[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Rules and Regulations]
[Page 61217-61219]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc05-3]
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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]
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