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 General Counsel's Report To The Society of The Plastics Industry, Inc.'s Food, Drug, and Comestics Packaging Materials Committee June 19 - 20, 2001 INTRODUCTION Ladies and Gentlemen: TABLE OF CONTENTS HHS Continues to Search for New FDA Commissioner FDA Implements Organizational Changes Members of Congress Continue to Push for a Single Food Safety Agency Panel Recommends More Study on Long-Term Effects of Alleged Endocrine Disruptors ACGIH Proposes Designation of "Suspected Human Carcinogen" for Mineral Oil Mists Food Irradiation Continues to Be a Controversial, Important Topic FDA Releases its Biotech Proposal NSF Offers Continuation of USDA Product Certification Programs 1. HHS Continues to Search for New FDA Commissioner
Another subpanel, charged with examining other environmental estrogens, found low- dose effects of nonylphenol, an industrial compound identified in drinking water, including a decrease in the volume of sexually dimorphic nuclei of the preoptic area of the hypothalamus in male rats, an increase in relative thymus weight, and prolonged estrus in females. In contrast, the subpanel found no evidence of low-dose effects of octylphenol, an intermediate for the production of surfactants, in a five-dose multigeneration study in rats. Thus, the massive undertaking by EPA and NPT left us with little more than what we had prior to the effort: conflicting toxicological reports and a new suggestion that still more costly, time consuming, and potentially frustrating testing should be undertaken. One obvious question concerns where the funding for such testing will come from. Since the low dose theory is counter-intuitive and gives rise to considerable skepticism, it would seem that the burden of proving it should be on the proponents. Meanwhile, in our view, the NTP report indicates that there is not a scientific basis at this point for EPA, FDA, or other regulators to make endocrine effects testing a general requirement for product clearances. The report is open for public comment until July 16, 2001. Please let us know whether you find aspects of the report on which the Committee should comment. We understand that the polycarbonate producers group within the American Plastics Council (APC) is evaluating the report for possible comment. This Committee, however, also may have issues or interests that should be represented in our own comments, which we certainly would attempt to coordinate with any APC comments. The report is available on the NTP’s website at http://ntp-server.niehs.nih.gov/. 5. Concern Over Mad Cow Disease Leads to USDA Ban on Imports of Animal Protein Products, Tallow Derivatives Probably Exempt In response to the problem of bovine spongiform encephalopathy (BSE), commonly known as “mad cow disease,” in certain parts of Europe and elsewhere, the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) instituted a ban on the importation of all processed animal proteins and certain products derived from these proteins, regardless of species of origin, from countries that are either affected by BSE or that have an unacceptably high risk for BSE. As we reported to you early this year, APHIS invoked the ban on December 7, 2000, after the European Union (EU) Scientific Steering Committee found that animal feed which was not derived from ruminants was cross-contaminated with the agent responsible for BSE (the most generally accepted theory is that the agent is a modified form of a normal cell protein known as a prion). The prohibited products include, but may not be limited to, meat and bone meal, blood meal, fish meal, poultry meal, tankage, offal, fat, glands or any product containing these substances. BSE-affected countries are listed on the APHIS home page at www.aphis.usda.gov. The ban subsequently was extended to include products that have been "stored, processed, or otherwise associated with a facility located in Europe and Oman." This ban apparently applies only to edible products. Imports of the products have been allowed only if APHIS can verify that they have not been commingled or cross-contaminated with ruminant products from Europe and Oman. In making the determination, APHIS has been applying the following factors:
