[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Proposed Rules]
[Page 56678-56680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-12]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 962
[Docket No. AMS-FV-07-0090; FV07-962-1 AN]
Handling Regulations for Leafy Greens Under the Agricultural
Marketing Agreement Act of 1937
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Agricultural Marketing Service (AMS) is issuing this
advance notice of proposed rulemaking in response to industry interest
in the establishment of a marketing program to address the handling of
fresh and fresh-cut leafy green vegetables. The program would allow
packers, processors, shippers, and marketers (collectively referred to
as handlers) to maintain the quality of their products by reducing the
risk of pathogenic contamination during the production and handling of
leafy greens. Authorities and regulations under the program would not
supplant those of the Food and Drug Administration (FDA), which is
responsible for ensuring that foods are safe, wholesome, and sanitary.
Comments are being sought from the public, particularly from growers,
handlers, buyers, and sellers of leafy green commodities, regarding
whether to issue such regulations under an AMS marketing program and if
so, the possible substance and implementation of the program.
DATES: Comments must be received by December 3, 2007.
ADDRESSES: Interested persons are invited to submit written comments
concerning the issues contained in this notice. 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 docket 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
.
FOR FURTHER INFORMATION CONTACT: Laurel May or Kathleen Finn, 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:
laurel.may@usda.gov or kathy.finn@usda.gov.
SUPPLEMENTARY INFORMATION: This advance notice of proposed rulemaking
invites comments on a potential regulatory program intended to maintain
the quality of leafy green commodities by reducing the risk of
pathogenic contamination during their production and handling. AMS is
considering implementation of a marketing agreement (agreement) in
response to heightened public and industry concern about the safe
production and handling of leafy greens.
Under the program being considered, handlers could voluntarily
enter into the agreement, but signatories would then be required to
comply with the agreement's regulations, which would specify Best
Practices for minimizing the risk of pathogenic contamination of leafy
greens. The Best Practices could include commodity-specific production
and handling guidelines that would be developed in cooperation with the
[[Page 56679]]
industry and based upon FDA's voluntary Guide to Minimize Microbial
Food Safety Hazards in Fresh Fruits and Vegetables, Guide to Minimize
Microbial Food Safety Hazards in Fresh-cut Fruits and Vegetables, and
other FDA-issued guidance (http://www.fda.gov).
The agreement could include a compliance certification and
verification program. For example, handlers could be required to
certify that the leafy green products they handle are produced in
accordance with the specified guidelines. Handlers would further
certify that the shipping, processing, and packing of their leafy green
products meet the agreement's specifications. Signatory handlers that
meet the agreement's requirements may be authorized to affix an
official certification mark to their leafy green products. Use of the
mark would certify that the products bearing the mark have been grown,
harvested, packed, shipped, processed, and/or handled in accordance
with the agreement's regulations.
Verification audits would be conducted by the Federal or Federal-
State Inspection Program to ensure that handlers have complied with the
prescribed requirements. Violation of the requirements could disqualify
a non-compliant handler from using the mark for a certain period of
time.
In addition to handling regulations, the agreement could include
consumer education, production research, generic promotion, or other
programs, depending upon the industry's needs and goals.
Pursuant to the requirements set forth in the Regulatory
Flexibility Act, the Department of Agriculture (USDA) would consider
the economic impact that implementation of the proposed agreement would
have on small entities and would prepare a regulatory flexibility
analysis for inclusion in any subsequent rulemaking action. The
informational impact of this action would also be considered under the
Paperwork Reduction Act. Any action undertaken as a result of this
advance notice would be reviewed by USDA under Executive Orders 12866
and 12988.
AMS is considering establishment of a marketing agreement rather
than a marketing order (order), which is another regulatory program
structure available through AMS. Below is a brief comparison of these
two regulatory instruments, which is intended to allow interested
persons a way to distinguish between an agreement and an order so they
may better be able to provide comments to USDA.
