Petitions for Rulemaking, 1988-1994 [E6-172]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Proposed Rules]
[Pages 1988-1994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-172]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 392

[Docket No. 00-019P]
RIN 0583-AC81


Petitions for Rulemaking

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
adopt regulations governing the submission to FSIS of petitions for 
rulemaking. The Agency is proposing this action to supplement existing 
non-regulatory guidance on the submission of petitions to FSIS to 
consider requests to issue, amend, or repeal regulations administered 
by the Agency. FSIS expects that this proposed rule, if adopted, will 
help to ensure the filing of well-supported petitions that contain the 
information necessary to proceed with consideration of the requested 
rulemaking in a timely manner.

DATES: Comments must be received on or before March 13, 2006.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by any of the following 
methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. FSIS prefers to receive comments 
through the Federal eRulemaking Portal. Go to https://
www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select the 
FDMS Docket Number to submit or view public comments and to view 
supporting and related materials available electronically. After the 
close of the comment period, the docket can be viewed using the 
``Advanced Search'' function in Regulations.gov.
    Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture, 
Food Safety and Inspection Service, 300 12th Street, SW., Room 102 
Cotton Annex, Washington, DC 20250.
    Electronic mail: fsis.regulationscomments@fsis.usda.gov. All 
submissions received must include the Agency name and docket number 00-
019P.
    All comments submitted in response to this proposal, as well as 
research and background information used by FSIS in developing this 
document, will be posted to the Regulations.gov Web site. The 
background information and comments also will be available for public 
inspection in the FSIS Docket Room at the address listed above between 
8:30 a.m. and 4:30 p.m., Monday through Friday.

[[Page 1989]]


FOR FURTHER INFORMATION CONTACT: Lynn Dickey, Ph.D. Director, 
Regulations and Petitions Policy Staff, Office of Policy, Program, and 
Employee Development, Food Safety and Inspection Service, U.S. 
Department of Agriculture; (202) 720-5627.

SUPPLEMENTARY INFORMATION:

Background

    The Administrative Procedure Act (APA) requires that Federal 
agencies give interested persons the right to petition for the 
issuance, amendment, or repeal of a rule (5 U.S.C. 553(e)). The 
administrative regulations of the Office of the Secretary of 
Agriculture provide that petitions from interested persons for the 
issuance, amendment, or repeal of a rule may be filed with the official 
that issued, or is authorized to issue, the rule (7 CFR 1.28). These 
administrative regulations also require that all such petitions be 
given prompt consideration, and that petitioners be notified promptly 
of the disposition made of their petitions (7 CFR 1.28).
    On December 2, 1993, FSIS published in the Federal Register a 
notice to provide guidelines on how to submit petitions for rulemaking 
to FSIS and to inform the public on how FSIS processes and responds to 
such petitions (58 FR 63570). This notice was issued in response to the 
Administrative Conference of the United States (ACUS) recommendation 
No. 86-6, which advised agencies to review their rulemaking petition 
procedures and practices and to adopt measures to ensure that the right 
to petition is a meaningful one. See 51 FR 46985, Dec. 30, 1986.
    When it published the 1993 notice, FSIS intended to encourage the 
filing of well-prepared, detailed petitions. Despite the published 
guidelines, however, petitions are still submitted to FSIS in various 
forms, often without adequate data and supporting documentation for 
FSIS to properly evaluate the merits of the requested action. As a 
result, FSIS program personnel often must expend significant time and 
resources to obtain the information needed to evaluate a petition, 
which prevents the Agency from considering and acting upon petitions 
effectively and efficiently. Therefore, FSIS is proposing to adopt 
regulations governing the submission of rulemaking petitions to issue, 
amend, or repeal a regulation administered by the Agency.

The Proposed Rule

General

    FSIS is proposing to amend title 9, subchapter D-Food Safety and 
Inspection Service Administrative Provisions, to add a new part 392-
Petitions for rulemaking. Proposed Sec.  392.1 describes the scope and 
purpose of part 392 and states that part 392 contains provisions 
governing the submission to FSIS of petitions for rulemaking. Proposed 
Sec.  392.1 states that part 392 will apply 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. The proposal contains this exception because the Agency has 
codified procedures for requests to amend certain provisions of the 
regulations. For example, 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).
    Proposed Sec.  392.2 describes the type of request that FSIS 
considers to be a petition for rulemaking and defines a petition as a 
written request to issue, amend, or repeal a regulation administered by 
the Agency. Proposed Sec.  392.2 also provides that a request to issue, 
amend, or repeal a document that interprets a regulation administered 
by the Agency may be made by petition. Such documents include FSIS 
Directives, Notices, and compliance guides.

