SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
August 1, 1997 Newsletter

* * * For Members Only * * *

Table of Contents

1. Senate FDA Reform Bill Left Pending as Congress Begins the August Recess

2. FDA Promulgates Final Rule Reducing Environmental Assessment Requirements for Certain Agency Submissions

3. Butadiene Evaluation May Finally Be a Priority at FDA

4. FDA Announces Availability of Draft Guidance on Submission of Documentation in Drug Applications for Container Closure Systems

5. Proposed Meeting with USDA and FDA to Discuss Regulation of Packaging Materials Used in Federally Inspected Meat and Poultry Facilities

6. Food Groups and Flavor and Extract Manufacturers Association Comment Favorably on FDA's Proposed GRAS Notification Procedure

7. Polystyrene Cups Not Likely to Require Warning Labels If Styrene Were to be Listed as a Reproductive Toxicant under California's Proposition 65

8. Endocrine Disruptor Advisory Group Proposes to Eliminate 30,000 Substances from Screening and Testing

In Brief . . .

* * *

To: The Society of the Plastics Industry, Inc.
    Food, Drug, and Cosmetic Packaging
    Materials Committee

Dear Ladies and Gentlemen:

     As Congress prepares for its annual August recess, the FDA reform bill sponsored by James Jeffords (R-VT), S.830, that contains the SPI-FDA agreed upon premarket notification (PMN) language for food-contact substances is in a holding pattern awaiting debate on the Senate floor. Although the majority of the issues over which Senate Democrats expressed concern apparently have been resolved, including the dissemination of information on the "off label" marketing of prescription drugs and third party reviews of FDA applications, Senator Edward Kennedy (D-MA) remains concerned about the national uniformity provisions in S.830 for non-prescription drugs and cosmetics and has, thus far, refused to agree to limit floor debate on the bill. Although the bill will not have been debated before Congress leaves on August first, we remain hopeful that the bill will brought to the floor shortly after the August recess, and that a companion bill that includes the PMN provisions for food-contact substances will be introduced at this time in the House of Representatives.

     On the late breaking news front, on Tuesday, July 29, FDA issued its final rule cutting way back on the situations in which Environmental Assessments need to be filed with Food Additive Petitions and requests for Threshold of Regulation determinations. The final rule can be viewed on the Government Printing Office's Federal Register Web site. While this means welcome relief from the need to file assessments in an even broader cross-section of FDA filings than originally proposed, thanks in large part to FDA's willingness to view the SPI comments filed in this proceeding in a favorable light, even more important is the fact that this action could break the biggest single logjam in the Office of Premarket Approval (OPA), i.e. the delays occasioned by the Environmental Staff's dalliance in reviewing the data, and usually asking for more information before making its almost always "Findings of No Significance Impact (FONSIs)."

     Another potential logjam breaker -- through not yet as definitive -- is a new set of statements made by FDA's Director of the Office of Premarket Approval's Division of Health Effects Evaluation, the highly respected Dr. David Hattan. As reported herein, Dr. Hattan has indicated the Agency is now giving high priority to making toxicological significance rulings on substances that are generally unwanted constituents of food-contact materials but that must be adjudged of no public health concern before a petition can be granted. He specifically cited 1,3-butadiene as a priority for evaluation, undoubtedly because at least five pending petitions have been held up for several years for a ruling that this monomer is highly unlikely to become component of food in any noteworthy amount as a result of its use in the manufacture of copolymers made with polybutadiene.

     In other areas of much interest, FDA recently announced the availability of a new draft guidance document on the submission of documentation in drug applications for container closure systems. Unfortunately, there are a number of serious ambiguities in FDA's current draft regarding the need to file food additive petitions and other potential concerns that may cause unnecessary confusion for companies supplying packaging materials to the drug industry. It is very important that you provide us with your comments on FDA's draft document since we believe the Drug Subcommittee will want to file public comments with the Agency. Also at FDA, the National Food Processors Association, the Grocery Manufacturers Association, the Flavor and Extract Manufacturers Association, and other groups have now filed comments supporting the Agency's proposed generally recognized as safe (GRAS) notification procedure. As did the comments we filed on behalf of SPI, these comments also expressed concern over the potential release of confidential information that could be included in the notifications.