Marketing Orders and Agreements
The Agricultural Marketing Agreement Act of 1937, as amended (7
U.S.C. 601-674), hereinafter referred to as the ``Act,'' authorizes the
implementation of Federal marketing orders and agreements designed to
establish and maintain orderly marketing conditions for the regulated
commodities. Orders and agreements are implemented by AMS following
public notice and hearing at the request of industries that demonstrate
interest in regulating the handling of commodities produced within
specified geographic areas.
Orders may include the authority to regulate the grade, size,
quality, packaging, inspection, and/or volume handled of certain
agricultural commodities. Orders may also provide for production and
marketing research, market development, and promotional activities.
Once established, compliance with order regulations is mandatory for
all handlers of the affected commodity within the production area.
Orders must be approved by growers in referenda prior to
implementation.
In comparison, agreements may be entered into by growers, handlers,
processors, or others engaged in the handling of any agricultural
commodity or its product. Signatories voluntarily agree to participate
in the programs and comply with the regulations established by the
agreements, which may include--but are not limited to--the types
authorized for orders.
Violation of order regulations may result in the assessment of
civil penalties. The violation of orders and agreements may result in
enforcement actions filed in the United States District courts.
Violation of agreements could also result in suspension of program
privileges, such as use of the program's certification mark. Under the
Perishable Agricultural Commodities Act, AMS is also authorized to
investigate and prosecute alleged violations concerning misbranding or
mislabeling of commodity containers, which would include misuse of a
certification mark developed under the agreement. The FDA is
responsible for determining whether a regulated product is causing an
illness and may recall products or take other actions to halt the
spread of that illness.
Orders and agreements offer flexibility in designing and modifying
requirements to reflect changes in production and handling practices.
Both are administered by committees of representatives that are
nominated by the industries and selected by USDA. Committees plan
annual program activities and submit budgets of expenditures for
approval by USDA. Programs are funded by assessments, which are levied
on handlers and based on the volume of commodity they handle.
USDA provides oversight of marketing programs to make sure the
orders and agreements operate in a manner consistent with the Act. AMS
representatives attend committee meetings and provide guidance to
program committees regarding implementation of regulations and conduct
of committee business and program activities. Regulations are
implemented following USDA approval through the public rulemaking
process. The Federal or Federal-State Inspection Programs inspect
commodities, audit handler procedures, and/or review handler records to
verify compliance with mandatory regulations under marketing orders and
agreements.
Background
In mid-September 2006, the FDA issued the first public alerts \1\
of a multi-state Escherichia coli (E. coli) outbreak linked to fresh
spinach grown in California's Salinas Valley. The resulting recall was
the largest ever for leafy green products. The produce industry
responded quickly to the recall in an effort to rebuild consumer
confidence and minimize the risk of future outbreaks.
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\1\ FDA Warning on Serious Foodborne E. coli O157:H7 Outbreak;
FDA News, September 14, 2006; http://www.fda.gov/bbs/topics/NEWS/2006/NEW01450.html
.
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Investigations by the FDA and the California Department of Health
Services, in cooperation with the Centers for Disease Control and
Prevention and USDA's Animal and Plant Health Inspection Service,\2\
concluded that the E. coli contamination might have been attributed to
environmental factors in the production area. In response, members of
the California industry initiated the establishment of a State
marketing agreement for handlers of leafy greens (http://www.caleafygreens.ca.gov/docs/resources.asp
), which became effective
February 10, 2007. Signatories to the State agreement certify that the
production, handling, shipment, and sale of leafy green products they
handle are compliant with commodity-specific food safety guidelines
adopted as Best Practices under the agreement. The Best Practices and
its guidelines are designed
[[Page 56680]]
to minimize the risk of pathogenic contamination. Compliance with the
Best Practices is verified by agricultural inspection agencies under
contract with the administrative Board established under the agreement.
