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National Organic Program--Submission of Petitions of Substances for Inclusion on or Removal From the National List of Substances Allowed and Prohibited in Organic Production and Handling
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 18, 2007 (Volume 72, Number 11)]
[Rules and Regulations]
[Page 2167-2170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja07-1]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket No. AMS-TM-06-0223; TM-06-12]
National Organic Program--Submission of Petitions 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 on Procedures for Submitting National List
Petitions.
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SUMMARY: This notice supersedes prior Department of Agriculture's
(USDA) National Organic Program's (NOP) published guidelines used to
submit petitions to amend the National List of Allowed and Prohibited
Substances (National List). The National List identifies the synthetic
substances that may be used and the non-synthetic substances that may
not be used in organic production. The National List also identifies
synthetic and non-synthetic substances that may be used in organic
handling. This notice provides guidance on who may submit petitions,
what substances may be petitioned and the information that is required
to be included within a submitted petition. Additionally, this notice
establishes new commercial availability evaluation criteria that will
be applied during the petition review of non-organic agricultural
substances for inclusion onto or removal from Sec. 205.606 of the
National List.
DATES: Effective Date: These guidelines will be in effect on January
19, 2007.
ADDRESSES: Petitions should be submitted in duplicate to: Program
Manager, USDA/AMS/TM/NOP, Room 4008-So., Ag Stop 0268, 1400
Independence Ave., SW., Washington, DC 20250. Phone: (202) 720-3252.
Fax: (202) 205-7808. To submit petitions electronically, contact the
USDA NOP for additional instructions.
FOR FURTHER INFORMATION CONTACT: National List Coordinator, National
Organic Program, USDA/AMS/TM/NOP, Room 4008-So., Ag Stop 0268, 1400
Independence Ave., SW., Washington, DC 20250. Phone: (202) 720-3252.
Fax: (202) 720-3252.
SUPPLEMENTARY INFORMATION:
Background
The Organic Foods Production Act of 1990 (OFPA), as amended (7
U.S.C. 6501 et seq.), authorizes the establishment of the NOP
regulations including the National List of Allowed and Prohibited
Substances (National List). This National List identifies the synthetic
substances that may be used and the non-synthetic substances that may
not be used in organic production, and also identifies synthetic and
non-synthetic substances that may be used in organic handling. The OFPA
and NOP regulations, in Sec. 205.105, specifically prohibit the use of
any synthetic substance for organic production and handling unless the
synthetic substance is on the National List. Section 205.105 also
requires that any non-organic, non-synthetic substance used in organic
handling must also be on the National List. Since the NOP regulations
became effective on October 21, 2002, the National List can only be
amended through rulemaking by either the National List Petition Process
or the National List Sunset Process. The guidelines contained in this
notice apply only to the National List Petition Process.
The ability for any person to petition to amend the National List
is authorized by the OFPA (7 U.S.C. 6518(n)) and the NOP regulations,
in Sec. 205.607. This authorization provides that any person may
petition the National Organic Standards Board (NOSB) for the purpose of
having a substance evaluated by the NOSB for recommendation to the
Secretary for inclusion on or removal from the National List. The NOSB
is authorized to review petitions under specified evaluation criteria
in OFPA (7 U.S.C 6518(m)), and forward recommendations for amending the
National List to the Secretary. Since the NOP regulations became
effective in October 2002, several petitions to include synthetic or
non-synthetic substances in their respective sections of the National
List have been reviewed by the NOSB. However, only a few of these
petitions were for inclusion of non-organic agricultural substances
onto the National List in Sec. 205.606.
Until recently, some producers, handlers and certifiers may have
misinterpreted Sec. 205.606 to mean that any non-organic agricultural
product which was determined by an accredited certifying agent to be
not commercially available in organic form could be used in organic
products, without being individually listed pursuant to the National
List procedures. In January 2005, the First Circuit decision in Harvey
v. Johanns held that such an interpretation is contrary to the plain
meaning of the OFPA and ordered that 7 CFR 205.606 shall not be
interpreted to create a blanket exemption to the National List
requirements specified in Sec. Sec. 6517 and 6518 of the OFPA (7
U.S.C. 6517-6518). Consistent with the district court's final judgment
and order, dated June 9, 2005, on July 1, 2005, the NOP published a
notice regarding Sec. 205.606 (70 FR 38090), and on June 7, 2006,
published a final rule revising Sec. 205.606 to clarify that the
section shall be interpreted to permit the use of a non-organically
produced agricultural product only when the product has been listed in
Sec. 205.606 pursuant to National List procedures, and when an
accredited certifying agent has determined that the organic form of the
agricultural product is not commercially available (71 FR 32803). As a
result, industry information provided to the NOP indicates that there
may be many non-organic agricultural substances that are being used in
organic products which will render currently certified products in non-
compliance when the court final order and judgment on Harvey v. Johanns
becomes fully effective on June 9, 2007.
