interstate shipment program,
FSIS does not believe that it should permit establishments that have
been deselected from the program and transitioned to become Federal
establishments to be re-selected for the program at a later date,
regardless of the reason for the deselection.
Deselection and State Operations
Comment: One comment stated that if the final regulations resulting
from the proposal allow selected establishments to produce some
products under State inspection and other products under the
cooperative interstate shipment program, FSIS must make clear that the
provision that requires that deselected establishments transition to
become Federal establishments only applies to operations conducted
under the cooperative interstate shipment program. The comment asserted
that selected establishments that produce certain products under a
State MPI program should be permitted to continue these operations
without transitioning to become a Federal establishment if the
establishment is deselected from the cooperative interstate shipment
program.
Response: The requirements associated with the cooperative
interstate shipment program only apply to operations that State-
inspected establishments conduct as part of that program. Thus,
deselected establishments that conduct operations under both the
cooperative interstate shipment program and the cooperative State MPI
program will be required to transition the operations subject to the
cooperative interstate shipment program to become a Federal
establishment. These establishments may continue to produce products
under the State MPI program if they maintain an appropriate separation
by time or space between operations.
4. Voluntary Withdrawal
Comment: Several comments requested that FSIS give selected
establishments that continue to be eligible for the cooperative
interstate shipment program the option to voluntarily leave the program
and revert back to operating under the State MPI program. The comments
noted that after being selected for the cooperative interstate shipment
program, some establishments may find that their businesses have
changed such that they no longer need to ship their products
interstate. The comments asserted that it makes no sense to force
establishments that are in full compliance with the program's
requirements but that no longer need to participate in the program to
become Federal establishments.
Most of the comments that requested that selected establishments be
permitted to voluntarily leave the cooperative interstate shipment
program and revert back to their State MPI programs also said that FSIS
should allow these establishments to re-enter the program at a later
date. These comments acknowledged that the rules should prohibit State-
inspected establishments from freely moving into and out of the program
and suggested that the final regulations prescribe a waiting period
that establishments that voluntarily leave the program must comply with
before they may re-apply for the program. Most comments suggested a
one-year waiting period, and one suggested a five year wait. One
comment asked whether an establishment that voluntarily leaves the
program will be allowed to re-apply for the program if it comes under
new ownership at a later date.
Response: FSIS has considered these comments and has concluded that
it would not be inconsistent with the law to allow a selected
establishment that is in full compliance with the cooperative
interstate shipment program to voluntarily leave the program and
operate under a State grant of inspection.
The 2008 amendments to the Acts require that any establishment
selected for the cooperative interstate shipment program that is in
violation of any requirement of the Federal Acts be ``transitioned to a
Federal establishment'' (21 U.S.C. 683(h) and 472(g)). However, the
statutes do not address situations in which an establishment that is in
full compliance with the Federal Acts elects to voluntarily withdraw
from the program for business reasons, e.g., the establishment is in
compliance with all
[[Page 24739]]
Federal standards but has been unable to establish a market for its
products outside of the State. FSIS has concluded that allowing these
establishments to voluntarily end their participating in the
cooperative interstate shipment program will give them the flexibility
they need to determine which inspection program can best meet their
business needs.
FSIS has also decided to permit establishments that have
voluntarily left the cooperative interstate shipment program to apply
for and be re-selected for the program at a later date. Allowing these
establishments to be re-selected for the program presents little
concern about regulatory forum shopping because they would be leaving
the program for business reasons and not because they are having
difficulty meeting Federal food safety standards.
In addition, establishments that voluntarily withdraw from the
cooperative interstate shipment program would need to re-apply through
the State and be re-selected by the FSIS Administrator in coordination
with the State in order participate in the program again at a later
date. Both FSIS and the States are unlikely to select an establishment
that has a history of applying for and then withdrawing from the
program. Therefore, FSIS has decided that the one-year waiting period
suggested by the comment is a reasonable amount of time for
establishments that voluntarily leave the program to wait before they
may re-apply for the program. Such a policy will give establishments
that are in full compliance with the program flexibility to re-apply
for the program if, at a later date, they find that there may be a
market for their products in other States.
Comment: One comment recommended that FSIS distinguish between
selected establishments that want to withdraw completely from the
program, and those that want to withdraw temporarily and resume
operations under the program at a later date. According to the comment,
such a distinction is necessary because many very small establishments
operate on a seasonal basis or part of the year. The comment stated
that the final regulations should include a process in which entities
that operate on a seasonal basis could apply for a temporary withdrawal
from the program. The comments said that the process could be similar
to the process used by Federal establishments to apply for a temporary
withdrawal of inspection.
One comment stated that it is not uncommon for very small
establishments to operate infrequently or in response to local consumer
demands. The comment noted that State MPI programs are generally able
to offer a great amount of flexibility in providing inspection services
to these small establishments upon request. The comment recommended
that FSIS provide for this type of practice in the final regulations
implementing the cooperative interstate shipment program. The comment
also stated that the decision to provide infrequent or sporadic
inspection should be the State's.
Response: As explained above, selected establishments that are in
compliance with the cooperative interstate shipment will be permitted
to voluntarily withdraw from the program. However, if these
establishments want to resume operations as a selected establishment,
they will need to re-apply and be re-selected for the program by the
FSIS Administrator in coordination with the States.
On the other hand, selected establishments that operate on a
seasonal basis may also request a voluntary suspension of inspection
from the State to cover times when the establishment does not operate.
Selected establishments that are granted a voluntary suspension will
not need to re-apply for selection to resume operations under the
cooperative interstate shipment program. As suggested by the comment,
the decision to provide infrequent or sporadic inspection in response
to a request from a selected establishment will be the State's.
Comment: One comment suggested that FSIS consider implementing an
open enrollment period during which State-inspected establishments
could get in or out of the interstate shipment program without
penalties, so long as they are qualified for the program. The comment
said that FSIS could limit the number of times that establishments are
allowed to make such changes. The comment claimed that such a program
would give State-inspected establishments the option to take advantage
of the program when it worked best for their business.
Response: The proposed regulations specified how State-inspected
establishments that are interested in participating in the cooperative
interstate shipment program are to apply for the program, and FSIS is
amending the proposed regulations to allow selected establishments that
are in compliance with the program to voluntarily end their
participation. Therefore, FSIS has concluded that it is unnecessary to
establish an open enrollment period in which State-inspected
establishments that qualify for the cooperative interstate shipment
program could enter or withdraw from the program.
The proposed regulations require that State-inspected
establishments that are interested in participating in the cooperative
interstate shipment program apply for the program through the State in
which the establishment is located (proposed 9 CFR 332.5(a)(1) and
381.515(a)(1)). The preamble to the proposed rule makes clear that
States participating in the cooperative interstate shipment program
will develop their own application procedures (74 FR 47653). Thus,
State-inspected establishments that are interested in participating in
the cooperative interstate shipment program will follow their State's
application procedures to request that they be selected for the
program.
As explained above, an establishment that has been selected for the
cooperative interstate shipment program and that is in compliance with
all of the programs requirements may voluntarily end its participation
at any time. Such establishments will be permitted to re-apply for the
program after a waiting period of one year.
5. Termination of State's Cooperative Agreement
Comment: Several comments asserted that selected establishments
that become ineligible for the cooperative interstate shipment program
because their State's agreement for the program was terminated should
not be required to transition to become Federal establishments.
Instead, the comments suggested that FSIS give these establishments the
option of either applying for a Federal grant or reverting back to the
State MPI program. The comments said that establishments that are
deselected because the State agreement is terminated have no control
over the circumstances under which they were deselected and, therefore,
it is unfair to require that they become Federal establishments.
A few comments asked FSIS to consider the impact of requiring that
selected establishments transition to Federal establishments if the
State's agreement for a cooperative interstate shipment program is
terminated. According to the comments, such a requirement could affect
the future viability of some of these establishments. The comments said
that it would be devastating to local markets if deselected
establishments had to shut down because they are not allowed to revert
back to the State MPI program.
Response: The 2008 amendments to the Acts do not require that
establishments that are no longer
[[Page 24740]]
eligible to participate in the cooperative interstate shipment program
because they are located in a State whose agreement for such a program
was terminated transition to become Federal establishments. Therefore,
FSIS is amending the proposed rule to give these establishments the
option to either revert back to the State MPI inspection program or
obtain a Federal grant of inspection.
If a State's agreement for a cooperative interstate shipment
program is terminated, some establishments that were operating under
the cooperative interstate shipment program may be willing to forgo
interstate shipment and revert back to the State MPI program because
they prefer to receive inspection services from State personnel. Other
establishments may prefer to continue to market their products
interstate under a Federal grant of inspection. It only seems fair to
give establishments that are in compliance with the requirements of the
program, but that become ineligible because of a situation that is
beyond their control, the option of transitioning to become a Federal
establishment or reverting back to the State program.
Comment: One comment stated that the decision to terminate a
State's agreement for a cooperative interstate shipment program should
not be taken lightly or without considering circumstances unique to the
State and its selected establishments. The comment suggested that FSIS
revise the provision in proposed rule that states: ``If the State fails
to develop a corrective action plan, or the selected establishment
coordinator for the State determines that the corrective action plan is
inadequate, the Administrator will terminate the agreement for the
cooperative interstate shipment program * * *'' to change ``will'' to
``may.'' The comment stated that this revision will provide an
appropriate degree of flexibility for the Administrator in deciding
whether to terminate an agreement for a cooperative interstate shipment
program.
Response: The proposed regulation provides that if the SEC
determines that designated State personnel are providing inspection
services to selected establishments in the State in a manner that is
inconsistent with the Federal Acts and implementing regulations, the
Administrator will provide an opportunity for the State to develop and
implement a corrective action plan to address inspection deficiencies
identified by the SEC (proposed 9 CFR 332.7(c) and 381.517(c)). The SEC
will advise the State on the issues that the State needs to address to
ensure that the corrective action plan adequately addresses the
deficiencies identified by the SEC. However, if the State fails to
develop a corrective action plan that adequately addresses the issues
identified by the SEC, FSIS believes that the Administrator has no
choice but to terminate the cooperative agreement. Therefore, the
Agency is not changing ``will'' terminate the agreement to ``may''
terminate the agreement, as suggested by the comment.
7. Transition Procedures
Comment: The proposed regulations provide that if a selected
establishment is deselected, FSIS will coordinate with the State where
the establishment is located to develop and implement a plan to
transition the establishment to become an official establishment. One
comment stated that FSIS needs to clearly state the procedures needed
to transition a selected establishment to become a Federal
establishment to ensure that all States and establishments that are
interested in participating in the program agreement fully understand
all of the requirements and potential consequences of deselection.
Response: The 2008 amendments to the Acts authorize FSIS to develop
a procedure to transition selected establishments to become Federal
establishments if they employ more than 25 employees on average, or if
the Administrator determines that they are in violation of any
provision of the Acts (21 U.C.S. 683(b), 683(h), 472(b) and 472(h)). In
the preamble to the proposed rule, the Agency explained that it was not
prescribing specific procedures to transition selected establishments
to become official establishments because the actions needed to
successfully make such a transition are likely to depend on the reason
the establishment was deselected (74 FR 47656). As an example, FSIS
noted that an establishment that was deselected for violating the Acts
would likely need to develop a corrective action plan to transition to
an official establishment, while an establishment that was deselected
for hiring additional employees would not.
Therefore, consistent with the proposal, FSIS has decided to not
prescribe specific procedures to transition selected establishments to
become Federal establishments, as suggested by the comment. As was
proposed, if a selected establishment is deselected from the
cooperative interstate shipment program, FSIS will coordinate with the
State where the establishment is located to develop and implement a
plan to transition the establishment. As noted in the preamble, at a
minimum, such a plan will include: (1) Adding the establishment to an
FSIS circuit; (2) replacing the establishment's State establishment
number with a Federal number; and (3) replacing the designated
personnel with FSIS personnel.
Comment: One comment noted that in the proposed rule FSIS outlined
some general procedures that would be necessary to transition a
selected establishment to become a Federal establishment (e.g.,
changing the establishment number and replacing state personnel with
FSIS inspection personnel) but that the Agency also explained it would
collaborate with the States to implement specific transition procedures
on a case-by-case basis. The comments stated that while this approach
may be appropriate in dealing with individual establishments in a
State, FSIS should develop specific procedures for instances when the
State's agreement for a cooperative interstate shipment program is
terminated.
Response: As discussed above, under this final rule, establishments
that are no longer eligible to participate in a cooperative interstate
shipment because they are located in a State whose agreement for such a
program was terminated will have the option to either revert back to
the State MPI inspection program or obtain a Federal grant of
inspection. Selected establishments that choose to operate under
Federal inspection will need to transition to become a Federal
establishment. FSIS will coordinate with the State where the
establishment is located to develop and implement a plan for the
establishment to obtain a Federal grant of inspection. Selected
establishments that choose to revert to the State MPI program will need
to obtain a State grant of inspection through the State in which they
are located.
