[Federal Register: June 18, 2009 (Volume 74, Number 116)]
[Rules and Regulations]
[Page 28872-28874]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn09-2]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 981
[Doc. No. AMS-FV-08-0045; FV08-981-2 IFR]
Almonds Grown in California; Revision of Outgoing Quality Control
Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim final rule with request for comments.
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SUMMARY: This rule revises the outgoing quality control regulations
issued under the California almond marketing order (order). The order
regulates the handling of almonds grown in California and is
administered locally by the Almond Board of California (Board). This
rule revises the term ``validation'' under the Salmonella bacteria
(Salmonella) treatment program by specifying that validation data must
be both submitted to and accepted by the Board's Technical Expert
Review Panel (TERP) for all treatment equipment prior to its use under
this program. This will help ensure that all treatment equipment meets
a 4-log reduction of Salmonella in almonds.
DATES: Effective June 19, 2009; comments must be received by August 17,
2009.
ADDRESSES: Interested persons are invited to submit written comments
concerning this rule. Comments must be sent to the Docket Clerk,
Marketing Order Administration Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC
20250-0237; Fax: (202) 720-8938, or Internet: http://
www.regulations.gov. Comments should reference the document number and
the date and page number of this issue of the Federal Register and will
be available for public inspection in the Office of the Docket Clerk
during regular business hours, or can be viewed at: http://
www.regulations.gov. All comments submitted in response to this rule
will be included in the record and will be made available to the
public. Please be advised that the identity of the individuals or
entities submitting the comments will be made public on the Internet at
the address provided above.
FOR FURTHER INFORMATION CONTACT: Terry Vawter, Senior Marketing
Specialist, or Kurt J. Kimmel, Regional Manager, California Marketing
Field Office, Marketing Order Administration Branch, Fruit and
Vegetable Programs, AMS, USDA; Telephone: (559) 487-5901, Fax: (559)
487-5906, or E-mail: Terry.Vawter@ams.usda.gov, or
Kurt.Kimmel@ams.usda.gov.
Small businesses may request information on complying with this
regulation by contacting Jay Guerber, Marketing Order Administration
Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence
Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202)
720-2491, Fax: (202) 720-8938, or E-mail: Jay.Guerber@ams.usda.gov.
[[Page 28873]]
SUPPLEMENTARY INFORMATION: This interim final rule is issued under
Marketing Order No. 981, as amended (7 CFR part 981), regulating the
handling of almonds grown in California, hereinafter referred to as the
``order.'' The order is effective under the Agricultural Marketing
Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter
referred to as the ``Act.''
The Department of Agriculture (USDA) is issuing this rule in
conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule is not intended to have retroactive effect.
This rule will not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with USDA a petition
stating that the order, any provision of the order, or any obligation
imposed in connection with the order is not in accordance with law and
request a modification of the order or to be exempted therefrom. Such
handler is afforded the opportunity for a hearing on the petition.
After the hearing, USDA would rule on the petition. The Act provides
that the district court of the United States in any district in which
the handler is an inhabitant, or has his or her principal place of
business, has jurisdiction to review USDA's ruling on the petition,
provided an action is filed not later than 20 days after the date of
the entry of the ruling.
This interim final rule revises the outgoing quality control
requirements under the Salmonella treatment program. This rule revises
the term ``validation'' by specifying that validation data must be both
submitted to and accepted by the Board's TERP for all treatment
equipment prior to its use under the program. The TERP consists of four
scientists, with a representative from the Food and Drug Administration
serving as an ex-officio member. This will help ensure that all
treatment equipment meets a 4-log reduction of Salmonella in almonds.
This action was unanimously recommended by the Board at a meeting on
May 20, 2008.
Section 981.42(b) of the order provides authority for the Board to
establish, with approval of the Secretary, such minimum quality and
inspection requirements applicable to almonds to be handled or to be
processed into manufactured product, as will contribute to orderly
marketing or be in the public interest. In such crop year, no handler
shall handle or process almonds into manufactured items or products
unless they meet the applicable requirements as evidenced by
certification acceptable to the Board. The Board, with approval of the
Secretary, may establish rules and regulations necessary and incidental
to the administration of this provision.
Section Sec. 981.442(b) of the order's administrative rules and
regulations provides authority for a mandatory treatment program to
reduce the potential for Salmonella in almonds. A mandatory program
went into effect in September 2007. Specifically, handlers must subject
their almonds to a treatment process that achieves a minimum 4-log
reduction in Salmonella prior to shipment. ``Log reduction'' describes
how much bacteria is reduced by a treatment process. A 4-log reduction
decreases bacteria by a factor of 10,000 (4 zeros). Handlers may treat
almonds themselves or transport the almonds to off-site facilities for
treatment. Also, handlers may ship untreated almonds to Board-approved
manufacturers within the U.S., Canada, and Mexico who agree to treat
the almonds appropriately. Handlers may also ship untreated almonds to
locations outside the U.S., Canada, and Mexico. Containers of untreated
almonds must be labeled ``unpasteurized.''
Paragraph 3 of Sec. 981.442(b) of the regulations specifies that
treatment processes must be validated by a Board-approved process
authority. Paragraph (i) of that section defines the term
``validation'' to mean that the treatment technology and equipment have
been demonstrated to achieve a 4-log reduction. Process authorities run
tests to ensure this parameter is met. A process authority is a person
who has expert knowledge of appropriate processes for the treatment of
almonds and meets criteria specified in paragraph (ii) of that section.
