[Federal Register: February 1, 2005 (Volume 70, Number 20)]
[Notices]
[Page 5129-5135]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe05-30]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[TM-03-03]
National Organic Program: Development, Issuance, and Use of
Guidance Documents
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Notice with request for comments.
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SUMMARY: This notice sets forth the U.S. Department of Agriculture's
(USDA) National Organic Program (NOP) procedures for the development,
issuance, and use of guidance documents. This document is intended to
make the NOP's procedures clearer to the public.
DATES: Comments must be submitted April 4, 2005.
ADDRESSES: Interested persons are invited to submit written comments on
this notice using the following addresses:
Mail: Richard H. Mathews, Associate Deputy Administrator,
National Organic Program, USDA-AMS-TMP-NOP, 1400 Independence Ave.,
SW., Room 4008 South., Ag Stop 0268, Washington, DC 20250-0268.
E-mail:
NOP.Guidance@usda.gov. (Not case sensitive)
Fax: (202) 205-7808.
Internet: http://www.regulations.gov.
Procedures for Submitting Comments: Comments on this notice must be
in writing and should be identified with the docket number TM-03-03.
Comments should identify the topic and section number of this notice to
which the comment refers. If you choose to comment, you should clearly
indicate if you are for or against the notice or some portion of it and
the reason(s) for your position. If you are suggesting changes to the
notice, you should include recommended language changes, as
appropriate, along with any relevant supporting documentation.
It is our intention to have all comments to this notice whether
submitted by mail, e-mail, or fax, available for viewing on the NOP
homepage. Comments submitted in response to this notice will be
available for viewing at USDA-AMS, Transportation and Marketing
Programs,
[[Page 5130]]
Room 4008-South Building, 1400 Independence Avenue, SW., Washington,
DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through
Friday (except for official Federal holidays). Persons wanting to visit
the USDA South Building to view comments received in response to this
notice are requested to make an appointment in advance by calling (202)
720-3252.
FOR FURTHER INFORMATION CONTACT: Keith Jones, Team Leader, Program
Development, National Organic Program, 1400 Independence Ave., SW.,
Room 4008-S, Ag Stop 0268, Washington, DC 20250-0268; Telephone: (202)
720-3252; Fax: (202) 205-7808; and e-mail: keith.jones@usda.gov.
SUPPLEMENTARY INFORMATION:
I. Related Documents
We have published five notices related to this action in the
Federal Register. The NOP final rule was published on December 21, 2000
(65 FR 80548). Two rules proposing to amend the NOP's National List
were published on April 16, 2003 (68 FR 18566), and May 22, 2003 (68 FR
27941). Two final rules amending the NOP's National List were published
on October 31, 2003 (68 FR 61987) and November 3, 2003 (68 FR 62215).
II. Statutory and Regulatory Authority
This notice is issued under the authority of the Organic Foods
Production Act of 1990 (Act), as amended (7 U.S.C. 6501 et seq.).
III. Background
The preamble to the March 13, 2000, NOP notice (65 FR 13543-44) and
the December 21, 2000, final rule (65 FR 80557) made several references
to program manuals as a mechanism for further clarifying regulatory
characteristics and expectations of the NOP. The NOP's goal is to use
program manuals to enable reliably uniform regulatory decisions.
The guidance documents referred to in this notice are the specific
documents that will comprise a program manual. The guidance documents
will address, over time, each final rule section, as appropriate, and
offer information, procedures, and protocols. Prior to the publication
of this notice the NOP communicated with accredited certifying agents,
their clients and program participants and the public on regulatory
characteristics and expectations through the publication and
dissemination of documents know as ``policy statements'' and through a
question and answer format (Q and A's). Issuance of policy statements
and Q and A's was viewed by the NOP as a temporary step toward the
publication of this notice. The guidance documents that would be
implemented by this action will replace the existing policy statements
and Q and A's.
These guidance documents will represent NOP's current thinking on a
particular topic. Consistent with earlier statements in the proposed
and final rule, they do not create or confer any rights for or on any
person and do not operate to bind NOP or the public. An alternative
approach may be used if such approach satisfies the requirements of the
Act and its implementing regulations. NOP will be available to discuss
alternative approaches to ensure that the alternative complies with the
Act and its implementing regulations. However, because a guidance
document represents the program's current thinking on the subject
addressed in the document, NOP will take steps to ensure that its staff
does not deviate from the guidance document without appropriate
justification and appropriate supervisory concurrence.
