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[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Rules and Regulations]
[Pages 57985-57990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23083]

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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 77, No. 182 / Wednesday, September 19, 2012 / 
Rules and Regulations

[[Page 57985]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0063; NOP-11-11FR]
RIN 0581-AD018

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 enact one recommendation submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on April 29, 2010. This final rule revises the annotation for one 
substance on the National List, methionine, to reduce the maximum 
levels of synthetic methionine allowed in organic poultry production 
after October 1, 2012. This final rule permits the use of synthetic 
methionine at the following maximum levels per ton of feed after 
October 1, 2012: laying and broiler chickens--2 pounds; turkeys and all 
other poultry--3 pounds. This action also corrects the Chemical 
Abstracts Service (CAS) numbers for the allowable forms of synthetic 
methionine.

DATES: Effective Date: This rule is effective on October 2, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, National Organic Program, 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 sections 205.600 through 
205.607. The 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 
nonagricultural 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. 
6501-6522), and NOP regulations, in section 205.105, specifically 
prohibit the use of any synthetic substance in 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 must 
also appear on the National List.
    Under the authority of the OFPA, the National List can be amended 
by the Secretary based on recommendations developed by the National 
Organic Standards Board (NOSB). Since established, the NOP has 
published multiple amendments to the National List: 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); December 12, 2007 (72 FR 70479); September 18, 
2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 
38693); August 24, 2010 (75 FR 51919); December 13, 2010 (75 FR 77521); 
March 14, 2011 (76 FR 13504); August 3, 2011 (76 FR 46595); February 
14, 2012 (77 FR 8089); May 15, 2012 (77 FR 28472); June 6, 2012 (77 FR 
33290); and August 2, 2012 (77 FR 45903). Additionally, a proposed 
amendment to the National List was published on January 12, 2012 (77 FR 
1980).
    This final rule amends the National List to enact a recommendation 
submitted to the Secretary by the NOSB on April 29, 2010.

II. Overview of Amendment

    The following provides an overview of the amendment made to the 
designated section of the National List regulations:

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule amends the listing for synthetic methionine at 
section 205.603(d)(1) of the National List regulations by removing the 
expiration date ``October 1, 2012'', revising the maximum levels of 
synthetic methionine allowed per ton of feed for organic poultry, and 
correcting the Chemical Abstracts Service (CAS) numbers in the 
annotation as follows:
    (d)(1) DL-Methionine, DL-Methionine-hydroxy analog, and DL-
Methionine-hydroxy analog calcium (CAS 's 59-51-8, 583-91-5, 
4857-44-7, and 922-50-9)--for use only in organic poultry production at 
the following maximum levels of synthetic methionine per ton of feed: 
laying and broiler chickens--2 pounds; turkeys and all other poultry--3 
pounds.
    Methionine is classified as an essential amino acid for poultry 
because it is needed to maintain viability and must be acquired through 
the diet. Methionine is required for proper cell development and 
feathering in poultry. Natural feed sources with a high percentage of 
methionine include blood meal, fish meal, crab meal, corn gluten meal, 
alfalfa meal, and sunflower seed meal. Synthetic methionine is also 
used in poultry feed. This substance is a colorless or white 
crystalline powder that is soluble in water. It is regulated as an 
animal feed nutritional supplement by the Food and Drug Administration 
(21 CFR 582.5475).
    In 2001, the NOSB evaluated a technical advisory panel analysis of 
methionine against the criteria provided in the OFPA, and determined 
that the use of synthetic methionine in organic poultry feed is 
compatible with a system of organic poultry production. Based on 
multiple NOSB recommendations, AMS has amended section 205.603 of the 
National List to allow methionine as a synthetic substance for use in 
organic poultry production four times (68 FR 61987, 70 FR 61217, 73 FR 
54057, and 75 FR 51919). AMS published a complete account of the past 
NOSB recommendations and rulemaking pertaining to methionine in the 
interim rule published in the Federal Register on August 24, 2010 (75 
FR 51919)

[[Page 57986]]

