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FOR IMMEDIATE RELEASE

SPI PROVIDES COMMENTS ON FDA BIOTERRORISM PROPOSALS THAT WOULD UNNECESSARILY BURDEN FOOD PACKAGING INDUSTRY

WASHINGTON, DC (March 11, 2003) - In extensive comments submitted to the U.S. Office of Management and Budget (OMB), The Society of the Plastics Industry, Inc. (SPI) challenged the information collection burden that would be imposed on suppliers of food packaging and other food-contact materials by two bioterrorism regulations proposed by the U.S. Food and Drug Administration (FDA).

The comments were submitted by the association's Food, Drug, and Cosmetics Packaging Materials Committee.

Primarily, SPI took issue with the proposed regulations on the basis that the U.S. Congress never intended for FDA to extend the prior notice of food import and food facilities registration requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to food packaging and other food-contact articles that do not yet contain food.

Citing the Paperwork Reduction Act of 1995, the trade association also maintained that the action would impose an undue paperwork burden on the plastics industry, while providing no significant protection against terrorism.

The FDA published the two proposed rules on February 3, 2003. The agency plans to have the regulations go into effect on October 12, 2003, to meet a December 12, 2003, statutory deadline for compliance. SPI's comments to OMB are a prelude to its filing comments with FDA in early April, again objecting to the extension of the requirements to food-contact articles.

In its communication to OMB, SPI was clear in commending Congress and the FDA for taking steps to protect the food supply against terrorism. The association maintained, however, that extending import notification and facilities registration to packaging that does not yet contain food is too indirect an approach to appreciably improve the security of the food consumed by Americans.

SPI also declared the FDA's definition of "food" to be unclear, as the proposal extends the registration requirements to "components of immediate food packaging" and "substances that migrate into food from food packaging and other articles that contact food." It suggested that this wording implies that packaging components such as polymers, additives or monomers, as well as houseware items such as dishware, cutlery and other such kitchen items that come into contact with food, also would be bound by the regulations.

Although FDA has indicated informally that the regulations are intended to apply only to "immediate" food packaging, SPI stated, "If the regulation continues to read this broadly, it will impose a significant paperwork burden on a large number of companies."

The full text of SPI's comments can be found on the association's Web site, www.plasticsindustry.org.

Founded in 1937, The Society of the Plastics Industry, Inc., is the trade association representing one of the largest manufacturing industries in the United States. SPI's 1,300 members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw material suppliers. The U.S. plastics industry employs 1.5 million workers and provides more than $330 billion in annual shipments. For more information, visit the Web at www.plasticsindustry.org.

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