The use of guidance documents to assist in developing uniform
regulatory decisions is a standard government practice, and the NOP has
reviewed examples of guidance documents from various Federal regulatory
agencies. Additionally, we may use public meetings as a forum for input
on the development and issuance of guidance documents as well as the
format and scope of the program manual. Your comments on this notice
will help AMS evaluate the potential effectiveness of the development,
issuance, and use of guidance documents in ensuring uniform regulatory
decisions.
Of course, if in developing program guidance, it appears that
modifications or changes in the NOP regulations are required, such
modifications would be made through notice and comment rulemaking.
IV. Overview of Procedures
A. Purpose
This ``Good Guidance Practices'' (GGP's) document sets forth NOP's
general policies and procedures for developing, issuing, and using
guidance documents. The purpose of this document is to help ensure that
program guidance documents are developed with adequate public
participation, that guidance documents are readily available to the
public, and that guidance documents are not applied as binding
requirements. The program wants to ensure uniformity in the
development, issuance, and use of guidance documents.
The purposes of guidance documents are to:
(1) Provide assistance to the regulated industry by clarifying
requirements that have been imposed by the Act or its implementing
regulations and by explaining how industry may comply with those
statutory and regulatory requirements; and
(2) provide specific review and enforcement approaches to help
ensure that NOP staff implements the program's mandate in an effective,
fair, and consistent manner. Certain guidance documents may provide
information about what the program considers to be the important
regulatory characteristics of production and processing practices. Some
may address appropriate certification protocols to verify adherence to
statutory and regulatory requirements. Others may explain NOP's views
on complex or controversial regulatory issues. Still others may address
how to avoid enforcement actions.
This document represents the program's codification of best
practices for developing, issuing, and using guidance documents. The
NOP may issue additional/more detailed procedures to implement the
general principles set forth herein.
B. Guidance Documents
The term ``guidance documents'' will refer to documents prepared by
the NOP, for accredited certifying agents, their clients and program
participants and the public that: (1) Relate to the production,
handling, processing, labels, labeling and marketing information,
certification, accreditation of certifying agents, the National List of
Allowed and Prohibited Substances, State Organic Programs, fees,
compliance, inspection and testing, reporting and exclusion from sale,
compliance, adverse action appeals process and enforcement policies
regarding agricultural products regulated under 7 CFR Part 205; (2)
describe the program's policy and regulatory approach to an issue; or
(3) establish inspection and enforcement policies and procedures.
``Guidance documents'' do not include documents relating to internal
NOP procedures, program reports, general information documents provided
to consumers, speeches, journal articles and editorials, media
interviews, press materials, letters addressing enforcement or
compliance actions, or other communications directed to individual
persons or firms.
[[Page 5131]]
C. Legal Effect of Guidance Documents
Guidance documents do not themselves establish legally enforceable
rights or responsibilities and are not legally binding on the public or
the program. Rather, they explain how the Act and its implementing
regulations apply to certain regulated activities. However, because a
guidance document represents the program's current thinking on the
subject addressed in the document, the NOP will take steps to ensure
that its staff does not deviate from the guidance document without
appropriate justification and appropriate supervisory concurrence.
Alternative methods that comply with the Act and its implementing
regulations are acceptable. If a regulated company or person wishes or
chooses to use an approach other than that set forth in a guidance
document, the NOP will, upon request, discuss with that company or
person alternative methods of complying with the Act and its
implementing regulations.
The NOP strongly encourages industry to discuss alternative
approaches with the NOP before implementing them to avoid unnecessary
or wasteful expenditures of resources.
D. Application of GGP's
NOP staff will adhere to these GGP's. Documents and other means of
communication excluded from the definition of guidance should not be
used to initially communicate new or different regulatory expectations
not readily apparent from the Act or its implementing regulations to a
broad public audience. Whenever such regulatory expectations are first
communicated to a broad public audience, these GGP's should be
followed. This does not limit the program's ability to respond to
questions as to how an established policy applies to a specific
situation or to questions about areas that may lack established policy.
However, such questions may signal the need to develop guidance in that
area.
