August 25, 2000

(202) 434-4120

simmons@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

In this letter we provide a brief overview of the Proposed Rule and Administrative Guidance on the Food-Contact Notification program made available on July 13, 2000. We also discuss the use of consumption factors by FDA, particularly the flexibility to develop factors lower than FDA’s "default" values for particular applications. In addition we report on legislative developments with respect to the National Uniformity for Food Act of 2000 (which would preempt California’s Proposition 65), the European Commission’s recent adoption of a "Green Paper" on polyvinyl chloride (PVC), FDA’s review of comments on labeling of irradiated foods and planned testing by Del Monte of e-beam irradiation for processed fruit and vegetable products, and the recent involvement of the National Academy of Sciences (NAS) in the dioxin debate.

1. Overview of Proposed Rule and Administrative Guidance to Implement the Food-Contact Notification Program

2. FDA Consumption Factors Are Not Graven in Stone

3. National for Uniformity for Food Act of 2000 Would Preempt Proposition 65

4. European Commission’s Adoption of PVC "Green Paper" Draws Fire From Industry

5. FDA Still Organizing Effort to Review Irradiation Labeling Comments: Del Monte to Test E-Beam Irradiation On Processed Fruits and Vegetables

6. National Academy of Sciences Asked to Mediate Dioxin Debate

As we reported to you in the last newsletter, on July 13, 2000, FDA published a proposed rule concerning implementation of the Food-Contact Notification (FCN) program (65 Fed. Reg. 43269). The proposed rule specifies the information required in an FCN, describes how the notification process is to be administered, and makes conforming changes to the existing regulations to account for the new program. FDA also announced the availability of a revised administrative guidance document regarding the preparation of notifications which is currently available on FDA’s website at http://vm.cfsan.fda.gov/~dms/opa-pmna.html. In reviewing the proposed rule and administrative guidance, we have concluded that these documents constitute a generally satisfactory approach to implementing the Food-Contact Notification program. We believe the Agency is to be congratulated on proposing procedures that, for the most part, should allow this expedited review process for food-contact materials to function as intended. We have identified a couple areas in these documents, which we discuss below, where we believe improvements or clarifications can be made and that appear to warrant comment by the Committee. Of course, we welcome the Committee’s input as we prepare comments on these topics; the deadline for comments is September 26, 2000.

Contents and Format for Notifications

The proposed rule, at Section 170.101, identifies the basic elements of information that must be provided in an FCN. Under Section 170.104 (b)(1), FDA will not accept an FCN that lacks any of the essential elements.

The administrative guidance document specifies the format in which the information is to be provided. The major change from the traditional format for food additive petitions is that the safety (toxicology) narrative is located in the first section of the FCN, the Comprehensive Summary. We have been accustomed to discussing the toxicology studies in a section of a petition that follows the calculation of dietary exposure based on the migration data. It does not seem critical to us where the toxicology discussion is located (and it should be noted that FDA’s proposed format is only a "recommendation," although it seems prudent to accept the Agency’s guidance in the absence of some compelling reason not to).

Based on FDA’s proposed rules and guidance, and our experience in having drafted and filed several FCN’s already, an FCN will require time, effort and cost equivalent to what has been required for food additive petitions for food-contact materials. This does not seem unreasonable in light of the 120-day deadline for FDA to complete its review, which necessitates that filings should be complete and well-organized.

When the proposed rule becomes effective, there will be the additional requirement to complete Form No. 3480, which is appended to the administrative guidance. This form predominantly consists of lists of the basic information contained in the FCN. There is some apparent redundancy between the form and the FCN itself in areas such as the description of the manufacturing process and discussion of the toxicology data. We hope, however, and would plan to comment to FDA, that the information provided on the form can be brief summaries of the more detailed discussion in the FCN. In that event, the content and format of the FCN, including Form No. 3480, as described in the proposed rule and the administrative guidance do not appear unreasonable.

