[Federal Register Volume 73, Number 135 (Monday, July 14, 2008)]
[Proposed Rules]
[Pages 40197-40201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15390]


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DEPARTMENT OF AGRICULTURE

Agriculture Marketing Service

7 CFR Part 205

[Docket Number AMS-TM-08-0025; TM-08-05PR]
RIN 0581-AC81


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 of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) on May 22, 2008. 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 1, 2010.

DATES: Comments must be received by August 13, 2008.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using the following addresses:
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-TMP-NOP, 1400

[[Page 40198]]

Independence Ave., SW., Room 4008-So., Ag Stop 0268, Washington, DC 
20250.
     Internet: www.regulations.gov.
    Written comments responding to this proposed rule should be 
identified with the docket number AMS-TM-08-0025. You should clearly 
indicate your position on the proposed continued allowance for the use 
of methionine in poultry production until October 1, 2010. You should 
clearly indicate 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.). Finally, you should also supply information on alternative 
substances or alternative management practices, where applicable, that 
support a change from the current exemption for methionine. Only the 
supporting material relevant to your position will be considered.
    It is our intention to have all comments concerning this proposed 
rule, 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 proposed rule 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 proposed rule are requested to make an appointment in 
advance by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Richard H. Mathews, Chief, Standards 
Development and Review Branch, Telephone: (202) 720-3252; Fax: (202) 
205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the NOP [7 
CFR part 205], the National List regulations Sec. Sec.  205.600 through 
205.607. This National List identifies the synthetic substances that 
may be used and the nonsynthetic (natural) substances that may not be 
used in organic production. The National List also identifies 
synthetic, nonsynthetic nonagricultural and nonorganic agricultural 
substances that may be used in organic handling. The Organic Foods 
Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq.), and 
NOP regulations, in Sec.  205.105, specifically prohibit the use of any 
synthetic substance for organic production and handling unless the 
synthetic substance is on the National List. Section 205.105 also 
requires that any nonorganic agricultural and any nonsynthetic 
nonagricultural substance used in organic handling be on the National 
List.
    Under the authority of the 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 nine times, October 31, 2003 (68 FR 
61987), November 3, 2003 (68 FR 62215), October 21, 2005 (70 FR 61217), 
June 7, 2006 (71 FR 32803), September 11, 2006 (71 FR 53299), June, 27, 
2007 (72 FR 35137), October 16, 2007 (72 FR 58469), December 10, 2007 
(72 FR 69569), and December 12, 2007 (72 FR 70479).
    This proposed rule would amend the National List to reflect one 
recommendation submitted to the Secretary by the NOSB on May 22, 2008. 
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 1, 2010. 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 Proposed Amendment

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

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This proposed rule would amend Sec.  205.603(d)(1) by changing 
``2008'' to ``2010''. Section 205.603(d)(1) would now read 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, 2010.
    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). 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.
    On January 10, 2005, two organic poultry producers petitioned the 
NOSB to extend the use of Methionine in organic poultry production 
beyond October 21, 2005. The petition was filed because the organic 
poultry industry had been unable to develop suitable non-synthetic 
alternatives for synthetic Methionine in organic poultry diets. The 
petition sought 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 demonstrated that research trials 
were underway to identify non-synthetic alternatives for phasing out 
synthetic Methionine in organic poultry diets.

[[Page 40199]]

    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 of March 3, 2005, Sec.  
205.603(d)(1) of the National List was amended (Friday, October 21, 
2005, 70 FR 61217) to allow the use of Methionine in organic poultry 
production until October 1, 2008.
    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB, at its May 2008 meeting, for extending the use 
of Methionine in organic poultry production until October 1, 2010. The 
NOSB evaluated this substance using criteria in the OFPA.
    The substance's evaluation was initiated after receipt, by 
Agricultural Marketing Service (AMS), of a petition filed in December 
2007 by the Methionine Task Force (MTF). The MTF requested that Sec.  
205.603(d)(1) be amended by removing the annotation date of ``October 
8, 2008.'' They also requested that Methionine, in the future, undergo 
the standard sunset process for review of materials on the National 
List. The MTF petition addresses the status of the most viable 
alternatives to synthetic Methionine and agrees that none of the 
alternatives are currently commercially available.
    Additionally, in response to the December 28, 2007, Advanced Notice 
of Proposed Rulemaking (ANPR) (72 FR 73667) announcing the 2008 sunset 
review of 12 substances on the National List, AMS received six comments 
supporting the relisting of DL--Methionine, DL--Methionine-hydroxyl 
analog, and DL--Methionine-hydroxyl analog calcium (CAS --59-
51-8; 63-68-3; 348-67-4). Because these substances have an expiration 
date (October 1, 2008) recommended by the NOSB and established by 
rulemaking, they were not included in the 2008 sunset review. These 
comments, however, have been considered by the NOSB in developing their 
recommendation and by the AMS in developing this proposed rule.
    The NOSB, at its May 20-22, 2008, meeting in Baltimore, Maryland, 
received and evaluated public comment on the petition to extend the use 
of Methionine in organic poultry production beyond October 1, 2008. The 
NOSB also considered comments received, regarding the need for 
Methionine, at its November 2007 meeting in Washington, DC.
    The NOSB has determined that while wholly natural substitute 
products exist, they are not presently available in sufficient supplies 
to meet poultry producers needs. Thus, the NOSB concluded that 
synthetic Methionine remains a necessary component of a nutritionally 
adequate diet for organic poultry. Loss of the use of Methionine, at 
this time, would disrupt the well-established organic poultry market 
and cause substantial economic harm to organic poultry operations. To 
prevent disruption to the organic poultry market, while the organic 
feed sector creates sufficient supplies of wholly natural substitute 
products, the NOSB has recommended extending the allowed use of 
Methionine in poultry production until October 1, 2010.
    AMS has reviewed and concurs with the NOSB's recommendation.
    The organic industry, in 2005, raised approximately 13.8 million 
birds, had organic poultry products sales of $161 million and organic 
egg sales of another $161 million. In addition to being sold as whole 
products, organic eggs and poultry are sold for use in the production 
of organic processed products such as eggnog, ice cream, soups, broth, 
noodles, French toast, pancakes, waffles, tartar sauce, hollandaise 
sauce, mayonnaise, salad dressing, cookies, cakes, cheese cakes, bread, 
and other bakery goods. Accordingly, it is not just the organic poultry 
market that would be adversely impacted should producers lose the use 
of Methionine at this time. Processors would likely be faces with 
sourcing conventional eggs and poultry, the use of which would 
disqualify their products from being labeled ``organic.'' Only organic 
agricultural ingredients are allowed in products labeled as ``organic'' 
unless the agricultural ingredient has been added to the National List 
and determined commercially unavailable.

