Federal Register: January 21, 2009 (Volume 74, Number 12)

DOCID: fr21ja09-40 FR Doc E9-1007

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

DOCUMENT ID: [Doc. No. AMS-LS-07-0131; LS-07-16]

NOTICE: NOTICES

DOCID: fr21ja09-40

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY:

United States Standards for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived From Such Livestock

DATES: Effective Date: Standard will become effective once related information collection provisions pursuant to the Paperwork Reduction Act (44 U.S.C. 35013520) are met.

DOCUMENT SUMMARY:

The Agricultural Marketing Service (AMS) is establishing a voluntary standard for a naturally raised marketing claim that livestock producers may request to have verified by the Department of Agriculture (USDA). This standard incorporates revisions made as a result of comments received from an earlier proposed standard. A number of livestock producers make claims associated with production practices in order to distinguish their products in the marketplace and there are a growing number of entities that are capturing valueadded opportunities by using alternative production methods to meet the demands of consumers and markets seeking meat and meat products from naturally raised livestock. This voluntary standard will allow livestock producers to utilize AMS' voluntary, third party verification services to provide validity to such naturally raised livestock claims and, in certain cases, access to markets that require AMS verification. AMS verification of this claim would be accomplished through an audit of the production process in accordance with procedures that are contained in Part 62 of Title 7 of the Code of Federal Regulations (7 CFR part 62).

SUMMARY:

United States Standards for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived from such Livestock

SUPPLEMENTAL INFORMATION

Section 203(c) of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1622), directs and authorizes the Secretary of Agriculture ``to develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.'' USDA is committed to carrying out this authority in a manner that facilitates the marketing of agricultural products. One way of achieving this objective is through the development and maintenance of voluntary standards by AMS. Utilization of this voluntary standard would be accomplished through an audit of the production process in accordance with procedures that are contained in Part 62 of Title 7 of the Code of Federal Regulations (7 CFR Part 62).

Paperwork Reduction Act

Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 3520), the information collection provisions associated with this notice have been submitted to OMB for approval as a new collection and will be published for public comment.

Background

Individuals and companies often highlight production and marketing practices in advertisements and promotions to distinguish their products in the marketplace. Since the late 1970s, livestock and meat producers (individuals and companies) have requested the voluntary services of AMS to verify or certify specific practices to increase the value of their products. The Livestock and Seed (LS) Program of AMS has provided certification through direct product examination for a number of production claims related to livestock and carcass characteristics. The validity of such claims utilizing LS Program voluntary certification services is enhanced since the product is labeled as ``USDA Certified.'' The LS Program also offers verification services through Quality System Verification Programs (QSVP; http:// www.ams.usda.gov/ARCaudits) to substantiate claims that cannot be determined by direct examination of livestock, their carcasses, component parts, or the finished product. The QSVP provides suppliers of agricultural products or services the opportunity to distinguish specific activities involved in the production and processing of their agricultural products and to assure customers of their ability to provide products or services of a consistently high quality. This is accomplished by documenting the quality management system and having the manufacturing or service delivery processes verified through independent, thirdparty audits by AMS.

In addition to the market differentiation that AMS certification and verification services provide, certain other markets require AMS certification or verification services as a prerequisite. This is especially true with certain foreign markets that require a competent government entity, such as AMS to provide the certification or verification activity. Since animal raising claims cannot be evaluated in finished products through direct product examination (as certification provides), the claims must be verified through the QSVP program.

The majority of claims currently citing naturally raised animal production methods are defined by the individual company selling the product. Depending upon the branded program making the claims, the production activities and associated requirements can vary since there is currently no standard to specify which attributes must be addressed and to what level, other than to be truthful and not misleading. This has led to confusion in the industry and the marketplace as to what requirements must be met in order to have a uniform, explicit claim that can be easily understood.

There has also been growing recognition that livestock producers targeting niche markets can provide the
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most valueadded alternatives by developing production systems that include the widest array of marketing opportunities. Thus, instead of losing the market premium of an animal intended to be marketed for a specific marketing claim because it no longer met program requirements, some premium could be obtained if the animal qualified for other value added markets.

The key to the success of this approach for the producer is to ensure that he or she develops a program scope, which encompasses all requirements that need to be addressed in any of the potentially applicable marketing strategies. Thus, animals may be shifted into other programs depending upon circumstances and management decisions. This allows producers more flexibility than an all or nothing approach, which would be the case if only one program was included in a marketing strategy. Producers must determine whether viable markets exist for any verification program they wish to make use of.