We note that detailed guidance on the content of the toxicology segment of the FCN (the safety narrative and the comprehensive toxicology profile) is provided in a separate guidance document, "Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations" (September, 1999), available on FDA’s Internet website at http://vm.cfsan.fda.gov/~dms/opa-pmnt.html. In our view, and as pointed out to FDA in comments we previously submitted on behalf of the Committee, the recommended toxicology discussion is unnecessarily burdensome in certain respects (such as an apparent requirement for separate detailed descriptions of every toxicity study on a substance, regardless of relevance to the food-contact use). Our experience to date, however, indicates that FDA is showing some flexibility by accepting toxicology segments of FCNs that are tailored to the particular situation (although clearly all relevant data need to be provided and discussed). In any event, the views of the Committee on this subject already have been provided to FDA, and the proposed rule and administrative guidance do not raise any new issues in this area.

Beginning of 120-Day Review Period

There is a potentially significant issue with respect to FDA’s proposed procedure for accepting FCNs and beginning the 120-day review period. Under proposed Section 170.104, "[i]n order for the 120-day review period to begin FDA must accept that notification." (Emphasis added) In contrast, Section 409 (h) of the Federal Food, Drug, and Cosmetic Act states that "[a] notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by [FDA]," (emphasis added), unless the Agency objects within that timeframe. In our view, the proposed rule must be made consistent with the statute, so that the FCN program will have a fixed 120-day review period as the law contemplates.

The proposal to start the review period from FDA’s "acceptance" of an FCN is not only inconsistent with the statute; it also would have the effect of extending the supposedly fixed review period for an uncertain amount of time, possibly 30 days or even more. The proposed rule does not impose a deadline for FDA to decide whether to accept an FCN. The administrative guidance merely states that "FDA intends to acknowledge receipt of a premarket notification in writing within 30 days of receipt." Under the proposed rule, it is this acknowledgment that constitutes FDA’s "acceptance," beginning the 120-day statutory review period. Thus, the proposed rule would extend FDA’s deadline to at least 150 days, and possibly longer since FDA has not committed definitely to make the acceptance decision within 30 days.

This aspect of the proposed rule is also inconsistent with FDA’s own operation of the program to date. So far, notifications have become effective 120 days from their receipt by the Notifications Control Assistant in the Office of Premarket Approval, as intended by the statute.

Although the statute does not appear on its face to allow for an "acceptance" period by FDA, we recognize that there may be instances in which the Agency wishes to reject a notification for procedural deficiencies. We agree, for example, that notifications should not be permitted for uses of substances that are already the subject of a regulation or threshold of regulation exemption (other than for multicomponent formulations, which FDA intends to allow). In addition, we do not believe it is an efficient use of Agency resources to review notifications that clearly do not meet the procedural requirements for FCNs, e.g., notifications that fail to include a comprehensive safety analysis, as required under proposed Section 170.101(a). Thus, we propose a modification of the proposed rules to provide for a 30-day initial review period, in which the Agency may reject a notification for the three procedural reasons outlined above. However, due to the statutory "receipt" language, this initial procedural review should not delay the running of the 120-day review period.

Good Laboratory Practices

In Section 170.101(c) of the proposed rule, FDA would require that all non-clinical laboratory studies submitted as part of a Food-Contact Notification be performed under (and so certified) Good Laboratory Practices (GLPs) as indicated in 21 C.F.R. Part 58. At first blush, this requirement seems broad enough to apply to analytical testing such as migration studies. However, 21 C.F.R. § 58.3(d) defines non-clinical studies that are subject to the GLP requirement as " in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety . . . The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article." We intend to suggest to FDA that they explicitly refer to this definition in the proposed rule, thereby clarifying that only toxicological or biological studies are subject to the GLP requirement.

2. FDA Consumption Factors Are Not Graven in Stone.

As you may recall from our previous reports, FDA has increased the consumption factor for PET from 5% to 21%, as indicated in the May, 2000 revision of the "Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations." A group of PET resin producers who are members of the American Plastics Council (APC) is working under the auspices of APC to present data to FDA in mid-September that would support a consumption factor for PET lower than 21%, probably in the neighborhood of 14% to 15%. In view of this discussion and activity around the PET consumption factor, we thought that it might be timely to review the subject of FDA consumption factors in general. In particular, as discussed more fully below, we want to remind Committee members that, even if FDA cannot be persuaded to reduce its consumption factor of 21% for PET, there is always the opportunity to establish a lower consumption factor for substances that will be used only with certain segments of the PET market. Over the years, we have had considerable success in persuading FDA to accept consumption factors lower than FDA’s "default" values for a variety of food-contact materials in specific applications.

