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Proposed Rule

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

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Proposed rule.


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.


Comments must be received by April 6, 2012.


Interested persons may submit written comments on this proposed rule using one of the following methods:

  • Federal eRulemaking Portal: 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

Document: For access to the document to read background documents or comments received, go to 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.


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


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- 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 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).

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 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 nameIs substance name included in current regulations?Is CAS # included in current regulations?Are CAS # and substance name included in proposed rule?
583-91-5DL—Methionine-hydroxy analogyesnoyes.
4857-44-7 and 922-50-9DL—Methionine-hydroxy analog calciumyesnoyes.

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

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 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]

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 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

For the reasons set forth in the preamble, 7 CFR part 205, subpart G is amended as follows:


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:

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.


1.  The petition is available from the NOP Web site in the Petitioned Substances Database

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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.

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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.

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4.  Organic Trade Association. 2011. Organic Industry Survey.

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[FR Doc. 2012-2628 Filed 2-3-12; 8:45 am]