[Federal Register Volume 60, Number 58 (Monday, March 27, 1995)]
[Notices]
[Pages 15744-15745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7470]



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Notices
                                                Federal Register
________________________________________________________________________

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.

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Federal Register / Vol. 60, No. 58 / Monday, March 27, 1995 / 
Notices

[[Page 15744]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service
[TM-94-00-4]


Procedure To Submit Names of Substances for Evaluation for 
Inclusion in the National List To Be Included in the National Organic 
Program

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice.

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SUMMARY: The Organic Foods Production Act of 1990, as amended (Act) (7 
U.S.C. 6501 et. seq.), requires the establishment of a national organic 
production program for producers and handlers of agricultural products 
that have been produced using organic methods. The Act requires the 
Secretary of Agriculture (Secretary) to establish a National List of 
approved synthetic and prohibited natural substances that shall be 
included in the standards for organic production and handling. The 
National Organic Standards Board (NOSB), established by the Secretary, 
is seeking applications (petitions) for substances to be considered for 
inclusion on the National List. Petitions for substances for the 
National List should be submitted by the date set forth below.

DATES: Petitions should be received by close of business, May 26, 1995.

ADDRESSES: Petitions should be sent to Michael Hankin, Senior Marketing 
Specialist, USDA, Agricultural Marketing Service (AMS), Transportation 
and Marketing Division (TMD), National Organic Program (NOP), Room 2510 
South Building, P.O. Box 96456, Washington, DC 20090-6456.

FOR FURTHER INFORMATION CONTACT: Ted Rogers, Marketing Specialist, 
USDA, AMS, TMD, NOP, Room 2510 South Building, P.O. Box 96456, 
Washington, DC 20090-6456. Phone 202/205-7804. Fax 202/205-7808.

SUPPLEMENTARY INFORMATION: Organic production and handling involves 
more than just the application or addition of certain acceptable 
substances. The Act in section 2114 (7 U.S.C. 6513) requires producers 
and handlers seeking certification under the Act to submit an organic 
plan to the certifying agent and the State organic certification 
program (if applicable). An organic plan is a plan of management of an 
organic farming or handling operation that has been agreed to by the 
producer or handler and the certifying agent that addresses all aspects 
of agricultural production or handling described in the Act, including 
crop rotation and other practices required under the Act.
    The Act in section 2112 (7 U.S.C. 6511) also requires producers and 
handlers of certified organic operations to maintain records concerning 
the production or handling of agricultural products sold or labeled as 
organically produced under the Act. These records are to include 
detailed histories of substances applied to fields or agricultural 
products, the names and addresses of persons who applied the 
substances, and the date, rate and method of application of such 
substances. Livestock records shall include, but not be limited to, the 
amount and source of medications administered and all feeds and feed 
supplements bought and fed (section 2110 of the Act (7 U.S.C. 6509)).
    Further, the Act requires the Secretary to establish a National 
List of approved synthetic and prohibited natural substances that shall 
be included in the standards established for the organic production and 
handling of agricultural products to be sold or labeled as organically 
produced. The Act in section 2103(21) (7 U.S.C. 6502(21)) defines 
synthetic as a substance that is formulated or manufactured by a 
chemical process or by a process that chemically changes a substance 
extracted from naturally occurring plant, animal, or mineral sources, 
except that such term shall not apply to substances created by 
naturally occurring biological processes.
    The Secretary in accordance with section 6518 of the Act (7 U.S.C. 
6518) established a NOSB. The purpose of the NOSB is to assist in the 
development of standards for substances to be used in organic 
production and to advise the Secretary on any other aspects of 
implementing the Act.
    The NOSB has initiated an evaluation of certain substances for 
inclusion on the National List. The NOSB's list of substances was 
generated from existing lists of established organic certification 
agencies and from input received from various people and organizations, 
including organic food processors and livestock producers. The 
substances currently being considered have been referred, in accordance 
with the Act, to technical advisors, selected by the NOSB, who will 
provide the NOSB with relevant scientific information. Also, in 
accordance with the Act, the NOSB will review information from the 
Environmental Protection Agency, the National Institute of 
Environmental Health Studies and other sources, as appropriate, in 
regards to the potential adverse human and environmental effects of a 
substance under consideration.
    Specifically, the NOSB will be considering:
    (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 physiological effects 
of the substance 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 available materials; and
    (7) Its compatibility with a system of sustainable agriculture.
    The results of the evaluations by the technical advisors will be 
utilized by the NOSB in formulating its own evaluation reports. Both 
the NOSB evaluations and those of the technical advisors will be 
submitted to the Secretary along with the NOSB's recommended list of 
substances. The [[Page 15745]] Secretary will consider the 
recommendations of the NOSB. The Secretary will then determine what 
substances should be proposed to be included in the National List and 
will publish the proposed list for public comment prior to establishing 
the National List.
    Once established, the National List may be amended. Proposed 
additions to the National List will also be published for public 
comment. Substances included in the National List will be reviewed by 
the NOSB and the Secretary at least every 5 years.