To provide context for our discussion, it may be helpful to review what consumption factors are and how they are used. The "consumption factor" (CF) is the fraction of the average person’s daily diet that is expected to contact specific packaging materials. Unlike the situation in Europe, FDA does not consider it reasonable to assume that a person’s entire diet will be packaged in any one material. The consumption factor, along with food-type distribution factors for the various types of food — aqueous, acidic, alcoholic, and fatty, is applied to migration data for a substance to estimate the dietary exposure from the intended use of the substance in contact with food. The resulting estimated daily intake (EDI) is then compared by FDA to the appropriate toxicology data to reach the ultimate conclusion of safety.

As it traditionally has done for food additive petitions in the guidance document, "Recommendations for Chemistry Data for Indirect Food Additive Petitions," FDA provides consumption factor values for various plastics and other materials now for food-contact notifications in Appendix IV of the "Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations (September 1999) Revision 1.1, May 2000", which may be accessed on FDA’s Internet website at http://vm.cfsan.fda.gov/~dms/opa-pmnc.html. FDA, however, never has insisted on use of its consumption factors when a different factor can be established by appropriate data. The FDA consumption factors are properly considered "default" values that will be applied in the absence of data supporting a different value. To support a lower consumption factor, it is generally necessary to present information to FDA establishing that a particular substance will be used only with part of a packaging or resin category for technical or functional reasons. FDA typically will not accept the argument that a new material will only capture part of a market for competitive or economic reasons, since the Agency assumes that a substance ultimately may capture its entire market. In our experience, where a legitimate technical reason can be shown for a food-contact material to be used in only a portion of a particular market, FDA has readily accepted use of a lower consumption factor.

This Committee has submitted to FDA data from industry surveys that helps support lower consumption factors for particular types of polystyrene and polyolefins. Data that divides a general resin category into more specific segments is most useful to FDA and to companies in establishing lower consumption factors in particular cases. For this reason, we hope that the data being developed by the PET resin companies in the APC activity will support the division of the overall PET consumption factor into lower discrete factors for particular applications. In this way, the data will be most useful for companies in establishing an FDA status for substances to be used with PET.

In summary, we would simply remind Committee members that you are not limited to use of the 21% consumption factor for PET or any other of FDA’s "default" consumption factors if a different CF can be supported by appropriate data.

3. National Uniformity for Food Act of 2000 Would Preempt Proposition 65

The National Uniformity for Food Act of 2000 ("Act"), (H.R. 2129, S. 1155), a bill that seeks to amend the Federal Food, Drug, and Cosmetic Act ("FFDCA") to provide for uniform food safety warning requirements, would have the effect of preempting California’s Proposition 65 for food packaging as well as for food products themselves. The Act would preempt state warning requirements unless they are identical to FFDCA provisions, with respect to food, or any component or package of the food. This legislation, if passed, would therefore preempt The California Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) as it applies to plastics and other food packaging materials.

Under Proposition 65, the state government of California publishes a list of chemicals "known to the state to cause cancer or reproductive toxicity." The Proposition 65 list is derived from lists maintained by a variety of "authoritative" bodies, such as the National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC). For products containing listed chemicals, warnings must be provided if consumer or workplace exposures exceed a "no significant risk level" (NSRL) established in accordance with California regulations. In our experience, plastic packaging materials containing substances listed under Proposition 65 have not required warnings since exposures have been below the applicable NSRL. Nevertheless, companies have had to spend time and money to establish compliance. In addition, other products, including some non-plastic food-contact materials, have been subject to warnings and state and private enforcement actions. One of the troublesome aspects of Proposition 65 is the "bounty hunter" provision, which allows private citizens (read plaintiffs’ trial lawyers) to bring actions on behalf of the state for financial penalties (and then, of course, to keep a share of the recovery). This has spawned a cottage industry of Proposition 65 lawyers in California.

The National Uniformity for Food Act does have several exceptions from its preemptive effect. For example, the Act allows States to establish their own notification requirements under an "imminent hazard authority." This authority is given in situations where the state must address imminent hazards that are likely to result in serious adverse health consequences. In addition, states may petition the federal government for permission to retain existing standards. If passed, however, it appears that the Act is likely to largely supplant Proposition 65 and other state labeling requirements for food and food packaging.