J. Federal Contribution, Technical Assistance, and Transition Grants
1. Federal Contribution 60% State Costs
As noted in the preamble to the proposed rule, the statute requires
that the Federal contribution for inspection services provided by
States that enter into an agreement for a cooperative interstate
shipment program be at least 60% of eligible State costs. In the
preamble, FSIS also explained that the Agency had tentatively concluded
that eligible State costs are those costs that a State has justified
and FSIS has approved as necessary for the State to provide inspection
services to selected
[[Page 24741]]
establishments in the State (74 FR 47650). The Agency requested
comments on whether it should codify this definition or any other
requirements related to State reimbursement for eligible costs in the
final rule.
Comment: Comments submitted by both State Departments of
Agriculture and consumer advocacy organizations stated that FSIS should
codify requirements related to reimbursement of States for at least 60%
of their eligible costs associated with the cooperative interstate
shipment program. According to some comments, codifying these
requirements would provide both States and FSIS personnel with
consistent guidance on the level of reimbursement and requirements for
receiving payment under the program. The comments also said that
codifying the reimbursement requirements will prevent ad hoc
interpretations and inequitable reimbursement policies over time.
Some comments requested that FSIS more clearly define ``eligible
costs.'' The comments specifically asked whether the following State
costs would be considered eligible costs under the final rule: (1)
Federal Indirect Cost Reimbursement to pay for office and
administrative support services; (2) rent for computers, (3)
administrative offices and field staff offices; and (4) fees associated
with information technology and laboratory services.
One comment supported the proposed definition of eligible State
costs as those direct costs that a State has justified and FSIS has
approved as necessary for the State to provide inspection services to
selected establishments in the State. The comment argued that these are
Federal taxpayer dollars that should be spent on Federal programs. The
commenter stated that it understands that the law requires FSIS to
reimburse States not less than 60% of eligible State costs but,
according to the comment, such reimbursement should be confined to
direct costs only. The comment asserted that costs that fall under
Federal Indirect Cost Reimbursement definitions should not be included.
Response: To be reimbursed for 60% of their eligible costs to
administer the cooperative interstate shipment program, States will
need to follow the same financial accountability and budget submission
requirements needed to receive the maximum 50% Federal reimbursement
under the cooperative State MPI program. These requirements include,
but are not limited to, the administrative rules for Federal grants and
cooperative agreements prescribed in USDA's Uniform Administrative
Requirements for Grants and Cooperative Agreements to State and Local
Governments regulations (7 CFR part 3016), as well as the principles
provided in the Office of Management and Budget's (OMB) circular A-87
``Cost Principles for State, Local, and Indian and Tribal Governments''
(2 CFR Part 225); OMB circular A-102, ``Grants and Cooperative
Agreements with State and Local Governments''; and OMB circular A-133,
``Audits of States, Local Governments, and Non-Profit Organizations''.
FSIS will only reimburse 60% of a State's costs to administer the
cooperative interstate shipment program if the State can justify that
the costs are necessary to provide inspection services to selected
establishments in the State and that the costs are allowable under the
applicable Federal cost principles or other terms and conditions of the
cooperative agreement. To make this clear, FSIS is codifying the
definition of eligible State costs that it had tentatively decided on
in the proposed rule. Thus, 9 CFR 321.3 and 381.187 of this final rule
provide that for purposes of the cooperative interstate shipment
program, eligible State costs are those costs that a State has
justified and FSIS has approved as necessary for the State to provide
inspection services to selected establishments in the State.
The Federal requirements and procedures for the financial
administration and operation of cooperative State agreements are
described in FSIS Directive 3300.1 ``Fiscal Guidance for Cooperative
Inspection Programs''. These requirements and procedures apply to all
cooperative inspection program agreements, including agreements for the
cooperative interstate shipment program. FSIS will update directive
3300.1 to specifically address the cooperative interstate shipment
program.
Comment: One comment asked whether a State's administrative costs
to begin an interstate shipment program will be eligible for at least
60% reimbursement from FSIS. The comment also asked whether there is
anything in the program that would prohibit a State from charging an
establishment a fee to participate in the program to help cover the
State's additional costs. Another comment asked whether the final rule
will require that States submit separate financial reports for
inspection costs associated with the State MPI program and for costs
associated with the cooperative interstate shipment program.
Response: As noted above, FSIS will only reimburse 60% of a State's
costs to administer the cooperative interstate shipment, including the
administrative costs to begin the program, if the State can justify
that the costs are necessary to provide inspection services to selected
establishments in the State and that the costs are allowable under the
applicable Federal cost principles or other terms and conditions of the
cooperative agreement. The 2008 amendments to the Acts are silent on
whether a State may charge an establishment a fee to participate in the
cooperative interstate shipment program. The proposed rule provides
that States are responsible for developing their own procedures for
establishments to apply to be selected for the cooperative interstate
shipment program.
The agreement between FSIS and a State for a cooperative interstate
shipment program is separate from the cooperative State MPI agreement.
Therefore, States that participate in the cooperative interstate
shipment program will be required to submit separate financial reports
for inspection costs associated with the State MPI program and for
costs associated with the cooperative interstate shipment program. The
States must also clearly document the time and cost that they spent to
provide administrative support for the State MPI program versus the
time and cost needed to provide administrative support for the
cooperative interstate shipment program.
Comment: Some comments supported the requirement that Federal
reimbursement for the cooperative interstate shipment program be in an
amount of not less than 60% of eligible State costs. The comments urged
FSIS to provide more funding if, and when, the budget allows.
One comment stated that in order for the program to succeed, it is
critically important for FSIS, the Obama Administration, and Congress
to commit sufficient resources to carry out the program. The comment
stated that under no circumstances should FSIS be required to absorb
these resources from its existing budget.
One comment stated that the higher the Federal contribution, the
more likely it is that State programs will be able to participate in
the interstate shipment program. The comment encouraged FSIS to be
creative in finding ways to increase the Federal contribution to the
program. The comment noted that cash infusions are the best way to
support the program, but that other contributions, such as equipment
(including computers discussed above) and services (including training
and
[[Page 24742]]
laboratory services), would also be helpful.
Response: FSIS agrees that the success of the cooperative
interstate shipment program will depend on the level of funding that
Congress provides for the Agency to administer the program.
2. Technical Assistance and Outreach
As required by the statute, FSIS established the Office of Outreach
Employee Education and Training (OOEET) to provide ``outreach,
education, and training to certain small and very small
establishments'' and to provide ``grants to States to provide outreach,
technical assistance, education, and training to certain small and very
small establishments'' (21 U.S.C. 683(f)).
In the preamble to the proposed rule, FSIS explains that the Agency
fulfilled this requirement by establishing the Office of Outreach
Employee Education and Training (OOEET). OOEET is responsible for
directing outreach, education, and training programs for FSIS to ensure
public health and food safety through both inspection and enforcement
activities. FSIS received several comments and suggestions on how OOEET
should provide outreach and technical assistance to support the
cooperative interstate shipment program. FSIS has included a general
description of these comments below. However, OOEET's outreach and
assistance activities were not specifically addressed in the proposed
rule. Thus, these comments are outside the scope of this rulemaking.
Comment: Some comments encouraged OOEET to work with other Federal
agencies to assist establishments that are interested in participating
in the cooperative interstate shipment program to acquire grants or
loans to fund modifications that they may need to make to their
facilities in order to comply with Federal standards. The comments
noted that in the preamble to the proposed rule, FSIS estimated that
establishments that need to make structural modifications or perform
new construction could incur costs in the range of $15,000 to $30,000.
The comments said that the States should not be expected to fund these
costs.
A few comments suggested that FSIS use USDA's ``Know Your Farmer,
Know Your Food'' initiative to provide information about USDA grant and
loan programs to help small and very small facilities upgrade their
infrastructure.
The consumer advocacy organization Food and Water Watch submitted
identical comment letters on behalf of 5,083 private citizens. The
comment letters supported FSIS's proposed regulation implementing the
cooperative interstate shipment program. The comments also suggested
that FSIS take a number of actions to ensure that the change to the new
program goes smoothly and is feasible for States and small
establishments.
Three comments reference a report issued by Food and Water Watch
entitled ``Where's the Local Beef?'' The comments stated that the
report provides a number of recommendations that FSIS should consider
for the technical assistance required under the statute. The comments
encouraged FSIS to consider these recommendations.
One comment stated that to ensure that States and establishments
receive the assistance that they need to participate in the program,
the Administration must budget, and Congress must appropriate, adequate
funding for outreach and training activities. The comment said that, in
particular, OOEET will need sufficient resources to conduct workshops,
training sessions, and other activities to ensure that small and very
small establishments in the new program understand the requirements
they are expected to meet.
Response: As noted above, the issues raised by these comments are
outside the scope of this rulemaking. However, the Agency will take
them into consideration when it implements this final rule.
3. Transition Grants
Under the statute, FSIS is authorized to provide ``transition
grants'' to States to assist the States in helping State-inspected
establishments transition to selected establishments (21 U.S.C. 683(g)
and 472(f)). In the proposed rule, FSIS explained that it has
tentatively decided to define transition grants as funds that a State
participating in a cooperative interstate shipment program must use to
reimburse selected establishments in the State for the cost to train
one individual in individual in HACCP requirements for meat and poultry
products and associated training in the development of Sanitation SOPs.
FSIS received several comments on the proposed definition of
transition grants.
Comment: Some comments supported FSIS' tentative conclusion to use
its transition grant authority to reimburse States for the costs of
HACCP training for establishment employees as an appropriate use of
these funds. According to one comment, FSIS has already created a
division to provide technical assistance for small and very small
establishments, i.e., OOEET, so it is not necessary to provide
transition grants to the States to use for duplicative outreach
services.
Other comments said that the proposed transition grant definition
is too narrow, unnecessarily restrictive, and does not reflect the fact
that training may be more urgently needed in other areas essential to
food safety, such as microbiological sampling, process control,
validation, determination of HACCP Critical Limits, or use of modern
monitoring techniques. The comments suggested that FSIS revise the
definition to allow the funds to be used to provide outreach, technical
assistance, education, and training that establishments may need to
become selected establishments and maintain this designation.
Other comments stated that while HACCP training is an appropriate
use of transition grants, it should not be the only use permitted for
these funds. The comments asserted that transition grants could be used
in some States for relevant state and local agencies to convene
workshops and listening sessions on the application of local, State and
Federal food safety regulations on small and very small processing
establishments. The comments asserted that these workshops could
generate approaches to improve and streamline food safety regulations,
including HACCP requirements, to ensure that they are appropriate for
achieving food safety standards in smaller facilities.
A few comments stated that FSIS should permit transition grant
funds to be used for tangible items, such as facility upgrades or other
one-time start up costs for establishments to become eligible for the
cooperative interstate shipment program. One comment said that, if
necessary FSIS could limit the amount it would provide to States to
reimburse selected establishments to $5,000 per establishment, which
was the Agency's estimated cost to train an individual in HACCP.
Two comments submitted by animal welfare advocacy organizations
stated that, in addition to HACCP training, FSIS should also allow
States to use transitions grant funds to reimburse selected
establishments for their costs to train personnel in humane handling
and humane slaughter.
Response: The comments indicate that there is a general lack of
consensus on the appropriate use of transition grant funds. Therefore,
because the comments offered no compelling reason to change it, FSIS is
adopting the proposed definition of transition grant as funds that a
State participating in a cooperative interstate shipment program must
use to reimburse selected establishments in the State for the cost
[[Page 24743]]
to train one individual in HACCP requirements for meat and poultry
products and associated training in the development of Sanitation SOPs.
FSIS has very limited authority for and experience in administering
grants for financial assistance outside the scope of cooperative
inspection programs, and its food safety focus suggests that it would
be of limited value for the Agency to gain such experience. Other USDA
agencies, such as Rural Development and the National Institute for Food
and Agriculture provide loans and grants of the kind that might be
useful for establishments that may need to make modifications to their
facilities to become eligible for the cooperative interstate shipment
program. FSIS will coordinate with these other USDA agencies in
developing and publicizing such programs, but will defer to them as
USDA's loan and grant program specialists.
A limited grants program to provide Federal funds to States so that
they may reimburse selected establishments for HACCP training is,
however, consistent with FSIS's authorities and capabilities. It will
help to ensure that establishments that participate in the cooperative
interstate shipment program are able to comply with Federal food safety
standards. Limiting the use of transition grants to HACCP training for
one individual will ensure that the costs associated with these grants
are limited, predictable, and simple to monitor.
Comment: One comment requested that FSIS provide more details on
the transition grants. The comment noted that while funds from
transition grants will be available to help establishments with the
costs of training on HACCP and SSOPs, some establishments are likely to
have already completed the necessary HACCP training. For those
establishments, the comment asked whether States could use transition
grant funds to reimburse the establishment's costs to send an employee
to advanced HACCP training courses or to send another employee for
training in basic HACCP and SSOPs. The comment also asked if the grant
includes all costs associated with the training, from travel costs to
the cost of registration or materials.
Response: The proposed rule requires that States use transition
grant funds to reimburse selected establishments for their costs to
train one individual in HACCP requirements for meat and poultry
products as required under 9 CFR 417.7 of the HACCP regulations and
associated training in the development of Sanitation SOPs. These
regulations require that the individual successfully complete a course
of instruction in the application of the seven HACCP principles to meat
or poultry product processing. Thus, transition grant funds may be used
to reimburse the costs associated with the basic training required to
comply with 9 CFR 417.7, which does not include advanced HACCP
training. The transition grant would include any costs that the
establishment can demonstrate were necessary to provide HACCP training
to one individual.
