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 September 12, 2002
(202) 434-4120 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 Food and Drug Administration's (FDA) announcement of a public meeting to be held on October 15, 2002 to discuss the Food-Contact Notification (FCN) process, as well as FDA's recent release of a draft guidance document on medical devices made with polyvinylchloride (PVC) using di-(2-ethylhexyl)phthalate (DEHP). We also address SPI's submission of comments to FDA concerning licensing of FCN rights, as well as SPI's participation in a Bioterrorism Act Implementation Coalition Recordkeeping Working Group. In addition, we report on FDA funding for fiscal year 2003, and provide updates concerning irradiation and irradiated food labeling. As a follow up to our last letter in which we discussed findings by Swedish researchers of elevated levels of acrylamide in food, we provide information on the World Health Organization's (WHO) recent meeting to discuss these findings. Further, we discuss recent developments in the European Union (EU), including the adoption of Directive 2002/72/EC ("Plastics Directive"), which is a consolidation of Directive 90/128/EEC ("Monomers Directive") and its first seven amendments, as well as other international items of interest to the Committee. Table of Contents
1. FDA Schedules Public Stakeholders' Meeting on FCN Process FDA has scheduled a day-long workshop on October 15, 2002 to discuss the FCN process. According to FDA, the purpose of the meeting is "so that notifiers and/or their representatives, consumer interest groups, and other interested members of the general public can have a better understanding of the FCN process, the information requirements of an FCN, and the common deficiencies to be avoided." FDA noted that the Agency frequently receives FCNs that are deficient and incomplete and stated that "[t]his meeting will assist notifiers and/or their representatives in submitting adequate and complete FCNs." The workshop will touch upon a variety of topics, divided among four general categories: administrative, chemical, toxicological, and environmental. The meeting will be held on the campus of the National Institutes of Health in the Lister Hill Center Auditorium, Building 38A, National Library of Medicine, in Bethesda, Maryland. Individuals interested in attending the meeting must register by email to wjt@cfsan.fda.gov or by fax to (202) 418-3131, providing name, title, business affiliation, address, and telephone and fax numbers, along with any questions they wish to have answered at the meeting. There is no charge to attend the meeting. Keller and Heckman LLP is planning to submit written comments and attend the meeting on behalf of this Committee, along with Susan Howe, SPI's Senior Technical Director, Worker and Product Safety, and the Committee's staff director. Of course, members of the Committee are also welcome to attend this public meeting. 2. SPI and APC Submit Separate Comments to FDA on Licensing of FCN Rights On August 5, 2002, Keller and Heckman LLP submitted comments on behalf of this Committee to FDA in response to the Agency's request for input on whether to establish a procedure by which holders of the rights to manufacture and market a food-contact substance that is the subject of an effective FCN would be able to transfer those rights by sale, licensing, or otherwise. As you may recall, the Advance Notice of Proposed Rulemaking (ANPR) published in a May 21, 2002 Federal Register notice (67 Fed. Reg. 35764) sought comments on this issue. FDA's request for comments stemmed from a submission it received from the American Plastics Council (APC), in response to the Agency's earlier request for comments on the July 2000 proposed rule on implementation of the FDA Modernization Act's FCN provisions. Because FDA deemed APC's comment to be outside the scope of the proposed rules on the FCN program, the Agency declined to address it in the final rule, and instead issued the ANPR. Although FDA issued the ANPR in response to APC's suggestion, APC filed separate comments agreeing with SPI that there is "no significant benefit to be gained by implementing a procedure to transfer or license the rights to a FCN." Specifically, in our comments to the Agency, we expressed SPI's view that the relatively rapid clearance of food-contact substances through the FCN mechanism significantly reduces the potential value of a right to transfer the clearance. Specifically, we noted that any company can bring about an effective FCN in 120 days and that much of the data underlying an effective FCN can be obtained by other companies through a Freedom of Information Act (FOIA) request. For these reasons, we advised FDA that there is no significant benefit to be gained by adding a procedure to transfer the rights acquired by an FCN. If FDA nevertheless decides to create such a procedure, we recommended that it should involve only a simple notification to the Agency that the transfer has occurred. SPI also requested FDA to provide guidance on the procedure to amend the name of the manufacturer/supplier in the event of a corporate name change or change in ownership or control. FDA has indicated in its administrative guidance document on the FCN process that the Agency would confirm the procedure for changing the name of a manufacturer/supplier, but this guidance has not yet been provided. 