To: The Society of the Plastics Industry, Inc.
Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

This letter provides our final report on developments during 1997 affecting food, drug, and cosmetic packaging. The past year saw the culmination of some 40 years of effort in the enactment of a more rational approach to Food and Drug Administration (FDA) regulation of packaging materials, the premarket notification system. It has been our pleasure to work with the Committee on this important achievement, and we look forward to continuing to work with you during the coming year to assure the proper implementation of this new system. We hope you have had a wonderful holiday season, and we extend our best wishes for a happy, healthy, and successful 1998.

1. Now that PMN System Is Law, Work Begins to Ensure that the Necessary Funding Is Appropriated

As most of you know by now, we were successful in our efforts to make sure that the premarket notification (PMN) system for food-contact substances was included in the Food and Drug Administration Modernization Act of 1997 that was enacted last month. Despite the fact that the PMN system was included in the law, our work is not yet complete. As we described in our November 11, 1997 letter to the Committee, the final language in the bill states that the PMN system will become effective on April 1, 1999, only if Congress appropriates at least $1.5 million to fund the program for the last six months of fiscal year (FY) 1999 (April through September). In subsequent years FDA must receive at least $3 million annually. Provisions are made to increase this amount if, during the course of the program, it turns out that funding is insufficient. FDA does not have to implement the program unless Congress has appropriated at least the amounts identified above. Thus, we are working actively, along with members of this Committee (and some companies' Washington representatives), to ensure that the funding for the PMN system is included in FDA's appropriations for FY 1999.

FDA and the Administration are now working on the federal budget for FY 1999. The President must submit this budget to Congress on February 2, 1998. We know from our conversations with Agency officials that FDA included funding for the PMN system in its own budget that was submitted to the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB). OMB has financial oversight over the budgets for all departments in the executive branch. As part of the budget process, HHS and OMB review FDA's budget and then 'pass-back' the budget to the Agency with their revisions. FDA then appeals those parts of the budget that have been denied, and which the Agency feels need to be included.

At this point, OMB and HHS have reviewed and questioned, along with a number of other funding items, FDA's request to fund the PMN program. In the ordinary course of the process, FDA has made an appeal to include funds for the PMN system in the budget. To ensure that both HHS and OMB understand the importance and benefits of the new system, SPI President Larry Thomas sent letters to both Donna Shalala, Secretary of HHS, and to Franklin Raines, Director of OMB, briefly explaining the PMN system and urging that funds for this program be included in the FDA budget presented by the President to Congress.

We also have been active in soliciting support on Capitol Hill for these funds. When Congress resumes at the end of January, we hope that the Conference Committee that negotiated S.830 will present a letter to the members of the House Appropriations Subcommittee on Agriculture (the Subcommittee with jurisdiction over FDA's budget) urging that these funds be included in the federal budget. In addition, we are working with the legislative staffs of several FDCPMC member companies to personally contact the appropriations committee members to explain the PMN program and the funding requirement.

In a related matter, we have been informed that FDA has already formed a group to begin drafting regulations for the PMN system. We are in the process of drafting comments to FDA regarding how we believe the system should be implemented and what information should be included in a notification. We will circulate our comments to the Committee for your input prior to their submission to FDA.

At the meeting of this Committee in Tampa at the beginning of December, members were offered the opportunity to sign up to be part of an ad hoc task group of the Legislative Subcommittee to work most closely with us on obtaining the necessary appropriations and drafting the regulations. Those who signed up at the meeting have been included on an E-mail list (participants without E-mail capability will receive faxes), which we will use to advise participants of developments related to PMN appropriations and regulations and to coordinate our activities in these areas. This group is open to any interested member of the Committee; if you would like to be added to the list, please send us your E-mail address or fax number (and the E-mail and fax numbers of any additional people in your company, such as your company's Washington representatives, who want to be part of this activity).

Of course, we will continue to keep the entire Committee advised of developments through our regular update letters and through special reports on any matters of unusual importance or urgency. In addition, as indicated previously, our suggestions for the PMN regulations will be circulated to the whole Committee for review and comment before being shared with FDA.

