Regulatory Comments and Petitions
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE
Petition for Rulemaking to Require )
Docket No. ______
submitted by the
CENTER FOR SCIENCE IN THE PUBLIC INTEREST
February 1, 2005
Hearing Clerk's Office
CITIZEN PETITIONThe Center for Science in the Public Interest ("CSPI")1 requests2 that the United States Department of Agriculture ("USDA") require that the foods that it regulates comply with the same allergen labeling standards that Congress established last year for foods regulated by the Food and Drug Administration ("FDA"). The USDA now permits but does not require food labels to clearly indicate the presence of allergens. The USDA's failure to mandate clear allergen labeling may jeopardize the health of food allergen-sensitive consumers by misleading them into thinking that foods regulated by the USDA are safe even though they actually contain major allergens when they do not clearly disclose the allergenic ingredients that all the foods regulated by the FDA must disclose beginning in January 2006.
I. Action RequestedThe Food Safety and Inspection Service ("FSIS") should amend its regulations on false or misleading labeling for meat and poultry products, 9 C.F.R. 317.8 and 381.129, to be consistent with the allergen labeling requirements of section 203 of the Food Allergen Labeling and Consumer Protection Act of 2003 ("FALCP Act"), Title II of P.L. 108-282 (attached).
The FALCP Act amends the Federal Food, Drug, and Cosmetic Act ("FFDCA") to provide that any ingredient in a food regulated by the FDA that is a major allergen defined as Crustacean shellfish, egg, fish, milk, peanuts, soybeans, tree nuts, and wheat must be listed by its ordinary name, such as "milk" rather than "whey" and "wheat" rather than "semolina." This allergen labeling requirement applies to flavoring, colors, and incidental additives and is mandatory beginning in 2006.3
The law provides two ways to comply with this requirement: (1) after the list of ingredients appears the word "Contains" followed by the name of the food source from which the major food allergen is derived or (2) the common or usual name of the major food allergen is followed in parentheses by the name of the food source from which it is derived.
II. Both Congress and the Food Safety and Inspection Service have determined that the failure to clearly disclose the presence of a major food allergen is a major public health concern.
Food allergens are a major public health problem. The Congressional findings in the FALCP Act state that approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies and that each year roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food.4
The USDA agrees that food allergens are a public health problem. In its "Allergens Voluntary Labeling Statements," the FSIS says "FSIS recognizes that there are many foods and food ingredients to which some individuals may have some degree of intolerance or possible allergic reaction. That is why complete labeling is so critically important."5
The USDA currently supports voluntary labeling for food allergens. The FSIS says "FSIS supports practices that promote accurate informative product labeling including voluntary statements on labels that alert people who have sensitivities or intolerances to the presence of specific ingredients. For example, a phrase such as 'Contains: milk, wheat, soy' has been accepted by the Agency on labeling immediately following the ingredients statement. Additionally, further clarification of the source of a specific ingredient in a parenthetical statement in the ingredients statement on labeling, e.g., 'whey (from milk),' is encouraged as a means of informing consumers who may be alerted to a more recognizable term."6
Thus, the FSIS already permits on a voluntary basis the two labeling formats that the FALCP Act mandates for foods regulated by the FDA.
III. The USDA's authority to prevent false or mislabeling labels gives it the legal basis for harmonizing its labeling regulations with the labeling requirements of the FALCP Act.
In passing the Federal Meat Inspection Act ("FMIA") Congress determined that "[i]t is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and meat food products distributed to them are properly marked, labeled and packaged."7 Congress made the same finding for poultry products in the Poultry Products Inspection Act ("PPIA").8
Section 1(n)(1) of the FMIA and section 4(h)(1) of the PPIA each provide that a food is misbranded "if its labeling is false or misleading in any particular."9 Section 7(d) of the FMIA and section 9(a)(2)(A) of the PPIA prohibit the sale of any food with a false or misleading label.10
The USDA used this legal authority in 1993 to require nutrition labeling. In 1990 Congress had passed the Nutrition Education and Labeling Act ("NLEA"), which amended the FFDCA to require certain nutrition information to be displayed on foods regulated by the FDA. In January 1993 the FSIS issued final regulations for nutrition labels for all meat and poultry products except single-ingredient, raw meat and poultry. The FSIS said it was trying to parallel the nutrition labeling requirements that the FDA issued at the same time pursuant to the NLEA.11 The FSIS said at that time that "it had statutory authority to require nutrition labeling based on the Secretary of Agriculture's determination that meat and poultry products, other than single-ingredient, raw products, would be misbranded in the absence of such information under section 1(n) of the FMIA and section 4(h) of the PPIA."12
Congress has determined that the failure to use ordinary names for major allergens (including those in flavorings, colors, and incidental additives13) is misleading to consumers when the foods are regulated by the FDA. In section 202(5) of the FALCP Act, Congress found that some of the current terms used for an ingredient "may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen; and in other cases the ingredient may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives." This Congressional finding indicates that foods regulated by the USDA would be misbranded if they do not comply with the labeling requirements of the FALCP Act.
Absent our requested action, beginning in January 2006 consumers may mistakenly believe that the absence of clear allergen information on a food regulated by the USDA means it does not contain a major allergen when in fact it may merely reflect the fact that the food is regulated by the USDA rather than the FDA.
In sum, the USDA has the legal authority to harmonize its labeling requirements with the labeling requirements of the FALCP Act. Failure to use this authority to harmonize its meat and poultry labeling regulations with the FDA's requirements would create a misleading impression on consumers, thereby rendering such products in violation of the FMIA and the PPIA.
