National Organic Program; Proposed Amendment to the National List of Allowed and Prohibited Substances (Livestock), 5717-5721 [2012-2628]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Proposed Rules]
[Pages 5717-5721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2628]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / 
Proposed Rules

[[Page 5717]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0063; NOP-11-11PR]
RIN 0581-AD18


National Organic Program; Proposed Amendment to the National List 
of Allowed and Prohibited Substances (Livestock)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would amend the U.S. Department of 
Agriculture's (USDA) National List of Allowed and Prohibited Substances 
(National List) to address 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, this proposed rule would revise the annotation for one substance 
on the National List, methionine, to reduce the maximum levels 
currently allowed in organic poultry production after October 1, 2012. 
This proposed rule would permit 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 proposes to correct the Chemical Abstract 
Service (CAS) numbers for the currently allowable forms of synthetic 
methionine and seeks comments on these changes.

DATES: Comments must be received by April 6, 2012.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., 
Room 2646-So., Ag Stop 0268, Washington, DC 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-11-0063; NOP-11-11PR, and/or Regulatory Information 
Number (RIN) 0581-AD18 for this rulemaking. You should clearly indicate 
whether you support the action being proposed for the substance in this 
proposed rule. You should clearly indicate the reason(s) for your 
position. You should also supply information on alternative management 
practices, where applicable, that support alternatives to the proposed 
action. You should also offer any recommended language change(s) that 
would be appropriate to your position. Please include relevant 
information and data to support your position (e.g. scientific, 
environmental, manufacturing, industry, impact information, etc.). Only 
relevant material supporting your position should be submitted. All 
comments received will be posted without change to https://www.regulations.gov.
    Document: For access to the document to read background documents 
or comments received, go to https://www.regulations.gov. Comments 
submitted in response to this proposed rule will also be available for 
viewing in person at USDA-AMS, National Organic Program, Room 2646-
South Building, 1400 Independence Ave. SW., Washington, DC, from 9 a.m. 
to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday (except 
official Federal holidays). Persons wanting to visit the USDA South 
Building to view comments received in response to this proposed rule 
are requested to make an appointment in advance by calling (202) 720-
3252.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 21, 2000, the Secretary established, within the 
National Organic Program (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 in organic production 
and nonsynthetic (natural) substances that may not be used. The 
National List also identifies nonagricultural nonsynthetic, 
nonagricultural synthetic, and nonorganic agricultural substances that 
may be used in organic production and handling. The Organic Foods 
Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501 et seq.), and 
the National Organic Program (NOP) regulations, in Sec.  205.105, 
specifically prohibit the use of any synthetic substance for organic 
production and handling unless the synthetic substance is on the 
National List. Section 205.105 also requires that any nonorganic 
agricultural or nonsynthetic nonagricultural substance used in organic 
handling appear on the National List.
    Under the authority of the OFPA, as amended (7 U.S.C. 6501-6522), 
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) and March 14, 2011 (76 FR 
13501). Additionally, a proposed amendment to the National List was 
published on May 5, 2011 (76 FR 25612).
    This proposed rule would amend the National List to reflect a 
recommendation submitted to the Secretary by the NOSB on April 29, 
2010. Based upon their evaluation of a petition submitted by industry 
participants and a third party technical review, the NOSB recommended 
that the Secretary amend Sec.  205.603 of the National List to change 
the annotation for one substance, methionine, for use in organic 
poultry production. The NOSB reviewed the use of synthetic methionine 
in organic poultry production using the evaluation criteria specified 
in the OFPA (7 U.S.C. 6517-

[[Page 5718]]

6518). The NOP is also proposing to correct the CAS numbers in the 
current listing for synthetic methionine and seeks public comment on 
these changes.