E. Procedures for Developing Guidance Documents
NOP has adopted a two-level approach to the development of guidance
documents. The procedures for developing a guidance document will
depend on whether that guidance document is a ``Level 1'' guidance or a
``Level 2'' guidance. Level 1 guidance documents generally include
guidance directed primarily to accredited certifying agents or other
members of the regulated industry that set forth first interpretations
of statutory or regulatory requirements, changes in interpretation or
policy that are of more than a minor nature, or address unusually
complex or highly controversial issues. Level 2 guidance documents
include all other guidance documents.
1. Development of Level 1 Guidance Documents. For Level 1 guidance
documents, the program will solicit public input prior to
implementation, unless: (1) There are significant regulatory
justifications for immediate implementation; (2) there is a new
statutory requirement, executive order, or court order that requires
immediate implementation, and guidance is needed to help effect such
implementation; or (3) the guidance presents a less burdensome policy
that is consistent with the purposes of the Act and implementing
regulations. In the latter situation, the program will solicit public
input upon issuance/implementation.
For Level 1 guidance, the program will, at a minimum, solicit
public input by (1) issuing a notice of availability of a draft of the
guidance in the Federal Register and indicating its availability on the
NOP home page and (2) posting the draft on the NOP home page or making
the draft otherwise available. The notice of availability will provide
information regarding how to obtain a copy of the draft guidance; hard
copies of the draft will be available upon request. The program may use
a single Federal Register notice of availability to solicit public
input on several different draft guidance documents. For Level 1
guidance documents, the program also may hold a public workshop to
discuss a draft and/or present a draft to the public when, for example,
there are highly controversial or unusually complex issues. Guidance
document notices and/or drafts will be posted on the NOP home page or
will be accessible from there.
Because the program recognizes that it is important to solicit
input prior to its decision to issue guidance and also, perhaps, during
the development of a draft of a Level 1 guidance, the program is
implementing various practices to obtain input at the earliest stages
of Level 1 guidance document development. For example, these GGP's
provide that the public will have an opportunity to comment on and
suggest areas for guidance development or revision and to submit draft
guidances for possible adoption by the program. (See the ``Guidance
Document Agenda'' and ``Guidance Proposal Policy'' set forth below.)
In addition, NOP may solicit or accept early input on the need for
new or revised guidance or assistance in the development of particular
guidance documents from interested parties such as the National Organic
Standards Board, consumer groups, trade associations, public interest
groups and the general public. The program may participate in meetings
with these various parties to obtain each party's views on priorities
for developing guidance documents. The program may also hold public
meetings and workshops to obtain input from each interested party on
the development or revision of guidance documents in a particular NOP
subject area.
Comments submitted on draft Level 1 guidance documents will be
submitted to the docket identified in the Federal Register notice and
on the NOP home page. All comments will be available to the public for
review. The program will review all comments. The program will make
changes to the guidance document in response to comments, as
appropriate.
2. Development of Level 2 Guidance Documents. For Level 2 guidance,
the NOP will provide an opportunity for public comment upon issuance.
Unless otherwise indicated, the guidance will be implemented upon
issuance. The availability of new Level 2 guidance documents should be
posted on the NOP home page as each guidance is issued. The program
will publish a list in the Federal Register of all new Level 2 guidance
documents issued during any quarter. The list of guidance documents
will not be published following any quarter in which no guidance
document was issued.
The NOP may, at its discretion, solicit comment before implementing
a Level 2 guidance document. The NOP will review all comments and may
make changes to the guidance in response to comments, as appropriate.
3. Comments on Guidance Documents In Use. For all guidance
documents comments will be accepted at any time. Comments on the
guidance documents in use should be submitted to NOP at the address
identified in the guidance. Guidance may be revised in response to such
comments, as appropriate.
4. Authorization Policy. All drafts of Level 1 guidance documents
that are made available for public comment will be signed by the Deputy
Administrator, Transportation and Marketing Programs. All final
versions of Level 1 guidance documents will receive the sign-off by the
Associate Administrator, AMS. All Level 2 guidance documents will
receive the sign-off of the Associate Deputy Administrator, NOP.
5. Guidance Document Agenda. The NOP will update all existing
policy
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statements and Q and A's to the guidance format using the standard
elements listed in this notice as soon as possible. On a semi-annual
basis, the NOP will publish in the Federal Register and on the NOP home
page possible topics for guidance document development or revision
during the next year. At that time, the NOP will specifically solicit
input from the public regarding these and additional ideas for new
guidance documents or guidance document revisions or priorities. The
NOP is not bound by the list of possible topics--i.e., it is not
required to issue every guidance document on the list and it is not
precluded from issuing guidance documents that are not included on the
list.
