06-9546. Product Labeling: Definition of the Term “Natural”

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of petition and public meeting; request for comments.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing receipt of a petition from Hormel Foods to establish a definition for the voluntary claim “natural” and to delineate the conditions under which the claim can be used on the labels of meat and poultry products. The use of the claim “natural” is an issue of significant interest to the Agency, to industry, and to the public. Therefore, the Agency is inviting comments on the issue generally and on the petition and, to facilitate the comment process, is announcing that it will hold a public meeting to discuss the petition. After the comment period closes, FSIS will initiate rulemaking on the claim “natural.” The Agency has decided to initiate rulemaking because it is the most appropriate, open, and transparent method to deal with issues surrounding the definition and use of the claim “natural.”

DATES:

The public meeting will be held on Tuesday, December 12, 2006, from 9 a.m. to 1 p.m. Comments on this notice must be received by January 11, 2007.

ADDRESSES:

The public meeting will be held in the rear of the Cafeteria, South Agriculture Building, United States Department of Agriculture (USDA), 1400 Independence Avenue, SW., Washington, DC 20250.

FSIS invites interested persons to send comments on this notice. FSIS will finalize an agenda on or before the meeting date and will post it on the FSIS Internet Web page http://www.fsis.usda.gov/​News?​Meetings_​&​_​Events/​. The petition discussed in this notice is available for viewing by the public in the FSIS Docket Room (see address below) and on the FSIS Web site at: http://www.fsis.usda.gov/​News?​Meetings_​&​_​Events/​. The official transcript of the meeting will be available for viewing by the public in the FSIS docket room and on the FSIS Web site http://www.fsis.usda.gov/​News?​Meetings_​&​_​Events/​ when it becomes available.

Comments on this notice may be submitted by any of the following methods:

• Mail, including floppy disks or CD-ROM's, and hand-or courier-delivered items: Send to FSIS Docket Room, Docket Clerk, USDA, FSIS, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 20250.
• Electronic mail: [e-mail].
• Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulation.gov and in the “Search for Open Regulations” box, select “Food Safety and Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select FDMS Docket Number 2006-0040 to submit or view public comments and to view supporting and related materials available electronically.

All submissions received by mail or electronic mail must include the Agency name and docket number 2006-0040. All comments sent in response to this document, as well as research and background information used by FSIS in developing this document, will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. Comments will also be posted on the Agency's Web site at http://www.fsis.usda.gov/​regulations_​&​_​policies/​regulations_​directives_​&​_​notices/​index.asp.

FOR FURTHER INFORMATION CONTACT:

For technical information: Dr. Robert C. Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program, and Employee Development, USDA, FSIS, 1400 Independence Avenue, SW., Washington, DC 20250, [phone], FAX: [phone], e-mail: [e-mail].

Pre-registration for this meeting is recommended. To pre-register, please contact Diane Jones by telephone at [phone] or be e-mail at [e-mail]. Persons requiring a sign language interpreter or special accommodations should contact Ms. Jones as soon as possible.

SUPPLEMENTARY INFORMATION:

Background

FSIS is the public health regulatory agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and truthfully labeled and packaged. In particular, FSIS develops and implements national policies to ensure that meat, poultry, and egg product labeling is truthful and non-misleading.

Labeling Guidance on the Voluntary Claim “Natural”

To guide manufacturers in the development of labeling that FSIS was likely to determine to be truthful and not misleading with regard to the voluntary claim “natural,” FSIS published policy guidance in the form of Standards and Labeling Policy Memorandum (Memo) 055, dated November 22, 1982. The policy guide states that the term “natural” may be used on labeling for meat products and poultry products provided that the applicant for such labeling demonstrates that:

(1) The product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed. Minimal processing may include: (a) Those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) those physical processes that do not fundamentally alter the raw product or that only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices. Relatively severe processes, e.g., solvent extraction, acid hydrolysis, and chemical bleaching, would clearly be considered more than minimal processing. Thus, the Policy Memo explained, the use of a flavor or flavoring, for example, that has undergone more than minimal processing would, in general, mean that a product in which the ingredient is used could not be called “natural.”

The Policy Memo acknowledged, however, that there are exceptions to this general view, and that the presence of an ingredient that has been more than minimally processed would not necessarily preclude a product from being promoted as “natural.” The Policy Memo stated that exceptions of this type would be granted on a case-by-case basis if it could be demonstrated that the use of such an ingredient would not significantly change the character of the product to the point that it could no longer be considered a “natural” product. In such cases, the “natural” claim would have to be qualified to clearly and conspicuously identify the ingredient, e.g., “all natural ingredients except dextrose, modified food starch, etc.”

Policy Memo 055 further stated that all products claiming to be “natural” or a “natural” food should be accompanied by a brief statement that explains what is meant by the term “natural,” i.e., that the product is a “natural” food because it contains no artificial ingredients and is only minimally processed. This statement should appear directly beneath or beside all “natural” claims or, if elsewhere on the principal display panel of the label, an asterisk should be used to tie the explanation to the claim.

According to the 1982 policy, the decision of the Agency to approve or deny the use of a “natural” claim may be affected by the specific context in which the claim is made. For example, claims indicating that a product is “natural” food, e.g., “natural” chili or “chili—a “natural” product” would be unacceptable for a product containing beet powder which artificially colors the finished product. However, “all natural ingredients” might be an acceptable claim for such a product.