2. Legislation Introduced in Congress that Would Give FDA Mandatory Recall and Civil Penalty Authority

Just before Congress recessed for the year, Rep. Frank Pallone (D-NJ) introduced legislation that would give FDA mandatory recall and civil penalty authority over adulterated and misbranded food. The bill is similar to the legislation introduced earlier this year that would give the same authority to USDA.

Pallone's bill is co-sponsored by a number of Democrats on the House Subcommittee on Health and Environment, including Reps. Brown (OH), Stupak (MI), and Eshoo (CA). If enacted, the bill would allow FDA to demand that a company cease distribution of adulterated or misbranded food, notify distributors about the product, recall the product, and/or provide notice to consumers after first consulting with the Secretary of Health and Human Services. The bill also provides that a person may be subject to a fine of $100,000 per day, per instance of adulterated or misbranded food.

As you may recall if you attended the FDA 101 presentation at the most recent Committee meeting, packaging materials that meet the definition of 'food additive' under the Federal Food, Drug, and Cosmetic Act, also meet the Act's definition of 'food.' Therefore, the recall and civil penalty authority in the Pallone bill would extend to food packaging materials that are 'food additives.' The recently enacted PMN legislation would not affect this situation because the definitions of 'food additive' and 'food' remain unchanged; the new system was simply created for FDA premarket clearance of food-contact substances, whether or not they are food additives.

The Pallone bill is an example of an unfortunate event, the recall of Hudson Foods meat due to the presence of E-coli in some of the product, being used as the predicate for enhanced enforcement authority that FDA and USDA have sought unsuccessfully for many years. As in the past, this substantial expansion of FDA's powers undoubtedly will be opposed vigorously by the food industry, and we would anticipate being involved in a supporting role in a coalition effort.

As many of you know, we believe mandatory recall and civil penalty authority for FDA (or USDA) is unnecessary and ill-advised. We are unaware of situations in which either agency has determined that a recall should occur, but has been unable to 'persuade' a company to take such action 'voluntarily.' The possibility of being named publicly by the government as unwilling to recall an unsafe product has proven to be a sufficiently powerful stimulus for companies to initiate 'voluntary' recalls. Similarly, there is no evidence to our knowledge that civil penalty authority is needed to enforce compliance with the law. Furthermore, unfortunate experience with the Environmental Protection Agency (EPA) suggests that civil penalties can become a fund-raising vehicle rather than a necessary enforcement tool.

3. Former FDA Official Jane Henney May Be the Leading Contender for New FDA Commissioner

Although no announcement is expected before the new year, the White House may be closer to selecting a nominee to be the new FDA Commissioner. Sources report that Administration officials have informally suggested to key Senators that the President may nominate Jane Henney, the current Vice President of Health Sciences at the University of New Mexico. Henney previously was FDA Deputy Commissioner for Operations under former Commissioner David Kessler. She left FDA in 1994.

The Administration put out feelers to assess Henney's chances before the Senate Committee on Labor and Human Resources, which must approve the President's nomination for FDA Commissioner before it can be voted on by the full Senate. Senator Kennedy, the Ranking Minority Member of the Labor Committee, is playing a key role as a strong advocate for Henney's nomination, and it is rumored that Henney has the support of Vice President Gore and the approval of HHS Secretary Donna Shalala.

Henney has been identified for some time as one of several potential nominees, and our contacts indicate that she is generally acceptable to industry. On the other hand, many companies have been favorably impressed by Michael Freidman's performance as lead Deputy Commissioner (essentially Acting Commissioner) following David Kessler's resignation. Dr. Friedman's status as a 'known quantity' makes him the preferred nominee in some industry circles, although probably not to the extent that would lead to open opposition to Henney.

4. Prospective EU Ban on BSE "Specified Risk Material" Postponed

As we reported in our October 8, 1997 letter to the Committee, considerable concern has been voiced by U.S. industry and government officials with regard to the European Commission Decision 97/534, which was adopted on July 30, 1997, to ban certain products based on concerns about bovine spongiform encephalopathy (BSE). This opposition appears to have prompted a postponement of the ban until April, 1998, at the earliest.

Decision 97/534, which prohibits the use of certain animal tissue deemed 'specified risk material' (brains, eyes, tonsils, spinal cords, and other parts of cows, sheep, and goats) that is considered to present a high risk for transmissible spongiform encephalopathy (TSE), is aimed at preventing the spread of BSE, a form of TSE more commonly known as "mad cow" disease. BSE has been linked by some to the degenerative disease in humans, Cruetzfeldt-Jakob disease, which caused the death of several individuals in Britain and elsewhere in recent years.

