[Federal Register: January 12, 2006 (Volume 71, Number 8)]
[Proposed Rules]
[Page 1988-1994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja06-23]
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
[[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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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