This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

5129

Vol. 70, No. 20

Tuesday, February 1, 2005

DEPARTMENT OF AGRICULTURE

Submission for OMB Review; 

Comment Request 

January 27, 2005. 

The Department of Agriculture has 

submitted the following information 

collection requirement(s) to OMB for 

review and clearance under the 

Paperwork Reduction act of 1995, 

Public Law 104–13. Comments 

regarding (a) whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(b) the accuracy of agency’s estimate of 

burden including the validity of the 

methodology and assumptions used; (c) 

ways to enhance the quality, utility and 

clarity of the information be collected; 

(d) 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 

should be addressed to: Desk Officer for 

Agriculture, Office of Information and 

Regulatory Affairs, Office of 

Management and Budget (OMB), 

Pamela_Beverly_OIRA_Submission@

OMB.EOP.GOV or fax (202) 395–5806 

and to Departmental Clearance Office, 

USDA, OCIO, Mail Stop 7602, 

Washington, DC 20250–7602. 

Comments regarding these information 

collections are best assured of having 

their full effect if received within 30 

days of this notification. Copies of the 

submission(s) may be obtained by 

calling (202) 720–8681. 

An agency may not conduct or 

sponsor a collection of information 

unless the collection of information 

displays a currently valid OMB control 

number and the agency informs 

potential persons who are to respond to 

the collection of information that such 

persons are not required to respond to 

the collection of information unless it 

displays a currently valid OMB control 

number. 

30-day Federal Register Notice 

Forest Service 

Title: Evaluation of the Environment 

Intervention Handbook. 

OMB Control Number: 0596–NEW. 

Summary of Collection: The 

Environmental Intervention Handbook 

is a tool for resource managers to 

address depreciative activities in 

recreation settings. The Forest Service 

(FS) and university researchers will 

contact recipients of a handbook 

designed to help managers reduce 

depreciative activities. Through those 

contacts they will evaluate the uses of 

the handbook, barriers to usage, and the 

need for the revision of the handbook or 

creation of supplementary materials. 

This will help the researchers improve 

their ability to provide information to 

natural resource managers on reducing 

activities like littering, vandalism, and 

other activities that cause damage. To 

gather this information, a mini-survey 

will be sent through the mail to all 

handbook recipients. 

Need and Use of the Information: The 

information from the survey will be 

used by FS to evaluate the application 

and uses of the handbook, the need for 

revision of the handbook, and the need 

for additional tools or supplementary 

information to be used with the 

handbook. Without the proposed 

information collection, assessment of 

how the handbook was used, how well 

it worked, whether or not we need to 

revise it, and if we need to provide 

additional tools will not be known. 

Description of Respondents:

Individuals or households. 

Number of Respondents: 50. 

Frequency of Responses: Reporting: 

On occasion. 

Total Burden Hours: 27.

Ruth Brown, 

Departmental Information Collection 

Clearance Officer.

[FR Doc. 05–1797 Filed 1–31–05; 8:45 am] 

BILLING CODE 3410–11–M

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. 

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, 

5130 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

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. 

Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 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 

5132 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

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 spotcheck 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. 

Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 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 

5134 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

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 

Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 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

DEPARTMENT OF AGRICULTURE

Foreign Agricultural Service 

Trade Adjustment Assistance for 

Farmers

AGENCY: Foreign Agricultural Service, 

USDA.

ACTION: Notice.

The Administrator, Foreign 

Agricultural Service (FAS), today 

accepted a petition filed by the Gollott’s 

Oil Dock and Icehouse, Inc., Biloxi, 

Mississippi, for trade adjustment 

assistance. Gollott’s represents 

Mississippi shrimpers. The 

Administrator will determine within 40 

days whether or not imports of shrimp 

contributed importantly to a decline in 

domestic producer prices of more than 

20 percent during the marketing year 

period beginning January 2003 through 

December 2003. If the determination is 

positive, all shrimp producers in 

Mississippi will be eligible to apply to 

the Farm Service Agency for technical 

assistance at no cost and for adjustment 

assistance payments.

FOR FURTHER INFORMATION CONTACT:

Jean-Louis Pajot, Coordinator, Trade 

Adjustment Assistance for Farmers, 

FAS, USDA, (202) 720–2916, e-mail: 

trade.adjustment@fas.usda.gov.

Dated: January 12, 2005. 

A. Ellen Terpstra, 

Administrator, Foreign Agricultural Service.

[FR Doc. 05–1749 Filed 1–31–05; 8:45 am] 

BILLING CODE 3410–10–P

DEPARTMENT OF COMMERCE

Economic Development Administration 

Notice of Petitions by Producing Firms 

for Determination of Eligibility To 

Apply for Trade Adjustment 

Assistance

AGENCY: Economic Development 

Administration (EDA).

ACTION: To give all interested parties an 

opportunity to comment. 

Petitions have been accepted for filing 

on the dates indicated from the firms 

listed below.

LIST OF PETITION ACTION BY TRADE ADJUSTMENT ASSISTANCE FOR PERIOD DECEMBER 17, 2004–JANUARY 21, 2005 

Firm name Address 

Date

petition

accepted 

Product 

C & M Technologies Group, Inc. .............. 51 South Walnut Street, Wauregan, CT 

06387 

12/27/2004 Wire, cable and cable assemblies. 

Leonardi Manufacturing Co., Inc. ............. 2728 Erie Drive, Weedsport, NY 13166 ... 12/27/2004 Metal stamped and press brake formed 

brackets and frames for automobiles 

and air conditioning units, and metal 

handbag and luggage frames. 

Adcor Industries, Inc. ................................ 234 South Haven Street, Baltimore, MD 

21224 

1/10/2005 Machinery and spare parts for the bottling 

industry. 

Bernier Cast Metals, Inc. .......................... 2626 Hess Street, Saginaw, MI 48601 .... 1/12/2005 Sand cast metal products, i.e. bearings 

and housings. 

All Service Plastic Molding, Inc. ............... 3365 Obco Court, Dayton, OH 45413 ...... 1/14/2005 Injection molded plastic parts, i.e. cases, 

boxes and plastic parts and accessories for automobiles. 

Holcombe Armature Company ................. 905 Rockmart Road, Villa Rica, GA 

30180 

1/21/2005 Starter motor and generator armatures 

for automotive and other internal combustion engine applications. 

The petitions were submitted 

pursuant to section 251 of the Trade Act 

of 1974 (19 U.S.C. 2341). Consequently, 

the United States Department of 

Commerce has initiated separate 

investigations to determine whether 

increased imports into the United States 

of articles like or directly competitive 

with those produced by each firm