[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Rules and Regulations]
[Pages 13501-13504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5716]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Rules
and Regulations
[[Page 13501]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-10-0051; NOP-10-04FR]
RIN 0581-AD04
National Organic Program; Amendment to the National List of
Allowed and Prohibited Substances (Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: The U.S. Department of Agriculture (USDA) is adopting as
final, without change, an interim rule published in the Federal
Register on August 24, 2010 (75 FR 51919). The interim rule amended the
National List of Allowed and Prohibited Substances (National List)
based upon a recommendation submitted to the Secretary of Agriculture
(Secretary) by the National Organic Standards Board (NOSB) on April 29,
2010. Consistent with the recommendation from the NOSB, the interim
rule revised the annotation of one substance on the National List,
methionine, to extend its use in organic poultry production until
October 1, 2012, at the following maximum levels of synthetic
methionine per ton of feed: laying chickens--4 pounds; broiler
chickens--5 pounds; turkeys and all other poultry--6 pounds.
DATES: Effective Date: This rule becomes effective March 15, 2011.
FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director,
Standards Division, National Organic Program, USDA-AMS-NOP, 1400
Independence Ave., SW., Room 2646-So., Ag Stop 0268, Washington, DC
20250, E-mail: [email protected]; 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. The National List identifies 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
nonsynthetic, nonagricultural synthetic, 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 Sec. 205.105, specifically prohibit the use of any
synthetic substance for organic production and handling unless included
on the National List. Section 205.105 also requires that any nonorganic
agricultural, and any nonsynthetic, nonagricultural substance used in
organic handling must also be on the National List.
Under the authority of the OFPA, the National List can be amended
by the Secretary based on proposed amendments developed by the NOSB.
Since established, the NOP has published fourteen 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); and December 13, 2010 (75 FR 77521). Additionally, proposed
amendments to the National List were published on November 8, 2010 (75
FR 68505).
As a result of a petition requesting to add synthetic methionine to
the National List, the NOSB initiated a review of this substance in
1999. Methionine is classified as an essential amino acid because it
cannot be biologically produced by poultry and is necessary to maintain
viability. The petitioners asserted that methionine was a necessary
dietary supplement for organic poultry and that there was an inadequate
supply of allowable organic feeds containing sufficient concentrations
of naturally occurring methionine. In 2001, the NOSB evaluated a
technical advisory panel analysis of methionine against the criteria
provided in the OFPA (7 U.S.C. 6517-6518), and determined that the use
of synthetic methionine feed supplementation is compatible with a
system of organic poultry production. Consistent with the NOSB's
recommendation, the Secretary amended the National List to allow
methionine as a synthetic substance for use in organic poultry
production at Sec. 205.603 of the NOP regulations beginning on October
31, 2003, with an expiration date of October 21, 2005 (68 FR 61987).
Based upon additional NOSB recommendations submitted in March 2005 and
May 2008, the Secretary subsequently amended the listing for methionine
on the National List by extending its allowance in organic poultry
production through October 21, 2008 (70 FR 61217), and again through
October 1, 2010 (73 FR 54057).
On July 31, 2009, a coalition of producers identified as the
Methionine Task Force (MTF) filed a petition that requested a five-year
extension on the allowance for synthetic methionine. The MTF proposed
to limit the total amount of synthetic methionine to be fed over the
life of the bird calculated as the average pounds of synthetic
methionine per ton of feed. The MTF proposed these limits per ton of
feed as follows: 4 pounds for laying chickens, 5 pounds for broiler
chickens, and 6 pounds for turkeys and all other poultry. Based upon
their deliberations and the public comment received, the NOSB concluded
that wholly natural sources of methionine are not currently available
and that extending the allowance for the synthetic form of methionine
was warranted. However, the NOSB did not accept the request to extend
its allowance on the National List for five years at the limitations
proposed by the petitioners because the NOSB felt that averaging the
pounds of synthetic methionine fed over the life of the bird could
result in higher levels of the substance being fed during certain
growth stages. As a result, the NOSB opted to modify the annotation
[[Page 13502]]
proposed by the petitioner by removing the language that would have
allowed averaging the maximum level of methionine over the life of the
bird and adding different limits on the feed allowance over time. On
April 29, 2010, the NOSB issued a recommendation to extend the
allowance for synthetic methionine for five years until October 1,
2015, with a step down in the amount allowed after two years.
