[Federal Register: September 19, 2000 (Volume 65, Number 182)]
[Proposed Rules]
[Page 56503-56505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se00-17]
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Proposed Rules
Federal Register
________________________________________________________________________
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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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, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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