The prospective ban, as originally adopted, would apply to the use and importation of specified risk material and would require a declaration from a "competent authority" that all products imported into the EU that are of animal origin and that are intended for use in food, feed, medical products, pharmaceuticals, or cosmetics contain no specified risk material. Depending on how it is interpreted and applied, the ban could affect the plastics industry by prohibiting tallow derivatives used as components of, and processing aids for, plastic articles; the tallow from which these products are manufactured may be produced, in part, from sources that fall under the definition of specified risk material. Tallow is also a significant component of many pharmaceutical and cosmetics products, and tallow itself is exported from the U.S. to the EU in large quantities for further processing.

The ban was supposed to take effect on January 1, 1998; however, EU officials have now announced that the ban will not take effect until at least April, 1998. In fact, the announcement suggested that the ban would be further considered at that time, instead of stating that the ban would actually go into effect. This was good news for FDA officials and industry representatives both here and in the EU who have been pressing for a narrowing of the ban's restrictions since it was announced last July. Before the postponement, some progress had been made on at least limiting the ban. In November, EU officials proposed exempting tallow derivatives if certain time and temperature conditions of manufacturing are met. Thus, it appears likely that, even if the ban is instituted in the future, certain exceptions for tallow will be made.

5. USDA and FDA Meet on SPI?s Proposal to Revise USDA's Current Requirement of Written FDA Confirmation Regarding the Status of Food-Contact Materials

As we have reported previously, in October we requested a meeting with USDA and FDA on behalf of SPI to discuss possible ways to avoid the regulatory difficulties currently experienced by companies supplying food-contact materials that are used in USDA-inspected meat and poultry facilities. Under the current system, USDA requires manufacturers of food-contact materials to guarantee that their products comply with the Federal Food, Drug, and Cosmetic Act. USDA's unwritten policy requires components of food-contact materials to be the subject of an official, written FDA evaluation; that is, they must either be listed in the food additive regulations or their use must be supported by a written FDA determination of safety. This policy ignores the fact that properly based self-determinations that a substance will not migrate to food or is generally recognized as safe (GRAS) for its intended use can form an appropriate and legal basis to conclude that the material is suitable for food-contact use. USDA, however, generally will not accept these legitimate self-determinations; rather, the Agency typically requires companies to obtain official concurrence from FDA. Therefore, companies are forced to file requests for Threshold of Regulation exemptions, food additive petitions, or possibly GRAS notifications.

In our October letter to USDA and FDA, we made several specific recommendations as to how USDA might accommodate appropriate self-determinations of FDA compliance. We know that USDA and FDA personnel met to consider our proposal and that they agreed to coordinate more closely in reviewing food-contact substances. We also understand from conversations with senior FDA officials that a written response to our concerns is being prepared. We anticipate that further discussions will be needed to achieve an acceptable resolution.

As a specific example of difficulties in this area, we discussed with FDA the fact that USDA and the Bureau of Alcohol, Tobacco, and Firearms request official FDA concurrence regarding the use of a catalyst, reaction control agent, or other polymerization aid, which does not normally require FDA clearance. We have had experiences where some officials at FDA have stated that the Agency no longer issues letters of "no objection," forcing companies to file Threshold of Regulation requests which result ultimately in the public disclosure of trade secret information. FDA officials have assured us that, while the Threshold of Regulation is the preferred process, in limited cases where it is appropriate, including times when confidential trade information needs protection from public scrutiny, it may be possible to obtain such a "no objection" letter from the Agency.

6. EPA Takes Action Against Microban Antimicrobial; Notice to Be Published Limiting the Treated Articles Exemption

In an effort to reign in what it views as unwarranted claims for some antimicrobials, EPA filed an enforcement action on December 5, 1997, against Microban, Inc. The complaint seeks a $160,500 civil penalty for improperly promoting Polymer Additive B, commonly known as triclosan. EPA asserts that the problematic claims appeared in a document provided to Hasbro, Inc., entitled "Public Relations Questions Regarding Microban" and on the label of a plastic toy treated with Microban. The actual claims are redacted from the complaint as confidential business information. The basis for the complaint, however, is known to be that Microban was responsible for the claims that gave rise to EPA's earlier enforcement action against Hasbro. In the earlier action EPA fined Hasbro for making public health claims for children's toys containing Microban Polymer Additive B.

