108th Congress

Food Allergies Research

P.L. 108-282 (S. 741, H.R. 2079)

Impact of Public Law

P.L. 108-282, the Minor Use and Minor Species Animal Health Act of 2004, amends the Food, Drug, and Cosmetic Act authorities related to conditional approval and designation of new animal drugs, food labeling requirements for information regarding allergenic ingredients in food consumed by humans, improvement and publication of data on food-related allergic responses, and inspections related to food allergens. The Act also contains the following research-related provisions:

• Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to convene an ad hoc panel of nationally known experts in the fields of allergy and immunology to review current basic and clinical research activities related to food allergies
• Requires the panel to make recommendations to the Secretary regarding the enhancement and coordination of food allergies research not later than 1 year after the date of enactment of the Act. The Secretary is required to make these recommendations public.

Legislative History

There is longstanding concern regarding the adequacy of drugs available for use in minor species (sheep, deer, game birds, catfish, and other aquatic species) and the lack of incentives for animal pharmaceutical manufacturers to invest in the development of relevant products. In response to these concerns, legislation was introduced to specifically address product development and approval issues.

Advocates are also increasingly vocal regarding the need for more stringent requirements for labeling of food products for known allergens and their derivatives in order to make labels more informative for people with food allergies. Their efforts resulted in the inclusion of relevant amendments to the above-mentioned legislation.

S. 741 was introduced by Senator Jeff Sessions (R-AL) on March 27, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions. On November 21, the measure was marked up, amended to include food labeling and food allergies research provisions, and ordered to be reported. S. 741 was reported out of the Senate Committee on Health, Education, Labor and Pensions on February 18, 2004, as amended and was passed by the Senate on March 8. Following receipt in the House, the measure was referred to the House Energy and Commerce Subcommittee on Health on June 14 and was marked up the following day. The House Committee on Energy and Commerce held its mark up on June 24 and reported out the measure on July 15. On July 20, the House passed S. 741 by a two-thirds majority vote. The President signed the measure on August 2 as P.L. 108-282.

H.R. 2079 was introduced by Representative Charles “Chip” Pickering, Jr. (R-MS) on May 15, 2003, and was referred to the House Committee on Energy and Commerce. Like S. 741, the bill as introduced did not contain food labeling or food allergies research provisions. No further action occurred on this legislation.