General Counsel's Report

(202) 434-4110

heckman@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

INTRODUCTION

Ladies and Gentlemen:

We are pleased to present this report on the status of matters involving our activities on behalf of The Society of the Plastics Industry, Inc.’s (SPI) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) since our June 21-23, 1999 meeting.

TABLE OF CONTENTS

I. Legislative Update

1. Food-Contact Notification Program Fully Funded; FDA Begins Implementation

II. Food and Drug Administration Activities

1. FDCPMC Works with the Food Irradiation Coalition to Expand Clearances for Irradiated Food

2. FDCPMC Files Comments on CFSAN Program Priorities for the Year 2000

3. FDA Issues Final Guidance Document on Container and Closure Systems for Packaging Human Drugs and Biologics, Adopts Some Revisions Recommended by the FDCPMC

4. FDA Proposes to Amend Section 314.70 of its New Drug Regulations Regarding Changes, Including Packaging Changes, to Approved New Drugs; FDCPMC Files Comments

5. SPI Represents Industry Regarding ANSI/NSF International Standard 61 on Materials for Contact with Potable Water

6. Update on Establishing USDA Compliance for Food-Contact Materials and Voluntary Certification Program for Equipment Used in Meat and Poultry Plants

7. Claims Continue to Be Aired about Alleged Health Risks from Plasticizers and Bisphenol A in Plastic Food-Contact Articles

III. International Activities

European Court of Justice Takes Action against France for Failure to Introduce Mutual Recognition Clause in Rubber Decree

I. Legislative Update

A. Food-Contact Notification Program Fully Funded; FDA Begins Implementation

Certainly the most significant development since our last report to the Committee is the funding of the long-awaited food-contact notification (FCN) program and the beginning of its implementation by the Food and Drug Administration (FDA). On October 22, 1999, President Clinton signed into law the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2000. Pub. L. No. 106-78. The Act includes $6 million for the implementation of the FCN program. As many of you know from our reports to the Committee over the last several years, the FCN program, also referred to as the Premarket Notification (PMN) program, was enacted as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA amended the Federal Food, Drug, and Cosmetic Act by adding Section 409(h), providing a new method of premarket review for food packaging and other types of food-contact materials.

The FCN program will result in a dramatic change from the current premarket clearance process under which it can take years to obtain the necessary clearances to market food-contact materials. Once a notification is submitted to FDA with the required safety data, a company can begin to market its product after 120 days, unless the Agency objects in writing. Unfortunately, implementation of this program has been delayed for the last two years because of language added to FDAMA during the legislative process that required specific funding to be appropriated for FDA to run the program. Monies appropriated in the Agriculture Appropriations Act fully fund the program for the coming year. Moreover, it is our understanding that FDA has decided to include the FCN program in the future as part of its base budget. Thus, in the absence of some dramatic change at FDA or in Congress, we expect funding for the FCN activity to be included in FDA’s budget as a routine matter. Continued funding should not require the intensive government affairs effort that SPI and member companies invested to obtain this initial budgetary allocation. Nor does it appear that the program will need to be supported by fees for filing the notifications.

On Monday, October 25, 1999, FDA announced its intentions with regard to beginning the program. Starting January 18, 2000, FDA will accept notifications to permit the use of new food-contact materials and new uses of food-contact materials. The Agency will accept some notifications before implementing the full program, and interested parties should consult FDA before filing. FDA is in the process of converting qualifying food additive petitions and Threshold of Regulation requests to notifications at the present time. In addition, the Agency is finalizing guidance documents and developing regulations to implement the notification program. Draft guidance documents were issued earlier this year describing the chemistry and toxicology requirements for submitting a complete notification, along with the administrative requirements and procedures. Copies of these documents are available on our website at www.khlaw.com. The draft guidances were discussed at a public meeting conducted by FDA officials, and Keller and Heckman submitted comments on these proposals on behalf of the Committee last spring. FDA intends to issue regulations and final guidances for the FCN program in the coming months.

After 40 years of effort by this Committee and Keller and Heckman (particularly Jerry Heckman), FDA is rationalizing its review of food-contact materials and differentiating it from the regulation of direct food additives. We look forward to working with the Committee, member companies, and FDA to realize the full benefit of this regulatory reform.

II. Food and Drug Administration Activities

A. FDCPMC Works with the Food Irradiation Coalition to Expand Clearances for Irradiated Food

Irradiation is considered one of the most effective means of eliminating dangerous, food-borne pathogens from food. Because of the importance of this technology to protecting the health and safety of consumers, several industry groups have been working to expand the clearances governed by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) for the types of food that can be treated with irradiation.

FDA not only clears irradiation for certain foods, but also has jurisdiction over the materials that can be used to hold prepackaged food during treatment. The range of food-contact materials currently authorized explicitly under the applicable food additive regulation (21 C.F.R. § 179.45) for use in holding food during irradiation is very limited. Thus, members of the Committee are interested in ensuring that, as the food irradiation clearances are expanded, a variety of packaging materials are available for use with this technology. Fortunately, packaging materials not explicitly cleared under Section 179.45 still may be used to hold food for irradiation as long as the materials are permitted for contact with food and do not have potential migrants that are significantly different in nature or amount as a result of irradiation.

