[Federal Register Volume 70, Number 145 (Friday, July 29, 2005)]
[Proposed Rules]
[Pages 43786-43788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14987]


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 Proposed Rules
                                                 Federal Register
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 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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  Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / 
Proposed Rules  

[[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: 
[email protected]. 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