This Federal Register Notice, developed in collaboration with the
NOSB and based on its October 2006 recommendation, modifies the
information to be included in a petition to provide for the review of
non-organic agricultural substances to be included onto Sec. 205.606.
This notice also clarifies the information to be submitted for all
types of petitions submitted to amend the National List.
[[Page 2168]]
Procedures for Submitting National List Petitions
Any person may submit a petition requesting a substance to be
reviewed by the NOP and NOSB at any time. Each substance to be
evaluated for the National List must be submitted in a separate
petition. Only single substances may be petitioned for evaluation;
formulated products cannot appear on the National List. When submitting
petitions, an official petition contact should be designated for all
correspondence and the petition should provide specific contact
information including name, address, phone number, fax number and e-
mail address.
To facilitate timely NOP review and NOSB consideration of
petitions, petitioners must provide concise yet comprehensive responses
to the required petition information items described under the
guideline heading ``Information to be included in a Petition.'' Upon
receipt, the NOP will review the petition for completeness of the
required petition information. If the required petition information is
incomplete, the petition will be returned to the petitioner with a
request for additional information.
Petitions for substance evaluations to add a substance onto, remove
a substance from, or amend a substance presently on the National List
involves a public and open process. Petition information not
categorized and accepted by USDA, pursuant to 7 CFR 1.27(d), as
Confidential Business Information (CBI) will be considered available to
the public for inspection. Published information usually cannot be
claimed as confidential. When a petition is considered complete and
forwarded for NOSB evaluation, except for CBI, the petition will be
made available for public inspection. Substance petitions that are
complete and under evaluation by the NOSB will be posted on the NOP Web
site at: http://www.ams.usda.gov/nop. Public comments may be submitted
to either the NOSB or the NOP for any petitioned substance being
evaluated by the NOSB. Comments also will be posted on the NOP Web site.
Overview of Petition Review by the NOSB
For each completed petition, the responsible NOSB committee reviews
petition information, technical reports and public comments, then
develops the recommendation for full NOSB consideration at a scheduled
public meeting. The NOSB determines when petitions will be reviewed at
their public meetings and when recommendations are forwarded to the
Secretary.
As provided for in OFPA (7 U.S.C 6518(m)), when evaluating
petitioned substances for amendment of the National List, the NOSB
shall consider:
(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.
If an agricultural substance is petitioned for amendment onto Sec.
205.606 of the National List, the NOSB shall verify that the material
is agricultural. Once the substance is verified to be agricultural, the
NOSB will determine if the substance is potentially commercially
unavailable. The NOSB will consider:
(A) Why the substance should be permitted in the production or
handling of an organic product;
(B) The current industry information regarding availability of and
history of unavailability of an organic form in the appropriate form,
quality, or quantity of the substance. Industry information includes,
but is not limited to the following: (1) Regions of production,
including factors such as climate and number of regions; (2) Number of
suppliers and amount produced; (3) Current and historical supplies
related to weather events such as hurricanes, floods, and droughts that
may temporarily halt production or destroy crops or supplies; (4) Trade
related issues such as evidence of hoarding, war, trade barriers, or
civil unrest that may temporarily restrict supplies, and (5) Other
issues which may present a challenge to a consistent supply.
After considering the petition at a scheduled public meeting, the
NOSB will forward its recommendation to the Secretary. Upon receipt,
the Secretary will evaluate the recommendation for inclusion onto or
removal from the National List. Proposed amendments to the National
List are published in the Federal Register as a Proposed Rule. After
considering and responding to public comments on the proposed rule,
amendments to the National List are effective only after publication in
the Federal Register as a Final Rule. A substance that has been
petitioned and recommended to be allowed for use by the NOSB is not
allowed for use in organic production or handling until the final rule
for amending the National List, if any, is effective.