(finalized on March 14, 2011 (76 FR 13501)).
    On July 31, 2009, the Methionine Task Force (MTF), which is 
comprised of organic poultry producers, submitted a new petition 
requesting to extend the allowance for synthetic methionine for five 
years until October 2014. In addition, the MTF proposed that the total 
amount of synthetic methionine in the diet remain below the following 
levels, calculated as the average pounds per ton of 100% synthetic 
methionine over the life of the bird: laying chickens--4 pounds; 
broiler chickens--5 pounds; and, turkey and all other poultry--6 
pounds. In consideration of the July 2009 petition and public comments, 
the NOSB issued two recommendations on April 29, 2010. These 
recommendations acknowledged a need for the continued allowance of 
synthetic methionine, and conveyed the intent to decrease the amount of 
synthetic methionine allowed in organic poultry production and 
encourage development of natural alternatives. One recommendation 
proposed to allow synthetic methionine in organic poultry production 
until October 1, 2012, at the following maximum levels per ton of feed: 
laying chickens--4 pounds; broiler chickens--5 pounds; and turkey and 
all other poultry--6 pounds. The first recommendation was implemented 
through a final rule published on March 14, 2011 (76 FR 13501).
    This final rule addresses the second NOSB recommendation on 
synthetic methionine from April 2010.\1\ This recommendation was based 
upon their evaluation of a petition submitted by the Methionine Task 
Force, a group of organic poultry producers, a third party technical 
review, and public comments received as part of their April 2010 public 
meeting.\2\ In their deliberations, the NOSB conveyed that the intent 
of this recommendation was to balance various interests including: (i) 
Providing for the basic maintenance requirements of organic poultry; 
(ii) satisfying consumer preference to reduce the use of synthetic 
methionine in organic poultry production; and (iii) motivating the 
organic poultry industry to continue the pursuit of commercially 
sufficient sources of allowable natural sources of methionine. A 
detailed discussion of the NOSB recommendation is available in the 
proposed rule which was published in the Federal Register on February 
6, 2012 (77 FR 5717).\3\
---------------------------------------------------------------------------

    \1\ NOSB recommendation on Methionine, April 2010. Retrieved 
from the NOP Web site at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5085081&acct=nosb.
    \2\ The technical report and the petition for synthetic 
methionine, submitted by Dave Matinelli on behalf of the Methionine 
Task Force on July 2009, is retrievable from the NOP Web site in the 
Petitioned Substances Database under ``Methionine'' at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5084508&acct=nopgeninfo.
    \3\ There is an incorrect statement about the April 2010 NOSB 
recommendation in the proposed rule (77 FR 5717). On page 5718, the 
proposed rule states that ``the second NOSB recommendation from 
April 2010 * * * proposed reduced maximum levels of synthetic 
methionine after October 1, 2015''. The date in this statement is 
incorrect. This statement should have read ``the second NOSB 
recommendation from April 2010 * * * proposed reduced maximum levels 
of synthetic methionine after October 1, 2012'' (emphasis added).
---------------------------------------------------------------------------

    This NOSB recommendation from April 2010 recommended that AMS 
delete the expiration date from the substance's current restrictive 
annotation to provide for use of synthetic methionine in organic 
production after its current expiration date, October 1, 2012.\4\ In 
response to the NOSB recommendation and public comment, this final rule 
removes the October 1, 2012 expiration date from the listing for 
synthetic methionine on the National List. In effect, removal of the 
expiration date from the current restrictive annotation provides for 
the use of synthetic methionine until it is reviewed again by the NOSB 
as part of either the substance's next sunset review or through the 
petition process.\5\
---------------------------------------------------------------------------

    \4\ On February 29, 2012, AMS published a correction to the 
proposed rule addressing this NOSB recommendation (77 FR 12216). 
This correction removed the October 2, 1012 date from the amendatory 
language for synthetic methionine which was proposed in the proposed 
rule. This date was included in error.
    \5\ A petition to change the annotation for methionine was 
submitted by the Methionine Task Force on April 8, 2011. The 
petition is retrievable from the NOP Web site in the Petitioned 
Substances Database under ``Methionine'' at: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase. The NOSB is 
currently reviewing the petition.
---------------------------------------------------------------------------