Required Information

    Proposed Sec.  392.3 describes the information that a petition must 
contain to be considered by FSIS. Proposed Sec.  392.3(a) provides that 
the petition must include the name, address and telephone number, and 
e-mail address of the person submitting the petition. Proposed Sec.  
392.3(b) provides that a petitioner should specifically state what 
regulatory action the petitioner is requesting, including the citation 
and exact wording of any existing regulation affected by the requested 
action. Proposed Sec.  392.3(c) provides that a petitioner state the 
factual and legal basis for the action requested in the petition, 
including all relevant information known to the petitioner, both 
favorable and unfavorable to the petitioner's position. This 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. This information is necessary to ensure that the Agency 
has a full understanding of the action requested.

Supporting Documentation

    Proposed Sec.  392.4 pertains to information that should be 
submitted in support of a rulemaking petition and is intended to 
provide petitioners with a clear idea of the type of supporting 
documentation that FSIS considers necessary to evaluate a petition. 
Although the documentation described in proposed Sec.  392.4 is not 
required for a petition to be considered by FSIS, inclusion of such 
documentation will allow the Agency to respond to the petition more 
effectively and efficiently. It will also help to expedite the 
rulemaking process should the petition be granted.
    Proposed Sec.  392.4(a) provides that information referred to or 
relied on in support of a petition should be included in full. It also 
provides that a copy of any source cited in a petition should be 
submitted with the petition. Including this information in the petition 
will allow the Agency to verify that the information used to support a 
petition is valid, and that the source of such information is 
accurately referenced by the petitioner. Proposed Sec.  392.4(b) 
provides a list of sources of information that the Agency 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.
    To promote consistency in the manner in which data are presented, 
if original research reports are used to support a petition, proposed 
Sec.  392.4(c) provides that the information should be presented in a 
form that would be acceptable for publication in a peer reviewed 
scientific or technical journal. For the same reason, if quantitative 
data are used to support a petition, proposed Sec.  392.4(d) provides 
that the presentation of such data should include a complete 
statistical analysis using conventional statistical methods.

Filing Procedures

    Proposed Sec.  392.5 sets out the procedures for filing a 
rulemaking petition with FSIS. Proposed Sec.  392.5(a) provides that 
any interested person may file a petition with FSIS. For purposes of 
this proposal, ``interested person'' means any individual, partnership, 
corporation, association, or public or private organization. Proposed 
Sec.  392.5(b) explains where to submit petitions for rulemaking to 
FSIS.

[[Page 1990]]

    Proposed Sec.  392.5(c) describes how FSIS will process petitions 
once they are submitted to the Agency. Under proposed Sec.  392.5(c), 
when a petition is received by FSIS, it will be stamped with the date 
of filing and assigned a petition number. The petition number assigned 
under proposed Sec.  392.5(c) is for tracking purposes, and FSIS 
intends for petitioners to refer to this number when they contact the 
Agency regarding their petitions. Once a petition has been filed with 
the Agency, under proposed Sec.  392.5(c), FSIS will inform the 
petitioner in writing and provide the petitioner with the number 
assigned to the petition along with the Agency contact for the 
petition.
    Proposed Sec.  392.5(d) provides that a petitioner may withdraw a 
petition at any time. To withdraw a petition, a petitioner should 
inform FSIS in writing, and the Agency will return the petition, along 
with any supporting data, to the petitioner. Once a petition is 
withdrawn, proposed Sec.  392.5(d) permits the petitioner to re-submit 
the petition at any time.

