August 1, 2000

(202) 434-4110

heckman@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

In this letter we discuss FDA’s recent release of proposed regulations and an Administrative Guidance to implement the Food-Contact Notification program. The current status of the program is also covered. We are also reporting on a report recently released by the Environmental Protection Agency concerning its safety assessment of dioxin, the proposed voluntary user fee funded certification program for meat and poultry processing equipment offered by USDA’s Agricultural Marketing Service, recent retirements from the Office of Premarket Approval, the Food Marketing Institute’s endorsement of a single food safety agency, developments with food irradiation, Europe’s continuing ban on soft PVC toys, the European Council’s support for strengthening the principle of mutual recognition, and the Office of the Inspector General (OIG) report recommending that FDA impose user fees on industry for food safety inspections.

Table of Contents

1. FDA Publishes Proposed Rule on Implementation of Food-Contact Notification and Announces Availability of Administrative Guidance Document

2. EPA Classifies Dioxin as a Human Carcinogen; FDA to Conduct National Survey Concerning Dioxin in Animal Feed

3. AMS Proposes Voluntary User-Free Program to Certify Meat and Poultry Processing Equipment

4. More Retirements from FDA Office of Premarket Approval

5. Food Marketing Institute Calls for Single Food Safety Agency

6. Nationwide Marketing of Irradiated Meat

7. House Appropriation Measure Pressures FDA for Alternate Labeling of Irradiated Foods

8. EC Decides to Extend Ban Again on Soft PVC Toys

9. European Council Resolution on Mutual Recognition

10. OIG Recommends User Fees for Food Safety Inspections

1. FDA Publishes Proposed Rule on Implementation of Food-Contact Notification and Announces Availability of Administrative Guidance Document

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 being administered, and establishes the procedure for revoking the effective status of a notification. FDA also announced the availability of a revised administrative guidance document regarding the preparation of notifications. Of particular interest, the administrative guidance document includes interim guidance for preparing Environmental Assessments pending publication of the final rule amending 21 C.F.R. § 25.32. The administrative guidance document is currently available on FDA’s website at http://vm.cfsan.fda.gov/~dms/opa-pmna.html.

Based on our initial review, it appears that the proposed rule and administrative guidance document do not raise many significant new issues. We plan to provide the Committee with a complete analysis of the proposed rule and administrative guidance, along with draft comments, in the very near future. We would appreciate any input from the Committee regarding FDA’s proposed rule and administrative guidance document in the next two weeks. The comment period extends until September 26, except that comments on FDA’s estimate of the information burden on industry under the Paperwork Reduction Act must be submitted by August 14.

As of May 3, FDA’s Office of Premarket Approval (OPA) had received 77 notifications under its premarket notification program for food-contact substances. The website, last updated July 26, 2000 lists 70 effective notifications. OPA Director Alan Rulis has said that the program "is off to a very successful start." This sentiment also was expressed in the June SPI FDCPMC Meeting in Baltimore, Maryland by Dr. Francis Lin. The premarket notification for food-contact substances program, which was funded out of FDA’s fiscal year 2000 budget and created through provisions of the Food and Drug Modernization Act of 1997, began accepting submissions January 18. Many of the notifications currently pending before OPA were converted from food additive petitions and Threshold of Regulation exemption requests.

2. EPA Classifies Dioxin as a Human Carcinogen; FDA to Conduct National Survey Concerning Dioxin in Animal Feed

Despite a scheduled delay to accommodate interagency review, and to the dismay of other food safety agencies, the Environmental Protection Agency’s (EPA’s) draft reassessment report on dioxin was publicly released before the planned June 9, 2000 date. The draft report 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 confirms that the primary dietary exposure to dioxin is through meat, fish, and dairy. Also counted among the main pathways for dioxin is human breast milk. The report did not find significant risk from dioxin through exposure to paper and paper products, including food packaging, medical products, and diapers.

