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 March 2, 2001
(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 discuss the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) ban on the importation of all processed animal proteins, and some products derived from these proteins, from countries that are either affected by bovine spongiform encephalopathy (BSE) or that have an unacceptably high risk for BSE. We also discuss the Food and Drug Administration's (FDA) final approval to allow food packaged with the materials listed under 21 C.F.R. Section 179.45 to be treated with e-beam and x-ray irradiation and other continuing issues surrounding the irradiation of food. In addition, the letter addresses the National Sanitation Foundation's (NSF) attempt to replace USDA's former programs for approving equipment and nonfood and proprietary substance used in meat and poultry processing plants. Finally, we report on a recent European court ruling that invalidated certain French regulations for not giving due regard to the European Union (EU) principle of mutual recognition, the European Commission's (EC) issuance of a Green Paper on Integrated Product Policy, and other matters of interest to the Committee.
Table of Contents
1. Concern Over Mad Cow Disease Leads to USDA Ban On December 7, 2000, USDA's 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. APHIS invoked the ban 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. On Feb. 9, APHIS extended the ban 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 will be 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 will apply the following factors:
We discussed the import ban on processed animal materials with members of the APHIS import/export staff, and it appears that the ban will not be applied to tallow derivatives, such as fatty acids, that have food-contact applications. The final rule implementing the ban, however, is still under development, so the ultimate scope of the ban is not yet certain. Indeed, we received conflicting advice from different APHIS officials on whether bulk shipments of tallow are included in the ban. It is probably 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 derivates because the extension applies only to products for edible applications. Although we do not expect the ban to apply to derivatives of tallow, there is no general processing-based exception at this time, and APHIS believes the EU guidelines for deactivating prions to be ineffective. Anything that may contain protein is subject to the ban regardless of the extent to which it has been treated with heat, pressure, or other processes intended to "deactivate" the BSE agent. At the moment, APHIS is working on a ruling that presumably will clarify the scope of this import prohibition. This ruling may not be published in the Federal Register for a month or more. In the interim, APHIS is considering whether a product subject to the extended "facility" ban may be excepted from the ban on a case-by-case basis. To be considered for such an exception, importers must submit answers to a questionnaire developed by APHIS to establish the lack of a cross-contamination risk. It is unclear whether this will be a practical option. We would be interested in hearing from any Committee members as to whether this APHIS ban is creating any difficulties. 2. NSF Offers Continuation of USDA Program and Assists in the Development of Equipment Certification Standard 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 new 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. NSF is now preparing a printed copy of the acceptable proprietary substances and nonfood compounds and has sent notices to all manufacturers of substances that were previously included in the USDA list. NSF has asked that manufacturers confirm that they want their products to be included in the next edition of the printed copy, the NSF White Book. To be included, NSF must receive the confirmation from manufacturers by March 15, 2001. 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. As we reported last month, 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. Although USDA has received several applications for certification, USDA has not completed the required reviews for any of these products. 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. 3. FDA Publishes Final Regulation on Use of Packaging in E-Beam and X-Ray Irradiation of Meat and Poultry 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. You may recall that the Agency had issued a temporary one-year authorization that was set to expire February 22, 2001. The petition, which was filed by the National Center for Food Safety and Technology on January 18, 2000, supposedly was reviewed under FDA's expedited review process for petitions that address enhancements of food safety. It remains unclear how "expedited" this review process really is. The final rule on the equivalence of the irradiation sources 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. This action by FDA, however, does not address the problem of the limited types of packaging cleared under Section 179.45. Fortunately, as we have advised the Committee previously, it is our position that materials having FDA compliance for food-contact use, but not listed in Section 179.45, may be used to hold food for irradiation if it can be shown that there is no significant change in the nature or amount of potential migrants from the packaging to the food as a result of treatment with irradiation. We have assisted several companies in making this determination. FDA also recently has provided us with guidance on the Agency's preferred protocol for testing packaging materials to obtain official clearance for holding food during irradiation. 