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 SPI
- Food, Drug, and * * * For Members Only * * *
To: SPI Food Drug and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: The last few weeks have seen exciting and fast-paced developments in our effort to enact legislation that would replace the current premarket approval system for food-contact substances with a simpler, faster notification system. As reported on our web site (www.khlaw.com), on September 24, the Senate passed S.830, the Food and Drug Administration (FDA) reform bill that contains the SPI-FDA agreed upon language for the premarket notification (PMN) system. In addition, on October 7, the House of Representatives passed H.R. 2469 that includes the PMN language, albeit without the fee provision. H.R. 2469 now goes to a conference committee so that differences with the Senate version can be resolved. We believe there is a good chance that the PMN proposal will be enacted into law this Fall, setting the stage for a dramatic change in the way food packaging and other food-contact materials are regulated in the United States. This letter updates you on the current status of the PMN legislation and provides you with some of the background regarding the events in Congress over the last few weeks. In addition, the letter discusses several recent developments at FDA, the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA) that may affect your business. Specifically, FDA and EPA appear to be close to resolving the jurisdictional issues over antimicrobials raised by the Food Quality Protection Act (FQPA). In addition, USDA has now eliminated the prior approval requirement for proprietary substances and non-food compounds. These substances include sanitizers, cleaning compounds, water treatments, pesticides, and lubricants that currently must be evaluated by USDA and authorized for use in federally inspected meat and poultry facilities. Two developments in the European Union (EU) may be of particular interest to the Committee: (1) the proposed ban, in response to "mad cow" disease, on materials derived from certain animal parts thought to transmit the disease (which threatens to be the subject of a trade battle with the U.S.), and (2) the reorganization of the Scientific Committee for Food (SCF), the body in the Community responsible for implementing the EU "positive list" for plastics used in contact with food. Finally, as discussed more fully at the end of this letter, we are pleased to offer those of you with Internet e-mail capability access to a new service that will allow us to inform you of important events in the timeliest manner possible. Please send your e-mail address to us at REGALERTS@khlaw.com and we will do the rest.
1. PMN Proposal Passed by Senate and House On September 24, the Senate overwhelmingly passed S.830, "The FDA Modernization and Accountability Act of 1997" by a vote of 98-to-2. As many of you know from our past letters, S.830 contains the SPI-FDA agreed upon language that would institute a PMN system for food-contact substances. The PMN language in S.830 would permit FDA to charge reasonable fees for these proprietary notifications. The final vote on S.830 concluded several weeks of debates and compromises over the bill's provisions regarding national uniformity for cosmetics and FDA's review of off-label uses for medical devices. Senator Kennedy led the opposition on these matters, joined by the Secretary of Health and Human Services (HHS), Donna Shalala. The compromises satisfied the major complaints of these opponents and, while Senator Kennedy and Secretary Shalala are still not entirely happy with the bill, HHS has backed away from the threat of a presidential veto that was made earlier. The PMN provision of the bill enjoyed widespread support in the Senate and the bill was passed with only minor technical changes in the language that we and FDA proposed. As it appeared that the Senate bill containing our PMN provision would be passed, our efforts focused on the House of Representatives to ensure that any FDA food reform bill passed in that chamber also would contain the PMN language. On October 7, the full House of Representatives passed by voice vote H.R. 1411, the consolidated FDA reform bill that contains our PMN language without the fee provision. H.R. 1411 is a consolidation of three FDA reform bills dealing with drugs (and the reauthorization of the Prescription Drug Users Fee Act (PDUFA)), medical devices, and foods - H.R. 1411, H.R. 1710, and H.R. 2469, respectively. The floor vote on H.R. 1411 elicited minimal controversy. But this vote was the culmination of two weeks of back-and-forth work with the members and staff of both parties that finally resulted in the Committee favorably recommending H.R. 2469, the food reform bill, to the