[Federal Register Volume 67, Number 79 (Wednesday, April 24, 2002)]
[Rules and Regulations]
[Pages 20009-20013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9840]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 390

[Docket No. 99-029F]
RIN 0583-AC75


Sharing Recall Distribution Lists With State and Other Federal 
Government Agencies

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is adding 
regulations concerning sharing distribution lists from a firm that is 
recalling meat or poultry products with State and other Federal 
agencies. This rule will permit FSIS to share with officials of State 
governments and of other Federal agencies, distribution lists without 
being compelled to disclose the information to the public under the 
Freedom of Information Act (FOIA). This action is necessary for 
improved public health protection and will facilitate cooperation among 
regulatory agencies.

EFFECTIVE DATE: This rule is effective July 31, 2002.

FOR FURTHER INFORMATION CONTACT: Ralph Stafko, Senior Policy Manager, 
Federal, State and Local Government Relations Staff, OPPDE, FSIS, U.S. 
Department of Agriculture, Washington, DC 20250, (202) 418-8900. FSIS 
has drafted a Memorandum of Understanding (MOU) for use by FSIS and 
State agencies in implementing this rule. For information on the MOU, 
contact Ralph Stafko at the telephone number above.

[[Page 20010]]


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 there is reason to believe that meat or poultry products in 
commerce are adulterated or misbranded, FSIS will request that the 
firms that introduced the products into commerce recall them.
    Recalls are voluntary actions taken by manufacturers or 
distributors in cooperation with Federal and State agencies. Although 
the product is marked ``inspected and passed,'' FSIS may determine, 
based on information that becomes available to the Agency after the 
product is shipped, that there is reason to believe that the product is 
not 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 
may detain or seize the product wherever it is located.

Sharing Recall Distribution Lists With State and Federal Agencies

    This final rule delineates the circumstances in which FSIS will 
share the distribution lists of a firm involved in a recall with State 
and other Federal agencies. Distribution lists are records that show 
where and when the product was shipped. Sharing these lists will 
contribute to improved public health protection by allowing for more 
effective and timely verification that products are removed from 
commerce. It will also have the effect of enhancing cooperation and 
effective communication with other agencies.
    Historically, FSIS' communications with State agencies had the same 
status as communication with any member of the public. Under the FOIA 
at 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.
    Thus, FSIS was unwilling to share distribution information with the 
States. Distribution information is confidential commercial information 
that is valuable to a firm and to its competitors. FSIS recognized that 
if it made the information regularly available to the public, firms 
would be unwilling to voluntarily share this information with the 
Agency. The Agency's ability to verify that recalls were proceeding 
effectively would be significantly hampered as a result, and the public 
health would consequently suffer.
    Beginning in 1996, however, with the publication of the Pathogen 
Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems 
final rule, FSIS has pointed out the need for a farm-to-table approach 
to food safety. The Agency has also pointed out that this approach 
needs to be supported by a seamless food safety system. As a result, 
FSIS has begun to work more and more closely with other Federal and 
State agencies. One type of situation in which FSIS has come to see 
cooperation as particularly important is that 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 some 
circumstances, to disclose certain confidential commercial information 
to other agencies while still protecting the confidentiality of the 
information in all other respects.
    Therefore, on September 19, 2000 (65 FR 56503), FSIS proposed to 
amend 9 CFR part 390 by adding a new section that would enable FSIS to 
share with State agencies and other Federal agencies certain 
confidential commercial information, specifically, distribution lists 
from the firm recalling a meat or poultry product, which are protected 
from mandatory public disclosure by exemption 4 of the FOIA (5 U.S.C. 
552(b)(4)).
    FSIS modeled its proposed rule, in part, on two Food and Drug 
Administration (FDA) regulations, 21 CFR 20.85 and 20.88, which permit 
FDA to disclose certain nonpublic information to State governments and 
other Federal officials without requiring FDA to make the information 
or documents available to the public.
    In response to the proposed rule, FSIS received 18 comments. After 
carefully analyzing the comments, FSIS has decided to adopt the 
proposed rule.
    Under 9 CFR 390.9, the Administrator or his/her designee may share 
distribution lists that have been obtained by FSIS with State and other 
Federal government agencies as part of a cooperative effort between 
agencies, in accordance with the following conditions.
    The State government officials will provide a written statement 
establishing their authority to protect distribution lists 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.
    Officials of other Federal agencies will need to provide a similar 
written commitment not to disclose the information and must refer any 
request for distribution lists to FSIS for response.
    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 rule limits the sharing of information to 
recalls.
    Under this final rule, 9 CFR 390.9 also provides that these 
government officials are not members of the public for purposes of 
disclosure of distribution lists submitted to FSIS, and that such 
disclosures will not invoke the requirements in 9 CFR part 390 for 
uniform access to records. Disclosure of distribution lists to 
government agencies as specified in this rule will be an authorized 
disclosure.
    This rule will do nothing to diminish public access to Agency 
records. The purpose of this 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 with 
Federal and State agencies.
    This regulation also is related to a Memorandum of Understanding 
(MOU) between FSIS and the Food and Drug Administration (FDA) signed in 
February 1999, which was intended to facilitate sharing of information. 
This MOU has been limited in effect by FSIS' inability to provide 
proprietary information on recalls to FDA. This regulation will remedy 
this limitation.

