October 31, 2002

(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 report on the Senate's confirmation of Dr. Mark McClellan as the Food and Drug Administration (FDA) Commissioner, as well as FDA's recent public meeting on the Food-Contact Notification (FCN) process. We also provide an update on FDA's review of acrylamide in food, and the Agency's recent draft action plan and public meeting to discuss this topic. This letter also addresses a recently issued guidance document regarding labeling for irradiated foods, as required by the Farm Security and Investment Act. Further, we discuss the European Commission's (EC) opinion on medical devices containing di(2-ethylhexyl) phthalate (DEHP)-plasticised polyvinylchloride (PVC), which concluded that no specific recommendations can be made to limit the use of DEHP in any particular patient group at this time. We conclude with several other international items of interest.

1. Senate Confirms Dr. Mark McClellan as FDA Commissioner
   
   
2. FDA's October 15, 2002 Stakeholders' Workshop on Food-Contact Notification (FCN) Process
   
   
3. FDA's Draft Action Plan and Public Meeting on Assessing Acrylamide in Food
   
   
4. FDA's Bioterrorism Website
   
   
5. Bill Would Provide FDA with Recall Authority
   
   
6. FDA Issues Guidance Document Regarding Labeling for Irradiated Foods
   
   
7. Citizen Groups Accuse the World Health Organization (WHO) of Ignoring Doubts about Safety of Irradiated Foods
   
   
8. UK Agency Chief Nominated as Head of European Food Safety Authority (EFSA)
   
   
9. European Commission (EC) Issues Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity
   
   
10. Taiwan Bans Disposable Cutlery and Food Containers
    
    
11. Australia to Debate Plastic Bag Levy
    
    

1. Senate Confirms Dr. Mark McClellan as FDA Commissioner

Dr. Mark McClellan, a White House health policy adviser for the American President's Council of Economic Advisers, was approved by the Senate in an October 17, 2002 voice vote to be the next FDA Commissioner. Previously, the Senate Committee on Health, Education, and Labor & Pensions had voted unanimously to approve the confirmation of McClellan as the new FDA Commissioner, a post that has been empty since former Commissioner Dr. Jane Henney resigned in January 2001. McClellan testified October 7, 2002 before the Senate Committee on Health, Education, and Labor & Pensions and fielded questions from Committee members on food safety and health care. Committee Chair Sen. Edward Kennedy (D-MA) showed unconditional support for McClellan and stated, "Dr. McClellan has the training, the experience and the stature to serve as the head of the country's most important public health regulatory agency." Before the Senate vote, Health and Human Services (HHS) Secretary Tommy Thompson released a statement stating that Dr. McClellan is a superb choice for FDA Commissioner because he could bring informed analysis and scientific knowledge combined with strong, compassionate leadership to important public policy decisions.

Dr. McClellan has no visible ties to the drug industry, which may have expedited his confirmation by the Senate. He was confirmed by the Senate for the position that he currently holds, and he held a position as deputy assistant secretary of the Treasury for economic policy during the Clinton administration. Dr. McClellan comes from a prominent political family in Texas where his mother, Carole Keeton Rylander, has served as mayor of Austin and is currently the State's comptroller. McClellan's brother, Scott, is a spokesman for the White House and managed his mother's campaign. Mark McClellan's masters degree in regulatory policy and his medical degree are from Harvard University, and his doctorate in economics is from the Massachusetts Institute of Technology. He has served as a member of the National Cancer Policy Board of the National Academy of Sciences and as a professor of economics and medicine at Stanford University.

2. FDA's October 15, 2002 Stakeholders' Workshop on Food-Contact Notification (FCN) Process

On October 15, 2002, FDA held an open workshop on the FCN program. The purpose of the workshop was to highlight some of the ways in which notifiers can help make the FCN process more efficient, as well as entertain industry comments and suggestions to assist FDA in improving the program. On behalf of this Committee, Keller and Heckman submitted several questions and suggestions to FDA for discussion at the meeting.

Dr. Mitchell Cheeseman, Director of the Division of Food Contact Substance Notification Review, Office of Food Additive Safety, urged attendees to "tell a complete story" with their FCN submissions. "Complete information helps us to help you," he stressed. Because the process is slowed considerably when reviewers must request additional information, providing complete information at the outset will benefit all parties. Dr. Cheeseman added that, while the Agency wants notifiers to assess the safety of all migrants, exhaustive treatment is not always necessary. "Often a brief, reasonable explanation of why something is not likely to migrate is all we're looking for."

In the end, Dr. Cheeseman said, the Agency's goals are to help industry to comply with the law, to enhance consumer confidence, to assure public health, and to make it easier to bring innovative products to the marketplace.

