Food Labeling Law, 2006

[Jean]

Here's the new law. The first part is a summary, followed by the whole technical thing.


Title: A bill to amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes.

SUMMARY:
Passed 8/2/2004--Public Law No: 108-282

Title II: Food Allergen Labeling and Consumer Protection - Food Allergen Labeling and Consumer Protection Act of 2004 - (Sec. 203) Amends the Federal Food, Drug, and Cosmetic Act to require a food that contains, or is derived from, a major food allergen to indicate that information on its label. Defines "major food allergen" as any of the following: milk, eggs, fish, Crustacea, tree nuts, wheat, peanuts, and soybeans. Provides that the labeling requirement must be met by stating the common or usual name of the food allergen in the list of ingredients or by other methods allowed by the Secretary. Requires allergens in flavoring, coloring, or incidental additives to also be labeled in accordance with these requirements.

(Sec. 204) Requires the Secretary to issue a report to Congress that: (1) analyzes the ways in which foods are unintentionally contaminated with major food allergens during manufacturing and processing; (2) estimates how common this contamination is; (3) advises whether good manufacturing practices or other methods can be used to reduce or eliminate this contamination; (4) describes the various types of advisory labels used by food processors, the manufacturing conditions associated with these labels, and the extent to which such labels are used; (5) describes how consumers with food allergies would prefer contamination information to be provided; (6) describes the inspections that have occurred and the violations discovered; and (7) assesses the extent to which contamination has been effectively addressed.

(Sec. 205) Directs the Secretary to inspect facilities to ensure that the facilities comply with practices to reduce or eliminate contamination and properly label food allergens.

(Sec. 206) Requires the Secretary to define and permit use of the term "gluten-free" on food labels.

(Sec. 207) Directs the Secretary, acting through the Director of the Centers for Disease Control, to improve the collection of, and publish national data on, the prevalence of food allergies, the incidence of serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to food. Authorizes appropriations.

(Sec. 208) Requires the Secretary, acting through the Director of the National Institutes of Health, to convene a panel of nationally recognized experts to review basic and clinical research efforts related to food allergies and to recommend ways to enhance and coordinate research activities concerning food allergies.

(Sec. 209) Directs the Secretary, in the Conference for Food Protection, to pursue certain revisions of the Food Code to provide guidelines for preparing allergen-free foods in food establishments.

(Sec. 210) Requires the Secretary to include technical assistance on the use of different modes of treatment for, and prevention of, allergic responses with the technical assistance provided to States and local agencies relating to trauma care and emergency medical services.



THE WHOLE THING

Title II
The intent of Title II of S. 741 is to require plain English ingredient labeling of products that contain milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans--collectively referred to as the eight major food allergens. This legislation amends the FFDCA to require that food ingredient statements identify in plain English when the food contains a major food allergen, including when a major food allergen is contained in flavorings, colorings, and incidental additives.

The legislation requires the Secretary of Health and Human Services (the Secretary) to issue a report to Congress about food allergen cross-contact, advisory labeling and food allergen inspections. The Secretary is required to conduct food allergen inspections under existing authority under the FFDCA.

This legislation provides for enhanced surveillance and for recommendations related to research concerning food allergens. The Centers for Disease Control and Prevention (CDC) is called upon to track food-allergic-related deaths and other clinically significant and serious adverse events. Additionally, the National Institutes of Health (NIH) is directed to convene a panel of experts to develop recommendations for research activities concerning food allergies.

This legislation directs the Secretary to pursue revision of the Food Code to provide guidelines for preparing allergen-free foods in food establishments. It also directs the Secretary to provide technical assistance relating to emergency treatment of allergic responses to foods.

Further, this legislation requires the Secretary to define by regulation the term `gluten-free' for voluntary use in food labeling.


IV. EXPLANATION OF BILL AND COMMITTEE VIEWS
Requirement of plain English labeling of the eight major food allergens

The legislation amends section 201 of the FFDCA to define the term `major food allergen.' It is defined to mean the eight most significant food allergens--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--and any food that contains protein derived from one of these eight food allergens (except for highly refined oils, ingredients derived from highly refined oils, and other food ingredients that are exempt under the legislation). Fish, Crustacean shellfish, and tree nuts are collective names that include a variety of different items. For example, the term `tree nuts' refers to a variety of individual nuts, including almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts. The term `Crustacean shellfish' refers to crabs, crawfish/crayfish, lobster, prawns, and shrimp. The term `fish' refers to a variety of different species of fish.

The committee has provided that food ingredients containing protein derived from milk, eggs, fish, shellfish, peanuts, tree nuts, wheat, or soybeans may nevertheless be excluded from the definition of `major food allergen' under one of three exceptions. First, highly refined oils and ingredients derived from highly refined oils are excluded from the definition of `major food allergen.' `Highly refined oils' are intended to signify refined, bleached, deodorized (RBD) oils. The committee notes, however, that the legislation does not change the common or usual name of highly refined oils; that is, highly refined oils would still be required to be identified by their common and usual name in the ingredient list, e.g., `peanut oil.' Second, the committee has also excluded from the definition of `major food allergen' food ingredients for which the Secretary has determined, based on scientific evidence presented in a petition, that the food ingredient does not cause an allergic response that pose a risk to human health.