PURPOSE: The NOSB has made an extensive effort to review existing 
organic certification organizations' lists of substances approved or 
prohibited for organic production and handling. However, it is possible 
that one or more substances currently appearing on these existing lists 
have not been included in the groups of substances being evaluated at 
this time by the technical advisors persons and the NOSB. In addition, 
there may be other substances that should be evaluated for inclusion on 
the National List which may be determined to be compatible with the 
organic management system of agricultural production and processing.
    This Notice establishes the procedure by which interested parties 
may petition the NOSB for the purpose of having a substance evaluated 
for recommendation to the Secretary for inclusion as a permitted 
synthetic or prohibited natural substance on the National List. Only 
the names of generic, single, active ingredients should be submitted; 
brand name products and formulations will not be evaluated or appear on 
the National List.
    A request that a substance be evaluated, along with the following 
information, is specifically requested.

DETAILED INFORMATION:
Substance name (generic or common name);
Manufacturer's name, address, and phone, if different from the 
petitioner;
Area of intended use (crops, livestock, or handling/processing);
Specific use of the substance within the area of intended use;
Sources from which the substance is derived;
Description of the manufacturing or processing procedures; and
Summary of previous reviews by State or private organic certification 
programs.

REGULATORY INFORMATION (as applicable):
EPA registration (include the registration number);
Food and Drug Administration registration;
State regulatory authority registration (include State registration 
number);
Chemical Abstract Service number or other product number; and
Labels of products that contain the petitioned substance.

SUPPLEMENTARY INFORMATION:
Detailed findings relevant to the substance's: detrimental chemical 
interactions with other materials used in organic farming; toxicity and 
persistence in the environment; environmental contamination resulting 
from its use and manufacture; effects on human health; and effects on 
soil organisms, crops and livestock;
Bibliographies;
Material Safety Data Sheet;
Information on the substance obtained from the National Institute of 
Environmental Health Studies; and
Information on whether all or part of any submission is believed to be 
confidential commercial information, and if so, what parts, and the 
basis for the belief it is confidential commercial information.

JUSTIFICATION: If petitioning for approval of a synthetic substance, 
state the reasons why the synthetic substance is necessary to the 
production, processing or handling of the organic product;
    If the substance may be defined as synthetic, describe natural 
substances or alternative cultural methods that could be utilized in 
place of the synthetic substance; and summarize the beneficial effects 
to the environment, human health, or farm ecosystem that might support 
the use of the synthetic substance instead of the natural substances or 
alternative cultural methods.
    If petitioning for prohibition of a natural substance, state the 
reasons why the natural substance should not be permitted in the 
production, processing or handling of the organic product.
    The information requested for petitioning for a substance to be 
evaluated for inclusion on the National List should be completed as 
fully as possible. Persons submitting petitions may be requested to 
supply additional information.
    Persons wishing to submit a petition should send the request and 
the information requested to: Michael Hankin, Senior Marketing 
Specialist, USDA, AMS, TMD, NOP, Room 2510 South Building, PO Box 
96456, Washington, DC 20090-6456.

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

    Dated: March 21, 1995.
Lon Hatamiya,
Administrator.
[FR Doc. 95-7470 Filed 3-24-95; 8:45 am]
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