[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Proposed Rules]
[Pages 31495-31499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13496]


========================================================================
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.

========================================================================


Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / 
Proposed Rules

[[Page 31495]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Doc. No. AMS-NOP-11-0003; NOP-10-13]
RIN 0581-AD13


National Organic Program, Sunset Review (2013)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Advance notice of proposed rulemaking with request for 
comments.

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

SUMMARY: The Organic Foods Production Act of 1990 (OFPA) requires 
sunset (expiration) of the exempted or prohibited use of substances on 
the National List of Allowed and Prohibited Substances (National List) 
under the National Organic Program (NOP). The exemptions and 
prohibitions granted on the National List 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 the substances are not 
reviewed by the NOSB and renewed by the Secretary within 5 years of 
their inclusion on the National List, then their authorized use or 
prohibition expires. As required by the OFPA, the allowed use of 11 
synthetic and nonsynthetic substances in organic production and 
handling will expire on November 3, 2013. A prohibition on one 
nonsynthetic substance in organic production will expire on November 3, 
2013. This advance notice of proposed rulemaking (ANPR) begins the 
public comment process on whether the identified existing exemptions or 
prohibition should be continued. This ANPR also establishes that the 
sunset review and renewal process must be concluded by November 3, 
2013. Finally, this ANPR discusses how the NOP will manage the sunset 
review and renewal process.

DATES: Comments must be submitted on or before August 1, 2011.

ADDRESSES: Interested persons may submit written comments on this ANPR 
using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, Room 2646-So., Ag Stop 0268, 
1400 Independence Ave., SW., Washington, DC 20250-0268.
    Written comments responding to this ANPR should be identified with 
the docket number AMS-NOP-11-0003; NOP-10-13. For detailed instructions 
on submitting comments and additional information on the rulemaking 
process, see the ``Guidance on Submitting Your Comments'' heading of 
the SUPPLEMENTARY INFORMATION section of this document. The NOP intends 
to have all comments concerning this ANPR, including names and 
addresses when provided, whether submitted by mail or internet, 
available for viewing on the Federal eRulemaking Portal internet site, 
http://www.regulations.gov. Comments submitted in response to this ANPR 
will also be available for viewing in person at USDA-AMS, National 
Organic Program, Room 2646-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: Melissa Bailey, Director, Standards 
Division, National Organic Program, USDA-AMS-NOP, 1400 Independence 
Ave., SW., Room 2646-So., Ag Stop 0268, Washington, DC 20250-0268. 
Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION:

Background

    The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et 
seq., authorizes the establishment of the National List. The National 
List identifies synthetic substances that are exempted (allowed) and 
nonsynthetic substances that are prohibited in organic crop and 
livestock production. The National List also identifies nonsynthetic 
and synthetic substances 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 the substances 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 under OFPA's sunset provision.
    This ANPR announces the sunset of 11 exempted substances and 1 
prohibition added to the National List on November 3, 2003 (68 FR 
61987) and November 4, 2003 (68 FR 62215), and previously renewed under 
the sunset process on November 3, 2008 (73 FR 59479). This ANPR 
establishes November 3, 2013, as the date by which the sunset review 
and renewal process must be concluded. The exemptions and prohibitions 
not renewed by this date 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 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, to provide 
ample opportunity for the public to make their views known and to 
inform the decisions of the NOSB.

Crops Production Substances

    The NOSB Crops Committee will review the continued exemption (use) 
of six listings of synthetic substances allowed for use in organic crop 
production on Sec.  205.601: copper sulfate (2 listings), ozone gas, 
peracetic acid (2 listings), and EPA List 3 inert ingredients. These 
six listings are scheduled to sunset (expire) on November 3, 2013. The 
Crops Committee will also review the continued prohibition of one

[[Page 31496]]

nonsynthetic substance, calcium chloride, listed on Sec.  205.602, 
scheduled to sunset on November 3, 2013. Table 1 contains the full 
listings of crop production substances to be reviewed under the 2013 
sunset process.