It has been our understanding that the ban does not apply to tallow derivatives, such as fatty acids, that have food-contact applications. Our contacts at APHIS have indicated that an interim rule to be published “any day” specifically exempts tallow derivatives, because these products are believed to be sufficiently purified to remove all proteins and, thus, the BSE infectious agent. However, we were cautioned that the rule as originally drafted could be changed to remove this exemption if concerns were raised during the final review process. With respect to bulk shipments of tallow, we have received conflicting advice from different APHIS officials on whether these are included in the ban. As we explained in previous letters, it is probable that such shipments will be included, because tallow may contain proteins and could be used in animal feed. Tallow intended for further processing into the derivatives that might be used in packaging materials, however, may be exempt from the ban, or, if not subject to a blanket exemption, then permitted for import on a case-by-case basis. The February 9 extension of the ban to products coming from any facility in Europe or Oman probably will not apply to tallow dedicated to production of derivatives because the extension applies only to products for edible applications. The USDA is not the only agency being pressured to invoke measures to prevent the spread of BSE in this country. Stating that BSE is “one of the most important public health issues facing the nation,” the House Energy and Commerce Committee requested from FDA details on the Agency’s efforts to prevent the spread of mad cow disease through import controls and restrictions on the use of animal feed. While the Committee requested an FDA response by April 30, as of mid-May the agency had yet to respond to the request. Meanwhile, possibly in response to this pressure, FDA recently issued an expanded BSE import alert which cautions ports to be on the lookout for, among other things, food additives derived from ruminant materials. We are attempting to contact FDA officials to obtain more information on the alert, but are hopeful that the import bulletin would not affect tallow derivatives intended for packaging materials since, in the past, the primary concern has been with non-purified ruminant material most likely to contain active infectious material. 6. ACGIH Proposes Designation of “Suspected Human Carcinogen” for Mineral Oil Mists The TLV (Threshold Limit Value) Committee of the American Conference of Governmental Industrial Hygienists (ACGIH) recently conducted a review of the current scientific literature on mineral oils and has proposed, based on the results of this review, that mineral oil mists be assigned an "A2 Suspected Human Carcinogen" status. The proposal was published as a notice of intended change in the 2001 ACGIH-TLV book. The background documentation, identified as "DDN-034 - Oil mist: Chemical Substance TLV® Draft Documentation, Notice of Intended Change" is available from ACGIH at a cost of $50.00. ACGIH, as well as the Occupational Safety and Health Administration (OSHA), currently includes in the definition of mineral oils and their mists the following substances: white mineral oil (considered food-grade), paraffin oil, cutting oil, hydraulic oil, transformer oil, lubricating oil, and others. Some plastics applications associated with potential generation of oil mists include metalworking and mold making, mist lubrication, mold release agents, oil-lubricating tools, and printing inks. Acute and chronic exposure to mineral oil mists is regulated by an OSHA permissible exposure limit of 5 mg/m3 as an 8-hour time-weighted average concentration. Along with the proposal to change the carcinogenicity classification, the ACGIH subcommittee also is proposing that the permissible occupational exposure TLV be lowered to 0.2 mg/m3. According to ACGIH staff, ACGIH accepts public comments on all of its proposed and final TLVs on an ongoing basis. However, the TLV Committee plans to meet this summer to make a final recommendation to the ACGIH Board of Directors on a TLV for mineral oil mists. For comments on the oil mist proposal to be considered by the TLV Committee in making that recommendation, ACGIH staff says that they should be submitted to ACGIH, preferably in electronic form, by June 29, 2001. If the TLV Committee and the Board vote to proceed, the new TLV and carcinogenicity status become final in 2002. Please advise us if this is a matter on which you believe the Committee should submit comments. 7. FDA Publishes Final Regulation on Use of Packaging in E-Beam and X-Ray Irradiation of Meat and Poultry; FDA Movement Toward Irradiation Testing Protocols Raises Concerns Since the Committee’s previous meeting, FDA has acted on several petitions involving the irradiation of food. Of most significance to the packaging industry, FDA finally acted favorably on the petition to allow food packaged with any of the materials listed under 21 C.F.R. Section 179.45 to be treated with e-beam and x-ray sources of irradiation, in addition to gamma sources. See 66 Fed. Reg. 10574. This final rule is helpful in opening up the use of all packaging materials currently cleared in Section 179.45 with e-beam and x-ray sources, which generally are preferred by industry at present, but does not address the problem of the limited types of packaging cleared under Section 179.45. By way of background, FDA permits certain types of irradiation as a means to treat specified foods for the purpose of controlling microbes, pathogens, pests, and the maturation of food. Regulations governing the irradiation of food are found in Title 21 of the Code of Federal Regulations, Part 