When a substance is added onto the National List, it will remain on
the List for 5 years after final rule becomes effective. As required by
the Sunset provision in OFPA (7 U.S.C 6517(e)), the NOSB must review
substances added to the National List at least once every 5 years per
the National List Sunset Process, to reaffirm or not reaffirm, the
status of each substance on the National List. Petitions to reevaluate
prior NOSB recommendations to include a substance onto or remove a
substance from the National List will be considered by the NOSB when
substantial new petition substance information is provided.
Submitting Petitions for Sec. 205.606
When submitting petitions to include a non-organic agricultural
substance onto Sec. 205.606, the petitioner must state in the petition
justification statement, why the substance should be permitted in the
production or handling of an organic product. Specifically, the
petition must include current industry information on availability of,
and history of unavailability of an organic form of the substance. When
providing information on commercial availability of the organic form of
an agricultural product, petitioners must be aware that the global
market is the universe of supply; commercial availability is not
dependent upon geographic location or local market conditions.
For petitions to remove a non-organic agricultural substance from
Sec. 205.606, the petitioner must state why the substance should be
prohibited from use in a non-organic form. Any information acquired
since the original petition to add the substance to the National List
should be provided.
Information To Be Included in a Petition
The guidelines for required information to be included in a
petition are as follows:
Item A--Please indicate which section or sections the petitioned
[[Page 2169]]
substance will be included on and/or removed from the National List.
? Synthetic substances allowed for use in organic crop
production, Sec. 205.601.
? Non-synthetic substances prohibited for use in organic
crop production, Sec. 205.602.
? Synthetic substances allowed for use in organic livestock
production, Sec. 205.603.
? Non-synthetic substances prohibited for use in organic
livestock production, Sec. 205.604.
? Non-agricultural (non-organic) substances allowed in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients),'' Sec. 205.605.
? Non-organic agricultural substances allowed in or on
processed products labeled as ``organic,'' Sec. 205.606.
Item B--Please provide concise and comprehensive responses in
providing all of the following information items on the substance being
petitioned:
1. The substance's chemical or material common name.
2. The manufacturer's or producer's name, address and telephone
number and other contact information of the manufacturer/producer of
the substance listed in the petition.
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. If the substance is an
agricultural ingredient, the petition must provide a list of the types
of product(s) (e.g., cereals, salad dressings) for which the substance
will be used and a description of the substance's function in the
product(s) (e.g., ingredient, flavoring agent, emulsifier, processing aid).
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 may follow the guidelines in the Instructions for
Submitting 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. If this information is not available, the petitioner should
state so in the petition.
7. Information regarding EPA, FDA, and State regulatory authority
registrations, including registration numbers. If this information does
not exist, the petitioner should state so in the petition.
8. The Chemical Abstract Service (CAS) number or other product
numbers of the substance and labels of products that contains the
petitioned substance. If the substance does not have an assigned
product number, the petitioner should state so in the petition.
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 and/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. If this information does not
exist, the petitioner should state so in the petition.
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. For
petitions to include non-organic agricultural substances onto the
National List, this information item should include research concerning
why the substance should be permitted in the production or handling of
an organic product, including the availability of organic alternatives.
Commercial availability does not depend upon geographic location or
local market conditions. If research information does not exist for the
petitioned substance, the petitioner should state so in the petition.
12. A ``Petition Justification Statement'' which provides
justification for any of the following actions requested in the petition:
A. Inclusion of a Synthetic on the National List, Sec. Sec. 205.601,
205.603, 205.605(b)
? Explain why the synthetic substance is necessary for the
production or handling of an organic product.
? Describe any non-synthetic substances, synthetic
substances on the National List or alternative cultural methods that
could be used in place of the petitioned synthetic substance.
? Describe the beneficial effects to the environment, human
health, or farm ecosystem from use of the synthetic substance that
support its use instead of the use of a non-synthetic substance or
alternative cultural methods.
B. Removal of a Synthetic From the National List, Sec. Sec. 205.601,
205.603, 205.605(b)
? Explain why the synthetic substance is no longer necessary
or appropriate for the production or handling of an organic product.
? Describe any non-synthetic substances, synthetic
substances on the National List or alternative cultural methods that
could be used in place of the petitioned synthetic substance.
