[Federal Register Volume 65, Number 135 (Thursday, July 13, 2000)]
[Proposed Rules]
[Pages 43259-43261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17689]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 65, No. 135 / Thursday, July 13, 2000 / 
Proposed Rules  

[[Page 43259]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[TM-00-04]
RIN 0581-AA40


Submission of Petitions for Evaluation of Substances for 
Inclusion on or Removal From the National List of Substances Allowed 
and Prohibited in Organic Production and Handling

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice of Guidelines and Call for National List Petitions.

-----------------------------------------------------------------------

SUMMARY: The Organic Foods Production Act of 1990, as amended, (Act) 
requires the Secretary of Agriculture (Secretary) to establish a 
National List of Allowed and Prohibited Substances (National List) 
which identifies the synthetic substances that may be used, and the 
nonsynthetic substances that cannot be used, in organic production and 
handling operations. The Act authorizes the National Organic Standards 
Board (NOSB) to develop and forward to the Secretary a recommended 
Proposed National List, and subsequent proposed amendments to it. The 
Act provides that persons may petition the NOSB to evaluate a substance 
for inclusion on or removal from the National List. This notice 
explains who can submit a petition, for what substances a petition can 
be submitted, and the information that should be included in a 
submitted petition. All submitted petitions will be evaluated by the 
Department of Agriculture's (USDA) National Organic Program (NOP) for 
completeness. If there is incomplete information, petitioners will be 
given a reasonable opportunity to provide the missing information. 
Petitioners should realize that providing incomplete information may 
increase the evaluation time or result in no substance evaluation. This 
notice also provides the name and address of the person to whom a 
petition should be submitted.

ADDRESSES: Petitions should be submitted in duplicate to: National 
Organic Standards Board, c/o Robert Pooler, Agricultural Marketing 
Specialist, USDA/AMS/TM/NOP, Room 2510-So., Ag Stop 0268, P.O. Box 
96456, Washington, D.C. 20090-6456. Phone: 202/720-3252. Fax: 202/205-
7808. e-mail: [email protected]. Petitioners are encouraged to submit 
the required information through one system of submission (mail, fax or 
e-mail).

FOR FURTHER INFORMATION CONTACT: Keith Jones, Program Manager, National 
Organic Program, USDA/AMS/TM/NOP, Room 2945-So., Ag Stop 0268, P.O. Box 
96456, Washington, D.C. 20090-6456. Phone: 202/720-3252. Fax: 202/690-
3924. e-mail: [email protected].

SUPPLEMENTARY INFORMATION: To help readers better understand the 
petition process, we have provided answers to some frequently asked 
questions about the National List and the petition process.

What Is the Purpose and Timing of This Notice?

    The NOSB submitted a Proposed National List to the Secretary that 
was subsequently published on March 13, 2000, as part of the NOP 
proposed rule, 65 FR 13512-13658, (2000). Based on information supplied 
to the NOSB by trade associations, certification organizations and 
other organic industry sources, there are many substances currently 
used in organic production and handling that have not been evaluated by 
the NOSB for inclusion on the National List. Evaluations of these 
materials must be expedited to prevent the disruption of many well-
established and accepted production, handling and processing systems. 
The NOP and the NOSB will be developing a workplan to process the 
potential evaluation of the numerous substances which may be presented 
to the NOSB and the NOP. Therefore, the organic industry is encouraged 
to initiate notification to the NOSB and the NOP on which substances 
should receive priority for evaluation. Substances that are petitioned 
and under evaluation by the NOSB will be announced on the NOP website: 
www.ams.usda.gov/nop. Interested individuals or groups can provide 
information or commentary to the NOSB or NOP for any substance being 
evaluated by the NOSB.

How Are National List Decisions Made?

    The NOSB reviews information from various sources in evaluating 
substances for inclusion on or removal from the National List. Sources 
include Technical Advisory Panels (TAP), the Environmental Protection 
Agency, the Food and Drug Administration, the National Institute of 
Environmental Health Studies, and the testimony of the public.
    TAP reviews assist the NOSB in evaluating substances being 
considered for addition to or removal from the National List. The NOP, 
on behalf of the NOSB, establishes contracts to conduct the TAP with 
qualified individuals or organizations who have specialized knowledge 
of the petitioned substances. These reviewers have expertise in such 
fields as organic production and handling, veterinary medicine, 
chemistry, or food handling and preparation. All contractors, whether 
an individual or an organization, must meet USDA contract requirements 
including the prevention of conflict of interest. Recent TAP reviews 
conducted for the NOSB have been performed under contract by the 
Organic Materials Review Institute (OMRI). However, the NOP on behalf 
of the NOSB may contract with any individual or organization having the 
necessary technical expertise to conduct TAP reviews for NOSB substance 
evaluations.
    TAP reports and the NOSB recommendations for each substance are 
submitted to the Secretary. The Secretary evaluates the recommendations 
and other documentation regarding each substance for inclusion on or 
removal from the National List.
    The Act requires that the initial Proposed National List and 
subsequent proposed amendments to it be published in the Federal 
Register for public comment.

