[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Proposed Rules]
[Page 13795-13798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr08-13]
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Proposed Rules
Federal Register
________________________________________________________________________
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.
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[[Page 13795]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-07-0136; TM-07-14]
RIN 0581-AC77
National Organic Program, Sunset Review (2011)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking with request for
comments.
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SUMMARY: Sunset of the exempted or prohibited use of substances under
the National Organic Program (NOP) is required by the Organic Foods
Production Act of 1990 (OFPA). This ANPR announces the sunset of 12
exempted substances added to the National List on September 12, 2006.
This ANPR establishes September 12, 2011, as the date by which the
sunset review and renewal process must be concluded. This advance
notice of proposed rulemaking (ANPR) also begins the public comment
process on whether the identified existing exemptions should be
continued. Finally, this ANPR discusses how the NOP will manage the
sunset review and renewal process.
DATES: Comments must be submitted on or before May 13, 2008.
ADDRESSES: Interested persons may submit written comments on this ANPR
using the following addresses:
Mail: Robert Pooler, Agricultural Marketing Specialist,
National Organic Program, USDA-AMS-TMP-NOP, 1400 Independence Ave.,
SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
Internet: www.regulations.gov.
Written comments responding to this ANPR should be identified with
the docket number AMS-TM-07-0136. You should clearly indicate your
position on continuing the allowance of the substances identified in
this ANPR and the reasons for your position. You should include
relevant information and data to support your position (e.g.,
scientific, environmental, manufacturing, industry impact information,
etc.). You should also supply information on alternative substances or
alternative management practices, where applicable, that support a
change from the current exemption of the substance. Only the supporting
material relevant to your position will be considered.
It is our intention to have all comments concerning this ANPR,
including names and addresses when provided, whether submitted by mail
or internet available for viewing on the Regulations.gov
(www.regulations.gov) internet site. Comments submitted in response to
this ANPR will also be available for viewing in person at USDA-AMS,
Transportation and Marketing Programs, National Organic Program, Room
4008--South Building, 1400 Independence Ave., SW., Washington, DC, from
9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday,
(except official Federal holidays). Persons wanting to visit the USDA
South Building to view comments received in response to this ANPR are
requested to make an appointment in advance by calling (202) 720-3252.
FOR FURTHER INFORMATION CONTACT: Robert Pooler, Agricultural Marketing
Specialist, National Organic Program, USDA/AMS/TM/NOP, Room 4008-So.,
Ag Stop 0268, 1400 Independence Ave., SW., Washington, DC 20250. Phone:
(202) 720-3252. Telephone: (202) 720-3252. E-mail:
Robert.pooler@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The OFPA, 7 U.S.C. 6501 et seq., authorizes the establishment of
the National List of exempted and prohibited substances. The National
List identifies synthetic substances (synthetics) that are exempted
(allowed) and nonsynthetic substances (nonsynthetics) that are
prohibited in organic crop and livestock production. The National List
also identifies nonsynthetics and synthetics that are exempted for use
in organic handling.
The exemptions and prohibitions granted under the OFPA are required
to be reviewed every 5 years by the National Organic Standards Board
(NOSB). The Secretary of Agriculture has authority under the OFPA to
renew such exemptions and prohibitions. If they are not reviewed by the
NOSB and renewed by the Secretary within 5 years of their inclusion on
the National List, their authorized use or prohibition expires. This
means that synthetic substances Hydrogen chloride (CAS 7647-
01-0) and Ferric phosphate (CAS 10045-86-0), currently allowed
for use in organic crop production, will no longer be allowed for use
after September 12, 2011. This also means that Egg white lysozyme (CAS
9001-63-2), L-Malic acid (CAS 97-67-6),
Microorganisms, Activated charcoal (CAS s7440-44-0; 64365-11-
3), Cyclohexylamine (CAS 108-91-8), Diethylaminoethanol (CAS
100-37-8), Octadecylamine (CAS 124-30-1), Peracetic
acid/Peroxyacetic acid (CAS 79-21-0), Sodium acid
pyrophosphate (CAS 7758-16-9), and Tetrasodium pyrophosphate
(CAS 7722-88-5), currently allowed for use in organic
handling, will no longer be allowed for use after September 12, 2011.
Expiration of the exempted or prohibited use of substances is
provided for under the OFPA's sunset provision. This ANPR announces the
sunset of 12 exempted substances added to the National List on
September 12, 2006. This ANPR establishes September 12, 2011, as the
date by which the sunset review and renewal process must be concluded.
Substances not renewed will be removed from the National List. This
ANPR also begins the public comment process on whether the existing
specific exemptions on the National List should be continued. This ANPR
discusses how the NOP will manage the sunset review and renewal
process.
Because these substances may be critical to the production and
handling of a wide array of raw and processed organic agricultural
products, their expiration could cause disruption of well-established
and accepted organic production, handling, and processing systems.
Therefore, the NOP is initiating the sunset review and renewal process
now, in order to provide ample opportunity for you to make your views
known.
