[Federal Register Volume 70, Number 203 (Friday, October 21, 2005)]
[Rules and Regulations]
[Pages 61217-61219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21166]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Number TM-05-02]


National Organic Program (NOP); Amendment to the National List of 
Allowed and Prohibited Substances (Livestock)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA) National List of Allowed and Prohibited Substances (National 
List) to reflect one recommendation submitted to the Secretary by the 
National Organic Standards Board (NOSB) on March 3, 2005. Consistent 
with the recommendation from the NOSB, this final rule revises the 
annotation of one substance on the National List, methionine, to extend 
its use in organic poultry production until October 21, 2008.

EFFECTIVE DATE: This rule becomes effective October 22, 2005.

FOR FURTHER INFORMATION CONTACT: Arthur Neal, Director of Program 
Administration, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the NOP 
regulations [7 CFR part 205], the National List (Sec. Sec.  205.600 
through 205.607). The National List identifies synthetic substances 
that are allowed and nonsynthetic substances that are prohibited in 
organic crop and livestock production. The National List also 
identifies nonsynthetic and synthetic substances that are allowed for 
use in certified handling operations. Under the

[[Page 61218]]

authority of the Organic Foods Production Act of 1990 (OFPA), as 
amended, (7 U.S.C. 6501 et seq.), the National List can be amended by 
the Secretary based on proposed amendments developed by the NOSB. Since 
established, the National List has been amended twice, October 31, 2003 
(68 FR 61987), and November 3, 2003 (68 FR 62215).
    This final rule amends the National List to reflect one 
recommendation submitted to the Secretary by the NOSB on March 3, 2005. 
Based on their evaluation of a petition submitted by industry 
participants, the NOSB recommended that the Secretary amend Sec.  
205.603(d)(1) of the National List by revising the annotation of 
methionine, a feed additive, to extend its use in organic poultry 
production until October 21, 2008. The use of methionine in organic 
production was evaluated by the NOSB using the evaluation criteria 
specified in OFPA (7 U.S.C. 6517--6518).

II. Overview of Amendment

    The following provides an overview of the amendment made to Sec.  
205.603 of the National List:

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule revises current paragraph (d)(1) of Sec.  205.603 
as follows:
    DL-Methionine, DL-Methionine-hydroxyl analog, and DL-Methionine-
hydroxyl analog calcium (CAS --59-51-8; 63-68-3; 348-67-4)--
for use only in organic poultry production until October 1, 2008.
    Methionine was petitioned for its continued use as a synthetic feed 
additive in organic poultry operations. Methionine is a colorless or 
white crystalline powder that is soluble in water. It is classified as 
an amino acid and considered to be an essential amino acid that is 
regulated as an animal feed nutritional supplement by the Food and Drug 
Administration (21 CFR 582.5475).
    The NOSB, at its February 28-March 3, 2005, meeting in Washington, 
DC, received and evaluated public comment on the petition to extend the 
use of methionine in organic poultry production beyond October 21, 
2005. The NOSB concluded that methionine is consistent with the 
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA; however, the 
NOSB maintained that non-synthetic alternatives must be developed 
during the additional extension on the use of synthetic methionine in 
organic poultry diets. Therefore, the NOSB recommended methionine be 
added to the National List for use only in organic poultry production 
until October 1, 2008, so that the organic poultry industry could 
continue its research to develop non-synthetic alternatives for the use 
of synthetic methionine.
    In response to the NOSB recommendation regarding the use of DL-
Methionine in organic livestock production, this action amends Sec.  
205.603(d)(1) of the National List regulation as follows:
    DL-Methionine, DL-Methionine-hydroxyl analog, and DL-Methionine-
hydroxyl analog calcium (CAS --59-51-8; 63-68-3; 348-67-4)--
for use in organic poultry production until October 1, 2008.

III. Related Documents

    Two notices were published regarding the meeting of the NOSB and 
its deliberations on the recommendation and substance petitioned for 
amending the National List. The substance and recommendation included 
in this final rule were announced for NOSB deliberation in the 
following Federal Register Notices: (1) 66 FR 48654, September 21, 
2001, and (2) 70 FR 7224, February 11, 2005, (Methionine). The proposed 
rule change was published for comment in the Federal Register on July 
29, 2005, 70 FR 43786. The substance and recommendation in this final 
rule were initially submitted for proposed rulemaking in the Federal 
Register Notice, 68 FR 18556, April 16, 2003, and added to the National 
List as final rule in the Federal Register Notice, 68 FR 61987, October 
31, 2003.

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the 
Secretary, at Sec.  6517(d)(1), to make amendments to the National List 
based on proposed amendments developed by the NOSB. Sections 6518(k)(2) 
and 6518(n) of OFPA authorize the NOSB to develop proposed amendments 
to the National List for submission to the Secretary and establish a 
petition process by which persons may petition the NOSB for the purpose 
of having substances evaluated for inclusion onto or deletion from the 
National List. The National List petition process is implemented under 
Sec.  205.607 of the NOP regulations. The current petition process (65 
FR 43259, July 13, 2000) can be accessed through the NOP Web site at 
http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined to be non-significant for purposes 
of Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This final rule is 
not intended to have a retroactive effect.
    States and local jurisdictions are preempted under Sec.  2115 of 
the OFPA (7 U.S.C. 6514) from creating programs of accreditation for 
private persons or State officials who want to become certifying agents 
of organic farms or handling operations. A governing State official 
would have to apply to USDA to be accredited as a certifying agent, as 
described in Sec.  2115 (b) of the OFPA (7 U.S.C. 6514 (b)). States are 
also preempted under Sec. Sec.  2104 through 2108 of the OFPA (7 U.S.C. 
6503 through 6507) from creating certification programs to certify 
organic farms or handling operations unless the State programs have 
been submitted to, and approved by, the Secretary as meeting the 
requirements of the OFPA.
    Pursuant to Sec.  2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a 
State organic certification program may contain additional requirements 
for the production and handling of organically produced agricultural 
products that are produced in the State and for the certification of 
organic farm and handling operations located within the State under 
certain circumstances. Such additional requirements must: (a) Further 
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) 
not be discriminatory toward agricultural commodities organically 
produced in other States, and (d) not be effective until approved by 
the Secretary.
    Pursuant to Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
final rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.), concerning meat, poultry, and 
egg products, nor any of the authorities of the Secretary of Health and 
Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
301 et seq.), nor the authority of the Administrator of the 
Environmental Protection Agency (EPA) under the Federal Insecticide, 
Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
    Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary 
to establish an expedited administrative

