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![]() February 1, 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 Bush Administration's regulatory moratorium, the resignation of Dr. Jane Henney as the Commissioner of the Food and Drug Administration (FDA), the 2001 agenda for the Center for Food and Applied Nutrition's (CFSAN's) Office of Premarket Approval (OPA) and other developments impacting the Food-Contact Notification program and continuing issues surrounding regulation of irradiated foods. We also report on the issuance of a new guidance document by the European Commission's (EC) Scientific Committee on Food regarding information required in an application for a safety assessment for food-contact materials, as well as the latest developments on the implementation of the precautionary principle in the European Union (EU), and the continued ban on polyvinyl chloride (PVC) toys containing phthalates. Finally, we report on the Environmental Protection Agency's (EPA) new children's health initiative, a final rule issued by the United States Department of Agriculture (USDA) on their voluntary certification program for meat and poultry processing equipment, and other matters of interest to the Committee.
Table of Contents
1. Bush Administration Acts Fast to Slow Things Down In a memo released Monday, January 22, 2001, President Bush's Chief of Staff, Andrew H. Card, Jr. directed department heads and acting department heads to postpone publication of proposed and final rules in the Federal Register. The move is in order to allow Bush appointees time to review the regulations and possibly to withdraw them. Card stated that the President wanted to communicate his "plan for managing the Federal regulatory process at the outset of his Administration." The Bush administration action will "temporarily" halt publication of proposed or final regulations. It appears as though "temporarily" could mean at least two months and possibly more as the memo calls for postponing for 60 days the effective date of regulations already published and, in addition, halting publication of proposed or final regulations until review by Bush appointees. Basically, all regulations not yet effective will be on hold. Proposed and Final regulations not yet sent to the Office of the Federal Register (OFR) are to be held "unless and until a department or agency head appointed by the President after noon on January 20, 2001, reviews and approves the regulatory action." Regulations already sent to the OFR and not yet published in the Federal Register are to be withdrawn for review and approval by Bush appointees. In addition, the effective date of regulations that have been published in the Federal Register but have not yet taken effect will be postponed for 60 days. The plan covers "regulations" as defined in section 3(e) of Executive Order 12866, i.e. "any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking." Exceptions exist for any regulations that impact critical health and safety functions. The Card memo urges voluntary participation in the moratorium by independent agencies, such as the Federal Trade Commission and the Federal Communications Commission, that are not directly subject to the President's authority. The move is designed to allow new Bush Administration appointees time to review recent rules, and could possibly result in substantive changes. The move is standard procedure when there is a change in political parties and can result in opportunities to revisit and direct substantive change. However, it can also result in delays in proposals and final rules sought by industry during a lengthy process of negotiation. The move by President Bush appears to be an affirmation of his campaign promise to take quick action once in the White House and to take a second look at initiatives during the waning days of the Clinton Administration. This "moratorium" on Federal Register publications pending review could significantly hold up any proposed rule and in fact affects even final rules that have not yet become effective. In addition, the moratorium may delay the publication of several long-anticipated Agency rules, including the Food and Drug Administration's (FDA) final rule on the implementation of the Food Contact Notification Program (FCNP). The proposed rule was published in the Federal Register on July 13, 2000, and the final version was expected to be published sometime in January. Now, it is unclear when we can expect to see the final rule. There are also implications for other recent rules. Health and Human Services' Standards for Privacy of Individually Identifiable Health Information was to be effective on February 26, 2001. That date will now be postponed until April 26, 2001 under the administration guideline. Another important rule, the Environmental Protection Agency's (EPA) proposed rule on a hydrochlorofluorocarbons (HCFC) allocation system will be affected by the moratorium. On the other hand, some rules, like the Occupational Safety and Health Administration's (OSHA) sweeping new ergonomics rule will not be affected by the moratorium. That rule became effective before the inauguration of President Bush. The full impact of the moratorium has yet to be seen. Suffice it to say that it could be a matter of months before many rules take effect. This may present opportunities, in some cases, to seek further agency review, or to urge speedy release of other regulatory actions that may be needed to clarify requirements for industry. 