The draft report coincides with the recent Report on Carcinogens 2000 issued by the Health and Human Services’ National Toxicology Program (NTP). NTP found that dioxin is "reasonably anticipated" to be a human carcinogen, and is currently involved in litigation concerning the upgrading of that designation to "known carcinogen." At a June 14 hearing, The Department of Health and Human Services asked the U.S. District Court judge overseeing the litigation to find that even if the plaintiffs (restaurant owners and a consulting firm representing the manufacturers of PVC) have standing, they cannot show that they meet the legal standard of suffering irreparable harm if dioxin is reclassified. The plaintiffs charge that NTP did not follow its own criteria in categorizing dioxin as a known human carcinogen.

FDA intends to issue a statement on the EPA report once it has completed its review. While the Agency does not disagree with EPA that humans are exposed to dioxin through dietary sources, FDA is reserving further comment on the extent of that exposure or the need to set action levels until it has a chance to consider the report and other information. The draft report was the subject of a peer review workshop on July 25-26 in Washington D.C. A revised draft report will be submitted to the EPA Science Advisory Board for another review with a meeting tentatively scheduled for October. EPA has stated its intent to complete its review of dioxin by the end of the year, but announced it will be accepting public comment up until two weeks after the October meeting.

3. AMS Proposes Voluntary User-Fee Program to Certify Meat and PoultryProcessing Equipment

As we reported to you in previous letters, following the elimination of the United States Department of Agriculture (USDA) program for giving prior approval of equipment used in meat and poultry plants, and responding to the concern expressed by industry regarding the need for a new program, Congress directed the Agricultural Marketing Service (AMS) of USDA to develop a voluntary certification program for processing equipment. AMS published an advance notice of proposed rulemaking on July 16, 1999, and we filed comments on that proposal on behalf of the Committee. Essentially, we advocated that any certification program adopt or utilize a sanitary standard that provides for adequate flexibility with respect to the basis for establishing FDA compliance of materials for the food-contact surfaces of equipment. FDA compliance has been the standard used by USDA for establishing the compositional suitability of a material for contact with meat and poultry.

On June 6, 2000, AMS published in the Federal Register a proposed rule to develop a voluntary user-fee funded program to inspect and certify equipment and utensils used in meat and poultry processing facilities (65 Fed. Reg. 35857). Such certification will provide third party assurance that the equipment meets minimum requirements for cleanability, suitability of materials used in construction, durability and inspectability. Manufacturers submitting an application to AMS requesting evaluation of equipment may request that an evaluation be performed on a prototype, manufactured equipment, or a drawing and materials list. AMS indicates that to provide certification, it may be necessary to conduct on-site reviews of actual equipment to fully evaluate the design and construction. AMS estimates that the total costs for a certification, including in-plant review will be $1,120 plus added travel costs for the on-site review. The cost to an applicant will be based on the time and expenses for the actual review.

AMS is proposing to certify equipment in accordance with a sanitary standard developed by the NSF/3-A Joint Committee on Food Processing Equipment . (Underwriters Laboratories had also proposed a sanitary standard for consideration by AMS, but was not chosen for the program). The NSF/3-A proposed standard, Hygiene Requirements for the Design of Meat and Poultry Processing Equipment, has been open for public comment for almost one year (to end in September, 2000) during which it has been intended for use by industry on a trial basis. If you will recall, based on our review of the standard, we found it unnecessary to submit comments as it provides for all the legitimate options for establishing FDA compliance of food-contact materials used in meat and poultry processing plants.

Whether this proposed AMS voluntary user-fee program will become a marketplace requirement or not remains to be seen. In the meantime, a self-determination that equipment complies with FDA's food additive regulations and principles of Hazard Analysis Critical Control Points (HACCP) should be sufficient for USDA. Some customers may require more - such as third party certification, which is currently being offered by NSF (using the NSF/3-A sanitary standard).

Comments on the proposed AMS program must be submitted by August 7, 2000, in duplicate to Barry L. Carpenter, Deputy Administrator, Livestock and Seed Program, Docket No. LS-99-12, Room 2092 South Agriculture Building, 1400 Independence Avenue, S.W., Washington, D.C. 20250-0249.