3. Dr. Mark McClellan Named as Leading Candidate for FDA Commissioner Recent reports indicate that Mark McClellan, a doctor who serves on the White House Council of Economic Advisers, has emerged as the leading candidate for FDA Commissioner. It is thought that Dr. McClellan's apparent lack of ties to the drug industry could help him win Senate confirmation. Most recently, Dr. McClellan was a professor of economics and medicine at Stanford University. 4. WHO Meets to Discuss Elevated Levels of Acrylamide in Food; FDA Announces Public Meeting on Acrylamide At an emergency meeting of the United Nations' World Health Organization (WHO) in July, a panel of WHO's food safety division examined reports of acrylamide in some starch-based food products cooked at high temperatures. Members of the panel indicated that the scientific evidence to date convinced them that acrylamide is a major concern and called on food processors to reduce levels of the compound. Members also said, however, that there currently is not enough information available to make recommendations about which foods consumers should eat or avoid. The panel plans additional research on this topic. The meeting was organized after initial tests in Sweden and subsequent studies in Norway, Britain, Switzerland, and the U.S. found high levels of acrylamide in some foods. Acrylamide, used to produce plastics and dyes and to purify drinking water, has been shown to be carcinogenic in rats, and is listed by WHO as a probable human carcinogen. While some scientists doubt the validity of the Swedish results, which were released at a government news conference before passing through peer review procedures in a scientific journal, the results have been replicated by testing conducted in other countries. FDA scientists participated in the WHO meeting and, in addition, FDA has developed its own draft methodology to measure levels of acrylamide in foods, "Detection and Quantitation of Acrylamide in Foods," which is available on FDA's website at www.cfsan.fda.gov/~dms/acrylami.html. While this document provides an analytical method for testing, FDA concedes that it has not been validated. At this time, FDA is testing several different foods, but indicates that it is unaware of any present data regarding acrylamide that would cause FDA to alter its current dietary recommendations for consumers. FDA announced in a September 12, 2002 Federal Register notice (67 Fed. Reg. 57827) that a public meeting entitled, "Assessing Acrylamide in the U.S. Food Supply" will be held on September 30, 2002 from 9:00 a.m. to 5:00 p.m. at the Center for Food Safety and Applied Nutrition, Food and Drug Administration, Harvey W. Wiley Building Auditorium, 5100 Paint Branch Parkway, College Park, Maryland. The purpose of the public meeting is to update the public on FDA's activities related to acrylamide in food, to present FDA's draft action plan on acrylamide, and to obtain and solicit comments on the action plan. FDA notes that the draft action plan will be made public on its website at www.cfsan.fda.gov/list.html on or before the date of the public meeting. 5. SPI Participates in Bioterrorism Act Implementation Coalition - Recordkeeping Working Group Susan Howe has been working with several industry groups on establishing an industry consensus with respect to FDA's implementation of the Bioterrorism Preparedness Act's recordkeeping requirements. (As you may know, the bioterrorism bill was signed into law by President Bush on June 12, 2002). Specifically, the Recordkeeping Working Group has been discussing issues associated with the new Section 414(b) of the Federal Food, Drug, and Cosmetic Act ("Regulations Concerning Recordkeeping"). The information called for in Section 414(b) is intended in general to provide the Agency with the means of determining who had custody of the affected food or its packaging throughout the channels of trade. The Working Group has agreed, in accordance with our understanding of the intent of Congress, that the recordkeeping requirement regarding immediate suppliers and customers does not apply to packaging suppliers. Companies engaged in packaging food, however, will be called upon to maintain records identifying the supplier of the packaging. These positions will be advanced in discussions with FDA regarding the promulgation of regulations to implement the recordkeeping provisions of the Bioterrorism Act. FDA plans to publish proposed regulations by the end of this year and a final rule by December 12, 2003. 6. FY 2003 Funding Bill for FDA; House and Senate Appropriations Committees Refuse to Shift FDA Legislative and Press Functions to HHS The House Appropriations Committee approved over $1.3 billion for FDA's budget for fiscal year 2003. This amount is $16 million more than last year, and $7 million more than the President requested. The extra $7 million is not earmarked for particular programs and instead will go to "ongoing functions." The Senate Appropriations Committee unanimously approved the fiscal year 2003 agriculture appropriations bill, which includes FDA's budget, and which will now be considered by the full Senate. Both the House and Senate panels in charge of FDA funding, however, have refused to appropriate money for a Bush administration proposal to consolidate the FDA Office of Public Affairs and Office of Legislation into the Department of Health and Human Services (HHS). This change met resistance in part because it would involve a transfer of jurisdiction from the Appropriations agriculture subcommittee to the Appropriations HHS/labor subcommittee, and Congressional committees generally do not like to surrender any jurisdiction. In addition, there are concerns about eroding FDA's ability to respond quickly to urgent public health issues. 