Specifically, the NOSB recommended that the amount of synthetic
methionine allowed per ton of feed be limited to 4 pounds for laying
chickens, 5 pounds for broiler chickens, and 6 pounds for turkeys and
all other poultry until October 1, 2012. The NOSB further recommended
that, after October 1, 2012, the allowance be reduced to 2 pounds for
laying chickens, 2 pounds for broiler chickens, and 3 pounds for
turkeys and all other poultry through October 1, 2015.
On August 24, 2010, the Secretary amended the National List through
publication of an interim rule with request for comments in the Federal
Register to reflect the first part of the NOSB's recommendation (75 FR
51919). This action extended the allowance for synthetic methionine
through October 1, 2012, at the levels specified by the NOSB. In the
interim rule, the USDA agreed to publish a final rule on the listing of
methionine, along with any changes if warranted, by March 2011.
Based upon the NOSB recommendation and comments received, this
final rule adopts, without change, the interim rule published on August
24, 2010 (75 FR 51919). Accordingly, this final rule continues the
exemption at Sec. 205.603(d)(1) for methionine as follows: DL-
Methionine, DL- Methionine-hydroxy analog, and DL-Methionine-hydroxy
analog calcium (CAS 59-51-8; 63-68-3; 348-67-4)--for use only
in organic poultry production until October 1, 2012, at the following
maximum levels of synthetic methionine per ton of feed: Laying
chickens--4 pounds; broiler chickens--5 pounds; turkeys and all other
poultry--6 pounds.
II. Related Documents
Since September 2001, four 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 four
notices were published in the Federal Register as follows: September
21, 2001 (66 FR 48654), February 11, 2005 (70 FR 7224), April 4, 2008
(73 FR 18491), and March 17, 2010 (75 FR 12723).
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), and the annotation was amended by final rule in the Federal
Register on October 21, 2005 (70 FR 61217). A proposal to amend the
annotation once again was published in the Federal Register on July 14,
2008 (73 FR 40197), and the annotation was amended by final rule on
September 18, 2008 (73 FR 54057). The annotation for methionine was
most recently amended through publication of an interim rule with
request for comments in the Federal Register on August 24, 2010 (75 FR
51919).
III. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501-6522), 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 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.
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 (68
FR 61987), dated October 31, 2003, adding methionine to the National
List was reviewed under this Executive Order and no additional
information related to Executive Order 12988 has been obtained since
then. 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 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
final 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. 601-612) requires
agencies to
[[Page 13503]]
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 current approval for the use of synthetic methionine
in organic poultry production was extended in the interim rule through
October 1, 2012, at levels that are consistent with current industry
practice. The effect of this final rule is to affirm the continued use
of synthetic methionine as amended. 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, 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.
Based on USDA data from the Economic Research Service (ERS), the
U.S. organic sector included nearly 13,000 certified organic crop and
livestock operations at the end of 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. 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. ERS estimated the number of certified
organic turkeys raised in the United States in 2008 at 398,531.\1\ The
Nutrition Business Journal calculated the market value for organic
laying chickens at $252,000,000 in 2008.\2\ In addition to being sold
as whole products, organic eggs and poultry byproducts are used in the
production of organic processed products including soups, broths,
prepared meals, ice cream and eggnog.
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\1\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
\2\ Nutrition Business Journal, 2009. U.S. Organic Food Sales by
Product ($Mil) 1997-2008, 2009(e)-2014(e)--Chart 22. Penton Media,
Inc.
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The USDA accredits certifying agents who provide organic
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 final 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 E-Government Act, to
promote the use of the Internet and other information technologies
increased opportunities for citizen access to Government information
and services, and for other purposes.
E. Discussion of Comments Received
AMS received 8 comments on the interim rule that extended the use
of synthetic methionine in organic poultry production until October 1,
2012, at the following maximum levels of synthetic methionine per ton
of feed: laying chickens--4 pounds; broiler chickens--5 pounds; turkeys
and all other poultry--6 pounds. Comments were received from two
organic livestock producers including one representing multiple
individuals, two trade associations, two non-profit advocacy groups and
two private individuals.
