[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Proposed Rules]
[Pages 73667-73671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25270]


 ========================================================================
 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. 72, No. 248 / Friday, December 28, 2007 / 
Proposed Rules  

[[Page 73667]]



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: 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 
(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: 
[email protected].

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