General Counsel's Report To The Society of The Plastics Industry, Inc.'s Food, Drug, and Comestics Packaging Materials Committee

November, 2001
Jerome H. Heckman
Ralph A. Simmons

INTRODUCTION

We are pleased to present this report on the status of matters in which we have been involved or which we have monitored on behalf of The Society of the Plastics Industry, Inc.'s (SPI's) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) since the June 29-30, 2001 meeting of the Committee.

TABLE OF CONTENTS

Update on Food-Contact Notification Program

Food Safety Bills Proposed to Combat Bioterrorism

FCN for Use of EVOH to Hold Food During Irradiation Stalled at FDA

FDA has New Chief Counsel, Still Searching for Commissioner

Final Rule Prohibiting Use of Certain Biocides in Organic Food Has Ambiguous Provision on Packaging Materials

1. Update on Food-Contact Notification Program

We are still waiting for the Food and Drug Administration (FDA) to publish a final rule implementing the Food-Contact Notification (FCN) program. This rule will specify the information required in an FCN, describe how the notification process is to be administered, and makes conforming changes to the existing regulations to account for the new program. The proposed rule was published in the Federal Register on July 13, 2000, and most recent reports indicated that the Agency had hoped to publish the final rule by September 30, 2001. It is unclear at this point when the final rule will be published, and the Agency's efforts to address bioterrorism concerns may further delay publication of the final rule.

One recently instituted rule with respect to FCNs that has been brought to our attention was not part of the proposed regulations describing how the FCN program will run, and creates at least some risk of thwarting the intent of the legislation establishing the FCN program. As you know, the statute implementing the program calls for a fixed 120 day time period that the Agency has to review FCNs; if the Agency does not object to the FCN within that time frame, the notification becomes effective. Currently, if FDA has questions about an FCN during the review period, it sends a letter to the notifier asking for clarification or the submission of additional information. It recently has come to our attention that FDA now intends to strictly enforce the requirement that responses to these questions be provided within ten business days; if the information is not received within that time frame, the Agency will "restart" the 120 day review period from the date of the submission of the additional information.

Previously, FDA has shown some flexibility with respect to the 10-day response period. If responses have been provided within a timeframe reasonably close to 10 days and the information has not required extensive review, the Agency has sometimes agreed not to restart the clock. Now, however, it appears that FDA intends to be less flexible on this score. Combined with the fact that we have been receiving some questions from the Agency that really are not significant for the safety review, there is some risk that the new rigidity on the 10-day deadline will be used to thwart the intent of the legislation creating the FCN program to have a fixed 120-day review period. We believe that the review period should only be restarted when the nature of the additional data submitted or the timing of the submission preclude FDA from completing a thorough review within 120 days.

On the positive side, we also have been told (and have experienced) that the Agency will now send requests for further information on FCNs to the notifier via facsimile or e-mail, since they understand that, when these requests are sent via U.S. Postal Service, the requests can take as many as five working days to reach the notifier.

Since our last report to the Committee, FDA has placed on its website a database providing cumulative estimated dietary intake (CEDI) and acceptable daily intake (ADI) information on some substances. As you probably know, one notable difference between Food Additive Petitions and FCNs is the new responsibility placed on submitters to calculate the cumulative estimated dietary intake (CEDI) to potential migrants. Submitters of FCNs are required to estimate the CEDI from all sources of exposure, rather than just the estimated dietary intake (EDI) from the use that is the subject of the notification.

The ADI, another critical aspect of notifications, is the highest intake level of the substance that may be cleared based on the available data. ADIs are determined from the lowest "no-observed effect level" (NOEL) established in feeding studies performed on the substance.

The CEDI/ADI database can be found on FDA's website at http://www.cfsan.fda.gov/~dms/opa-edi.html. The database certainly is not exhaustive, and the Agency continues to compile information on substances and add them to the list. Submitters can continue to contact FDA to obtain CEDI/ADI information for those substances not found on the database.

Finally, you may recall that, at the June meeting of the FDCPMC, FDA's Dr. Mitchell Cheeseman provided information on the Office of Food Additive Safety's (OFAS) development of a program for accepting electronic submissions. On July 31, 2001, FDA announced the availability of two draft guidances in this regard, entitled "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format - General Considerations" and "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions." See 66 Fed. Reg. 39517 (July 31, 2001). The general guidance document is available on FDA's website at http://www.cfsan.fda.gov/~dms/opaeguid.html; the guidance specifically addressing electronic submissions of food additive and color additive petitions also is available on FDA's website at http://www.cfsan.fda.gov/~dms/opaegui2.html. Further guidance on electronic submissions was provided during an FDA webcast, a tape of which can be viewed on the Agency's website at http://www.cfsan.fda.gov/~dms/opaesub.html.