full House of Representatives by unanimous vote. The history of how this bill made its way through Committee is an interesting example of the complexities of the legislative process. Senator Whitfield (R-KY) sponsored the food reform bill and, originally, the bill contained the SPI-FDA agreed upon language for the PMN system. However, before the bill was marked up in the Health and Environment Subcommittee, the PMN language was removed because Rep. Tom Bliley (R-VA), the chairman of the Commerce Committee, opposed the provision of the PMN proposal that would allow FDA to collect fees for the notifications. On the other side, Rep. Dingell, the ranking minority member, and FDA did not want the provision included in the bill without the fees. So the PMN language was dropped from the bill entirely due to the controversy. During the Subcommittee mark-up later that week, Rep. Bart Stupak (D-MI) offered an amendment to place the PMN language back into the bill with the fees. He subsequently withdrew this amendment after Rep. Bliley promised to work with him to resolve the fee issue. Before Rep. Stupak withdrew the amendment, he spoke in support of the PMN proposal and identified several industry groups that supported premarket notification for food-contact substances. Among the groups that Rep. Stupak cited were the National Food Processors Association (NFPA) and the Grocery Manufacturers Association (GMA). While both groups support the PMN legislation, they advised the Congress that they could not support fees of any type. Both GMA and NFPA sent letters to the Hill stating their opposition to fees, although both organizations also clearly stated their support for the PMN system. During the week between the Subcommittee mark-up of the FDA reform bills and the mark-up of the bills by the full Commerce Committee, we were engaged in intensive discussions with members of the Committee and their staff personnel to marshal support for the PMN legislation. As you know, we issued an urgent appeal to the Committee for your companies to contact Members of Congress to indicate your support for the PMN system, including your willingness to pay reasonable fees in return for a reasonable FDA review period for food-contact substances. A number of companies did respond positively to our request for assistance, and the contacts made by those companies undoubtedly played a significant role in persuading the Commerce Committee to include the PMN provision in H.R. 2469, albeit without the fees language. The PMN system has bipartisan support, and including the provision in the FDA reform legislation without the fees, leaving that issue to be resolved in the House/Senate conference, was seen as the best way to obtain the ultimate enactment of the PMN reform. It is the intent of FDA and Reps. Dingell and Stupak to try to make sure that the fees authority is included in the final legislation that emerges from the House/Senate Conference. On behalf of SPI, we have adhered to the position taken in our original discussions with FDA, which is that SPI member companies are willing to pay reasonable filing fees for the notifications. We will keep you informed in future letters regarding the status of the PMN proposal as events occur. If you would like to receive faster updates, see the article below regarding our new Regulatory Update Service or visit our web site or SPI's.
2. Biomaterials Liability Bill Approved by Subcommittee Most of Congress' attention since the August recess has focused on the passage of the appropriations bills for the coming fiscal year. There has been little activity concerning any of the biomaterials liability bills or the broader product liability bills that have been introduced in both chambers. See our July 16, 1997 letter. If enacted, these bills would provide some protection for suppliers of raw materials for medical devices against their having to defend unfounded lawsuits. Some progress has been made on one bill, H.R. 872, known as the Gekas bill. On September 12, the House Judiciary Subcommittee on Commercial and Administrative Law voted favorably on H.R. 872 and sent it to the full Judiciary Committee. The Gekas bill provides a shield for suppliers in liability cases where the supplier's product met the manufacturer's specifications. The protection would not extend to breast implant cases, addressing one of the major issues that caused the President to veto last year's product liability legislation. During the mark-up, the Subcommittee voted to adopt an amendment that would allow victims or manufacturers to file post-trial motions to bring suppliers of raw materials back into liability cases if evidence is presented at trial demonstrating negligence on the part of the supplier. Mark-up by the full Judiciary Committee has not yet been scheduled.
