[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Proposed Rules]
[Pages 56678-56680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19629]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected] or [email protected].

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ FDA Finalizes Report on 2006 Spinach Outbreak, FDA News, 
March 23, 2007, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html.
---------------------------------------------------------------------------

    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