We also have learned that EPA is preparing a public notice on the subject of "treated articles," which it hopes to publish before year end and which apparently will emphasize the narrow scope of the treated article exemption from the need for registration as a pesticide. It appears to be EPA's intent that any claim beyond control of economic or aesthetic problems in processing and industrial uses will be considered to be outside the scope of the exemption and require separate registration. This appears to be a narrowing of the exemption even beyond the position taken by EPA in enforcement actions to date. In particular, it seems that claims for protecting an article by providing a micro-organism free surface where no economic or aesthetic benefit is gained (even in the absence of any express or implied public health claim) will require registration of the article.

Virtually concurrent with the Microban enforcement action, Assistant EPA Administrator Lynn R. Goldman announced the creation of a new Office of Consumer Safety and Right-to-Know within the Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Subsequently Ms. Goldman issued a "clarification" that the new office is actually only a proposed concept at this time. The proposed new office would have jurisdiction over issues that previously have been entrusted to other agencies, including FDA, the Occupational Safety and Health Administration (OSHA), the Consumer Products Safety Commission (CPSC), and the Federal Trade Commission (FTC). Whether this extension of EPA's pesticide jurisdiction actually will be implemented remains to be seen, along with the relationship of this new office to the other agencies.

7. EPA's EDSTAC Continues Work on Screening Tests for Endocrine Modulators

EPA's Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) is continuing to work toward recommending a battery of tests to screen chemicals for potential endocrine modulating effects. At its December 2-3, 1997 meeting, the group narrowed the number of possible tests for Tier 1 screening to determine whether a substance should be further studied. Many members of the workgroup evaluating the tests, however, feel that further validation of these assays is necessary. The workgroup will meet for the last time at the next EDSTAC plenary meeting on February 3, 1998, and is scheduled to present its report to the full committee. EDSTAC will then develop a report which will be submitted to EPA's Science Advisory Board after the final scheduled EDSTAC meeting in June, 1998. It is important to note that, while the EDSTAC recommendations will be certainly persuasive, they are not binding, and EPA will make the final determination on the appropriate screening procedure that will be selected.

8. Coalition of Companies Seek Expedited Review of Direct Food Additive Petitions Through the Use of User Fees

Monsanto and Procter and Gamble publicly unveiled their proposal to institute user fees in exchange for faster reviews by FDA of direct food additive petitions at the Food and Drug Law Institute Annual Educational Conference held in December in Washington. Monsanto and Procter and Gamble have been holding meetings privately over the last year with interested parties from industry, including SPI. The proposal would, among other things, provide for market exclusivity or data compensation for those companies who pay user fees for the expedited review of their petitions.

9. USDA's Organic Food Regulations Contain Some Questionable Provisions Applicable to Food-Contact Substances

On December 16, 1997, USDA published its proposed rule for the marketing of organic produce and processed foods. 62 Fed. Reg. 65850. The new rules establish requirements for certification of these foods and standards for products that will be labeled as organic. Most of the regulation deals with items such as labeling, certification, and the production and handling of livestocks and crops; however, two of the provisions in the proposed rule have potentially adverse, and likely unintended, consequences for food-contact materials.

First, Section 205.17(b)(1) of the proposed rule prohibits packaging materials that contain a synthetic fungicide, preservative, or fumigant from contact with organic foods. A number of food packaging materials, however, contain preservatives to inhibit any potential microbial growth in the material. We believe that the regulations should be clarified to prohibit the use of preservatives and other antimicrobials in packaging materials only when they have an effect on the food itself and not only on the package.

In a second instance where we do not believe that USDA has considered fully the impact on the use of antimicrobials, Section 205.18 of the proposed rule concerns the prevention of pests in an organic handling facility and sets forth a hierarchy of methods that may be used to control these pests. Because of the definition of pest under FIFRA, these provisions could be interpreted as not only applying to such obvious facility pests as rodents and insects, but to microbial organisms. Thus, such potential food-contact substances such as hard surface sanitizers and conveyor belts with an antimicrobial component could be considered to fall within the purview of Section 205.18.