How Long Can a Substance Appear on the National List and Will the 
List Change?

    The Act (7 U.S.C. 6517(e)) requires that substances appearing on 
the National List be reviewed by the NOSB and the Secretary at least 
once every 5 years following implementation of the NOP. Once a 
substance evaluation is

[[Page 43260]]

completed and a recommendation is forwarded to the Secretary, the NOSB 
will not reevaluate its decision within the 5 year period unless 
substantive new information becomes available.

What Criteria Does the NOSB Use to Evaluate Petitioned Substances?

    The Act (7 U.S.C. 6518(m)) requires that the NOSB consider the 
following criteria for each substance evaluated:
    (1) The potential of such substances for detrimental chemical 
interactions with other materials used in organic farming systems;
    (2) The toxicity and mode of action of the substance and of its 
breakdown products or any contaminants, and their persistence and areas 
of concentration in the environment;
    (3) The probability of environmental contamination during 
manufacture, use, misuse or disposal of such substance;
    (4) The effect of the substance on human health;
    (5) The effects of the substance on biological and chemical 
interactions in the agroecosystem, including the substance's 
physiological effects on soil organisms (including the salt index and 
solubility of the soil), crops and livestock;
    (6) The alternatives to using the substance in terms of practices 
or other materials; and,
    (7) It's compatibility with a system of sustainable agriculture.

How Does the NOSB Evaluate Substances Such as Processing Aids or 
Adjuvants?

    In addition to the criteria cited in the Act, the NOSB developed 
internal guidelines for evaluating processing substances such as 
synthetic processing aids or adjuvants for inclusion on or removal from 
the National List during their February 1999 meeting. For specific 
information about these guidelines, please refer to the USDA NOP 
website: www.ams.usda.gov/nop/nosbfeb99.html, or write the Program 
Manager, National Organic Program, USDA/AMS/TM/NOP, Room 2945-So, Ag 
Stop 0268, PO Box 96456, Washington, D.C. 20090-6456. Phone: 202/720-
3252. Fax: 202/690-3924. e-mail: [email protected].

When Can the NOSB be Petitioned?

    The NOSB can be petitioned at any time for substances not 
previously evaluated by the NOSB. For substances receiving a prior 
recommendation by the NOSB restricting or prohibiting its use, a 
petition may be filed only when significant new information may alter 
the established NOSB recommendation. However, the NOSB and the NOP 
expects that amending the National List will be a continuous process. 
For instance, the National List may need to be amended to accommodate 
development of new substances or technologies in organic production or 
handling of foods. Recommendations to amend the National List result 
from the review and deliberation of the TAP reports and other 
information by the NOSB Committees (Crop, Livestock, Processing or 
Materials). These committees forward their recommendations to the 
entire NOSB which considers, then accepts, modifies or rejects these 
recommendations during scheduled public meetings or conferences 
conducted periodically, as needed.

Who Can Submit a Petition?

    Any person may submit a petition. Each substance to be evaluated 
must be submitted in a separate petition.

To Whom Should a Petition be Submitted?

    Petitions should be submitted in duplicate to: National Organic 
Standards Board, c/o Robert Pooler, Agricultural Marketing Specialist, 
USDA/AMS/TM/NOP, Room 2510-So., Ag Stop 0268, P.O. Box 96456, 
Washington, D.C. 20090-6456. Phone: 202/720-3252. Fax: 202/205-7808. e-
mail: [email protected].

What Are the Substances for Which a Petition May be Submitted?

    Only single substances or ingredients may be petitioned for 
evaluation. Formulated products cannot appear on the National List. 
Substances that appear on USDA's current Proposed National List, 65 
Fed. Reg.13626-13628 (2000), should not be petitioned for inclusion on 
the National List.

What Information Has to be Included in the Petition?