Another critical key to success is understanding that there are commonly understood and verifiable programs available in the market, but that AMS' verification can augment or complement these programs. Consistent with its mission, AMS has determined that it can best support producers and the development of markets, by providing verification services and, as necessary, defining standards based on their experience with USDA Certified Programs and USDA QSVP, research into standard practices and procedures, and requests from the livestock and meat industries.

With respect to the Naturally Raised Claim, AMS developed and proposed a standard with explicit attributes that could easily be understood by market participants as the basis for a naturally raised marketing claim as it relates to live animal production practices. As part of this process, AMS has obtained input from a number of individual experts in government, industry, academia, and other interested parties while establishing this voluntary standard. Relationship of the Naturally Raised Claim to Other Marketing Claims

The U.S. Standard for the Naturally Raised Claim for Livestock and the Meat and Meat Products Derived from such Livestock is intended to stand alone or to be used in conjunction with other marketing claims. This flexibility is intended to allow producers to develop marketing plans utilizing recognized standards and terms, and to ensure product characteristics are expressed and understood more clearly by market participants. It does not limit in any way the ability of market participants to make additional marketing claims.

USDA's Food Safety and Inspection Service (FSIS), under the authority of the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601, 607) and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451, 457), regulates domestic and imported meat and poultry product labeling, standards, and ingredients. AMS' standard for a naturally raised marketing claim would be verified, as provided in 7 CFR Part 62. However, since this is a voluntary marketing claim standard, FSIS will not necessarily limit the use of the term naturally raised to labels in which participants employ and meet AMS' standard. FSIS label approval requirements for the use of the term naturally raised and other claims about livestock production practices are based upon the substantiation provided at the time of label approval application. QSVP verified claims, like other label approval applications, must be submitted to FSIS for approval. Any specific labeling questions not related to AMS services should be directed to FSIS.

Meat products marketed under a specific production marketing claim should not be construed to imply that it is safer or somehow better than conventionally produced livestock and the meat and meat products derived from such livestock. Rather, marketing claims are meant to distinguish or differentiate products in the marketplace; thus, allowing purchasers to assess the value of their purchase on factors other than price.
Comments and Responses on the Proposed Naturally Raised Marketing Claim Standard

AMS proposed the Naturally Raised Marketing Claim standard as a notice and request for comments in the November 28, 2007, Federal Register Notice (72 FR 67266). AMS then reopened and extended the comment period in the January 31, 2008, Federal Register Notice (73 FR 5789) because a number of interested producers, processors, and marketers requested additional time to evaluate the impact of the requirements of the proposed standard in order to provide more meaningful and substantive comments.

By the close of the comment period, AMS received over 44,000 comments concerning the Naturally Raised Marketing Claim standard from consumers, veterinarians, trade and professional associations, non profit organizations, national organic associations, as well as consumer, agriculture, and animal advocacy organizations, retail and meat product companies, food service, livestock producers, and allied animal industries. Approximately 43,000 of the over 44,000 comments received were form letter comments. A breakout of the comments by issues raised, including the comments from form letters, and AMS' responses follow.

The majority of the commenters felt the scope of the Naturally Raised Marketing Claim standard was too narrow and thus opposed the standard as proposed; however, nearly all of the commenters concurred that the three core criteria proposed (animals raised without growth promotants and antibiotics and have never been fed mammalian or avian byproducts) in the November 28, 2007, Federal Register Notice (72 FR 67266) should be a part of a naturally raised marketing claim standard.

AMS has determined that these three core criteria best represent the current industry consensus of naturally raised claims existing in the marketplace and that broadening the focus of the proposed standard would limit the usefulness of the claim to a very small segment of producers, would render it unlikely to be used, and would be of little value in facilitating the marketing of agricultural products. Commenters that were in favor of the standard identified additional clarifications, practices, and attributes for consideration which will be addressed below in the specific sections for each issue raised. The revisions incorporated into the standard include (1) a clarification of the meaning of animal byproducts, (2) the addition of a prohibition of aquatic byproducts, and (3) a provision that would allow coccidiostats for parasite control as long as their use is disclosed. The majority of the comments received provided information related to one or more of the categories below as a justification for or against the proposed standard or as a suggested revision to the proposed standard. Diet

Comments: AMS received many comments regarding the diet of naturally raised livestock. Some commenters wanted the diet of naturally raised livestock to be restricted to a vegetarian diet or a grass diet, while other commenters suggested allowing a grain fed diet. Some commenters stated that AMS should regulate the diet to be natural to the species. Others commented that the diet of naturally raised livestock should allow organic
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grains only while other commenters stated that the proposed standard should prohibit genetically modified feedstuffs.