    The NOSB also recommended a reduction in the maximum levels of 
synthetic methionine allowed in organic poultry feed as part of their 
April 2010 recommendation. In response to this recommendation, this 
final rule amends the listing for synthetic methionine by reducing the 
maximum levels of the substance allowed per ton of feed for organic 
poultry from ``laying chickens--4 pounds; broiler chickens--5 pounds; 
turkeys and all other poultry--6 pounds'' to ``laying and broiler 
chickens--2 pounds; turkeys and all other poultry--3 pounds''.
    Through this final rule, AMS is also correcting the CAS numbers for 
the forms of synthetic methionine specified on the National List. CAS 
numbers are numeric identifiers which are used to uniquely identify 
substances. As discussed in the proposed rule, two of the three CAS 
numbers in the current listing for synthetic methionine are not 
appropriately specified in the regulation (77 FR 5719). An overview of 
the changes is provided in Table 1.

            Table 1--Overview of Corrections to CAS Numbers for Allowed Forms of Synthetic Methionine
----------------------------------------------------------------------------------------------------------------
                                                       Is substance name   Is CAS     Are CAS 
                                                          included in         included in     and substance name
          CAS              Substance name          current             current        included in final
                                                         regulations?        regulations?            rule?
----------------------------------------------------------------------------------------------------------------
59-51-8.........................  DL-Methionine.....  yes...............  yes...............  yes.
348-67-4........................  D-Methionine......  no................  yes...............  no.
63-68-3.........................  L-Methionine......  no................  yes...............  no.
583-91-5........................  DL-Methionine-      yes...............  no................  yes.
                                   hydroxy analog.
4857-44-7 and 922-50-9..........  DL-Methionine-      yes...............  no................  yes.
                                   hydroxy analog
                                   calcium.
----------------------------------------------------------------------------------------------------------------

III. Related Documents

    A notice was published in the Federal Register announcing a meeting 
of the NOSB and its planned deliberations to address a petition 
pertaining to the use of methionine in organic poultry production on 
March 17, 2010 (75 FR 12723).
    The current listing for methionine was codified through publication 
of an interim rule with request for comments in the Federal Register on 
August 24, 2010 (75 FR 51919), and reaffirmed by a final rule published 
on March 14, 2011 (76 FR 13501).

[[Page 57987]]

    The proposal to allow the use of methionine as specified in this 
final rule was published as a proposed rule on February 6, 2012 (77 FR 
5717).

IV. Statutory and Regulatory Authority

    The OFPA 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 the 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 or deletion from the National List. The National List 
petition process is implemented under section 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.

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 (OMB).

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 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 governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in section 
6514(b) of the OFPA. States are also preempted under section 6503 
through 6507 of the OFPA 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 section 6507(b)(2) of the OFPA, 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 section 6519(f) of the OFPA, this final rule would not 
alter the authority of the Secretary under the Federal Meat Inspection 
Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 
451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), 
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. 301-399), nor the authority of the 
Administrator of the Environmental Protection Agency under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 6520 of the OFPA 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 final decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) 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). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this final rule would not be 
significant. The effect of this final rule is to continue the allowance 
of synthetic methionine in poultry production, which would otherwise 
expire in October 2012. While the rule will reduce the rates of 
synthetic methionine allowed in organic poultry feed, this action 
amends the regulations such that small entities will continue to have 
access to a substance for use in organic poultry production. AMS 
concludes that the economic impact of extending the allowance for 
synthetic methionine in organic poultry production, if any, will be 
minimal to small agricultural service firms. Accordingly, AMS 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 $7,000,000, and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to NOP's Accreditation and International Activities 
Division, the number of certified U.S. organic crop and livestock 
operations totaled over 17,000 in 2010. Based on USDA data from the 
Economic Research Service (ERS) in 2008, these operations contained 
more than 4.8 million certified acres consisting of 2,665,382 acres of 
cropland and 2,160,577 acres of pasture and rangeland.\6\ The total 
acreage under organic management represents a twelve percent increase 
from 2007. Organic poultry production has steadily contributed to the 
overall growth in the organic food market. ERS estimated that there 
were 5,538,011 laying chickens and 9,015,984 broiler chickens raised 
under organic management in 2008.\7\ ERS estimated the number of 
certified organic turkeys raised in the United States in 2008 at 
398,531. Based on the USDA data reported by the National Agricultural 
Statistical Service (NASS), the US market value for organic eggs, and 
laying and broiler chickens was calculated at $352,831,850 in 2008.\8\ 
In addition to being sold as whole products, organic eggs and poultry 
by-products are used in the production of organic processed products 
including

