[Federal Register Volume 65, Number 182 (Tuesday, September 19, 2000)]
[Proposed Rules]
[Pages 56503-56505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24032]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 65, No. 182 / Tuesday, September 19, 2000 / 
Proposed Rules  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 390

[Docket No. 99-029P]


Sharing Recall Information With State and Other Federal 
Government Agencies

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) proposes to add 
regulations concerning sharing recall information with State and other 
Federal government agencies. This proposed rule would permit FSIS to 
disclose to officials of State governments certain proprietary 
information without being compelled to disclose the information to the 
public under the Freedom of Information Act (FOIA). Also, the proposed 
rule would advise the public that FSIS will share proprietary 
information with other Federal agencies. Specifically, this proposal 
addresses situations where, during a recall activity, it is beneficial 
for FSIS to share certain proprietary information from a firm with 
State and other Federal government agencies. This action is necessary 
to facilitate cooperation in regulatory activities and will contribute 
to improved public health protection.

DATES: Submit comments on or before November 20, 2000.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, Docket #99-029P, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th 
Street, SW., Washington, DC 20250-3700. All comments submitted in 
response to this proposal will be available for public inspection in 
the Docket Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Charles Gioglio, Director, Recall 
Management Division, Office of Public Health and Science, FSIS, U.S. 
Department of Agriculture. The mailing address is Maildrop 343, 3rd 
Floor--Room 333, 1400 Independence Avenue, SW., Washington, DC 20250. 
Telephone number (202) 690-6389.

SUPPLEMENTARY INFORMATION:

Background

Overview of Recalls of Meat and Poultry Products

    FSIS is responsible for ensuring that meat and poultry products are 
safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat 
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), 
which require Federal inspection and regulation of meat and poultry 
products prepared for distribution in commerce for use as human food. 
When meat or poultry products in commerce are found to present an 
actual or potential health hazard to consumers, or otherwise to violate 
the provisions of the FMIA or PPIA, FSIS will request that firms recall 
the suspect products.
    Recalls are voluntary actions taken by manufacturers or 
distributors in cooperation with Federal and State agencies. A product 
is recalled when found to be adulterated or misbranded under provisions 
of the FMIA or PPIA. Although the product is marked, inspected and 
passed, FSIS may determine, based on information that has become 
available to the Agency, the product is no longer eligible to bear the 
mark of inspection.
    FSIS does not have statutory authority to order recalls. Recall 
actions are initiated by a firm, either on its own initiative or at the 
request of FSIS. If a firm does not agree to initiate a recall, FSIS 
has authority to detain and seize the product once it is located. A 
recall may be undertaken by a firm that manufactures, wholesales, or 
distributes meat or poultry products. Retail establishments are exempt 
from inspection. However, when meat or poultry products are 
manufactured at retail establishments and found to be adulterated, FSIS 
expects the retail establishment to recall the product. FSIS will 
coordinate with State agencies to accomplish the recall. Firms can be 
large corporations, partnerships, or family owned businesses.
    When firms conduct recalls, the Recall Management Division (RMD) of 
FSIS classifies the health risk associated with the recalled products. 
A Class I recall involves a health hazard situation where there is a 
reasonable probability that the use of the product will cause serious, 
adverse health consequences or death. Class II recalls involve a 
potential health hazard situation where there is a remote probability 
of adverse health consequences from the use of the product. Class III 
recalls involve a situation where the use of the product will not cause 
adverse health consequences. RMD also recommends the scope (the amount 
and kind of product recalled) of the recall, distributes recall 
notification reports to public health officials, and assists FSIS' 
Office of Congressional and Public Affairs in notifying the public 
through press releases. Information on all recalls is posted on the 
FSIS web site, www.fsis.usda.gov. FSIS' Office of Field Operations, 
compliance personnel verify that firms conduct voluntary recalls and 
evaluate their effectiveness through checks performed in the field.

Changes in Recall Policy and New Recall Directive

    Over the last few years, firms have initiated several major Class I 
recalls at FSIS' request, one of which involved over 25 million pounds 
of product believed to be contaminated with E. coli O157:H7. In 
November 1997, FSIS created a Recall Working Group to assess the 
adequacy of its current recall policies and practices. Based on a full 
review of issues presented to it, the Recall Working Group determined 
that the Agency's recall policies and procedures are basically sound; 
however, the Working Group believed that some improvements could be 
made in the recall process.
    Based on its careful consideration of that report and the comments 
on it, and in consultation with the Secretary of Agriculture and the 
Under Secretary for Food Safety, FSIS issued on January 19, 2000 a new 
version of FSIS Directive 8080.1 (Revision 3), ``Recall of Meat and 
Poultry Products'' and issued a Guide (as an amendment to the new 
Directive), ``Product Recall Guidelines for Establishments.'' The main 
purpose of the Directive is to update the Agency's procedures and to 
set out two new policies. First, FSIS has begun issuing

[[Page 56504]]

press releases for all meat and poultry recalls. The press releases are 
drafted to reflect the health risk presented by the product being 
recalled, and how the product is identifiable to consumers and users.
    Second, the Directive defines the circumstances in which FSIS will 
consider a recall to be completed. The Agency states that it will 
consider a recall to be complete when the recalling firm has made all 
reasonable efforts to recover the product, and it either has disposed 
of the product or has it under control. FSIS addressed this concern in 
response to complaints that some recalls remained open for months and 
even years.
    The Guide outlines the actions that a firm should take in 
anticipation of a recall and in the event that the plant decides to 
recall product. The Guide states that a firm should prepare and 
maintain a detailed, written recall plan. It further states that this 
plan should describe, on a step-by-step basis, the procedure that the 
firm will follow when recalling a product.