    A petition seeking evaluation of a substance must indicate within 
which of the following categories the substance is being petitioned for 
inclusion on or removal from the National List:
    (1) Synthetic substance's allowed for use in organic crop 
production;
    (2) Nonsynthetic substances prohibited for use in organic crop 
production;
    (3) Synthetic substances allowed for use in organic livestock 
production;
    (4) Nonsynthetic substances prohibited for use in organic livestock 
production; and
    (5) Nonagricultural (nonorganic) substances allowed in or on 
processed products labeled as ``organic'' or ``made with organic 
(specified ingredients).''
    The petition must also include, as applicable, the following 
information:
    1. The substance`s common name.
    2. The manufacturer`s name, address and telephone number.
    3. The intended or current use of the substance such as use as a 
pesticide, animal feed additive, processing aid, nonagricultural 
ingredient, sanitizer or disinfectant.
    4. A list of the crop, livestock or handling activities for which 
the substance will be used. If used for crops or livestock, the 
substance's rate and method of application must be described. If used 
for handling (including processing), the substance`s mode of action 
must be described.
    5. The source of the substance and a detailed description of its 
manufacturing or processing procedures from the basic component(s) to 
the final product. Petitioners with concerns for confidential business 
information can follow the guidelines in the Instructions for 
Submitting Confidential Business Information (CBI) listed in #13.
    6. A summary of any available previous reviews by State or private 
certification programs or other organizations of the petitioned 
substance.
    7. Information regarding EPA, FDA, and State regulatory authority 
registrations, including registration numbers.
    8. The Chemical Abstract Service (CAS) number or other product 
numbers of the substance and labels of products that contains the 
petitioned substance.
    9. The substance's physical properties and chemical mode of action 
including (a) chemical interactions with other substances, especially 
substances used in organic production; (b) toxicity and environmental 
persistence; (c) environmental impacts from its use or manufacture; (d) 
effects on human health; and, (e) effects on soil organisms, crops, or 
livestock.
    10. Safety information about the substance including a Material 
Safety Data Sheet (MSDS) and a substance report from the National 
Institute of Environmental Health Studies.
    11. Research information about the substance which includes 
comprehensive substance research reviews and research bibliographies, 
including reviews and bibliographies which present contrasting 
positions to those presented by the petitioner in supporting the 
substance's inclusion on or removal from the National List.
    12. A ``Petition Justification Statement'' which provides 
justification for one of the following actions requested in the 
petition:

[[Page 43261]]

    When petitioning for the inclusion of a synthetic substance on the 
National List, the petition should state why the synthetic substance is 
necessary for the production or handling of an organic product. The 
petition should also describe the nonsynthetic substances or 
alternative cultural methods that could be used in place of the 
petitioned synthetic substance. Additionally, the petition should 
summarize the beneficial effects to the environment, human health, or 
farm ecosystem from use of the synthetic substance that support the use 
of it instead of the use of a nonsynthetic substance or alternative 
cultural methods.
    When petitioning for the removal of a synthetic substance from the 
National List the petition must state why the synthetic substance is no 
longer necessary or appropriate for the production or handling of an 
organic product.
    When petitioning for the inclusion on the National List of a 
nonsynthetic or nonagricultural substance as a prohibited substance the 
petition must state why the nonsynthetic or nonagricultural substance 
should not be permitted in the production or handling of an organic 
product.
    When petitioning for the removal from the National List of a 
nonsynthetic or nonagricultural substance as a prohibited substance the 
petition must state why the nonsynthetic or nonagricultural substance 
should be permitted in the production or handling of an organic 
product.
    13. A Commercial Confidential Information Statement which describes 
the specific required information contained in the petition that is 
considered to be Confidential Business Information (CBI) or 
confidential commercial information and the basis for that 
determination. Petitioners should limit their submission of 
confidential information to that needed to address the areas for which 
this notice requests information. Instructions for submitting CBI to 
the National List Petition process are presented in the instructions 
below:
    (a) Financial or commercial information the applicant does not want 
disclosed for competitive reasons can be claimed as CBI. Applicants 
must submit a written justification to support each claim.
    (b) ``Trade secrets'' (information relating to the production 
process, such as formulas, processes, quality control tests and data, 
and research methodology) may be claimed as CBI. This information must 
be (1) commercially valuable, (2) used in the applicant's business, and 
(3) maintained in secrecy.
    (c) Each page containing CBI material must have ``CBI Copy'' marked 
in the upper right corner of the page. In the right margin, mark the 
CBI information with a bracket and ``CBI.''
    (d) The CBI-deleted copy should be a facsimile of the CBI copy, 
except for spaces occurring in the text where CBI has been deleted. Be 
sure that the CBI-deleted copy is paginated the same as the CBI copy. 
(The CBI-deleted copy of the application should be made from the same 
copy of the application which originally contained CBI.) Additional 
material (transitions, paraphrasing, or generic substitutions, etc.) 
should not be included in the CBI-deleted copy.
    (e) Each page with CBI-deletions should be marked ``CBI-deleted'' 
at the upper right corner of the page. In the right margin, mark the 
place where the CBI material has been deleted with a bracket and ``CBI-
deleted.''
    (f) If several pages are CBI-deleted, a single page designating the 
numbers of deleted pages may be substituted for blank pages. (For 
example, ``pages 7 through 10 have been CBI-deleted.'')
    (g) All published references that appear in the CBI copy should be 
included in the reference list of the CBI-deleted copy. Published 
information usually cannot be claimed as confidential.
    However, the National List substance evaluations will involve a 
public and open process. Nonconfidential information will be available 
for public inspection.
    The NOP Program Manager may request additional information from the 
petitioner following receipt of the petition.
    In accordance with the Paperwork Reduction Act of 1980, Public Law 
44 U.S.C. 3501 et seq., the information collection requirements 
contained in this notice have been previously approved by OMB and were 
assigned OMB control number 0581-0181.

    Authority: 7 U.S.C. 6501-6522.

    Dated: July 7, 2000.
Sharon Bomer Lauritsen,
Acting Deputy Administrator, Transportation and Marketing.
[FR Doc. 00-17689 Filed 7-12-00; 8:45 am]
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