[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Pages 43958-43961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12565]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 327 and 381
[Docket No. 03-033F; FDMS Docket Number FSIS-2005-0026]
RIN 0583-AD08
Frequency of Foreign Inspection System Supervisory Visits to
Certified Foreign Establishments
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) FSIS is amending
9 CFR parts 327 and 381 to bring the frequency with which foreign
inspection systems are required to make supervisory visits to certified
establishments into agreement with the frequency with which the Agency
makes supervisory visits to domestic establishments. This final rule
does not affect in-plant inspection requirements. FSIS is deleting the
requirement that supervisory visits take place ``not less frequent[ly]
than one such visit per month.'' Instead, FSIS will require foreign
inspection systems to make ``periodic supervisory visits'' to certified
establishments to ensure that establishments meet FSIS requirements for
certification to export meat and poultry to the United States.
DATES: Effective Date: September 5, 2006.
FOR FURTHER INFORMATION CONTACT: Ms. Sally White, Director,
International Equivalence Staff, FSIS Office of International Affairs;
(202) 720-6400; [email protected].
SUPPLEMENTARY INFORMATION:
Background
On August 18, 2004, FSIS published a proposal in the Federal
Register (69 FR 51194-51196) to amend 9 CFR 327.2(a)(2)(iv)(A) and 9
CFR 381.196(a)(2)(iv)(A) to provide that supervisory visits by a
representative of the foreign inspection system are to occur at
periodic intervals to ensure that establishments and products meet the
requirements for certification to the United States on an ongoing
basis. This change would make the Agency's requirements for foreign
inspection programs as consistent as possible with the FSIS domestic
inspection program. It would also allow foreign countries flexibility
in structuring their programs.
Upon the effective date of this final rule, FSIS will send an
official letter to each eligible country announcing: The change from
the monthly requirement and requesting, in writing, formal notice of
the eligible country's projected frequency of supervisory visits; an
explanation of why the proposed frequency will ensure that the eligible
country's system produces safe, wholesome, unadulterated, and properly
labeled and packaged product on an ongoing basis; and an explanation of
how the system will ensure that any immediate need for supervisory
intervention will be recognized and met. The frequency of periodic
supervisory visits will be evaluated for adequacy by FSIS through its
annual audit process, in which the ongoing eligibility of an exporting
country is reviewed.
Comments
FSIS received four comments on the proposed rule. One comment
supported the proposal. Three comments raised concerns, with one
calling for the proposal to be withdrawn. The concerns expressed in
these three comments are summarized and answered below.
Equivalence With U.S. Domestic Inspection System Culture
Two comments noted that FSIS has stated that there are continual
contacts between its inspectors in domestic plants and supervisors
through means other than personal visits and questioned whether such
intensive interaction exists within exporting countries that would no
longer be held to monthly supervisory visits.
FSIS Response
The Agency notes that the inspection system of a country requesting
eligibility to export meat and poultry products to the United States is
thoroughly investigated during the equivalence evaluation process
described at length in the proposal to this final rule. A key part of
the evaluation is an assessment of in-plant implementation of
inspection system procedures, which includes an examination of the
appropriate level of supervisory oversight for certified
establishments. An applying country must demonstrate that its
inspection system, as implemented, includes features equivalent to
those of the U.S. system before the country can be found equivalent.
As stated above, upon the effective date of this final rule, FSIS
will send an official letter to each eligible country announcing the
change from the monthly requirement. FSIS will request formal notice in
writing of the eligible country's projected frequency of supervisory
visits and an explanation of why the proposed frequency will ensure
that the eligible country's system produces safe and wholesome product
on an ongoing basis. Each eligible country will also be asked to
describe, in writing, how its system will ensure that any immediate
need for supervisory intervention will be recognized and met. The
frequency of periodic supervisory visits will be evaluated for adequacy
by FSIS in its annual audits reviewing the ongoing eligibility of an
exporting country.
Equivalence With Domestic State Inspection Systems
Another comment noted that the 28 State inspection systems are
required to be ``at least equal to'' the Federal inspection system, and
that many federally-inspected plants have reported supervisory visits
more frequently than the monthly requirement that will be eliminated
for eligible exporting countries by the final rule.
[[Page 43959]]
FSIS Response
The Agency notes that, as it does not set a mandatory frequency for
itself, it does not require a set frequency of supervisory visits from
the ``equal to'' State inspection systems. Thus, there is no compelling
reason for the Agency to require exporting countries to meet a specific
frequency that is not mandatory for any domestic program. Supervisory
visits in domestic establishments under Federal inspection occur at the
frequency required by local conditions and by Agency concerns regarding
the situation at a given plant. Thus the frequency of visits varies
from plant to plant, but overall such visits occur less frequently than
once a month.
