SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
February 18, 1998 Newsletter

* * * For Members Only * * *

Table of Contents

1. Appropriation for Food-Contact Notification Not Included in President's Budget; Efforts Continue to Persuade Congress to Fund Program

2. FDA Acts on Fewer Food Additive Petitions in 1997

3. Working Group Established to Respond to Concerns over USDA's Audit Procedures

4. FDA Developing Guidelines for Testing Recycled Paper for Food-Contact Applications

5. Levitt Replaces Shank as CFSAN Director

6. White House Reportedly Near to Announcing its Nomination for FDA Commissioner

7. FDA Belatedly Publishes Lists of Medical Devices Exempt (and Not Exempt) from 510(k) Requirement

8. European Commission Update

9. Korea Proposes New Packaging Standards

To: SPI Food Drug and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

This letter reports on several issues of interest to the Committee. Most importantly, we discuss the fact that funding for the new Food-Contact Notification program was not included in the President's 1999 Federal Budget. We believe that the success of this program is dependent on these funds, and we are making every effort to ensure that Congress includes this appropriation in the final Federal Budget. Toward that end, we would appreciate any help you and your respective companies may be able to offer to inform your Congressional representatives of the importance of this program to industry. We explain this situation in detail in the first article.

The letter also discusses several developments at the Food and Drug Administration (FDA), including a new Director for the Center for Food Safety and Applied Nutrition (CFSAN), the development of guidelines for recycled paper, and an update on FDA's recent performance on processing Food Additive Petitions. We also report on a new Working Group that has been formed to respond to our concerns regarding the United States Department of Agriculture's (USDA's) audits of food-contact materials used in meat and poultry plants. Finally, we update you on some global regulatory developments in the European Union and in Korea.

1. Appropriation for Food-Contact Notification Not Included in President's Budget; Efforts Continue to Persuade Congress to Fund Program

We continue to work actively, along with the Washington representatives of several FDCPMC member companies, to have funding for the new food-contact notification (FCN) ¹ system included in FDA's fiscal year (FY) 1999 budget. As most of you will recall, the Food and Drug Administration Modernization Act of 1997 (FDAMA) that was enacted into law this past fall set up the notification system for food-contact substances that we had long advocated. The new law, however, did not follow the funding approach to which we had agreed at FDA's insistence, i.e., reasonable fees for filing notifications. Instead, Congress directed that the FCN system would be funded by FDA's budget, and advocated strongly that additional funding should be appropriated for this purpose to avoid diversion of other Agency resources. Now, with the return of Congress and the submission of the President's budget proposal, we are exerting every effort to ensure that this more efficient, faster process for marketing new food-contact materials is funded so that FDA will implement it as intended.

Unfortunately, the appropriation for the FCN system was not included in the President's budget, which was sent to Congress on February 2. During the initial part of the budgetary process, we had several conversations with officials at FDA who assured us that the Agency would include money for the PMN system in its budgetary request. In addition, Larry Thomas, President of SPI, sent letters to Frederick Raines, the Director of the Office of Management and Budget, and Donna Shalala, Secretary of the Department of Health and Human Services, to urge their support of this budgetary item. While FDA requested that monies for the FCN system be included in its budget, this item, along with several other requests, was cut by OMB, which believes, ironically, that these funds should be raised by user fees. What OMB stubbornly ignores, however, is that the Agency cannot collect user fees without statutory authorization, which you all know Congress refused to provide for this activity even though the packaging industry was willing to pay reasonable fees, if necessary.

If funds are not ultimately appropriated for the FCN system, we are concerned that the system may not be implemented as we (and most FDA officials) originally envisioned. Legally speaking, FDA would still be required to commence the program even if no money is appropriated (provided that the overall funding for the Center for Food Safety and Applied Nutrition (CFSAN) meets a certain level). This twist arises from the language of FDAMA itself. Section 309(b) of the new law states that the FCN program shall not operate in any fiscal year unless Congress has appropriated an amount equal to or exceeding $1.5 million in 1999 ($3 million in the fiscal years thereafter) or the amount specified in the budget request of the President, whichever is less. Since the President requested nothing in his budget, FDA will still be required to implement the FCN system even if no funds are appropriated. The problem, however, and the reason we believe every effort should be made to bring about the appropriate funding, is that FDA officials will be extremely unhappy about having to implement this system without additional funds. The lack of funding will buttress the arguments of some within the Agency who already want to limit severely the application of the program, making it the exception rather than the rule for FDA clearance of food-contact substances.