II. Overview of Amendment

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

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This proposed rule would amend paragraph Sec.  205.603(d)(1) by 
removing the expiration date ``October 1, 2012'' and revising the 
maximum levels of synthetic methionine per ton of feed allowed for 
organic poultry.
    Methionine is classified as an essential amino acid because it 
cannot be biologically produced by poultry and is necessary to maintain 
viability. 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).
    The NOSB initiated a review of this substance in 1999, as a result 
of a petition requesting to add synthetic methionine to the National 
List for poultry. 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 Sec.  205.603 of the National List on October 31, 
2003, to allow methionine as a synthetic substance for use in organic 
poultry production until October 21, 2005 (68 FR 61987). Based upon 
subsequent NOSB recommendations in March 2005 and May 2008, the 
Secretary amended the listing for methionine to continue the use 
through October 21, 2008 (70 FR 61217), and again through October 1, 
2010 (73 FR 54057). The 2005 and 2008 NOSB recommendations to continue 
the allowance for methionine were informed by updates on the 
development of allowable natural alternatives, none of which had 
attained commercial viability. While expressing a strong preference for 
supplementation with allowable natural sources of methionine, the NOSB 
concluded that terminating the allowance for synthetic methionine would 
disrupt the well-established organic poultry market, and cause 
substantial economic harm to organic poultry producers. The NOSB and 
stakeholders agreed that the organic feed sector would continue to 
research and develop sufficient supplies of allowable organic and 
natural sources. A complete account of the past NOSB recommendations 
and rulemaking pertaining to methionine is available in the interim 
rule that was published in the Federal Register on August 24, 2010 (75 
FR 51919).
    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.\1\ 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 NOP codified this recommendation 
through a National List amendment published in the Federal Register on 
August 24, 2010 (75 FR 51919), and reaffirmed on March 14, 2011 (76 FR 
13501).
---------------------------------------------------------------------------

    \1\ The petition is available from the NOP Web site in the 
Petitioned Substances Database https://www.ams.usda.gov/NOP.
---------------------------------------------------------------------------

    The second NOSB recommendation from April 2010, which is the 
subject of this rulemaking, proposed reduced maximum levels of 
synthetic methionine after October 1, 2015. The NOSB recommended that 
the annotation for synthetic methionine be revised to read: For use 
only in organic poultry after October 1, 2012, at the following maximum 
levels per ton: laying and broiler chickens--2 pounds per ton; turkeys 
and all other poultry--3 pounds per ton. The listing would be subject 
to review within five years in accordance with the OFPA provision for 
the sunset of National List substances (7 U.S.C 6517(e)). In effect, 
amending the methionine listing in 2012 would trigger a sunset review 
of synthetic methionine by the NOSB by 2017.
    At its April 2010 business meeting, the NOSB considered public 
comments from organic poultry producers, certifying agents, consumer 
organizations, and trade associations regarding the step-down 
recommendation. In public comment, the NOSB was challenged on the 
scientific basis for the step-down levels. The MTF maintained that the 
recommended step-down would be disproportionately greater for broiler 
chickens (5 pounds to 2 pounds/ton of feed) as compared to layers (4 
pounds to 2 pounds/per ton of feed), and was not substantiated. The MTF 
further noted that pullets have the highest methionine demands due to 
their growth rate and advised an allowance of 3 pounds methionine per 
ton of feed for birds up to 27 weeks of age for basic health 
requirements. According to the MTF, a bird is fully feathered and 
reaches the adult weight at 27 weeks and has higher methionine demands 
during this period. That proposal would permit broilers to receive an 
average of 3 pounds/ton of feed throughout the entire lifespan, as they 
are generally slaughtered before 27 weeks of age.
    In the discussion at the April 2010 meeting, the NOSB maintained 
that the proposed step-down levels were developed in consultation with 
animal welfare experts and nutritionists and would be sufficient for 
poultry maintenance requirements, but would not provide growth 
enhancement. The NOSB explained that the step-down levels were also 
based on information from feed mills, specifically, the amount of 
methionine added to mixes for various poultry, i.e., starters, pullets, 
layers, broilers, turkeys, etc. The NOSB noted that none of the feed 
mixes in its research contained methionine at levels exceeding the 
average levels recommended by the MTF, and that some feed mixes 
contained significantly less methionine. The maximum methionine levels 
in the MTF petition were provided as average quantities in feed over 
the life of the bird. The NOSB objected to the MTF proposal on the 
basis that it would allow feed with higher levels of methionine to be 
fed to poultry for certain intervals. Furthermore, the NOSB stated that 
it did not favor imposing a requirement on