Changes in Recall Policy and Sharing Recall Information With State and 
Federal Agencies

    This proposed rule is intended to facilitate the sharing of certain 
proprietary (non-public) information (e.g., distribution lists) with 
State and other Federal government agencies in order to enhance 
cooperation in recall activities, contribute to improved public health 
protection, and maintain effective communication with these agencies. 
FSIS has modeled this proposed rule, in part, on two Food and Drug 
Administration (FDA) regulations, 21 CFR 20.85 and 20.88, that permit 
FDA to disclose certain proprietary information to State governments 
and other Federal officials without requiring FDA to make the 
information or documents available to the public.
    Historically, FSIS' communications with State agencies generally 
had the same status as communication with any member of the public. In 
accordance with 5 U.S.C. 552(a)(3)(A), any record of the Agency that is 
disclosed in an authorized manner to any member of the public is 
available for disclosure to all members of the public.
    There are times when public disclosure of information will 
undermine legitimate private rights and government responsibilities. In 
drafting the FOIA (5 U.S.C. 552), Congress recognized the need for the 
Federal government to be able to withhold certain categories of 
information from public disclosure. Examples of such categories of 
records relevant to FSIS include:
    1. Trade secret and confidential commercial information (5 U.S.C. 
552 (b)(4));
    2. Predecisional documents to protect the deliberative process (5 
U.S.C. 552 (b)(5)); and
    3. Information the disclosure of which may invade personal privacy 
(5 U.S.C. 552 (b)(6)).
    FSIS works closely with Federal and State agencies in situations 
involving outbreaks of foodborne illness and the recall of meat and 
poultry products to protect the public health. To enhance cooperation 
with State and other Federal government agencies, FSIS needs the 
ability, in certain circumstances, to disclose confidential commercial 
information to other agencies.
    Therefore, FSIS is proposing to amend 9 CFR part 390 by adding a 
new section that will enable FSIS to share with other State agencies 
non-public information that is protected from mandatory public 
disclosure by exemption 4 of the FOIA (5 U.S.C. 552(b)(4)). Exemption 4 
covers two broad categories of information in Federal agency records--
trade secret information and information that is: (1) commercial or 
financial, (2) obtained from a person, and (3) privileged or 
confidential (''confidential commercial information''). The new section 
also addresses sharing of information with other Federal agencies which 
is not limited by FOIA, but is included in the proposed rule to clearly 
advise persons that information will be shared with other Federal 
agencies.
    The Agency is proposing to provide that the Administrator or 
designee may disclose confidential commercial information submitted to 
FSIS to State and other Federal government agencies as part of a 
cooperative effort between agencies, provided that:
    The State government officials have provided a written statement 
establishing authority to protect confidential commercial information 
from public disclosure and a written commitment not to disclose such 
information without the submitter's written permission or written 
confirmation from FSIS that the information is no longer confidential. 
Federal agencies must provide a written commitment not to disclose the 
information, but to refer the confidential commercial information to 
FSIS in order for FSIS to respond to the request for information.
    FSIS intends that the disclosure of information to other agencies 
will be for the purpose of recalls of meat and poultry products. The 
regulatory text of this proposed rule limits the sharing of information 
to recalls.
    The proposed amendment to 9 CFR part 390 would establish that the 
above government officials are not members of the public for purposes 
of disclosure of confidential commercial information submitted to FSIS, 
and that such disclosures would not invoke the requirements in 9 CFR 
part 390 of uniform access to records. Disclosure of confidential 
commercial information to government agencies as specified in the 
proposed amendment would be an ``authorized'' disclosure.
    FSIS believes this proposed rule will do nothing to diminish 
current public access to Agency records. The purpose of this proposed 
rule is not to reduce the number or types of records that will be 
available to the public from FSIS but to enhance the Agency's ability 
to engage in information exchanges.
    Also, this proposed regulation is related to a Memorandum of 
Understanding (MOU) between FSIS and the Food and Drug Administration 
(FDA) signed in February 1999 that facilitates sharing of information. 
This MOU is limited in effect by FSIS' inability to provide proprietary 
information on recalls to FDA or other affected authorities. This 
regulation would remedy this limitation of the MOU.

Compliance With Executive Order 12866 and the Regulatory Flexibility 
Act of 1996

    This rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    The Administrator, FSIS, has determined that this action will not 
have a significant economic impact on a substantial number of small 
entities as defined by the Regulatory Flexibility Act (5 U.S.C. 601) 
because this rule promotes cooperation among FSIS, other Federal and 
State agencies.

