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 April 3, 2000 (202) 434-4110 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: In this letter we provide you with an update on the implementation by the Food and Drug Administration (FDA) of the Food-Contact Notification program. As an attachment to this letter, we have included a suggested form of a letter assuring customers of FDA compliance on the basis of an effective notification. We also report on recent activity concerning irradiation of food and packaging materials for this application, the Environmental Protection Agency’s Children’s Health Initiative, and the European Commission’s concerns with the use of genetically modified additives, phthalates, and azo dyes in food packaging. Table of Contents
1. FDA's Dr. Mitchell Cheeseman Provides Further Information at SPI Meeting on Plans to Implement FCN Program FDA officially initiated its Food-Contact Notification program, as scheduled, on January 18, 2000. As we reported to you in our last letter, even before the starting date, FDA had provided information on the chemistry, toxicology, and anticipated administrative procedures associated with the program. Although final guidance and pertinent amendments to the regulations have yet to be issued, the procedures and parameters of the system are beginning to take shape on a case-by-case basis. More specifically, we have obtained additional information from the Agency on how to handle the Environmental Assessment (EA) requirement for notifications, and on the scope of products eligible for the notification program. These developments are explained more fully below. Seven notifications already have become effective; these were pending food additive petitions that FDA allowed to be converted to notifications. These effective notifications are listed on the Agency’s website at the following address: http://vm.cfsan.fda.gov/~dms/opa-fcn.html. As notifications begin to become effective, and in response to requests from members of the Committee, we have drafted the attached customer assurance letter concerning products covered by effective food-contact notifications. Unfortunately, we are still awaiting revised administrative guidance (updating the version released last March) and the completion of direct final rulemaking for the notification program’s implementing regulations, including amendment of the regulations on environmental assessments. We understand that these documents are in process, and we hope they will be issued reasonably soon; but we do not have any reliable information on the anticipated schedule. We also are awaiting finalization of the draft guidance documents "Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations" and "Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations." On February 9, 2000, we submitted comments on behalf of the Committee with respect to the revised versions of these documents that were released late last year. In those comments we recommended modifications to the format and organization for the Toxicology Data Package and Comprehensive Toxicology Profile, and also commented on the data requirements necessary to establish the safety of certain food-contact substances. On a personnel note, Dr. Mitchell Cheeseman, with whom we have been working closely on notification matters, is on a temporary detail to the Legislative Affairs Office for the next several months. Dr. Francis Lin is assuming Dr. Cheeseman’s responsibilities for the notification program in the interim. Environmental Assessments During the December meeting of the Food, Drug, and Cosmetic Packaging Materials Committee, FDA’s Dr. Cheeseman indicated that the Agency was working on a guidance document for environmental impact data for notifications and planning to issue a direct final rule that would amend the environmental assessment (EA) regulations to make notifications eligible for the categorical exclusions currently available for petitions. The plan to issue environmental guidance is confirmed on FDA’s website in the introduction to the inventory of effective notifications. In the absence of such guidance, as we began to prepare notifications, we sent FDA a letter requesting information on the environmental impact data required for notifications. Subsequently, Dr. Buzz Hoffman, head of the Environmental Review Team, indicated that, until general guidance is issued, the environmental impact data needed for notifications must be determined on a case-by-case basis. Since the regulations on categorical exclusions from the need for an EA have not been amended to apply to notifications, an EA will be required for every notification. The amount of information required, however, will depend on various factors. Dr. Hoffman implied that the amount of information needed would not be significant for a notification that would qualify for a categorical exclusion if it were a petition. To determine the scope of an EA for a notification during the period before the guidance is issued and regulations are amended, Dr. Hoffman indicated that prospective filers of notifications should submit to the Agency a description of the substance, the intended use, and the environmental information that would be required if the filing were a petition or threshold of regulation request. FDA will then respond with advice on the required content of the environmental assessment. In the case of pending petitions or threshold or regulation requests that have been converted, FDA itself is handling the development of environmental impact analyses to allow the notifications to become effective. Scope of Food-Contact Notifications As can be seen from the listing of effective notifications on FDA’s website, the Agency has determined that notifications may be filed for monomers. We understand that there was some question within FDA as to whether the language of the statute creating food-contact notification allows notification of monomers. Now, that issue has been resolved in favor of such notifications, which are effective for the monomer as supplied by the notifying supplier when used by its customers to make particular polymers specified in the notification. In addition, we understand that FDA intends to permit notifications for formulated products, extending even to finished food-contact articles. If, however, a formulated product is composed entirely of materials already cleared by FDA for the intended use, it appears that the Agency will not commit to completing the review within 120 days because the notification is not legally required. Similarly, FDA has suggested that notification is now the appropriate vehicle to obtain concurrence in the suitable purity of recycled material, but these filings also may not enjoy the benefit of the 120-day deadline because they too are not mandatory. Finally, FDA’s position is not yet clear on the issue of listing products by tradename in letters and the website list on effective notifications. The current website list includes one tradename, but also accompanied by a chemical description.