2. FDA Looks for a New Commissioner Dr. Bernard Schwetz, the former acting deputy commissioner of the FDA has taken over as the acting head of the Agency for the time being, until the end of the transition period created by outgoing Commissioner Jane Henney's resignation. Dr. Schwetz has served as acting deputy commissioner since 1999. Previously, he had served as a senior advisor for science at FDA and as a director of the National Center for Toxicological Research in Jefferson, Arkansas. The news was communicated to FDA employees through a memo dated January 22, 2001. Dr. Henney had been asked to vacate her office on January 19, 2001 upon acceptance of her resignation by the Bush administration. Wisconsin Governor Tommy Thompson (R), the newly appointed head of the Department of Health and Human Services (HHS), was sharply criticized by Senate Democrats during his recent confirmation hearing before the Committee on Health, Education, Labor, and Pensions for removing a Commissioner who still enjoyed broad support. The new administration has yet to name its candidate as the next FDA Commissioner, although several names are circulating. Among those reportedly being considered are former FDA acting commissioner Michael Friedman, Covington and Burling Partner Peter Barton Hutt, University of Pittsburgh School of Pharmacy Dean Randy Juhl, former FDA drug center official Murray Lumpkin, FDA oncology drug products division chief Richard Pazdur, former Health Care Financing Administration (HCFA) chief William Roper, former Health Resources and Services Administration (HRSA) administrator David Sundwall, and Georgetown School of Medicine Associate Dean Raymond Woosley. 3. OPA Released its Agenda for FY 2001 FDA's Office of Premarket Approval released its agenda for fiscal year 2001. Among the top goals for 2001 are the finalization of procedures for pre-submission consultations for new food additive petitions, as well as a final rule for food-contact notifications, which as discussed above, may be at least a temporary victim of the regulatory moratorium. Long term goals posted on the Agency's "B-list" (secondary priority) include development of a final rule for the GRAS notification program and the publication of four revised Redbook chapters (toxicology guidance for direct food additives) on the Internet. Nevertheless, it is unclear whether any new regulations can be issued by FDA in the near future in light of the regulatory moratorium discussed above. 4. FDA Evaluates the Use of Computational Toxicology Tools to Predict Carcinogencity of New Food-Contact Substances Dr. Mitchell Cheeseman of FDA recently has provided information on work that he is dong with colleagues at the Agency, including Dr. Alan Bailey and Dr. Edward Machuga, to evaluate the use of computer programs to predict the carcinogencity of untested substances. There is a thinking at FDA that such tools may be particularly useful in the Agency's Food-Contact Notification program, which requires relatively rapid decision making to meet the 120-day statutory review deadline. In particular, the Agency is looking at the following commercially available computational systems: MULTICASE, MCASE ONCOLOGIC , and TOPKAT. FDA ultimately is expected to outline its thinking on this matter in a guidance document, with the hope of reducing the testing and administrative burdens associated with predicting the carcinogenic potential of food-contact substances expected to be present at low levels in the human diet. In the meantime, FDA already is using these programs as part of the review process for some submissions. 5. Buzz Hoffman Retires From His Post at FDA As of December 31, 2000, Buzz Hoffman retired from his post as Chief of the Environmental Review Staff in FDA's Office of Premarket Approval. There has been no word yet on who may take over the position. 6. NTP Declines to Include Talc on its List of Carcinogens; Bisphenol A Now Being Evaluated by NTP During the December meeting of the Committee, some of you expressed concern that the National Toxicology Program (NTP) was considering adding talc to its list of carcinogens. Shortly after the meeting, however, NTP announced that talc will not be included on the list. Meanwhile, at the request of the EPA, NTP is studying the potential health effects of bisphenol A. The substance is commonly employed in the manufacture of polycarbonate plastics and epoxy resins intended for food contact. NTP specifically is studying whether low doses of bisphenol A have an effect on human reproductive health. EPA requested that NTP conduct a scientific peer review to evaluate low-dose effects and dose-response relationships for potentially endocrine-disrupting chemicals to determine whether EPA's guidelines for reproductive and developmental toxicity testing are adequate for endocrine-active chemicals. 