179, "Irradiation in the Production, Processing and Handling of Food." Section 179.45 specifies materials that have been cleared by FDA specifically to package food intended to be irradiated. Because few food packaging materials are listed in Section 179.45, a number of companies are attempting to win FDA clearance of additional materials. To that end, appropriate studies must be conducted to demonstrate the potential for formation and migration of radiolytic byproducts from the packaging materials to the food. Generally, a company will first determine if radiolytic byproducts are formed as a result of the irradiation process and, if so, it will determine whether these byproducts migrate to food at levels that are considered to be safe. It should be noted that, in our view, all packaging materials do not need to be listed in Section 179.45 to have a suitable FDA status for holding food during irradiation. If a material has FDA compliance for contact with food generally, we consider it suitable to hold 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. In this regard, a recent protocol for irradiation testing provided by FDA to certain companies currently seeking FDA clearance of packaging materials for the irradiation of food has raised some significant questions on this issue. This document, titled “Testing Protocols for Determining Exposure to Radiolysis Products from Packaging Materials Irradiated in Contact with Food,” was provided to us following discussions on the appropriate testing of particular materials for irradiation. While the document has not yet been cleared by FDA for general release, the Agency is expected ultimately to issue formal guidance on irradiation testing. The draft document details two different protocols, either of which can be used: a "step-wise" approach, and a "direct migration" approach. The “step-wise” approach involves irradiation of the packaging material using a range of doses to determine the dose/response curve for the formation of the various radiolytic byproducts, if any. Once byproducts are identified and their levels in the packaging are determined, it is assumed that 100 percent of the byproducts will migrate into the contacted food. If the calculated level of any byproducts in the food is too high to evaluate without additional toxicity studies -- 0.5 parts per billion (ppb) in the diet -- migration studies must be carried out on the irradiated packaging to determine the actual level of the byproducts in the contacted food. Again, the dietary level for any migrating byproducts must be below 0.5 ppb if toxicity testing is to be avoided. A level higher than 0.5 ppb, of course, triggers the usual prescribed series of toxicology studies to demonstrate the safety of the packaging materials under these conditions of use. Also included in the “step-wise” approach is the requirement to carry out the same studies on a “check sample,” which is a standard reference polymer obtained from the National Institute for Standards and Technology (NIST). The results obtained on the standard reference polymer by the company will be compared to the results obtained by FDA on the same standard reference polymer, as a way of verifying that the irradiation studies were carried out correctly. The “direct migration" approach essentially goes directly to the migration studies, after a quick screen to identify any low-molecular-weight radiolytic byproducts. This approach does not require the use of a “check sample.” Rather, validation of the testing is done with the use of spiked “surrogate” chemicals to represent any byproducts found to migrate into contacted food. Using either of FDA’s two draft recommended testing protocols will involve a substantial amount of work that is very costly to conduct in terms of both time and money. On behalf of certain companies, we have commented to FDA on ways to simplify and clarify the recommended testing. We currently are drafting additional comments and suggestions on the draft test procedures and plan to submit them to FDA before the protocol is finalized in the form of a guidance document. 8. Food Irradiation Continues to Be a Controversial, Important Topic As we have reported in previous letters, FDA published an advance notice of proposed rulemaking (ANPR) in the Federal Register in February 1999 soliciting comments on revisions to labeling requirements for irradiated foods. (64 Fed. Reg. 7834 (February 17, 1999)). In response, FDA received over 4,500 comments. Early this year, and in the face of Congressional pressure to finalize its rules on irradiation labeling, the Agency reported that development of irradiation labeling rules has been stalled by an apparent lack of consensus over alternative language for disclosure statements about irradiation processing. The Agency referred to the voluminous comments it received, most of which supported special labeling for irradiated foods but did not specify preferred labeling requirements. In the meantime, Public Citizen is lobbying