COMMENTS OF JEROME H. HECKMAN
General Counsel

The Society of the Plastics Industry, Inc. (SPI)

Prepared for Presentation

At the Food and Drug Administration's Stakeholders
Meeting On Premarket Notification

March 12, 1999

Bethesda, Maryland

Ladies and Gentlemen:

The Society of the Plastics Industry appreciates this opportunity to exchange information on the implementation and administration of the new premarket notification program for food-contact substances authorized by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The interest of the plastics industry in bringing about a more expeditious clearance process is well known and of long standing. We believe this interest to be shared by all of the packaging industries. Fortunately, we were able to work closely with the FDA staff in bringing about the FDAMA amendments. Now we think Dr. Mitch Cheeseman and his associates on the FDA staff deserve our thanks and congratulations for starting the effectuation process by issuing the Agency's information documents and calling this meeting. We are all most anxious to see a sound program in place as soon as possible because we are convinced that it will benefit the public, the Agency, and industry.

Legislatively, there is obviously a bit of additional work to be done because the funding mechanism we and FDA agreed upon in 1997 was not accepted by the Congress. As a result, the implementation of the program is dependent upon an annual "Special Appropriation" which requires legislative action that, at best, presents a difficult challenge every year. We will continue to support and work for a funding system based on reasonable cost recovery charges for premarket notification reviews so that industry can be more certain that the system will be implemented consistently, fully, and successfully. Obviously, to achieve this goal, we and FDA will need to convince Congress that charging on a cost recovery basis for notification processing does not amount to imposing a new regulatory burden, but we believe a clear distinction can be made between charges for proprietary services such as clearances by premarket notification, and other regulatory functions designed solely to protect the public. A copy of a memorandum of law (Attachment A) supporting this view is being submitted with this statement so our views on this subject will be a matter of record.

We will continue to try to help FDA convince Congress that cost-recovery fees are the way to deal with this matter. Indeed, SPI has very recently submitted testimony to the House Appropriations Subcommittee with jurisdiction over FDA's budget stressing the importance of this program to the industry and urging positive consideration of the FDA budget proposal. Until there is a fee plan authorized and in place, we urge the Agency to press forward with this program, not only because of its importance to the industry, but because we believe that, in the long run, it will save resources for FDA. We are also convinced that effectuating the plan successfully will help demonstrate its value to garner support from the regulated industries so that they can and will ultimately convince the Congress that this is the way to go.

While we have attempted to fully digest the FDA information papers circulated so very recently, and are now commenting on some of the key points, it is important for it to be understood that the issues FDA has dealt with in a generally fair way in the papers are complex and warrant more careful consideration after the papers have had wider circulation. Thus, while we now turn to the making of specific comments on these issues, we also look forward to supplementing our statements, and perhaps expanding this discussion after this meeting.

It seems clear to us that, to be successful, the notification program will need to accommodate the following "critical control point" elements:

1. The program must be set up so that FDA can adequately review notifications within the 120 day time frame set forth in the statute. Last year, we sent the Agency a set of proposed regulations containing the suggestions of the SPI Food, Drug, and Cosmetic Packaging Materials Committee for implementation of a food contact notification system. A key point of our proposal urged the use of submission forms designed to standardize the format in which information is provided to the Agency, so that the chemists, toxicologists, and consumer safety officers who review the data can deal with similar formats. We continue to believe that the use of this plan, or a slightly modified version, will facilitate initial screening of notifications for completeness, notification of the party that has filed a form if it is not complete, and ultimate processing of the notifications. This being the case, we are now resubmitting these proposed regulations so that they will be a part of the official record. They are included as Attachment B to this statement.

2. As also indicated in the SPI draft regulations, we believe that the notification program must provide a simple mechanism that can be used to assure customers in national and international trade that a notification has been filed and has become effective. Under the plan envisaged in Attachment B, this would be accomplished by FDA simply stamping a copy of an appropriate notification form "Notification Effective" after the passage of the 120 day review period.

