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[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Rules and Regulations]
[Pages 13501-13504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5716]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
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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: Melissa.bailey@ams.usda.gov; 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]
BILLING CODE 3410-02-P
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