FDA is not quite ready, however, to accept electronic submissions of FCNs. One sticking point that remains with regard to electronic submissions is FDA's instructions that submissions must be delivered via CD- ROM, diskettes, Zip disks, or electronic tape. In other words, the Agency is not accepting a purely electronic, online delivery, but still requires physical delivery of the "electronic" submission, which proved to be a major obstacle recently when the anthrax scare caused FDA to stop accepting deliveries. An email address designed to accept submissions would need to be secure, and FDA does not have a secure e-mail address established at OFAS' current Washington, D.C. location. A secure email address will not be established until OFAS moves to its permanent location in College Park, Maryland.

2. Food Safety Bills Proposed to Combat Bioterrorism

The September 11th terrorist attacks have again brought to the forefront concerns about the safety of the nation's food supply and renewed calls in Congress for the creation of a single food safety agency and FDA mandatory food-recall authority. Recently proposed legislation also would provide FDA with increased authority over imported food. In general, the legislation being proposed expands FDA's authority without regard to whether an emergency exists requiring extraordinary action. A bill introduced by Sen. Hillary Rodham Clinton (D-N.Y.) would provide FDA with the authority to recall and detain immediately any contaminated food. In addition, Clinton's "Protecting the Food Supply from Bioterrorism Act" (S. 1551) would allow FDA to inspect food processing facilities overseas to ensure that they meet U.S. safety standards; currently FDA can only conduct inspections once food is at U.S. borders. The bill also calls for additional funding to improve testing and surveillance technology to allow inspectors to identify food pathogens more quickly.

A House bill, the "Imported Food Safety Act of 2001" (H.R. 3075), would give FDA authority over imported food, including fresh fruits and vegetables, that is similar to the authority the U.S. Department of Agriculture (USDA) has for imported meat and poultry. The bill proposes a user fee for imported foods, and allocates the projected $56 million per year that would be generated by these user fees for use to fund increased border inspections and research and development of tests for detection of microbial and pesticide contamination. The bill also mandates country-of-origin labeling for imported foods subject to FDA regulation, and establishes severe criminal penalties for the international adulteration of food.

Finally, the most recent incarnation of a bill seeking to create an independent, single food safety agency in place of the current regulatory scheme was introduced in early October by Sen. Richard Durbin (D-Ill.). At a hearing October 10th before a Senate Governmental Affairs subcommittee, government and industry representatives weighed in on the Safe Food Act of 2001 (S.1501). A similar bill, introduced May 1st by Rep. Rosa DeLauro (D-Conn.), is pending in the House.

According to Sen. Durbin, the current food safety system is "fragmented" by the involvement of 12 different federal agencies executing 35 different laws. A report recently issued by the General Accounting Office concurs with Durbin's assessment. Testifying at the hearing, Robert A. Robinson, managing director of Natural Resources and Environment at GAO, said that food safety problems persist, "largely because food safety responsibilities are still divided among several agencies that continue to operate under different regulatory approaches." Robinson cited a 1998 report issued by the National Academy of Sciences (NAS), which found that "there are inconsistent, uneven, and at times archaic food statutes that inhibit use of science-based decision-making in activities related to food safety, and these statutes can be inconsistently interpreted and enforced among agencies."

Tim Hammonds, president and CEO of the Food Marketing Institute, lent measured support to Durbin's proposal. Hammonds said that the designation of a single food safety agency has become imperative, but emphasized that "we are on record in support of designating a single food agency, not in support of creating an entirely new agency." According to Hammonds, "too much expertise would be lost, too much of our existing credibility would be squandered, and too much time would be wasted if we attempt to create an entirely new agency from scratch." Instead, Hammonds suggested centralizing resources, responsibility, and authority within one of the existing agencies, and then elevating "the status of this group to a level appropriate to our new challenges."

Health Secretary Tommy Thompson is on record opposing Durbin's measure to create a new bureaucracy, pointing out that FDA, if given adequate funding, has the expertise to oversee food safety.

