[Federal Register Volume 74, Number 67 (Thursday, April 9, 2009)]
[Rules and Regulations]
[Pages 16104-16108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8106]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 392

[Docket No. 00-019F; FDMS Docket No. FSIS-2005-0020]
RIN 0583-AC81


Petitions for Rulemaking

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
administrative regulations to add a new part that establishes 
regulations governing the submission to FSIS of petitions for 
rulemaking. The new regulations supersede existing guidance on the 
submission of petitions to FSIS to issue, amend, or repeal its 
regulations. FSIS is taking this action to help ensure the filing of 
well-supported petitions that contain information that the Agency needs 
to proceed with consideration of the requested rulemaking in a timely 
manner.

DATES: Effective Date: June 8, 2009.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Director, Policy 
Issuances Division, Office of Policy and Program Development, Food 
Safety and Inspection Service, U.S. Department of Agriculture; (202) 
720-5627.

SUPPLEMENTARY INFORMATION: 

Background

    On January 12, 2006, FSIS published a proposal in the Federal 
Register to establish regulations governing the submission to FSIS of 
petitions to issue, amend, or repeal a regulation administered by the 
Agency (71 FR 1988). As discussed in that proposed rulemaking, FSIS had 
previously published guidelines in 1993 on how to submit petitions for 
rulemaking to the Agency (58 FR 63570, December 2, 1993). Despite the 
existence of this guidance, rulemaking petitions are submitted to FSIS 
in various forms, often without adequate data and supporting 
documentation for FSIS to properly evaluate the merits of the requested 
action. The measures proposed in the January 12, 2006, proposed rule 
are designed to encourage the filing of well-supported petitions that 
contain information that the Agency needs to evaluate a requested 
rulemaking in a timely manner. The comment period for the proposed rule 
closed on March 12, 2006.

Comments and FSIS Response

    FSIS received only one comment in response to the January 12, 2006, 
proposal. The comment was generally supportive of the proposed 
regulations but also expressed the view that when preparing Notices and 
Directives, FSIS should provide an opportunity for public comment prior 
to the issuance of these documents. According to the comment, FSIS 
Notices and Directives may have the same effect on the industry as 
regulations. The comment recommended that FSIS adopt a rule that would 
specifically provide opportunity for stakeholders to participate in the 
development of these documents.
    The January 12, 2006, proposed rule proposed to establish 
regulations for the submission to FSIS of petitions for rulemaking. 
Establishing a new process for making draft FSIS Notices and Directives 
available for comment is outside the scope of this rulemaking. Under 
this final rule, however, persons may certainly petition the Agency to 
issue, amend or repeal such documents.
    The comment also stated that, when evaluating petitions for 
rulemaking, FSIS must take into account that small and very small 
establishments have limited resources and may not have access to all of 
the data that FSIS considers necessary to evaluate a petition for 
rulemaking.
    In the preamble to the proposed rule, FSIS acknowledged that some 
small entities may not have access to certain data that is readily 
available to large companies or industry trade associations. As stated 
in the preamble, the Agency will take these limitations into 
consideration when it evaluates petitions submitted by small entities.

The Final Rule

    In this final rule FSIS is establishing regulations governing the 
submission to FSIS of petitions for rulemaking. As noted above, the one 
comment submitted in response to the January 12, 2006, proposed rule 
raised no objections that were within the scope of the proposed 
rulemaking. Therefore, FSIS is finalizing the proposed rule without 
changes.
    As was proposed, FSIS is adding a new part 392--Petitions for 
rulemaking to title 9, subchapter D of the CFR. As stated in Sec.  
392.1, part 392 contains provisions governing the submission to FSIS of 
petitions for rulemaking and applies to all requests to initiate 
rulemaking, except to the extent that other provisions in the FSIS 
regulations prescribe procedures for submitting requests to amend a 
regulation. As discussed in the preamble to the proposed rule, Sec.  
392.1 includes this exception because FSIS' regulations already contain 
procedures on how to submit requests to amend certain sections of the 
regulations. For example, as noted in the proposal, a request to amend 
the regulations to authorize a new Reference Amount or Product Category 
identified in 9 CFR 317.312(b) and 381.412(b) must be submitted as a 
labeling application in accordance with the provisions of 9 CFR 
317.312(g) and 381.412(g).
    Section 392.2 defines a ``petition'' as a written request to issue, 
amend, or repeal a regulation administered by the Agency. Section 392.2 
also provides that a request to issue, amend, or repeal a document that 
interprets a regulation administered by the Agency, such as an FSIS 
Directive, Notice, or compliance guide, may be made by petition.
    Section 392.3 describes the information that a petition is required 
to contain to be considered by FSIS. Section 392.3(a) requires that a 
petition include the name, address and telephone number, and e-mail 
address (if available) of the person submitting the petition. Section 
392.3(b) requires that a petition contain a full statement of the 
action requested by the petitioner, including the citation and exact 
wording of any existing regulation affected by the requested action. 
Section 392.3(c) requires that a petition include a statement of the 
factual and legal basis for the requested action, including all 
relevant information known to the