4. National Fisheries Institute Petitions FDA to Allow Ionizing Radiation of Crustaceans In other irradiation news, the National Fisheries Institute has asked FDA to allow ionizing radiation to treat crustaceans and processed crustaceans. The petition should qualify for expedited review, since it involves a process used to control foodborne pathogens. Meanwhile, Public Citizen continues to urge FDA to deny pending food additive petitions that seek approval of food irradiation. Public Citizen also 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 Public Citizen claims may mislead consumers into believing that an irradiated food has not been irradiated. 5. French Court Rules that France's Regulation Requiring PreMarket Approval of Imported Processing Aids Violates EC Treaty on the Free Movement of Goods A recent French Court ruling represents a victory for industry in that it acknowledges the principle of mutual recognition. It also establishes that imported processing aids legally marketed in other Member States need not be cleared in France when French authorities do not demonstrate that their use in food raises a safety concern. The case began in 1998 when French authorities brought an enforcement action against Bio Springer, a manufacturer of yeast extracts using enzyme preparations, claiming they violated French law by using enzymes that were not authorized for use in the manufacture of foodstuffs or food ingredients under French regulations. The enzyme preparations at issue are used as processing aids within the meaning of the EU definition. Since there is no specific EU legislation regulating processing aids, their marketing and conditions of use can be determined by each Member State, provided they comply with EC Treaty provisions, such as the free movement of goods. However, Member States are entitled to restrict the free movement of goods where they can demonstrate that the marketing of such products endangers human health. In France, processing aids are subject to a premarket approval procedure that is applicable to domestic and imported processing aids. Keller and Heckman's Jean Savigny and Rachida Semail, acting in support of Bio Springer local counsel, argued that the French regulations requiring premarket approval of processing aids constitute a trade barrier for imported processing aids legally marketed in the Member States of origin. They further argued that these trade barriers were unjustified in the case at stake, since no risk to public health associated with the use of the products was demonstrated. They thus argued that France's premarket approval procedure for processing aids was disproportionate and violated the free movement of goods. The French Court agreed with Bio Springer's position and dismissed the charges that the French authorities had brought against them. This case provides further support for the proposition that regulations and authorities in EU Member States must take due account of the principle of Free Movement of Goods (mutual recognition) in imposing national restrictions on safe processing aids (and potentially other products as well). As we have advised the Committee before, in some situations, the Treaty provisions on Free Movement of Goods can support the EU- wide use of packaging materials permitted in one or more Member States. 6. European Commission Releases Green Paper on Integrated Product Policy The EC has issued a Green Paper on "Integrated Product Policy," an approach to environmental policy that seeks to make products more environmentally friendly. The Green Paper itself 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. 7. U.S. Considers Three Options for Dealing with Precautionary Principle The debate over the precautionary principle is heating up again as parties to the Codex Alimentarius Commission prepare for the April 23-27, 2001 meeting of the Codex Alimentarius Committee on General Principles in Paris. The principle stands for the proposition that it is better to require a full set of toxicology data and a complete assessment of all possible risks before allowing new technology or products on the market. As we have reported previously, it has been a source of disagreement between the U.S. and the EU, with consumer groups and some European government authorities lobbying for fully invoking the principle and the U.S. arguing that it allows governments to invoke nonscientific factors when making risk-management decisions. During a public preparatory meeting in advance of the Paris meeting, the U.S. Codex Office outlined three options for dealing with the precautionary principle: (1) The precautionary principle is a trade issue, not a science-based food safety issue appropriate for discussion by Codex. (2) Precautionary decisions are appropriate for national governments, but not for international standards. (3) A French discussion paper on precaution, with appropriate modifications, could be the basis for a U.S. position. None of these choices seems particularly appealing to industry. Option (1) is worrisome, because it is not clear that another preferable forum will exist to give the various positions a full airing and, hopefully, to avoid unilateral and standardless applications of the principle. Also, there are fears that mere acknowledgement of the existence of a "precautionary principle" could place pressure on the World Trade Organization (WTO) to apply it in trade circumstances. Arguments for the second option are somewhat complex and may be difficult to carry forward successfully (and it is not clear that individual country decisions without common criteria are desirable). Finally, the French position currently favors the application of a "precautionary principle" which is unacceptable both to U.S. industry and to the U.S. government, for the trade-related reasons mentioned earlier. * * * As always, if you have any questions on the above, or if we can be of assistance in any other way, please do not hesitate to contact me, Jerry Heckman or Deborah Ziffer. Cordially yours, Ralph A. Simmons 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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