Because we feel that an appropriation is crucial to assure full implementation of the program, we are working with the Washington representatives of several of your companies and with allied trade associations, such as the Can Manufacturers Institute, the American Forest and Paper Association, and the Flexible Packaging Association to garner support on Capitol Hill. We have contacted the staffs of the Appropriations Committees in both the House and Senate to make sure they are aware of the importance of the FCN system to the food-packaging industry (and to proper allocation of FDA's resources) and that the industry was willing to pay fees for the system when the legislative proposal was introduced. In the next few weeks, several meetings are scheduled with the members of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and the Senate Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies - the two Subcommittees with jurisdiction over FDA's budget - to impress upon the members and their staffs the benefits and importance of our request. We also anticipate that members of the House/Senate Conference Committee on the FDAMA legislation may be willing to send "Dear Colleague" letters to the Appropriations Committee members to show their support for the funding measure. The Conference Committee substituted the appropriation for the fees, and urged in the Committee's report that FDA receive appropriated funds for the FCN activity so that funds would not need to be reallocated from other Agency programs. FDA is scheduled to appear at hearings before the House Appropriations Subcommittee on February 25, and a decision will probably be made by both the House and Senate Subcommittees on the inclusion of FCN funding by mid-to-late April.

We ask that any of your companies which can be of assistance contact your Congressional representatives and urge inclusion of the money for the FCN system in FDA's budget. The success of our efforts will depend in large part on how much constituent support we can show. If you would like examples of the types of letters that you could send, or would like some short background information to share with other officials at your company, please let us know and we will get this out to you as quickly as possible.

2. FDA Acts on Fewer Food Additive Petitions in 1997

After two consecutive years of improved performance in processing food additive petitions, FDA's progress slowed in 1997. Last year, FDA acted on only 31 food additive petitions, compared to 51 petitions in 1996 and 48 petitions in 1995. Petitioners withdrew four petitions in 1997 in comparison to 24 in 1996, and 10 in 1995. In addition, FDA's Office of Premarket Approval (OPA) denied one petition in 1997, none in 1996. The Agency had been making strides at reducing the number of pending petitions. Pending petitions declined from 163 in 1994 to 132 in 1996. Unfortunately, however, this last year marked a reversal of that positive trend. As of December 31, 1997, the Agency had yet to process 146 pending petitions: 101 for food-contact substances, 32 for direct food additive substances, six petitions for the radiation treatment of food, and seven pending FDA food additive proposals.

In addition, two prior sanction proposals were pending with FDA at the end of last year, and FDA issued only two generally recognized as safe (GRAS) affirmations in 1997, with 61 GRAS affirmation petitions, three tentative final GRAS affirmations, and 68 FDA-initiated GRAS affirmation proposals still pending as of December 31, 1997. As many of you know from the information provided in our May 12, 1997 letter, FDA proposed a GRAS notification system in April of last year that would replace the GRAS affirmation process. 62 Fed. Reg. 18938 (April 17, 1997). As proposed, the new rule would presumptively convert all pending GRAS affirmation petitions to notifications when the rule becomes final. Petitioners so affected would be able at that time to (1) amend their affirmation petition to meet the new notification requirements, (2) submit a food additive petition for the substance and request that FDA cross-reference the information in the GRAS affirmation petition, or (3) submit a completely new notice in accordance with the notification procedure.

FDA attributed the drop in performance to the Agency's allocation of personnel to work on recent reform efforts. FDA also insists that its performance in 1995 and 1996 was bolstered by the OPA's intentional processing of the simpler, more straightforward petitions in an effort to reduce the Agency's backlog of pending petitions.

It is unclear what level of performance we may expect this year from the Agency, particularly in light of its substantial responsibilities for implementation of FDAMA and the President's Food Safety Initiative. In the long term, however, reforms such as the new Food-Contact Notification system, FDA's proposed GRAS notification rule, reduced environmental assessment requirements, and administrative upgrades such as an effective electronic tracking system for filings should result in a consistent and substantial increase in the annual number of submissions processed by FDA each year.