K. Potential Benefits
FSIS received several comments on the potential benefits of
allowing small and very small State-inspected establishments to ship
meat and poultry products in interstate commerce. Following is a
general description of these comments categorized by potential benefit.
1. Expand Markets for Small Establishments
Several comments said that allowing State-inspected products to
ship meat and poultry products interstate will benefit small and very
small State-inspected establishment by providing new markets for their
products. The comments also stated that, as small processors expand
their markets, consumers will also benefit from an increase in product
choice.
2. Rural Development
Some comments stated that, if implemented correctly, the
cooperative interstate shipment program will provide opportunities for
rural development. One comment said that a workable cooperative
interstate shipment program will stimulate small business sales, expand
rural development and jobs, and increase local tax bases, strengthening
the stability of rural communities. Another comment noted that
increasing the market opportunities for small processors is important
to rural development because it will help to maintain and increase jobs
in the rural areas where many of these small processors are located.
3. Small Farmers and Livestock Producers
Several comments stated that allowing State-inspected processing
plants to ship products interstate will benefit small farmers and local
livestock and poultry producers by providing them with access to
processing plants that can sell meat and poultry products across State
lines. The comments noted that farmers rely on processing plants to
sell their products to consumers, and that allowing interstate shipment
of State-inspected products will help family farmers raising livestock
and poultry, as well as small processing plants, to increase their
access to larger markets.
One commenter had conducted a survey of farmers across the country
in spring 2009 to identify barriers to local food marketing. The
comment noted that by far, the number one barrier mentioned was access
to processing plants for meat, poultry, and value-added crops.
Several comments said that, in addition to expanding markets for
local livestock and poultry producers, allowing small State-inspected
processing plants to ship products interstate will also benefit these
local producers by reducing travel costs that many must incur to send
their livestock to a federally-inspected establishment. One comment
said that a producer in central Wyoming estimated that he could save
almost $220,000 per year if he could have his animals processed locally
in a state-inspected establishment. Some comments noted that many small
livestock and poultry producers prefer to have their products processed
in small State-inspected establishments, but that for some of these
producers, the closest small processing establishment may be located
across State lines.
Some comments stated that the cooperative interstate shipment
program could benefit cattle producers by increasing the demand for
beef. The comment said that allowing state-inspected establishments to
ship interstate will provide many smaller packing plants with an
opportunity to expand into new markets. According to the comment,
growth and new opportunities for these smaller plants means that they
will have the opportunity to buy more cattle from producers. The
comment asserted that this further demand for cattle will provide more
competition in the market and will potentially provide more
opportunities for cattlemen.
One comment stated that the increased market opportunities for
small processors will be passed on to livestock and poultry producers,
which will lead to increased on-farm revenues.
A few comments stated that the proposed cooperative interstate
shipment program will offer independent family farmers and niche
producers whose operations use humane and sustainable animal
agricultural practices greater opportunity to market their products to
a broader range of consumers. One comment believed that the proposed
[[Page 24744]]
rule has the potential to benefit small organic livestock operations.
According to the comment, it is often difficult for these producers to
find local slaughter or processing facilities.
One comment stated that the proposed interstate shipment program
has the potential to benefit not only family farmers but the animals
they raise by reducing the stress associated with long transport times
to slaughter.
Some comments stated that the proposed rule will enhance the USDA's
``Know Your Farmer, Know Your Food'' initiative by helping to break
down structural barriers that have inhibited local food systems from
thriving.
4. Protect Public Health
One comment stated that the proposed program will protect public
health by facilitating traceback of State-inspected products that may
be the subject of a recall.
Response: FSIS agrees that these comments all identify potential
benefits associated with the cooperative interstate shipment program.
L. Interstate Shipment and Humane Handling of Livestock
Comment: A few comments noted that the proposed rule did not
mention the Federal Humane Methods of Slaughter Act (HMSA). One comment
stated that, while the FMIA incorporates the HMSA by reference, it is
imperative that FSIS make clear in the final rule's codified text that
establishments must be in compliance with the HMSA and all State humane
handling requirements to be eligible for the cooperative interstate
shipment program.
One comment stated that in May 2008, the commenter published a
report on the enforcement of humane slaughter laws in the United
States. The comment explained that the report included results from a
series of public records requests that the commenter made to the 30
States accredited to administer the Federal humane slaughter laws (the
27 States with cooperative agreements for State MPI programs and 3
States with cooperative programs for custom plants).
Based on this report, the comment concluded that most states that
operate meat inspection programs are not enforcing the HMSA at state-
inspected establishments. The comment said that small state-inspected
establishments are probably less likely to have staff and management
with training in humane handling and slaughter as Federal
establishments, and that small state-inspected establishments are also
probably less likely to have specialized equipment for proper animal
handling or a facility design that promotes humane handling and
slaughter.
Response: To qualify for the cooperative interstate shipment
program, establishments will need to comply with, and States will need
to enforce, standards that are ``the same as'' those imposed under the
Federal Acts and implementing regulations. As noted by the comments,
the FMIA incorporates the HMSA by reference. Therefore, selected
establishments must comply with, and participating States must enforce,
humane handling procedures that are ``the same as'' those imposed under
the HMSA and FSIS's implementing regulations.
Because the FMIA incorporates the HMSA, it is not necessary to
include additional requirements to implement the HMSA in the
regulations implementing the cooperative interstate shipment program.
Comment: One comment suggested that as part of its outreach efforts
to small and very small establishments, FSIS include training in the
humane handling of livestock and poultry during slaughter and
processing. One comment suggested that FSIS grade and identify
establishments based on how humanely they raise their livestock.
Response: These comments are outside the scope of the proposed
rule.
M. Miscellaneous Comments
Comment: A few comments noted that many small and very small
establishments process bison, elk, and other species that are not
amenable to the Federal Acts. The comments asked whether FSIS would
address the processing of these species in the final rule implementing
the cooperative interstate shipment program. One comment asked whether
the final regulations will permit selected establishments to continue
to slaughter non-amenable species under the State inspection program.
The comment also asked whether the ``same as'' standard proposed for
the cooperative interstate shipment program will affect State-inspected
operations related to non-amenable species.
Response: The cooperative interstate shipment program does not
cover operations for the processing of bison, elk, and other species
that are not amenable to the FMIA or PPIA. However, as discussed above,
this final rule will allow State-inspected establishments to operate
under both the State MPI program and the cooperative interstate
shipment program. Under this final rule, selected establishments may
continue to slaughter and process non-amenable species under the State
inspection program as long as they maintain an appropriate separation
of time or space between these operations and the operations conducted
under the cooperative interstate shipment program. Because operations
associated with non-amenable species are not eligible for the
cooperative interstate shipment program, these operations are not
affected by the ``same as'' standard required for the program.
Comment: One comment stated that FSIS must make clear in the final
rule that state-inspected horse slaughter facilities are not eligible
to participate in the new cooperative interstate shipment program. The
comment noted that currently there are no such facilities in operation
in the United States, but expressed concern that providing certain
state-inspected establishments access to the interstate market may
encourage some small establishments to initiate new horse slaughter
operations. The comment stated that Congress has made its intent clear
that Federal funding must not be used to inspect such facilities, and
FSIS must not allow establishments to use the cooperative interstate
shipment program to circumvent the law.
The comment also stated that any attempt by FSIS to regulate horse
slaughter facilities must comply with the National Environmental Policy
Act, 42 U.S.C. 4231 et seq., and cited Humane Society of the United
States v. Johanns (520 F.Supp.2d 8 (D.D.C. 2007)) to support this
statement. The comment asserted that unless FSIS makes clear that the
final rule does not encompass horse slaughter, the Agency will need to
prepare an Environmental Impact Statement or Environmental Assessment
before finalizing the rule to avoid a potential violation of a federal
court order.
Response: As noted by the comment, the FY 2010 Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies
Appropriations Act prohibits the use of appropriated funds and user
fees to pay the salaries of expenses of personnel to inspect horses
prior to slaughter for human food (Pub. L. 111-80, Sec. 739). FSIS
will comply with these and any future restrictions on the use of
appropriated funds as it implements the cooperative interstate shipment
program.
Comment: One comment suggested that, when developing the final rule
to implement the cooperative interstate shipment program, FSIS should
review its data on FSAs, NRs, suspensions, HACCP deviations, number of
lab tests, and laboratory results to compare FSIS regulatory oversight
of very small State-
[[Page 24745]]
inspected establishments with large and small establishments. According
to the comment, this information may help identify specific areas of
concern that the Agency should address in the final rule.
Response: FSIS believes that this final rule provides the
appropriate level of Federal oversight required under the 2008
amendments to the Acts. The data identified by the comment will be
useful to FSIS in overseeing the program.
Comment: One comment asked whether the labels for products produced
in establishments selected to participate in the cooperative interstate
shipment program will be granted expedited review so that they can
begin to operate under the new program more quickly. The comment also
asked whether such labels would be approved by the FSIS Labeling and
Program Delivery Division (LPDD). The comment stated that it would be
disappointing if an establishment's ability to participate in the
cooperative interstate shipment program was delayed because of the
label approval process.
Response: The labels of meat and poultry products produced under
the cooperative interstate shipment program will be subject to FSIS'
prior label approval system to ensure that such labels comply with
Federal labeling requirements. The SEC for the State where a selected
establishment is located will coordinate with the State to facilitate
the label submission process. The SEC will also verify that the labels
applied to meat and poultry products produced under the cooperative
interstate shipment program have been evaluated and approved by LPDD,
except for generically approved labeling authorized for use in Title 9
of the Code of Federal Regulations (CFR), Sec. Sec. 317.5 and 381.133.
Because the labels of meat and poultry products produced in selected
establishments are required to bear a Federal mark, it is essential
that these labels comply with all Federal labeling requirements.
Comment: One comment requested that FSIS explain whether, under the
final rule, E. coli O157:H7 would be considered an adulterant if
detected on an intact muscle cut of beef. The comment asserted that if
E. coli O157:H7 is only considered an adulterant if it is detected in a
ground beef sample, selected establishments whose operations are
limited to further processing will be subject to enforcement action,
i.e., deselection, for upstream contamination over which they have no
control.
Two comments suggested that in the final rule, FSIS add a provision
to ensure that selected establishments whose operations are limited to
further processing are not subject to enforcement actions for product
contamination that originated in an upstream slaughter facility.
Response: These comments address issues associated with FSIS's
existing policies with respect to E. coli O157:H7. They are outside the
scope of this rulemaking.
Comment: One comment stated that processors and regulatory staff
have been trained to recognize ``shall'' as an indication of mandatory
requirements. The comment inserted suggested revisions to the proposed
codified text, such as replacing ``will'' with ``shall.'' According to
the comment, the suggested revisions are needed to make clear which
provisions of the regulations are mandatory.
Response: This is the only comment to make these suggested
revisions. FSIS believes that the language in the codified text clearly
articulates the requirements associated with the cooperative interstate
shipment program.
Comment: One comment noted that throughout the proposed regulations
FSIS uses the terms such as ``in compliance with the Acts'' or
``consistent with the Acts.'' The comment stated that since State meat
and poultry inspection programs already comply with the FMIA and PPIA,
FSIS needs to make clear that most references to ``the Act'' in the
proposed regulation are intended to refer to the new legislation, i.
e., Title V of these Acts. According to the comment, Section 11015 of
the 2008 Farm Bill did not amend the existing sections of FMIA and
PPIA, but rather created a new section in each of these Acts. The
comment suggested that FSIS revise ``in compliance with the Acts'' to
``in compliance with this Act'' to make this clear.
Response: In the final codified text, ``this Act'' was changed to
``this chapter.'' As used in the statutes, ``this chapter'' means the
FMIA and PPIA, not section 11015 of the 2008 Farm Bill (see 21 U.S.C.A.
683 and 472, Historical and Statutory Notes, References in Text). Thus,
the terms ``in compliance with the Acts'' or ``consistent with the
Acts'' better reflect the intent of the statutes than ``in compliance
with this Act'' meaning section 11015 of the 2008 Farm Bill.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been reviewed under Executive Order 12866. It
has been determined to be significant, but not economically significant
for purposes of E.O. 12866 and, therefore, has been reviewed by the
Office of Management and Budget (OMB).
Currently, 27 States administer cooperative State meat or poultry
inspection (MPI) programs. These States have approximately 1,873
establishments that would be eligible to apply for selection into the
new cooperative interstate shipment program. However, because
participation in the new program is voluntary, FSIS will not know how
many States and establishments will apply to participate until this
final rule becomes effective and establishments are selected for the
program.
In the proposed rule's Preliminary Regulatory Impact Analysis
(PRIA), FSIS explained that information obtained through the Agency's
outreach activities indicated that, as of July 2008, about 170
establishments in sixteen States had approached the State MPI programs
to express interest in the new cooperative interstate shipment program.