Public Display

    To encourage the submission of information that can be disclosed to 
the public, proposed Sec.  392.6 provides for public display of 
rulemaking petitions and any supporting documentation. When it conducts 
a review of a rulemaking petition, FSIS relies on the information and 
data submitted in support of, or in opposition to, the petition to 
determine whether to grant the petition and initiate rulemaking. Under 
section 553 of the APA (5 U.S.C. 553), if FSIS grants a petition and 
commences rulemaking, the Agency will publish a notice of proposed 
rulemaking (NPRM) in the Federal Register and give interested persons 
an opportunity to participate in the rulemaking through the submission 
of written data, views, or arguments (5 U.S.C. 553(b) and (c)).
    To provide meaningful input on the issues associated with an NPRM, 
the public must be informed of the data and information that provide 
the basis for initiating the rulemaking. The Agency believes that all 
interested persons should have access to this information early in the 
rulemaking process. Therefore, under proposed Sec.  392.6(a), 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.
    The FOIA provides public access to all records under the custody 
and control of Federal agencies, except those that are protected from 
release by one or more of the nine exemptions. One of the nine 
exemptions that prohibits information from being disclosed to the 
public is Exemption 4, which protects trade secrets and other 
confidential commercial information (5 U.S.C. 552(b)(4)). If a 
petitioner submits supporting documentation that contains trade secrets 
or other confidential commercial information that would be exempt from 
public disclosure under the FOIA, FSIS is responsible for making the 
final determination with regard to the disclosure or non-disclosure of 
such information (E.O. 12600, 52 FR 23781 (June 23, 1987) and 7 CFR 
1.11(a)).
    Proposed Sec.  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. 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.
    To ensure compliance with the FOIA, proposed Sec.  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 such information would 
provide the basis for granting the petition, FSIS will inform the 
petitioner in writing. FSIS will provide the petitioner with an 
opportunity to withdraw the petition or the supporting documentation, 
or to modify the supporting documentation to permit public disclosure.

Comments

    To encourage public participation in the petition process, FSIS 
intends to permit interested persons to submit comments on rulemaking 
petitions filed with the Agency. Proposed Sec.  392.7 sets out the 
procedures for submitting comments on a petition that has been filed 
with FSIS. Proposed Sec.  392.7(a) provides that any interested person 
may submit written comments on a petition. The comments may support or 
oppose a petition in whole or in part. If a person chooses to comment 
on a petition, proposed Sec.  392.7(b) provides that the comments be 
submitted within 60 days of the posting date of the petition, and that 
the comments identify the number assigned to the petition to which the 
comments refer.
    Proposed Sec.  392.7(c) provides that FSIS will consider all 
comments that are timely submitted as part of its review of a 
rulemaking petition. Under proposed 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. 
Those persons that wish to request an alternative action to the action 
requested by a petition are advised in proposed Sec.  392.7(e) to 
submit the request as a separate petition, not as a comment on the 
petition. The Agency is proposing that alternatives be submitted in 
this way to ensure that it receives the full information necessary to 
evaluate the suggested alternative action.
    Proposed Sec.  392.7(f) provides that 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. FSIS will take 
no further action on the suggested alternative action unless the 
commenter submits an appropriate petition for rulemaking.

Expedited Review

    One of FSIS' food safety goals is to enhance the public health by 
reducing the risk of foodborne illness associated with the consumption 
of meat, poultry, and egg products to the greatest extent possible. 
Therefore, to reflect this goal, proposed Sec.  392.8(a) provides for 
expedited review of 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. For a petition to qualify for expedited 
review, proposed Sec.  392.8(b) provides that 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. Proposed Sec.  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, but the petition will still be subject to all other 
provisions that are applicable to rulemaking petitions.

Availability of Guidance on the Internet

    In conjunction with this proposed rule, FSIS plans to post 
information

[[Page 1991]]

related to petitions for rulemaking on the FSIS Internet site. 
Therefore, proposed Sec.  392.9 states that information related to the 
processing of petitions for rulemaking may be found on the FSIS Web 
site. If FSIS adopts this proposed rule, the site will include a 
document that clearly explains the petition filing process, 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. FSIS also intends to post all 
petitions for rulemaking that are submitted to the Agency, and any 
comments received on the petitions, on its Internet site.