At the direction of the Committee, Keller and Heckman has been representing SPI as a member of the Food Irradiation Coalition (FIC), which is a group of 20 trade associations and other interested parties that was organized by the National Food Processors Association (NFPA) to expand the regulatory clearances for irradiation of food. FIC submitted a petition to FDA on August 23, 1999 requesting that the Agency approve irradiation as a treatment for ready-to-eat (frozen, refrigerated, and dried) meat, poultry, fruit, and vegetable products. In addition to submitting this petition, the Coalition is promoting other changes to facilitate irradiation such as (1) concurrent FDA and USDA review of direct food additives, including radiation, for meat and poultry; and (2) legislative reclassification of irradiation as a "process," which would simplify regulatory clearance of new uses of irradiation.

FDA has indicated that the petition for irradiation of ready-to-eat foods is likely to qualify for expedited review because it involves technology for enhancing food safety. At the behest of the FIC, Senators Richard Lugar (R-Ind.) and Tom Harkin (D-Iowa) sent a letter to Health and Human Services Secretary Donna Shalala urging that FDA place the Coalition’s petition for irradiation of ready-to-eat foods on this expedited review track. USDA Secretary Dan Glickman also received a copy of the letter, which included a request for USDA to work closely with FDA during the review process to avoid duplicative efforts and facilitate expeditious review. Although industry has been working to speed up the clearances for irradiation, other groups have expressed opposition. More specifically, the Health and Energy Institute presented Congress and FDA with a petition, signed by 13,000 petitioners, opposing the use of food irradiation and challenging the FIC petition.

B. FDCPMC Files Comments on CFSAN Program Priorities for the Year 2000

On September 28, 1999, Keller and Heckman submitted, on behalf of the Committee, comments to FDA on program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for the year 2000. Our comments focused on recommending that CFSAN give priority consideration to two aspects of premarket review of food-contact materials. First, we encouraged CFSAN to implement fully the FCN program, so that it will function, as envisioned, as a replacement for the food additive petition process for food-contact materials. Second, we recommended that CFSAN take steps to improve petition review time, and in particular suggested process changes within the Center’s Division of Health Effects and Evaluation (DHEE), the office responsible for toxicological review of petitions, which is the part of the review process that involves significant delays for many petitions.

C. FDA Issues Final Guidance Document on Container and Closure Systems for Packaging Human Drugs and Biologics; Adopts Some Revisions Recommended by FDCPMC

FDA has published its final guidance document on the information about container and closure systems that applicants should provide to the Agency in support of new drug and biologics submissions. The final guidance, dated May 1999, follows a draft version, which was made available on July 15, 1997. We submitted comments on the draft document in 1997 on behalf of the Committee.

We are pleased to report that several areas pointed out in the comments we submitted were clarified in the final FDA document. Although the guidance has not been modified to incorporate all of our suggested changes and continues to suggest including more information in a Drug Master File (DMF) than we would advise, the document explicitly states that DMF holders may include in their files "as much or as little information as they choose." Thus, FDA acknowledges that there is no legal obligation to include in a DMF the detailed information mentioned in the guidance.

We also note that FDA has removed from this guidance document most of the discussion that appeared in the draft version regarding notification requirements as they apply to changes in container closure systems. We suggested some significant changes to this section in our comments to the Agency. Instead of modifying the section, the Agency has indicated that it will provide additional guidance on post-approval packaging changes "in the future." Some of this guidance is now provided in a document entitled "Changes to an Approved NDA or ANDA," which currently is available in draft form. This draft guidance document, which has been issued concurrently with some revisions proposed by FDA to its regulation (21 C.F.R. § 314.50) on changes to approved drug products (including packaging), contains a section on the reporting requirements that arise as a result of various types of changes to packaging materials. See related article below. FDA officials also have indicated to us that they plan to develop an additional guidance document focusing solely on post-approval changes to packaging materials (this document is being referred to by FDA as the "PAC PAC" document). The "PAC PAC" guidance, however, is not expected to be completed for at least two years.

D. FDA Proposes to Amend Section 314.70 of its New Drug Regulations Regarding Changes, Including Packaging Changes, to Approved New Drugs; FDCPMC Files Comments

FDA is proposing to amend Section 314.70 of its new drug regulations (21 C.F.R. § 314.70, "Supplements and other changes to an approved application") to implement provisions of FDAMA with respect to manufacturing changes to approved new drugs. See 64 Fed. Reg. 34608 (June 28, 1999). Section 314.70 sets forth the criteria for determining when a change, including a packaging change, to an approved new drug requires the filing of a supplemental new drug application (SNDA), when FDA prior approval is needed, and when notice in an annual report is sufficient. The proposed amendment to Section 314.70 updates and slightly modifies these requirements. As indicated in the previous article, FDA also has announced the availability of a draft guidance document which provides recommendations on the types of information that should be developed in connection with a change to an approved application, and which reporting category to use.