[[Page 16105]]

petitioner, both favorable and unfavorable to the petitioner's 
position. Section 392.3(c) also states that the statement of the 
factual and legal basis should identify the problem that the requested 
action is intended to address and explain why the requested action is 
needed to address the problem.
    Section 392.4 describes the information that should be submitted in 
support of a rulemaking petition. As was discussed in the preamble to 
the proposal, the documentation described in proposed Sec.  392.4 is 
not required for a petition to be considered by FSIS. Rather, Sec.  
392.4 is intended to provide petitioners with a clear idea of the type 
of supporting documentation that FSIS considers necessary to evaluate a 
petition in an efficient and effective manner.
    Section 392.4(a) provides that information referred to or relied on 
in support of a petition should be included in full, and that a copy of 
any source cited in a petition should be submitted with the petition. 
Section 392.4(b) lists sources of information that FSIS considers 
appropriate to use in support of a petition. These sources include, but 
are not limited to, professional journal articles, official government 
statistics, official government reports, scientific textbooks, research 
reports, and industry data.
    Section 392.4(c) provides that if original research reports are 
used to support a petition, the information should be presented in a 
form that would be acceptable for publication in a peer reviewed 
scientific or technical journal. Section 392.4(d) states that if 
quantitative data are used to support a petition, the presentation of 
these data should include a complete statistical analysis using 
conventional statistical methods.
    Section 392.5 sets out the procedures for filing a rulemaking 
petition with FSIS. Under Sec.  392.5(a), any interested person may 
file a petition with FSIS. Section 392.5(a) provides that, for purposes 
of part 392, an ``interested person'' means any individual, 
partnership, corporation, association, or public or private 
organization. Section 392.5(b) explains that to file a petition with 
FSIS, a person should submit the petition to the FSIS Docket Clerk at 
the address provided in that paragraph. Section 392.5(c) states that 
when FSIS receives a petition, the Agency will stamp it with the date 
of filing and assign the petition a number. Section 392.5(c) provides 
that FSIS will inform the petitioner in writing when a petition has 
been filed with the Agency. Section 392.5(c) also states that FSIS will 
provide the petitioner with the number assigned to the petition along 
with an Agency contact for the petition.
    Section 392.5(d) contains procedures for withdrawing a petition. 
Under Sec.  392.5(d) a petition may be withdrawn at any time. Section 
392.5(d) provides that if a petitioner elects to withdraw a petition, 
the petitioner should inform FSIS in writing. Once a petition is 
withdrawn, Sec.  392.5(d) permits the petitioner to resubmit the 
petition at any time.
    Section 392.6 provides for public display of rulemaking petitions 
and any supporting documentation. Section 392.6(a) provides that unless 
material is exempt from public disclosure under the Freedom of 
Information Act (FOIA) (5 U.S.C 552 et seq.), or under any other 
applicable laws or regulations, all rulemaking petitions, along with 
any supporting documentation filed with a petition, will be available 
for public inspection in the FSIS docket room and posted on the FSIS 
Web site. Section 392.6(b) provides that if FSIS can not readily 
determine whether information submitted by a petitioner is privileged 
or confidential business information, FSIS will request that the 
petitioner submit a written statement that certifies that the petition 
does not contain confidential information that should not be put on 
public display. As explained in the proposed rule, when it issues the 
request, FSIS will also specify a date by which the petitioner must 
respond. If the petitioner fails to provide the certification by the 
specified date, FSIS will assume that the information is confidential.
    Section 392.6(c) provides that if FSIS determines that information 
submitted in support of a petition is exempt from public disclosure 
under the FOIA, or any other applicable laws or regulations, and that 
the information would provide the basis for granting the petition, FSIS 
will inform the petitioner in writing. Under Sec.  392.6(c), the 
petitioner will then have an opportunity to withdraw the petition or 
the supporting documentation, or modify the supporting documentation to 
permit public disclosure.
    Section 392.7 sets out the procedures for submitting comments on a 
petition that has been filed with FSIS. Section 392.7(a) provides that 
any interested person may submit written comments on a petition. 
Section 392.7(b) provides that comments on a petition should be 
submitted within 60 days of the posting date of the petition, and that 
the comments should identify the number assigned to the petition to 
which the comments refer.
    Section 392.7(c) provides that FSIS will consider all comments that 
are timely submitted as part of its review of a rulemaking petition. 
Under Sec.  392.7(d), these comments will become part of the petition 
file and, like the petition, will be on public display in the FSIS 
docket room and posted on the FSIS Web site. Section 392.7(e) provides 
that a comment on a petition that is actually a request for an 
alternative regulatory action should be submitted as a separate 
petition rather than as a comment. Under Sec.  392.7(f), if FSIS 
determines that a comment received on a petition is in fact a request 
for an alternative action, the Agency will inform the commenter in 
writing. Section 392.7(f) also provides that FSIS will take no further 
action on the suggested alternative action unless the commenter submits 
a petition for rulemaking.
    Under Sec.  392.8(a), petitions that request actions that are 
intended to enhance the public health by removing or reducing foodborne 
pathogens or other potential food safety hazards that might be present 
in or on meat, poultry, or egg products qualify for expedited review. 
Section 392.8(b) provides that for a petition to be considered for 
expedited review, the petitioner must submit scientific information 
that demonstrates that the requested action will reduce or remove 
foodborne pathogens or other potential food safety hazards, and how it 
will do so. Section 392.8(c) explains that if FSIS determines that a 
petition should receive expedited review, the Agency will review the 
petition ahead of other pending petitions. As noted in the proposal, if 
a petition receives expedited review, the petition will still be 
subject to all other provisions that apply to rulemaking petitions.
    Section 392.9 provides that information related to the submission 
and processing of petitions for rulemaking may be found on the FSIS Web 
site. In conjunction with the issuance of this final rule, FSIS has 
developed a page on its Web site that explains the petition filing 
process. Also posted on this Web page is a description of the type of 
information that is required for FSIS to consider a petition for 
rulemaking and the type of information that FSIS recommends be 
submitted with a petition for rulemaking. In addition, after this rule 
becomes effective, all petitions for rulemaking that are submitted to 
the Agency, and any comments received on the petitions, will be posted 
on the FSIS Web site.