Definition of ``Periodic''
One comment asked if the Agency will define ``periodic'' and
require uniformity among countries eligible to export meat and poultry
products to the United States.
FSIS Response
As there is no domestic requirement for a specific frequency of
supervisory visits to plants, ``periodic'' will mean a frequency
determined by exporting countries as adequate to ensure that certified
establishments continually meet FSIS equivalency requirements, as
evaluated and verified by the Agency. As stated above, upon the
effective date of this final rule, FSIS will send an official letter to
each eligible country announcing the change from the monthly
requirement and will request formal notice, in writing, of the eligible
country's projected frequency of supervisory visits.
Timely Information
One comment asked whether the Agency has a mechanism for staying
current with regulatory or procedural changes in exporting countries.
FSIS Response
The Agency has long maintained a system of exchanging official
letters with trading partners to provide notice of any relevant changes
in both regulations and inspection procedures. FSIS, furthermore,
conducts an ongoing system of equivalence verification to update the
original equivalence evaluation. One key element of this verification
system is a recurring document analysis of the laws, regulations, and
implementing policies of the foreign food regulatory system to ensure
that an equivalent infrastructure is in place, and that timely
notification of any relevant changes has been made through the system
of official letters. As stated above, upon the effective date of this
final rule, FSIS will send official letters to all eligible countries
informing them of the change from the monthly requirement and
requesting formal notice of their projected frequency of supervisory
visits.
The second key element of the equivalence verification process is
the annual on-site food regulatory system audit conducted by FSIS
technical specialists in every country that exports meat or poultry
products to the United States. During these annual system audits, FSIS
seeks evidence that the exporting country has instituted sanitary
measures adequate to provide the same level of protection that is
ensured by our domestic system. The system audit focuses on two
essential components of safe food production, industry process control
and government regulatory control. The frequency of periodic
supervisory visits would be evaluated for adequacy by FSIS in the
annual audits.
The third component of equivalence verification is port-of-entry
reinspection, where FSIS randomly samples meat and poultry products as
they enter the United States to ensure that exporting country
certificates are authentic and accurate, and that products meet all
U.S. standards pertaining to safe, wholesome, unadulterated, and
properly labeled and packaged product. Although records are maintained
on each certified establishment, reinspection is designed to verify
effectiveness of the foreign inspection system. Port-of-entry
reinspection is directed by the Automated Import Information System
(AIIS), a centralized computer database that stores daily reinspection
results from all ports of entry for each country and for each
establishment. When a shipment is presented for reinspection, the AIIS
scans its existing records to determine whether the foreign country,
the establishment, and the product are eligible for export to the
United States. The shipment is refused entry if any component of
eligibility is absent.
Given these well-established mechanisms, and the additional FSIS
request for notice of an exporting country's projected frequency of
periodic supervisory visits, the Agency is confident that it will
quickly become aware of any changes in an exporting country's
regulatory system and practice.
Terrorism
One comment stated that eliminating the requirement for monthly
supervisory visits could undercut the war on terrorism by loosening
control of products destined for export to the United States.
FSIS Response
As described above, the inspection system of a country requesting
eligibility to export meat and poultry products to the United States is
analyzed intensively during the equivalence evaluation process, which
includes a review of in-plant implementation of inspection system
procedures. A country applying for eligibility must demonstrate that
its inspection system, as implemented, includes features equivalent to
those of the U.S. system before the country can be found equivalent.
As stated above, upon the effective date of this final rule, FSIS
will send an official letter to each eligible country announcing the
change from the monthly requirement and requesting formal notice in
writing of the eligible country's projected frequency of supervisory
visits. FSIS will also request that each country explain why the
proposed frequency will ensure that its system produces safe and
wholesome product on an ongoing basis, and describe how the system will
ensure that any immediate need for supervisory intervention will be
recognized and met.
To verify the continuing equivalence of an eligible exporting
country, FSIS maintains a comprehensive system of import inspection
controls as described above, which includes recurring document analysis
of a foreign country's inspection system, annual on-site audits, and
port-of-entry reinspection. During the Agency's annual audits of those
foreign countries exporting meat, poultry, and egg products to the
United States, information is provided to the exporting countries on
the FSIS security guidelines for food processors and for the
transportation and distribution of meat, poultry, and egg products.
FSIS auditors also report to the appropriate inspection officials any
potential threats that they observe during the audit. In these annual
equivalence/verification audits, FSIS will evaluate the frequency of
periodic supervisory visits for adequacy.
FSIS has also developed strong internal resources for food defense
that provide an extra margin of protection against potential terrorism
involving the food supply. These resources include the Office of Food
Defense and Emergency Response (OFDER), a dedicated, full-time staff
whose sole responsibility is food security, and Import Surveillance
Liaison Officers who are stationed around the country to augment the
efforts of traditional FSIS inspectors assigned to import houses.