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\2\ FDA Finalizes Report on 2006 Spinach Outbreak, FDA News,
March 23, 2007, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html
.
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Although AMS has not received an official proposal, members of the
leafy greens industry have expressed interest in the establishment of
similar standards through a Federal marketing program. Industry
discussions have focused on the need for a program with national scope.
In response, AMS is considering the development of a marketing
agreement as previously described in this document. AMS believes that
an agreement, rather than an order, is more likely to meet the needs of
the produce industry across the fifty States and the District of
Columbia. Agreements offer greater flexibility in designing regulatory
programs since the programs authorized for agreements are not limited
to those specified for orders under the Act. Also, handlers voluntarily
enter into agreements, giving individuals the opportunity to determine
whether they want to participate, which may be more responsive to the
needs of a nationwide industry.
As part of its review, AMS is seeking public comments and proposals
regarding establishment of a nationwide agreement for the handling of
leafy green products. If further development is warranted by response
to this request, AMS would publish a notice of hearing on a proposed
marketing agreement in the Federal Register in accordance with the
provisions of sections 556 and 557 of title 5 of the United States Code
and the applicable rules of practice and procedure governing the
formulation of marketing agreements and orders (7 CFR part 900). Public
hearings regarding the proposed agreement would be held throughout the
country, and handler sign-ups would be conducted if the agreement was
approved by USDA.
Agency Request for Information
AMS is soliciting the views of growers, handlers, buyers, sellers,
consumers, and other interested persons on a possible marketing
agreement to regulate the handling of leafy green commodities.
Additionally, AMS is interested in any information from industry
organizations that could assist with the development of leafy green
produce industry profiles. The agency will use information, comments,
and proposals received to evaluate whether development of such an
agreement for the fifty States and the District of Columbia should be
pursued. In particular, AMS invites responses to the following
questions:
(1) Would the handling of leafy greens be better addressed though
regulations under a voluntary marketing agreement signed by handlers,
or under a mandatory marketing order regulating handlers and approved
by a producer referendum?
(2) Would such a program be better implemented on a national or a
regional basis?
(3) How should the United States be subdivided into smaller regions
for the purposes of committee representation and program
administration?
(4) How should committee membership be allocated to adequately
represent the interests of industry throughout all regions of the
United States?
(5) What process should the committee follow to recommend
regulations appropriate to the various regions? For example, would
regulations for handling leafy greens on the east coast differ from
those on the west coast, and if so, how should the administrative
committee address the differences while developing recommendations for
regulations?
(6) What specific problems or issues should be addressed by such a
marketing program?
(7) Would Best Practices based upon FDA guidelines be the best
criteria for regulation of leafy green handling, or are there other
criteria available that might better meet the industry's needs?
(8) Which specific leafy green commodities should be included under
the program's handling regulations?
(9) What are potential obstacles to the implementation of such a
marketing program? For example, would distance make it impractical for
the committee to meet frequently? Might regional subcommittees be
appointed to meet more frequently and consider local matters for
presentation at annual national committee meetings?
(10) What are the potential costs associated with the
implementation of such a program, including changes to current
production and handling procedures, assessments, and audits?
(11) How would a marketing program complement, duplicate, or
conflict with any other existing programs, such as state food safety
regulations? and
(12) Are there other issues and/or suggestions about such a
marketing program?
All views are solicited so that every aspect of this potential
regulation may be studied prior to formulating a proposed rule, if
warranted, by AMS. This request for public comment does not constitute
notification that the agreement described in this document is or will
be proposed or adopted.
A 60-day comment period is provided to allow sufficient time for
interested parties to comment on a possible leafy green marketing
program. All timely written comments received will be considered before
any subsequent rulemaking action is undertaken.
Authority: 7 U.S.C. 601-674.
Dated: October 1, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E7-19629 Filed 10-3-07; 8:45 am]
BILLING CODE 3410-02-P