These sixteen States have in total 1,133 establishments that could
potentially be eligible for the new program. However, more recent
Agency outreach activities conducted after the proposed rule was
published indicate that there now may be only four States interested in
participating in the cooperative interstate shipment program.\3\ The
four States that have recently expressed interest in the program are
North Dakota, Ohio, Wisconsin, and Vermont. According to the State
Directors of these four States, the total number of establishments in
these States that might participate is between 27 and 102, and the
actual number will depend on the language of the final rule. This
finding is consistent with information provided in the public comments
submitted in response to the proposed rule that indicated that the
participation number we estimated in the proposed rule was too high.
Therefore, we have adjusted the budget impact downward by incorporating
the new information.
---------------------------------------------------------------------------
\3\ These four States have each signed an agreement with the
Agency to conduct a comparative analysis to determine what the
States would need to do to meet the ``same as'' requirements for the
cooperative interstate shipment program. FSIS provided funds for the
States to conduct the assessment.
---------------------------------------------------------------------------
Expected Benefits of the Proposed Action
State-inspected establishments selected to participate in the new
cooperative interstate shipment program will be permitted to ship and
sell their meat and poultry products in interstate and foreign
commerce. Thus, this final
[[Page 24746]]
rule will benefit these establishments by opening new markets for their
products.
This final rule will also benefit consumers by generating more
product choices, as more products can be shipped to new markets. In
addition, requiring that products produced under the cooperative
interstate shipment program bear a Federal inspection legend that
includes an official State selected establishment inspection number
will allow consumers to identify that these products were produced
under the cooperative interstate shipment program if such products are
ever the subject of an investigation or recall.
States that participate in the program will benefit because the law
requires that FSIS reimburse them for at least 60% of their eligible
costs related to inspection of selected establishments in the State.
FSIS provides up to 50% of the costs to provide inspection under the
existing cooperative State MPI programs. States are likely to benefit
from the 10% increase in reimbursement for the cooperative interstate
shipment program because, as explained below, for many States, the
costs to administer the new program are not expected to greatly exceed
the costs to administer the State MPI programs.
The Agency received several comments that identified additional
potential benefits of allowing small and very small State-inspected
establishments to ship meat and poultry products in interstate
commerce. These benefits include:
1. Rural development: Allowing certain small and very small State-
inspected establishments to ship their products across State lines may
stimulate small business sales, expand rural development and jobs, and
increase local tax bases, strengthening the stability of rural
communities, where many of these small establishments are located.
2. Benefits for small farmers and livestock producers: Allowing
State-inspected processing plants to ship products in interstate
commerce will benefit small farmers and local livestock and poultry
producers by providing them with access to processing plants that can
sell meat and poultry products across State lines. It will also benefit
local producers by reducing travel costs that many must incur to send
their livestock to a federally-inspected establishment, as the closest
small processing establishment may be located across State lines.
Expected Costs of the Proposed Action
1. Costs to the participating establishments. To be eligible to
participate in the cooperative interstate shipment program, a State-
inspected establishment must be in compliance with: (1) The State-
inspection program of the State in which the establishment is located
and (2) the FMIA or PPIA, and their implementing regulations. Before
State-inspected establishments can be selected to participate in a
cooperative interstate shipment program, they will need to apply for
selection into the program and demonstrate that they comply with both
State and Federal requirements.
Thus, an establishment that chooses to apply for selection into the
program will incur one-time start-up costs associated with filing an
application, training employees, meeting regulatory performance
standards, obtaining label approval, and implementing a food safety
system that complies with all Federal requirements (e.g. Sanitation SOP
and HACCP requirements).
In addition, to qualify for a cooperative interstate shipment
program, some State-inspection establishments may need to invest in
structural modifications to their facilities in order to comply with
Federal standards. Based on information obtained through FSIS' outreach
activities with the States in 2008, in the PRIA of the proposed rule,
the Agency estimated that the cost for State-inspected establishments
to fully comply with Federal standards, as required by the law, will
range from $1,500 to $50,000. FSIS did not receive any comments or new
information in response to the proposed rule to suggest changes to
these estimates.
According to most State Directors, the cost to very small
establishments that do not need to make structural modifications to
their facilities is likely to be in the range of $5,000 to $10,000. If
the establishments need to make structural modifications or perform new
construction, the estimated range would be about $15,000 to $30,000.\4\
However, because the cooperative interstate shipment program is a
voluntary program, establishments that choose to incur the costs
associated with participating in the program will most likely do so
because they anticipate that such participation will provide an overall
net benefit for them.
---------------------------------------------------------------------------
\4\ Note that under this final rule, establishments selected for
the program will be eligible to be reimbursed the cost to train one
employee in HACCP and Sanitation SOPs.
---------------------------------------------------------------------------
Looking at the potential for the establishments to experience new
(incremental) burden or expenses due to State inspection under the
proposed cooperative interstate shipment program, FSIS believes that
there will be essentially no change. FSIS is aware that the cooperative
State MPI programs are not identical to the Federal inspection program.
FSIS anticipates that States may need to modify their existing
inspection procedures when providing inspection services to selected
establishment in the State to ensure that these establishments receive
inspection services that are ``the same as'' those required under the
Federal program. However, since the State programs are required to be
``at least equal to'' the Federal inspection programs now, FSIS
anticipates that changes that States will need to make to provide
inspection to selected establishments will largely be procedural, and
there will not be any particular increase or decrease in overall State
effort that would change the burden of the inspection regimen on the
establishments.
2. Costs to the participating States. States that choose to
participate in the program will be required to pay 40 percent of the
eligible costs related to inspection of establishments in the State
that are selected for the program. Under the current cooperative
program, the States are paying 50 percent of the eligible inspection
costs. Although the inspection costs under the new program may be
different from the costs under the existing program, the States' share
of 40 percent or less is unlikely to be higher than its current share.
One area the States will have to address is the laboratory services
that they will be using to analyze samples collected under the
cooperative interstate shipment program. To demonstrate that the
laboratory services used by a State are sufficient for the State to
qualify for the cooperative interstate shipment program, the State will
need to show that the laboratory is accredited by an internationally
recognized organization that accredits food testing laboratories
against the ISO 17025 ``General requirements for the competence of
testing and calibration laboratories'' and AOAC ``Guidelines for
Laboratories Performing Food Microbiological and Chemical Analyses of
Food and Pharmaceuticals Testing'' written by the Analytical Laboratory
Accreditation Criteria Committee (ALACC). The assessment body that FSIS
uses, the American Association for Laboratory Accreditation (A2LA), is
the sole organization that incorporates ALACC into their program
requirements. State labs would need to use A2LA or another accrediting
body that incorporates ALACC and is a signatory and in good standing to
the Mutual Recognition Arrangements of
[[Page 24747]]
the International Laboratory Accreditation Cooperation (ILAC).
Currently three State labs are ISO 17025 accredited--Minnesota,
North Carolina, and Florida (FL does not have a State MPI program),
four States are actively seeking ISO 17025 accreditation--Ohio,
Wisconsin, North Dakota, and Vermont, and four States use commercial
labs that are ISO accredited.
States that use laboratories that do not use the methods described
in FSIS's Laboratory Guidebooks may incur costs to adopt such methods
to analyze samples under the cooperative interstate shipment program.
If a test or product described in the FSIS Guidebook is not
commercially available, FSIS will assist the laboratory in developing
an appropriate alternative method.
To assist the States in developing laboratory services that are
``the same as'' those provided under the Federal inspection program,
FSIS is adopting a ``phased in'' approach for the States to become ISO
17025 accredited. FSIS's Office of Public Health Science (OPHS) intends
to provide advice and answer questions from State labs as they seek ISO
accreditation. FSIS estimates the cost for a State lab to obtain the
necessary accreditation to be ``the same as'' to be somewhere between
$28,000 and $350,000. These costs reflect the costs associated with
purchasing additional equipment, hiring additional staff (QC manager
for Chemistry, QC manager for Microbiology, Document Control Clerk, and
additional analysts,) the initial application fee to apply for ISO
17025 accreditation, the annual fee to maintain accreditation, and the
accrediting body's assessment fee.
States that choose to participate in the interstate shipment
program may need to make certain modifications to their State
inspection programs to provide inspection services to selected
establishments in a manner that is ``the same as'' the Federal
inspection program. However, most States that have implemented State
meat and poultry products inspection (MPI) programs have incorporated
the Federal requirements into their programs.\5\ Thus, State costs to
train State personnel are likely to be minimal because many State
personnel have received training in Federal inspection methodology as
part of the State MPI program. In addition, as noted above, FSIS offers
training courses in Federal inspection methodology to State inspection
personnel. FSIS's OOEET will coordinate with States participating in
the cooperative interstate shipment program to provide the necessary
training for designated State personnel.
---------------------------------------------------------------------------
\5\ Based on Agency's most recent (FY 2009) review of the 27
States' self-assessment reports (including the State Laboratory
Activity Tables) by the Federal State Audit Branch, Internal Control
and Audit Division of the Office of Program Evaluation, Enforcement,
and Review.
---------------------------------------------------------------------------
States may incur some costs associated with the processing and
evaluation of applications submitted by establishments requesting to be
selected for the cooperative interstate shipment program. However,
because the States will develop their own application procedures, FSIS
is unable to estimate these costs with any certainty.
FSIS anticipates that States may need to revise their State
inspection procedures when providing inspection services to selected
establishments in the State to ensure that these inspection services
are ``the same as'' those provided under the Federal program. However,
since the cooperative State MPI programs are required to be ``at least
equal'' to the Federal inspection programs now, FSIS anticipates that
changes will largely be procedural, and there will not be any
particular increase or decrease in overall State effort or cost. FSIS
has no basis on which to assume anything else.
Expected FSIS Budgetary Effects
The new cooperative interstate shipment program that we are
implementing in this final rule is expected to have budgetary effects
on FSIS. This section discusses the baseline costs and activities,
i.e., what is happening now before the cooperative interstate shipment
program option is available, and then lays out the incremental effects
on FSIS. The PRIA in the proposed rule presented a baseline scenario
outlining the Agency's spending for the Federal-State cooperative
inspection programs for FY 2009 through 2014 in case the cooperative
interstate shipment program option is not enacted (see table below).\6\
We did not receive any data or comment in response to the proposed rule
to suggest changes to these numbers.
---------------------------------------------------------------------------
\6\ For details, including assumptions, for the baseline
scenario, please see the proposed rule ``Cooperative Inspection
Programs: Interstate Shipment of Meat and Poultry Products,''
September 16, 2009, 74 FR 47658-47659.
Table 1--Baseline: Cost Federal State Coop Program With No Change
----------------------------------------------------------------------------------------------------------------
2010 Total 5-
FSIS level costs, fiscal year (Budget) 2011 2012 2013 2014 year
----------------------------------------------------------------------------------------------------------------
FSIS costs........................ $15.3 $15.9 $16.5 $17.1 $17.8 $82.5
Reimburs. to States............... 50.3 52.1 54.1 56.2 58.4 271.1
-----------------------------------------------------------------------------
Total......................... 65.7 68.0 70.5 73.3 76.1 353.6
----------------------------------------------------------------------------------------------------------------
FSIS Staff Years.................. 29 29 29 29 29 ...........
----------------------------------------------------------------------------------------------------------------
Federal reimbursement............. $50.3 $52.1 $54.1 $56.2 $58.4 $271.1
State program spending............ 50.3 52.1 54.1 56.2 58.4 271.1
-----------------------------------------------------------------------------
Total MPI program............. 100.7 104.2 108.1 112.4 116.7 542.1
----------------------------------------------------------------------------------------------------------------
Number of plants.................. 1,873 1,873 1,873 1,873 1,873 ...........
----------------------------------------------------------------------------------------------------------------
Economic Assumptions from OMB for the 2010 Budget
----------------------------------------------------------------------------------------------------------------
State & Local Exp, %.............. 3.1 3.5 3.8 3.9 3.9 ...........
FSIS Civilian pay, %.............. 5.1 4.1 4.1 4.1 4.1 ...........
Non-Pay Expenditure, %............ 0.8 1.2 1.4 1.6 1.6 ...........
----------------------------------------------------------------------------------------------------------------
[[Page 24748]]
Interstate Scenario
To evaluate this scenario, we must estimate the number of
establishments and States that will seek to participate and be selected
for the new cooperative interstate shipment program. Then we will
discuss the likely incremental changes in activity that could
reasonably suggest any changes in cost or burden for FSIS, the States,
or establishments.
As noted above, in the proposed rule, through its outreach
activities, FSIS had identified sixteen States that expressed an
interest in the new cooperative interstate shipment program. These
States have a total of 1,133 establishments that could potentially be
eligible for the new program. Because participation in the cooperative
interstate shipment program is voluntary, the Agency could not estimate
with certainty the number of eligible establishments that will choose
to participate. Therefore, in the proposed rule, for illustration
purposes, the Agency estimated the costs for three scenarios: 200, 400
and 600 establishments.
However, comments received in response to the proposed rule
suggested that the Agency overestimated both the number of States and
establishments that were interested in participating in the program.