Similarly, Bernard Schwetz, acting principal deputy commissioner of the FDA, withheld his support for Durbin's single-agency approach, although he did acknowledge that FDA should be granted the requisite statutory authority to act quickly in the face of threats to food safety.

Industry representatives also spoke out in opposition to the single-agency effort. John Cady, president and CEO of the National Food Processors Association, said that the current system can meet new challenges through stronger communication and coordination. "We are not convinced that a new layer of management, led by a single administrator, would achieve the goal of enhanced U.S. food safety," he said. Rather, improvements can be made through the creation of a unified food safety policy, drawing on the expertise of various existing agencies.

3.   FCN for Use of EVOH to Hold Food During Irradiation Stalled at FDA

As we have been reporting to you, the National Center for Food Safety and Technology (NCFST) submitted to FDA an FCN for the use of ethylene/vinyl acetate/vinyl alcohol (EVOH) to hold food during irradiation. The FCN was submitted late July and, therefore, is scheduled to become effective sometime late November. However, NCFST's George Sadler informed participants at the 10th Annual Meeting of the Council on Ionizing Radiation Measurements and Standards in Gaithersburg, MD, that FDA is expected to reject the FCN.

It is unclear to us what the holdup with the FCN is, but apparently it has come as somewhat of a surprise to NCFST, since NCFST felt that the crucial issues with the FCN were discussed and agreed upon with FDA during the course of presubmission meetings. FDA's position on the EVOH FCN is a setback to Sadler, because it was to be the first in a series of FCNs for other polymers to be used during irradiation.

As we have explained in previous letters, in our view, all packaging materials intended for holding food during irradiation do not need explicit FDA clearance to have a suitable FDA status for the intended use. If a material has a suitable FDA status for use in food packaging applications, generally, we consider it suitable for use in holding food for irradiation if it can be demonstrated that no significant change in the potential migrants is caused by irradiation. Of course, testing usually is required to support such a conclusion, and appropriate FDA guidance would be helpful to companies in conducting the proper tests. As discussed in our May 10, 2001 letter, a recommended protocol for irradiation testing has been provided by FDA to certain companies (and, we understand, to NCFST) currently seeking FDA clearance of packaging materials for the irradiation of food. While there has been no published guidance from FDA in this regard, it is our understanding that the Agency plans to issue formal guidance on irradiation testing.

4.  FDA has New Chief Counsel, Still Searching for Commissioner

On August 20, 2001, Daniel Troy joined FDA as its new chief legal counsel. Mr. Troy's most recent position was as a partner with Wiley, Rein, & Fielding. During his tenure at Wiley, Mr. Troy wrote two books: Retroactive Legislation (1998), and Advertising and Free Speech: the Merits of Full Constitutional Protection (December, 2001 expected). National Review, National Law Journal, and American Spectator are among the periodicals in which his work has been published. In addition, Mr. Troy has appeared on CNN's Burden of Proof, and CNBC's Bull Session and Inside Business. He received his J.D. from Columbia University.

Mr. Troy also is known for his First Amendment challenge to fundamental FDA regulations disallowing the promotion of off-label uses of drugs, which indicate that he may support an anti-regulatory atmosphere at FDA. His viewpoint in this regard is described in his July 23, 1999 The Wall Street Journal article, "FDA Censorship Could Cost Lives." This article suggests that pharmaceutical companies that do not promote the off-label uses of their products facilitate physician malpractice because a doctor could be committing malpractice by failing to prescribe an off-label use that could improve patient health.

The search for a new FDA Commissioner, however, is still on. Various groups have objected to the possible nomination of the two candidates widely rumored as the front-runners, Dr. Lester Crawford and Michael Astrue. Congressional opposition to any potential candidate from the food or drug industry led one candidate, Michael Astrue, to withdraw from consideration. Opposition from consumer groups hasn't deterred Dr. Crawford, however, who publicly responded to the groups' allegations that he is unfit for the job. In the midst of the controversy, another name has been recirculated as a possible candidate: Peter Barton Hutt, a former FDA Chief Counsel who currently is a partner with the Washington, D.C. law firm Covington and Burling.

Thus, the Bush Administration appears to have made little progress in selecting a Commissioner since the President took office last January. This fact has not gone unnoticed by the various groups anxious to see a new Commissioner lead the Agency in preventing bioterrorism.