The only diet requirement addressed in the proposed standard was that livestock have never been fed mammalian or avian byproducts. Many commenters expressed support for this requirement; however, numerous commenters asked that the definition of animal byproducts be clarified. Some commenters asserted that pigs were omnivores and that eggs and milk were commonly used in pigs' diet and requested that the requirement of no mammalian and avian derived products be clarified to prohibit slaughter byproducts but not food items such as eggs and milk in the porcine diet. Some commenters also suggested aquatic byproducts be prohibited.

Agency Response: As stated previously, the only diet requirement addressed in the proposed standard was that livestock have never been fed mammalian or avian byproducts. After reviewing the comments received suggesting the clarification of the definition of mammalian and avian byproducts, AMS has determined to revise the standard to clarify the definition of animal byproduct to specifically state what is prohibited. For the purpose of the Naturally Raised Marketing Claim standard, AMS will prohibit animal (mammalian, avian, and aquatic) by products derived from the slaughter/harvest processes including meat and fat, animal waste materials (e.g., manure and litter), and aquatic byproducts (e.g., fishmeal and fish oil). This prohibition includes meat byproducts as defined by FSIS in 9 CFR 301.2. Mammalian and avian products (e.g., milk and eggs) that are not derived from the slaughter/ harvest processes are allowed.

The remainder of the comments regarding diet were considered, but not incorporated into the standard as AMS has determined the standard, with the revisions made, is appropriate and will be most useful in meeting the needs of producers as they develop a program scope and marketing strategies. In addition, as we point out above, the Naturally Raised Marketing Claim can be used in conjunction with other marketing claims, thus accommodating many of the suggestions made regarding diet. This flexibility allows producers to develop marketing plans incorporating other recognized standards and terms in the livestock and meat industries thereby allowing product characteristics to be articulated in the marketplace and to be more clearly understood by market participants.

Production Issues

Comments: AMS received numerous comments regarding the living and raising conditions of livestock to be included in a naturally raised marketing claim standard. Commenters suggested that animals be raised in an environment natural to the species, allowed to exhibit natural behaviors, and allowed to socialize. Some commenters wanted animals to graze or be pastured only and many commenters stated that animals should not be confined (e.g., free range, no Confined Animal Feeding Operations (CAFOs), no cages, or no crates). Other commenters also suggested that livestock be raised in sunshine, allowed fresh air, provided clean water, and in inclement weather, provided uncrowded enclosure with good manure handling.

Commenters also provided input regarding animal handling and welfare (live animal and slaughter). Numerous commenters stated that the standard should require animals to be treated and raised humanely using acceptable animal welfare practices, and that animals should be humanely slaughtered. Some commenters specifically requested that the standard include requirements regarding the humane handling of downers while other commenters requested that downer animals be prohibited.

AMS received comments on environmental stewardship and sustainability. Commenters stated that sustainable production methods should be used and that AMS should require conservation and sustainable environmental measures.

Additional production/management practices that AMS received comments on were suggestions to prohibit genetic selection, early weaning, artificial insemination, tail docking, and surgical mutilation. Many commenters also expressed the view that meat from cloned animals be prohibited. Some commenters also stated that the standard should require smaller herd sizes and allow as little interference from humans as possible. AMS received comments requesting that the proposed standard also include poultry and dairy production requirements.

Agency Response: The comments received provided no clear, unified approach other than that the three core criteria proposed (animals raised without growth promotants and antibiotics and that have never been fed mammalian or avian byproducts) should be a part of a naturally raised marketing claim. Accordingly, the comments did not provide an adequate basis to establish a broader, more encompassing standard.

Therefore, AMS determined that it was not appropriate to expand the scope of this standard to incorporate the diverse range of suggested practices or attributes into the naturally raised standard. Furthermore, attempting to broaden the list of practices or attributes incorporated in a standard to be applied on a nationwide basis would be inherently difficult as practices vary from region to region and by producer. Due to the geographic diversity of the United States, livestock production practices vary considerably due to soils, climate, and availability of the production inputs and other necessities such as shelter, feedstuffs, and labor.

AMS concluded that many of the production activities identified through the comment process would be more appropriately addressed as standards themselves or incorporated into other more encompassing standards or marketing programs that they would be more appropriately associated with. AMS reiterates that the naturally raised standard was designed to stand alone or be used in conjunction with other marketing claims. For example, the naturally raised claim can be used in conjunction with other descriptive marketing claims such as ``grass (forage) fed.'' This flexibility is intended to allow producers to develop marketing plans incorporating a variety of appropriate standards, assuring that their products' characteristics are communicated to and understood by market participants.

