[Federal Register Volume 73, Number 51 (Friday, March 14, 2008)]
[Proposed Rules]
[Pages 13795-13798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5103]


 ========================================================================
 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. 73, No. 51 / Friday, March 14, 2008 / 
Proposed Rules  

[[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.

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

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: 
[email protected].

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.

------------------------------------------------------------------------
                                                    Then the recommended
    If the currently listed      And is a (an). .   alternative  should
   substance is used in. . .            .              be 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,

[[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
----------------------------------------------------------------------------------------------------------------
                                                                                            Documentation  (TAP;
               Question                       Yes               No             N/A\1\       petition; regulatory
                                                                                               agency; other)
----------------------------------------------------------------------------------------------------------------
                            Category 1. Adverse impacts on humans or the environment?
----------------------------------------------------------------------------------------------------------------
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]
----------------------------------------------------------------------------------------------------------------
                         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 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]
----------------------------------------------------------------------------------------------------------------
                   Category 3. Is the substance compatible with organic production practices?
----------------------------------------------------------------------------------------------------------------
1. Is the substance consistent with
 organic farming and handling? [Sec.
 6517c(1)(A)(iii); Sec.
 6517c(2)(A)(ii)]

[[Page 13798]]

 
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?
----------------------------------------------------------------------------------------------------------------
\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