6. Guidance Proposal Policy. If a member of the public wishes to
propose one or more topics for new guidance or guidance revisions, or
to propose one or more draft guidance documents for adoption by NOP,
that person should submit the proposal to the NOP. The submission
should include a statement regarding why new or revised guidance is
necessary. The statement should clearly and completely address the
scope of the issue, its effect on accredited certifying agents, their
clients and program participants and/or the public, and how a guidance
document would enable reliably uniform regulatory decisions.
If the NOP agrees that the proposed topic should be covered by a
guidance document, it will develop a guidance document in accordance
with these GGP's. If the NOP agrees that a guidance document should be
updated/revised, it will develop a revision in accordance with these
GGP's. If the submitter has proposed a draft of the guidance document
that the NOP agrees can form the basis for a guidance document, the NOP
will follow the GGP's for issuing and implementing a guidance document
based on that proposed draft.
7. Review and Revision of Guidance Documents. The NOP intends to
review existing guidance documents on a regular basis. As part of the
``Guidance Proposal Policy,'' an individual may request review or
revision of a particular guidance document on the basis that it is no
longer current. Such requests should be accompanied by an explanation
of why the guidance is out of date and how it should be revised. The
NOP will review such requests to determine if the guidance document at
issue needs to be updated/revised. The NOP will, when appropriate,
update or revise that guidance document in accordance with these GGP's.
In addition, when significant changes are made to an applicable statute
or regulation, the NOP will, on its own initiative, review and, as
appropriate, revise guidance documents relating to that changed statute
or regulation.
F. Standard Elements
1. Nomenclature. All guidance documents will include: (a) the
umbrella term ``guidance'', (b) information that identifies the NOP as
having produced the document, and (c) the regulatory activity to which
and/or the persons to whom the document applies. In practice, the
majority of guidance documents issued will be called ``guidance for
industry.''
2. Statement of Nonbinding Effect. All guidance documents will
include language such as this guidance represents the NOP's current
thinking on this topic. This guidance is designed to assist interested
parties in complying with the requirements of the Organic Foods
Production Act of 1990 (OFPA) and its implementing regulations. It does
not create or confer any rights for or on any person and does not
operate to bind the NOP or the public. You may use an alternative
approach if the approach satisfies the requirements of OFPA and its
implementing regulations. Before adopting an alterative approach, the
NOP strongly encourages industry to discuss any alternative approach
with the NOP in order to avoid unnecessary or wasteful expenditures and
to ensure the proposed alternative approach complies with OFPA and its
implementing regulations.
3. Absence of Mandatory Language. Because guidance documents are
not binding, mandatory words such as ``shall,'' ``must,'' ``require,''
and ``requirement'' are inappropriate unless they are being used to
describe or discuss a statutory or regulatory requirement. Before a new
guidance is issued, it will be reviewed to ensure that mandatory
language has not been used, except to describe or discuss a statutory
or regulatory requirement.
4. Other Standard Elements. Each guidance document will include the
dates of issuance, date of effect and latest revision. Documents that
are being made available for comment will include a ``draft'' notation.
When a guidance supersedes another guidance document, the new guidance
document will identify the document that it is superseding. Superseded
documents that remain available for historical purposes will be stamped
or otherwise identified as superseded. All guidance documents will
include a cover sheet that is modeled after the example in Appendix A
attached to this document.
G. NOP Implementation of GGP's
1. Education. All current and new NOP employees involved in the
development, issuance, or application of guidance documents will be
provided a copy of and directed to review the program's GGP's. The
program will conduct additional training of employees involved in the
development and use of guidance documents that will describe in more
detail how to develop and use guidance documents under these GGP's.
This training will emphasize the principles set forth in section III,
above, regarding the legal effect of guidance documents.
The program also will educate the public about the legal effect of
guidance. These GGP's and the statement of the nonbinding effect of
guidance that will be included in every future guidance document and on
the comprehensive list of guidance documents (discussed in section VIII
below) will help to educate the public about the legal effect of
guidance. The NOP staff will take the opportunity to state and explain
the legal effect of guidance when speaking to the public about guidance
documents.