     We are reporting on two other matters of interest to the Committee. The first is an evaluation our office conducted on behalf of the Styrene Information and Research Center (SIRC) in which we concluded that, were styrene to be listed as a reproductive toxicant under California's Proposition 65, which we emphasize is only a possibility at this point, potential exposure to styrene from its use in polystyrene foam cups likely would not require warning labels. The second is an ongoing discussion with the advisory committee convened by the Environmental Protection Agency (EPA) to advise the Agency on screening and testing substances for their potential endocrine modulating effects to eliminate 30,000 substances from review based on their relatively high molecular weight. Although the Committee has not unanimously endorsed this proposal, there is agreement that some cut-off based on molecular weight may be scientifically justified. These and other issues of interest are addressed below.

     Senate leaders had hoped to bring the FDA reform bill (S.830) that contains the SPI-FDA agreed-upon premarket notification (PMN) language for food-contact substances to a vote on the Senate floor on Monday, July 28. However, floor debate was postponed due in large part to lingering concerns by Senator Edward Kennedy (D-MA) and others regarding the national uniformity provisions in the bill that would preempt state regulation of over-the counter (OTC) drugs and cosmetics. Opponents of the national uniformity provisions believe they go too far in wiping out state regulations, especially for cosmetics. Reportedly, a compromise is in the making that would limit the national uniformity language in the bill to OTC drugs, thus allowing state regulation of cosmetics to remain in place. However, without consensus on the national uniformity issue, Senate leaders have not been able to reach an agreement with ranking minority members limiting floor discussion on the bill. Senator Trent Lott (R-MS), Senate Majority Leader, has made it clear that he will not bring the bill to the floor without a time agreement with so many other key issues to handle before the August recess, which is scheduled to begin Friday, August 1.

     Although consensus on the scope of the national uniformity provisions of S.830 remains to be reached, agreement on of the bill's other contentious issue, a proposed amendment to allow for the dissemination of information on "off-label" uses of prescription drugs, appears near at hand. Specifically, Senators Connie Mack (R-FLA) and Bill Frist (R-TN) have reached a tentative agreement with Senator Kennedy that would allow a pharmaceutical company to send research articles, study results, and other information to doctors on the efficacy of drug products for illnesses not sanctioned under the products FDA-approved new drug application. The latest compromise would allow a manufacturer to distribute this information provided it files with FDA a protocol, study plan, and time frame for a supplemental new drug application for the proposed off-label use. S.830's sponsor, Senator James Jeffords (R-VT), believes that an agreement can be reached on this and the national uniformity issue, and that the bill can be brought to the floor shortly after Congress returns September 2 from the August recess.

     In the House of Representatives, the House Commerce Committee also hopes to consider a bill similar to S.830 shortly after the August recess. However, Representative Joe Barton (R-TX) of the Commerce Committee has filed a number of questions with FDA regarding the Agency's possible misuse of funding under the Prescription Drug User Fee Act (PDUFA). Representative Barton's questioning and the fact that a companion bill to S.830 has not yet been introduced means that an FDA reform measure will not be passed out of the Committee until sometime in September or later. Nonetheless, we are unaware of any strong opposition in the House to FDA reform, and remain reasonably confident that a bill similar to S.830 will be introduced and passed after the August recess. A number of recent Washington Post articles and editorials provide a flavor of some of the contentious issues and driving forces behind S.830. If you are interested, these can be found by searching the "archives" link in the Washington Post's Web site for the phrase "Food and Drug Administration."