Comments and Responses

    As stated above, FSIS received eighteen comments on the proposed 
rule from trade and professional associations, consumer advocacy 
groups, a State Department of Health, and a Federal government agency. 
The regulatory text of this final rule incorporates changes made in 
response to these comments.

General Comments

    Most of the commenters expressed general support for sharing 
distribution lists with State and other Federal government agencies 
without being compelled to disclose the information to the public under 
the FOIA. Many of

[[Page 20011]]

these commenters, however, did recommend revisions of specific 
provisions in the rule. One commenter generally opposed the proposed 
rule.
    FSIS responses to all of the relevant comments follow.
    Comment: Most of the commenters stated that FSIS should specify 
what ``confidential commercial information'' and ``proprietary 
information'' may be shared with State and Federal agencies.
    Response: FSIS agrees with the comment. The Agency's intent in the 
proposed rule was to share certain confidential commercial information, 
i.e., distribution lists, from firms with Federal and State agencies. 
Distribution lists are records of where and when product was shipped 
from the firm recalling the product. Distribution lists also include 
lists from the establishment's secondary and tertiary distributors. 
Therefore, FSIS has modified the final regulation and the phrases 
``confidential commercial information'' and ``proprietary information'' 
have been removed wherever they appear and replaced with the term 
``distribution lists.''
    Comment: Several commenters asserted that sharing recall 
information should be permitted only when there is a Class I recall. 
Class I recalls involve a health hazard situation where there is a 
reasonable probability that the use of the product will cause serious, 
adverse health consequences or death.
    Response: FSIS disagrees with this comment. A Class II recall 
involves a remote chance of an adverse health consequence but still 
involves a potential health hazard. Therefore, in the interest of 
public health protection, distribution lists should, and will, be 
shared in the event of a Class II recall.
    However, because Sec. 390.9(a)(2) requires that the disclosure be 
in the interest of public health, FSIS will not share information in 
Class III recall instances, where the use of a product will not cause 
adverse health consequences.
    Comment: Most commenters urged that information be limited to those 
other Federal or State agencies that are responsible for enforcing food 
safety statutes and that can assist FSIS in verifying the removal of 
products.
    Response: FSIS agrees with the comment. This rule specifically 
addresses food recall activities. The Agency has modified the rule to 
state that distribution lists will be distributed to agencies that are 
involved in food safety to assist FSIS in recall verification 
activities.
    Comment: Numerous commenters said that confidential commercial 
information should not be released to any State that does not have a 
confidentiality statute that protects the state from releasing 
confidential commercial information to the public.
    The commenters went on to say that, even though FSIS will only 
disclose confidential commercial information provided that the State 
government officials give a written statement to establish their 
authority to protect the information from public disclosure, it is only 
acceptable if the State has protective laws in place that disallow 
sharing such information with the public.
    Related comments asked that FSIS enter into Memorandums of 
Understanding (MOUs) or cooperative agreements with State and Federal 
agencies with whom FSIS plans to share information. The comments said 
that these agreements would ensure that the receiving agency 
understands exactly which information must be kept confidential, and 
that the agency agrees to do so.
    Response: FSIS agrees. As the proposed rule stated, State and 
Federal government agencies must provide a written statement 
establishing their authority to protect confidential commercial 
information from public disclosure.
    FSIS intends to enter into MOUs, cooperative agreements, or other 
appropriate documents with State and other Federal agencies that are 
interested in receiving distribution lists, on the condition that FSIS 
expects that the agencies report back to FSIS the results of the use of 
the distribution list information.
    Comment: Several commenters requested that when FSIS receives a 
request for confidential commercial information belonging to a firm, 
that the Agency notify the firm immediately, as provided by 7 CFR 1.11.
    Response: FSIS will, of course, comply with existing Departmental 
regulatory requirements and will notify the firm that provided the 
information to FSIS.
    Comment: Some commenters requested that FSIS make even more clear 
in the preamble to the final rule just what the consequences or 
penalties will be should a State or Federal employee who had been the 
recipient of shared confidential commercial information accidentally or 
purposefully release this information without authorization.
    Response: The penalty for an unauthorized disclosure is that FSIS 
will not share information with the agency involved and will cancel the 
MOU or agreement with it. Also, a firm can pursue its legal remedies in 
the case of unauthorized disclosures of its distribution lists.
    Comment: Two commenters said that as written, proposed section 
390.9(a)(1) appears to be misworded and suggested revised wording. The 
proposed section 390.9(a)(1) stated ``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.''
    Response: FSIS agrees that the section appears to be misworded and 
has revised Sec. 390.9(a)(1) to be more clear. The sentence will read 
as follows:

    Federal government agencies must provide a written commitment 
not to disclose the information and to refer any request for 
distribution lists to FSIS for response.