3. An important goal of the notification program is to make it applicable to the broad range of food-contact materials so that Food Additive Petitions will be rare or non-existent. One of the benefits of this program is that it will provide FDA with a more complete awareness of the materials that are being used in food-contact applications. To work as envisioned, the program should encourage the electronic filing of notifications for food contact surface formulations as well as individual components of such formulations. For many years, the Food Safety and Inspection Service of the Department of Agriculture, the Canadian Health Protection Branch, and the authorities in such foreign countries as Switzerland have handled such formulation clearance efforts without undue difficulty so this job can certainly be done successfully. It is recognized that the handling of formulations within the prescribed 120 day time period will require that all components which would require clearance as "indirect food additives" under the present system are not only identified but must themselves be the subject of notifications. Where a formulation is submitted without adequate information about its components, or a suitable reference to an existing master file set up by a supplier of the component, the draft regulations in Attachment B contemplate a delay in the commencement of the 120 day review period.

4. It is a contemplated new characteristic of the premarket notification system for food contact substances that the data submitted be treated as proprietary and that an effective notification be applicable only to the filing party. Of course, it is also contemplated that an effective notification will permit the use of a substance which has been the subject of a notification by customers of the filing party; this needs to be made very clear in any final regulations. FDA has requested comments in its meeting notice on how the Agency should handle proprietary information. There are two main stages at which this question will be of importance, i.e. during Agency review of a notification and, subsequently, when the notification becomes effective and will be the subject of possible public attention. We deal with these questions in the indicated order:
   1. Any data submitted in a notification should be treated as completely confidential, there being no need to treat it otherwise since a notification can only be used to establish a position for the filing party, not to take issue with other clearances or policies. There will be situations, perhaps many of them, when a supplier will not wish to divulge details about the nature and manufacture of his product to customers who use it in a formulation or compound. Where this data is needed to clear a new notification covering, for example, a formulation in which a notified or otherwise exempt substance is to be used, the information needed to make the formulation notification before FDA complete can be provided in a Master File established for cross reference purposes by the manufacturer. This is commonly done with regard to New Drug and Device applications, and is effectively done by means of collateral letters in the Canadian and other systems. In none of these cases is divulgence of proprietary information deemed desirable or necessary.

   2. The other critical time where disclosure is concerned relates to what FDA will include in its "inventory" of clearances that may be accessed by interested parties or the public. We submit that this matter would best be handled by listing nothing more than the name of the notifying company, the chemical designation for a substance, or the trade name for a formulation along with a general characterization, and the intended uses covered by the notification. An example might be "Doe Company, polyethlylene paracrudylene for use in contact with all foods and under all conditions of use" for a substance; for a formulation the designation could be "Doe Company Doealac XYZ film for meat and poultry wrap." Experience teaches that customers for such products will likely ask for more information from their suppliers and will be given it where there is a legitimate reason for disclosure. On the other hand, FDA need not and should not be in the business of disclosing proprietary information to a notifier's competitors.

Having set forth some of the major goals that we believe the new food contact system should be designed to achieve, I turn now to the questions the Food and Drug Administration has asked those attending this session to try to answer. First, with regard to the number of notifications to be expected, we are not presently in a position to make a truly educated guess. About all we can do is urge the Agency to keep careful statistics on the notifications received, how many are for single substances and how many for formulations, and on the time actually required to deal with the various cases that will be presented. We are advised that the Canadian Health Protection Branch handles as many as 1200 inquiries a year with a very small staff but we also know that many of the inquiries are duplicative so that prior reviews can be relied on to give quick responses. This will no doubt be the case in this country, too. We assume that the main reason for the interest in the number of notifications that will be filed is so that the Agency can make a better estimate of the number of staff members who will need to do this work, and how much the effort will cost. While it is true that we can only make vague and uncertain guesses now, we believe it will be possible to develop much harder numbers within a short time after the program is in place. The data acquired can then be used effectively to convince Congress that the program is truly worthwhile and should be permanently funded or supported by cost recovery fees. It is unfortunate that this presents a bit of the proverbial "chicken and the egg" dilemma, but it is our position that some temporary discomfort with funding should be countenanced for the sake of making the case for a better permanent financing plan.