                                 Table 1--Crops Committee Sunset 2013 Substances
----------------------------------------------------------------------------------------------------------------
       National list section                       Substance listing                         Sunset date
----------------------------------------------------------------------------------------------------------------
                        Synthetic substances allowed for use in organic crop production.
----------------------------------------------------------------------------------------------------------------
205.601(a)(3).....................  Copper sulfate--for use as an algicide in       November 3, 2013.
                                     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.
205.601(a)(5).....................  Ozone gas--for use as an irrigation system      November 3, 2013.
                                     cleaner only.
205.601(a)(6).....................  Peracetic acid--for use in disinfecting         November 3, 2013.
                                     equipment, seed, and asexually propagated
                                     planting material.
205.601(e)(4).....................  Copper sulfate--for use as tadpole shrimp       November 3, 2013.
                                     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.
205.601(i)(8).....................  Peracetic acid--for use to control fire blight  November 3, 2013.
                                     bacteria.
205.601(m)(2).....................  EPA List 3--Inerts of unknown toxicity--for     November 3, 2013.
                                     use only in passive pheromone dispensers.
----------------------------------------------------------------------------------------------------------------
                     Nonsynthetic substances prohibited for use in organic crop production.
----------------------------------------------------------------------------------------------------------------
205.602(c)........................  Calcium chloride, brine process is natural and  November 3, 2013.
                                     prohibited for use except as a foliar spray
                                     to treat a physiological disorder associated
                                     with calcium uptake.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

Handling Substances

    The NOSB Handling Committee will review the continued exemption 
(use) of six nonagricultural (nonorganic), nonsynthetic substances 
allowed as ingredients in or on processed products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
groups(s)).'' The allowed uses of the following six substances listed 
on Sec.  205.605(a) are scheduled to expire on November 3, 2013: agar-
agar, animal enzymes, calcium sulfate, carrageenan, glucono delta-
lactone, and tartaric acid.
    The Handling Committee will also review the continued exemption 
(use) of two nonagricultural (nonorganic), synthetic substances allowed 
as ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups(s)).'' The 
allowed uses of the following two substances listed on Sec.  205.605(b) 
are scheduled to expire November 3, 2013: cellulose and tartaric acid. 
Table 2 contains the full listings of handling substances that will be 
reviewed under the 2013 sunset process.

                               Table 2--Handling Committee Sunset 2013 Substances
----------------------------------------------------------------------------------------------------------------
       National list section                       Substance listing                         Sunset date
----------------------------------------------------------------------------------------------------------------
Nonsynthetics allowed:
    205.605(a)....................  Agar-agar.....................................  November 3, 2013.
    205.605(a)....................  Animal enzymes--(Rennet-animals derived;        November 3, 2013.
                                     Catalase-bovine liver; Animal lipase;
                                     Pancreatin; Pepsin; and Trypsin).
    205.605(a)....................  Calcium sulfate--mined........................  November 3, 2013.
    205.605(a)....................  Carrageenan...................................  November 3, 2013.
    205.605(a)....................  Glucono delta-lactone--production by the        November 3, 2013.
                                     oxidation of D-glucose with bromine water is
                                     prohibited.
    205.605(a)....................  Tartaric acid--made from grape wine...........  November 3, 2013.
Synthetics allowed:
    205.605(b)....................  Cellulose--for use in regenerative casings, as  November 3, 2013.
                                     an anti-caking agent (non-chlorine bleached)
                                     and filtering aid.
    205.605(b)....................  Tartaric acid--made from malic acid...........  November 3, 2013.
----------------------------------------------------------------------------------------------------------------

The Sunset Process

    All substances currently on the National List have been previously 
evaluated 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, 2013. All substances identified 
under this notice were previously renewed under the sunset