Economic Impact

Impacts/Net Benefits Associated With the Proposed Action

    This proposed action is new. No significant changes in recall 
activities are expected as a result of this action.
    1. Net benefits are likely to be increased public health 
protection.
    2. Net benefits are likely to be enhanced communications and 
cooperation between FSIS and State and other Federal agencies.

Expected Benefits

    During a meat or poultry recall, FSIS will be able to share 
sensitive,

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confidential proprietary information with State agencies and other 
Federal agencies without having to disclose this information to the 
general public or media under the Freedom of Information Act. This will 
enable FSIS staff to verify that adulterated, un-healthful, or 
misbranded products are removed from consumer channels quickly and 
efficiently and to protect the public health.
    Because of the proposed rule, the sharing of recall information 
will help all the government agencies work aggressively together to 
find solutions that will enhance public health and provide consumer 
protection from foodborne illnesses. The State agencies will provide a 
written agreement not to disclose such information without the 
submitter's written permission or written confirmation from FSIS. 
Federal agencies must agree not to release the information but to refer 
the information to FSIS for a response to the requestor. This will 
ensure that the other government agencies do not inadvertently share 
this information with the public. Increased consumer protection and 
public health, and efficiency in government are the basic benefits of 
this proposed rule.

Expected Costs

    There are minimal costs associated with sharing recall information 
with State and other Federal agencies. Costs will consist of the labor 
it takes to draft and agree to Memorandum of Understandings, and the 
labor it takes to share the information with these agencies, but these 
costs are already absorbed by the labor cost of these officials. There 
are no costs to industry.

Expected Effects on Small Entities

    No disproportionate significant economic impact will be experienced 
by small entities. FSIS will share with States and other Federal 
officials confidential and proprietary information of both large and 
small entities, if the recall warrants it.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
proposed rule, FSIS will announce it and provide copies of this Federal 
Register publication in the FSIS Constituent Update. FSIS provides a 
weekly FSIS Constituent Update, which is communicated via fax to over 
300 organizations and individuals. In addition, the update is available 
on line through the FSIS web page located at http://www.fsis.usda.gov. 
The update is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, recalls, and any other types of information that could affect 
or would be of interest to our constituents/stakeholders. The 
constituent fax list consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through these various channels, FSIS is able to provide 
information to a much broader, more diverse audience. For more 
information and to be added to the constituent fax list, fax your 
request to the Congressional and Public Affairs Office, at (202) 720-
5704.

Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations,'' FSIS has considered potential 
impacts of this proposed rule on environmental and health conditions in 
low-income and minority communities.
    Sharing recall information with other agencies will benefit FSIS, 
the regulated industry and consumers. Thus, this proposed regulation 
does not adversely affect the public health or environment in low-
income and minority communities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule. However, 
the administrative procedures specified in 9 CFR 390.7 must be 
exhausted prior to any judicial challenge of the application of the 
provisions of this proposed rule, if the challenge involves any 
decision of an FSIS employee relating to a denial of access of 
information.

Paperwork Requirements

    There are no paperwork or recordkeeping requirements associated 
with this proposed rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

List of Subjects in 9 CFR Part 390

    Confidential business information, Freedom of information, 
Government employees.
    For the reasons set forth in the preamble, FSIS proposes to amend 9 
CFR part 390 as follows:
    1. The heading of 9 CFR part 390 is revised to read as follows:

PART 390--FREEDOM OF INFORMATION AND PUBLIC INFORMATION

    2. The authority citation for part 390 continues to read as 
follows:


    Authority: 5 U.S.C. 301, 552; 7 CFR 1.3, 2.7.
    3. Section 390.9 is added to read as follows:


Sec. 390.9  Communications with State and other Federal government 
agencies.

    (a) The Administrator of the Food Safety and Inspection Service 
(FSIS) or designee, may authorize the disclosure of confidential 
commercial information submitted to FSIS, or incorporated into agency-
prepared records, to State and other Federal government agencies as 
part of a recall of meat or poultry products, provided that:
    (1) The State agency has provided both a written statement 
establishing its authority to protect confidential commercial 
information from public disclosure and a written commitment not to 
disclose any such information provided by FSIS without the written 
permission of the submitter of the information or written confirmation 
by FSIS that the information no longer has confidential status. Federal 
government agencies must provide a written commitment not to disclose 
the information, but to refer the confidential commercial information 
to FSIS in order for FSIS to respond to the request for information; 
and
    (2) The Administrator of FSIS or designee determines that 
disclosure would be in the interest of public health.
    (b) This provision does not authorize the disclosure to State or 
other Federal government agencies of trade secret information, unless 
otherwise provided by law or pursuant to an express written 
authorization provided by the submitter of the information.
    (c) Information disclosed under this section is not a disclosure of 
information to the public. Disclosures made under this section do not 
waive any FOIA exemption protection.

    Done in Washington, DC on September 13, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-24032 Filed 9-18-00; 8:45 am]
BILLING CODE 3410-DM-P