Glycerine oleate (Glycerol monooleate) (CAS 37220-82-9)
was also added to the National List on September 12, 2006, but for use
only until December 31, 2006. Because
[[Page 13796]]
authorized use of this substance expired on December 31, 2006, it is
not included in this sunset review.
The Sunset Process
As the first step in this process, we invite public comment on the
specific exemptions currently on the National List that are described
in this document. All substances currently on the National List have
been previously evaluated and determined by the NOSB for consistency
with OFPA and its implementing regulations. According to Sec. 6517(e)
of the OFPA, these substances must be reviewed by the NOSB and renewed
by the Secretary for their use to continue after 5 years of their
addition to the National List which will be September 12, 2011. Public
comments submitted will be considered in the review and renewal
process.
The NOP will forward comments received under this ANPR to the NOSB
for review. The NOSB will review the exemptions of the substances
designated to sunset, including the public comments received during
this review. The NOSB will review each of the substances listed in this
ANPR and may determine that certain substances warrant a more in-depth
review and require additional information or research that considers
new scientific data and technological and market advances.
Following the NOSB's review, the NOSB will make a recommendation to
the Secretary about the continuation of specific exemptions for the
substances listed in this ANPR. After the Secretary receives the NOSB's
recommendations, the NOP will publish a proposed rule enacting the NOSB
recommendations. This proposed rule will provide an additional
opportunity for you to express your views. Comments received on the
proposed rule will be used to develop a final rule. Because the sunset
review and renewal process involves rulemaking, the NOP believes it is
appropriate to initiate the process now.
Guidance on Submitting Your Comments
Comments That Support Existing Exemptions
If you provide comments that support the renewal of any or all
existing exemptions included within this ANPR, you should clearly
indicate this and provide your reasons and any relevant documentation
that supports your position.
Comments That Do Not Support Continuing an Existing Exemption
If you provide comments that do not support continuing an existing
exemption, you should provide reasons why the use of the substance
should no longer be allowed in organic agricultural production and
handling. The current exemptions were originally recommended by the
NOSB based on evidence available to the NOSB at the time of review
which demonstrated that the substances were found to be: (1) Not
harmful to human health or the environment, (2) necessary because of
the unavailability of wholly nonsynthetic alternatives, and (3)
consistent and compatible with organic practices. Therefore, comments
against the continued exemption of a substance should demonstrate how
the current substance is: (1) Harmful to human health or the
environment, (2) not necessary to the production of the agricultural
products because of the availability of wholly nonsynthetic substitute
products, or (3) inconsistent with organic farming and handling.
An Appendix to this ANPR contains worksheets to assist you in
gathering relevant information concerning these issues. These
worksheets are not required to submit a comment. These worksheets are
used by the NOSB to develop their recommendations to the Secretary to
include an exempted substance on the National List. You do not have to
answer the questions on the worksheets; they are intended only to help
you provide substantive comments to the NOSB when you provide comments
on the specific substance.
In addition, comments that do not support the continued use of a
substance(s) listed within this ANPR should also provide evidence
concerning viable alternatives for the substance you believe should be
discontinued. Viable alternatives include, but are not limited to:
alternative management practices that would eliminate the need for the
specific substance; other currently exempted substances that are on the
National List which could eliminate the need for this specific
substance; and other organic or nonorganic agricultural substances.
Such evidence also should adequately demonstrate that the alternative
has a function and effect that equals or surpasses the specific
exempted substance that you do not want to be continued. Assertions
about an alternative substance except for those alternatives that
already appear on the National List should, if possible include the
name and address of the manufacturer of the alternative. Further, your
comments should include a copy or the specific source of any supportive
literature, which could include product or practice descriptions;
performance and test data; reference standards; name and address of
producers who have used the alternative under similar conditions and
the date of use; and an itemized comparison of the function and effect
of the proposed alternative(s) with substance under review. The chart
below can help you describe recommended alternatives for different
types of organic operations in place of a current exempted substance
that you do not want to be continued.
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Then the recommended
If the currently listed And is a (an). . alternative should
substance is used in. . . . be a (an). . .
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Crop or Livestock Production.. Synthetic --Another currently
substance. listed synthetic
substance;
--Nonsynthetic
substance; or
--Management
practice.
Crop or Livestock Production.. Synthetic inert --Another currently
substance listed synthetic
(pesticidal). substance or
--Nonsynthetic
substance.
Handling...................... Synthetic --Another currently
substance. listed synthetic
substance;
--Nonsynthetic (non-
ag) substance; or
--Management
practice.
Handling...................... Nonsynthetic (non- --Agricultural
ag) substance. substance; or
--Management
practice.
Handling...................... Nonorganic --Organic
agricultural agricultural
product. product.
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The NOP understands that supportive technical or scientific
information for synthetic alternatives not currently on the National
List may not be easily available to organic producers and handlers.