Congress to ensure that FDA does not authorize less alarming irradiation labeling options. The group is particularly concerned that FDA will allow use of such terms as “cold pasteurized,” which it claims may mislead consumers into believing that an irradiated food has not been irradiated. Public Citizen also is urging FDA to deny pending food additive petitions that seek approval of food irradiation, and continues to voice its concern that FDA has approved petitions involving irradiation of foods without conducting toxicological tests. Of particular concern to Public Citizen is the “ready to eat” petition, which would widely broaden the scope of foods allowed to be irradiated. The group has called upon FDA to conduct toxicological tests on the foods that are subjects of this petition (cooked poultry products, refrigerated and frozen entrees, frozen sandwiches, and some prepared fruits and vegetables). FDA action on the “ready-to-eat” petition has been rumored to be imminent for several months now. Although Public Citizen continues to urge FDA to reject petitions involving the irradiation of food, representatives from companies that have developed x-ray, e-beam and gamma irradiation say that they are ready to begin servicing the food industry on a mass scale once FDA approves broader use of the technology. On an international level, despite strong opposition, the European Commission is planning to expand the list of food products that can be treated with irradiation. If approved by the full Commission, three additional groups of products will be allowed to be treated with irradiation: (1) herbs, dried fruit and flakes, and germs of cereals; (2) mechanically recovered chicken meat, chicken offal, egg white and gum arabic; and (3) frog legs and peeled shrimp. Both the European Office of Consumers Union and the European Community of Consumer Cooperatives filed comments criticizing the proposal. As expected, many other consumer advocacy groups in the EU strongly oppose the proposal as well. Even some food industry associations filed comments against the proposal, likely due to fear that consumers will reject their products if they suspect the products were treated with irradiation. Meanwhile, Health Canada has approved proposals for irradiating ground beef and poultry, but the proposals still face several hurdles before companies can begin irradiating meat. The approvals still must be ratified by the Canadian cabinet and posted in the Canada Gazette for public comment. Canada currently allows irradiation of certain food products, including onions, flour, and spices. Finally, during its March 12 – 16, 2001 meeting, the Codex Alimentarius Committee on Food Additives and Contaminants approved a proposal to remove the current 10 kiloGray dose cap for food irradiation. The full Codex Commission will consider adopting the proposal during its biennial meeting in July. As expected, Public Citizen immediately opposed the proposal, arguing that chemical changes to food caused by high-dose irradiation have not been studied adequately. 9. FDA Releases its Biotech Proposal The new FDA proposal for premarket notice of bioengineered foods was published in the Federal Register on January 18, 2001, together with a notice of availability of a draft guidance on voluntary labeling of these products. The proposal and draft guidance, while satisfactory to industry, did not receive a warm welcome from Congress and certain public interest groups. The proposed rule establishes a procedure for voluntary consultation to be followed by a mandatory notification to the Agency before biotech foods can be legally marketed, and the draft guidance keeps labeling of biotech products purely voluntary. Premarket Notification Procedure Mandatory The primary thrust of the proposed rule is the requirement for a submission of information to the Agency on all biotech foods at least 120 days prior to their commercial distribution. It does not appear that food additives, and packaging materials that are food additives, would be subject to the requirement. If FDA does not object to the marketing of the foods within that time period, they are legally marketable. This new “Premarket Biotechnology Notice” (PBN) would be mandatory for any food derived from a genetically modified plant, including those modified to contain a pesticidal substance, whether it is to be used for human or animal consumption. Bioengineered foods that have been previously approved by FDA (and are already on the market) will be excluded from the notification requirement. Biotech Labeling Still Voluntary FDA repeated in the Federal Register the Agency’s existing position that there is “no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by new techniques present any different or greater safety concern than foods developed by traditional plant breeding.” The Agency continues to require that biotech foods containing unexpected allergens or significantly different nutritional properties bear appropriate disclosures on