3. EPA and FDA Move Closer to Resolving the Jurisdictional Question Over Antimicrobials As reported in our June 6 letter to the Committee, EPA and FDA announced a tentative agreement on May 8, 1997 concerning the jurisdictional issue raised by the Food Quality Protection Act (FQPA) with respect to antimicrobials used in food-contact applications. The agreement was aimed at preserving the status quo, with FDA continuing to have regulatory authority over antimicrobials used in food packaging. Tolerances for residues of antimicrobials used on food-contact surfaces other than packaging (e.g., food processing equipment), however, would wind up under EPA jurisdiction. Since EPA continued to maintain that the FQPA automatically transferred jurisdiction over virtually all antimicrobials previously regulated by FDA to EPA, both agencies agreed that a rulemaking would be necessary to return jurisdiction of antimicrobials with regard to food packaging to FDA. As the Agencies worked toward that rulemaking, discussions continued to reveal additional issues (such as when does a raw agricultural commodity, subject to USDA's jurisdiction with respect to use of antimicrobials, become a processed food within FDA's authority). Unfortunately, while the agencies have been working out the details of the jurisdictional issue, many pending and subsequently filed petitions remain in jurisdictional limbo until the rulemaking is completed. At this time we believe that the agencies have inched closer to resolving the issue. On September 17, EPA and FDA officials met for further discussions, and the outcome, as we understand it, is that FDA will regulate the use of antimicrobials on all foods other than crops in the field. To accomplish this, EPA and FDA have agreed to amend the definition of "pest" to expand the exclusion for microorganisms from processed food to all food except crops. The new definition of "pest," would allow antimicrobial substances to be deemed food additives rather than pesticides in more applications. EPA and FDA officials hope to publish a joint notice proposing such a rulemaking in the Federal Register this Fall. The change in the definition of "pest," however, leaves open questions to be answered before the rulemaking is finalized. For instance, it remains to be seen how the line will be drawn between processing plants (where microorganisms will not be considered pests) and the field (where they will be considered pests). While there is legal precedent for treating packaging and food-contact surfaces as food, it appears that these substances will not be considered food for purposes of the definition of "pest," and jurisdiction for antimicrobial residues will be shifted back to FDA based upon some other rationale that has not yet been disclosed.
4. FSIS Eliminates the Prior Approval Requirement for Equipment Used in Meat and Poultry Plants On August 25, 1997, USDA's Food Safety Inspection Service (FSIS) eliminated the requirement for prior approval of equipment and establishment drawings and specifications, and certain partial quality control programs in federally-inspected meat and poultry plants. 62 Fed. Reg. 45016. Under the prior approval system, in effect since 1975, FSIS's Equipment Branch evaluated all equipment intended to be used in meat and poultry facilities. The primary objective of the FSIS review was to insure that the equipment could properly be cleaned and inspected and would not adulterate food. To obtain approval, it has been necessary for equipment components to have official confirmation by FDA of an acceptable regulatory status for contact with food, meaning coverage by a food additive or GRAS regulation, a Threshold of Regulation exemption, or a letter from FDA on some other basis. Approved equipment was listed by manufacturer or distributor name and type or model number in FSIS's Accepted Meat and Poultry Equipment, commonly known as the "Equipment Book." The final rule, which was proposed on May 2, 1996 (51 Fed. Reg. 19578), is part of a broader program of regulatory reform designed to shift responsibility for specific operational issues to the establishments themselves through the Hazard Analysis Critical Control Point (HACCP) program, thus allowing the Agency to concentrate on broader food safety concerns. As part of this same process, FSIS announced on August 25, 1997, that it is proposing to eliminate the approval requirement for proprietary substances and non-food compounds used in meat and poultry plants. (See the related discussion regarding this issue below.) FSIS seeks to allow establishments the flexibility to design their facilities and equipment in the manner they deem best to maintain a sanitary environment for food processing. FSIS, however, will continue to verify through inspections that sanitation requirements are met. Manufacturers and distributors of equipment used in these facilities, as well as food processors, submitted comments to FSIS regarding their concerns about the elimination of the prior approval system. Twenty-seven comments were received by FSIS regarding the rule. Many of these comments urged FSIS to retain the approval system. These groups expressed concern that the prior approval system minimized the risk of differing opinions on the suitability of equipment resulting from the subjective interpretations of individual inspectors. In response to these concerns, FDA stated that the proper design and implementation of sanitation standard operating procedures (SOPs) and HACCP will minimize any differences of opinion between inspectors. To provide the industry with some guidance as to the proper requirements for equipment, FSIS will preserve the general guidance information provided in the introduction to the Equipment Book. The Agency stated that this guidance should not be interpreted as a set of regulations, but as a statement of basic principles with illustrative examples. The specific application of these principles will depend, in part, on a facility's implementation of its SOP and HACCP plans. FSIS also will issue a final edition of the Equipment Book, reflecting the Equipment Branch's decisions through November 1996. The current language of 9 C.F.R. ' 308.5(a) and 381.53(a) will be preserved and all equipment must still meet these general criteria. Essentially, this means that equipment must be composed of materials deemed suitable for food-contact under the Federal Food, Drug, and Cosmetic Act and that the equipment must be designed in a fashion that allows it to be thoroughly cleaned.