2. FDA Issues Provisional Clearance for Use of Packaging in E-Beam and X-Ray Irradiation of Meat and Poultry The FDA has 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. This action was prompted by a February 8, 2000 letter sent by USDA’s Food Safety and Inspection Service (FSIS) Administrator Thomas Billy. In his letter, Billy requested that FDA allow irradiation of pre-packaged meat and poultry using machine sources on all packaging materials currently listed in Section 179.45, to further promote the public health benefit expected from increased irradiation of meat and poultry. In a February 28 response to Billy’s letter, Dr. Alan Rulis, Director of the Center for Food Safety and Applied Nutrition’s Office of Premarket Approval, indicated that the Agency currently has no food safety concerns regarding the use of any of the three sources of radiation with the packaging materials listed in Section 179.45. The provisional clearance is subject to the following conditions: (1) the trial period begins on February 22, 2000 and lasts not more than one year; (2) the irradiation processor will comply with all general provisions for food irradiation listed in Sections 179.45 and 179.26; (3) the machine sources of X-radiation and/or electron beams are used at dose levels not to exceed those specified in Section 179.45 for the packaging materials used, and at dose levels not to exceed those specified in Section 179.26 for the foods packaged; (4) with the exception of the radiation source, as noted above, the packaging materials must comply with all other provisions of Section 179.45; and (5) FSIS will monitor the participating establishments and immediately inform FDA of any unexpected findings. This trial period will facilitate the use of x-ray and e-beam for irradiating meat and poultry while FDA conducts an expedited review of a Food Additive Petition filed on January 18, 2000 by the National Center for Food Safety and Technology (NCFST), at the Illinois Institute of Technology, proposing that the food additive regulations be amended to formally allow X-ray and electron beam radiation sources to be used with all packaging materials currently listed for use with gamma radiation under Section 179.45. With the February clearance by USDA of irradiation of certain red meat, to go along with the previous clearance for poultry, a number of food companies are poised to implement e-beam and x-ray treatment of some products more rapidly than FDA is able to act on the NCFST petition. In our view, listing in Section 179.45 is not an absolute legal prerequisite for use of packaging material to hold food for irradiation. A material that, absent irradiation, has a suitable FDA status for the intended conditions of contact with food also may be considered in compliance to hold food for irradiation as long as it can be shown that the process does not create a significant change in the nature or amount of potential migrants. We recognize that FDA has suggested it may hold a contrary view and that users of the packaging may feel more comfortable with official FDA concurrence. Nevertheless, we consider our position to be sound and fully protective of the public health since it is based on establishing no significant change in an otherwise suitable material. 3. Consumer Survey Shows Acceptance of Irradiation to Combat Foodborne Pathogens; FDA Issues Revised Brochure on the Safety of Food Irradiation Research conducted by the International Food Information Council indicates that most consumers appreciate the food safety benefits of food irradiation and are willing to try irradiated foods; however, they do want irradiated foods to be labeled as such. Although consumers liked the radura symbol, they felt that it should be accompanied by an informative statement such as "cold pasteurized (irradiated) to eliminate harmful bacteria." FDA currently requires irradiated foods to be labeled with the radura symbol along with the phrase "treated with irradiation." Most consumers felt that the best way to educate the public about food irradiation is through the mainstream media and consumer brochures from government and supermarkets. Such a brochure, entitled "Food Irradiation: A Safe Measure," was recently released by FDA. The brochure explains food irradiation and its benefits, and attests to the safety and effectiveness of the process. It also emphasizes that irradiation is not a substitute for proper food handling and lists the safety precautions that consumers should follow when handling food. The brochure is available on FDA’s website at http://www.fda.gov/opacom/catalog/irradbro.html In the wake of the recent approval of red meat irradiation, described above, the American Meat Institute hosted a conference for the media last month to discuss the future of the technology. Much of the discussion centered around consumer surveys showing acceptance of the process. One speaker noted that irradiated chicken currently is not widely available in the marketplace, due in part to the fact that there are limited suitable packaging options for irradiated chicken.
