[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\
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\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).
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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\
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\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.
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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
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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?
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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.
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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\
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\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.
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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.
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\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.
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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.
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\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.
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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