7. FDA Reports to Congress on Status of Irradiation Labeling; FDA Approves Use of Ultraviolet Irradiation for Juice Products 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. Earlier this month, 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 which supported special labeling for irradiated foods but did not specify preferred labeling requirements. Congress has mandated that FDA publish a final rule on this matter by March 1, 2002. The Agency expects to issue a proposed rule to amend the irradiation regulations sometime during fiscal 2001. In the meantime, FDA is focusing on reviewing food additive petitions to approve the use of irradiation with various foods. This past November, FDA amended Part 179 of its food additive regulations to allow the use of ultraviolet irradiation to reduce human pathogens and other microorganisms in juice products. See 65 Fed. Reg. 71056 (November 29, 2000). The action was in response to a food additive petition filed by California Day-Fresh Foods, Inc. The consumer interest group Public Citizen immediately challenged the action, alleging that FDA continues to ignore data indicating that irradiated food products are not safe. As we have reported previously, Public Citizen is objecting every time FDA clears a new use of irradiation to treat food against pathogens. 8. FDA Released its Biotech Proposal The new FDA proposal for the 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. 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. 9. EC Scientific Committee on Food Issues New Guidance Document Regarding Applications for Safety Assessments The European Commission's (EC) Scientific Committee on Food has issued a new guidance document discussing the information needed in an application for a safety assessment for food-contact materials. The document, entitled "Guidelines of the Scientific Committee on Food for the Presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorization," replaces the existing Chapter II in the "Note for Guidance" document. The new guideline is substantially similar to the existing Chapter II, but differs in a few significant respects. First, because there was substantial overlap in information contained in the existing Chapters II and III (SCF-WG Explanatory Guidance of the SCF Guidelines for Food Contact materials), much of the information provided in Chapter III was removed from the new guideline. Thus, the new guidance document should be read and used in conjunction with Chapter III. Second, the new guidelines now indicate that, where 90-day oral toxicity studies are needed, they should be conducted on two species, while the previous version required 90-day studies to be conducted only on one species (an interesting development considering the European sensitivity to animal testing). The new guidelines also indicate that long-term toxicity/carcinogenicity studies should be conducted on two species (the previous version was silent on the number of species that should be tested when long term studies are required). Finally, the new guidelines make clear that toxicity data are not needed for petitions to clear direct food additives or food ingredients for use in food-contact applications. The new guideline document can be obtained from the EC's website at http://europa.eu.int/comm/food/fs/sc/scf/out82_en.pdf. The "Note for Guidance" document, which contains Chapter III, also can be accessed from the website at http://cpf.jrc.it/webpack/downloads/nguidance.pdf. In another SCF development, we understand that Dr. P. Tobback, a Belgian professor working in the Food and Microbiological Technology Department of the Belgian University of Leuven, and a member of the SCF since 1997, has succeeded Dr. Ada Knaap as Chairman of the Food Contact Working Group of the SCF. 10. EU Council Approves Resolution on Precautionary Principle; Sweden Opens EU Presidency with Threat to Extend Precautionary Principle to Chemical Industry Before the expiration of its EU presidency late last year, France managed to obtain European Council approval of the resolution on the precautionary principle. As you may recall from our previous letters, the principle holds that no new technology should be permitted in the marketplace without a full set of toxicology data and a complete assessment of all possible risks to humans and the environment. Sweden has now taken over presidency of the EU, and has promised to make environmental concerns high on its agenda; included in this is a plan to apply the precautionary principle to the chemical industry. Such a move by the Swiss is likely to be at odds with the U.S. and, specifically, with the new Bush Administration's anticipated policies on the environment. U.S. industry has argued consistently that the precautionary principle, without rigorous definition, will impose undue burdens on the development of new technologies. The EU resolution has been criticized as not being specific enough on issues such as the need for real scientific evidence of a risk to public health before invoking the principle. By way of background, the Presidency of the EU is a powerful office that rotates among the members, with each country taking six months in turn. The country holding the presidency sets the agenda and hosts all the main meetings among heads of government and the regular meetings among all the national ministers of labor, finance, transport, the environment, and other portfolios. Of the 80 ministerial-level meetings scheduled under the Swedish presidency, 44 are to be held in various locations around Sweden, many in remote and rural areas which recorded strong majorities against joining the EU in the national referendum six years ago. The Swedish focus on the chemical industry comes as no surprise, as it is linked with the current comprehensive review of