Information Needed To Conduct Regulatory Analyses

    In the January 12, 2006, proposed rule, FSIS explained that as part 
of the

[[Page 16106]]

regulatory development process, Federal agencies are required by law, 
Executive Order, and regulation to conduct certain analyses on the 
impact of proposed and final agency regulations. FSIS briefly described 
the statutes and Executive orders that most often affect rulemakings 
conducted by FSIS (see 71 FR 1988, 1991).
    As discussed in the preamble to the proposed rule, once a petition 
is granted, the subsequent rulemaking often requires that FSIS expend 
substantial resources to conduct the prescribed regulatory impact 
analyses. Therefore, one of the factors that the Agency considers when 
evaluating a petition for rulemaking is whether it should commit 
resources to the development of a particular rule and the analyses that 
would be required if the Agency were to grant the petition.
    In the January 12, 2006, proposal, FSIS did not propose to require 
that petitions include data on the potential impacts of a requested 
regulatory action. However, FSIS did explain that it may be able to 
more efficiently and effectively evaluate and act on a petition if the 
petitioner includes supporting data that FSIS can use in connection 
with the required impact analyses.
    Consistent with the proposal, this final rule does not require that 
petitioners submit data on the impacts of a requested regulatory 
action. However, FSIS strongly encourages the submission of these data 
to help make the Agency's review of rulemaking petitions more effective 
and efficient and to facilitate regulatory development in the event a 
petition is granted.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been reviewed under Executive Order 12866. It 
has been determined to be non-significant for purposes of E.O. 12866 
and, therefore, has not been reviewed by the Office of Management and 
Budget (OMB).
    This final rule establishes regulations governing the submission of 
rulemaking petitions to FSIS. It specifies the type of information that 
must be included in a rulemaking petition if the petition is to be 
granted and describes the type and quality of data that should be 
submitted in support of a petition.
    This final rule will benefit persons interested in filing a 
rulemaking petition with FSIS by providing clear guidance on how to 
prepare and submit a petition to best ensure prompt and appropriate 
consideration by the Agency. This final rule will also benefit 
petitioners by promoting a more timely resolution of their requested 
regulatory actions.
    Persons interested in petitioning FSIS to issue, amend, or repeal a 
regulation will bear the costs associated with preparing a rulemaking 
petition. These costs will vary depending on the complexity of the 
requested action and the type of documentation needed to support the 
petition. However, because the decision to submit a petition for 
rulemaking is voluntary, persons interested in the issuance, amendment, 
or repeal of a regulation administered by FSIS will most likely submit 
a rulemaking petition if the benefits of the requested action outweigh 
the costs of preparing the petition. By encouraging consistency in the 
content of rulemaking petitions and the submission of adequate 
supporting documentation, this final rule will reduce the 
administrative costs associated with the FSIS' review and evaluation of 
rulemaking petitions, as well as expedite the time it takes for the 
Agency to review petitions.
    In addition to this final rule, FSIS considered the option of no 
rulemaking. Under this option, prospective petitioners would continue 
to rely on the guidelines for the submission, consideration, and 
disposition of petitions that FSIS published in the 1993 Federal 
Register notice. FSIS rejected this option because the Agency 
determined that its procedures for submitting petitions need certain 
clarification, and that the importance of these procedures should be 
underscored by adopting this final rule and codified to make them 
readily available to prospective petitioners.