3. Working Group Established to Respond to Concerns over USDA's Audit Procedures

USDA and FDA have established a working group to address issues raised in our October 1, 1997 letter to both Agencies regarding USDA's audit requirement that all food-contact substances used in meat and poultry plants have some type of official sanction from FDA. The working group will be headed by John Demaré of USDA, and will include Sandra Varner and John Bryce of FDA's Office of Premarket Approval, and all four chemists who report to Mr. Demaré at USDA - William Jones, Penelope Zervos, Elaine Miletta, and Susan Zuk. A date for the first meeting of the group has not yet been set.

As many of you know from our earlier letters to the Committee, last year we wrote officials at both USDA and FDA in an attempt to resolve a problematic situation involving USDA's inspection audits of meat and poultry facilities. Specifically, our letter addressed the issue that, although a supplier guarantee of FDA compliance is legally sufficient for a USDA-inspected facility to use a food-contact material, upon auditing these records, USDA typically will demand that there be a food additive regulation or other official FDA sanction for every component of a food-contact material. In light of FDA's recent policy to require submission of a publicly disclosable Food Additive Petition or Threshold of Regulation request, this USDA policy forces companies to disclose sensitive confidential information about their products, as well as bear the time and costs associated with submitting unnecessary requests to FDA.

In our October 1 letter to the Agencies, we suggested, as an alternative to the current situation, that USDA ensure that facially valid supplier assurances of compliance exist for food-contact materials, but not necessarily require FDA confirmation of these assurances. John Damaré of FSIS responded to our request and wrote that the working group is intended to "ensure the timely exchange of information, and facilitate uniform and consistent interpretations relating to food-contact applications." In our January 12, 1998 response to Mr. Damaré, we requested the opportunity to provide input to the working group. We will, of course, keep you updated on our progress with this matter.

4. FDA Developing Guidelines for Testing Recycled Paper for Food-Contact Applications

FDA is developing guidelines for the paper industry's use in testing paper products made from reclaimed pulp to ensure that the finished product will be of a suitable purity for use in food-contact applications. The guidelines are expected to be patterned after "Points To Consider for the Use of Recycled Plastics in Food Packaging," the document that the Agency developed several years ago with assistance from SPI for testing products made from recycled plastics. Like "Points To Consider," the recycled paper testing guidelines are expected to recommend studies with surrogate contaminants to determine whether a particular process is sufficient to remove the range of unwanted substances that might be present in recycled paper. In the case of polymeric material, FDA was concerned that reclaimed plastic containers might be contaminated as a result of consumers storing hazardous substances in containers prior to placing them in the recycling stream.

While recognizing that paper is not expected to be contaminated in the same way as plastics, FDA still feels that surrogate contaminant testing is appropriate to represent the following classes of substances that might be present in reclaimed pulp from the use of paper that had not originally been cleared for use in contact with food: (1) inks, (2) photoinitiators, (3) defoamers, (4) slimicides, (5) optical brighteners, (6) coating materials, (7) adhesives, and (8) polynuclear aromatic hydrocarbons. FDA is expected to identify "spiking" levels and particular substances that may be used as surrogates for each contaminant class in the forthcoming guidance document. In addition, the Agency is expected to recommend that both virgin and recycled paper products be tested for the presence of the following substances: (1) polychlorinated biphenyls (PCBs), (2) heavy metals, (3) dioxins, and (4) microbiological contaminants.

In our experience, paper recycling often relies on excluding undesirable components from the feedstock as much or more than processing the recycled pulp to remove contaminants. Since the potential contaminants in paper are more readily identifiable than in plastics, we believe it is more appropriate to test recycled pulp for certain substances of concern and do testing to compare the recycled pulp to virgin pulp. So far, however, FDA seems committed to surrogate removal testing.

A draft guidance document is expected to be available this summer, at which point FDA officials plan to meet with interested parties to discuss the guidance document. Prior to issuing the guidance document, an FDA official is expected to publish a paper explaining FDA's position on this issue.

5. Levitt Replaces Shank as CFSAN Director

In a surprising move, Dr. Fred Shank was replaced as director of FDA's Center for Food Safety and Applied Nutrition (CFSAN) and assigned to a new post as Senior Advisor to the FDA Commissioner for External Academic Affairs. The move brought an abrupt end to Dr. Shank's nearly ten years as the Center's Director. Dr. Shank will be replaced by Joseph Levitt, an attorney who has served in a variety of positions within FDA, including Chief of Staff in the Office of the Commissioner, acting Deputy Commissioner, and Director of Executive Operations. Mr. Levitt has served most recently as Deputy Director for Regulations and Policy at FDA's Center for Devices and Radiological Health where he was well regarded for his leadership as a manager and his ability to find consensus between competing interests over complex problems.