EU chemicals policies (See the International Subcommittee's Report to the FDCPMC, dated December 2000). In April, 1998, the Council began reviewing EU legislation on the use of certain chemicals, and, while no legislative proposals have been provided thus far, there are some indications that the regulatory landscape in this area may be overhauled significantly. The Council is scheduled to issue a "White Paper" early this year which is expected to set forth a new EU policy on chemicals which fully reflects the precautionary principle, and specifies the obligations incumbent on manufacturers. We are monitoring this situation closely, and will continue to keep the Committee updated on events in this area. 11. EC Extends Ban on PVC Toys Containing Phthalates The EC has extended, for the fourth time, the ban on polyvinyl chloride (PVC) toys containing phthalates. You may recall from previous reports that the ban, initially adopted on December 7, 1999, requires the Member States to prohibit the marketing of toys and childcare articles intended to be placed in the mouth by children under three years of age, made of soft PVC containing one or more of the following phthalates: 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). As we have reported to you previously, 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 despite 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. The decision, which was due to expire at the end of November 2000, is now extended until the end of March, 2001. 12. EC Outlines New Policy for Eco-Friendly Manufactured Products The European Commission's environment directorate has submitted a draft green paper to the other directorates outlining a proposed EU policy to reduce the environmental burden of manufactured products. The paper could be adopted by the full Commission next month unless it meets serious opposition. The proposed policy urges the use of market instruments to internalize products' external environmental costs over their whole lifecycle. Among the possibilities suggested: differentiated taxation rates according to the product's environmental performance; deposit-refund schemes to encourage consumers to dispose of products properly; and, the introduction of producer responsibility for goods at the end of their lives. The proposal encourages the use of ecolabels, and goes so far as to say that their scope should be extended to cover as many products as possible. 13. European Union and Canada to Expand Irradiation Clearances 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. 14. Outcry Following StarLink™ Incident Renews Calls for Single Food Safety Agency In our December General Counsel's Report to the Committee, we discussed the recent accidental contamination of human food with StarLink™, a genetically modified corn product that was not approved for human consumption. The incident received a great deal of attention from the press and led to accusations that the government agencies responsible for regulating food products are inadequate. Continued fallout from the situation has renewed cries in Congress for the consolidation of federal food safety regulation into a single food safety agency. Members of Congress calling for such a move have stated that regulation of bioengineered food products would likely fall under the oversight of the United States Department of Agriculture (USDA). 15. GAO Reiterates Recommendation for a Single Food Agency As we have reported to you previously, the General Accounting Office (GAO) has been advocating the creation of a single food agency as a means to reduce the incidence of foodborne illness in the United States. In a mid-January report, GAO repeated its concerns over the fragmentation of the current food safety system and the need for a risk-based inspection system administered by a single agency. Although stopping short of directly supporting a single agency, former President Bill Clinton's Council on Food Safety issued a report on January 19, 2001, indicating that establishment of a single food safety authority would be disruptive in the short-term, but might be the most efficient long-term solution. As immediate steps, however, the Council recommended mandatory recall and civil monetary penalty authority for FDA and USDA, along with implementation of a food safety strategic plan, reducing the number of areas with overlapping jurisdiction, and generally strengthening existing laws. 16. Australia New Zealand Food Authority to Require Labeling of Genetically Modified Food Products In our December General Counsel's Report to the Committee, we discussed numerous international biotech regulations expected to be in place early this year, most of which will require the labeling of genetically modified food products. Now, the Australia New Zealand Food Authority (ANZFA) has joined the list of countries who have reacted to concerns about the biotech food supply by passing a new regulation, Standard A18, requiring the labeling of food products produced using gene technology. Beginning December 7, 2001, genetically modified food products being sold in Australia and New Zealand must bear a label including the statement "genetically modified" in conjunction with the name of the modified food, ingredient, or processing aid. Products subject to the requirement include food or ingredients containing new genetic material or protein as a result of