5. USDA Proposes to Eliminate Requirement of Agency Approval of Proprietary Substances and Nonfood Compounds Prior to Use in Federally Inspected Meat and Poultry Establishments As a further step toward achieving the goals of the President's Reinvention of Government initiative (i.e., to have fewer, clearer, and more user-friendly regulations), USDA's FSIS is proposing additional revision to its regulatory requirements concerning sanitation in official meat and poultry establishments. A proposed rule in this regard, which was published in the August 25, 1997 issue of the Federal Register (62 Fed. Reg. 45045) would amend the meat and poultry sanitation regulations to do the following: (1) consolidate the sanitation regulations that currently appear in 9 C.F.R. Parts 308 (applicable to meat establishments) and 381 (applicable to poultry establishments) into a single part of the regulations applicable to both meat and poultry establishments; (2) eliminate unnecessary differences between the meat and poultry sanitation requirements; and (3) convert many "highly prescriptive" regulatory requirements to performance standards. Of particular interest to Committee members, the proposed rule, if promulgated, would eliminate the requirement of FSIS prior approval of proprietary substances and nonfood compounds used in federally inspected meat and poultry facilities. Under 9 C.F.R. ' 381.60, "Use of compounds," nonfood compounds and substances such as sanitizers, cleaning compounds, water treatments, pesticides, and lubricants currently must be evaluated and authorized by FSIS for use in federally inspected meat and poultry facilities prior to such use. If, after reviewing a company's application for authorization of a compound, FSIS concludes that the product is acceptable for use, the Agency issues a letter of authorization to the applicant, and the material is placed on USDA's AList of Proprietary Substances and Nonfood Compounds." (The authorized or approved compounds list, which is compiled for the use of USDA inspectors when inspecting meat and poultry plants, is divided into various categories, based on how a material is intended to be used.) The current proposal would eliminate the prior-approval requirement for proprietary substances and nonfood compounds, and replace it with the following, more general requirement, which will appear in new Section 416.4(c): Cleaning compounds and sanitizing agents used must be safe and effective under the conditions of use and their use must not cause the contamination or adulteration of the product. While the replacement regulation specifically refers to cleaning compounds and sanitizing agents, it does not explicitly mention substances such as lubricants used on processing equipment, which also are included within the scope of the existing Section 381.60. Such substances will continue to be subject to the general requirement that they not adulterate meat and poultry products, and will continue to be required to meet any applicable requirements of other regulatory agencies, such as FDA. Under the new rule, FSIS would no longer be required to review compound formulations and product labels to ensure that the applicable USDA and FDA requirements are met; rather, the burden would be placed on industry to ensure compliance. Thus, the sometimes burdensome application process for lubricants and other compounds would be eliminated. At the same time, companies would no longer be able to rely on a listing in USDA's "List of Proprietary Substances and Nonfood Compounds" as evidence that a particular product has been shown to be safe and suitable for its intended use. As you may know, USDA has required explicit FDA confirmation of a material's suitable regulatory status as a condition of authorization for use in meat and poultry plants. While the proposed rule would eliminate the requirement for USDA authorization, it is not clear whether USDA inspectors would continue to impose the requirement for formal FDA confirmation of compliance through random audits of supplier assurances in the files of inspected facilities, as is presently the case with respect to packaging materials. The proposed rule is open for public comment; the deadline for filing comments is October 24, 1997. Please let us know if you believe comments should be filed on behalf of the Committee.
6. FDA Issues Performance Report for Food Additive Petitions FDA has issued its first annual report assessing the Agency's performance in reviewing applications for human drugs, biological products, medical devices, food and color additives, and veterinary drugs. The Product Review Performance Report is FDA's effort at establishing clear performance goals for reviewing new applications by measuring the Agency's performance in four areas:
The Center for Food Safety and Applied Nutrition (CFSAN) reported that the on-time review of Food Additive Petitions (FAPs) and Color Additive Petitions was 31% in Fiscal Year (FY) 1995. This represents a decrease from the Agency's 53% record in FY 1994. The Center attributed the decrease to a reengineering of the review process so that now complete reviews are done before responding to a petitioner. The Center also reported that the median time for petition approval decreased from 37 months in FY 1993 to 27 months in FY 1996. During this time the number of petitions approved increased 55%. The number of overdue petitions declined from FY 1993 to FY 1996 by 23%. CFSAN's portion of the report contains a specific discussion of indirect additive petitions and the Center's efforts to speed up the review of these substances, which are considered to "present relatively little safety concern." The report notes that 60-80% of the food and color additive petitions historically have been for indirect additives and that FDA devotes as much as 40% or more of its work effort toward reviewing these petitions. The report then discusses CFSAN's efforts to review indirect additive petitions more efficiently by adopting the Threshold of Regulation policy and instituting Special Project Team review of petitions that meet certain criteria. The CFSAN report essentially shows that FDA has made progress in accelerating the review of food additive petitions, but the Agency still takes over two years to complete a task required by statute to be completed within six months. This demonstrates the continuing need for the 120-day PMN process for the low-risk category of food-contact substances.