The most recent Agency outreach activities confirmed this assertion. As
of November 2010, only four States (North Dakota, Ohio, Wisconsin, and
Vermont) expressed interest in participating and, according to the
State Directors, about 27 to 102 establishments may apply for selection
into the program through these four States. Therefore, we revised the
three scenarios to be (1) 27 establishments in four States
participating from FY 2011 through 2014, (2) 102 establishments from
four States from FY 2011 through 2014, and (3) 102 establishments from
4 States in FY 2011, then the participation increases to 200
establishments from all 27 eligible States in FY 2012 through 2014. The
Agency understands that there are many other possible scenarios.
Nevertheless, it is difficult to determine with any certainty which
scenarios are more likely to occur than others; and the farther out (in
terms of fiscal years) the projection, the greater the uncertainty.
These three scenarios are for illustration purposes only as the number
of participating States and establishments can go up or down depending
on the perception of the final rule, the experience of the program once
it starts, and other socio-economic factors.
We started with the change in Federal costs for the program caused
by the new statutory reimbursement level. For the cooperative
interstate shipment program the law requires that FSIS reimburse States
for their eligible costs related to the inspection of selected
establishments in the State in an amount not less than 60 percent of
eligible State costs. Under the existing law, FSIS may reimburse a
State for up to 50 percent of eligible State costs to administer and
enforce the cooperative State MPI. This analysis projects the effects
of the different reimbursement rate on FSIS fiscal requirements
assuming no change in State level activity over the baseline. FSIS
assumes that States will not change their level of activity associated
with selected establishments in the cooperative interstate shipment
program as discussed above.
To calculate this figure, FSIS estimated average per establishment
spending for the cooperative interstate shipment program for the
establishments in four States. For FY 2011, the estimated additional
State reimbursement for inspection of an establishment selected for the
cooperative interstate shipment program compared to the reimbursement
for an establishment operating under the cooperative State MPI program,
is $12,415 (per establishment)in North Dakota, $5,283 in Ohio, $16,123
in Wisconsin, and $3,314 in Vermont.\7\ This and analogous figures are
reflected in the tables below in the ``Total grants to States'' line
for the 27, 102, and 102-200 establishment scenarios.
---------------------------------------------------------------------------
\7\ For methodology of calculating this please see 74 FR 47659-
47660.
To summarize, for each State we took the allocation for FY 2010
under the cooperative State MPI program, divided by the number of
establishments, and then multiplied it by 1.2.
---------------------------------------------------------------------------
Under section 11015 of the 2008 Farm Bill, FSIS is required to
oversee the inspection activities of State personnel designated to
provide inspection to selected establishments in the State. FSIS will
incur costs associated with providing the necessary oversight. FSIS
also expects to incur new costs for outreach and training. This will
result in increased demand for FSIS staff and resources. In summary,
this includes state coordinators, Deputy District Managers (DDM),
outreach and training staff, and lab analysts to certify State
laboratories, transition grants to hone establishment staff skills with
HACCP and SOPs, and associated operating expenses and travel expenses.
The statute requires FSIS to appoint a Federal employee to be a
State Coordinator. As explained earlier in this document, the State
Coordinator prescribed by the statute is referred to as the ``selected
establishment coordinator'' (SEC) in this proposed rule. The SEC is
required by statute to visit selected establishments with a frequency
that is appropriate to ensure that such establishments are operating in
a manner that is consistent with the FMIA and PPIA, including
regulations and policies there under and to: (1) Provide oversight and
enforcement of the program, and (2) oversee the training and inspection
activities of State-personnel designated to provide inspection services
to the selected establishments. SECs will further provide quarterly
reports on each selected establishment under his or her jurisdiction to
document their level of compliance with the requirements of the Acts.
We estimate that 2 to 3 full-time equivalent FSIS employees will be
able to perform the SEC functions for the 4 States interested in
participating in the cooperative interstate shipment program. It is
expected that early in the program the SEC time will initially focus on
outreach and start-up activities (including establishment selection)
and shift over until it is more completely the oversight activities
stipulated in the Acts.
In the start-up period, in addition to SEC outreach efforts, FSIS
expects to incur costs for outreach and training, and administration
from OOEET for the small and very small establishments that are
considering the cooperative interstate shipment program, that decide to
apply for the program, and for those who are selected to participate in
the program. OOEET will conduct face-to-face workshops in every State
to provide information to establishment owners and operators about the
requirements of the new cooperative interstate shipment program. These
workshops will not only educate the interested owners and operators
about the requirements, they will also help them meet the requirements.
This allocation will cover the cost of developing, printing, and
shipping the workshop materials, as well as the cost of traveling
Agency personnel to conduct the workshops, and the cost of meeting
space. The cost is reflected in the tables below in the ``Training/
Outreach'' line. The reason these costs do not change between the
scenarios of 27 and 102 is because the information will be provided in
a classroom. Costs are expected to be largely the same whether
attendance is high or low. Also, note that these costs drop sharply for
each subsequent year as the cooperative interstate shipment program
specific effort changes to operating training for establishments
selected to participate in the program.
[[Page 24749]]
In the start-up period, transition grant authority under 9 CFR
332.12 and 9 CFR 381.522 will be used to provide States funds to
reimburse selected establishments in the State for their costs to train
one individual in HACCP and associated training in Sanitation SOP
requirements. The Agency estimates that the cost of training each
establishment specialist will average about $5,000, including staff
time and travel necessary for the training. Since this is a new expense
necessary to implement the cooperative interstate shipment program and
since statute authorizes it without State matching funds, these costs
will be entirely new costs for FSIS that are part of ``Total grants to
States'' in Table 2 below. This training will only be needed in the
start-up period and, accordingly, appears only in FY 2011 in Table 2
for all three scenarios, and again in FY 2012 in the 102-200
establishments scenario when more establishments participate.
SECs are likely to be supervised by Deputy District Managers (DDMs)
at the equivalent of about 1 DDM per 300 establishments. This is
similar to the ratio of DDM effort used to manage frontline FSIS
supervisors in the Federal programs. For the four States scenario,
though, since the numbers of establishments are less than 300, there
will be one DDM. This is reflected in the ``DDM'' line of the tables
below.
FSIS estimates that two laboratory staff will be needed to complete
periodic audits of the State inspection program laboratory systems and
otherwise coordinate with the laboratories to ensure the sampling and
testing programs are ``the same as'' the Federal program. We anticipate
that the program needs two lab staff regardless of how many
establishments eventually participate because most of the labs
typically have a chemistry residue program and a microbiology program.
This is reflected in the ``Lab staff'' line of the tables below.
Travel costs are included on the ``Travel--SC & lab staff'' line in
the tables below. The SECs will need to travel a fair amount to
complete their duties and the lab staff will need to travel some.
Travel for SECs and lab staff starts in FY 2011.
As noted above, early in the program the SEC's duties will
initially focus on outreach and start-up activities and later will
shift to the oversight activities stipulated in the Acts. Thus, we
project about $6,150 for travel for each SEC in the first year and
$6,300 per year for subsequent years.\8\
---------------------------------------------------------------------------
\8\ The PRIA stated that the estimated travel cost per SEC's in
subsequent years would be $630. This was a technical error and
should have read $6,300.
---------------------------------------------------------------------------
For the lab staff we based our trips to the State program
laboratories on one audit of each laboratory to make an initial
assessment, so that would be one trip to the labs for each of the 4
States. Because most of the labs typically have a chemistry residue
program and a microbiology program, two lab-auditors will go on each
trip--one chemist and one microbiologist. These labs would also need a
follow-up the next year and then we would make a judgment as to whether
there needed to be annual visits after that. We based the number of
audits on the figures that we had regarding the number of States that
will participate. Each trip ran about $1,500 for each auditor.
Finally, there are the normal operating expenses associated with
field operations including office space, communications costs,
information technology costs (such as laptop computers), other
equipment, and office supplies. FSIS estimates $3,500 per new staff for
laptop, LincPass, and Black Berries. These costs are generally stable
over time, although they inflate and, of course, are a little higher in
the start-up year. These costs are found in the ``Equipment and admin''
line of the tables below.
Table 2, below, summarizes the incremental costs to FSIS to operate
the new cooperative interstate shipment program in the three scenarios:
27, 102 and 102-to-200 establishments.
Table 2--Cooperative Interstate Shipment Program Cost Estimates--Three Scenarios ($ Millions)
----------------------------------------------------------------------------------------------------------------
Fiscal year 2011 2012 2013 2014 4-Year
----------------------------------------------------------------------------------------------------------------
Interstate Program--Summary of Incremental Cost Estimates
----------------------------------------------------------------------------------------------------------------
Costs if 27 establishments..................... 1.09 0.95 0.83 0.87 3.74
Costs if 102 establishments.................... 1.94 1.43 1.34 1.40 6.11
Costs if 102, then 200 establishments.......... 1.94 4.22 4.40 4.58 15.14
----------------------------------------------------------------------------------------------------------------
Interstate Program with 27 Establishments
----------------------------------------------------------------------------------------------------------------
Number of establishments....................... 27 27 27 27 ...........
Total grants to States *....................... 0.28 0.15 0.15 0.16 ...........
Total salaries & benefits...................... 0.51 0.53 0.55 0.58 ...........
DDM............................................ 0.09 0.10 0.10 0.11 ...........
State coordinator (SC)......................... 0.16 0.17 0.17 0.18 ...........
Lab staff...................................... 0.25 0.26 0.27 0.29 ...........
Operating expenses............................. 0.31 0.26 0.12 0.12 ...........
Travel-SC & lab staff.......................... 0.02 0.02 0.03 0.03 ...........
Training/Outreach.............................. 0.21 0.19 0.04 0.04 ...........
Equipment and admin............................ 0.07 0.07 0.07 0.07 ...........
----------------------------------------------------------------
Total...................................... 1.09 0.95 0.83 0.87 3.74
----------------------------------------------------------------------------------------------------------------
Interstate Program with 102 Establishments
----------------------------------------------------------------------------------------------------------------
Number of establishments....................... 102 102 102 102 ...........
Total grants to States *....................... 0.99 0.50 0.52 0.54 ...........
Total salaries & benefits...................... 0.59 0.61 0.63 0.67 ...........
DDM............................................ 0.09 0.10 0.10 0.11 ...........
State coordinator (SC)......................... 0.24 0.25 0.26 0.27 ...........
Lab staff...................................... 0.25 0.26 0.27 0.29 ...........
[[Page 24750]]
Operating expenses............................. 0.36 0.30 0.18 0.18 ...........
Travel-SC & lab staff.......................... 0.03 0.3 0.03 0.03 ...........
Training/Outreach.............................. 0.21 0.19 0.05 0.05 ...........
Equipment and admin............................ 0.12 0.11 0.11 0.11 ...........
----------------------------------------------------------------
Total...................................... 1.94 1.43 1.34 1.40 6.11
----------------------------------------------------------------------------------------------------------------
Interstate Program with 102, then 200 Establishments
----------------------------------------------------------------------------------------------------------------
Number of establishments....................... 102 200 200 200 ...........
Total grants to States *....................... 0.99 1.64 1.20 1.25 ...........
Total salaries & benefits...................... 0.59 2.25 2.35 2.45 ...........
DDM............................................ 0.09 0.16 0.17 0.18 ...........
State coordinator (SC)......................... 0.24 1.83 1.91 1.98 ...........
Lab staff...................................... 0.25 0.26 0.27 0.29 ...........
Operating expenses............................. 0.36 0.82 0.85 0.89 ...........
Travel-SC & lab staff.......................... 0.03 0.09 0.10 0.10 ...........
Training/Outreach.............................. 0.21 1.40 1.12 0.35 ...........
Equipment and admin............................ 0.12 0.36 0.38 0.39 ...........
----------------------------------------------------------------
Total...................................... 1.94 4.22 4.40 4.58 15.14
----------------------------------------------------------------------------------------------------------------
* Note ``Total grants to States'' includes funding for Transition Grants to help establishments train one person
in HACCP and SOPs per Sec. 332.12 and Sec. 381.522.
Effect on Small Entities--Regulatory Flexibility Analysis
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the FSIS Administrator certifies that this rule will not
have a significant economic impact on a substantial number of small
entities. This certification is based primarily on the fact that (1)
the program is voluntary, and (2) the rule will benefit very small and
certain small establishments that operate under cooperative State MPI
programs. Based on FSIS's HACCP (Hazard Analysis and Critical Control
Points) size definitions, very small establishments have fewer than 10
employees or generate less than $2.5 million in annual sales; small
establishments have 10 or more but fewer than 500 employees and
generate more than $2.5 million in annual sales; and establishments
having 500 or more employees are large establishments. Thus, very small
State-inspected establishments and small State-inspected establishments
that have fewer than 25 employees on average will be eligible to
participate in the cooperative interstate shipment program.
This final rule will benefit very small and certain small
establishments that operate under cooperative State MPI programs. Under
section 11015, State-inspected establishments that employ on average 25
or fewer employees would be permitted to be selected to participate in
a cooperative interstate shipment program. The law also permits the
Secretary to select State-inspected establishments that employ, on
average, more than 25 but less than 35 employees to participate in the
program. However, to remain in the program, these establishments must
employ, on average, 25 or fewer employees three years after the
regulations implementing the new cooperative interstate shipment
program become effective. FSIS provides for the selection of State-
inspected establishments that employ, on average, more than 25 but
fewer than 35 employees in the implementing regulations. Thus, this
rule will benefit these very small and small State-inspected
establishments by allowing them to ship meat and poultry products in
interstate and foreign commerce, thereby opening new markets for their
products.