4. More Retirements from FDA Office of Premarket Approval

As we have been reporting to you, a number of FDA’s Office of Premarket Approval (OPA) personnel have retired in the last several months. We have previously mentioned retirements by Eugene Coleman, Julius Smith, and Greg Cramer. Now, Krishna Misra, the OPA toxicologist most familiar with packaging materials issues, also has retired after 40 years with FDA. Dr. Misra was involved in the promulgation of a significant number of food additive regulations; he reviewed almost all the indirect food additive petitions and more recently Food-Contact Notifications, as well as advised on toxicology requirements for those submissions. Also retired last month is Hiltje Irausquin, an OPA petition reviewer, who has worked almost exclusively on direct additive and GRAS petitions.

5. Food Marketing Institute Calls for Single Food Safety Agency

In a surprise move, the Food Marketing Institute (FMI), one of the largest and most influential food trade associations, recently announced its support for a single food safety agency to better protect the public health and use limited food safety resources more effectively. As we have reported to you previously, Senator Richard Durbin (D-Ill.) introduced a bill in June of 1999 proposing to consolidate in a single agency the food safety, labeling, and inspection functions currently performed by FDA, USDA, and the Department of Commerce.

Although consumer groups, such as the Center for Science in the Public Interest (CSPI) and Safe Tables Our Priority (STOP), endorsed the legislation, industry groups expressed opposition to a single food safety agency on the basis that such an entity would merely evolve into a "super bureaucracy."

FMI asserts that the only way to achieve meaningful reform of food regulation is by centralizing regulatory authority. In its position, FMI has gone beyond even the National Academy of Sciences which convened an expert panel two years ago and recommended the designation of a federal official to be in charge of food safety activities.

6. Nationwide Marketing of Irradiated Meat

As we have been reporting to you, FDA approved, on a one year trial basis beginning February 22, 2000, the use of materials cleared under 21 C.F.R. § 179.45 to prepackage meat and poultry for irradiation by electron beam and x-ray, as well as gamma ray, which currently is the only source for which most packaging materials are cleared in Section 179.45. In May, ground beef patties irradiated with e-beam were successfully test marketed in the Minneapolis area. Sure-Beam, a subsidiary of Titan Corporation, in partnership with Minnesota-based Huisken Meats marketed the meat under the brand names "Trail’s Best" and "Happy Trails." Sure-Beam and Schwan’s Foods announced their intent to market irradiated meat products nationwide through a home delivery network. All the irradiated products will be labeled with the radura symbol and language describing the e-beam process. Sure-Beam also has entered into contracts with Tyson Foods, Cargill, Emmpak, IBP and Hawaii Pride. Titan has entered into joint ventures to irradiate tropical fruits and poultry, and is researching the use of irradiation on processed foods.

We continue to receive a steady stream of inquiries about packaging materials to hold food for irradiation, including materials not listed in Section 179.45. As we have indicated in the past, materials with a suitable regulatory status for use with the intended food types and under the intended temperatures, but not listed in Section 179.45, may be used to hold food for irradiation if it can be shown that there is no significant change in the type or amounts of potential migrants.

7. House Appropriations Measure Pressures FDA for Alternate Labeling of Irradiated Foods

The House Appropriations Committee is putting pressure on FDA to encourage the Agency to soften its current labeling requirements for irradiated food. In the report that accompanies the fiscal year 2001 Agriculture Appropriations Act, the committee included language recommending that FDA develop alternative language that would be less alarming to consumers. Specifically, the Committee wants FDA to promulgate final regulations by September 30, 2001 to allow labeling for irradiated foods that does not necessarily include the word "radiation." In addition, the report language is critical of FDA for failing to promulgate a final rule updating the irradiation labeling requirements since passage of the Food and Drug Administration Modernization Act of 1997.