The Act is currently in the Senate Committee on Agriculture, Nutrition, and Forestry. There are currently 37 co-sponsors of the Act and it appears that its chances of passing may be dependent on the amount of time the bill gets discussed on the floor of the Senate. Opposition to this legislation is most likely to come from Senator Boxer (D) of California. The 106^th Congress’ targeted adjournment date is October 6, 2000, so there is not a great deal of time remaining for action on this bill. It should be noted that this has been a high legislative priority of the Grocery Manufacturers of America (GMA) and others in the food industry for at least a decade. Not surprisingly, consumer advocacy groups, such as the Center for Science in the Public Interest (CSPI), are opposed, as are state officials concerned about losing the ability to control products such as dietary supplements, which are not subject to FDA regulation as extensive as for other products.

On July 26, 2000, the European Commission (EC) adopted a "Green Paper" on the environmental issues associated with polyvinyl chloride (PVC) to promote an integrated approach among European Union (EU) Member States for evaluating the lifecycle environmental impact of PVC and designing measures to protect human health and the environment. The Green Paper recommendations are based primarily on the data generated from a study program that was initiated by the EC in 1999-2000. The Green Paper specifically addresses the structure and economic importance of the PVC industry, the use of additives in the manufacture of PVC, and the management of PVC waste, including recycling and disposal.

European PVC producers have expressed dissatisfaction with the Green Paper, especially with regard to the characterization of the PVC lifecycle. In particular, industry finds the PVC-specific proposals regarding waste management to be misdirected; they assert that the Paper focuses undue attention on waste management, which is not an issue specific to PVC, but part of a larger discussion on resources generally. PVC producers also indicate that the Green Paper ignores the voluntary commitment signed by the members of the PVC industry to address, among other things, the reduction of heavy metal stabilizers in PVC production, and the development of new recycling technologies.

Comments on this document are being accepted until the end of November 2000. At the beginning of 2001, the EC plans to present a Communication setting out a comprehensive Community strategy on the environmental issues associated with PVC. Additional information on the Green Paper on PVC can be found at the following EC website: http://europa.eu.int/comm/environment/pvc.

5. FDA Still Organizing Effort to Review Irradiation Labeling Comments; Del Monte to Test E-Beam Irradiation on Processed Fruits and Vegetables

As we have reported to you previously, FDA solicited comments on its advance notice of proposed rulemaking (ANPR) concerning revisions of labeling requirements for irradiated foods which it published in the Federal Register in February 1999 (64 Fed. Reg. 7834 (February 17, 1999)). The Agency has not yet reviewed the 4,500 comments it received last year, although George Pauli of the Office of Premarket Approval in the Center for Food and Applied Nutrition recently indicated that the matter is being attended to. The House stated in its 2001 Agricultural Bill that it expects a status report on the proposed regulation by November 15.

In the meantime, companies are still looking into using irradiation on their food products. Most recently, Del Monte Foods Co. announced that it will be testing e-beam irradiation on processed fruit and vegetables in plastic and glass containers. Del Monte does not intend to test market these products anytime soon, and will engage in preliminary testing only at this time.

As we have been reporting to you, the Environmental Protection Agency (EPA) released a draft reassessment report that classifies dioxin as a human carcinogen, and estimates that, in worst-case scenarios, dioxin may pose a risk as high as 1 in 100 to 1 in 1,000 for the general population. The report also confirms that food is the primary source of exposure to dioxin. On August 1, in an effort to resolve the interagency debate over dioxin, the EPA, the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) requested that the National Academy of Sciences (NAS) initiate a comprehensive study into whether widespread dioxin contamination in air and water affects the domestic food supply and whether regulatory action is warranted to protect the public health. Environmentalists, who are pushing for finalization of EPA’s draft dioxin assessment, are concerned that waiting for such an NAS report will delay efforts to reduce environmental levels of dioxin. Industry officials, on the other hand, are raising concerns that FDA and USDA efforts to examine dioxin are being overlooked because of EPA’s aggressive position.

* * *

As always, if you have any comments or if we can provide further information on any of the issues discussed above, please do not hesitate to contact us.

Cordially yours,

Ralph A. Simmons

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