[[Page 57988]]

soups, broths, prepared meals, ice cream, and egg nog. U.S. sales of 
organic food and beverages have grown from $1 billion in 1990 to $26.7 
billion in 2010. Sales in 2010 represented 7.7 percent growth over 2009 
sales.\9\
---------------------------------------------------------------------------

    \6\ U.S. Department of Agriculture, Economic Research Service. 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
    \7\ Ibid.
    \8\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. 2010. The 2007 Census of Agriculture, Organic 
Production Survey (2008): Volume 3, Special Studies, Part 2, AC-07-
SS-2, Tables 10 & 11, pp 69-91. http://www.agcensus.usda.gov/Publications/2007/Online_Highlights/Organics/ORGANICS.pdf.
    \9\ Organic Trade Association. 2011. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

    In addition, USDA has 93 accredited certifying agents who provide 
certification services to producers and handlers under the NOP. 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 accredited certifying agents 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 final rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

E. Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

F. Comments Received on Proposed Rule NOP-11-11

    AMS received 38 comments on the proposed rule. Comments were 
received from organic livestock producers, consumers, accredited 
certifying agents, trade associations, non-profit organizations, 
advocacy groups, and a methionine manufacturer. The majority of 
comments supported a continued allowance for synthetic methionine in 
organic poultry production after its current expiration date, October 
1, 2012. Nine comments specifically supported the amendment as 
proposed. Seven of these nine comments further stated their support for 
the proposed action because it will meet the intent of the NOSB to 
phase out the use of synthetic methionine in organic poultry production 
over time. Three commenters opposed the proposed rule as they wanted no 
synthetic methionine to be included in organic poultry diets.
Changes Requested But Not Made
    Many commenters stated that the proposed reduction in the maximum 
levels of synthetic methionine allowed per ton of feed could pose 
issues for some organic producers. These commenters described their 
concerns with the proposed reduction, including the lack of 
commercially available natural sources of methionine, and 
considerations pertaining to animal health and welfare and the 
environment.
    Commenters stated that natural alternatives to compensate for the 
reduction in synthetic methionine are not commercially available at 
quantities that would meet the nutritional requirements of the birds. 
Commenters acknowledged that research was ongoing to identify high 
methionine feeds, but noted that these alternatives are not produced in 
sufficient quantities to meet the demand of the organic poultry market. 
Some commenters stated that, in the absence of natural alternatives, 
synthetic methionine continues to be important for overall production 
output, increased flock uniformity and reduced feed costs. Some 
commenters noted that poultry diets are corn and soybean based and 
suggested that producers may need to meet the nutritional requirement 
for methionine by overfeeding protein with extra soybean meal. A 
commenter questioned if a sufficient quantity of organic soybeans were 
available for this strategy of overfeeding soybean meal to compensate 
for reduced synthetic methionine levels. One commenter also suggested 
that feed costs could rise by 20% if producers opt to overfeed protein 
sources in response to the reduced levels.
    Some commenters cited scientific literature and National Research 
Council (NRC) \10\ recommendations on the quantity of methionine needed 
in a poultry diet to optimize animal health. The commenters stated that 
the nutritional requirements for birds change over time with greater 
methionine demand early in life and early in the laying period, and 
that the proposed reduction in synthetic methionine would not align 
with the nutritional demands of the birds during certain life stages. 
Commenters also referenced the benefits to animal welfare when the 
nutritional requirement for methionine is met. Commenters noted that 
diets with inadequate amounts of methionine could lead to increased 
feather pecking and cannibalism.
---------------------------------------------------------------------------

