FDA Proposal Revs Up Use of New Food-Contact Packaging Materials

The Food and Drug Administration (FDA) recently presented its ideas on implementing the pre-market notification (PMN) system for food-contact substances required by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This program may help you market products in new packaging materials sooner than before. The PMN program is intended to expedite review of new food packaging materials while maintaining the same high standards for safety as exist today.

Through a series of draft guidance documents, FDA outlined the parameters of the food-contact notification system, including what information will be required and how it should be presented.

At a public meeting held at the National Institute of Health on March 12, industry was invited to comment on the guidance documents. FDA will use these comments to refine its ideas and prepare to issue, as necessary, a proposed rule to implement its plans. You can view the FDA guidance documents at www.fda.gov or call us for a copy.

Automatic Green Light

FDAMA allows packaging material suppliers to file a pre-market notification with FDA 120 days prior to introducing a new food-contact material into interstate commerce. Packaging manufacturers or their materials suppliers must notify FDA of the identity and intended use of a substance and the basis of its safety determination. (See Regulatory Update, Jan. 1998.)

Within 120 days of filing the notification, use of the new foodcontact substance may begin unless the Agency determines that--based on the information and data submitted in connection with the notification--such use of the substance has not been shown to be safe or the Agency finds that the submission of a petition is required to ensure public safety.

This is a significant improvement over the current system in which manufacturers of food-contact substances must submit a food additive petition and then wait to receive FDA authorization before using it--a process that can literally take years to accomplish. This new system is the response from Congress to continued industry frustration over the regulatory excess required for many food packaging and food-contact substances by the 1958 Food Additives Amendment.

Speed Bump

Although the food-contact notification system is likely to be used for the majority of food packaging materials, it won't be available for all. FDA will insist on a full pre-market review and approval of a food contact material through the petition process under these three circumstances:

1. When an intended use of a substance increases its cumulative dietary concentration to greater than 1 part per million (ppm) or for biocides, greater than 200 parts per billion (ppb);

2. When the acceptable daily intake (ADI) for the substance does not exceed the cumulative estimated dietary intake (EDI) by a factor of 5 or larger; and

3. When there are carcinogenicity studies on the substance that have not been previously reviewed by the Agency and which are not clearly negative for carcinogenicity.

FDA will also not permit a notification to be filed for the use of a substance that it determines is already permitted by a food additive regulation found in 21 C.F.R. Parts 173-189, or that is the subject of an exemption under FDA's threshold of regulation policy (21 C.F.R. [sections] 170.39).

On the other hand, FDA does not intend to permit the simultaneous submission and review of both a food additive petition and a notification for the same use of a food-contact substance. If a food additive petition is filed for a food-contact substance and FDA determines that the petition should be the subject of a notification, FDA will request the petitioner to resubmit the matter as a PMN and vice versa if a PMN is filed that should be a food additive petition.

Lane Restrictions

Another critical difference from the current system is that FDA restricts use of the food contact material to only the manufacturer or supplier who submits the notification. It does not authorize the marketing of a similar or identical substance produced or prepared by a different manufacturer.

In addition, FDA is proposing that the manufacturer of a substance cleared under a PMN must re-file if changes are made (1) to the specifications for the food-contact substances, (2) to the manufacturing method for the food-contact substance that result in substantive changes in product purity, product identity, or levels of impurities or (3) to the use level or conditions of use for the material.

The information required to be submitted with a notification is similar to the information that is presently required for a food additive petition. In particular, detailed information must be provided on the chemical identity of the food-contact substance and the impurities and residual reactants that may be present in the finished product.

Information also needs to be provided on the intended conditions of use for the material (for example, the maximum temperature and duration at which the food will be in contact with the packaging material and the type of food that will be in contact with it) and the intended technical effect of the material. As in the current petition process, however, the most critical information will be that dealing with dietary intake estimates and toxicology data.

Caution! More Work Ahead

The draft chemistry guidance document that FDA has issued is substantially the same as the current chemistry guidelines for food additive petitions, with some minor modifications regarding the consumption factors for several polymer packaging materials (that is, the percentage of food in our daily diet that is estimated to be packaging in various materials), as well as some additional suggestions about testing of dual ovenable and microwave packaging materials.

Unfortunately, this is not the case with respect to the draft toxicology data requirements. First, as noted above, FDA is requiring a fivefold difference between the ADI and EDI for a substance before a notification will qualify. This is, in effect, an additional safety factor that the Agency is building into its review criteria. The Agency already uses a safety factor of 1,000 to 2,000 for subchronic studies and 100 in the case of chronic studies to offset any potential risk caused by scientific uncertainty. No rationale has been provided with respect to the use of this new fivefold safety factor.

Of even greater concern, however, FDA is considering a requirement for genetic toxicity testing for dietary exposures that are greater than 0.5 ppb up to 50 ppb. In particular, the Agency suggests that it will require a test for gene mutation in bacteria and either an in vitro test for chromosomal damage using mammalian cells or in vitro mouse lymphoma assay. Right now, for exposures in this range, FDA only requires acute toxicity studies.

It's not clear that these genotoxicity tests will allow FDA to make any better safety determinations at these low levels of exposure than the acute studies that are already required.

More importantly, however, it's not clear how the Agency intends to view the data once it is submitted. For example, if a positive or ambiguous result is obtained from one study, while a negative result is obtained from the other, how will the Agency use this information? Will a positive study require some additional genotoxicity studies to be performed, or will the Agency require more advanced studies to be conducted, such as 90-day subchronic or 2-year chronic toxicity studies?

Finally, the Agency needs to clarify the materials upon which such genotoxicity studies need to be performed. It is generally recognized, for example, that polymeric materials do not present the same type of concerns as the monomers and other reactants from which they may be made. Thus, if genotoxicity testing may be required, it should be limited to monomers only.

Gas Up

FDA intends to maintain an inventory of effective pre-market notifications that will include the substances that the subject of a notification, the permitted conditions of use, any necessary limitations or specifications for the substance, and the manufacturer or supplier (notifier) of the substance. It's not clear how confidentiality concerns for chemical identity and the like will be handled. Confidential information in a notification, however, can be protected to the same extent as today when included in a food additive petition.

FDA is required to implement the food-contact notification system no later than October 1, 1999, if Congress continues to provide adequate funding for the program. FDAMA specifically permits the Agency not to implement or run the program if Congress does not appropriate sufficient funds in any one year to administer it.

Sufficient funds for fiscal year 2000 are defined as $3 million in the legislation. So far, Congress has not included such funds in any appropriation measure for FDA at this time, and the White House may attempt to get this money by way of user fees instead of an appropriation from Congress. However, some in Congress have balked at user fees in the past and are likely to do so in the future.

So, implementation of the notification system continues to be iffy and will remain so until Congress inserts a permanent funding provision or FDA realizes the importance of the program to industry and becomes wed to it.

George Misko, Partner, Keller & Heckman Inquiries or comments may be sent to Mr. Misko at 1001 G St., N. W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

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