III. Related Documents

    Since September 2001 three notices have been published announcing 
meetings of the NOSB and its planned deliberations on recommendations 
involving the use of Methionine in organic poultry production. The 
three notices were published in the Federal Register as follows: (1) 
September 21, 2001 (66 FR 48654), (2) February 11, 2005 (70 FR 7224), 
and (3) April 4, 2008 (73 FR 18491). Methionine was first proposed for 
addition to the National List in the Federal Register on April 16, 2003 
(68 FR 18556). Methionine was added to the National List by final rule 
in the Federal Register on October 31, 2003 (68 FR 61987). A proposal 
to amend the annotation for Methionine was published in the Federal 
Register on July 29, 2005 (70 FR 43786). The annotation for Methionine 
was amended by final rule in the Federal Register on October 21, 2005 
(70 FR 61217).

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the 
Secretary 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 on 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 (72 FR 
2167, January 18, 2007) can be accessed through the NOP Web site at 
http://www.ams.usda.gov/nop/Newsroom/FedReg01_18_07NationalList.pdf.

A. Executive Order 12866

    This action has been determined not 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. 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 the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A

[[Page 40200]]

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 
proposed 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 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, 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. 
The impact on entities affected by this proposed rule would not be 
significant. The current approval for the use of Methionine in organic 
poultry production will expire October 1, 2008. The effect of this 
proposed rule would be to allow the continued use of Methionine through 
October 1, 2010. The AMS concludes that this action would have minimal 
economic impact on small agricultural service firms. Accordingly, 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 $6,500,000 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 6,949 
certified organic crop and livestock operations. These operations 
reported certified acreage totaling more than 2.09 million acres of 
organic farm production. Data on the numbers of certified organic 
handling operations (any operation that transforms raw product into 
processed products using organic ingredients) were not available at the 
time of survey in 2001; but they were estimated to be in the thousands. 
By the end of 2005, the number of U.S. certified organic crop, 
livestock, and handling operations totaled about 8,500. Based on 2005 
USDA, Economic Research Service, data from USDA-accredited certifying 
agents, U.S. certified organic acreage increased to 4 million acres.
    The U.S. sales of organic food and beverages have grown from $1 
billion in 1990 to nearly $17 billion in 2006. The organic industry is 
viewed as the fastest growing sector of agriculture, representing 
almost 3 percent of overall food and beverage sales. Since 1990, 
organic retail sales have historically demonstrated a growth rate 
between 20 to 24 percent each year, including a 22 percent increase in 
2006.
    In 2005, U.S. retail sales of organic poultry products were $161 
million. The growth rate for organic poultry retail sales is estimated 
at between 23 and 38 percent per year. Organic egg sales were $161 
million in 2005 and are projected to grow at a rate of 8 to 13 percent 
per year. The organic industry, in 2005, raised approximately 13.8 
million birds. Organic poultry is raised in 40 of the 50 states. In 
addition to being sold as whole products, organic eggs and poultry are 
used in the production of organic processed products such as eggnog, 
ice cream, soups, broth, noodles, French toast, pancakes, waffles, 
tartar sauce, hollandaise sauce, mayonnaise, salad dressing, cookies, 
cakes, cheese cakes, bread, and other bakery goods.
    In addition, USDA has 95 accredited certifying agents who 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

    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 of 1995, 44 
U.S.C. 3501, et seq., or OMB's implementing regulations at 5 CFR part 
1320.
    The AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.
    The AMS is committed to complying with the E-Government Act, to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for extending the

[[Page 40201]]

use of Methionine, a synthetic substance, in organic poultry production 
until October 1, 2010. The NOSB evaluated this substance using criteria 
in the OFPA. The substance's evaluation was initiated by a petition 
from the MTF.
    The NOSB has determined that while wholly natural substitute 
products exist, they are not presently available in sufficient supplies 
to meet poultry producer needs. Therefore, synthetic Methionine is 
presently a necessary component of a nutritionally adequate diet for 
organic poultry. Thus, loss of the use of Methionine, at this time, 
would disrupt the well-established organic poultry market and cause 
substantial economic harm to organic poultry operations. Accordingly, 
the NOSB has recommended extending the allowed use of synthetic 
Methionine in poultry production until October 1, 2010.
    AMS believes that a 30-day period for interested persons to comment 
on this rule is appropriate because the continued use of Methionine is 
critical to organic production, and this rulemaking should be completed 
before October 1, 2008, to avoid any disruptions to the market place.

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.


Sec.  205.603  [Amended]

    2. Section 205.603(d)(1) is amended by removing ``2008'' and adding 
``2010'' in its place.

    Dated: July 1, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E8-15390 Filed 7-11-08; 8:45 am]
BILLING CODE 3410-02-P