[[Page 5719]]

certifying agents to calculate average methionine content of feed.
    The NOSB conveyed the expectation that reduced maximum levels would 
serve as an incentive to further progress in the development of 
allowable natural alternatives to synthetic methionine. The 
availability of natural sources of methionine significantly contributed 
to the NOSB's rationale for extending the use of methionine beyond 
2012. The NOSB acknowledged that options for natural sources of 
methionine are constrained by the NOP prohibition on the feeding of 
mammalian or poultry slaughter by-products to poultry. Consequently, 
organic and allowable natural sources of methionine in organic 
commercial poultry feed need to be derived from plants, insects, or 
other allowable sources. During the April 2010 meeting, the NOSB heard 
public comment about research in the development of natural sources of 
methionine, including high methionine corn, microbial-produced 
methionine, insect meal, and alfalfa nutrient concentrate. However, the 
comments conveyed that none of these sources are commercially 
available.
    In its deliberations, the NOSB also explored an association between 
management practices and dependence on synthetic methionine. Some 
public comments asserted that the allowance for methionine fosters 
management practices that curtail proper outdoor access for poultry, 
where naturally occurring sources of methionine, such as insects, are 
available. The NOSB acknowledged that certain production practices 
contribute to the need for synthetic methionine, but stated that birds 
would not obtain sufficient methionine from outdoor access or pasturing 
to alleviate a need for methionine supplementation. The NOSB also 
considered that the breed of bird can affect methionine needs. The NOSB 
acknowledged that the breeds used in organic production are generally 
the same as those in nonorganic production, and that greater breed 
variety in organic poultry production could reduce the need for 
synthetic methionine. Ultimately, the NOSB was not persuaded that 
changes in management practices could eliminate the need for synthetic 
methionine by 2012.
    In summary, the NOSB conveyed that the step-down recommendation 
balanced various interests: (i) Providing for the basic maintenance 
requirements of organic poultry; (ii) satisfying consumer preference to 
reduce the use of synthetic methionine; and (iii) motivating the 
organic poultry industry to continue the pursuit of commercially 
sufficient sources of allowable natural sources of methionine.
    The Secretary has reviewed and proposes to accept the NOSB's 
recommendation. Consistent with the NOSB's recommendation, this 
proposed rule would amend Sec.  205.603(d)(1) of the National List by 
revising the listing for synthetic methionine to extend its use beyond 
October 1, 2012, at the following maximum levels per ton of feed: 
laying and broiler chickens--2 pounds; turkeys and all other poultry--3 
pounds.
    The NOP recognizes that the MTF submitted a new petition for 
revised maximum allowable levels of synthetic methionine on April 8, 
2011. The NOP anticipates that the NOSB will consider this petition at 
a future meeting. In the meantime, the NOP believes it is necessary to 
move forward issuing this proposed rule to address the April 2010 NOSB 
recommendation. This is necessary to prevent any gap in the allowance 
of synthetic methionine in the diets of organic poultry due to the 
current expiration date of October 1, 2012.
    This proposed rule also seeks comment on a correction of the 
Chemical Abstract Service (CAS) numbers for the forms of synthetic 
methionine reviewed and allowed by the NOSB. CAS numbers are numeric 
identifiers which are used to uniquely identify substances. The current 
listing and CAS numbers for methionine are as follows: DL--Methionine, 
DL--Methionine hydroxy analog, and DL--Methionine hydroxy analog 
calcium (CAS 59-51-8; 63-68-3; 348-67-4). The letters D-- and 
L-- refer to specific isomers of the substance, and DL-- refers to a 
mixture of both D and L (racemic mixture). The CAS number for DL--
Methionine is 59-51-8, as is indicated as such in the current 
regulations. The NOP understands that the other CAS numbers included in 
the current listing do not refer to DL--Methionine hydroxy analog and 
DL--methionine hydroxy analog calcium, respectively. Instead, these CAS 
numbers refer to D--Methionine (CAS 63-68-3) and L--Methionine 
(CAS 348-67-4). DL--Methionine hydroxy analog is a synthetic 
methionine product containing a minimum of 88% (racemic) 2-hydroxy-4-
(methylthio)butanoic acid. DL--methionine hydroxy analog calcium is a 
synthetic methionine product that contains a minimum of 97% (racemic) 
2-hydroxy-4-methyl(thio)butanoic acid calcium salt. While DL--
Methionine hydroxy analog and DL--Methionine hydroxy analog calcium are 
forms of synthetic methionine that were reviewed and approved by the 
NOSB, the CAS numbers for those forms were not appropriately specified 
in the regulation. This proposed rule would amend the specified CAS 
numbers to include CAS 583-91-5 for DL--Methionine hydroxy 
analog, and CAS s 4857-44-7 and 922-50-9 for DL--Methionine 
hydroxy analog calcium.
    The NOP is proposing to delete the CAS numbers for D--Methionine 
(CAS 63-68-3) and L--Methionine (CAS 348-67-4), since 
only the racemic mixture of DL--Methionine (CAS 59-51-8) is 
used in commercial poultry feed. An overview of the changes is provided 
in Table 1.