[[Page 43960]]
The Agency, furthermore, participates in the Federal International
Trade Data System (ITDS), a multi-department, multi-agency initiative
establishing a single, automated system for sharing data on the
inspection and certification of products moving in foreign commerce.
With these notification and auditing mechanisms and other
initiatives in place, FSIS believes it can verify that countries
eligible to export meat and poultry products to the United States
maintain, among other things, food defense procedures and practices
that are equivalent to those of the United States.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. It has
been determined to be not significant for purposes of E.O. 12866 by the
Office of Management and Budget (OMB).
The main effect of this action is to give eligible countries the
flexibility to structure their own supervisory programs as they deem
necessary so as to ensure that establishments continue to meet the
requirements for certification to export to the United States. This
action will enable the United States to meet its obligation as a
signatory to the World Trade Organization (WTO) ``Agreement on the
Application of Sanitary and Phytosanitary Measures'' not to impose
import requirements on inspection systems or establishments in an
exporting country that are more stringent than those applied
domestically. No costs should ensue from this final action.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. When this final rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Effect on Small Entities
This action affects only how foreign countries perform inspection
and will not have any effect on domestic establishments. Therefore, the
Administrator, FSIS, has made a determination that this final rule will
not have a significant impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
Expected Effect on FSIS, Other Federal Agencies, State and Local
Governments and Foreign Countries
This final action is expected to have no effect upon FSIS or other
Federal agencies. It is likely to have only minimal effects on foreign
countries. The action will not affect State and local governments.
Expected Environmental Effects
Amending 9 CFR parts 327 and 381 to bring the frequency with which
foreign inspection systems are required to make supervisory visits to
certified establishments into agreement with the frequency with which
the Agency makes supervisory visits to domestic establishments is an
activity that will not have a significant individual or cumulative
effect on the human environment. Therefore, this action is
appropriately subject to the categorical exclusion from the preparation
of an environmental assessment or environmental impact statement
provided under 7 CFR 1b.4(6) of the U.S. Department of Agriculture
regulations.
Paperwork Requirements
No new paperwork requirements are associated with this final rule.
Foreign countries wanting to export meat and meat products to the
United States are required to provide information to FSIS certifying
that their inspection systems provide standards equivalent to those of
the United States, and that the legal authority for the systems and
their implementing regulations are equivalent to those of the United
States, before they may start exporting such product to the United
States. FSIS collects this information one time only. This information
collection was approved under OMB number 0583-0094. The final rule
contains no other paperwork requirements.
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_&_Policies/2005_Interim_&_Final_Rules_Index/index.asp.
The Regulations.gov Web site is the central online rulemaking
portal of the United States Government. It is being offered as a public
service to increase participation in the Federal Government's
regulatory activities. FSIS participates in Regulations.gov and will
accept comments on documents published on the site. The site allows
visitors to search by keyword or Department or Agency for rulemakings
that allow for public comment. Each entry provides a quick link to a
comment form so that visitors can type in their comments and submit
them to FSIS. The Web site is located at http://www.regulations.gov/.
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, recalls, 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_and_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 account.
List of Subjects
9 CFR Part 327
Imported products.
9 CFR Part 381
Imported poultry products, poultry inspection.
0
For the reasons discussed in the preamble, FSIS is amending 9 CFR parts
327 and 381, as follows:
PART 327--IMPORTED PRODUCTS
0
1. The authority for part 327 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
2. Section 327.2(a)(2)(iv)(A) is revised to read as follows:
[[Page 43961]]
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
(a) * * *
(2) * * *
(iv) * * *
(A) Periodic supervisory visits by a representative of the foreign
inspection system to each establishment certified in accordance with
paragraph (a)(3) of this section to ensure that requirements referred
to in paragraphs (a)(2)(ii)(A) through (H) of this section are being
met: Provided, That such visits are not required with respect to any
establishment during a period when the establishment is not operating
or is not engaged in producing products for exportation to the United
States;
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
3. The authority for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
Subpart T--Imported Poultry Products
0
4. Section 381.196(a)(2)(iv)(A) is revised to read as follows:
Sec. 381.196 Eligibility of foreign countries for importation of
products into the United States.
(a) * * *
(2) * * *
(iv) * * *
(A) Periodic supervisory visits by a representative of the foreign
inspection system to each establishment certified in accordance with
paragraph (a)(3) of this section to ensure that requirements referred
to in paragraphs (a)(2)(ii)(A) through (H) of this section are being
met: Provided, That such visits are not required with respect to any
establishment during a period when the establishment is not operating
or is not engaged in producing products for exportation to the United
States;
* * * * *
Done at Washington, DC, on July 31, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. E6-12565 Filed 8-2-06; 8:45 am]
BILLING CODE 3410-DM-P