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.

Proposed Rules Federal Register

5717 

Vol. 77, No. 24 

Monday, February 6, 2012 

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: http:// 

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 http://www.regulations.gov. 

Document: For access to the 

document to read background 

documents or comments received, go to 

http://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 §§ 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 § 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 § 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– 


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5718 Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Proposed Rules 

1The petition is available from the NOP Web site 

in the Petitioned Substances Database http:// 

www.ams.usda.gov/NOP. 

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 § 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 § 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 wellestablished 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). 

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 


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

CAS # Substance name 

Is substance name 

included in current 

regulations? 

Is CAS # included 

in current 

regulations? 

Are CAS # and 

substance name included in 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-hydroxy analog ....................... yes ......................... no ........................... yes. 

4857–44–7 and 922–50–9 DL—Methionine-hydroxy analog calcium .......... yes ......................... no ........................... yes. 


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5720 Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Proposed Rules 

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 § 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 http:// 

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 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 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 § 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 § 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 


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Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Proposed Rules 5721 

2U.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/. 

3U.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. 

4Organic Trade Association. 2011. Organic 

Industry Survey. www.ota.com. 

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 byproducts 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

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 

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. 

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 § 205.603(d)(1) is amended 

by revising paragraph (d)(1) to read as 

follows: 

§ 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 

SMALL BUSINESS ADMINISTRATION 

13 CFR Part 115 

RIN 3245–AG39 

Surety Bond Guarantee Program— 

Quick Bond Guarantee Application and 

Agreement 

AGENCY: Small Business Administration. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

implement a streamlined application 

process in the Prior Approval Program 

of the Surety Bond Guarantee (SBG) 

Program for contract amounts not 

exceeding $250,000 and would make 

other minor administrative changes to 

the SBG Program regulations to, among 

other things, clarify the procedures for 

submitting the application forms and 

paying of fees, and delete an obsolete 

reference to a form. 

DATES: Comments must be received on 

or before April 6, 2012. 

ADDRESSES: You may submit comments, 

identified by RIN: 3245–AG39 by any of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Office of Surety Guarantees, 

Suite 8600, 409 Third Street SW., 

Washington, DC 20416. 

• Hand Delivery/Courier: Office of 

Surety Guarantees, 409 Third Street 

SW., Washington, DC 20416. 

SBA will post all comments on http:// 

www.regulations.gov. If you wish to 

submit confidential business 

information (CBI) as defined in the User 

Notice at www.regulations.gov, please 

submit the information to Ms. Barbara 

Brannan, Management Analyst, Office of 

Surety Guarantees, 409 Third Street 

SW., Washington, DC 20416 or send an 

email to Barbara.brannan@sba.gov. 

Highlight the information that you 

consider to be CBI and explain why you 

believe SBA should hold this 

information as confidential. SBA will 

review the information and make the 

final determination whether it will 

publish the information. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Barbara Brannan, Office of Surety 

Guarantees, (202) 205–6545, email: 

Barbara.brannan@sba.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background Information 

Through the Surety Bond Guarantee 

(SBG) Program, SBA guarantees bid, 

payment, and performance bonds for 

contracts up to $2 million for small and 

emerging contractors who cannot obtain 

bonds through regular commercial 


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