FDA Promulgates Final Rule Reducing Environmental Assessment Requirements for Certain Agency Submissions

     As you will recall, on April 3, 1996, the Food and Drug Administration( FDA) announced a proposed rule to more efficiently implement the National Environmental Policy Act (NEPA) by, among other things, decreasing the regulatory burden on industry with regard to filing environmental assessments (EAs) in conjunction with certain food additive petitions (FAPs), generally recognized as safe (GRAS) affirmation petitions, and Threshold of Regulation requests. (See our May 13, 1996 letter.) Of particular interest to the Committee, FDA had proposed to expand the classes of actions for which an EA is not required (known as "categorical exclusions") to include the following categories: (1) food additive petitions and Threshold of Regulation requests for functional components of food packaging present at no greater than 5 percent-by-weight of the finished packaging material, and (2) food additive petitions and Threshold of Regulation requests for components of the food-contact surface of permanent or semi-permanent equipment or other food-contact articles intended for repeated use. We filed comments on behalf of SPI endorsing these proposed categorical exclusions and urging the Agency to exclude EAs for actions on food additive petitions, Threshold of Regulation requests, and GRAS petitions for all components of food packaging materials, except where a specific finding is made that such an assessment is needed or worthwhile. (Our comments in this regard were filed prior to the Agency's proposal to replace the GRAS affirmation petition process with a more streamlined GRAS notification system.)

     We are pleased to report that, although FDA did not provide categorical exclusions for all actions involving packaging materials, the Agency did provide exclusions for the categories listed in the proposal, as well as several other categories the Agency did not originally consider. FDA's final rule, which incorporates most, but not all, of the changes advocated in the SPI comments, was published in the July 29 issue of the Federal Register (62 Fed. Reg. 40570 (July 29, 1997)). Agreeing, with the SPI view that categorical exclusions applicable to food additive petitions should also apply to GRAS petitions, FDA has categorically excluded GRAS affirmation petitions in all cases in which food additive petitions and Threshold of Regulation requests for food-contact materials are categorically excluded from the EA requirement. Also, in response to our comments, FDA has expanded the classes of categorical exclusions to include petitions and Threshold of Regulation requests for both functional and non-functional components of food packaging materials present at less than 5-percent of the finished package, provided the components remain with the finished package through use by consumers. FDA has further categorically excluded from the EA requirement petitions and Threshold of Regulation requests proposals relative to coatings of finished food packaging materials, even if they are present at greater than 5 percent by weight of the package. Finally, the final rule continues to exclude petitions and Threshold of Regulation requests for repeated-use food-contact articles from the need to file an EA.

     FDA declined to expand the categorical exclusions to include actions on all food packaging materials; in particular, FDA declined to categorically exclude from the EA requirement actions involving components present in a finished food package at greater than 5 percent by weight. Nonetheless, for actions in this category and for other actions that still require submission of an EA, the final rule does eliminate the need to include information on possible environmental effects at the site of manufacture. Instead, FDA states that the EA "shall focus on issues relating to the use and disposal from use of FDA-regulated articles." FDA plans to develop specific guidance for preparing EAs for those categories of petitions that still require EA preparation. This guidance will focus on the relevant issues surrounding the proposed action and will take into consideration the extent to which other laws and regulations adequately control potential environmental impacts.

     The final rule becomes effective on August 28, 1997; with respect to submissions pending before the Agency on August 28, 1997 for which the Agency has not issued a finding of no significant impact (FONSI) as required under NEPA, petitioners may submit an amendment claiming a categorical exclusion in accordance with this rule.

3. Butadiene Evaluation May Finally Be a Priority at FDA

     In a recent interview with Food Chemical News, David Hattan, Director of the Office of Premarket Approval's reorganized Division of Health Effects Evaluation (DHEE), stated that reviewing food additive petitions is now the top priority at DHEE. Hattan indicated that action on petitions will take priority over competing projects, such as completion of the Redbook II. In an effort to deal with the petition backlog, DHEE is focusing its attention on substances that are of potential concern in a number of pending petitions. In particular, Hattan identified 1,3-butadiene as a target for priority evaluation. Conclusions from the review of butadiene by CFSAN's Cancer Assessment Committee currently are holding up several pending petitions involving materials containing polymers made from this substance.

