A Brief History of Bioterrorism Legislation

By Keller and Heckman LLP’s Packaging Practice Group

Fall 2001: an Intense Congressional Session

In the aftermath of the terrorist attacks of September 11, 2001, the protection of U.S. citizens against further terrorist threats became the top priority for the federal government. There was an overwhelming conviction that every effort had to be taken to minimize the risks that any similar attacks could be carried out successfully in the future, to anticipate any potential vulnerability on American territory, and to take immediate action to protect any such potential target from terrorists.

In this context, Congress was determined to act quickly to ensure the safety of the food supply in this new era of bioterrorist threats, because food is a vulnerable medium for spreading infectious diseases. Discussions of a single food safety agency were revived, and there was generally broad support for increased funding for food safety and agriculture counterterrorism programs. Unfortunately, the story that follows shows the truth in that age-old expression: "There are two things you don't want to see being made "sausage and legislation."

Several bills were quickly introduced, with emotions running high in Congress Senator Hillary Rodham Clinton (D-N.Y.) introduced two bills. The first, entitled "Protecting the Food Supply from Bioterrorism Act" (S.1551), offered to provide FDA with the authority, long sought by some, to recall and detain immediately any contaminated food. The second would allow FDA to inspect food processing facilities overseas to ensure they met U.S. safety standards, and would grant more funding to improve testing and surveillance technology so that inspectors could identify food pathogens more quickly.

A House bill, the "Imported Food Safety Act of 2001" (H.R. 3075), proposed:

• to grant FDA authority over imported food similar to the authority granted to the U.S. Department of Agriculture (USDA) over imported meat and poultry;
• to establish a system of country-of-origin labeling and user fees for imported food to fund a significant increase of border inspections and detection of food contamination; and
• to establish severe criminal penalties for the intentional contamination of food.

In addition, Senator Richard Durbin (D-Ill.) introduced the "Safe Food Act of 2001" (S.1501), seeking to create a single food agency.

Late 2001: Two Bioterrorism Bills Emerge

In December 2001, after much debate and more bills introduced in both the House and Senate, the "Public Health Security and Bioterrorism Response Act of 2001" (H.R. 3448) was introduced as a bipartisan effort by Reps. W.J. "Billy" Tauzin (R-La) and John Dingell (D-Mich). On December 12th, only a few days after its introduction, the bill was approved overwhelmingly by the House. The bill, which contained the main elements of the Bioterrorism Act as finally enacted,

• provided FDA with authority to detain articles of food for up to 30 days if there is credible evidence or information that such article presents a threat of serious adverse health consequences,
• imposed registration requirements on facilities located anywhere in the world manufacturing, processing, packing or holding food for consumption in the U.S.,
• required a 24-hour advance notice for imports of articles of food into the U.S., and
• imposed recordkeeping requirements for articles of food.

The Senate had its own version of the bipartisan bill, introduced by Sens. Edward Kennedy (D-Mass) and William Frist (R-Tenn), and adopted as the "Bioterrorism Preparedness Act of 2001" (S.1765). In addition to essentially the same provisions found in H.R. 3448, S.1765 added clauses to increase security at various agencies, guard facilities against potential bioterrorist attacks, and prevent the theft of biological agents and toxins. The Senate bill also added provisions granting increased funding to FDA and USDA to improve their inspection capacity and to conduct research and training to enhance food safety and security.

In reviewing both bioterrorism bills, attorneys at Keller and Heckman LLP (K&H), became concerned that Congress was using the broad definition of "food" from the Federal Food, Drug, and Cosmetic Act (FFDCA). This definition extends to food packaging and other food-contact materials in many applications. K&H, acting on behalf of its longstanding client, The Society of the Plastics Industry, Inc. (SPI), and SPI's Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC), contacted Congress to inform legislators and their staffs about its concerns. The firm's contacts on Capitol Hill were shocked to learn that their bills could be interpreted to extend to packaging materials not yet in contact with food. They recognized that the provisions for registration of facilities, import notification, and recordkeeping would be very burdensome on suppliers of packaging materials, without a commensurate improvement in public safety. Everyone agreed that terrorists are highly unlikely to attack the food supply indirectly by contaminating packaging materials. Nevertheless, Congress was determined to pass this legislation quickly, and would not entertain amendments. Faced with this dilemma, K&H pursued the only available option—a declaration of congressional intent in the record of deliberations on the bills, known as "legislative history."

May 2002: Bioterrorism Legislation Is Adopted by House and Senate, K&H Obtains Clarification of Scope

K&H and SPI convinced the House and Senate to clarify that congressional intent did not envision extending provisions such as prior notice of food imports and registration of food facilities to food-contact materials. As a result of these efforts, Congress inserted into the record language indicating that the prior notice of imported food does not apply to packaging materials:

The Managers intend that the requirements of this section [import notification] should not be construed to apply to packaging materials if, at the time of importation, such materials will not be used for, or in contact with, food as defined under section 201 of the FFDCA. Nothing in this section shall be construed to alter or amend the regulatory treatment of food packaging materials or food contact substances under the FFDCA.