their labels, as the main concern of FDA remains to prevent false or misleading labeling as opposed to requiring special labeling of biotech foods. Consequently, labels containing statements such as “GMO free” are not currently considered acceptable by FDA, as the complete absence of bioengineered material in food products is difficult to assess, and the label might be misleading in implicitly conveying the message that a food is of superior quality if it does not contain such material. Products that do contain bioengineered material do not have to be labeled differently from other products (except for the cases cited above). Federal statutes mandate that the labeling of food must reveal all facts that are “material,” and FDA concluded in the Federal Register publication that “the use, or absence of use, of bioengineering in the production of a food is not a fact that is material either with respect to consequences resulting from the use of the food or due to representations on the labeling.” It is therefore up to the manufacturers and distributors to decide whether they want to add a biotech mention in the labeling of their product. 10. EU Study Recommends Incentives for “Green” Products; U.S. Federal and State Legislative Proposals Seek to Reduce Environmental Impact of Packaging The European Commission (EC) recently issued a green paper on “Integrated Product Policy,” an approach to environmental policy that seeks to make products more environmentally friendly. This green paper proposes a strategy to strengthen and refocus product-related environmental policies to promote the development of a market for “greener” products, and requests public comment on the strategies discussed in the Paper. The full Paper can be viewed at http://europa.eu.int/comm/environment/ipp/0168_en.pdf. The Paper states that the most effective way to encourage the development of “greener” products is by “getting the price right” to encourage consumers to purchase the products. It advocates lowering or eliminating the value added tax for products carrying the EU’s Eco-label, using “state aid” to financially support the development of environmentally preferable products, eliminating subsidies on products that are not environmentally friendly, and making it mandatory for governments to purchase “green” products. In the U.S., further recycling initiatives are being sought by some federal and state legislators. In early May, Rep. Lynn Rivers (D-Mich) introduced a bill that would establish a national beverage container recycling program. The bill, entitled the National Beverage Container Reuse and Recycling Act of 2001, would amend the Solid Waste Disposal Act to provide consumers with a 10-cent refund for the return of empty, unbroken containers. It would apply to a wide variety of beverage containers, including those made of metal, glass, and plastic, that have a capacity of up to one gallon, and that hold wine coolers, sparkling or carbonated water, fruit juice, beer, soft drinks, and other beverages. The bill seems certain to attract strong opposition from the food industry. On the state level, a bill has been introduced in California that would require a plastic pollution prevention fee to be paid by companies packaging products in plastic containers if a 50% statewide plastics recycling rate is not attained by January 1, 2005. The fee would be equal to the difference between the scrap value and the cost of recycling for each resin type. Currently, California’s plastics recycling law requires a 25% statewide recycling rate, but food and beverage containers are exempt. The new bill does not contain an exemption for food and beverage containers. It is sponsored by state Senator Wesley Chesbro, who has previously proposed toughening California’s existing plastics recycling law, including ending the exemption for food and beverage containers. Efforts also continued in Hawaii to pass container deposit legislation during the Spring session. Companion bills were introduced in both the House and the Senate. However, the bill did not make it out of Committee before the Hawaii legislature adjourned. In Iowa there is talk of expanding the current deposit system beyond the current soft drink and beer to include other beverages such as water. In the past, these proposals have not gone very far. We are monitoring these situations and will continue to update the Committee on any developments. 