Washington, DC
February 1, 2005
[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]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[TM-03-03]
National Organic Program: Development, Issuance, and Use of
Guidance Documents
This document in PDF format:
http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-1748.pdf
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Notice with request for comments.
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 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 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 |