    \10\ The NRC is a branch of the National Academy of Sciences. 
The NRC determines the nutritional requirements for livestock 
species in various phases of production based upon a compilation of 
scientific studies.
---------------------------------------------------------------------------

    Some commenters also raised concerns about the environmental 
impacts of poultry diets with lower levels of synthetic methionine. 
These commenters stated that studies show that inclusion of synthetic 
methionine in poultry diets reduced greenhouse gas production, reduced 
nitrogen waste and required less land be cultivated to produce the same 
amount of poultry products as those without methionine supplementation. 
Other commenters noted that producers may choose to meet the methionine 
needs of the birds by overfeeding protein. These commenters stated that 
increased protein in the diet has been shown to lead to more nitrogen 
excretion and an increase in ammonia levels in poultry houses.
    To address these concerns, commenters recommended alternatives to 
the proposed reduction in the levels of synthetic methionine. Some 
commenters suggested that the annotation on synthetic methionine should 
align with the methionine recommendation from the National Research 
Council. Some commenters stated that the maximum levels of methionine 
per ton of feed should remain at the levels currently codified (i.e. 
for laying chickens--4 pounds; for broiler chickens--5 pounds; and 
turkey and all other poultry--6 pounds). Other commenters suggested 
that, if the proposed reduction in synthetic methionine levels is 
finalized at 2 pounds for laying and broiler chickens and at 3 pounds 
for turkeys and all other poultry, then the annotation should specify 
that these levels be based upon an average amount of synthetic 
methionine per ton of feed fed over the life of the birds. These 
commenters noted that this latter approach would be consistent with the 
request of the 2011 petition submitted by the Methionine Task Force.
    Consistent with the NOSB recommendation, AMS is maintaining the 
proposed amendment to allow synthetic methionine in organic poultry 
production after October 1, 2012, at reduced levels. The NOSB received 
numerous public comments at their April 2010 public meeting regarding 
the use of synthetic methionine in organic poultry production. During 
their deliberations, the NOSB also reviewed technical information on 
synthetic methionine in accordance with the criteria in OFPA (7 U.S.C. 
6517-6518) and the NOP regulations for synthetic substances on the 
National List (Sec.  205.600). As part of their decision making, the 
NOSB is mandated by OFPA to evaluate whether alternative practices make 
the use of a substance

[[Page 57989]]