Currently, the regulation does not specify that process authorities
submit validation data to the Board's TERP in order to ensure that the
treatment equipment meets the program's 4-log requirement. Thus, the
Board recommended that the regulation be revised accordingly. This will
help ensure that all treatment equipment meets the program's 4-log
requirement. Paragraph (3)(i) of Sec. 981.442(b) of the regulations
issued under the order is revised accordingly.
Initial Regulatory Flexibility Analysis
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this rule on small entities. Accordingly, AMS has
prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and the rules issued thereunder, are unique in
that they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 6,200 producers of almonds in the
production area and approximately 100 handlers subject to regulation
under the marketing order. Additionally, the Board estimates there are
about 15 process authorities and 30 almond manufacturers under the
Salmonella treatment program. Small agricultural producers are defined
by the Small Business Administration (13 CFR 121.201) as those having
annual receipts of less than $750,000, and small agricultural service
firms are defined as those whose annual receipts are less than
$7,000,000.
Data for the most recently-completed crop year indicate that about
50 percent of the handlers shipped under $7,000,000 worth of almonds.
Dividing average almond crop value for 2006-07 reported by the National
Agricultural Statistics Service of $2.258 billion by the number of
producers (6,200) yields an average annual producer revenue estimate of
about $364,190. Based on the foregoing, about half of the handlers and
a majority of almond producers may be classified as small entities.
While data regarding the size of the process authorities and almond
manufacturers is not available, it may be assumed that some process
authorities and manufacturers may be classified as small entities.
This rule revises Sec. 981.442(b)(3)(i) of the order's
administrative rules and regulations. This rule revises the term
``validation'' under the Salmonella treatment program to specify that
validation data must be both submitted to and accepted by the TERP for
each piece of treatment equipment prior to its use under the program.
This revision will help ensure that all treatment equipment meets the
program's 4-log requirement prior to its use. Authority for this action
is provided in Sec. 981.42(b) of the order.
Regarding the overall impact of this action on affected entities,
it is expected to be minimal. Validation data is
[[Page 28874]]
already submitted to the Board's TERP for review. This action simply
specifies that such data must be accepted by the TERP for all treatment
equipment prior to its use under the program.
The Board's Food Quality and Safety Committee (committee) met on
April 22, 2008, to consider this change. The committee considered
maintaining the status quo whereby equipment could be used under the
program that had completed validation testing, but had not been
accepted by the TERP. The committee concluded that acceptance by the
TERP was important in order to help ensure that all treatment equipment
consistently meets the 4-log requirement of the program. The Board
agreed with the committee and ultimately recommended that the term
``validation'' be revised accordingly.
This action does not impose any additional reporting and
recordkeeping requirements on California almonds handlers, process
authorities, or almond manufacturers. As with all Federal marketing
order programs, reports and forms are periodically reviewed to reduce
information requirements and duplication by industry and public sector
agencies.
AMS is committed to complying with the E-Government Act, to promote
the use of the Internet and other information technologies to provide
increased opportunities for citizen access to Government information
and services, and for other purposes.
In addition, USDA has not identified any relevant Federal rules
that duplicate, overlap, or conflict with this rule.
Further, the committee and Board meetings where this issue was
discussed were widely publicized throughout the California almond
industry and all interested persons were invited to attend the meetings
and participate in deliberations on all issues. The issue was discussed
at two committee meetings in April 2008 and at two Board meetings, one
in April and one in May 2008. All of these meetings were public
meetings, and all entities, both large and small, were able to express
views on this issue. Finally, interested persons are invited to submit
information on the regulatory and informational impacts of this action
on small businesses.
A small business guide on complying with fruit, vegetable, and
specialty crop marketing agreements and orders may be viewed at: http:/
/www.ams.usda.gov/AMSv1.0/
ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBus
inessGuide. Any questions about the compliance guide should be sent to
Jay Guerber at the previously mentioned address in the FOR FURTHER
INFORMATION CONTACT section.
This rule invites comments on a revision to the outgoing quality
control requirements currently prescribed under the almond marketing
order. Any comments received will be considered prior to finalization
of this rule.
After consideration of all relevant material presented, including
the Board's recommendation, and other information, it is found that
this interim final rule, as hereinafter set forth, will tend to
effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good
cause that it is impracticable, unnecessary, and contrary to the public
interest to give preliminary notice prior to putting this rule into
effect and that good cause exists for not postponing the effective date
of this rule until 30 days after publication in the Federal Register
because: (1) This rule makes a revision to the requirements concerning
validation contained in the current regulations to help ensure that all
treatment equipment meets a 4-log reduction in Salmonella in almonds;
(2) handlers are aware of this action since the Board unanimously
recommended this revision at a public meeting, and interested parties
had an opportunity to provide input; and (3) this rule provides a 60-
day comment period and any comments received will be considered prior
to finalization of this rule.
List of Subjects in 7 CFR Part 981
Almonds, Marketing agreements, Nuts, Reporting and recordkeeping
requirements.
0
For the reasons set forth in the preamble, 7 CFR part 981 is amended as
follows:
PART 981--ALMONDS GROWN IN CALIFORNIA
0
1. The authority citation for 7 CFR part 981 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
0
2. Paragraph (b)(3)(i) in Sec. 981.442 is revised to read as follows:
Sec. 981.442 Quality control.
* * * * *
(b) * * *
(3) * * *
(i) Validation means that the treatment technology and equipment
have been demonstrated to achieve in total a minimum 4-log reduction of
Salmonella bacteria in almonds. Validation data prepared by a Board-
approved process authority must be submitted to and accepted by the
TERP for each piece of equipment used to treat almonds prior to its use
under the program.
* * * * *
Dated: June 12, 2009.
Craig Morris,
Acting Associate Administrator.
[FR Doc. E9-14281 Filed 6-17-09; 8:45 am]