     Butadiene, which is cleared for use in a number of indirect food additive applications, has been the subject of recent studies concerning its potential carcinogenicity. EPA is working on a second round of butadiene risk assessments, and FDA is reportedly nearly through with a review of toxicological data in preparation for a safety evaluation of the substance which can be present in tiny amounts as a constituent in food-contact polymers or copolymers. At the same time, SPI is planning to provide FDA with data on the potential exposure to butadiene from food packaging, which the Butadiene Task Group has collected at FDA's request. SPI used the data, which is based on surveys submitted to known manufacturers, to calculate a "worst case" exposure to butadiene from its use in food-contact applications. Hopefully, once FDA has reviewed the SPI exposure data and has conducted a safety assessment for the substance, the Agency will be able to complete action on the food additive petitions for materials that involve butadiene-based polymers that are currently pending.

4. FDA Announces Availability of Draft Guidance on Submission of Documentation in Drug Applications for Container Closure Systems

     FDA has just announced the availability of a draft guidance document entitled, "Guidance for Industry: Submission of Documentation in Drug Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics" (see 62 Fed. Reg. 37925 (July 15, 1997)). This guidance, when completed, will supersede FDA's February, 1987 "Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics." It does not supersede the SPI Compliance Assistance Program Manual entitled, "Drug Master File: Plastics Packaging for Drug Products" although the Drug Subcommittee is now working on a revision that should be circulated soon.

     The draft guidance document sets forth the Agency's version of the types of information on container/closure systems that should be included in drug applications for different categories of drugs, including inhalation drug products, drug products for injection, liquid-based oral and topical drug products, solid oral dosage forms, etc. It also discusses notification and testing responsibilities that arise as a result of changes to container/closure systems after a drug application has been approved. Unfortunately, in our opinion, this document contains many internal inconsistencies and "overkill" statements that could create additional hurdles for packaging materials suppliers to overcome in establishing that their products are suitable for use in drug packaging applications. A few of our concerns in this regard are discussed below.

     First, FDA opines in some parts of the document that substances used to produce components of drug packaging materials must be the subject of an indirect food additive regulation (see Guidance Document at page 39); in other parts of the document, FDA properly states that this is merely a recommendation. In citing the need for food additive clearances for drug packaging components, FDA seems to be indicating that a food additive clearance for a packaging component is evidence that the component is safe for use in drug packaging applications -- even in the case of topically applied drug products. Indeed, FDA even directs drug packaging suppliers to cite an "applicable" food additive regulation to help establish safety. The implication that clearance under the food additive regulations is a "requirement" for drug packaging components is simply in error. The food additive regulations are not intended to apply to drug packaging materials and have never been a requirement for drug packaging materials use in the past. While a food additive clearance for a material may provide a measure of comfort that the substance has been reviewed by FDA and found to be safe for use in applications involving potential dietary exposure, for applications involving different routes of exposure, such as topical exposure, a safety determination made in the context of a food additive petition may be of little or no relevance. Furthermore, the level of exposure to a material resulting from its use in a drug packaging applications is likely to be markedly different than the exposure resulting from a food packaging use. Thus, it is inappropriate to imply that there is a necessity for a safety evaluation based on the potential exposure from use in food packaging applications for a drug packaging material.

     Moreover, many materials permitted for use in food packaging applications are not the subjects of food additive regulations clearing the intended use; rather, many food packaging components are permitted for their intended uses on the basis of "no migration," generally recognized as safe (GRAS) determinations, or are exempted from the need for a food additive regulation under the "Threshold of Regulation" rule. Consequently, requiring that all drug packaging materials be the subject of an explicit food additive regulation, in effect, places more stringent regulatory requirements on drug packaging materials than on food packaging materials.