7. Phthalate Esters Panel of the American Chemistry Council Refutes Health Care Without Harm's (HCWH) Conclusions Regarding Phthalates; FDA Releases Draft Guidance Document on Medical Devices Made with PVC Using DEHP The consumer group, Health Care Without Harm (HCWH), recently released a report detailing the levels of phthalates in cosmetics, "Not Too Pretty: Phthalates, Beauty Products & the FDA." The report states that 52 out of 72 products tested contained phthalates, and HCWH claims that loopholes in federal law allow the cosmetics industry to add phthalates to products without any required testing, monitoring of health effects, or labeling. Phthalates have been shown to cause male reproductive effects in the developing fetus in laboratory animals. HCWH is calling for FDA to use its authority to prohibit the marketing of all cosmetics used by women of childbearing age that contain chemicals like phthalates, which are alleged to cause birth defects. A phthalate esters panel set up by the American Chemistry Council, however, refutes HCWH's claim. Specifically, the phthalate esters panel takes the position that HCWH's conclusions are based on a faulty premise and that its main argument is speculative. The panel stated that the levels of exposure are too low to be as harmful as implied in HCWH's report, and further stated that aggregating exposures to compute risk in the manner performed by HCWH is not sound science. The panel disputes HCWH's charge that the Centers for Disease Control and Prevention (CDC) found higher levels of phthalates in women of childbearing age than in the normal population. Of the 289 people studied, only a few of the 90 women aged between 20 and 40 in the study had levels above average; the panel stated that, since the sample size is so small, there is no justification for the sweeping statements being made. In 1985, the Cosmetic Ingredient Review (CIR) expert panel had found that phthalates used in cosmetics and personal care products were safe for use. In June, however, the CIR panel voted that the scientific evidence on which its 1985 decision was based is no longer current and, therefore, further study of available data needs to be done. The new data will be used to do a risk analysis through assessment of bodily load of phthalates in individuals, the likely absorption rate, and exposure levels through various products. While FDA is a non-voting participant in the CIR panel and relies on it for advice, the Agency is not bound by its recommendations. In addition, on September 6, 2002, FDA released a draft guidance document titled, "Medical Devices Made with Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP);" the document can be accessed on FDA's website at www.fda.gov/cdrh/ode/guidance/1407.html. FDA is accepting comments on this guidance document until December 5, 2002. In the document, FDA offers suggestions on ways to reduce or eliminate risks that may be associated with DEHP, such as by labeling certain devices with their DEHP content or eliminating DEHP in certain devices that may result in high aggregate exposures in sensitive patient populations. While FDA confirms that there are no human studies that show the toxic and carcinogenic effects of DEHP that have been demonstrated in laboratory animals, FDA is concerned with the small subset of medical devices where PVC-containing DEHP may come into contact with the tissue of a sensitive patient population for a period of time that may raise concerns regarding aggregate exposure to DEHP. FDA cites devices used in Neonatal Intensive Care Units (NICUs) as one example. FDA recommends considering the feasibility of replacing PVC-containing DEHP with either alternative materials or plasticizers, or using coatings that may minimize patient exposure to DEHP. In addition, FDA suggests labeling devices to indicate the presence of DEHP. While FDA "believes there is insufficient information to justify requiring device manufacturers to disclose the presence of this chemical in the device's labeling," the Agency states that there is considerable interest among consumers in mitigating risks that exposure to DEHP may involve. 