Thus, while these comments regarding production practices were considered, they were not incorporated into the standard. Finally, the inclusion of poultry and dairy production requirements in the standard is outside the scope of the standard which is intended for livestock and the meat and meat products derived from such livestock. Use of Antibiotics, Growth Promotants, Health Treatments, and Pesticides and Chemicals

Comments: Many commenters agreed with the proposed standard that for naturally raised livestock, antibiotics should be prohibited at all stages of the animal's life. However, other commenters expressed that medical treatment should be allowed only when sick. One specific issue commenters raised involved the question of whether to allow coccidiostats for parasite control. The majority of the commenters who specifically commented on this topic were in favor of the use of coccidiostats/parasite control while
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others felt coccidiostats should not be allowed. AMS also received a few comments on whether the proposed standard should or should not allow vaccines. One commenter specifically stated that the proposed standard should address what is excluded rather than what is allowed. Regarding the use of growth promotants, many commenters agreed with the proposed standard that for naturally raised livestock growth promotants and hormones should be prohibited. Other commenters also suggested that the proposed standard should prohibit chemicals and use of pesticides.

Agency Response: AMS has incorporated a suggested revision to the proposed standard as a result of the comments received on this subject. In the proposed standard, coccidiostats, which include ionophores and sulfonamides, were prohibited. Based upon our evaluation of the comments and after further consideration of the issue, AMS has determined that coccidiostats in the form of ionophores (not sulfonamides) when used as a preventative measure for coccidiosis, as well as for the prevention and treatment of other types of parasitism, should be allowable. Coccidiosis is a parasitic disease of the intestinal tract of livestock animals, primarily of young or immune compromised animals. Coccidiosis is an infectious disease that causes either severe illness with possible death or subtle illness causing stress and debilitation of the animal, resulting in secondary disease that further jeopardizes the health of the animal. Treatment and control must include both good animal husbandry measures, as well as the use of anticoccidial drugs to prevent further disease and premise contamination. When marketed, the animals or meat product must be clearly identified with a statement that no antibiotics other than ionophores were used to prevent parasitism. Ionophores may only be used according to the manufacturer's label recommendations for coccidiostat levels (parasite control).

AMS has concluded that for the Naturally Raised Marketing Claim standard, the use of vaccines is acceptable and appropriate. The use of vaccines, according to manufacturers' label recommendations, is an important component of control and prevention of infectious diseases and protects against losses from disease in livestock herds. Vaccination is an essential part of good herd management and animal husbandry practices. AMS has also concluded that if antibiotics are used for medical treatment when animals are sick, the animals cannot be marketed as naturally raised. AMS has not incorporated standards related to the use of pesticides and chemicals because it is unclear whether the variation in practices from region to region would allow such a standard to meet the needs of producers throughout the Nation as they define and determine the scope of their programs and develop marketing plans.

Finally, AMS is clarifying the standard to make clear that production promotants are included within the term ``growth promotants.''
Additional Issues Raised Including Perceptions Associated With the Naturally Raised Claim

Comments: AMS received numerous comments comparing the Naturally Raised Marketing Claim standard to the FSIS label approval policies with respect to the term natural for meat products. Many commenters requested that AMS address what the commenters perceive as confusion between the terms natural and naturally raised. Some commenters felt that the Naturally Raised Marketing Claim should be linked to the FSIS policies regarding the use of the natural claim and that a single standard cover naturally raised livestock all the way to the meat product and meat processing (make naturally raised a class of natural); however, there were many other commenters who asserted that the naturally raised claim should continue to be distinct from the natural claim.

Many commenters tended to compare the Naturally Raised Marketing Claim standard to other marketing programs. Commenters requested that the Naturally Raised Marketing Claim standard not compromise other labels such as organic and Certified Naturally Grown. Some commenters requested that the requirements for a naturally raised standard be created at a higher threshold than organic, while other commenters thought it should be similar to organic or ``organiclike'', while others thought it was or should be ``organiclight''.

AMS received comments stating that the Naturally Raised Marketing Claim standard would contribute to confusion in the marketplace but also received other comments stating that the proposed standard provided clarity. Many commenters stated that the proposed standard would mislead consumers; however, other commenters stated that the proposed standard is a step in the right direction and is long overdue. Many commenters felt that single, separate standards (e.g., ``no antibiotics used,'' and ``no supplemental growth promotants administered,'' and ``no animal byproducts'') would indicate raising practices more accurately rather than one umbrella claim and urged AMS to abandon or withdraw the proposed naturally raised standard.

Some commenters also stated that the proposed standard would create a competitive disadvantage for small farmers and companies and confer an advantage on large corporate farms and businesses. Some commenters stated that the Naturally Raised Marketing Claim standard should be mandatory while other commenters asserted that the standard should be voluntary. A few commenters stated that the Government should not be involved with marketing claims and should leave the development of marketing claims to producers and industry.