Although it is unlikely that our requested changes in USDA's food labeling regulations would require a risk assessment and cost-benefit analysis by the Office of Risk Assessment and Cost-Benefit Analysis,14 the FSIS may be unable to issue final allergen labeling regulations by January 1, 2006 (when foods regulated by the FDA must comply with the FALCP Act's requirements). The USDA should, therefore, immediately announce that it is planning to propose such regulations in order to protect the pubic health15 and strongly encourage manufacturers to label their products in accordance with the proposed rule.
The undersigned certifies that to the best of his knowledge and belief this petition includes all information and views on which the petition relies and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
1 Petitioner Center for Science in the Public Interest, a nonprofit organization based in Washington, D.C., is supported by about 900,000 members in the United States and Canada who subscribe to its Nutrition Action Healthletter. CSPI has been working to improve the nation's health through better nutrition and safer food since 1971.
2 This petition is submitted pursuant to section 4(e) of the Administrative Procedure Act, 5 U.S.C. 553(e), 7 C.F.R. 1.28, and 58 Fed. Reg. 63570 (December 2, 1993).
3 The FALCP Act is very specific on the labeling that is required, and the allergen labeling requirements are mandatory beginning in January 2006 even if the FDA does not issue any final regulations by that date.
4 See section 202 (1) of the FALCP Act.
5 "Allergens Voluntary Labeling Statements" http://www.fsis.usda.gov/oppde/larc/ingedients/allergens.htm (visited January 3, 2005).
6 Id. The FSIS goes on to say "The Agency will consider any non-misleading symbols, statements, or logos that industry may want to include on labeling to inform consumers of the presence of potential food allergens in meat, poultry, or egg products. Requests to consider such features need to be submitted to the Agency as a policy inquiry, and not as label approval submissions." Id.
7 21 U.S.C. 602.
8 21 U.S.C. 451.
9 21 U.S.C. 601(n)(1) and 21 U.S.C. 453(h)(1).
10 21 U.S.C. 607(d) and 21 U.S.C. 458(a)(2)(A).
11 58 Fed. Reg. 632-665 (January 6, 1993) at 632. The nutrition labeling regulations are codified at 9 C.F.R. Part 317, Subpart B, and Part 381, Subpart Y.
12 58 Fed. Reg. at 637.
13 The Secretary of Agriculture has the legal authority to determine whether spices, flavorings, and colorings shall be listed separately or designated without naming each one. Section 1(n)(9) of the FMIA and section 4(h)(9) of the PPIA, 21 U.S.C. 601(n)(9) and 453(h)(9). The Secretary can use this legal authority to require that flavorings or colorings containing a major allergen be separately identified.
14 The Department of Agriculture Reorganization Act of 1994, 7 U.S.C. 2204e(b)(1), requires that the Secretary's Office of Risk Assessment and Cost-Benefit Analysis complete a risk assessment and cost-benefit analysis for each proposed major USDA regulation that relates to human health, safety, or the environment. The statute defines a "major regulation" as one that is likely to have an annual impact on the United States economy of at least $100 million in 1994 dollars. 7 U.S.C. 2204e(c). The only cost to the food industry of complying with our requested action is the printing of new labels, which are periodically reprinted in any event.
15 A similar issue has arisen with harmonizing the USDA's labeling requirements with the FDA's requirement that beginning in 2006 the amount of trans fat be disclosed. The FSIS has announced that it "is planning to publish a proposal that is consistent with FDA's rules to establish provisions in the Federal meat and poultry inspection regulations on trans fat declarations in the Nutrition Facts panel on product labeling. In the interim, FSIS will not object to the voluntary declaration of trans fatty acids in Nutrition Facts panels on labeling of food product under its jurisdiction if the declaration is made in accordance with FDA regulations published in the Federal Register on July 11, 2003, that amend 21 CFR part 101." "Trans Fat Declaration in the Nutrition Facts Panel on Product Labeling" http://www.fsis.usda.gov/oppde/larc/policies/transfat.htm (visited January 6, 2005).
Attachment: section 203 of the Food Allergen Labeling and Consumer Protection Act of 2003, P.L. 108-282
Section 203 of P.L. 108-282
FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING ALLERGENIC SUBSTANCES.
(a) IN GENERAL- Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
`(w)(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either--
`(A) the word `Contains', followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or
`(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when--
`(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or
`(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 201(qq)(2)(A) or (B).
`(2) As used in this subsection, the term `name of the food source from which the major food allergen is derived' means the name described in section 201(qq)(1); provided that in the case of a tree nut, fish, or Crustacean shellfish, the term `name of the food source from which the major food allergen is derived' means the name of the specific type of nut or species of fish or Crustacean shellfish.
`(3) The information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.
`(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.
`(5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Secretary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health.
`(6)(A) Any person may petition the Secretary to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection.
`(B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by the Secretary and the petitioner.
`(C) The burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.
`(D) A determination regarding a petition under this paragraph shall constitute final agency action.
`(E) The Secretary shall promptly post to a public site all petitions received under this paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary's response to each.
`(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing--
`(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or
`(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409.
`(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.
`(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary.
`(x) Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.'.
(b) EFFECT ON OTHER AUTHORITY- The amendments made by this section that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens.
(c) CONFORMING AMENDMENTS-
(1) Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by section 102(b)) is amended by adding at the end the following:
`(qq) The term `major food allergen' means any of the following:
`(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
`(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:
`(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.
`(B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).'.
(2) Section 403A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking `or 403(i)(2)' and inserting `403(i)(2), 403(w), or 403(x)'.
(d) EFFECTIVE DATE- The amendments made by this section shall apply to any food that is labeled on or after January 1, 2006.