We would appreciate receiving your views on whether the Committee should submit comments to USDA to request that these provisions be clarified. Comments must be filed by March 16, 1998.

10. FDA Publishes Guidance on Making Non-Controversial Rules Final Immediately

On November 21, FDA published a Guidance for FDA and Industry: Direct Final Rule Procedures that explains the Agency's new process for expedited rulemaking. The direct final rule procedure allows FDA to use a process faster than the normal notice-and-comment rulemaking for rules that will be routine or noncontroversial. When a rule is promulgated using the direct rule process, it may become effective in 135 days provided that FDA does not receive any significant adverse comments.

The FDA Guidance document states that FDA can use direct rulemaking when it does not anticipate receiving any significant adverse comment or when a rule may qualify for exemption from notice-and-comment rulemaking. Once FDA makes the determination that the proposed rule is eligible for this process, it will publish the full text of the rule in the Federal Register along with all the material that would be required in a preamble to a regularly promulgated rule.

After the rule is published, FDA must accept comments for 75 days. If no adverse comments are received, the rule will go into effect 60 days after the end of the comment period. FDA will publish a notice confirming the effective date within 30 days of the end of the comment period. If "significant adverse comment" is received, FDA must withdraw the rule and also must publish a notice within 30 days of the end of the comment period. When a rule is withdrawn any comments received will be considered in developing the final rule using the normal procedure.

FDA defines "significant adverse comment" as comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or why the rule would be ineffective or unacceptable without a change. In general, the test is whether a comment would require a substantive response from the Agency in a normal notice-and-comment rulemaking. Comments recommending a rule change in addition to the rule that was published will not be considered a significant adverse comment. In addition, if the comment only applies to part of a rule, and that part can be severed, FDA may adopt as final those parts of the rule that are not the subject of the adverse comment.

11. FDA Considering Moving Cosmetics from CFSAN to CDER

FDA's Associate Commissioner for Policy Coordination, William Hubbard, announced recently that the Agency is considering moving the Office of Cosmetics and Colors from the Center for Food Safety and Applied Nutrition (CFSAN) to the Center for Drug Evaluation and Research (CDER). Hubbard stated that discussions are very preliminary at this point and that, regardless of the outcome, the regulation of color additives will stay at CFSAN. This possible move apparently reflects the view by CFSAN Director Fred Shank that cosmetics have such a low priority at CFSAN that responsibility should be shifted to an office where the products might receive at least some greater attention. Initial reactions from CDER, however, indicate that this industry, traditionally the least regulated of those within FDA's jurisdiction, would not rate high among CDER's priorities either. The cosmetics industry, through the Cosmetic, Toiletry and Fragrance Association (CTFA), has indicated a preference to remain under CFSAN.

12. Proposition 65-type Legislation Introduced in Massachusetts

As had been rumored for some time, legislation similar to California's Proposition 65 was introduced in the Massachusetts State Senate before it recessed for the holidays. The bill (S.488) was favorably reported out of the Natural Resources Committee but its prospects for final passage in the next legislative session are still far from certain.

S.488 would require a warning label prior to any exposure from a consumer product to a substance found by the state of Massachusetts to cause cancer, reproductive toxicity, developmental toxicity, or neurotoxicity. The bill provides both criminal and civil penalties for violations and, like California's Proposition 65, contains a citizens suit provision that would award claimants initiating lawsuits the cost of litigation, including attorney and expert witness fees.

13. OPA to Improve Web Site

FDA's Office of Premarket Approval is reportedly developing a more "user friendly" web site. The idea for the updated web site was generated from a June focus group which made a number of suggestions to OPA concerning their premarket petition review and approval process. Reportedly, the new site will be easier to use and contain more information of interest to industry, including more information in the "industry guidance" section. The proposal suggests that a list of all approved food ingredients, a list of pending petitions, a petition format and checklist for potential petitioners, and examples of successful petitions would be posted in the "industry guidance" section. The changes to the web site will likely be approved at the end of this month and users of the web site will notice the changes after the first of the year. OPA's web site can be accessed through the FDA home page, www.fda.gov.

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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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