Some comments endorsed the amendment that extended the allowance
for synthetic methionine. These commenters asserted that continuing the
allowance was critical to the organic poultry industry, citing
methionine as a nutrient necessary for proper feather development and
cell growth. These comments further voiced that, while research
continues on meeting the nutritional requirements of poultry through
natural sources of methionine, the limited commercial availability of
feed containing natural sources of methionine supports the need for
continuing the allowance of synthetic forms of the substance on the
National List.
One comment strongly advocated for future inclusion of synthetic
methionine on the National List for a five-year sunset review cycle
after the October 1, 2015, expiration of the current petition-based
NOSB recommendation. The interim rule for which we requested comments
does not address the listing of methionine beyond its current
expiration date of October 1, 2012. We plan to address the allowance
for synthetic methionine after this date through a separate rulemaking
action.
Changes Requested But Not Made
Two comments in favor of extending the use of methionine did not
believe the limitations for use in different types of poultry as
specified in the interim rule are necessary. One of these comments
indicated concern that limiting the use of methionine to certain levels
may impact the management practices of poultry producers by reducing
the flexibility of producers to balance poultry rations with changing
environmental conditions. However, based upon additional statements
provided in this comment and testimony provided during NOSB
deliberations, we believe that maximum levels in the interim rule are
consistent with current industry practice and, therefore, will be
feasible for most producers without major changes to their current
management approach. The other comment related to limiting the
allowable levels of methionine in specific groups of poultry
recommended relisting methionine without annotation. The rationale
provided by the comment is that the future ``step down'' proposed by
the NOSB has the potential for increased recordkeeping by the producer
and the certification agency. Because the action in the interim rule
did not address the ``step down'' portion of the NOSB recommendation,
this rationale does not apply to the current amendment and, therefore,
we do not believe a change to the annotation as codified in the interim
rule is warranted.
A few comments rejected the provisions in the amendment and argued
in favor of an immediate prohibition on the use of synthetic
[[Page 13504]]
methionine in organic poultry production. One comment did not express
an opinion pertinent to the specifics of the amendment. The few
comments opposing the extension of the allowance for synthetic
methionine stated that use of the substance was incompatible with the
regulatory definition of ``organic production.'' Another comment
objecting to extending the allowance questioned whether OFPA sanctions
the use of a synthetic amino acid. This comment also cited natural
alternatives to synthetic methionine and suggested that the continued
allowance of synthetic methionine continues to delay the commercial
development of alternatives to the synthetic form.
In developing their recommendation on the continued allowance for
synthetic methionine on the National List, the NOSB reviewed the
substance against the evaluation criteria of 7 U.S.C. 6517 and 6518 of
the OFPA. The NOSB recommended that, after October 1, 2012, the
annotation for methionine be amended to reduce the maximum amount of
the substance allowed and establish October 1, 2015, as the expiration
date. The NOSB's intent is that a step down 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. We plan to address this step down through a future rulemaking
action. We believe that the current amendment should remain as codified
in the interim rule. At this time, the record supports the rationale of
the NOSB that synthetic methionine remains critical in organic poultry
production and that its removal from the National List would have
significant adverse impacts on the industry.
Two comments maintained that adequate wholly natural sources of
methionine are in fact available and suggested that these alternatives
should be sufficient for organic poultry production. The NOSB
considered the availability of such alternatives in development of
their recommendation and, based upon the public comment received,
determined that alternatives are not available in sufficient quantities
to meet the needs of the organic poultry industry. We concur with the
NOSB's finding and, therefore, disagree with the comments suggesting
that there are presently viable alternatives to justify removal of
synthetic methionine from the National List.
After full consideration of these comments, we have determined that
the record supports retaining the provisions in the interim rule to
extend the use of synthetic methionine in organic poultry production
until October 1, 2012, at the following maximum levels of synthetic
methionine per ton of feed: laying chickens--4 pounds; broiler
chickens--5 pounds; turkeys and all other poultry--6 pounds. This
provision remains consistent with the NOSB's April 29, 2010
recommendation.
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.
PART 205--NATIONAL ORGANIC PROGRAM
Accordingly, the interim rule amending 7 CFR part 205, subpart G
published at 75 FR 51919 on August 24, 2010, is adopted as a final rule
without change.
Dated: March 4, 2011.
David R. Shipman,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2011-5716 Filed 3-11-11; 8:45 am]
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