2. Monitoring. The NOP will monitor staff's use of guidance
documents. As part of this process, NOP will monitor the development
and issuance of guidance documents to ensure that these GGP's are being
followed. In addition, NOP will spot-check the use of guidance
documents to ensure that they are not being applied as binding
requirements. Finally, NOP will spot-check the use of documents and
communications that are not defined as guidance, such as warning
letters and speeches, to ensure that these documents are not being used
to initially express a new regulatory expectation to a broad public
audience.
Three years after these GGP's have been implemented; the program
will perform an internal review to determine whether these GGP's have
been successful in achieving NOP's goal in issuing them. The internal
review will determine whether the GGP's are ensuring: (1) Adequate
public participation in the development of guidance, (2) that guidance
documents are readily available to the public and (3) that guidance
documents are not being applied as binding requirements. The internal
review will also examine the results of the program's monitoring
efforts as well as the number and results of appeals relating to the
development and/or use of guidance documents.
[[Page 5133]]
H. Dissemination/Availability to Public
A comprehensive list of all current guidance documents will be
maintained on the NOP home page. New guidance documents will be added
to the list within 30 days of issuance. NOP will publish the
comprehensive list in the Federal Register annually. NOP will publish a
Federal Register notice that lists all guidance documents that were
issued during any quarter and all guidance documents that have been
withdrawn during the same quarter. Publication will not occur following
any quarter in which no guidance document was issued or withdrawn.
The guidance document list will include the name of each guidance
document, the document issuance/effective/revision dates, and
information to obtain copies of the document. The list will be
organized by NOP and will group guidance documents by their intended
users and/or the regulatory activities to which they apply. The list
also will include (properly identified) draft documents being made
available for public comment.
The NOP will be responsible for maintaining a comprehensive set of
guidance documents and making those guidance documents available to the
public. All guidance documents made available will be included on the
comprehensive list. To the extent feasible, guidance documents will be
made available electronically (e.g., on the NOP home page). The NOP
will make all guidance documents available in hard copy, upon request.
I. Appeals
These GGP's should foster the development and use of guidance
documents consistent with NOP's intended goal of regulatory decisions
that will be reliably uniform throughout the world. Nevertheless, an
effective appeal mechanism is needed to address instances in which the
GGP's may not have been followed or the GGP's fail to achieve their
purpose. The NOP will provide an opportunity for appeal by a person who
believes that GGP's were not followed in issuing a particular guidance
document or who believes that a guidance document has been treated as a
binding requirement.
As a general matter, a person with a dispute involving a guidance
document should begin with the supervisor of the person applying the
guidance document. If the issue cannot be resolved at that level, the
matter should be brought to the next level. This process would continue
on up the chain of command. If a matter is unresolved at the level of
the Associate Deputy Administrator, NOP, the Deputy Administrator for
Transportation and Marketing Programs or the Administrator of AMS may
be asked to become involved.
The language below will be inserted into and made part of the
program manual for the National Organic Program.
National Organic Program Good Guidance Practices
What Are Good Guidance Practices?
Good guidance practices (GGP's) are the National Organic Program's
(NOP) policies and procedures for developing, issuing, and using
guidance documents.
What Is a Guidance Document?
A guidance document is a document prepared by the NOP for
accredited certifying agents, their clients and program participants,
and the public that describe the NOP's current interpretation of or
policy on a regulatory issue. Guidance documents include, but are not
limited to:
Documents related to the production, handling, labels,
labeling and market information, certification, accreditation of
certifying agents, the National List of Allowed and Prohibited
Substances, State Organic Programs, fees, compliance, inspection and
testing, reporting and exclusion from sale, compliance, adverse action
appeals process and enforcement policies regarding agricultural
products regulated under the National Organic Program;
Documents that describe NOP's policy and regulatory
approach to an issue; or
Documents that establish inspection and enforcement
policies and procedures.
Guidance documents do not include documents that relate to internal
NOP procedures, program reports, general information documents provided
to consumers or agriculture and food professionals, speeches, journal
articles and editorials, media interviews, press materials, letters
regarding enforcement or compliance actions, memoranda of
understanding, or other communications directed to individual persons
or firms.
What Other Terms Have a Special Meaning?
Level 1 guidance documents include guidance documents that set
forth initial interpretations of statutory or regulatory requirements;
set forth changes in interpretation or policy that are of significance;
include complex issues; or cover highly controversial issues. Level 2
guidance documents are guidance documents that set forth existing
practices or minor changes in interpretation or policy. Level 2
guidance documents include all guidance documents that are not
classified as Level 1. The term ``you'' refers to all affected parties
outside of NOP.