Such information may,
[[Page 13797]]
however, be available from the research community including
universities, or other sources, including international organic
programs.
Request for Comments
The NOP requests that you comment whether the NOSB should continue
to recommend the following exemptions on the National List of Allowed
and Prohibited Substances for organic agricultural production and
handling:
Section 205.601 Synthetic Substances Allowed for Use In Organic
Crop Production
(h) As slug or snail bait. Ferric phosphate (CAS 10045-
86-0).
(n) Seed preparations. Hydrogen chloride (CAS 7647-01-
0)-for delinting cotton seed for planting.
Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as
Ingredients In or on Processed Products Labeled As ``Organic'' or
``Made With Organic (Specified Ingredients or Food Groups(S))''
(a) Nonsynthetics allowed:
Egg white lysozyme (CAS 9001-63-2).
L-Malic acid (CAS 97-67-6).
Microorganisms--any food grade bacteria, fungi, and other
microorganism.
(b) Synthetics allowed:
Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only
from vegetative sources; for use only as a filtering aid.
Cyclohexylamine (CAS 108-91-8)--for use only as a
boiler water additive for packaging sterilization.
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization.
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization.
Peracetic acid/Peroxyacetic acid (CAS 79-21-0)--for use
in wash and/or rinse water according to FDA limitations. For use as
a sanitizer on food contact surfaces.
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent.
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products.
All comments will be considered in the development of the NOSB's
recommendations to the Secretary.
Authority: 7 U.S.C. 6501 et seq. and 7 CFR part 205.
Dated: March 10, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
Appendix
This Appendix contains worksheets to assist you in gathering
relevant information concerning the compatibility of substances with
evaluation criteria of the OFPA. These worksheets are not required to
submit a comment. These worksheets are used by the NOSB to develop
their recommendations to the Secretary to include an exempted or
prohibited substance on the National List. You do not have to answer
the questions on the worksheets; they are intended only to help you
provide substantive comments to the NOSB when you provide comments on
the specific substance.
Evaluation Criteria For Substances Added to the National List
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Documentation (TAP;
Question Yes No N/A\1\ petition; regulatory
agency; other)
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Category 1. Adverse impacts on humans or the environment?
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1. Is there environmental
contamination during manufacture,
use, misuse, or disposal? [Sec.
6518m.3]
2. Is the substance harmful to the
environment? [Sec. 6517c(1)(A)(i);
Sec. 6517(c)(2)(A)i]
3. Does the substance contain List 1,
2, or 3 inerts? [Sec. 6517c
(1)(B)(ii)]
4. Is there potential for detrimental
chemical interaction with other
materials used? [Sec. 6518m.1]
5. Are there adverse biological and
chemical interactions in agro-
ecosystem? [Sec. 6518m.5]
6. Are there detrimental physiological
effects on soil organisms, crops, or
livestock? [Sec. 6518m.5]
7. Is there a toxic or other adverse
action of the material or its
breakdown products? [Sec. 6518m.2]
8. Is there undesirable persistence or
concentration of the material or
breakdown products in environment?
[Sec. 6518 m.2]
9. Is there any harmful effect on
human health? [Sec. 6517c(1)(A)(i);
Sec. 6517c(2)(A)i; Sec. 6518m.4]
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Category 2. Is the Substance Essential for Organic Production?
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1. Is the substance formulated or
manufactured by a chemical process?
[Sec. 6502(21)]
2. Is the substance formulated or
manufactured by a process that
chemically changes a substance
extracted from naturally occurring
plant, animal, or mineral, sources?
[Sec. 6502(21)]
3. Is the substance created by
naturally occurring biological
processes? [Sec. 6502(21)]
4. Is there a wholly natural
substitute product? [Sec.
6517c(1)(A)(ii)]
5. Is the substance used in handling,
not synthetic, but not organically
produced? [Sec. 6517c(1)(B)(iii)]
6. Is there any alternative
substances? [Sec. 6518m.6]
7. Is there another practice that
would make the substance unnecessary?
[Sec. 6518m.6]
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Category 3. Is the substance compatible with organic production practices?
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1. Is the substance consistent with
organic farming and handling? [Sec.
6517c(1)(A)(iii); Sec.
6517c(2)(A)(ii)]
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2. Is the substance compatible with a
system of sustainable agriculture?
[Sec. 6518m.7]
3. Is the substance used in
production, and does it contain an
active synthetic ingredient in the
following categories:
a. Copper and sulfur compounds;
b. Toxins derived from bacteria;
c. Pheromones, soaps,
horticultural oils, fish
emulsions, treated seed, vitamins
and minerals?
d. Livestock parasiticides and
medicines?
e. Production aids including
netting, tree wraps and seals,
insect traps, sticky barriers,
row covers, and equipment
cleaners?
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\1\ If the substance under review is for crops or livestock production, all of the questions from 205.600(b) are
N/A--not applicable.
[FR Doc. E8-5103 Filed 3-13-08; 8:45 am]
BILLING CODE 3410-02-P