Finally, the committee has provided for a notification process to exclude from the definition of a major food allergen those food ingredients that contain protein derived from one of the major eight protein sources but do not contain the allergenic protein and for food ingredients for which the Secretary has previously made a determination that the use of 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 of the FFDCA. The committee recognizes that the GRAS notification process is not included as part of this exception. The committee encourages FDA to adopt a reasonable standard for determining whether a food ingredient `does not contain an allergenic protein.' For example, while the committee recognizes that thresholds for the major eight allergens have not yet been established by the scientific community, if they are established, ingredients containing allergenic proteins below the established threshold would be eligible for the notification procedure.

The committee intends that the Secretary will provide guidance to industry on the information that would be useful for making a determination that foods that contain protein derived from one of the eight food allergens do not cause an allergic response that poses a risk to human health. The committee also intends that the Secretary provide an appropriate process for providing such information to the Secretary that minimizes the burden on the food manufacturer.

The legislation requires FDA to post the petitions and notifications for exemption from allergen labeling to a public site as well as FDA's responses to such petitions and notifications. In instances when FDA concludes that a notification or petition has provided data demonstrating that the food ingredient should be exempt from the definition of `major food allergen,' the exemption will apply to any product bearing or containing the ingredient under the same conditions of use described in the notification or petition.

The legislation also amends section 403 of the FFDCA to provide two new misbranding provisions. The first of these, section 403(w), requires that the eight major food allergens be labeled on foods that are not raw agricultural products. Under section 403(w), manufacturers will have two options as to how they must label the eight major food allergens on such foods. Under either plain English allergen labeling option, the term for a major food allergen--milk, egg, wheat, peanuts, soybeans, or, in the case of the collective terms `fish,' `Crustacean shellfish,' or `tree nuts,' the common or usual name for the relevant specific members of the class, such as `cod,' `shrimp,' or `almond'--will appear in the food label if the food is, or it bears or contains, a major food allergen as defined in section 201(qq). These plain English allergen labeling requirements apply only to foods for which an ingredient list is required in a label or labeling under the FFDCA.

Manufacturers may choose to summarize the allergen information using the terms for the major food allergens from which any ingredients in the food are derived in a statement at the end of, or immediately adjacent to, the ingredient list. This information must appear in a type size no smaller than the type size used in the ingredient list.

Alternatively, manufacturers may place the term for the appropriate major food allergen in parentheses within the ingredient list after the common or usual name of the ingredient derived from that major food allergen. There are two exceptions to this requirement. First, the listing of the term for the food allergen is not required to appear in parentheses after an ingredient name if the ingredient name uses the term for the major food allergen (for example, `milk' need not appear in parentheses after `milk' or `milk by-product,' nor need `almond' appear after `almond'). Second, the term for a food allergen need not be placed after an ingredient if the term for that food allergen appears elsewhere in the ingredient list; the food allergen term need only appear once in the ingredient statement, 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 excluded from the definition of a major food allergen. For example, if a food contained highly refined peanut oil and a natural flavoring containing peanut as a constituent, the term `peanut' would have to appear in parentheses after `natural flavoring' in the ingredient list, because peanut oil is not a `major food allergen' under this legislation.

These two options can be illustrated by an example. If a food were to have as ingredients semolina, rice flour, rolled oats, pine nuts, tomato juice, whey, sodium caseinate, and natural flavoring, with the natural flavoring including peanuts as a constituent, the major food allergens in the food could be labeled in two ways. First, the following statement could appear at the end of, or immediately adjacent to, the list of ingredients: `Contains wheat, milk, pine nuts, and peanuts.' Second, the ingredient list could read: `Ingredients: semolina (wheat), rice flour, rolled oats, pine nuts, tomato juice, whey (milk), sodium caseinate, and natural flavoring (peanuts).'

These two examples illustrate several aspects of the allergen labeling requirements. In the second example, `milk' does not appear in parentheses after `sodium caseinate' because it has already appeared after `whey.' In the examples, the natural flavoring includes peanuts as a constituent and so peanut is labeled as an allergen in the food. In other words, the food allergen labeling requirement applies to flavorings, colorings, and incidental additives. Only the peanut constituent of the natural flavoring ingredient is identified, however; the other constituents of the flavoring--or indeed of any coloring or incidental additive--are not required to be listed under either plain English labeling option permitted under the legislation.