Are You or NOP Required To Follow a Guidance Document?
No. Guidance documents do not establish legally enforceable rights
or responsibilities. They do not legally bind the public or NOP. You
may choose to use an approach other than the one set forth in a
guidance document. However, your alternative approach must comply with
all applicable Federal and State statutes and regulations. NOP is
willing to discuss an alternative approach with you to ensure that your
alternative complies with all applicable Federal and State statutes and
regulations. However, although guidance documents are not legally
binding, they represent the NOP's current thinking. Therefore, NOP
employees may depart from guidance documents only with appropriate
justification and supervisory concurrence.
Can NOP Use Means Other Than a Guidance Document To Communicate New
Program Policy or a New Regulatory Approach to a Broad Public Audience?
The program may not continually use documents or other means of
communication that are excluded from the definition of guidance
document to informally communicate new or different regulatory
expectations to a broad public audience. These GGP's must be followed
whenever regulatory expectations that are not readily apparent from the
Statute or regulations are first communicated to a broad public
audience. These GGP's do not limit the NOP's ability to respond to
questions as to how an established policy applies to a specific
situation or to questions about areas that may lack established policy.
How Can You Participate in the Development and Issuance of Guidance
Documents?
You can provide input on guidance documents that NOP is developing
under the procedures described below under the heading ``What are NOP's
procedures for the developing and issuing guidance documents?'' You may
also suggest areas for guidance document development. Your suggestions
should address why a guidance document is necessary, should
[[Page 5134]]
clearly and completely address the scope of the issue, its effect on
accredited certifying agents, their clients and program participants
and/or the public, and how a guidance document would enable reliably
uniform regulatory decisions. You may also submit drafts of proposed
guidance documents for NOP to consider. When you do so, you should mark
the document ``Guidance Document Submission'' and send it to: USDA/AMS/
TMP/NOP, 1400 Independence Ave., SW., Room 4008 South, Ag Stop 0268,
Washington, DC 20250-0268. NOP may designate an electronic e-mail
address for the purpose of receiving comments on guidance documents. At
any time, you may suggest that NOP revise or withdraw an already
existing guidance document. Your suggestion should address why the
guidance document should be revised or withdrawn and, if applicable,
how it should be revised. Annually, NOP will publish, both in the
Federal Register and on its Web site, a list of possible topics for
future guidance document development or revision during the next year.
You can comment on this list (e.g., by suggesting alternatives or
making recommendations on the topics that NOP is considering). To
participate in the development and issuance of guidance documents
through one of these mechanisms described above, you should contact the
program. If NOP agrees to draft or revise a guidance document, you can
participate in the development of that guidance document under the
procedures described below.
What Are NOP's Procedures for Developing and Issuing Guidance
Documents?
Before NOP prepares a draft of a Level 1 guidance document, NOP can
seek or accept early input from individuals or groups outside the
program. For example, NOP can do this by participating in or holding
public meetings and workshops. After NOP prepares a draft of a Level 1
guidance document, NOP will publish a notice in the Federal Register
announcing that the draft guidance document is available. NOP will then
post the draft guidance document on the NOP website and make it
available in hard copy on request and invite your comment on the draft
guidance document. To submit your comments, see the paragraph ``How
should you submit comments on a guidance document?'' below. After NOP
prepares a draft of a Level 1 guidance document, NOP can also hold
public meetings or workshops or present the draft guidance document to
an advisory committee for review. After providing an opportunity for
public comment on a Level 1 guidance document, NOP will review all
comments received and prepare the final version of the guidance
document incorporating suggested changes when appropriate. NOP will
then publish a notice in the Federal Register announcing that the
guidance document is available, post the guidance document on the NOP
website and make it available in hard copy on request, and implement
the guidance. After providing an opportunity for comment, NOP may
decide that it should issue a revised draft of the guidance document.
In this case, NOP will follow the applicable steps listed in the
paragraph describing how NOP develops and issues guidance documents.