Agency Response: AMS reiterates that the Naturally Raised Marketing Claim standard is independent of and distinct from FSIS label approval policies governing use of natural claims with regard to postharvest processing. The naturally raised claim pertains only to preharvest livestock production practices. AMS developed the Naturally Raised Marketing Claim standard to be a distinct standard. AMS is adopting this standard at this time because it fills a need that has been identified to AMS. Nonetheless, AMS recognizes that there is considerable merit in the comments that suggested that there is a need for AMS and FSIS to coordinate the definitions of `naturally raised' and `natural' to avoid creating consumer confusion. AMS and FSIS are committed to developing a coordinated approach to defining labeling terms that will maximize consistency and minimize differences when similar terminology is addressed by the two agencies. FSIS intends to address this matter in a forthcoming Federal Register document, and AMS will work with FSIS on that document. It is clearly distinguishable from the USDA organic standard, as well as from other marketing claims (e.g., grass fed) and similar programs.

AMS has concluded that the standard is clear, reasonable, and attainable. AMS believes this standard will create marketing opportunities for all businesses, small and large. AMS QSVP is voluntary and not mandatory. Producers will choose to comply with the standard, be certified by AMS, and/or place a claim on their product based on whether doing so would meet their production and marketing needs. They will not be required to do so.

Accordingly, AMS establishes the following voluntary U.S. Standard for
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Livestock and Meat Marketing Claims, by this notice.
U.S. Standards for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived From Such Livestock

Background: This claim applies to livestock used for meat and meat products that were raised entirely without growth promotants, antibiotics, and animal (mammalian, avian, and aquatic) byproducts derived from the slaughter/harvest processes including meat and fat, animal waste materials (e.g., manure and litter), or aquatic by products (e.g., fishmeal and fish oil).

The administration of growth promotants, including natural hormones, synthetic hormones, production promotants, estrus suppressants, beta agonists, or other synthetic growth promotants is prohibited from birth to slaughter. Collectively, these substances are referred to in the Naturally Raised Marketing Claim standard as ``growth promotants.''

No antibiotics can be administered, by any method (e.g., through feed or water, or by injection), from birth to slaughter. This includes lowlevel (subtherapeutic) or therapeutic level doses, sulfonamides, ionophores (except for ionophores used as coccidiostats for parasite control as long as the animals marketed or meat product label states no antibiotics other than ionophores were used to prevent parasitism), or any other synthetic antimicrobial. Ionophores may only be used according to manufacturer's label recommendations for coccidiostat levels (parasite control). If an animal is in need of medical attention, proper treatment should be administered in an attempt to improve the health of the animal. If any prohibited substances are administered, the treated animal must be identified and excluded from the program. Vitamin and mineral supplementation is permissible.

Verification of the claim will be accomplished through an audit of the production process. The producer must be able to verify for AMS that the Naturally Raised Marketing Claim standard requirements are being met through a detailed, documented quality management system.

Claim and Standard:

Naturally RaisedLivestock used for the production of meat and meat products that have been raised entirely without growth promotants, antibiotics (except for ionophores used as coccidiostats for parasite control), and have never been fed animal (mammalian, avian, or aquatic) byproducts derived from the slaughter/harvest processes, including meat and fat, animal waste materials (e.g., manure and litter), and aquatic byproducts (e.g., fishmeal and fish oil). All products labeled with a naturally raised marketing claim must incorporate information explicitly stating that animals have been raised in a manner that meets the following conditions: (1) No growth promotants were administered to the animals; (2) no antibiotics (other than ionophores used to prevent parasitism) were administered to the animal; and (3) no animal by products were fed to the animals. If ionophores used only to prevent parasitism were administered to the animals, they may be labeled with the naturally raised marketing claims if that fact is explicitly noted.

Authority: 7 U.S.C. 16211627.

Dated: January 13, 2009.
James E. Link,
Administrator, Agricultural Marketing Service.
[FR Doc. E91007 Filed 11609; 8:45 am]
BILLING CODE 341002P

FOR FURTHER INFORMATION CONTACT

Martin E. O'Connor, Chief, Standards, Analysis, and Technology Branch, Livestock and Seed Program, AMS, USDA, Room 2607S, 1400 Independence Avenue, SW., Washington, DC 202500254; facsimile: (202) 7201112; telephone: (202) 7204486; or email: Martin.OConnor@usda.gov. Additional information can also be found by accessing the Web site at http://www.ams.usda.gov/SAT.