![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
National Organic Program (NOP); Sunset Review (2008)
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Proposed Rules]
[Page 73667-73671]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-26]
========================================================================
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.
========================================================================
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-07-0124; TM-07-12]
RIN 0581-AC76
National Organic Program (NOP); Sunset Review (2008)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking with request for
comments.
-----------------------------------------------------------------------
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 11
exempted substances and 1 prohibited substance added to the National
List on November 3 and 4, 2003. This ANPR establishes November 3, 2008,
as the date by which the sunset review and renewal process must be
concluded. This advance notice of proposed rule-making (ANPR) also
begins the public comment process on whether the identified existing
exemptions or prohibitions 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 January 28, 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 Avenue.,
SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
• Internet: http://www.regulations.gov.
Written comments responding to this ANPR should be identified with
the docket number AMS-TM-07-0124. You should clearly indicate your
position to continue the allowance or prohibition 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 or prohibition 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
(http://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: This action has been determined not
significant for purposes of Executive Order 12866, and therefore, has
not been reviewed by the Office of Management and Budget.
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 Copper sulfate, Ozone gas, Peracetic
acid, and EPA List 3 Inerts, currently allowed for use in organic crop
production, will no longer be allowed for use after November 3, 2008.
Calcium chloride currently prohibited from use in organic crop
production, except as a foliar spray to treat a physiological disorder
associated with calcium uptake, will be allowed after November 3, 2008.
This also means that Agar-agar, Carageenan, and Tartaric acid,
currently allowed for use in organic handling, will be prohibited after
November 3, 2008. Finally, Animal enzymes, Calcium sulfate, Glucono
delta lactone, and Cellulose, currently allowed for use in organic
handling, will no longer be allowed for use after November 4, 2008.
Expiration of the exempted or prohibited use of substances is
provided for under the OFPA's sunset provision. This ANPR announces the
sunset of 11 exempted substances and 1 prohibited substance added to
the National List on November 3 and 4, 2003. This ANPR establishes
November 3, 2008, 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 or prohibitions 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
[[Page 73668]]
the sunset review and renewal process now, in order to provide ample
opportunity for you to make your views known.
Initially, Tartaric acid was inadvertently included in the 2007
sunset process (70 FR 35177, June 17, 2005) and recommended for renewal
by the NOSB (November 17, 2005). However, because Tartaric acid was not
scheduled to sunset until October 31, 2008, it was not included in the
2007 sunset proposed rule (72 FR 9872, March 6, 2007). Consequently,
Tartaric acid will receive consideration under this sunset review and
the NOSB will consider comments previously submitted in response to the
2007 sunset ANPR.
DL-Methionine, DL-Methionine-hydroxyl analog, and DL-Methionine-
hydroxyl analog calcium (CAS #--59-51-8; 63-68-3; 348-67-4)
were added to the National List on November 3, 2003, for use in organic
poultry production. Initially these substances carried an expiration
date of October 21, 2005. Effective October 22, 2005, the expiration
date was amended to October 1, 2008. Because these substances have an
expiration date recommended by the NOSB and established by rulemaking,
they are not included in this sunset review. The NOP National List
petition process would have to be employed for these substances to be
authorized for use after October 1, 2008.
The Sunset Process
As the first step in this process, we invite public comment on the
specific exemptions or prohibitions 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 or prohibition to
continue after 5 years of their addition to the National List which
will be November 3, 2008. 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 and prohibitions 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 and
prohibitions for the substances listed in this ANPR. After the
Secretary receives the NOSB's recommendations, the NOP will publish a
proposed rule based on 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 with a thirty-day comment period.
Guidance on Submitting Your Comments
Comments That Support Existing Exemptions or Prohibitions
If you provide comments that support the renewal of any or all
existing exemptions or prohibitions 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 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.
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.
[[Page 73669]]
------------------------------------------------------------------------
Then the recommended
If the currently listed And is a (an). . alternative should be
substance is used in... . a (an). . .
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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, however, be available from the research community
including universities, or other sources, including international
organic programs.
Comments That Do Not Support Continuing an Existing Prohibition
If you provide comments against continuation of the prohibition on
the use of Calcium chloride, you should specify how Calcium chloride is
now consistent with the criteria in the OFPA and the NOP regulation.
When this prohibition was originally recommended by the NOSB, it was
accepted because the evidence available to the NOSB at the time of
review demonstrated that the substance, except as annotated, was found
to be harmful to human health or the environment and was inconsistent
and not compatible with organic practices. Therefore, any comments
against continuation of the prohibition on the use of Calcium chloride
should provide new information, including a copy of the specific source
of any supportive literatures showing that Calcium chloride is no
longer harmful to human health or the environment and is consistent and
compatible with organic practices.