Administrative Concerns

According to Dr. Anna Shanklin, a Consumer Safety Officer (CSO) for the Division of Food Contact Substance Notification Review, the Agency has received, as of October 7, 2002, a total of 291 FCNs. Of that number, 206 are now effective. In addition, 48 were withdrawn after phase-I review; three were withdrawn after phase-II review; one was not accepted; and 36 are currently under review. These numbers actually add up to 294, which we believe to be the correct number of total FCNs received so far.

Dr. Shanklin explained the standard procedure the Division follows when it receives an FCN. Upon receipt by the notification control assistant, the receipt date is logged and the 120-day effective date is set. The notification is then sent to the individuals who will review its toxicology, chemistry, and environmental aspects, and to the CSO. Those individuals will then hold a phase-I review meeting, ideally within three weeks, to determine whether the Agency will accept the notification.

If the notification is accepted, the notifier will be sent an acknowledgment letter, and the notification will move to phase-II review. If the notification is not accepted, the notifier receives a deficiency letter, and can then opt either to withdraw the notification or respond to the deficiency within 10 business days. If the response is acceptable, the notification moves to phase-II review-but if the deficiency is of the type that "hinders the review process," the 120-day clock will not start until the Agency receives the information that rectifies the deficiency.

Keller and Heckman noted that FDA has stated its intent to determine whether an FCN is complete and reviewable within 30 days of receipt, and to send an acknowledgment letter to that effect. However, the firm has received acknowledgment letters anywhere from 90 days after submission to a few days before the FCN was due to become effective, leaving the notifier uncertain as to when the notification will become effective. Dr. Cheeseman recognized that acknowledgment letters are sometimes late, and asked to be informed of the specific circumstances when this happens.

Keller and Heckman also pointed out that FDA has been inconsistent in setting deadlines for notifiers to respond to Agency requests for information. Some CSOs have set deadlines as short as two days, based on their assumption that the information should be easy to obtain. However, notifiers often have difficulty obtaining information, particularly where data is required from third parties, such as suppliers and laboratories, and where parties are located outside the U.S. The firm also pointed out that a significant portion of the response time can be lost while a deficiency notice is in the mail, and requested that it be made a policy for the Agency to send requests for additional information by fax or email.

Dr. Cheeseman agreed that the 10-day response time should be incorporated into the Administrative Guidance. "I believe that we can make the change, and I'll say so today," he remarked.

Confidentiality Issues

Typically, FCNs contain confidential trade secret information that, under 21 C.F.R. § 20.61(c), is exempt from disclosure to the public under the Freedom of Information Act (FOIA). Thus, notifiers often mark trade secret information as "confidential" in FCN submissions, and provide a "sanitized" version of the FCN to assist the Agency in responding to any FOIA requests it may receive.

Keller and Heckman partner Ralph Simmons pointed out that FDA has, on occasion, taken issue with a claim of confidentiality and has disclosed information marked by the notifier as "confidential." It is Keller and Heckman's position that, if FDA determines that any information identified as confidential nevertheless should be disclosed in response to a FOIA request for an effective FCN, the Agency should contact the notifier before releasing the information and allow the notifier time to respond as provided by 21 C.F.R. § 20.61(e). According to Simmons, the Agency's failure to make contact with a notifier before information was made public has, in fact, resulted in the release of confidential information.

Drs. Shanklin and Cheeseman responded that FDA is not bound to provide notice if the Agency determines that information claimed as confidential is, in fact, not confidential. The Agency is relying on an exception to the procedure where there is a specific regulation describing the disclosability of information. "We're not required to discuss that in advance," Dr. Shanklin said. "However, if we think there is likely information in a gray area, we'll seek to discuss it."

Efficacy Debate

Dr. Kirk Arvidson of the Division of Food Contact Substance Notification Review provided an overview of the Agency's chemistry recommendations. According to Arvidson, a notification should include information about the identity of the food-contact substance and its composition; a description of the use and the typical and maximum use level of the substance; data to support that the substance achieves the intended technical effect and that the use level is the minimum amount of the substance needed to achieve the technical effect; migration testing and analytical methods; and consumer exposure to the substance.

Keller and Heckman partner Jerome Heckman took issue with Arvidson's assertion that the Agency has the authority to require efficacy data beyond a statement of intended conditions of use, referencing an analysis he recently authored on the topic (see the article, U.S. Agencies Lack Authority to Question Efficacy of Food Additives, Yet Questions Continue to Be Raised, on Keller and Heckman's website at www.packaginglaw.com).