The decision to replace Dr. Shank is thought to be an effort on the part of acting Commissioner Dr. Michael Friedman and Deputy Commissioner for Policy William Schultz to install a director who can respond to the increased focus placed on the Center as it implements the President's food safety initiative as well as oversee the Center's other reform efforts. In the past, this position has been held by a physician or scientist, and the appointment of Mr. Levitt, who is an attorney, may mark a decision by FDA officials that a strong manager is more important in this role than a person with a scientific background. Mr. Levitt has earned a very good reputation within the Agency in his past positions, and already has begun to meet with top CFSAN managers and office directors. One of the new Director's first priorities will be to hire several food safety experts to complement the Center's existing staff.

6. White House Reportedly Near to Announcing its Nomination for FDA Commissioner

The Clinton Administration may be very close to announcing the nomination of Dr. Jane Henney, University of New Mexico Vice President of Health Affairs, for the job of FDA Commissioner. The Commissioner position has been vacant for over a year, since the resignation of Dr. David Kessler. Food Chemical News is reporting that Dr. Henney's name has cleared the White House, and may be sent formally to Capitol Hill for consideration in the next week. As we reported in our last letter, Senator Edward Kennedy is strongly supporting Dr. Henney's nomination, but she may run into opposition from Senate Republicans, who frequently oppose any nominee with Senator Kennedy's blessing. In addition, Dr. Henney's nomination is not supported by the medical device industry, which views her with skepticism because of her role in the regulation of devices during her earlier tenure at FDA under Dr. Kessler.

The other top candidate for the FDA Commissioner post reportedly is Dr. Michael Friedman the current "acting" Commissioner at the Agency. Donna Shalala, HHS Secretary, has come forward in support of Dr. Friedman's nomination, but he may also come under attack from Congressional conservatives. If the Henney and Friedman nominations run into trouble, Dr. David Challoner, President for Health Affairs at the University of Florida, may emerge as a possible candidate for the FDA Commissioner position. Dr. Challoner was originally included on a list of potential commissioner candidates, but his name was thought to have been dropped from consideration. Recently, however, it has been rumored that Dr. Challoner has been placed on a "short list" of alternatives if the Administration is forced to come up with another nominee.

7. FDA Belatedly Publishes Lists of Medical Devices Exempt (and Not Exempt) from 510(k) Requirement

Although the majority of our coverage of the FDAMA has focused on its codification of a notification system for food-contact materials, another important aspect of this legislation is that it requires FDA to reduce the regulatory burdens on medical device manufacturers. In this regard, several medical device provisions of FDAMA are intended to streamline the PMN system for medical devices established under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the Act). FDAMA amends the Act to add new sections 510(l) and 510(m), which exempt most Class I devices and certain listed Class II devices from 510(k) PMN requirements.² Class I devices intended for uses that are of "substantial importance in preventing impairment of human health" or that pose a possible "unreasonable" risk of illness or injury, however, will not be exempt. Because these terms are not defined, it may be difficult for device manufacturers to determine whether their devices are exempt. For this reason, under FDAMA, FDA was charged with preparing, by January 20, 1998, a specific list of exempt devices.

Although FDA missed the January 20 deadline, FDA's proposal to exempt Class I medical devices from 510(k) requirements was published on February 2, 1998. FDA officials claimed that the delay was due, in part, to the Office of Management and Budget's (OMB) review of the lists. In any event, FDA has decided to publish two Class I lists as part of the implementation plan. One list includes 190 exempt devices and the other list covers the 53 Class I products placed in a "reserve" category where 510(k)s will continue to be required. (A list of Class II devices that will be exempt from 510(k)s was published in the January 21, 1998 issue of the Federal Register. All three lists were scheduled to become effective on February 19.)

Included in the "reserve" list of class I devices that still require 510(k)s are three products that may be of specific interest to some Committee members: surgeon's gloves, covered under 21 CFR § 878.4460; liquid bandages, covered under 21 CFR § 880.5090; and patient examination gloves, covered under 21 CFR § 880.6250. These devices are likely included in the "reserve" list because many of them contain natural rubber latex, which, as reported in our December 29, 1997 letter, has been associated with severe allergenic reactions. Industry is encouraged to comment on the Class I medical device lists before May 4, 1998 and the Class II medical device list before April 21, 1998.

