[Federal Register: April 24, 2002 (Volume 67, Number 79)]
[Rules and Regulations]
[Page 20009-20013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap02-2]
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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://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 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