FDA Excludes Food Packaging Materials from Bioterrorism Regs

Date: Dec 01, 2003

The U.S. Food and Drug Administration (FDA) has issued interim final rules implementing The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (known as the Bioterrorism Act) that require food company facility registration and prior notification for food product imports. The food packaging industry got some good news as FDA decided to exclude food packaging and other food-contact materials from the scope of the interim regulations.

Close call
As originally proposed, FDA's regulations would have required the registration of all facilities involved in the manufacture, packaging or distribution of "food," as well as notification to FDA prior to the import of any food product. Because of the broad manner in which food was defined in the proposed regulations, food-contact substances - that is, materials used in contact with food for packaging and the like - were included within the scope of the regulations.

As released in interim final form, however, FDA's regulations on facility registration and import notification now exempt all materials and articles defined as "food-contact substances" under the Federal Food, Drug and Cosmetic Act. This exclusion definition covers all food packaging articles, all materials used to make those articles, all other food-contact articles (such as food processing equipment and countertops, refrigerators and the like for home and institutional use) and the materials used to make those articles.

Although it appeared obvious that food-contact materials not yet in contact with food should not be included, it appeared that the law would sweep these items into the mix.

Unfortunately, FDA did not follow the expressed intent of Congress in initially proposing the regulations. The Agency suggested that only certain types of packaging materials would be included within the scope of the regulations (that is finished articles intended to directly contact food). But the proposed regulations were so broad as to include all packaging materials and just about anything that could be used to make a packaging material.

In response to the proposed regulations, a number companies and trade associations worked hard to explain to federal officials and legislators that food-contact materials needed different treatment than traditional food products.

Fortunately, FDA (and the White House) heard the hue and cry, saw the limited usefulness of including packaging materials in light of the burdens that would result, and listened. Consequently, FDA promulgated a set of interim final regulations exempts all "food-contact substances," avoiding significant costs to the packaging and allied industries. Although the interim final regulations are subject to further public comment and possible revision, it is unlikely that the Agency will modify its decision about products.

FDA will accept comments on the interim rules through the end of the year, and then plans to re-open the comment period next March to see if more refinements are needed.

Used with permission. Copyright FOOD & DRUG PACKAGING, December, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.