[[Page 31497]]

process on November 4, 2008 (73 FR 59479), and must be reviewed again 
by November 3, 2013.
    This notice requests public comments about the continued use or 
prohibition of the substances identified. Public comments submitted 
will be considered in the review and renewal process. The NOP will 
forward comments received under this notice to the NOSB for review. The 
NOSB will review the listings of allowed and prohibited substances 
scheduled to sunset, including the public comments received during this 
review. The NOSB will review each of the substances listed in this 
notice 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 and reviews the NOSB's recommendations, the NOP will 
publish a proposed rule regarding the NOSB recommendations. This 
proposed rule will provide an additional opportunity for the public to 
submit written comments. 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 for substances scheduled to sunset in 2013.

Guidance on Submitting Your Comments

    Written comments responding to this ANPR should be identified with 
the docket number AMS-NOP-11-0003; NOP-10-13. You should clearly 
indicate your position on continuing 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.).
    Comments, regardless of whether they support or do not support the 
continued use of a substance(s) listed within this ANPR, should provide 
evidence concerning the viability of alternatives for the substance 
under sunset review. 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 should adequately address whether any alternatives have a 
function and effect equivalent to or better than the specific exempted 
substance, and whether you want the substance to be renewed or do not 
want its use to be continued. Assertions about alternative substances, 
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; names and addresses of producers or handlers 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 the substance under review. The information 
provided in Table 3 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.
    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.

Comments That Support Existing Exemptions and Prohibitions

    Comments in support of a continued exemption of a substance should 
demonstrate that the substance is: (1) Not harmful to human health or 
the environment, (2) necessary to the production of the agricultural 
products because of the unavailability of wholly nonsynthetic 
substitute products, and (3) consistent with organic production and 
handling. Comments in support of a continued prohibition should explain 
how the use of the substance would continue to be: (1) harmful to human 
health or the environment, or (2) inconsistent with organic farming and 
handling.

Comments That DO NOT Support Continuing Existing Exemptions or 
Prohibitions

    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.
    If you provide comments that do not support continuing an existing 
exemption or prohibition, you should provide reasons why the use of the 
substance should no longer be allowed or prohibited in organic 
agricultural production and handling. Specifically, comments that 
support the removal of a substance from the National List should 
provide information to demonstrate that the substance is: (1) Harmful 
to human health or the environment; (2) unnecessary because of the 
availability of alternatives; or (3) inconsistent with organic farming 
or handling. Comments that do not support a continued prohibition 
should explain how the use of the substance would not be: (1) harmful 
to human health or the environment, or (2) inconsistent with organic 
farming and handling.

          Table 3--Guidance on Submitting Comments for Alternatives to Substances on the National List.
----------------------------------------------------------------------------------------------------------------
    If the currently listed                                  Then the recommended alternative should be a (an) .
  substance is used in . . .           And is a . . .                                . .
----------------------------------------------------------------------------------------------------------------
Crop Production...............  Synthetic substance........  --Another currently listed synthetic substance;
                                                             --Nonsynthetic substance; or
                                                             --Management practice.

[[Page 31498]]

 
Crop Production...............  Synthetic inert substance    --Another currently listed synthetic substance; or
                                 (pesticidal).               --Nonsynthetic substance.
Handling......................  Nonsynthetic (non-           --Agricultural substance; or
                                 agricultural) substance.    --Management practice.
Handling......................  Synthetic substance........  --Another currently listed synthetic substance;
                                                             --Nonsynthetic (non-agricultural) substance; or
                                                             --Management practice.
----------------------------------------------------------------------------------------------------------------

    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.

Request for Comments

    The NOP requests that you comment whether the NOSB should continue 
to recommend the exemptions and prohibitions listed above on the 
National List of Allowed and Prohibited Substances for organic 
agricultural production and handling. All comments will be considered 
in the development of the NOSB's recommendations to the Secretary.

    Authority:  7 U.S.C. 6501-6522 and 7 CFR part 205

    Dated: May 24, 2011.
Rayne Pegg,
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.