8. Proposal Would Allow USDA to Require Irradiation of Raw Meat and Poultry Products; FDA Releases Study on Consumer Attitudes toward Labeling of Irradiated Foods Proposed language that could be added to the fiscal 2003 agriculture appropriations bill would give the U.S. Department of Agriculture (USDA) Secretary authority to require irradiation of raw meat and poultry products under the Hazard Analysis and Critical Control Points (HACCP) system for biological hazards if current control of these hazards is inadequate, scientifically validated methods of pathogen control exist, and the hazard constitutes a nationwide health risk. While the origin of the proposed amendment is unclear, officials of USDA's Food Safety and Inspection Service (FSIS) denied being the source of the language. FDA recently sent Congress a study on irradiation that found that most consumers do not view the food label "treated with irradiation" as a warning, and consumers oppose replacing the term and its accompanying radura symbol with alternative terms such as "electronically pasteurized" or "cold pasteurized." The study was sent to Congress five months after it was due, and two months after lawmakers passed the Farm Bill requiring FDA to consider alternative ways to label irradiated food. This survey appears to be at odds with FDA Deputy Secretary Lester Crawford's congressional testimony in March that consumers view the label "treated with irradiation" as a warning. In May, the Farm Bill was signed into law with a provision requiring FDA to determine if labels other than "treated with irradiation" should be allowed. The law provides that industry can ask the HHS Secretary to use the term "pasteurization" on the labels of irradiated foods. If the Secretary does not respond within 120 days, the label can be used; the law also directs the HHS Secretary to revisit the issue of food irradiation labeling through the regulatory process. During that process, any company could petition the Secretary to use alternative labeling terminology, and the Secretary has 180 days to approve it, or it is denied. Consumer organizations have objected to the fact that there is no requirement that the public be notified and no opportunity for public input in this process. 9. EC Issues Directive 2002/72/EC ("Plastics Directive") - A Consolidation of the "Monomers Directive" and its First 7 Amendments The European Commission (EC) has adopted a consolidated version of the so-called "Monomers Directive" (90/128/EEC) and all of its existing amendments (1st Amendment - 7th Amendment). This Directive, 2002/72/EC (also known as the "Plastics Directive"), relating to plastic materials and articles intended to come into contact with foodstuffs, repeals and replaces Directive 90/128/EEC and all of its amendments. (Since this Directive relates to both monomers and additives for food-contact articles that are made entirely of plastic, we have been advised that it is considered more appropriate in the EU to refer to the Directive as the "Plastics Directive" rather than the "Monomers Directive.") The consolidated Plastics Directive became effective on September 5, 2002. Article 10(1) of Directive 2002/72/EC confirms that this date will not affect the provisions included in the 5th, 6th, and 7th Amendments for which the deadlines for Member States' implementation measures have not yet elapsed. None of the proposed modifications included in the draft 8th Amendment to Directive 90/128/EEC are included, since this Amendment has not yet been adopted. If and when adopted, the so-called "8th Amendment" is likely to become the "1st Amendment" to Directive 2002/72/EC. 10. Revision of the EU Packaging and Packaging Waste Directive Directive 94/62/EC on packaging and packaging waste is in the process of being reviewed by the EC. In this regard, the EC presented a December 7, 2001 proposal for the amendment of Directive 94/62/EC containing the following main points:
The proposed changes are limited in scope and do not address important aspects of Directive 94/62/EC, such as prevention, reuse, producer responsibility, or the applicability of "New Approach" (the "New Approach" deems products which comply with harmonized CEN Standards as compliant with the "essential requirements" laid down in EU directives). The Commission's proposal is now in the process of being reviewed by the European Parliament (EP) and the Council of Ministers. The changes made by the EP during its first reading (on September 3, 2002) include the following:
This is, however, far from being the last stage in the adoption of the amendments, as the Commission's proposal will now be reviewed by the Council of Ministers, and will go back to the EP in case the Council proposes further amendments (in line with the "co-decision" legislative procedure). The entry into force of the final measures is not expected prior to the end of 2003. 11. EC Scientific Committee on Food Finds Food-Contact Products Made with Bisphenol A (BPA) To Be Safe The EC Scientific Committee on Food has reviewed the available data, and has found food-contact products made with bisphenol A (BPA) to be safe. As you know, BPA is used in polycarbonate plastic and in some coatings. BPA has been scrutinized in recent years by scientists exploring whether estrogen-containing substances may cause health problems in low doses. The Scientific Committee on Food reevaluated potential hazards from migration of BPA and recommended a new maximum tolerable daily intake level of 0.01 mg/kg of body weight. It is believed that only a small residual amount of BPA survives processing when used in the manufacture of food packaging materials so that the potential migration to food is very low. The opinion is available online at europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf. The Irish government has reported that a tax on plastic shopping bags in the Republic of Ireland has cut their use by more than 90% and raised over 3 million euros in revenue, which will be spent on environmental projects. The tax was introduced five months ago in an attempt to curb litter. Shoppers now are being encouraged to use non-plastic, reusable bags. In the three months after the tax was introduced, shops reportedly handed out just over 23 million plastic bags-approximately 277 million fewer than before the tax was implemented. The so-called "plastax" is being closely watched by other countries, particularly Great Britain. 