Since 1982, except for the conditions in points (1) and (2) of the Policy Memo stated above, FSIS modified the guidance on occasion to make it consistent with prevailing policies, to reflect case-by-case decisions made by the Agency, and to update references to regulations. In August 2005, FSIS modified the guidance by acknowledging that sugar, sodium lactate (from a corn source), and natural flavorings from oleoresins or extractives could be acceptable for products bearing “natural” claims.

The Agency has come to recognize, based on the controversy that has arisen about “natural” in recent months, that there is significant disagreement about aspects of the August 2005 policy modification, particularly the recognition of sodium lactate as an ingredient that could be included in products that bear a “natural” claim. The Agency has received information that raises questions about when, and if, a food to which sodium lactate has been added would be fairly characterized as “natural.” The Agency has come to believe that this question, like numerous others alluded to in this document, is best resolved through a rulemaking process. Therefore, FSIS has removed the reference to sodium lactate from the 2005 modification. As the Agency moves through the stages of rulemaking on “natural,” “natural” claims for foods in which sodium lactate is used will continue to be considered by FSIS on a case-by-case basis, in light of factors such as the level used, the claimed technical effect of the sodium lactate, and the actual effect that it is having on the product.

Advances in Food Processing

In recent years, the longstanding policy on “natural” has been challenged by advances in food processing and in packaging methods, e.g., the use of techniques such as high pressure processing, food ingredients that are regulated to provide multiple technical effects, and modified atmosphere packaging. The value and integrity of the 1982 policy is challenged further by new uses of ingredients that have previously been used for flavoring purposes, for example, as antimicrobial agents. While the food safety purpose of using antimicrobial agents is important, their effects raise questions as to whether they can be used in products labeled “natural.”

Petition

On October 9, 2006, Hormel Foods submitted a petition to FSIS for rulemaking to codify in the Federal meat and poultry inspection regulations a definition of “natural.” The petitioner requested that FSIS begin rulemaking procedures to clarify the circumstances in which the claim may be used on the labeling of a meat or poultry product. The petition states that, consistent with FSIS's longstanding policy, a meat or poultry product should not be labeled as “natural” unless (1) It does not contain artificial flavorings, artificial coloring ingredients, other artificial or synthetic ingredients, or chemical preservatives; and (2) it is not more than minimally processed. The petition further states that consumer confidence and consistency in labeling dictate that exceptions for specific chemical preservatives and synthetic ingredients should not be allowed.

In support of the need for a regulatory definition of “natural,” the petition explains that consumer interest and concern in natural products are rising. Meat and poultry food manufacturers are seeking to establish marketing presence in this growing area of labeling. The petitioner cites the difficulty in maintaining a level playing field among manufacturers wishing to establish a marketing presence with FSIS's acceptance of ingredients such as sodium lactate and the AMS National Organic Program “national list” of food substances as a reference to support that such ingredients may be considered “natural.” According to the petition, as a result, there is a significant likelihood of inconsistent guidance that provides an opportunity for food manufacturers to manipulate exceptions in the policy and to undercut the intent for “natural” labeling. The petitioner requests that the Agency conduct rulemaking regarding the claim “natural” to provide clarity and certainty in its use of product labeling in the interest of consumer protection and consumer confidence in labeling.

Public Meeting

FSIS is holding a public meeting in order to gain public input on the use of the “natural” claim and the points raised by the petition, the ideas set out in this notice, and the impact of possible changes discussed herein. Following the public meeting, the Agency intends to initiate rulemaking on “natural” claims.

In order to benefit from this public meeting, FSIS seeks input on the following questions concerning the petition discussed above:

1. Considering the types of food processing methods that are commonplace today, as opposed to 24 years ago when the policy on “natural” claims was established, is it reasonable to include as part of the definition of “natural” a stipulation that products, to be eligible to bear the claim, can be no more than minimally processed? Are there any accommodations necessary to allow for certain operations because food processing and packaging techniques for enhancing safety may disqualify a product as “natural?”

2. What are the implications and conflicts that exist with regard to using current and new food processing methods, e.g., chlorine in poultry chillers; steam pasteurization of carcasses; high pressure processing; and modified atmosphere packaging and uses of certain classes of ingredients, e.g., antimicrobial agents, and the meaning of the claim “natural” on the labels of meat and poultry products?

3. Are there available data, in addition to the data provided in the petition, from consumer studies on views, perceptions, and beliefs about what the claim “natural” means on the labels of food products, including meat and poultry products? What do consumers think that the terms “minimal processing,” “artificial and synthetic,” and “preservatives” mean?

4. Do food safety and consumer protection benefits of using what historically may have been considered more than minimal processing techniques and antimicrobial agents outweigh conflicts with the meaning of “natural?” In recent years, FSIS has put a great deal of emphasis on improving food safety. In some ways, however, some definitions of “natural” might unnecessarily undercut this objective. For example, some definitions of “natural” could discourage the use of antimicrobials, which are used to reduce and prevent the growth of Listeria monocytogenes in foods. The Agency seeks comment on how it best determines an appropriate and rational balance between the need to ensure the safety of the food supply and the need to ensure that labels are truthful and not misleading.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov/​regulations/​2006_​Notices_​Index/​. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to constituents and stakeholders. The update is communicated via Listserv, a free electronic mail subscription service for industry, trade and farm groups, consumer interest groups, allied health professionals, and other individuals who have asked to be included. The update is available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/​news_​and_​events/​email_​subscription/​. Options range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their account.

Done at Washington, DC on: December 1, 2006.

Barbara J. Masters,

Administrator.