Information Required for Regulatory Analyses and Request for Comments

    When considering a petition for rulemaking, in addition to 
evaluating the technical merits of the requested action, FSIS also 
weighs a number of factors to determine whether, on balance, granting 
the petition would be an appropriate use of Agency resources. Some of 
these factors include: the degree to which the requested action is 
consistent with Agency priorities; the resources that the Agency would 
need to conduct the required analyses associated with the requested 
action; the resources available to the Agency to conduct the required 
analyses; the amount and quality of information submitted by the 
petitioner on the impacts of the requested action; and, if the 
petitioner did not submit data on the impact of the requested action, 
whether the information is obtainable by the petitioner with reasonable 
effort.
    As part of the regulatory development process, FSIS is required by 
law, Executive Order, and regulation to conduct certain analyses on the 
impact of proposed and final agency regulations. To comply with these 
requirements, FSIS must often commit a significant amount of time and 
resources to conduct the prescribed analyses. Following is a list of 
U.S. statutes and Executive orders that most often affect rulemakings 
conducted by FSIS.
     The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) 
requires that Federal agencies consider the effect of proposed rule 
changes on small businesses, non-profit organizations, and government 
jurisdictions.
     Executive Order 12866--Regulatory Planning and Review 
requires, among other things, that agencies (1) assess costs and 
benefits of regulatory alternatives and select those that maximize net 
benefits, (2) issue a regulation only when benefits justify the costs, 
and (3) submit rules to the Office of Management and Budget (OMB) for 
review when OMB designates the rules as ``significant.''
     The Paperwork Reduction Act (44 U.S.C. et seq.) prohibits 
Federal agencies from conducting or sponsoring the collection of 
information from regulated parties without first obtaining the approval 
of OMB.
     Public Law 103-354, Federal Crop Insurance Reform and 
Department of Agriculture Reorganization Act of 1994 requires that FSIS 
publish an analysis of the risks addressed by a proposed regulation if 
the regulation is likely to have an annual impact on the economy of the 
United States of $100 million dollars or more (in 1994 dollars), and 
its primary purpose is to regulate issues of human health, human 
safety, or the environment.
    Once a petition is granted, the subsequent rulemaking often 
requires that FSIS expend resources to conduct the impact analyses 
described above. Thus, when FSIS evaluates a petition for rulemaking, 
it does more than analyze the technical merits of the requested 
regulatory action. The Agency also determines whether it is willing to 
commit resources to the development of the resulting rulemaking and the 
required impact analyses. When making this determination the Agency 
considers, among other things, whether the requested action is 
consistent with Agency priorities, and whether the Agency has available 
resources for regulatory development in the event the petition is 
granted. The Agency may be able to more efficiently consider a petition 
if, in addition to the requested regulatory action, the petitioner 
includes data that FSIS could use to conduct the required regulatory 
impact analyses.
    FSIS is not proposing to require that petitions for rulemaking 
include data needed to complete the analyses described above. However, 
the Agency encourages the submission of these types of data for two 
reasons. First, the Agency will assess the appropriateness of granting 
a petition based, in part, on whether ultimately the rulemaking will 
not fail under any one of the impact analyses. Therefore, FSIS would 
like to have as much information as possible available as part of the 
petition review. Second, the Agency's resources for both petition 
review and regulatory development are limited, and significant 
information is often readily available to petitioners, i.e., the 
information is either in the petitioner's possession or is more readily 
obtainable by the petitioner than by the Agency. Including information 
on the impact of a requested action in a rulemaking petition would 
facilitate review of rulemaking petitions and regulatory development in 
the event a petition is granted.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
It has been determined to be not significant for purposes of E.O. 12866 
and, therefore, has not been reviewed by the Office of Management and 
Budget (OMB).
    This proposed rule will benefit both prospective petitioners and 
FSIS by facilitating the review and evaluation of rulemaking petitions 
filed with the Agency. This proposal establishes procedures for the 
submission of rulemaking petitions. It specifies what should be 
included in a rulemaking petition and describes the type and quality of 
data that should be submitted in support of a petition. If this 
proposal is issued as a final rule, it will provide clear guidance to 
persons who would like to petition FSIS to issue, amend, or repeal a 
regulation administered by the Agency.
    This proposed action will benefit persons interested in filing a 
rulemaking petition with FSIS by providing information on how to 
prepare and submit a petition to best ensure prompt consideration by 
the Agency. Petitioners will also benefit from this proposed action 
because it will promote a more timely resolution of their petitions. 
This proposed action will benefit FSIS by encouraging consistency in 
the content of the petitions submitted to the Agency and by reducing 
the number of incomplete petitions filed with the Agency.
    Under this proposed rule, persons interested in petitioning FSIS to 
issue, amend, or repeal a rule 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 issuing, 
amending, or repealing 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 proposed rule will reduce 
the administrative costs to FSIS associated with the review and 
evaluation of rulemaking petitions, as well as expedite the time it 
takes for the Agency to review petitions.