Effect on Small Entities

    The Administrator, FSIS, has determined that this final rule will 
not have a significant impact on a substantial number of small 
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). 
The decision to submit a petition for rulemaking is voluntary, and 
therefore, small entities are not required to comply with these final 
regulations unless they choose to submit a rulemaking petition. 
Furthermore, although FSIS continues to encourage petitioners to submit 
relevant data needed to prepare the regulatory analyses that would be 
required should the petition be granted, the submission of this 
information is not required under this final rule. FSIS is aware that 
some small entities may not have access to certain data that are 
readily available to large companies or industry trade associations. 
FSIS will take this into consideration when evaluating petitions 
submitted by small entities.

Executive Order 12988

    This final 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.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it online through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations_&_policies/2009_Interim_&_Final_Rules_Index/index.asp.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. Through the Listserv and Web page, FSIS is able to provide 
information to a much broader and more diverse audience. In addition, 
FSIS offers an e-mail subscription service which provides automatic and 
customized access to selected food safety news and information. This 
service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range from recalls to export information 
to regulations, directives and notices. Customers can add or delete 
subscriptions themselves, and have the option to password protect their 
accounts.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or record 
keeping requirements included in this final rule have been submitted 
for approval to the Office of Management and Budget (OMB). This 
information collection request is at OMB awaiting approval. FSIS will 
collect no information

[[Page 16107]]

associated with this rule until the information collection is approved 
by OMB.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, 1400 Independence Ave., SW., Room 3532 
South Building, Washington, DC 20250-3700; (202) 720-0345.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601 et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

List of Subjects

    Administrative practice and procedure, Freedom of information.

0
For the reasons discussed in the preamble, FSIS is amending 9 CFR 
Chapter III as follows:

SUBCHAPTER D--FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE 
PROVISIONS

0
Subchapter D is amended by adding a new part 392 to read as follows:

PART 392--PETITIONS FOR RULEMAKING

Sec.
392.1 Scope and purpose.
392.2 Definition of petition.
392.3 Required information.
392.4 Supporting documentation.
392.5 Filing procedures.
392.6 Public display.
392.7 Comments.
392.8 Expedited review.
392.9 Availability of additional guidance.

    Authority: 5 U.S.C. 553(e), 7 CFR 1.28.


Sec.  392.1  Scope and purpose.

    This part contains provisions governing the submission of petitions 
for rulemaking to the Food Safety and Inspection Service (FSIS). The 
provisions in this part apply to all rulemaking petitions submitted to 
FSIS, except to the extent that other parts or sections of this chapter 
prescribe procedures for submitting a request to amend a particular 
regulation.


Sec.  392.2  Definition of petition.

    For purposes of this part, a ``petition'' is a written request to 
issue, amend, or repeal a regulation administered by FSIS. A request to 
issue, amend, or repeal a document that interprets a regulation 
administered by FSIS may also be submitted by petition.


Sec.  392.3  Required information.

    To be considered by FSIS, a petition must contain the following 
information:
    (a) The name, address, telephone number, and e-mail address (if 
available) of the person who is submitting the petition;
    (b) A full statement of the action requested by the petitioner, 
including the exact wording and citation of the existing regulation, if 
any, and the proposed regulation or amendment requested;
    (c) A full statement of the factual and legal basis on which the 
petitioner relies for the action requested in the petition, including 
all relevant information and views on which the petitioner relies, as 
well as information known to the petitioner that is unfavorable to the 
petitioner's position. The statement should identify the problem that 
the requested action is intended to address and explain why the 
requested action is necessary to address the problem.


Sec.  392.4  Supporting documentation.