Recognizing that this language was less than completely clear, in response to K&H's request for clarification, Rep. John Shimkus (R-Ill), the manager of the bill in the House, also offered comments which appeared in the Congressional Record of May 24, 2002, confirming that the prior notice requirements for imported food shipments do not apply to food packaging materials:

Mr. Speaker, in addition to my statement for the record on May 22, 2002 during floor consideration of H.R. 3448, let me clarify that language included in the Conference Report regarding Section 307 as it relates to food packaging materials. Section 307 dealing with prior notice of imported food shipments should not be construed to apply to food packaging materials or other food contact substances if, at the time of importation, they are not used in food.

Unfortunately, Congress did not provide such explicit clarification of its intent regarding the registration requirement for food facilities or recordkeeping Nevertheless, K&H and SPI were hopeful that, in issuing regulations to implement the legislation, FDA would recognize that Congress did not intend most of the bioterrorism legislation to apply to empty food packaging or packaging materials. K&H and SPI did not ask that packaging be exempt from administrative detention, which would apply only if FDA has credible evidence of a threat of serious injury or death.

February 2003: FDA Proposes Bioterrorism Regulations, Misses Congressional Intent

The Public Health Security and Bioterrorism Preparedness and Response Act was signed into law June 12, 2002. Under the Act, FDA was required to promulgate four sets of regulations to implement the provisions of the Act relating to registration, import notice, and recordkeeping requirements, and set forth procedures to implement the Agency's new detention authority. FDA published the first two proposed rules on registration and import notification in the February 3, 2003 Federal Register. Unfortunately, the two proposed regulations defined food broadly, to include "substances that migrate into food from food packaging and other articles that contact food," thereby subjecting the food packaging industry to the same facility registration and importation notice requirements imposed on food processors.

During meetings with industry to discuss the proposed rules, FDA officials indicated that the intent of both proposals was to cover only finished packaging that would be in direct physical contact with food. This interpretation, however, was not in accord with the language of the proposed regulations themselves or with the language of the legislation or with the statements of congressional intent.

April - May 2003: K&H/SPI Comments on First Two Proposed Bioterrorism Regulations, FDA Issues Proposals on Recordkeeping and Administrative Detention

On April 4, 2003, K&H, again acting on behalf of SPI, submitted comments to the Office of Management and Budget (OMB) and FDA, setting forth the packaging industry's position regarding the scope of the facilities registration and import notice provisions of the Act and FDA's misinterpretation of congressional intent. K&H continued its efforts and met as part of an industry coalition with FDA and Department of Health and Human Services (HHS) officials on several occasions to obtain exemption of food packaging materials from the registration and prior notice of import regulations. On May 9, 2003, FDA published two proposed regulations to implement the Agency's administrative detention authority and the recordkeeping requirements under the Act. Both proposed regulations incorporated the definition of food under FFDCA, extending the scope of the provisions to food-contact materials. K&H submitted comments on behalf of SPI urging exemption of food packaging materials from the recordkeeping regulation on the basis of congressional intent and because records kept by food processors of the packaging suppliers will be adequate in the unlikely event of a terrorist act against the packaging. K&H did not request exemption from the administrative detention process, however, for the reasons discussed above.

Similar to the two previous proposed regulations, FDA did indicate its intent to exclude outer packaging and mere components of a packaging material from the scope of the recordkeeping provisions, but again the regulations as proposed did not reflect FDA's stated intent. K&H filed comments to OMB and FDA on both regulations to further clarify the scope of the two regulations with regard to food contact materials, and to point out the unnecessary burdens imposed on the food contact industry with the current implementation of the recordkeeping provisions of the Act, in violation of congressional intent.

October 2003: FDA Issues Two Interim Final Rules, Exempts Food Packaging Materials

After reviewing the comments it received on its two proposed regulations of February 2003 implementing the registration and import notice requirements, FDA issued on October 9, 2003 two interim final rules implementing these provisions. Most notably, after the extensive work by K&H and SPI, FDA revised its interpretation of the scope of the two provisions, and exempted food packaging materials from both facility registration and import notice requirements by explicitly excluding food contact substances from the definition of food in the two regulations.

Bioterrorism Legislation in 2004: Recent Developments

On June 4, 2004, FDA published its final rule on administrative detention, which did maintain a broad definition of food under the provisions of the regulation. Thus, under the final rule, FDA has the authority to detain food contact materials if the Agency has credible evidence or information that an article presents a threat of serious adverse health consequences or death to humans or animals.

It is still uncertain at this time whether the final rules on recordkeeping requirements, to be issued in the near future, will contain the exemptions for food-contact materials found in the registration and import notice regulations.