                                           NOSB Evaluation Criteria for Substances Added to the National List
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              Documentation (TAP; petition; regulatory
                  Question                            Yes                   No                N/A\1\                       agency; other)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Category 1. Adverse impacts on humans or the environment?
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Are there adverse effects on environment
 from manufacture, use, or disposal? [Sec.
 205.600 b.2].
2. Is there environmental contamination
 during manufacture, use, misuse, or
 disposal? [Sec.   6518 m.3].
3. Is the substance harmful to the
 environment? [Sec.
 6517(c)(1)(A)(i);6517(c)(2)(A)(i)].
4. Does the substance contain List 1, 2, or
 3 inerts? [Sec.   6517(c)(1)(B)(ii); Sec.
 205.601(m)(2)].
5. Is there potential for detrimental
 chemical interaction with other materials
 used? [Sec.   6518(m)(1)].
6. Are there adverse biological and chemical
 interactions in agro-ecosystem? [Sec.
 6518(m)(5)].
7. Are there detrimental physiological
 effects on soil organisms, crops, or
 livestock? [Sec.   6518(m)(5)].
8. Is there a toxic or other adverse action
 of the material or its breakdown products?
 [Sec.   6518(m)(2)].
9. Is there undesirable persistence or
 concentration of the material or breakdown
 products in environment?[Sec.   6518(m)(2)].
10. Is there any harmful effect on human
 health? [Sec.   6517(c)(1)(A)(i); Sec.
 6517(c)(2)(A)(i); Sec.   6518(m)(4)].
11. Is there an adverse effect on human
 health as defined by applicable Federal
 regulations? [Sec.   205.600(b)(3)].
12. Is the substance GRAS when used
 according to FDA's good manufacturing
 practices? [Sec.   205.600(b)(5)].
13. Does the substance contain residues of
 heavy metals or other contaminants in
 excess of FDA tolerances? [Sec.
 205.600(b)(5)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crop or livestock production, all of the questions from Sec.   205.600(b) are N/A--not applicable.


[[Page 31499]]


                                             Category 2. Is the substance essential for organic production?
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 natural source of the
 substance? [Sec.   205.600(b)(1)].
5. Is there an organic substitute? [Sec.
 205.600(b)(1)].
6. Is the substance essential for handling
 of organically produced agricultural
 products? [Sec.   205.600(b)(6)].
7. Is there a wholly natural substitute
 product? [Sec.   6517(c)(1)(A)(ii)].
8. Is the substance used in handling, not
 synthetic, but not organically produced?
 [Sec.   6517(c)(1)(B)(iii)].
9. Is there any alternative substances?
 [Sec.   6518(m)(6)].
10. Is there another practice that would
 make the substance unnecessary? [Sec.
 6518(m)(6)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crop or livestock production, all of the questions from Sec.   205.600(b) are N/A--not applicable.


                                       Category 3. Is the substance compatible with organic production practices?
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Is the substance compatible with organic
 handling? [Sec.   205.600(b)(2)].
2. Is the substance consistent with organic
 farming and handling? [Sec.
 6517(c)(1)(A)(iii); Sec.
 6517(c)(2)(A)(ii)].
3. Is the substance compatible with a system
 of sustainable agriculture? [Sec.
 6518(m)(7)].
4. Is the nutritional quality of the food
 maintained with the substance? [Sec.
 205.600(b)(3)].
5. Is the primary use as a preservative?
 [Sec.   205.600(b)(4)].
6. Is the primary use to recreate or improve
 flavors, colors, textures, or nutritive
 values lost in processing (except when
 required by law, e.g., vitamin D in milk)?
 [Sec.   205.600(b)(4)].
7. 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 crop or livestock production, all of the questions from 205.600(b) are N/A--not applicable.

[FR Doc. 2011-13496 Filed 5-31-11; 8:45 am]
BILLING CODE 3410-02-P