[Federal Register Volume 74, Number 116 (Thursday, June 18, 2009)]
[Rules and Regulations]
[Pages 28872-28874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14281]


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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: [email protected], or 
[email protected].
    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: [email protected].

[[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=MarketingOrdersSmallBusinessGuide. 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]
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