    Comment: One commenter questioned the meaning and effect of the 
review under Executive Order 12988, Civil Justice Reform, as it states 
that ``This rule: (1) Preempts State and local laws and regulations 
that are inconsistent with this rule.'' The commenter wanted to know if 
the proposed rule preempts sunshine or open records laws which many 
states have and which give the public a right of access to governmental 
records.
    Response: This final rule has no preemptive effect. Therefore, 
agencies must follow the edicts of their State law. A State agency in a 
State with such a law would not be able to enter into an MOU with FSIS 
that would violate such a law.
    Comment: A commenter stated that FSIS should address its concerns 
about whether information released as a result of this rule could hurt 
the marketing ability of small establishments, by raising the danger of 
disclosure of confidential sales lists to competing establishments and 
businesses.
    Response: These concerns are not warranted. This rule has been 
developed to protect the confidentiality of such information.
    FSIS has built mechanisms into the regulation to protect 
information by requiring written commitments not to disclose 
information and written assurances that the State agencies and other 
Federal agencies that receive the information have the means and the 
intent to protect the confidentiality of the information. FSIS has 
every confidence that they will do so.
    Comment: One commenter stated that FSIS should work with each State 
government to develop a list of authorities that should receive 
information, e.g., the State's health department and State agencies 
that run

[[Page 20012]]

State-operated institutions (prisons, schools, hospitals, etc.).
    Response: FSIS disagrees. With the MOU, it is unnecessary to 
specify the agencies. However, the only agencies that need the list are 
those that assist FSIS in recall effectiveness checks. State agencies 
understand the sensitivity of the information. State schools, 
hospitals, or prisons, while they may need to know of the recall, have 
no need for the distribution lists. Schools, prisons, hospitals, as 
well as any other recipients of recalled product, are notified directly 
by the recalling firm.

General Opposition

    Comment: One commenter generally opposed the proposed rule for two 
key reasons:
    1. The proposed rule would substantially weaken Freedom of 
Information (FOIA) protections relating to certain types of 
confidential information by authorizing FSIS to share this information 
with State government agencies; and
    2. The proposed rule does not clearly identify the scope of 
information that may be shared, or the circumstances under which 
information may be shared.
    Response: FSIS stated in the proposal that it would share 
confidential commercial information with other government entities in 
conjunction with a recall. This broad statement satisfied any legal 
notice requirement. However, in the final rule, FSIS is specifying the 
information it intends to disclose. As mentioned previously, FSIS will 
share distribution lists with Federal and State agencies and has 
modified this final regulation to reflect this clarification.
    FSIS disagrees that this rule would weaken Freedom of Information 
(FOIA) protections relating to confidential information by authorizing 
FSIS to share this information with States. FSIS will maintain the 
confidentiality of distribution lists and will only share this 
information with agencies that agree to partner with FSIS to 
effectively determine recalled product removal.
    Further, FSIS has required that safeguards be in place in any State 
with which the information is to be shared, so that the confidentiality 
of the information can, and will, be protected. The Agency will deny a 
request for distribution lists if the government officials are unable 
to assure FSIS of their ability and willingness to protect the 
information.

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 between FSIS and other Federal 
and State agencies.

Economic Impact

Impacts/Net Benefits Associated with this Action

    This action is new. No significant changes in recall activities are 
expected as a result of this action.
    1. Net benefits are likely to include increased public health 
protection.
    2. Net benefits are likely also to include 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 
distribution lists 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. Doing so will help FSIS to 
verify that adulterated, unhealthful products are removed from consumer 
channels quickly and efficiently and to protect the public health.
    Because of this rule, the sharing of recall information will help 
all the government agencies to work cooperatively to 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 any request for the information to FSIS for 
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 will be the basic benefits of this 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 for FSIS to share the information with these agencies. 
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 State and other Federal 
government officials confidential and proprietary information 
(distribution lists) 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 
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 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 regulation does not 
adversely affect the

[[Page 20013]]

public health or environment in low-income and minority communities.

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Will not preempt 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 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 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, 9 CFR part 390 is 
amended to read 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 distribution lists 
(records that show where and when product was shipped) obtained from a 
firm recalling products, or incorporated into agency-prepared records, 
to State and other Federal government agencies to verify the removal of 
the recalled product, provided that:
    (1) The State agency has provided both a written statement 
establishing its authority to protect confidential distribution lists 
from public disclosure and a written commitment not to disclose any 
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 and to refer any request for distribution lists to FSIS for 
response; 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: April 15, 2002.
Margaret O'K. Glavin,
Acting Administrator.
[FR Doc. 02-9840 Filed 4-23-02; 8:45 am]
BILLING CODE 3410-DM-P