13. Increased Canadian Food Inspection Agency (CFIA) Authority Packaging materials that are used in contact with meat, poultry, seafood, dairy products, eggs, fresh and processed fruits and vegetables, grains, honey, or maple syrup are subject to regulation by the Canadian Food Inspection Agency (CFIA), in addition to regulation by Canada's Health Products and Food Branch (HPFB). Finished articles (e.g., equipment or food packaging) that are intended for use in facilities that must be registered with CFIA (i.e., facilities that produce meat, poultry, seafood, dairy products, eggs, fresh and processed fruits and vegetables, grains, honey, and maple syrup) must be approved by CFIA prior to use1. In an effort to consolidate food inspection authority, CFIA recently has been given the authority to inspect not only CFIA-registered food processing facilities, but non-CFIA-registered food processing facilities as well. This new inspection authority does not, however, change CFIA's jurisdiction with regard to packaging. 14. Food Standards Australia New Zealand (FSANZ) Has Replaced the Australia New Zealand Food Authority (ANZFA) As you may know, Australia regulates food packaging materials under the Australian Food Standards Code (the Code), a binding code issued by the National Health and Medical Research Council2. Established under The Australia New Zealand Food Authority Act of 1991, the Food Standards Australia New Zealand (FSANZ) (which replaced the Australian New Zealand Food Authority (ANZFA) on July 1, 2002), in consultation with the States and Territories of Australia, is responsible for developing food standards under the Code, and for coordinating the food surveillance activities of government agencies in Australia. FSANZ, however, does not enforce food standards or determine whether or not a food, food label, or food packaging material complies with the Code; rather, enforcement of the Code and any related standards is the responsibility of the respective States and Territories because the Code and all subsequent standards are incorporated by reference directly into the laws of the States and Territories of Australia and New Zealand. While the Code does not contain a specific standard applicable to food packaging, Standard A13 of the Code, "Foreign Objects in Food or Packages of Food," indicates that food packaging materials must not adulterate food, and specifically addresses the following items: (1) ink on printed food-contact packages; (2) labels applied directly to foods; (3) cooking gauges inserted into meat; and (4) sachets used to absorb moisture in food packages. In addition, this section indicates that substances are permitted for use in food packaging applications if, among other things, they are "composed of materials that will not contaminate or migrate into the food."3 Furthermore, for any food packaging material not listed above, it is generally recognized that food packaging materials that comply with U.S. and EU regulations are permitted for use in packaging food in Australia, so long as the materials do not adulterate food. As noted above, FSANZ replaced the ANZFA on July 1, 2002. FSANZ now has authority over the entire food supply chain, including setting new mandatory safety standards for the food manufacturing industry and equivalent standards for primary producers (i.e., farmers or fishermen). The new ANZ Food Regulation Ministerial Council (previously the ANZ Food Standards Council) has assumed the ANZFA board's policymaking role. FSANZ is itself responsible for approving standards and variations to standards, which differs from ANZFA's previous role in only recommending new food standards to the Food Standards Council for approval or rejection. When reviewing future food standards, FSANZ will follow ministerial guidelines and notify the ministerial council of any approval. The council may then reject, amend, or seek a review of any standard notified to it by FSANZ. Former Victorian Health Minister Rob Knowles has been appointed the chairperson of the inaugural FSANZ Board. * * * 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 Jerry Heckman, Colleen Evale, or me. Cordially yours, Ralph A. Simmons 1. Materials that are approved for packaging in food facilities under CFIA's authority are listed on CFIA's Reference List of Accepted Construction Materials, Packaging Materials and Non-Food Products. This list can be found on CFIA's website at: www.inspection.gc.ca/english/ppc/reference/cone.shtml. 2. See FOOD STANDARDS CODE, P27 Commonwealth of Australia Gazette (Aug. 27, 1987, as amended). 3. FOOD STANDARDS CODE, A13(3)(b). Back to TopMore About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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