11. NSF Offers Continuation of USDA Product Certification Programs The NSF International (NSF) has recently developed two programs applicable to the use of products in federally inspected meat and poultry facilities. In the past, the Food Safety and Inspection Service (FSIS), a branch of the USDA, required federally inspected facilities to use only those nonfood compounds and proprietary substances (lubricants and sanitizers, for example) that had been approved under a USDA authorization program. FSIS also formally reviewed and approved the design of equipment used in meat and poultry facilities. USDA discontinued both of these programs in an effort to eliminate “command and control” requirements that were contrary to the Agency’s current Hazard Analysis and Critical Control Point (HACCP) philosophy. USDA no longer considers its lists of accepted equipment and substances to be effective and now requires facility operators to determine whether a particular product is acceptable under the facility’s HACCP plan. Under HACCP, meat and poultry establishments must identify and manage critical control points, areas where chemical, physical, and microbial contamination may occur. Once these points are identified, the processor must reduce contamination risk and maintain documentation describing any corrective actions taken. With the elimination of the prior approval programs, the regulated industry no longer had a readily available list of products acceptable for use in their facilities. Responding to requests from the regulated industry for assistance in identifying acceptable products, NSF developed a registration program for nonfood substances and assisted in the development of a certification standard for equipment. Proprietary Substances and Nonfood Compounds Under NSF’s registration program for proprietary substances and nonfood compounds, manufacturers of substances used in federally inspected meat and poultry processing facilities voluntarily register their products with NSF. This program is intended to provide meat and poultry processors a list of products which have been found to be acceptable for use in federally inspected facilities. Proprietary substances include antifoaming agents, marking agents, poultry and hog scald media, and fruit and vegetable washing products. Nonfood compounds are products that are used in and around food processing areas, but are not intended for direct contact with food. Such substances include maintenance and cleaning chemicals, sanitizers, lubricants, and water treatment chemicals. NSF’s program essentially mirrors the requirements, categories, and product designations from the previous USDA program. In fact, to begin the program, NSF included all of the substances previously authorized by USDA in their list of “approved” compounds. The NSF program also allows ingredient manufacturers to participate in the program by registering their active ingredients and other additives. Although somewhat similar to a master file under the former USDA program, ingredient manufacturers now may provide formulation information on a confidential basis to NSF and receive the additional benefit of having their product included in a separate listing for acceptable ingredients. This should allow finished product manufacturers to choose ingredients from a list of products that have already been reviewed by NSF and may result in a streamlined review process for finished products. In addition to products included on the former USDA list, manufacturers may now “register” new products with NSF. The registration process includes a formulation and label review, determination of appropriate use classification and category codes. To distinguish substances that were previously listed by USDA and those that are NSF “registered” in the official Internet listing of these products, NSF uses different colors for the two types of listing. The online listing is available at http://www.nsf.org/usda. Manufacturers of registered products may include the NSF registration mark on their product labels. Equipment Working closely with USDA’s Agriculture Marketing Service and the regulated industry, NSF also has developed a voluntary certification standard for equipment used in federally inspected meat and poultry facilities. AMS has adopted the ANSI/NSF/3-A standard as the standard to be applied in the AMS voluntary certification program for equipment, which was established at the request of industry to fill the void created by the end of the USDA FSIS program. This certification program became effective on January 8, 2001. When a manufacturer files an application for certification under this program, USDA specialists will review the design, inspect equipment, and determine if the equipment complies with the performance criteria in the ANSI/NSF/3-A standard. Upon completion of the review, the product may be marked with official identification symbol to indicate that the equipment has been “accepted” by USDA. In addition, USDA will include the product on its Internet listing of accepted products, available at http://www.ams.usda.gov. Although third parties, such as NSF, also may certify food processing equipment to the ANSI/NSF/3-A standard, products certified by third parties may not include the USDA “accepted equipment” mark nor will they be included in USDA’s list of accepted products. Back to Top More About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . 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 © Copyright 2005 The Society of the Plastics Industry.
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