Currently, 27 States administer cooperative State meat or poultry
inspection (MPI) programs. These States have approximately 1,873
establishments that would be eligible to apply for selection into the
new cooperative interstate shipment program. As mentioned earlier in
the preamble to this final rule, the Agency's most recent outreach
activities indicate that four States may be interested in participating
in the program and the number of establishments in these States that
might participate is between 27 and 102. However, because participation
in the new program is voluntary, FSIS will not know how many States and
establishments will apply to participate until this final rule becomes
effective and establishments are selected for the program.
As discussed above, costs to the participating establishments are
likely to be small. An establishment that chooses to apply for
selection into the program will incur one-time start-up costs
associated with filing an application, training employees, meeting
regulatory performance standards, obtaining label approval, and
implementing a food safety system that complies with all Federal
requirements (e.g. Sanitation SOP and HACCP requirements). In addition,
to qualify for a cooperative interstate shipment program, some State-
inspection establishments may need to invest in structural
modifications to their facilities in order to comply with Federal
standards. Based on information obtained through FSIS' outreach
activities with the States in 2008, in the PRIA of the proposed rule,
the Agency estimated that the cost for State-inspected establishments
to fully comply with Federal standards, as required by the law, will
range from $1,500 to $50,000. Looking at the potential for the
establishments to experience new (incremental) burden or expenses due
to State inspection under the proposed cooperative interstate shipment
program, FSIS believes that there will be essentially no change. FSIS
did not receive any comments or new information in response to the
proposed rule to suggest changes to these estimates.
Because the cooperative interstate shipment program is a voluntary
[[Page 24751]]
program, establishments that choose to incur the costs associated with
participating in the program will most likely do so because they
anticipate that such participation will provide an overall net benefit
for them.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to government
information and services, and for other purposes.
Executive Order 13175
This final rule has been carefully evaluated for potential tribal
implications in accordance with Executive Order 13175, ``Consultation
and Coordination with Indian Tribal Governments.'' FSIS has concluded
based on its evaluation that this final rule will not have any direct
or substantial effects on Indian Tribes, on the relationship between
the Federal Government and Indian Tribes, or on the distribution of
power or responsibilities between the Federal Government and Indian
Tribes. This final rule implements the Congressional enactment
providing that States with approved MPI programs, that is State
established and administered meat or poultry inspection programs,
approved by FSIS pursuant to the Federal meat and poultry inspection
laws, may now be eligible in their discretion to participate in the
cooperative interstate shipment program established by this final rule.
Accordingly, because this program is only authorized under law and this
rule is for States with approved MPI programs, there are no significant
tribal implications. Nonetheless, FSIS will include Tribes and
intertribal organizations, involved in or interested in the meat and
poultry sectors, in the Agency's outreach efforts associated with
implementation and administration of this final rule. In addition, if
and when a State, with an MPI program approved by FSIS, satisfies the
requirements of this final rule and enters into an agreement with FSIS
regarding a cooperative interstate shipment program, FSIS will conduct
outreach to Tribes and intertribal organizations to ensure that they
are fully aware of the cooperative interstate shipment program in that
State, and to ensure that meat or poultry establishments on Tribal
lands have the opportunity to participate in the approved State
interstate shipment program if they are interested in doing so.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue,
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this final rule, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov/regulations/2011_Interim_&_Final_Rules_Index.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to our constituents and
stakeholders. The Update is communicated via Listserv, a free e-mail
subscription service consisting of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals who have requested to be included.
The Update also is available on the FSIS Web page. Through Listserv and
the Web page, FSIS is able to provide information to a much broader,
more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at http://www.fsis.usda.gov/news_&_events/email_subscription/. Options range from recalls to
export information to regulations, directives and notices. Customers
can add or delete subscriptions themselves, and have the option to
password protect their accounts.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995, the information collection and recordkeeping requirements
included in this rule were submitted for approval to the Office of
Management and Budget (OMB) when the proposed rule was published. OMB
preapproved the information collection; the OMB Control number is 0583-
0144.
The estimated number of respondents in the preapproved information
collection reflects the number of States and establishments that FSIS
estimated would participate in the cooperative interstate shipment
program when the Agency issued the proposed rule. FSIS believes that it
overestimated the participation by States and establishments in the
proposed rule. However, the Agency's final estimated hours of paperwork
burden per respondent is the same as the estimate provided in the
proposed rule.
Title: ``Cooperative Inspection Programs: Interstate Shipment of
Meat and Poultry Products.''
Type of collection: New.
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this final rule in accordance with the Paperwork
Reduction Act. Under this final rule, FSIS is requiring certain
information collection and recordkeeping activities.
States that are interested in participating in the cooperative
interstate shipment program are required to submit a request for an
agreement to establish such a program through the appropriate FSIS
District Office. In their requests, States must: (1) Identify
establishments in the State that the State recommends for initial
selection into the program, if any; (2) include documentation to
demonstrate that the State is able to provide necessary inspections
services to selected establishments in the State and conduct any
related activities that would be required under a cooperative
interstate shipment program; and (3) agree to comply with certain
conditions to assist with enforcement of the
[[Page 24752]]
program. States that have entered into an agreement with FSIS for a
cooperative interstate shipment program must submit, through the FSIS
district office, an evaluation of each State-inspected establishment
that has applied, and that the State recommends be selected, for the
cooperative interstate shipment program.
Under this final rule, State inspected establishments selected to
participate in the cooperative interstate shipment program will be
required to develop and maintain the same records that are required
under the Acts and their implementing regulations. Selected
establishment will also be required to give the FSIS selected
establishment coordinator (SEC) access to all establishment records
required under the Acts and implementing regulations. Most States that
have cooperative State meat or poultry products inspection (MPI)
programs have incorporated the Federal standards into their programs.
Thus, most establishments selected to participate in the interstate
shipment program are currently required to maintain records that comply
with Federal standards. However, establishments located in States that
have implemented recordkeeping requirements that are ``at least equal
to'' but not identical to Federal requirements will need to modify
their recordkeeping procedures to comply with Federal standards. All
selected establishments will be required to give the FSIS SEC access to
their records upon request.
Estimate of Burden: When it proposed these regulations, FSIS
estimated that 16 of the 27 States that currently have agreements for
cooperative State meat or poultry products inspection programs will
prepare and submit a request to FSIS to establish a cooperative
interstate shipment program. The Agency also estimated that
approximately 400 establishments will apply for the program. Thus, FSIS
estimated that each of the 16 States mentioned above will need to
prepare and submit, on average, 25 evaluations for the State-inspected
establishments that have applied for, and that the State recommends,
for selection into the program, for an estimated total of 400
evaluations.
FSIS estimates that it will take approximately 40 hours for each
State to prepare and submit a request to establish a cooperative
interstate shipment program, for a total burden of 640 hours. The
Agency estimates that it will take each State approximately 24 hours to
prepare an evaluation of a State-inspected establishment's
qualifications to be selected for a cooperative interstate shipment
program, for a total burden of 9,600 hours.
FSIS estimates that if all of the 400 establishments that apply are
selected for the program, approximately 100 of these establishments
will need to modify their recordkeeping procedures to come into
compliance with Federal standards. The extent to which these
establishments will need to modify their recordkeeping procedures will
depend on requirements under the State inspection program. Because
recordkeeping requirements under the State inspection program must be
``at least equal to'' the Federal requirements, these modifications
should be minor. FSIS estimates that it will take approximately 16
hours for each establishment that is currently maintaining records
under State standards to review and revise its recordkeeping
procedures, and about 5 minutes for each establishment to file these
records, for a total burden of approximately 1608 hours.
All of the estimated 400 establishments that participate in the
program will be required to give the SEC access to all records required
under the Federal Acts. FSIS estimates that it will take each
establishment approximately 15 minutes to assist the SEC to locate the
necessary records for review on the initial visit, for a total burden
of 100 hours. FSIS estimates that these establishments will need to
spend and approximately 5 minutes to assist the SEC locate records for
review for each subsequent visit. If the SEC visits each selected
establishment at least once a month, the total burden per establishment
per year will be 1 hour, for a total estimated annual burden of 400
hours.
Respondents: State agencies that administer cooperative State meat
and poultry products inspection programs and State-inspected
establishments selected to participate in a cooperative interstate
shipment program.
Estimated number of respondents: 416 (16 States and 400 State-
inspected establishments).
Estimated number of responses per respondent: One request to
establish a cooperative interstate shipment program per State and 25
evaluations of State-inspected establishments per State, on average.
A one-time modification of records for each selected establishment
whose recordkeeping does not comply with all Federal standards. One
initial SEC visit in which each selected establishment will need to
provide the SEC with access to all required records. Each establishment
selected for the program will need to provide the FSIS access to its
records on an ongoing basis.
Estimated Total Annual Burden on Respondents: 11,848 hours to
establish and implement the cooperative interstate shipment program in
16 States. Once the program has been implemented, an estimated annual
burden of 400 hours for selected establishments to provide the SEC
access to establishment records on-going basis.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue, SW., Room 3532
South Building, Washington, DC 20250.
Proposed Regulations
List of Subjects
9 CFR Part 321
Grant programs-agriculture, Intergovernmental relations, Meat
inspection.
9 CFR Part 332
Grant programs-agriculture, Intergovernmental relations, Meat
inspection.
9 CFR Part 381
Grant programs-agriculture, Intergovernmental relations, Poultry
and poultry products.
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III as follows:
PART 321--COOPERATION WITH STATES AND TERRITORIES
0
1. The authority citation for part 321 is revised to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
2. Section 321.3 is added to read as follows:
Sec. 321.3 Cooperation of States for the interstate shipment of
carcasses, parts of carcasses, meat, and meat food products.
(a) The Administrator is authorized under 21 U.S.C. 683(b) to
coordinate with States that have meat inspection programs as provided
in Sec. 321.1 of this part to select certain establishments operating
under these programs to participate in a cooperative program to ship
carcasses, parts of carcasses, meat, and meat food products in
interstate commerce. A cooperative program for this purpose is called a
``cooperative interstate shipment program.''
(b) Establishments selected to participate in a cooperative
interstate shipment program described in this
[[Page 24753]]
section must receive inspection services from designated State
personnel that have been trained in the enforcement of the Act. If the
designated personnel determine that the carcasses, parts of carcasses,
meat, and meat food products prepared in establishments selected to
participate in the cooperative interstate shipment program comply with
all requirements under the Act, these items will bear an official
Federal mark of inspection and may be shipped in interstate commerce.
The Administrator will assign an FSIS ``selected establishment
coordinator,'' who will be an FSIS employee, to each State that
participates in a cooperative interstate shipment program to provide
Federal oversight of the program and enforcement of the program's
requirements. The Federal contribution for inspection services provided
by States that enter into a cooperative interstate shipment program
under this section will be at least 60 percent of eligible State costs.
Eligible State costs are those costs that a State has justified and
FSIS has approved as necessary for the State to provide inspection
services to selected establishments in the State.
(c) Part 332 of this subchapter prescribes conditions under which
States and establishments may participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate a cooperative interstate
shipment agreement with a State if the Administrator determines that
the State is not conducting inspection at selected establishments in a
manner that complies with the Act and the implementing regulations in
this chapter.
0
3. Part 332 is added to read as follows:
PART 332--SELECTED ESTABLISHMENTS; COOPERATIVE PROGRAM FOR
INTERSTATE SHIPMENT OF CARCASSES, PARTS OF CARCASSES, MEAT, AND
MEAT FOOD PRODUCTS
Sec.
332.1 Definitions.
332.2 Purpose.
332.3 Requirements for establishments; ineligible establishments.
332.4 State request for cooperative agreement.
332.5 Establishment selection; official number for selected
establishments.
332.6 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
332.7 Federal oversight of a cooperative interstate shipment
program.
332.8 Quarterly reports.
332.9 Enforcement authority.
332.10 Deselection of ineligible establishments.
332.11 Transition to official establishment.
332.12 Transition grants.
332.13 Separation of operations.
332.14 Voluntary withdrawal.
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 332.1 Definitions.
Cooperative interstate shipment program. A cooperative meat
inspection program described in Sec. 321.3 of this subchapter.
Cooperative State meat inspection program. A cooperative State-
Federal meat inspection program described in Sec. 321.1 of this
subchapter.
Designated personnel. State inspection personnel that have been
trained in the enforcement of the Act and any additional State program
requirements in order to provide inspection services to selected
establishments.
Interstate commerce. ``Interstate commerce'' has the same meaning
as ``commerce'' under Sec. 301.2 of this subchapter.
Selected establishment. An establishment operating under a State
cooperative meat inspection program that has been selected by the
Administrator, in coordination with the State where the establishment
is located, to participate in a cooperative interstate shipment
program.
Sec. 332.2 Purpose.
This part prescribes the conditions under which States that
administer cooperative State meat inspection programs and
establishments that operate under such programs may participate in a
cooperative interstate shipment program.