An Appendix to this ANPR contains worksheets to assist you in
gathering relevant information concerning these issues. These
worksheets are not required for you 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 to help you provide substantive comments
to the NOSB when you provide comments on the specific substance.
Request for Comments
The NOP requests that you comment whether the NOSB should continue
to recommend the following exemptions and prohibition 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
(a) As algicide, disinfectants, and sanitizer, including irrigation
system cleaning systems.
(3) Copper sulfate--for use as an algicide in aquatic rice systems,
is limited to one application per field during any 24-month period.
Application rates are limited to those which do not increase baseline
soil test values for copper over a timeframe agreed upon by the
producer and accredited certifying agent.
(5) Ozone gas--for use as an irrigation system cleaner only.
(6) Peracetic acid--for use in disinfecting equipment, seed, and
asexually propagated planting material.
(e) As insecticides (including acaricides or mite control).
(3) Copper Sulfate--for use as tadpole shrimp control in aquatic
rice production, is limited to one application per field during any 24-
month period. Application rates are limited to levels which do not
increase baseline soil test values for copper over a timeframe agreed
upon by the producer and accredited certifying agent.
(i) As plant disease control.
(7) Peracetic acid--for use to control fire blight bacteria.
(m) As synthetic inert ingredients as classified by the
Environmental Protection Agency (EPA), for use with nonsynthetic
substances or synthetic substances listed in this section and used as
an active pesticide ingredient in accordance with any limitations on
the use of such substances.
(2) EPA List 3--Inerts of unknown toxicity allowed:
(ii) Inerts used in passive pheromone dispensers.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
(c) Calcium chloride, brine process is natural and prohibited for
use except as a foliar spray to treat a physiological disorder
associated with calcium uptake.
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:
Agar-agar.
Animal enzymes--(Rennet--animals derived; Catalase--bovine liver;
Animal lipase; Pancreatin; Pepsin; and Trypsin).
Calcium sulfate--mined.
Carageenan.
Glucono delta-lactone--production by the oxidation of D-glucose
with bromine water is prohibited.
Tartaric acid
(b) Synthetics allowed:
Cellulose--for use in regenerative casings, as an anti-caking agent
(non-chlorine bleached) and filtering aid.
Tartaric acid
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: December 21, 2007.
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
[[Page 73670]]
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
----------------------------------------------------------------------------------------------------------------
Documentation (TAP; petition;
Question Yes No N/A\1\ regulatory agency; other)
----------------------------------------------------------------------------------------------------------------
Category 1. Adverse impacts on humans or the environment?
----------------------------------------------------------------------------------------------------------------
1. Is there environmental contamination
during manufacture, use, misuse, or
disposal? [Sec. 6518 m.3]
2. Is the substance harmful to the
environment? [Sec.
6517c(1)(A)(i);6517(c)(2)(A)i]
3. Does the substance contain List 1, 2,
or 3 inerts? [Sec. 6517 c (1)(B)(ii)]
4. Is there potential for detrimental
chemical interaction with other
materials used? [Sec. 6518 m.1]
5. Are there adverse biological and
chemical interactions in agro-
ecosystem? [Sec. 6518 m.5]
6. Are there detrimental physiological
effects on soil organisms, crops, or
livestock? [Sec. 6518 m.5]
7. Is there a toxic or other adverse
action of the material or its breakdown
products? [Sec. 6518 m.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. 6517 c (1)(A)(i) ; 6517
c(2)(A)i; Sec. 6518 m.4]
----------------------------------------------------------------------------------------------------------------
Category 2. Is the Substance Essential for Organic Production?
----------------------------------------------------------------------------------------------------------------
1. Is the substance formulated or
manufactured by a chemical process?
[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?
[6502 (21)]
3. Is the substance created by naturally
occurring biological processes? [6502
(21)]
4. Is there a wholly natural substitute
product? [Sec. 6517 c (1)(A)(ii)]
5. Is the substance used in handling,
not synthetic, but not organically
produced? [Sec. 6517 c (1)(B)(iii)]
6. Is there any alternative substances?
[Sec. 6518 m.6]
7. Is there another practice that would
make the substance unnecessary? [Sec.
6518 m.6]
----------------------------------------------------------------------------------------------------------------
Category 3. Is the substance compatible with organic production practices?
----------------------------------------------------------------------------------------------------------------
1. Is the substance consistent with
organic farming and handling? [Sec.
6517 c (1)(A)(iii); 6517 c (2)(A)(ii)]
2. Is the substance compatible with a
system of sustainable agriculture?
[Sec. 6518 m.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?
----------------------------------------------------------------------------------------------------------------
\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.
[[Page 73671]]
[FR Doc. E7-25270 Filed 12-27-07; 8:45 am]
BILLING CODE 3410-02-P