5. Final Rule Prohibiting Use of Certain Biocides in Organic Food Has Ambiguous Provision on Packaging Materials

A final rule prohibiting the use of certain synthetic fungicides, preservatives, or fumigants in organic food handling could be read to apply to components of packaging materials. On Dec. 21, 2000, USDA's Agricultural Marketing Service issued the rule, pursuant to the Organic Foods Production Act of 1990 (OFPA), establishing the National Organic Program (NOP) (see 65 Fed. Reg. 80548). The NOP includes comprehensive standards relating to the production, handling, labeling, importation, and certification of organic products derived from agriculture and livestock. In addition, the NOP established a National List of Allowed and Prohibited Substances for use in organic production and handling operations (known as the "National List"), and a procedure by which individuals may petition for amendments to, or deletions from, the list. The rule became effective on April 21, 2001, and will be fully implemented on Oct. 21, 2002.

The NOP final rule includes some ambiguous language relating to packaging materials used with organic food products. More specifically, 7 C.F.R. § 205.272 ("Commingling and contact with prohibited substance prevention practice standard") prohibits, in organic handling operations, the use of "packaging materials, and storage containers, or bins that contain a synthetic fungicide, preservative, or fumigant" (see 7 C.F.R. § 205.272(b)(1)).

The OFPA and the final rule do not explain the meaning of "contain" used in this provision, and there is nothing in the legislative history or the preamble to the proposed rule to shed any light on the scope of this proscription. However, there is a strong argument that neither Congress nor USDA, which implements the NOP, intended to regulate organic food packaging materials that have no technical effect on the food (e.g., to ripen food, impart flavor, or protect the food against pests or spoilage). NOP personnel also have opined in verbal communications with Keller and Heckman that the final rule is not designed to reach food-packaging components that are not intended to affect the food product.

There are several aspects of the final rule that imply USDA is not concerned with components of packaging that are not expected to migrate to, or commingle with, organic food. First, The National List (codified in 7 C.F.R. Sections 205.600 - 205.607) does not include typical food packaging components (e.g., monomers, or polymer additives) as permitted or prohibited substances. The National List is simply silent on the use of packaging materials in contact with organic foods. Second, materials used to package food already are regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA's food additive regulations. Although the NOP program is based on preferential standards (i.e., for determining the proper labeling of a food as "organic") and not food safety standards (which are FDA's responsibility), it is unlikely that USDA is interested in prohibiting the use of packaging materials that have FDA compliance.

Lastly, other parts of Section 205.272 can be read to suggest that USDA is not concerned with the migration of de minimis levels of synthetic fungicides, preservatives, and fumigants used solely as packaging components, but rather is addressing in its final rule a more significant level of contact. For example, paragraph (b)(2) prohibits the "use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless the reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used."

This provision clearly refers to synthetic fungicides, preservatives, and fumigants that are used with food packaging in a manner that allows them to be removed through conventional cleaning processes. These substances, to be sufficiently removed in compliance with this paragraph, would need to be incorporated superficially into the packaging material (e.g., in a surface treatment) and, thus, would be in a position in the material to contact and compromise the organic status of the food product. This organic standard, therefore, does not appear to contemplate those substances that are bound into the packaging material, and would only migrate to food at levels determined to be insignificant by FDA, if at all.

In light of the foregoing, it is difficult to imagine that the NOP intends to prohibit the use of a component of food packaging that has a suitable FDA status. What seems more plausible is that the NOP, in using the word "contain" in Section 205.272, intended only to reach those synthetic fungicides, preservatives or fumigants used to treat organically produced food, or its packaging, that could possibly compromise the organic integrity of the food.

For example, a paperboard carton treated with a synthetic fumigant or a food preservative that is intended to act on the food itself would likely be considered under the NOP regulations to "contain" a prohibited substance if the components of the fumigant or preservative are not approved on the National List. However, the packaging materials themselves (in this example, the components of the paperboard) would not be considered prohibited unless they have such high levels of the additives that they may transfer to the food and compromise its organic nature.

It is important, as the implementation date of the final rule nears, that USDA further clarify its policies relating to the operation of the NOP. Already, we have been surprised by comments made by USDA regarding the scrutiny that will be directed at processing aids used in organic production.

Toward this end, companies may request that the NOP issue a formal policy statement on the packaging, or any other issue, through its website at: http://www.ams.usda.gov/nop/nop2000/nop2/contact_information.htm. In the meantime, the available evidence strongly suggests that packaging materials containing synthetic fungicides, preservatives, or fumigants that do not migrate to food at significant levels, may be used with organic food under the NOP final rule.

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