Food irradiation labeling has been under scrutiny lately due in large part to the recent transfer of regulatory authority for red meat irradiation petitions from USDA to FDA. Both House and Senate Appropriators have focused on the issue of red meat irradiation in hearings held earlier this year. During a House Appropriations subcommittee hearing, FDA Commissioner Dr. Jane Henney indicated that the Agency would not consider labeling irradiated meats as "electronically pasteurized." At a Senate hearing the subject was raised when Sen. Slade Gorton (R-WA) asked for a status report on the labeling of irradiated red meat. CFSAN director Joe Levitt responded that, in assessing this issue, the Agency has had to contend with polarized viewpoints, such as the on-going debate between consumer groups, who believe irradiated foods should be clearly labeled in plain, undisguised language, and industry which advocates using an alternative to the term "irradiated." By directing FDA to allow alternative labeling for irradiated foods, House appropriators signaled their agreement with industry in the debate over labeling.

The fiscal year 2001 Agriculture Appropriations Act passed the House of Representatives on July 11, 2000 and the Senate on July 20. It appears that the conference report on this bill, which also will require House and Senate approval, has not yet been filed.

8. EC Decides to Extend Ban Again on Soft PVC Toys

On May 30, 2000 the European Commission (EC) prolonged for the second time the decision it adopted on December 7, 2000 requiring the Member States to prohibit the marketing of toys and childcare articles intended to be placed in the mouth by children under three years of age, made of soft PVC containing one of more of the following phthalates: di-iso-nonyl phthalate (DINP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP), and butylbenzyl phthalate (BBP). As we have reported to you previously, the decision alleged a "serious and immediate risk" to children, and required Member States to take all necessary measures to implement the decision in less than 10 days. This action was taken in spite of strong opposition from the Commission’s own scientific advisors (the Scientific Committee for Toxicology, Ecotoxicity and the Environment (CSTEE)) who took the view that the data do not indicate a significant risk. The decision, which was originally due to expire on March 8, 2000, and then on June 6, 2000, is now extended until the end of August.

9. European Council Resolution on Mutual Recognition

As we have advised the Committee on a number of past occasions, there is a provision of European Union (EU) law, known as mutual recognition, that provides a sound legal basis for marketing a product, including, but not limited to a packaging material, throughout the EU predicated on a suitable regulatory status in any one of the EU member countries. This principle is part of the Treaty of Rome, a founding document of the EU. The practical utility of this doctrine, however, has been reduced somewhat by lack of widespread knowledge of its existence and some reluctance by certain countries, particularly France, to fully accept and implement it. A resolution of the European Council encouraging the use of mutual recognition appeared in the May 19, 2000 issue of the Official Journal of the European Communities. The significance of this resolution is that there is now further support for relying on mutual recognition to establish a suitable regulatory status for food packaging materials in the European Union (EU) Member States. For example, Article 17 of the Resolution states that the Council,

"Encourages economic operators and citizens to make full use of the mutual recognition principle by:

(a)availing themselves of their right to benefit from mutual recognition;

(b)informing Member States and the Commission of any problems they encounter and using legal procedures available in national and Community legislation, where necessary;

(c)using information material provided by the Member States and the Commission.

The Resolution also invites the Commission to take measures to improve the application of the mutual recognition principle by, for example, increasing the awareness of citizens and economic operators through information campaigns, guidebooks, and brochures. We will continue to monitor this issue and welcome any information from the Committee on experience with the use of mutual recognition in the EU.

For more information on how the principle of mutual recognition applies to food-contact materials, see the following Keller and Heckman website: http://www.khlaw.com/mutual.htm.

The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) in its annual cost-saving report has suggested to FDA for the fourth year in a row that the Agency request from Congress the right to impose user fees on industry for conducting food safety inspections. OIG estimates that user fees would save almost $76 million in the first year. OIG also suggested that FDA ask Congress for authority to impose user fees for premarket review and approval of medical devices and inspections of manufacturing facilities. This has been a standard position of HHS and the Office of Management and Budget, but there has been general opposition from industry and little enthusiasm in Congress (or even at FDA in most cases).

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