NOP will not seek your comment before it implements a Level 1 guidance
document if NOP determines that prior public participation is not
feasible or appropriate. When public participation is determined
infeasible or inappropriate, NOP will prepare a guidance document,
publish a notice in the Federal Register announcing that the guidance
document is available on request, post the guidance document on the NOP
website and make it available in hard copy, immediately implement the
guidance document; and invite your comment when it issues or publishes
the guidance document. If NOP receives comments on the guidance
document, NOP will review those comments and revise the guidance
document when appropriate. If a version is revised, the new version
will be placed on the NOP website.
Procedures for Developing and Issuing Level 2 Guidance Documents.
After NOP prepares a Level 2 guidance document, NOP will post the
guidance document on the NOP website and make it available in hard copy
on request, immediately implement the guidance document, unless
indicated otherwise when the document is made available, and invite
your comment on the Level 2 guidance document. If NOP receives comments
on a Level 2 guidance document, NOP will review those comments and
revise the document if appropriate. If revised, the new version will be
placed on the NOP website. You may comment on any guidance document at
any time, using the procedures described below. NOP will revise
guidance documents in response to your comments when appropriate.
How Should You Submit Comments on a Guidance Document?
If you choose to submit comments on any guidance document, you must
send your comments to: USDA/AMS/TMP/NOP, 1400 Independence Ave., SW,
Room 4008 South, Ag Stop 0268, Washington, DC 20250-0268. NOP may
designate an electronic e-mail address for the purpose of receiving
electronic comments on guidance documents. Comments should identify the
docket number on the guidance document, if such a docket number exists.
For documents without a docket number, the title of the guidance
document should be included. Comments will be available to the public
in accordance with NOP's public comment access policy.
What Standard Elements Must NOP Include in a Guidance Document?
A guidance document must include the term ``guidance'' and identify
that NOP is issuing the document. The guidance document must identify
the activity to which and the people to whom the document applies. The
document must prominently display a statement of the document's
nonbinding effect and include the date it is issued as well as its
effective date. The document should note if it is a revision to a
previously issued guidance and identify the document being replaced,
and contain the word ``draft'' if the document is a draft guidance.
Guidance documents will not use mandatory language such as ``shall,''
``must,'' ``required,'' or ``requirement,'' unless NOP is quoting from
existing statutory or regulatory requirements. (Note that draft
guidance documents that are the product of international negotiations
may not follow these standard elements, however, any final guidance
document issued according to this provision must contain these standard
elements described in this paragraph.)
Who, Within NOP, Can Approve Issuance of Guidance Documents?
The NOP will have written internal procedures for the approval of
guidance documents. Those procedures will ensure that issuance of all
documents is approved by appropriate NOP and AMS staff.
How Will NOP Review and Revise Existing Guidance Documents?
The NOP will periodically review existing guidance documents to
determine whether they need to be changed or withdrawn. When
significant changes are made to an applicable statute or regulation,
NOP will review and, if appropriate, revise
[[Page 5135]]
guidance documents relating to the change in statute or regulation.
Also, as discussed above, you may at any time suggest that NOP revise a
guidance document.
How Will NOP Ensure That NOP Staff Is Following These GGP's?
All current and new NOP employees involved in the development,
issuance, or application of guidance documents will be trained
regarding the program's GGP's. NOP will monitor the use of guidance
documents by NOP staff to ensure that GGP's are being followed in the
absence of an approved alternative approach.
How Can You Get Copies of NOP Guidance Documents?
NOP will make copies available in hard copy on request and through
the NOP website.
How Will NOP Keep You Informed of the Guidance Documents That Are
Available?
NOP will maintain on its website a list of all current guidance
documents. New documents will be added to this list within 30 days of
issuance. Annually, NOP will publish in the Federal Register its
comprehensive list of guidance documents. The comprehensive list will
identify documents that have been added to the list or withdrawn from
the list since the previous comprehensive list. NOP's guidance document
lists will include the name of the guidance document, issuance and
revision dates, and information on how to obtain copies of the
document.
What Can You Do If You Believe That Someone at NOP Is Not Following
These GGP's?
If you believe that someone at NOP did not follow the procedures in
this section or that someone at NOP treated a guidance document as a
binding requirement, you should contact that person's supervisor. If
the issue cannot be resolved, you should contact the next highest
supervisor. If you are unable to resolve the issue, you may ask the
Deputy Administrator for Transportation and Marketing Programs, or the
Administrator of AMS to become involved.
Dated: January 26, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 05-1748 Filed 1-31-05; 8:45 am]
BILLING CODE 3410-02-P