    (a) Information referred to or relied on in support of a petition 
should be included in full and should not be incorporated by reference. 
A copy of any article or other source cited in a petition should be 
submitted with the petition.
    (b) Sources of information that are appropriate to use in support 
of a petition include, but are not limited to:
    (1) professional journal articles,
    (2) research reports,
    (3) official government statistics,
    (4) official government reports,
    (5) industry data, and
    (6) scientific textbooks.
    (c) If an original research report is used to support a petition, 
the information should be presented in a form that would be acceptable 
for publication in a peer reviewed scientific or technical journal.
    (d) If quantitative data are used to support a petition, the 
presentation of the data should include a complete statistical analysis 
using conventional statistical methods.


Sec.  392.5  Filing procedures.

    (a) Any interested person may file a petition with FSIS. For 
purposes of this part, an ``interested person'' is any individual, 
partnership, corporation, association, or public or private 
organization.
    (b) To file a petition with FSIS, a person should submit the 
petition to the FSIS Docket Clerk, Department of Agriculture, Food 
Safety and Inspection Service, Room 2534 South Building, 1400 
Independence Ave., SW., Washington, DC 20250-3700.
    (c) Once a petition is submitted in accordance with this part, it 
will be filed by the FSIS Docket Clerk, stamped with the date of 
filing, and assigned a petition number. Once a petition has been filed, 
FSIS will notify the petitioner in writing and provide the petitioner 
with the number assigned to the petition and the Agency contact for the 
petition. The petition number should be referenced by the petitioner in 
all contacts with the Agency regarding the petition.
    (d) If a petitioner elects to withdraw a petition submitted in 
accordance with this part, the petitioner should inform FSIS in 
writing. Once a petition has been withdrawn, the petitioner may re-
submit the petition at any time.


Sec.  392.6  Public display.

    (a) All rulemaking petitions filed with FSIS, along with any 
documentation submitted in support of a petition, will be available for 
public inspection in the FSIS docket room and will be posted on the 
FSIS Web site at http://www.fsis.usda.gov/.
    (b) If FSIS cannot readily determine whether information submitted 
in support of a petition is privileged or confidential business 
information, FSIS will request that the petitioner submit a written 
statement that certifies that the petition does not contain 
confidential information that should not be put on public display. If 
the petitioner fails to submit the certification within a time 
specified by FSIS, the Agency will consider the information to be 
confidential.
    (c) If FSIS determines that a petition, or any documentation 
submitted in support of a petition, contains information that is exempt 
from public disclosure under the Freedom of Information Act (5 U.S.C. 
552 et seq.) or any other applicable laws or regulations, and that the 
information would provide the basis for granting the petition, FSIS 
will inform the petitioner in writing. FSIS will provide the petitioner 
an opportunity to withdraw the petition or supporting documentation, or 
modify the supporting documentation to permit public disclosure.


Sec.  392.7  Comments.

    (a) Any interested person may submit written comments on a petition 
filed with FSIS.
    (b) Comments on a petition should be submitted within 60 days of 
the posting date of the petition and should identify the number 
assigned to the petition to which the comments refer.
    (c) FSIS will consider all timely comments on a petition that are 
submitted in accordance with this

[[Page 16108]]

section as part of its review of the petition.
    (d) All comments on a petition will become part of the petition 
file and will be available for public inspection in the FSIS docket 
room and posted on the FSIS Web site at http://www.fsis.usda.gov/.
    (e) Any interested person who wishes to suggest an alternative 
action to the action requested by the petition should submit a separate 
petition that complies with these regulations and not submit the 
alternative as a comment on the petition.
    (f) If FSIS determines that a comment received on a petition is in 
fact a request for an alternative action, the Agency will inform the 
commenter in writing. The Agency will take no further action on the 
requested alternative action unless the commenter submits an 
appropriate petition for rulemaking.


Sec.  392.8  Expedited review.

    (a) A petition will receive expedited review by FSIS if the 
requested action is intended to enhance the public health by removing 
or reducing foodborne pathogens or other potential food safety hazards 
that might be present in or on meat, poultry, or egg products.
    (b) For a petition to be considered for expedited review, the 
petitioner must submit scientific information that demonstrates that 
the requested action will reduce or remove foodborne pathogens or other 
potential food safety hazards that are likely to be present in or on 
meat, poultry, or egg products, and how it will do so.
    (c) If FSIS determines that a petition warrants expedited review, 
FSIS will review the petition ahead of other pending petitions.


Sec.  392.9  Availability of additional guidance.

    Information related to the submission and processing of petitions 
for rulemaking may be found on the FSIS Web site at http://www/
fsis.usda.gov/.

    Done at Washington, DC, on: April 6, 2009.
Alfred V. Almanza,
Administrator.
 [FR Doc. E9-8106 Filed 4-8-09; 8:45 am]
BILLING CODE 3410-DM-P