[Federal Register: July 29, 2005 (Volume 70, Number 145)]
[Proposed Rules]
[Page 43786-43788]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy05-22]
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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.
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[[Page 43786]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. TM-05-02]
National Organic Program; Proposed Amendment to the National List
of Allowed and Prohibited Substances (Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend 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). Consistent
with the recommendation from the NOSB, this proposed rule would revise
the annotation of one substance on the National List, Methionine, to
extend its use in organic poultry production until October 21, 2008.
DATES: Comments must be received by August 15, 2005.
ADDRESSES: Interested persons may comment on this proposed rule using
the following procedures:
Mail: Comments may be submitted by mail to: Arthur Neal,
Director of Program Administration, National Organic Program, USDA-AMS-
TMP-NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268,
Washington, DC 20250.
E-mail: Comments may be submitted via the Internet to:
National.List@usda.gov. or to http://www.regulations.gov.
Fax: Comments may be submitted by fax to: (202) 205-7808.
Written comments on this proposed rule should be
identified with the docket number TM-05-02. Commenters should identify
the topic and section number of this proposed rule to which the comment
refers.
Clearly indicate if you are for or against the proposed
rule or some portion of it and your reason for it. Include recommended
language changes as appropriate.
Include a copy of articles or other references that
support your comments. Only relevant material should be submitted.
It is our intention to have all comments to this proposed rule,
whether submitted by mail, E-mail, or fax, available for viewing on the
National Organic Program (NOP) homepage. Comments submitted in response
to this proposed rule will be available for viewing in person at USDA-
AMS, Transportation and Marketing, 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 proposed rule are requested to
make an appointment in advance by calling (202) 720-3252.
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 regulations (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 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 proposed rule would amend 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).
A 15-day comment period has been deemed appropriate to allow
interested persons to respond to this proposed rule. Fifteen days is
deemed appropriate because, under the NOP regulations (7 CFR part
205.603(d)), the authorized use of Methionine will expire for organic
poultry operations on October 21, 2005. Final rulemaking to extend the
use of Methionine in organic poultry production, if adopted, should be
completed before October 21, 2005. Any comments that are received
timely will be considered before a final determination is made in this
matter.
II. Overview of Proposed Amendment
The following provides an overview of the proposed amendment made
to Sec. 205.603 of the National List:
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
This proposed rule would revise 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).
Methionine was originally included on the National List on October
31, 2003 with an early expiration date of October 21, 2005, (the normal
time period for the use of a substance contained in the National List
is five years, beginning with the date the substance appears on the
National List regulations).
[[Page 43787]]
Methionine was petitioned by organic livestock producers as a part of
the NOSB's 1995 initial review of synthetic amino acids considered for
use in organic livestock production. The petitioners asserted that
Methionine was a necessary dietary supplement for organic poultry, due
to an inadequate supply of organic feeds containing sufficient
concentrations of naturally-occurring Methionine. Petitioners suggested
synthetic Methionine would be fed as a dietary supplement to organic
poultry at levels ranging from 0.3 to 0.5 percent of the animal's total
diet. The petitioners also asserted that a prohibition on the use of
synthetic Methionine would contribute to nutritional deficiencies in
organic poultry thereby jeopardizing the animal's health After
consideration of the justification provided for the inclusion of
Methionine and an assessment under the evaluation criteria provided in
OFPA (7 U.S.C. 6517-6518), the NOSB considered the use of synthetic
Methionine to be consistent with OFPA and recommended its inclusion
onto the National List for use in organic poultry production with an
early expiration on its use (October 21, 2005). The NOSB recommended an
early expiration on the use of Methionine to encourage the organic
poultry industry to phase out the use of synthetic Methionine in
poultry diets and develop non-synthetic alternatives to its use as a
feed additive.
Since the inclusion of Methionine on Sec. 205.603(d)(1) of the
National List on October 31, 2003, the organic poultry industry has
been unable to develop suitable non-synthetic alternatives for the
substitution of synthetic Methionine in organic poultry diets. As a
result, on January 10, 2005, the two organic poultry producers
petitioned the NOSB to extend the use of Methionine in organic poultry
production beyond October 21, 2005, to provide additional time for
development of non-synthetic alternatives. Preliminary research results
on nonsynthetic alternatives to synthetic Methionine was provided to
the NOSB. Although considered inconclusive, the preliminary results
have demonstrated that research trials were underway to identify non-
synthetic alternatives for phasing out synthetic Methionine in organic
poultry diets.
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 proposes to
amend Sec. 205.603(d)(1) of the National List regulation as follows:
DL-Methionine, DL-Methionine-hydroxyl analog, and DL-
Methioninehydroxyl 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 proposed 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
substance and recommendation in this proposed rule was initially
submitted for proposed rulemaking in the Federal Register Notice, FR 68
18556, April 16, 2003, and added to the National List as final rule in
the Federal Register Notice, FR 68 61987, October 31, 2003.
IV. Statutory and Regulatory Authority
The Organic Foods Production Act of 1990 (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, does not have to be 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. The final rule
adding Methionine to the National List was reviewed under this
Executive Order and no additional related information has been obtained
since then. This proposed 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
regulation would not alter the authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection 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
[[Page 43788]]
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 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 proposed rule would have an impact on a substantial number of
small entities. However, AMS has determined that the impact on entities
affected by this proposed rule would not be significant. The effect of
this proposed 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 Administrator of the AMS
hereby 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 97 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 believe 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 proposed
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. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB for extending the use of Methionine, a synthetic
substance, in organic poultry production until October 21, 2008. The
NOSB evaluated this substance using criteria in the OFPA. The
substance's evaluation was initiated by a petition from two organic
poultry producers. The NOSB has determined that no wholly natural
substitute product is presently available. Loss of the use of this
substance would disrupt many well-established and accepted organic
poultry operations. Therefore, this substance is presently a necessary
component of a nutritionally adequate diet for organic poultry.
Accordingly, AMS believes that a 15-day period for interested persons
to comment on this rule is appropriate.
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.
For the reasons set forth in the preamble, 7 CFR part 205, subpart
G is proposed to be amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
2. Section 205.603, paragraph (d)(1) is revised 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: July 25, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 05-14987 Filed 7-28-05; 8:45 am]
BILLING CODE 3410-02-P