Sec. 332.3 Requirements for establishments; ineligible
establishments.
(a) An establishment that operates under a cooperative State meat
inspection program may apply to participate in a cooperative interstate
shipment program under this part if:
(1) The establishment employs on average no more than 25 employees
based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer
than 35 employees as of June 18, 2008. If selected to participate in a
cooperative interstate shipment program, an establishment under this
paragraph must employ on average no more than 25 employees as of July
1, 2014, or it must transition to become an official establishment as
provided in Sec. 332.11 of this part.
(b) An establishment that has 25 or fewer employees based on the
following standards is considered to have 25 or fewer employees on
average for purposes of this part.
(1) All individuals, both supervisory and non-supervisory, employed
by the establishment on a full-time, part-time, or temporary basis
whose duties involve handling the meat or meat food products prepared
by the establishment are counted when calculating the total number of
employees.
(2) All individuals employed by the establishment from a temporary
employee agency, professional employee organization, or leasing concern
whose duties involve handling the meat or meat food products prepared
by the establishment are counted when calculating the total number of
employees.
(3) The average number of employees is calculated for each of the
pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-
time employees.
(5) If the establishment has not been in business for 12 months,
the average number of employees is calculated for each of the pay
periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered
employees unless their duties involve handling the meat or meat food
products prepared by the establishment.
(7) The total number of employees can never exceed 35 individuals
at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a
cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average
(except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as
provided in Sec. 321.2 of this subchapter as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18,
2008, but that were re-organized on a later date by the person that
controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State meat
inspection that employed more than 35 employees as of June 18, 2008,
that were reorganized on a later date by the person that controlled the
establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under Sec.
332.11 of this part;
[[Page 24754]]
(7) Establishments that are in violation of the Act; and
(8) Establishments located in States without a cooperative State
meat inspection program.
(9) Establishments located in a State whose agreement for a
cooperative interstate shipment program was terminated by the
Administrator as provided in Sec. 321.3(d) of this subchapter.
(d) An establishment that meets the conditions in paragraph (a) of
this section and that is not an ineligible establishment under
paragraph (c) of this section may apply for selection into a
cooperative interstate shipment program through the State in which the
establishment is located.
Sec. 332.4 State request for cooperative agreement.
(a) State participation in a cooperative interstate shipment
program under this part is limited to States that have implemented
cooperative State meat inspection programs.
(b) To request an agreement for a cooperative interstate shipment
program under this part, a State must submit a written request to the
Administrator through the FSIS District Office for the FSIS District in
which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be
selected for the program that the State recommends for initial
selection into the program, if any;
(2) Demonstrate that the State is able to provide the necessary
inspection services to selected establishments in the State and conduct
any related activities that would be required under a cooperative
interstate shipment program established under this part; and
(3) Agree that, if the State enters into an agreement with FSIS for
a cooperative interstate shipment program, the State will:
(i) Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
(ii) Notify the selected establishment coordinator for the State of
the results of any laboratory analyses that indicate that a product
prepared in a selected establishment may be adulterated or may
otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected
establishments in the State that have been deselected from a
cooperative interstate shipment program to become official
establishments.
(c) If the Administrator determines that a State that has submitted
a request to participate in a cooperative interstate shipment program
qualifies to enter into a cooperative agreement for such a program, the
Administrator and the State will sign a cooperative agreement that sets
forth the terms and conditions under which each party will cooperate to
provide inspection services to selected establishments located in the
State.
(d) After the Administrator and a State have signed an agreement
for a cooperative interstate shipment program as provided in paragraph
(c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment
coordinator for the State and
(2) Coordinate with the State to select establishments to
participate in the program as provided in Sec. 332.5(b) of this part.
Sec. 332.5 Establishment selection; official number for selected
establishments.
(a) An establishment operating under a cooperative State meat
inspection program will qualify for selection into a cooperative
interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the
program;
(2) Has the appropriate number of employees under Sec. 332.3(a) of
this part;
(3) Is not ineligible to participate in a cooperative interstate
shipment program under Sec. 332.3(c) of this part;
(4) Is in compliance with all requirements under the cooperative
State meat inspection program; and
(5) Is in compliance with all requirements under the Act and the
implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an
establishment that meets the conditions in paragraph (a) of this
section must be selected by the Administrator, in coordination with the
State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative
interstate shipment program as provided in paragraph (b) of this
section, the State is to assign the establishment an official number
that reflects the establishment's participation in the cooperative
interstate shipment program and advise the FSIS selected establishment
coordinator for the State of the official number assigned to each
selected establishment in the State. The official number assigned to
every selected establishment must contain a suffix, e.g., ``SE,'' that
identifies the establishment as a selected establishment and that
identifies the State, e.g., ``SETX,'' for ``selected establishment
Texas.''
(d) Failure of the State to comply with paragraph (c) of this
section will disqualify the State from participation in the cooperative
interstate shipment program.
Sec. 332.6 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
(a) A cooperative interstate shipment program will commence when
the Administrator, in coordination with the State, has selected
establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating
in a cooperative interstate shipment program must be provided by
designated personnel, who will be under the direct supervision of a
State employee.
(c) Carcasses, parts of carcasses, meat, and meat food products
prepared in a selected establishment and inspected and passed by
designated State personnel must bear an official Federal mark, stamp,
tag, or label of inspection in the appropriate form prescribed in part
312 of this subchapter that includes the information specified in Sec.
332.5(c) of this part.
(d) Carcasses, parts of carcasses, meat, and meat food products
prepared in a selected establishment that comply with the conditions in
paragraph (c) of this section may be distributed in interstate
commerce.
Sec. 332.7 Federal oversight of a cooperative interstate shipment
program.
(a) The FSIS selected establishment coordinator for a State that
has entered into an agreement for a cooperative interstate shipment
program will visit each selected establishment in the State on a
regular basis to verify that the establishment is operating in a manner
that is consistent with the Act and the implementing regulations in
this chapter. The frequency with which the SEC will visit selected
establishments under the SEC's jurisdiction will be based on factors
that include, but are not limited to, the complexity of the operations
conducted at the selected establishment, the establishment's schedule
of operations, and the establishment's performance under the
cooperative interstate shipment program. If necessary, the selected
establishment coordinator, in consultation with the District Manager
that covers the State, may designate qualified FSIS personnel to visit
a selected establishment on behalf of the selected establishment
coordinator.
(b) The selected establishment coordinator, in coordination with
the
[[Page 24755]]
State, will verify that selected establishments in the State are
receiving the necessary inspection services from designated personnel,
and that these establishments are eligible, and remain eligible, to
participate in a cooperative interstate shipment program. The selected
establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and
continues to employ, 25 or fewer employees, on average, as required
under Sec. 332.3(a) of this part, unless the establishment is
transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing
inspection services to selected establishments in a manner that
complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that the State staffing levels for each selected
establishments are appropriate to carry out the required inspection
activities; and
(4) Assessing each selected establishment's compliance with the Act
and implementing regulations under this chapter.
(c) If the selected establishment coordinator determines that
designated personnel are providing inspection services to selected
establishments in the State in a manner that is inconsistent with the
Act and the implementing regulations in this chapter, the Administrator
will provide an opportunity for the State to develop and implement a
corrective action plan to address inspection deficiencies identified by
the selected establishment coordinator. If the State fails to develop a
corrective action plan, or the selected establishment coordinator for
the State determines that the corrective action plan is inadequate, the
Administrator will terminate the agreement for the cooperative
interstate shipment program as provided in Sec. 321.3(d) of this
chapter.
Sec. 332.8 Quarterly reports.
(a) The selected establishment coordinator will prepare a report on
a quarterly basis that describes the status of each selected
establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section
will:
(1) Include the selected establishment coordinator's assessment of
the performance of the designated personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected establishments that the selected
establishment coordinator has verified are in compliance with the Act
and implementing regulations in this chapter, those that have been
deselected under Sec. 332.10 of this part, and those that are
transitioning to become official establishments under Sec. 332.11 of
this part.
(c) The selected establishment coordinator is to submit the
quarterly report to the Administrator through the District Manager for
the State where the selected establishments identified in the report
are located.
Sec. 332.9 Enforcement authority.
(a) To facilitate oversight and enforcement of this part, selected
establishments operating under a cooperative interstate shipment
program must, upon request, give the FSIS selected establishment
coordinator or other FSIS officials access to all establishment records
required under the Act and the implementing regulations in this
chapter. The Administrator may deselect any selected establishment that
refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any
appropriate enforcement action provided for in part 500 of this chapter
if they determine that a selected establishment under their
jurisdiction is operating in a manner that is inconsistent with the Act
and the implementing regulations in this chapter. Selected
establishments participating in a cooperative interstate shipment
program are subject to the notification and appeal procedures set out
in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any
of the reasons specified in Sec. 500.3 or Sec. 500.4 of this chapter,
FSIS will:
(1) Provide an opportunity for the establishment to implement
corrective actions and remain in the cooperative interstate shipment
program, or
(2) Move to deselect the establishment as provided in Sec. 332.10
of this part.
(d) The decision to deselect a selected establishment under a
suspension will be made on a case-by-case basis. In making this
decision, FSIS, in consultation with the State where the selected
establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
Sec. 332.10 Deselection of ineligible establishments.
(a) The Administrator will deselect a selected establishment that
becomes ineligible to participate in a cooperative interstate shipment
program for any reason listed under Sec. 332.3(c) of this part.
(b) An establishment that has been deselected must transition to
become an official establishment as provided in Sec. 332.11 of this
part.
Sec. 332.11 Transition to official establishment.
(a) If an establishment is deselected from a cooperative interstate
shipment program as provided in Sec. 332.10 of this part, FSIS, in
coordination with the State where the establishment is located, will
develop and implement a plan to transition the establishment to become
an official establishment. Except that an establishment that was
deselected from a cooperative interstate shipment program because it is
located in a State whose agreement for such a program was terminated
may either transition to become an official establishment or transition
to become a State-inspected establishment under the cooperative State
meat inspection program.
(b) An establishment that has been deselected from a cooperative
interstate shipment program and successfully transitioned to become an
official establishment may withdraw from the Federal inspection program
and resume operations under the cooperative State meat inspection
program after operating as an official establishment in full compliance
with the Act for a year.
Sec. 332.12 Transition grants.
(a) Transition grants are funds that a State participating in a
cooperative interstate shipment program under this part may apply for
to reimburse selected establishments in the State for the cost to train
one individual in the seven HACCP principles for meat or poultry
processing as required under Sec. 417.7 of this chapter and associated
training in the development of sanitation standard operating procedures
required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment
program that receives a transition grant must use grant funds to
reimburse the training costs of one employee per each selected
establishment in the State. Any other use of such funds is prohibited.
Sec. 332.13 Separation of operations.
A selected establishment may conduct operations under the
cooperative State meat inspection program if the establishment
implements and maintains written procedures for complete physical
separation of product and process for each operation by time or space.
[[Page 24756]]
Sec. 332.14 Voluntary withdrawal.
A selected establishment that is in full compliance with the
requirements in this part may voluntarily end its participation in a
cooperative interstate shipment program and operate under the
cooperative State meat inspection program. Establishments that
voluntarily end their participation in the cooperative may re-apply for
the program after operating under the cooperative State meat inspection
program for one year.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
4. The authority citation for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
0
5. Add Sec. 381.187 to subpart R to read as follows:
Sec. 381.187 Cooperation of States for the interstate shipment of
poultry products.
(a) The Administrator is authorized under 21 U.S.C. 472(b) to
coordinate with States that have poultry products inspection programs
as provided in Sec. 381.185 of this subpart to select certain
establishments operating under these programs to participate in a
cooperative program to ship poultry products in interstate commerce. A
cooperative program for this purpose is called a ``cooperative
interstate shipment program.''
(b) Establishments selected to participate in a cooperative
interstate shipment program described in this section must receive
inspection services from designated State personnel that have been
trained in the enforcement of the Act. If the designated personnel
determine that the poultry products prepared in establishments selected
to participate in the cooperative interstate shipment program comply
with all requirements under the Act, these items will bear an official
Federal mark of inspection and may be shipped in interstate commerce.
The Administrator will assign an FSIS ``selected establishment
coordinator,'' who will be an FSIS employee, to each State that
participates in a cooperative interstate shipment program to provide
Federal oversight of the program and enforcement of the program's
requirements. The Federal contribution for inspection services provided
by States that enter into a cooperative interstate shipment program
under this section will be at least 60 percent of eligible State costs.
Eligible State costs are those costs that a State has justified and
FSIS has approved as necessary for the State to provide inspection
services to selected establishments in the State.
(c) Subpart Z, of this part 381 prescribes conditions under which
States and establishments may participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate a cooperative interstate
shipment agreement with a State if the Administrator determines that
the State is not conducting inspection at selected establishments in a
manner that complies with the Act and the implementing regulations in
this chapter.
0
6. Add subpart Z to read as follows:
Subpart Z--Selected Establishments; Cooperative Program for Interstate
Shipment of Poultry Products
Sec.
381.511 Definitions.
381.512 Purpose.
381.513 Requirements for establishments; ineligible establishments.
381.514 State request for cooperative agreement.
381.515 Establishment selection; official number for selected
establishments.