Turning now to another issue raised by the Agency in the Meeting Notice, we do not believe that the present waste of resources on environmental analyses serves any useful purpose. In the entire history of the National Environmental Policy Act and its application to food contact substances only one Environmental Impact Statement has ever been prepared. This was in 1976 and the conclusion did not affect any product clearance or use. Yet today as much or more FDA time is often consumed by environmental reviews as is used in the chemistry and toxicology evaluations -- the safety evaluations -- and the regulation writing process combined. This unnecessary expenditure of resources should not be continued in the food contact notification review process especially since no major federal action will be taken in allowing a notification to become effective, and certainly history as well as common sense has shown that FDA has never had to deny the clearance of a food contact material because of a finding of significant adverse impact on the environment. By way of the third attachment to this statement, Attachment C, we are submitting for the record a comprehensive analysis of the law and the facts on this subject. This analysis discusses judicial cases standing for the proposition that federal agency procedures analogous to this food-notification process do not constitute "major federal actions," and, therefore, do not trigger the need for an environmental assessment under the National Environmental Policy Act. In addition, the attached memorandum shows that FDA clearance of a food-contact material, whether by notification or otherwise, cannot have a significant impact on the environment due to control of environmental effects by other regulatory bodies and due to the fact that FDA's decisions in this area cannot affect the solid waste stream significantly. We believe you will find this discussion helpful and convincing as to FDA's power to exclude food contact notifications from environmental review and we urge you to move confidently in this direction.

On the subject of when petitions should be required, our reflexive response is "never again" unless no other course is left open to the Agency. We were pleased to note that the FDA paper entitled "Information for Stakeholders Meeting on Premarket Notifications for Food Contact Substances," generally referred to as the "Admin paper," indicates in two paragraphs on page 6 that, even when FDA might otherwise decide a petition is necessary because dietary exposure of more than 1 part per million is projected, or an Acceptable Daily Intake does not exceed five times a projected Estimated Daily Intake, the door will still be open for notification treatment if an agreement on the handling of the matter in this way can be reached. We can understand the Agency's likely need to see and evaluate more comprehensive toxicology or chemistry data in some of these cases, but we would hope that this would never preclude its advising a notifier that it should consider delaying the filing of a notification until the necessary data are in hand, or until it can be agreed that the Agency has enough data in its files to pass on the notification promptly. In this area, as in most of the subjects covered in the Admin paper, we believe FDA has set forth a reasoned and reasonable approach provided we are interpreting its views correctly. This is something we certainly hope we will find out in the later portions of this meeting and in any subsequent proceedings to come.

We are in general agreement with the Admin paper's specifications for what a notification should contain, as is evidenced by a review of our Attachment A, the SPI proposed food contact notification regulations. We recommend that electronic filings be much encouraged until such time as everyone is in a position to make them, so that the day when paper filings are considered dinosaurs will come as quickly as possible. As always, when one discusses what should be in a notification, the "devil is in the details" so that we believe some questions could be the subject of more explanation as to the Agency's intent. For example, it is indicated on page 8 that a separate or new notification would be needed if "changes are made in the specifications for the food contact substances." It is submitted that this proviso should include qualifiers as in the case of the manufacturing method paragraph that follows it. In short, it would appear reasonable to say that new notifications are needed where a change in a specification changes the character of the product, or its suitability for the intended use. Similar recommended refinements will no doubt occur in the aftermath of the discussions here so that we and others can make additional useful suggestions during the comment period.

Due to time constraints, I will not try to deal in any further depth here with the questions of when should petitions be required, and what sort of data should be presented in a notification. My colleague, Dr. Borodinsky will discuss the toxicology and chemistry questions raised by the information papers on this subject. We trust FDA will indeed consider the record open for an extension of these remarks since we do plan to deal with the potential problems our clients, the members of the SPI Committee, have called to our attention, and with any other conceptual issues that arise in this session, in the comments we will file by March 22, and then in any subsequent meetings or proceedings that flow from this excellent start.

Once more, we thank the Agency for the constructive way in which it has moved on this matter and for all we are sure it will do to help everyone make the premarket notification concept a beneficial advance and a model program for other nations to use as a benchmark for their food contact regulatory systems.

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