such as synthetic methionine unnecessary. The NOSB recommended an 
allowance for lower levels of synthetic methionine based on their 
perspective that implementing management strategies and different 
housing practices should lessen or eliminate the need for synthetic 
methionine in organic production. The NOSB also believed that a 
reduction in the levels allowed after October 1, 2012, will stimulate 
further market development of natural alternatives and drive management 
changes in the organic poultry industry. Amending the listing for this 
substance on the National List to allow higher levels of the substance 
than recommended by the NOSB would not meet the intent of the NOSB to 
phase out the use of this synthetic methionine in organic poultry 
production over time. Therefore, consistent with the NOSB 
recommendation, AMS is codifying the amendment to synthetic methionine 
through this final rule as proposed.
    One commenter suggested that poultry diets without synthetic 
methionine may not be in compliance with the Association of American 
Feed Control Officials' Model Feed Bill and Regulations which have been 
adopted in 18 states. This rule allows for synthetic methionine in 
organic poultry feed in accordance with its restrictive annotation on 
the National List. This action is not requiring the formulation of 
organic poultry feed without synthetic methionine.
    Some commenters questioned the process through which the NOSB made 
its April 2010 recommendation to the NOP. Commenters reiterated that 
methionine requirements for poultry and the commercial availability of 
natural sources of methionine have not changed since the NOSB began its 
deliberations on the allowance for synthetic methionine in organic 
production. Therefore, commenters questioned, with the same 
information, the NOSB decision to further restrict the use of synthetic 
methionine in their April 2010 recommendation. One commenter also 
stated that the NOSB should have accepted additional public comment at 
the April 2010 meeting on the reduced levels of the substance in their 
recommendation prior to voting. One commenter disputed the information 
provided to the NOSB Livestock Committee by anonymous feed mills and 
scientific experts about the feed requirements for poultry.
    On March 17, 2010, a notice was published in the Federal Register 
announcing a meeting of the NOSB and its planned deliberations to 
address a petition pertaining to the use of methionine in organic 
poultry production (75 FR 12723). In response to this notice, the NOSB 
accepted both written and oral public comment on this issue in advance 
of making their recommendation. All comments were considered alongside 
the technical information as part of the NOSB's recommendation on 
synthetic methionine to the Secretary.
    Two commenters suggested that, if organic poultry were produced 
using synthetic substances, then the organic poultry products from 
these poultry should be labeled as produced through use of a synthetic. 
The NOP regulations authorize the use of synthetic substances that have 
been recommended by the NOSB and included on the National List by the 
Secretary. Requiring labeling for the use of synthetic inputs as 
suggested by the commenters is outside the scope of this rulemaking.
    Several commenters provided comments in reference to the petition 
submitted in 2011 by the Methionine Task Force.\11\ A few comments 
regarding the 2011 petition addressed the potential for increased audit 
times based on upon the petitioner's request and the need for NOSB to 
consider use of a natural omnivorous diet as an alternative to the 
petitioner's request. Other comments supported the 2011 petition and 
urged the NOSB to review it as soon as possible. These comments are 
outside the scope of this rulemaking. The NOSB is currently reviewing 
this petition and would accept comments on any NOSB proposal to address 
this petition as part of a future NOSB meeting.
---------------------------------------------------------------------------

    \11\ The 2011 petition is available on line at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090283&acct=nopgeninfo. This petition 
requests an allowance for synthetic methionine as follows: The 
allowed maximum average pounds per ton of 100% synthetic methionine 
(MET) in the diet over the life of the bird be at the following 
levels: Laying chickens--2.5 lbs; Broiler chickens--3 lbs; Turkeys 
and all other poultry--3 lbs.
---------------------------------------------------------------------------

    AMS specifically requested comments on proposed corrections to the 
CAS numbers for the allowed forms of methionine. One comment was 
received from a trade association on this issue. The commenter stated 
that correcting the CAS numbers (348-67-4 for D-Methionine and 63-68-3 
for L-Methionine) would not impact any poultry feeds currently on the 
market, but noted that the correction would prevent the addition of D-
methionine or L-methionine in future feed formulations. AMS is 
retaining the corrections as proposed to ensure that the appropriate 
CAS numbers are reflected in the annotation for synthetic methionine on 
the National List. Forms of synthetic methionine which are not 
indicated by their CAS number on the National List at section 205.603 
would need to be petitioned for review by the NOSB.

G. General Notice of Public Rulemaking

    This final rule reflects a recommendation submitted to the 
Secretary by the NOSB for extending the use of synthetic methionine in 
organic poultry production. The NOSB evaluated this substance using 
criteria in the OFPA in response to a petition. 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, some allowance for synthetic methionine is a 
necessary component of a nutritionally adequate diet for organic 
poultry. Pursuant to 5 U.S.C. 553, it is found and determined upon good 
cause that it is impracticable and contrary to the public interest to 
give preliminary notice prior to putting this rule into effect in order 
to ensure the continued use of synthetic methionine after October 1, 
2012, and avoid any disruption to the organic poultry market.

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 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(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-hydroxy analog, and DL-Methionine-
hydroxy analog calcium (CAS 's 59-51-8, 583-91-5, 4857-44-7, 
and 922-50-9)--for use only in organic poultry production at the 
following maximum levels of synthetic methionine per ton of feed: 
Laying and broiler chickens--2

[[Page 57990]]

pounds; turkeys and all other poultry--3 pounds.
* * * * *

    Dated: September 13, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-23083 Filed 9-18-12; 8:45 am]
BILLING CODE 3410-02-P
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