381.516 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
381.517 Federal oversight of a cooperative interstate shipment
program.
381.518 Quarterly reports.
381.519 Enforcement authority.
381.520 Deselection of ineligible establishments.
381.521 Transition to official establishment.
381.522 Transition grants.
381.523 Separation of operations.
381.524 Voluntary withdrawal.
Subpart Z--Selected Establishments; Cooperative Program for
Interstate Shipment of Poultry Products
Sec. 381.511 Definitions.
Cooperative interstate shipment program. A cooperative poultry
products inspection program described in Sec. 381.187 of this part.
Cooperative State poultry products inspection program. A
cooperative State-Federal poultry products inspection program described
in Sec. 381.185 of this part.
Designated personnel. State inspection personnel that have been
trained in the enforcement of the Act and any additional State program
requirements in order to provide inspection services to selected
establishments.
Interstate commerce. ``Interstate commerce'' has the same meaning
as ``commerce'' under Sec. 381.1 of this part.
Selected establishment. An establishment operating under a State
cooperative poultry products inspection program that has been selected
by the Administrator, in coordination with the State where the
establishment is located, to participate in a cooperative interstate
shipment program.
Sec. 381.512 Purpose.
This subpart Z prescribes the conditions under which States that
administer cooperative State poultry products inspection programs and
establishments that operate under such programs may participate in a
cooperative interstate shipment program.
Sec. 381.513 Requirements for establishments; ineligible
establishments.
(a) An establishment that operates under a cooperative State
poultry products inspection program may apply to participate in a
cooperative interstate shipment program under this subpart if:
(1) The establishment employs on average no more than 25 employees
based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer
than 35 employees as of June 18, 2008. If selected to participate in a
cooperative interstate shipment program, an establishment under this
paragraph must employ on average no more than 25 employees as of July
1, 2014, or it must transition to become an official establishment as
provided in Sec. 381.521 of this subpart.
(b) An establishment that has 25 or fewer employees based on the
following standards is considered to have 25 or fewer employees on
average for purposes of this subpart.
(1) All individuals, both supervisory and non-supervisory, employed
by the establishment on a full-time, part-time, or temporary basis
whose duties involve handling the poultry products prepared by the
establishment are counted when calculating the total number of
employees.
(2) All individuals employed by the establishment from a temporary
employee agency, professional employee organization, or leasing concern
whose duties involve handling the poultry products prepared by the
establishment are counted when calculating the total number of
employees.
(3) The average number of employees is calculated for each of the
pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-
time employees.
(5) If the establishment has not been in business for 12 months,
the average
[[Page 24757]]
number of employees is calculated for each of the pay periods in which
the establishment has been in business.
(6) Volunteers who receive no compensation are not considered
employees unless their duties involve handling the poultry products
prepared by the establishment.
(7) The total number of employees can never exceed 35 individuals
at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a
cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average
(except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as
provided in Sec. 381.186 of this part as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18,
2008, but that were re-organized on a later date by the person that
controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State poultry
products inspection program that employed more than 35 employees as of
June 18, 2008, that were reorganized on a later date by the person that
controlled the establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under Sec.
381.521 of this subpart;
(7) Establishments that are in violation of the Act; and
(8) Establishments located in States without a cooperative State
poultry products inspection program.
(9) Establishments located in a State whose agreement for a
cooperative interstate shipment program was terminated by the
Administrator as provided in Sec. 381.187(d) of this part.
(d) An establishment that meets the conditions in paragraph (a) of
this section and that is not an ineligible establishment under
paragraph (c) of this section may apply for selection into a
cooperative interstate shipment program through the State in which the
establishment is located.
Sec. 381.514 State request for cooperative agreement.
(a) State participation in a cooperative interstate shipment
program under this subpart is limited to States that have implemented
cooperative State poultry products inspection programs.
(b) To request an agreement for a cooperative interstate shipment
program under this subpart, a State must submit a written request to
the Administrator through the FSIS District Office for the FSIS
District in which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be
selected for the program that the State recommends for initial
selection into the program, if any;
(2) Demonstrate that the State is able to provide the necessary
inspection services to selected establishments in the State and conduct
any related activities that would be required under a cooperative
interstate shipment program established under this subpart; and
(3) Agree that, if the State enters into an agreement with FSIS for
a cooperative interstate shipment program, the State will:
(i) Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
(ii) Notify the selected establishment coordinator for the State of
the results of any laboratory analyses that indicate that a product
prepared in a selected establishment may be adulterated or may
otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected
establishments in the State that have been deselected from a
cooperative interstate shipment program to become official
establishments.
(c) If the Administrator determines that a State that has submitted
a request to participate in a cooperative interstate shipment program
qualifies to enter into a cooperative agreement for such a program, the
Administrator and the State will sign a cooperative agreement that sets
forth the terms and conditions under which each party will cooperate to
provide inspection services to selected establishments located in the
State.
(d) After the Administrator and a State have signed an agreement
for a cooperative interstate shipment program as provided in paragraph
(c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment
coordinator for the State and
(2) Coordinate with the State to select establishments to
participate in the program as provided in Sec. 381.515(b) of this
subpart.
Sec. 381.515 Establishment selection; official number for selected
establishments.
(a) An establishment operating under a cooperative State poultry
products inspection program will qualify for selection into a
cooperative interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the
program;
(2) Has the appropriate number of employees under Sec. 381.513(a)
of this subpart;
(3) Is not ineligible to participate in a cooperative interstate
shipment program under Sec. 381.513(c) of this subpart;
(4) Is in compliance with all requirements under the cooperative
State poultry products inspection program; and
(5) Is in compliance with all requirements under the Act and the
implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an
establishment that meets the conditions in paragraph (a) of this
section must be selected by the Administrator, in coordination with the
State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative
interstate shipment program as provided in paragraph (b) of this
section, the State is to assign the establishment an official number
that reflects the establishment's participation in the cooperative
interstate shipment program and advise the FSIS selected establishment
coordinator for the State of the official number assigned to each
selected establishment in the State. The official numbers assigned to
every selected establishment must contain a suffix, e.g., ``SE,'' that
identifies the establishment as a selected establishment; that includes
the letter ``P,'' which identifies the establishment as a poultry
establishment; and that identifies the State, e.g., ``SEPND,'' for
``selected establishment poultry North Dakota.''
(d) Failure of a State to comply with paragraph (c) of this section
will disqualify the State from participation in the cooperative
interstate shipment program.
Sec. 381.516 Commencement of a cooperative interstate shipment
program; inspection by designated personnel and official mark.
(a) A cooperative interstate shipment program will commence when
the Administrator, in coordination with the State, has selected
establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating
in a cooperative interstate shipment program must be provided by
designated personnel, who will be under the direct supervision of a
State employee.
(c) Poultry products processed in a selected establishment and
inspected and passed by designated State
[[Page 24758]]
personnel must bear an official Federal mark, stamp, tag, or label of
inspection in the appropriate form prescribed in subpart M of this part
that includes the information specified in Sec. 381.515(c) of this
subpart.
(d) Poultry products processed in a selected establishment that
comply with the conditions in paragraph (c) of this section may be
distributed in interstate commerce.
Sec. 381.517 Federal oversight of a cooperative interstate shipment
program.
(a) The FSIS selected establishment coordinator for a State that
has entered into an agreement for a cooperative interstate shipment
program will visit each selected establishment in the State on a
regular basis to verify that the establishment is operating in a manner
that is consistent with the Act and the implementing regulations in
this chapter. The frequency with which the SEC will visit selected
establishments under the SEC's jurisdiction will be based on factors
that include, but are not limited to, the complexity of the operations
conducted at the selected establishment, the establishment's schedule
of operations, and the establishment's performance under the
cooperative interstate shipment program. If necessary, the selected
establishment coordinator, in consultation with the District Manager
that covers the State, may designate qualified FSIS personnel to visit
a selected establishment on behalf of the selected establishment
coordinator.
(b) The selected establishment coordinator, in coordination with
the State, will verify that selected establishments in the State are
receiving the necessary inspection services from designated personnel,
and that these establishments are eligible, and remain eligible, to
participate in a cooperative interstate shipment program. The selected
establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and
continues to employ, 25 or fewer employees, on average, as required
under Sec. 381.513(a) of this part, unless the establishment is
transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing
inspection services to selected establishments in a manner that
complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that the State staffing levels for each selected
establishments are appropriate to carry out the required inspection
activities; and
(4) Assessing each selected establishment's compliance with the Act
and implementing regulations in this chapter.
(c) If the selected establishment coordinator determines that
designated personnel are providing inspection services to selected
establishments in the State in a manner that is inconsistent with the
Acts and the implementing regulations in this chapter, the
Administrator will provide an opportunity for the State to develop and
implement a corrective action plan to address inspection deficiencies
identified by the selected establishment coordinator. If the State
fails to develop a corrective action plan, or the selected
establishment coordinator for the State determines that the corrective
action plan is inadequate, the Administrator will terminate the
agreement for the cooperative interstate shipment program as provided
in Sec. 381.187(d) of this part.
Sec. 381.518 Quarterly reports.
(a) The selected establishment coordinator will prepare a report on
a quarterly basis that describes the status of each selected
establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section
will:
(1) Include the selected establishment coordinator's assessment of
the performance of the designated personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected establishment that the selected
establishment coordinator has verified are in compliance with the Act
and implementing regulations in this chapter, those that have been
deselected under Sec. 381.520 of this subpart, and those that are
transitioning to become official establishments under Sec. 381.521 of
this subpart.
(c) The selected establishment coordinator is to submit the
quarterly report to the Administrator through the District Manager for
the State where the selected establishments identified in the report
are located.
Sec. 381.519 Enforcement authority.
(a) To facilitate oversight and enforcement of this subpart,
selected establishments operating under a cooperative interstate
shipment program must, upon request, give the FSIS selected
establishment coordinator or other FSIS officials access to all
establishment records required under the Act and the implementing
regulations in this chapter. The Administrator may deselect any
selected establishment that refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any
appropriate enforcement action provided for in part 500 of this chapter
if they determine that a selected establishment under their
jurisdiction is operating in manner that is inconsistent with the Act
and the implementing regulations in this chapter. Selected
establishments participating in a cooperative interstate shipment
program are subject to the notification and appeal procedures set out
in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any
of the reasons specified in Sec. 500.3 or Sec. 500.4 of this chapter,
FSIS will:
(1) Provide an opportunity for the establishment to implement
corrective actions and remain in the cooperative interstate shipment
program, or
(2) Move to deselect the establishment as provided in Sec. 381.520
of this subpart.
(d) The decision to deselect a selected establishment under a
suspension will be made on a case-by-case basis. In making this
decision, FSIS, in consultation with the State where the selected
establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
Sec. 381.520 Deselection of ineligible establishments.
(a) The Administrator will deselect a selected establishment that
becomes ineligible to participate in a cooperative interstate shipment
program for any reason listed under Sec. 381.513(c) of this subpart.
(b) An establishment that has been deselected must transition to
become an official establishment as provided in Sec. 381.521 of this
subpart.
Sec. 381.521 Transition to official establishment.
(a) If an establishment is deselected from a cooperative interstate
shipment program as provided in Sec. 381.520 of this subpart, FSIS, in
coordination with the State where the establishment is located, will
develop and implement a plan to transition the establishment to become
an official establishment. Except that an establishment that was
deselected from a cooperative interstate shipment program because it is
located in a State whose agreement for such a program was terminated
may either transition to become an official establishment or transition
to become a State-inspected establishment under the
[[Page 24759]]
cooperative State poultry products inspection program.
(b) An establishment that has been deselected from a cooperative
interstate shipment program and successfully transitioned to become an
official establishment may withdraw from the Federal inspection program
and resume operations under the cooperative State poultry products
inspection program after operating as an official establishment in full
compliance with the Act for a year.
Sec. 381.522 Transition grants.
(a) Transition grants are funds that a State participating in a
cooperative interstate shipment program under this subpart may apply
for to reimburse selected establishments in the State for the cost to
train one individual in the seven HACCP principles for meat or poultry
processing as required under Sec. 417.7 of this chapter and associated
training in the development of sanitation standard operating procedures
required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment
program that receives a transition grant must use grant funds to
reimburse the training costs of one employee per each selected
establishment in the State. Any other use of such funds is prohibited.
Sec. 381.523 Separation of operations.
A selected establishment may conduct operations under the
cooperative State poultry products inspection program if the
establishment implements and maintains written procedures for complete
physical separation of product and process for each operation by time
or space.
Sec. 381.524 Voluntary withdrawal.
A selected establishment that is in full compliance with the
requirements in this part may voluntarily end its participation in a
cooperative interstate shipment program and operate under the
cooperative State poultry products inspection program. Establishments
that voluntarily end their participation in the cooperative may re-
apply for the program after operating under the cooperative State
poultry products inspection program for one year.
Done at Washington, DC, on: March 31, 2011.
Alfred V. Almanza,
Administrator.
[FR Doc. 2011-9865 Filed 4-29-11; 8:45 am]
BILLING CODE P