the genetic modification, or having altered characteristics, such as a changed nutritional value, compared with non-modified food. The Standard specifically excludes the following foods from the requirement: highly refined food, where the effect of the refining process is to remove novel DNA and/or protein; processing aids and additives, except where novel DNA and/or proteins remain present in the food; flavorings present in the food in concentrations less than 1g/kg; and foods, ingredients, or processing aids in which genetically modified foods are unintentionally present in quantities below 10g/kg. As we have pointed out previously, although attention has not yet been focused on food-contact substances containing genetically modified products, the regulations demonstrate the general level of concern about exposure to GMOs, which could eventually spill over to the food packaging arena as well. Thus, the issue is one that industry should monitor closely. 17. EPA Announces Voluntary Children's Chemical Evaluation Program The EPA recently issued a formal announcement of a children's health initiative that may affect producers and users of certain food-contact substances. The Voluntary Children's Chemical Evaluation Program (VCCEP), which was announced in the December 26, 2000 Federal Register, is one of three programs established under the Chemical Right-to-Know Initiative announced by former Vice-President Al Gore on April 21, 1998. The VCCEP is intended to provide data to enable the public to understand the potential health risks to children associated with certain chemical exposures. As part of the VCCEP pilot, EPA is asking companies that manufacture and/or import any of 23 listed chemicals to volunteer to sponsor the evaluation of the chemical(s). Some of these chemicals, such as benzene and acetone, are used in the production of food-contact articles. More information on the program, as well as a complete list of the chemicals to be evaluated in the VCCEP pilot, can be found on EPA's website at http://www.epa.gov/opptintr/chemrtk/childhlt.htm. 18. USDA's Agricultural Marketing Service Finalizes Rule on Voluntary Certification of Meat and Poultry Processing Equipment As we reported to you in previous letters, following the elimination of the United States Department of Agriculture (USDA) program for approving equipment used in meat and poultry plants, and responding to concern expressed by industry regarding the need for a new program, Congress directed the Agricultural Marketing Service (AMS) of USDA to develop a voluntary certification program for processing equipment. On June 6, 2000, AMS published in the Federal Register a proposed rule to develop a voluntary user-fee funded program to inspect and certify equipment and utensils used in meat and poultry processing facilities. (65 Fed. Reg. 35857). The program is intended to provide third party assurance that the equipment meets minimum requirements for cleanability, suitability of materials used in construction, durability and inspectability. The final rule regarding this certification program was published in the Federal Register on January 5, 2001 (66 Fed. Reg. 1189). Based on a preliminary review, it does not appear that the final rule differs significantly from what was proposed last August. In particular, conformance with sanitary standards developed by NSF/3-A Joint Committee on Food Processing Equipment, including the already established Hygiene Requirements for the Design of Meat and Poultry Processing Equipment, remains the basis for certification under this program. 19. HCWH Report Alleges Plasticizers Pose a Serious Health Threat to Ill Infants The organization Health Care Without Harm (HCWH) released a report stating that plasticizers in PVC medical products pose significant health risks to premature or critically ill infants. HCWH claims that the plasticizer diethylhexyl phthalate (DEHP) leaches out of the medical products and exposes infants requiring intensive care to DEHP at levels up to three orders of magnitude higher than adult exposure levels. DEHP is added to plastic medical devices to impart needed flexibility and other attributes. HCWH chose to focus on critically ill infants because they believe that the infants experience higher exposures to DEHP and are more susceptible to reproductive tract damage. The report, entitled "Neonatal Exposure to DEHP [diethylhexyl phthalate] and Opportunities for Prevention in Europe," warns of possible adverse effects on infants' developing reproductive systems, and calls upon neonatal facilities to replace medical products containing PVC and DEHP with substitute materials. 20. Korea Passes New Packaging Regulations Korea's Ministry of Environment (MOE) has instituted a ban on the use of PVC shrink wrap due to environmental concerns. Beginning January 1, 2001, products except those specifically exempted from the ban are not permitted to be packaged in PVC shrink wrap. Five categories of products are exempt from the prohibition: petroleum products; pharmaceutical products; animal and vegetable oil; chemicals and pesticide; and products requiring freezing. The MOE exempted these products from the prohibition because of the functional difficulties associated with using alternative materials. * * * 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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