7. Update on DEHP and Proposition 65 We reported in our June 6, 1997 letter that a group in California is suing 60 cheese manufacturers and retailers, under the bounty hunter provision in California's Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65, alleging a failure to warn consumers of exposure to di(2-ethylhexyl) phthalate (DEHP). DEHP is a plasticizer that is listed as prior sanctioned for use with high water content foods under Section 181.27 of the food additive regulations. It also is listed under Proposition 65 as a potential carcinogen. Previously, this group had brought a similar lawsuit against medical device manufacturers regarding the presence of DEHP in those products. In response to these attacks, the DEHP Healthcare Industry Task Force has petitioned the State of California to revise its Proposition 65 listing of DEHP and raise the no significant risk level (NSRL) for the chemical. The petition relies upon new studies, demonstrating that, while DEHP may cause cancer in rats, the results are not applicable to humans. Both the EU and Canada have determined that DEHP is not a human carcinogen. DEHP's listing on Proposition 65 was the result of research showing the chemical to be a rodent carcinogen. Multi-year research is being conducted by the Chemical Manufacturers Association (CMA) that is directed specifically to DEHP's effects on humans, if any; preliminary results of these studies indicate that DEHP is not a human carcinogen. The DEHP Task Force Petition proposes that the current NSRL be raised from 80 micrograms/day to 140,000 micrograms/day for ingestion and inhalation and 1,400,000 micrograms/day for intravenous and other non-oral exposures. The adoption of this new NSRL should eliminate the need for warnings regarding any use of DEHP in plastics articles such as tubing for liquids, etc.
8. EU Ban on Products Derived from Animal Parts that May Transmit "Mad Cow" Disease Concern in United States industry and government circles is mounting over an EU Directive adopted on July 30, 1997 that will ban the use of tallow, gelatin, and other products derived from the brain, spine, and certain other parts of cows, sheep, and goats that may be contaminated with transmissible spongiform encephalopathy (TSE). This ban, scheduled to take effect January 1, 1998, derives from concerns over bovine spongiform encephalopathy (BSE), a form of TSE that is commonly known as "mad cow" disease, and that may have been linked to Cruetzfeldt-Jakob disease, a degenerative disease in humans that caused the death of several people in Britain last year. The Directive will ban the use and importation of "specified risk material" in the EU. Specified risk material is defined as the brain, spine, eyes, and tonsils of cows, sheep, and goats and the spleens of goats. The ban also requires that all products of animal origin intended for food, feed, medical products, pharmaceuticals, or cosmetics shall be accompanied by a declaration from an appropriate body certifying that the product was not derived from specified risk material. The ban is significant to the plastics industry as products derived from tallow are used in plastic articles. The ban also will have a drastic impact on the pharmaceutical industry, and several companies have threatened to move their manufacturing operations to take advantage of more lenient self-policing provisions applicable to materials produced in the EU. Over 80% of all pharmaceuticals contain tallow, as well as many cosmetics, plastics and food products, representing billions of dollars a year in sales. The Directive can be read broadly to ban the import of any product that contains tallow or gelatin derived from animals, unless a competent authority in the exporter's country certifies that the tallow is not made from specified risk material or the country can certify that it is free of both BSE and TSE. While the United States is BSE-free, and has never had a reported case of "mad cow" disease, the United States cannot certify it is free from TSE. Furthermore, in the United States, tallow generally is rendered by boiling the entire animal carcass, and industry will need more time to change its processing methods to ensure specified risk material is removed if the ban goes into effect. Despite the broad interpretation of this ban that is being reported in the press, we do not believe that the EC considered the use of tallow in plastics when the ban was enacted. We also believe the language of the July 30, 1997 Directive can be read to exclude plastics containing tallow that may have come from specified risk material, provided that they are not used in certain applications. This alternative interpretation views the Directive as having separate requirements for specified risk material and for products derived from specified risk material. Specified risk material, the actual tissue from cows, sheep, and goats, cannot be used for any purpose in the EU, nor can this tissue be imported. Products of animal origin that may been derived from specified risk material, however, are regulated separately. These products