The term `pine nuts' is in the summary of allergy information in the first example, but it need not appear after `pine nut' in the ingredient list in the second example because the repetition is unnecessary. The first example illustrates the committee's intent that the term for the relevant specific member of the class `fish' or `Crustacean shellfish' or `tree nuts' is required to be used whenever an ingredient is, or is derived from, an example from one of these food categories. The second example illustrates the committee's intent that an ingredient whose common or usual name uses the term for the major food allergen--in the example, `pine nuts' clearly uses the term for pine nuts--need not be followed by a parenthetical repeating the term. Finally, all major food allergens are required to be labeled consistently on the food label: either in the summary of allergen information at the end of, or immediately adjacent to, the ingredient list, or using parentheses after ingredients.

The committee intends that the use of the term `milk' in either of these examples does not violate the standard of identity for milk established under FDA regulations. Used in this context, the term `milk' is used to identify a major food allergen and not the identity of the ingredient or the food.

The legislation gives FDA the authority to modify or eliminate these requirements by regulation. This authority is limited in a few respects, however. First, FDA may modify one or both labeling options. Second, FDA may not eliminate all major food allergen labeling by eliminating both labeling options; rather, FDA may eliminate only one of the approaches. Third, and most significantly, FDA must demonstrate in the regulation that modification or elimination of an allergen labeling requirement is necessary to protect public health. The committee considers this standard to impose a high burden on the Secretary to justify changing these requirements of the legislation.

In addition, the legislation amends section 403A of the FFDCA to give the modification to the ingredient label required by section 403(w) the same preemptive effect over State and local ingredient labeling that the current ingredient labeling has.

The committee understands that many manufacturers have already labeled their foods in conformity with one of the plain English allergen labeling options, and it expects that most foods will be labeled in compliance with these requirements before January 1, 2006. In any case, all foods that contain an ingredient that is or that contains a major food allergen must be labeled by January 1, 2006. This fixed date by which all affected foods must be labeled in accordance with these requirements will give consumers greater certainty that they will be able to rely on food labels as of that date. Importantly, this requirement does not require the relieving of food products that are in the marketplace before the effective date. In other words, this legislation does not require food products to be pulled from the marketplace and relabeled in conformance with the requirements of this legislation if they were labeled before January 1, 2006.

The committee intends the requirements of section 403(w) to be self-implementing. FDA will not be required to issue regulations to implement section 403(w). FDA may issue guidance, should the agency find that guidance would assist manufacturers or distributors, particularly small businesses, to comply with the requirements in this legislation.

The legislation also adds a second misbranding provision to account for other food allergens. In particular, section 403(x) provides that FDA has the authority to require by regulation appropriate labeling of any spice, flavoring, coloring, or incidental additive ingredient that is, or includes as a constituent, a food allergen that is not a major food allergen. The committee does not intend the listing of all spices or flavorings in a product but intends that the Secretary will require the food allergen to be identified on the label in a manner consistent with this legislation. In addition, the legislation provides that the amendments made by it do not otherwise alter FDA's authority to require the labeling of other food allergens that are not major food allergens. Finally, the legislation amends section 403A of the FFDCA to give requirements under section 403(x)--which provides for an exception to a current labeling exemption for spices, flavorings, colorings, and incidental additives that has preemptive effect over State and local labeling requirements--the same preemptive effect over State and local labeling requirements that the current exemption has.

Food allergy surveillance, research, and response

The committee is concerned that the prevalence of food allergies is uncertain and the incidence of clinically significant and serious adverse events is not being systematically monitored. In response to these concerns, the legislation requires the Centers for Disease Control and Prevention to better capture information on the prevalence of food allergies, the incidence of clinically significant or serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to foods. In addition, the legislation requires the National Institutes of Health to convene a panel of nationally recognized experts to review current clinical research efforts and develop recommendations for enhancing and coordinating research activities concerning food allergies.

The legislation directs the Secretary, in the Conference for Food Protection, to pursue revision of the Food Code to provide recommendations and guidance on preparing allergen-free foods in food establishments. The Secretary should refer to private guidelines, including the Food Allergy and Anaphylaxis Network and Food Allergy Initiative's document entitled: Food Allergy Training Guide for Restaurants and Food Services, as a model during development.

Finally, the legislation directs the Secretary to provide technical assistance to States and localities about treatment of food allergic responses by trauma care and emergency medical services. Currently, the preferred treatment for anaphylaxis from food allergy is an auto-injector epinephrine device. The legislation does not specify this treatment, so that the Secretary will continue to provide such technical assistance as new treatments are developed.

Celiac disease and gluten labeling

The legislation directs the Secretary, after consulting with appropriate experts and stakeholders, to promulgate a regulation to define and permit the use of the term `gluten-free' as a voluntary claim on the food label. The committee intends that this `gluten-free' claim not be a claim for special dietary use, a nutrient content claim, or a health claim. The legislation requires that the proposed rule regarding this claim be issued not later than 2 years after the date of enactment of the legislation, and that the final rule be issued not later than 4 years after the date of enactment of the legislation.