Currently, Section 314.70 provides for three separate reporting categories for changes to an approved new drug application: (1) changes that must be reported in an SNDA and approved before the change is made; (2) changes that must be reported in an SNDA, but which may be made before FDA approval; and (3) changes that do not require FDA approval and that may simply be reported in the applicant's annual report. Changes of material type for a container and closure system for a drug product (for example, from glass to high density polyethylene (HDPE) or from HDPE to polyvinyl chloride) require the submission of an SNDA and FDA prior approval, while changes within a container and closure system (for example a change from one HDPE to another HDPE) based upon a showing of equivalency to the approved system under a protocol approved in the application or published in an official compendium (for example, the United States Pharmacopeia (USP)) do not require FDA prior approval and are simply described in the annual report.

The proposed amendment to Section 314.70 slightly modifies the categories, and provides four reporting categories for changes: (1) changes that must be reported in a supplement requiring FDA prior approval ("major changes"); (2) changes that require a supplement to be submitted at least 30 days prior to distribution of the drug product made with the change ("moderate changes"); (3) changes that may be implemented when FDA receives a supplement (also considered "moderate changes"); and (4) changes that may be described in the next annual report ("minor changes"). Under the proposed rule, changes to a container and closure system "that may affect the impurity profile of the drug product" are considered major changes requiring a submission of an SNDA and prior FDA approval. Changes in a container and closure system that are not expected to affect the quality of the final drug product will fall within the category of moderate changes requiring submission of an SNDA at least 30 days prior to making the change, unless they are specifically covered by another category. This represents some relaxation in the current rule, which requires prior FDA approval of an SNDA for all changes in material type for containers and closures.

The new draft guidance indicates that FDA has heightened its reporting requirements with respect to changes within container and closure systems for sterile liquid drugs, and relaxed somewhat its reporting requirements for changes to container and closure systems for nonsterile liquid and solid dosage forms. For sterile liquid drugs, FDA is proposing to require prior Agency approval of an SNDA for all packaging changes, even within a material type and with a showing of equivalency. With respect to solid oral dosage forms, the guidance document suggests a further liberalization of the notice requirements beyond the explicit provisions of the proposed amendments to Section 314.70. Specifically, FDA indicates in the new guidance that changes within container and closure systems for solid drugs need not be based upon a showing of equivalency to the approved system based on a protocol in the application or in an official compendium, provided that any new component materials have been used in contact with other approved solid oral dosage forms.

On September 14, 1999, we submitted, on behalf of the Committee, comments on FDA’s proposal. Our comments focused on the heightened reporting requirements applicable to changes within packaging materials for sterile liquid dosage forms. Specifically, we noted that FDA has not provided any justification for requiring an approved supplemental new drug application for any change within the container/closure for a sterile liquid dosage form, even if the change is made based upon a showing of equivalency to the approved system under a protocol approved in the application or published in an official compendium. We consider such a requirement to be unduly burdensome, and FDA has given some indication that the proposal will be modified on this point.

E. SPI Represents Regarding ANSI/NSF International Standard 61 on Materials for Contact with Potable Water

As you may recall from our letters, the Committee has formed a self-funded task group to address the certification of products for use in drinking water applications under the American National Standards Institute (ANSI)/NSF International Standard 61. Several FDCPMC member companies are concerned that products which had been certified for several years under Standard 61 were now being questioned about their eligibility for recertification. Because of these questions, companies are also concerned about the certification of new products. FDCPMC representatives met with NSF officials to discuss these issues, and the FDCPMC now represents the plastics industry on the Joint Committee on Drinking Water Additives.

Dr. Lester Borodinsky, Technical Advisor to the FDCPMC attended the September 22-23, 1999 meeting of the Joint Committee and made a presentation on the basis for estimating the migration of additives from water pipes. There is concern that the method that NSF International is employing to estimate chronic exposure to migrants from plastics significantly exaggerates the actual levels that could occur. In response to Dr. Borodinsky’s presentation, the Drinking Water Additives Committee formed a Task Group to study possible excessive conservatisms in Standard 61. The NSF Task Group expects the FDCPMC to play a substantial role in resolving this issue.

F. Update on Establishing USDA Compliance for Food-Contact Materials and Voluntary Certification Program for Equipment Used in Meat and Poultry Plants

USDA requires that manufacturers of food-contact materials used in federally-inspected meat and poultry plants guaranty that their materials comply with the Federal Food, Drug, and Cosmetic Act for their intended conditions of use. As part of its regular audit of meat and poultry processing facilities, USDA inspectors periodically review guaranties provided to meat and poultry plants by their suppliers.

As of September 30, 1998, however, the Compound and Packaging Review Branch of USDA's Food Safety and Inspection Service (FSIS) was disbanded. This office formerly verified the FDA status of food-contact materials covered by supplier guaranties selected for audit by the plant inspectors. Although USDA policy still calls for food-contact materials used in meat and poultry plants to have an official FDA sanction, the Agency is no longer reviewing formulations to confirm compliance with this policy. Therefore, where USDA formerly insisted on formal FDA clearance of food-contact materials, it appears now that companies should be able to make their own determinations of compliance for use of packaging and other food-contact materials in USDA-inspected plants.