                                Table 1--Overview of Proposed Corrections to CAS Numbers for Allowed Forms of Methionine
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                Are CAS  and
             CAS                  Substance name     Is substance name included in   Is CAS  included in   substance name included in
                                                                   current regulations?          current  regulations?             proposed 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.
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[[Page 5720]]

III. 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 current annotation 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).

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 on or deletion from the National List. The National List 
petition process is implemented under Sec.  205.607 of the NOP 
regulations. The current petition process (January 18, 2007, 72 FR 
2167) can be accessed through the NOP Web site at https://www.ams.usda.gov/NOPFilingaPetition.

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 proposed rule is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A 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) be consistent with the OFPA, (c) not be 
discriminatory toward agricultural commodities organically produced in 
other States, and (d) not be effective until approved by the Secretary.
    Pursuant to Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601-695), the Poultry Products 
Inspection Act (21 U.S.C. 451-472), 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. 301-397), nor 
the authority of the Administrator of the Environmental Protection 
Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 
U.S.C. 136-1364).
    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 persons 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. Executive Order 13175

    This proposed 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.

D. 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 proposed rule would not be 
significant. The current approval for the use of synthetic methionine 
in organic poultry production will expire October 1, 2012. The effect 
of this proposed rule is to allow the continued use of synthetic 
methionine beyond October 1, 2012. 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

[[Page 5721]]

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.\2\ 
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.\3\ 
In addition to being sold as whole products, organic eggs and poultry 
by-products are used in the production of organic processed products 
including 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.\4\
---------------------------------------------------------------------------

    \2\ U.S. Department of Agriculture, Economic Research Service. 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. https://www.ers.usda.gov/Data/Organic/.
    \3\ 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. https://www.agcensus.usda.gov/Publications/2007/Online_Highlights/Organics/ORGANICS.pdf.
    \4\ Organic Trade Association. 2011. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

    The USDA accredits 93 certifying agents who provide certification 
services to producers and handlers. A complete list of names and 
addresses of accredited certifying agents may be found on the AMS NOP 
Web site, at https://www.ams.usda.gov/nop. AMS believes that most of 
these entities would be considered small entities under the criteria 
established by the SBA.

E. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

F. General Notice of Public Rulemaking

    This proposed rule reflects a recommendation submitted to the 
Secretary by the National Organic Standards Board (NOSB) in April 2010 
to modify the annotation for extending the use of synthetic methionine 
in organic poultry production beyond October 1, 2012. This proposed 
rule would also correct the CAS numbers for synthetic methionine. A 60-
day period for interested persons to comment on this rule is provided 
and deemed appropriate.

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

    1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority:  7 U.S.C. 6501-6522.

    2. Section Sec.  205.603(d)(1) is amended by revising paragraph 
(d)(1) 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 
after October 2, 1012, 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.
* * * * *

    Dated: January 31, 2012.
Robert C. Keeney,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2012-2628 Filed 2-3-12; 8:45 am]
BILLING CODE 3410-02-P