C. Inclusion of a Prohibition of a Non-Synthetic, Sec. Sec. 205.602
and 205.604
? Explain why the non-synthetic substance should not be
permitted in the production of an organic product.
? Describe other non-synthetic substances or synthetic
substances on the National List or alternative cultural methods that
could be used in place of the petitioned substance.
D. Removal of a Prohibited Non-Synthetic From the National List,
Sec. Sec. 205.602 and 205.604
? Explain why the non-synthetic substance should be
permitted in the production of an organic product.
? Describe the beneficial effects to the environment, human
health, or farm ecosystem from use of the non-synthetic substance that
supports its use instead of the use of other non-synthetic or synthetic
substances on the National List or alternative cultural methods.
E. Inclusion of a Non-Synthetic, Non-Agricultural Substance Onto the
National List, Sec. 205.605(a)
? Explain why the substance is necessary for use in organic handling.
? Describe non-synthetic or synthetic substances on the
National List or alternative cultural methods that could be used in
place of the petitioned synthetic substance.
? Describe any beneficial effects on the environment, or
human health from the use of the substance that support its use instead
of the use of non-synthetic or synthetic substances on the National
List or alternative cultural methods.
F. Removal of a Non-Synthetic, Non-Agricultural Substance From the
National List, Sec. 205.605(a)
? Explain why the substance is no longer necessary for use
in organic handling.
[[Page 2170]]
? Describe any non-synthetic or synthetic substances on the
National List or alternative cultural methods that could be used in
place of the petitioned substance.
G. Inclusion of a Non-Organically Produced Agricultural Substance Onto
the National List, Sec. 205.606
? Provide a comparative description on why the non-organic
form of the substance is necessary for use in organic handling.
? Provide current and historical industry information/
research/evidence that explains how or why the substance cannot be
obtained organically in the appropriate form, appropriate quality, and
appropriate quantity to fulfill an essential function in a system of
organic handling.
? Describe industry information on substance non-
availability of organic sources including but not limited to the
following guidance regarding commercial availability evaluation
criteria: (1) Regions of production, including factors such as climate
and number of regions; (2) Number of suppliers and amount produced; (3)
Current and historical supplies related to weather events such as
hurricanes, floods, and droughts that may temporarily halt production
or destroy crops or supplies; (4) Trade related issues such as evidence
of hoarding, war, trade barriers, or civil unrest that may temporarily
restrict supplies, and (5) Other issues which may present a challenge
to a consistent supply.
H. Removal of a Non-Organically Produced Agricultural Substance From
the National List, Sec. 205.606
? Provide a comparative description as to why the non-
organic form of the substance is not necessary for use in organic handling.
? Provide current and historical industry information/
research/evidence that explains how or why the substance can be
obtained organically in the appropriate form, appropriate quality, and
appropriate quantity to fulfill an essential function in a system of
organic handling.
? Provide new industry information on substance availability
of organic sources including but not limited to the following guidance
commercial availability evaluation criteria: (1) Region of production,
including factors such as climate and number of regions; (2) Number of
suppliers and amount produced; (3) Current and historical supplies
related to weather events such as hurricanes, floods, or droughts that
temporarily halt production or destroy crops or supplies; (4) Trade
related issues such as evidence of hoarding, war, trade barriers, and
civil unrest that may temporarily restrict supplies and; (5) Any other
issues which may present a challenge to a consistent supply.
13. A Confidential Business 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. Final determination regarding whether
to afford CBI treatment to submitted petitions will be made by USDA
pursuant to 7 CFR 1.27(d). Instructions for submitting CBI to the
National List Petition process are presented in the instructions below:
(a) Financial or commercial information the petitioner does not
want disclosed for competitive reasons may 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 cannot be claimed as confidential.
(h) Final determination regarding whether to afford CBI treatment
to submitted petitions will be made by USDA pursuant to 7 CFR 1.27(d).
If a determination is made to deny CBI treatment, the petitioner will
be afforded an opportunity to withdraw the submission.
No additional collection or recordkeeping requirements are imposed
on the public by this rule.
Accordingly, OMB clearance is not required by Sec. 305(h) of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., or OMB's
implementation regulation at 5 CFR, part 1320.
Authority: 7 U.S.C. 6501-6522.
Dated: January 10, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E7-596 Filed 1-17-07; 8:45 am]
BILLING CODE 3410-02-P