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appeals procedure under which persons may appeal an action of the 
Secretary, the applicable governing State official, or a certifying 
agent under this title that adversely affects such person or is 
inconsistent with the organic certification program established under 
this title. The OFPA also provides that the U.S. District Court for the 
district in which a person is located has jurisdiction to review the 
Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) 
requires agencies to consider the economic impact of each rule on small 
entities and evaluate alternatives that would accomplish the objectives 
of the rule without unduly burdening small entities or erecting 
barriers that would restrict their ability to compete in the market. 
The purpose is to fit regulatory actions to the scale of businesses 
subject to the action. Section 605 of the RFA allows an agency to 
certify a rule, in lieu of preparing an analysis, if the rulemaking is 
not expected to have a significant economic impact on a substantial 
number of small entities.
    Pursuant to the requirements set forth in the RFA, the Agricultural 
Marketing Service (AMS) performed an economic impact analysis on small 
entities in the final rule published in the Federal Register on 
December 21, 2000 (65 FR 80548). The AMS has also considered the 
economic impact of this action on small entities and has determined 
that this final rule would have an impact on a substantial number of 
small entities. However, AMS has determined that the impact on entities 
affected by this final rule would not be significant. The effect of 
this final rule would be to allow the use of additional substances in 
agricultural production and handling. This action would relax the 
regulations published in the final rule and would provide small 
entities with more tools to use in day-to-day operations. The AMS 
concludes that the economic impact of this addition of allowed 
substances, if any, would be minimal and entirely beneficial to small 
agricultural service firms. Accordingly, the USDA certifies that this 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $6,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    The U.S. organic industry at the end of 2001 included nearly 6,600 
certified crop and livestock operations, including organic production 
and handling operations, producers, and handlers. These operations 
reported certified acreage totaling more than 2.34 million acres, 
72,209 certified livestock, and 5.01 million certified poultry. Data on 
the numbers of certified handling operations are not yet available, but 
likely number in the thousands, as they would include any operation 
that transforms raw product into processed products using organic 
ingredients. Growth in the U.S. organic industry has been significant 
at all levels. From 1997 to 2001, the total organic acreage grew by 74 
percent; livestock numbers certified organic grew by almost 300 percent 
over the same period, and poultry certified organic increased by 2,118 
percent over this time. Sales growth of organic products has been 
equally significant, growing on average around 20 percent per year. 
Sales of organic products were approximately $1 billion in 1993, but 
reached $15 billion in 2004. In addition, since the implementation of 
OPFA on October 21, 2002, USDA has accredited 99 certifying agents who 
have applied to USDA to be accredited in order to provide certification 
services to producers and handlers. A complete list of names and 
addresses of accredited certifying agents may be found on the AMS NOP 
Web site, at http://www.ams.usda.gov/nop. AMS believes that most of 
these entities would be considered small entities under the criteria 
established by the SBA.

D. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et 
seq., the existing information collection requirements for the NOP are 
approved under OMB number 0581-0181. No additional collection or 
recordkeeping requirements are imposed on the public by this final 
rule. Accordingly, OMB clearance is not required by section 350(h) of 
the Paperwork Reduction Act, or OMB's implementing regulation at 5 CFR 
part 1320.

E. Discussion of Comments Received

    Thirteen (13) comments were received on the proposed revision to 
extend the use of synthetic methionine in organic poultry production 
until October 21, 2008. Commenters included poultry producers, poultry 
processors, consumers, a poultry nutritionist, a certifying agent, and 
a feed industry organization. The majority of the comments were in 
support of the proposed revision. One commenter, however, opposed 
extending the use of synthetic methionine and questioned the need to 
provide the industry with three years to identify a nonsynthetic 
alternative. The commenter suggested that a nonsynthetic alternative 
could be identified in a shorter time period. We have taken this 
commenter's position into consideration, and based on the research 
updates, public testimonies, and comments received from other sectors 
of the industry, we believe that three years is a reasonable time-
period to complete research to identify nonsynthetic alternatives to 
using synthetic methionine in organic poultry production.
    Pursuant to 5 U.S.C. 553, it found and determined that good cause 
exists for not postponing the effective date of this rule until 30 days 
after publication in the Federal Register because the use of methionine 
will expire for organic poultry operations on October 21, 2005.

List of Subjects in 7 CFR Part 205.

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

0
For the reasons set forth in the preamble, 7 CFR part 205, Subpart G is 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority: 7 U.S.C. 6501-6522.


0
2. Section 205.603 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  205.603  Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (d) * * *
    (1) DL-Methionine, DL-Methionine-hydroxyl analog, and DL-
Methionine-hydroxyl analog calcium (CAS --59-51-8; 63-68-3; 
348-67-4)--for use in organic poultry production until October 1, 2008.
* * * * *

    Dated: October 18, 2005.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. 05-21166 Filed 10-19-05; 10:37 am]
BILLING CODE 3410-02-P