The FDA, Heckman remarked, has never been granted the statutory authority to demand proof of efficacy or that some defined amount of a substance is required to accomplish an intended purpose. [Section 309 of the Act says that if a tolerance is required with respect to an additive, something that is almost never the case, a Petitioner must indicate what amount is the least that can be used to accomplish the intended purpose.] Otherwise, he said, FDA cannot require data on whether food additives are effective, and cannot make any determination about an additive based on efficacy considerations. Further, the legislative history of the governing statutes makes it clear that requesting efficacy data on food additives is inappropriate. Heckman acknowledged that the Agency is entitled to information as to the intended use of food-contact substances to aid in the evaluation of its safety, and can deny a notification if it makes a finding that a substance will work a deception on consumers, but that is the limit of the Agency's authority. "It is time for FDA to stop perpetuating the myth that petitioners or notifiers must prove that use of a substance will be efficacious," he remarked. "Requiring efficacy data is neither necessary nor proper; FDA must rule on safety, but the marketplace will decide on efficacy since no one will go to the expense of using a substance in packaging that accomplishes no purpose."

3. FDA's Draft Action Plan and Public Meeting on Assessing Acrylamide in Food

FDA presented its draft action plan for assessing acrylamide in food at a public meeting on September 30, 2002; the plan is available on FDA's website at www.cfsan.fda.gov/~dms/acryplan.html. The plan outlines FDA's goals and planned actions regarding acrylamide, which the Swedish National Food Administration discovered in a variety of fried and oven-baked foods. By way of background, the Swedish research indicated that acrylamide formation is associated with high temperature cooking of certain foods, and these findings have been confirmed by Norway, the United Kingdom (UK), Switzerland, and the U.S. Acrylamide is a potential human carcinogen, neurotoxicant, and genotoxicant, but its actual impact on public health is unknown. While FDA announced that it has confirmed the presence of acrylamide in foods, it noted that the amount of the potential carcinogen varies widely within a given food category, depending on how specific brands of foods are processed. Agency officials indicate that further testing of different kinds of foods, the mechanisms by which acrylamide is formed, and the toxicological effects of acrylamide is needed before the Agency makes any public recommendations about dietary changes. FDA is continuing to test different food samples to gain additional insight at this time.

At FDA's September 30, 2002 public meeting, Terry Troxell, Ph.D., FDA, discussed FDA's overall goal for assessing acrylamide in the food supply through scientific investigation and risk management decision making, and prevention and/or reduction of potential risk of acrylamide in foods to the greatest extent feasible. Secondary goals include:

1) Assess the dietary exposure of U.S. consumers to acrylamide.
2) Develop rapid screening methods and validate confirmatory methods of analysis.
3) Assess risks associated with acrylamide in foods.
4) With partners, identify mechanisms responsible for the formation of acrylamide in foods and identify means to reduce exposure.
5) Inform and educate consumers and processors about the potential risks throughout the assessment process.
6) Develop and foster public/private partnerships to gather scientific and technological information and data for assessing the human risk.

4. FDA's Bioterrorism Website

FDA's new bioterrorism website is available online at www.fda.gov/oc/opacom/hottopics/bioterrorism.html. It includes information on countering and preparing for bioterrorism, threats to the food supply, FDA congressional testimony regarding the safety of the U.S. food supply, and frequently asked bioterrorism questions. The website also has a link to FDA's Bioterrorism Act information page.

5. Bill Would Provide FDA with Recall Authority

Legislation introduced by Rep. Frank Pallone (D-NJ) would amend the Federal Food, Drug, and Cosmetic Act to allow FDA to order a company to immediately cease distribution of a food product "when there is a reasonable basis for believing that the food is adulterated and presents a risk to human health." The bill would then give the company subject to the order the right to an informal hearing to be held "on the actions required by the order, and on whether the order should be amended to require a recall of the food involved." The legislation would require the HHS Secretary to specify a timeframe for the recall's completion, while the company subject to the recall would be required to submit reports of the recall's progress. The National Food Processors Association (NFPA) and the Grocery Manufacturers of America (GMA) both oppose the bill, and believe that the present system is sufficient to protect public health. The Pallone bill, introduced as H.R. 5488 on September 26, 2002, has been referred to the House Energy & Commerce Committee for further action.

6. FDA Issues Guidance Document Regarding Labeling for Irradiated Foods

FDA recently issued a guidance document, "Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by Irradiation." The document is available on FDA's website at www.fda.gov/OHRMS/DOCKETS/98fr/02d-0385-gdl0001-vol1.pdf. FDA issued this guidance to interested parties who wish to petition the Agency for approval of labeling for a food that has been treated by irradiation. The Farm Security and Investment Act requires that FDA revise current regulations governing the labeling of irradiated foods and further requires that, until the Agency issues the rule, it must consider a firm's petition for alternative labeling of irradiated foods that is "truthful and not misleading." FDA then has six months to approve or deny the petition and, if no decision is made, the petition is deemed denied. The Agency's guidance indicates that food firms wanting to gain Agency support for alternative labeling on irradiated foods must submit consumer research showing consumers understand the intent of the proposed labeling. Public Citizen, a long-time opponent of food industry attempts to replace current irradiation labeling with new terms such as "cold pasteurization," reportedly is pleased with this requirement, since it believes that consumer research indicates that consumers think alternative names for irradiation are misleading.