cannot be imported into the EU when they are intended for food, feed, medical products, or cosmetics without a declaration from a component authority that they have not been derived from specified risk material. It appears that his provision would allow plastics and other materials that are not intended for use as food, feed, medical products, or cosmetics and that may contain a substance derived from risk material, such as tallow, to be imported without restriction. As food-contact substances are not considered food in the EU, plastic food packaging containing animal tallow may not be required to be accompanied by a certificate. We are currently trying to determine the proper interpretation of the ban with greater certainty. In any event, materials used as medical devices or actually as a component of food, pharmaceuticals, or cosmetics would require a declaration. FDA and personnel in the U.S. Trade Representative's office are voicing strong opposition to the ban on a number of grounds. FDA is concerned that (1) it will be deemed the competent authority that will have to provide the required declaration for US exports to Europe; (2) it has neither the money or resources to perform this type of task; and (3) a declaration that material has not been derived from specified risk material cannot be validated. FDA officials are currently participating in meetings with officials in Europe to discuss those issues. The Agency also is concerned that the ban may create shortages in the U.S. of medical products manufactured in Europe. The U.S. Trade Representative has threatened legal action against the EU if the ban is implemented, charging that the Directive is a violation of World Trade Organization regulations; and U.S. cattle farmers are threatening to sue the EU in the European Court of Justice over the ban.
9. Reorganization of the EU Scientific Committee for Food In response to severe criticism about the handling of "mad cow" disease, the European Commission (EC) is currently in the process of reorganizing the Scientific Committee for Food (SCF). The SCF is responsible for reviewing substances for listing in the Monomers Directive (90-128-EEC), the EU positive list of substances for use in plastic materials that contact food. The SCF has been transferred from Directorate General (DG) III to DG XXIV. This transfer is significant because DG III was responsible mainly for issues relating to business and industry and DG XXIV is responsible for consumer protection, and is known for being very responsive to consumer activities. The Scientific Committee for Food will become the Scientific Committee on Food, and all of the members of the current SCF, including the working group, will have to reapply for positions on the new committee. It appears that the reorganized SCF will be composed largely, if not entirely, of scientists from academia. Scientists with governmental affiliations will not be considered, and it is unclear whether industry scientists will be considered, although they may apply. Many of the current members of the SCF feel that the manner in which DG XXIV has handled the reorganization appears to challenge the integrity of the Committee and are not inclined to reapply. Currently, there are no plans to change any of the submission procedures and we have been advised that the SCF will continue to follow the same policies set forth in the Practical Guide for the submission of technical dossiers to clear the use of new food-contact materials. It also is expected that existing decisions (including SMLs and other limitations in the Monomers Directive and its amendments) will remain intact despite the reorganization. On a positive note, DG XXIV will be posting the minutes of SCF meetings and a number of other documents of interest to the packaging industry on the internet at the following address http://europa.eu.int/en/comm/spc/spc.html.
10. E-Mail Regulatory Update Service In the next few weeks, we will be providing a new service that will provide "Regulatory Alerts" through broadcast e-mail over the Internet. This service will be available to members of the FDCPMC, along with all of our clients. Interested members with e-mail capability will receive these ARegulatory Alerts@ when matters arise that are deemed especially important or that require time sensitive responses from you. The "Regulatory Alerts" e-mail will allow us to update you in the timeliest manner and has an added advantage in that "Alerts" can be sent to each person in your company that could benefit from this type of information if you wish. The service also will make it easier for you to comment on regulatory issues as they arise. To receive the "Regulatory Alerts" by e-mail, please send your e-mail address to AREGALERTS@khlaw.com or provide us with your e-mail address by regular mail or telephone.
As always, should you have any questions or comments about these subjects, please do not hesitate to let us know. Cordially yours, Jerome H. Heckman (202) 434-4110 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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