[[Page 1992]]

    In addition to the proposed 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 it determined that 
its procedures for submitting petitions need clarification, and that 
they should be codified to best ensure adherence.

Effect on Small Entities

    The Administrator, FSIS, has made an initial determination that 
this proposed 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 the proposed regulations unless they choose to submit a rulemaking 
petition. Furthermore, although FSIS encourages petitioners to submit 
data needed to complete the regulatory analyses that would be required 
should the petition be granted, it is not proposing to require such a 
submission. As discussed above, if a petitioner does not include data 
on the potential impact of the requested regulatory action, FSIS will 
consider whether the information is obtainable with reasonable effort. 
FSIS is aware that some small entities may not have access to certain 
data that is readily available to large companies or industry trade 
associations. FSIS would take this into consideration when evaluating 
petitions submitted by small entities.

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.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
this proposed rule comes to the attention of the public--including 
minorities, women, and persons with disabilities--FSIS will announce it 
online through the FSIS Web page located at https://www.fsis.usda.gov.
    The Regulations.gov Web site is the central online rulemaking 
portal of the United States government. It is being offered as a public 
service to increase participation in the Federal government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at https://www.regulations.gov.
    FSIS also will 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, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
broader and more diverse audience.
    In addition, FSIS offers an electronic mail subscription service 
that provides an automatic and customized notification when popular 
pages are updated, included Federal Register publications and related 
documents. This service is available at https://www.fsis.usda.gov/news_
and_events/email_subscription/ and allows FSIS customers to sign up 
for subscription options in eight categories. 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 proposed rule will be submitted 
for approval to the Office of Management and Budget (OMB).
    Title: Petitions for Rulemaking.
    Type of Collection: New.
    Abstract: FSIS is proposing to adopt regulations governing the 
submission to FSIS of petitions for rulemaking. The Agency is proposing 
this action to supplement existing non-regulatory guidance on the 
submission of petitions to FSIS to consider requests to issue, amend, 
or repeal regulations administered by the Agency. The proposed 
regulations contain information on how to prepare and submit a petition 
to FSIS to best ensure prompt consideration by the Agency.
    Estimate of burden: FSIS estimates that developing a petition to 
issue, amend, or repeal a regulation in accordance with this proposed 
rule will take an average of 40 hours.
    Respondents: Manufacturers of meat and poultry products, trade 
organizations, consumer organizations, or unaffiliated individuals.
    Estimated number of respondents: 5.
    Estimated number of responses per respondent: 1.
    Estimated total annual burden on respondents: 200 hours.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, 112 Annex, 300 12th St., SW., Washington, 
DC 20250. Comments are invited on: (1) Whether the proposed collection 
of information is necessary for the proper performance of the functions 
of the agency, including whether the information will have practical 
utility; (2) the accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to John O'Connell, see address above, and the 
Desk Officer for Agriculture, Office of Information and Regulatory 
Affairs, Office of Management and Budget, Washington, DC 20253. 
Comments are requested by July 19, 2005. To be most effective, comments 
should be sent to the Office of Management and Budget (OMB) within 30 
days of the publication date.
    FSIS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies, in general, 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.

[[Page 1993]]

List of Subjects in 9 CFR Part 392

    Administrative practice and procedure, Freedom of Information.

    For the reasons discussed in the preamble, FSIS proposes to amend 9 
CFR Chapter III as follows:

Subchapter D--Food Safety and Inspection Service Administrative 
Provisions

    Subchapter D would be 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 such 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 102 Cotton Annex Building, 300 12th 
Street, 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 https://www.fsis.usda.gov/.
    (b) If FSIS can not 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 by any interested 
person to FSIS 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 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 https://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.

[[Page 1994]]

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 https://www/
fsis.usda.gov/.

    Done at Washington, DC, on January 6, 2006.
Barbara J. Masters,
Administrator.
 [FR Doc. E6-172 Filed 1-11-06; 8:45 am]
BILLING CODE 3410-DM-P