7. Citizen Groups Accuse the World Health Organization (WHO) of Ignoring Doubts about Safety of Irradiated Foods

Three non-governmental organizations, U.S.-based Public Citizen, the UK Food Commission, and Active Consumers Denmark, recently accused the United Nation's (UN) WHO of ignoring doubts about the safety of irradiated food. The report, "Bad Taste - The Disturbing Truth about the World Health Organization's Endorsement of Food Irradiation," questions whether WHO's 1999 assessment of food irradiation was conducted "independent of efforts to further the legalization, commercialization, and consumer acceptance of irradiated foods." Among other points, the report charged that WHO dismissed recent evidence that unique chemical byproducts formed in irradiated foods (cyclobutanones) promoted the cancer-forming process in rats. The report called on the UN agencies to place a moratorium on any further recommendations to expand food irradiation.

8. UK Agency Chief Nominated as Head of European Food Safety Authority (EFSA)

Geoffrey Podger, chief executive of the UK's food-safety agency, was nominated October 1, 2002 to the position of executive director of the EFSA. Podger, a career civil servant, has worked for the UK Department of Health since 1982 and was responsible for the establishment and development of the UK Food Standards Agency.

In a press release announcing the nomination, Dr. Stuart Slorach, chairman of the EFSA Management Board, said "This is an important step towards making the European Food Safety Authority fully operational. But there is another step before a formal appointment can be made as the nominated candidate will make a statement to the European Parliament before being appointed." Podger is expected to appear before the Environment Committee of the European Parliament before the end of October. Podger's name was included on a "short list" of candidates drawn up by the EC following an open call for expressions of interest from around the European Community.

The appointment of an executive director is a critical step in the process of establishing the four key elements of the EFSA. A Management Board, consisting of a Commission representative and 14 individuals, met for the first time in September. Two tasks remain: the setting up of the EFSA's Scientific Committee and Panels and the establishment of an Advisory Forum. Additional information is available on the EFSA's website at www.efsa.eu.int.

9. European Commission (EC) Issues Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity

The EC recently issued an opinion on "Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity." The opinion is available at europa.eu.int/comm/food/fs/sc/scmp/out43_en.pdf". The opinion recognizes that di(2-ethylhexyl) phthalate (DEHP) is able to diffuse through polyvinylchloride (PVC) and may leach into its environment; thus, patients using PVC medical devices containing DEHP may be exposed to this material.

The opinion reviews DEHP toxicity, and concludes that the main target organs for DEHP toxicity are the liver, kidney, and testes. Further, the general view of DEHP toxicity is that mechanisms for adverse effects exist in rodents, but these do not appear to be of great significance in non-human primates, and the evidence that such mechanisms could be operative in humans is lacking. In addition, the opinion indicates that there are no reports concerning any adverse effects in humans following exposure to DEHP-PVC, even in neonates or other groups of relatively high exposure. The report concludes that no specific recommendations can be made to limit the use of DEHP in any particular patient group at this time, and no Tolerable Intake Value for DEHP in medical devices can be recommended. It is, however, strongly proposed that detailed studies be performed and further data collected to monitor this situation.

10. Taiwan Bans Disposable Cutlery and Food Containers

As part of Taiwan's campaign to reduce the use of plastic, its Environmental Protection Agency has banned the use of disposable plastic cutlery and food containers in government-operated grocery stores, restaurants in government buildings, military installations, and schools, as of October 1, 2002. This new measure is in addition to a July 1, 2002 prohibition on providing retail customers with free plastic carrier bags. About 70 percent of the restaurants recently inspected now use reusable utensils, while the others have opted for disposable ones made of materials other than plastic. Retailers who do not comply will be fined according to Taiwan's Waste Disposal Act. The ban currently affects over 7,700 stores and restaurants, but it may be widened next year to include more than 70,000 businesses.

11. Australia to Debate Plastic Bag Levy

The Australian Parliament is considering several proposed bills to impose a levy on each plastic shopping bag used at supermarket checkouts, as a way to combat a litter and disposal problem. Federal Environment Minister David Kemp will consider levy proposals if current plastic bag recycling measures are found to have failed; however, this evaluation of the effectiveness of recycling measures may take a year to complete. A voluntary recycling campaign will be introduced in March next year as part of a "Clean Up Australia" publicity campaign. Minister Kemp is thought to support the levy, although the government still has two years left of its five-year agreement with industry not to introduce a plastic bag levy. In Ireland, a similar levy has cut plastic bag use by 90 percent.

* * *

As always, if you have any comments, or if we can provide additional information regarding any of the issues discussed above, please do not hesitate to contact Jerry Heckman, Colleen Evale, or me.

Cordially yours,

Ralph A. Simmons

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