4. Developments in EPA’s Voluntary Children’s Chemical Safety Testing Program The Environmental Protection Agency (EPA) has a children’s health initiative that may affect producers and users of certain food-contact substances. This EPA program is being followed closely by SPI’s Occupational Health and Environmental Issues Committee (OHEIC), but we want to ensure that members of the Food, Drug, and Cosmetic Packaging Materials are aware of the situation. For more information on this issue, please contact Lynne Harris of SPI, (202) 974-5217, who is directing OHEIC’s activities concerning this EPA program. The Voluntary Children’s Chemical Safety Testing Program (VCCSTP) is one of three programs established under the Chemical Right-to-Know Initiative announced by Vice-President Al Gore on April 21, 1998. As the name suggests, the VCCSTP would identify chemicals for "voluntary" testing by industry to determine their potential effect on children’s health. Draft documents concerning this program were made available by EPA in early March, 2000, and will likely be further developed before the final stakeholder meeting on VCCSTP being held on April 26-27, 2000. The draft documents include chemical selection criteria, chemical deletion criteria, chemical list clarification, test battery and tiers, a program flow chart, and animal welfare considerations. Some of the chemicals proposed for testing in the draft documents are used in food-contact applications, such as naphthalene, styrene, and biphenyl. The complete preliminary list is attached for your reference.
5. European Commission Initiates Inquiry into the Use of Genetically Modified Additives in Food Packaging In response to theoretical concerns raised by Spain regarding the potential of genetically modified (GM) additives to migrate to food from plastic food packaging, the European Commission is launching an inquiry into the subject. Dr. Luigi Rossi, the food packaging expert in the Commission, has called for the plastics industry to submit an information paper to the Standing Committee on Food for discussion. The questions to be addressed by the industry paper concern the removal of genetically modified organisms (GMOs) during processing, traceability of GMOs, and alternative non-GM sources. In the February 2000 issue of EU Food Law , Dr. Rossi indicates that the concerns over migration of GM food packaging additives to food are not supported by current scientific knowledge. At this time, we do not know whether there are any industry plans to respond to Dr. Rossi’s request for information
6. European Commission Continues Ban on Phthalate-Containing PVC Teething Toys Intended for Children under Three; Italy Bans Use of Phthalates in Contact with Foods Rich in Fat On December 7, 1999 the European Commission instituted a ban on childcare articles made of polyvinyl chloride (PVC) containing any of six designated phthalates and intended to be placed in the mouth by children under three years of age. The six phthalates specified were 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). 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. Because the ban was due to expire on March 8, 2000, the Commission on March 3 extended it for three additional months. In another development concerning phthalates, Italy published in the February edition of its Official Journal, the Decree of Health Ministry Number 538/99, which prohibits the use of phthalates in any object in contact with foods rich in fat, and limits the use of phthalates to a maximum level of 5% in articles in contact with other food products. The use of phthlates in food-contact materials has already been the subject of regulation in Italy. However, heightened concerns over migration of these substances from PVC, and the toxicological implications of such migration, has prompted stricter regulation. Manufacturers have one year to sell products which do not comply with the provisions of the decree.
7. EU Directive Restricts Use of Some Azo Dyes in Consumer Products Responding to the Scientific Committee for Toxicology, Ecotoxicity and the Environment (CSTEE) opinion regarding the risk of cancer from consumer products colored with azo dyes, the European Commission recently proposed an amendment to Directive 76/769/EEC (relating to Restrictions to the Marketing and Use of Dangerous Substances and Preparations). This opinion recommends that azo dyes be added to the list of dangerous substances included in Annex I of the Directive. The draft Directive, which was adopted by the Commission on December 13, 1999, appeared in the March 28, 2000 Official Journal of the European Communities. CSTEE expressed concern that azo compounds can break down in the human body into carcinogenic aromatic amines, and recommended that the Commission take action to restrict the use of azo dyes in consumer products. The Directive would specifically ban those azo dyes that can be reduced in the digestive tract into any of 21 listed aromatic amines of concern. Although azo dyes are occasionally used as colorants for plastic articles, the proposed ban specifically applies only to those azo dyes used to color textiles and leather products that have the potential to come into direct and prolonged contact with human skin or oral cavities. Although this directive does not currently affect the use of azo dyes in food-contact articles in the EU, the Commission’s action indicates a growing concern in the toxicology community over the use of azo compounds in consumer products. Back to Top More 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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