8. European Commission Update

The paperwork involved in petitioning the European Commission's (EC's) Scientific Committee on Food (SCF) for authorization to use a substance in food-contact materials has been reduced, albeit slightly. The Petitioner Summary Data Sheet necessarily included with the Technical Dossier in a food-contact materials petition now should be submitted only to the European Commission (to RIVM and TNO Laboratories, respectively), and not to the SCF Working Group, as previously required. A future revision to the Practical Guide will reflect this amended procedure. Meanwhile, the SCF is reminding petitioners that toxicological data relevant to the petition need not be submitted to TNO Laboratories.

The next full SCF meeting is scheduled for March 18-19, 1998, and the SCF Working Group will meet at the end of February, 1998. With regard to the Fifth Amendment to the Monomers Directive, no new draft is available yet, and it is unclear when exactly this Amendment will be finalized. Briefly, it seems that the hold-up at this point is the need to deal with industry requests to eliminate specific migration limits for certain materials.

Also scheduled to be discussed at the Working Group meeting is the controversial issue of testing food-contact substances for bioaccumulation potential. At present, the SCF recommends, as a preliminary measure, assessing bioaccumulation potential through the results of the octanol water partition coefficient determination (log POW). If the log POW is greater than 4, actual bioaccumulation data are needed. The SCF has not indicated, however, how much data should be generated. Thus, the SCF has proposed that to address the bioaccumulation potential of substances that are the subject of petitions it will review each petitioner's demonstration of the substance's lack of bioaccumulation and decide on a case-by-case basis how to proceed.

9. Korea Proposes New Packaging Standards

We recently received a translation of a proposal by the South Korean Ministry of Health and Welfare for new specifications and standards for materials used in food-contact applications. The new regulations are intended to broaden and clarify the existing standards for materials as well as to harmonize the Korean regulations with international standards.

As proposed, the new regulations will expand the number of materials covered by standards from 5 to 30. Specifically, the thirty standards cover food-contact equipment, containers, and packaging made from the following materials (set forth in the terminology used in the English-language version of the Korean proposal): polyvinyl chloride (PVC), polyethylene (PE), fluorinated polyethylene, polypropylene (PP), polystyrene (PS), polychlorovinylidene (PVdC), polyethylene terephthalate (PET), phenolformaldehyde (PF), melamine formaldehyde (MF), urea formaldehyde (UF), polyacetal, polyoxymethylene (POM), polyformaldehyde, polymethylmethacrylate (PMMA), polyamide/nylon, polymethylpentene (PMP), polycarbonate (PC), polyvinylalcohol (PVA), polyurethane, polybutene-1 (PB), butadiene resin, acrylonitrile-butadiene styrene (ABS) and acrylonitrile styrene (AS), polymethacrylstyrene (MS), polybutyleneterephthalate (PBT), polyarylsulfon (PASF), polyarylate (PAR), hydroxybutyl polyester (HBP), polyacrylonitrile (PAN), flurororesins (FR), ionomer resins, ehtylenevinylacetate (EVA), methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), polyethylenenaphthalate (PEN), cellophane, rubber materials, paper or processed paper materials, metals, woods, and glass, ceramic, enamel, and pottery.

Most of these standards consist of fairly general compositional definitions for the materials, maximum lead and cadmium limitations, limitations on the amount of heavy metals in general, evaporation residue, and limitations on certain residual monomers and by-products that are specific to the material that is the subject of the specification. The proposed regulations prohibit the use of dioctyl phthalate.

The original deadline for comments on the proposal was February 12, but extension of this date may be requested due to delays in obtaining an English translation. Please let us know if any of you are interested in further information or in commenting on the proposed regulations.

On a separate note, we have received unconfirmed reports that China is no longer accepting a suitable FDA status as a sufficient basis for permitting the use of food-contact materials in the U.S.. Reportedly, this may be in retaliation for a refusal to permit entry of a material from China the U.S. We would be interested in any information that you have to share on this matter.

As always, should you have any questions or comments about these subjects, please do not hesitate to let us know.

Cordially yours,

Ralph A. Simmons

(202) 434-4120
simmons@khlaw.com Back to Top

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