     Another point of concern is FDA's statement that, "[s]ince it is assumed that virgin polymers and resins will be used in the manufacturing of drug product packaging components, any processes that involve regrind materials should be explicitly identified." (see Guidance Document at page 17.) As many of you know, the Drug Packaging Subcommittee of the Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) assisted FDA in completing a study comparing the properties of high density polyethylene (HDPE) containers made using virgin materials with HDPE made using regrind for use in packaging solid oral dosage forms. The results of the studies showed that all of the containers tested passed the requirements of the Unites States Pharmacopeia (USP) for HDPE containers used to package dry drugs, whether the containers were produced using regrind or virgin resin. Therefore, we believe it is not necessary to differentiate between HDPE resin (or probably any others) produced using virgin materials and HDPE resin produced using regrind.

     Also of concern is the way in which the draft guidance document discusses the notification requirements that arise as a result of a change made to a packaging material for a drug that is the subject of an approved application. In some parts of the document, FDA implies that a Supplemental New Drug Application (SNDA) is required if any change to a container/closure system (either within the same container type or to another container type) is made. FDA does make clear in other parts of its document that changes within a container/closure system that are shown to be equivalent to the previous system based on an approved protocol or specifications in an official compendium (such as USP) require only notification to FDA in a drug company's annual report. However, by implying in some parts of the Guidance Document that a company must file a SNDA prior to making any change in the formulation of a drug packaging component, without making it explicitly clear that this requirement does not always apply, FDA is further complicating the already difficult situation that resin suppliers face when trying to convince customers that minor formulation changes that result in an equivalent resin do not require new stability studies and a SNDA.

     Written comments on the draft Guidance Document may be submitted to FDA by September 15, 1997. In this regard, input on the concerns noted above or other issues of concern regarding the draft Guidance Document are solicited.

5. Proposed Meeting with USDA and FDA to Discuss Regulation of Packaging Materials Used in Federally Inspected Meat and Poultry Facilities

     Following up on reports in our May 12 and July 16, 1997 letters, we are now working toward setting up a meeting with officials from the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) to discuss the problems presented by USDA's policy of not accepting manufacturers' self-determinations of the FDA status of their products that are used in federally inspected meat and poultry facilities. As we have previously informed you, USDA, when evaluating supplier assurance letters during routine audits of federally inspected facilities, is not accepting self-determinations by packaging manufacturers that their products comply with FDA requirements on the basis that components may be considered generally recognized as safe (GRAS) for the intended use or on the basis that components are not reasonably expected to become components of food. Rather, if a particular component of a packaging material is not explicitly listed in an applicable food additive regulation or prior sanctioned, or is not the subject of a specific GRAS determination or "Threshold of Regulation" letter issued by FDA, USDA is requiring companies to obtain official concurrence from FDA of the acceptability of the material for the intended use. This policy, in effect, forces companies to file with FDA requests for a Threshold of Regulation exemption or, possibly, GRAS notifications even in situations in which such filings are not required by FDA.

     To further complicate matters, because USDA is requesting information regarding all of the details of a packaging product's composition, some companies have provided USDA with information on solvents, catalysts, and other production aids that are used in the production of a resin and that are considered part of the basic resin. Because these types of materials are not normally subject to independent regulatory consideration by FDA and, thus, typically are not listed in the food additive regulations, USDA has insisted that these companies obtain FDA concurrence of their suitability for use in producing food packaging materials. As many of you know, FDA's basic current policy is not to issue "no-objection" letters even for catalysts or solvents, and instead require companies to file Threshold of Regulation requests, which can make the data about the use of reaction control agents -- usually closely guarded trade secrets -- publicly available. Therefore, USDA's current policies -- in addition to adding a serious nuisance factor -- raise serious concerns with respect to public disclosure of trade secret information.

     We have now spoken with USDA's John Damare regarding the need to resolve this situation, and also with Dr. Alan Rulis, the Director of FDA's Office of Premarket Approval. Mr. Damare has indicated that he hopes FDA will prepare for USDA a list of "categories" of substances for which specific FDA concurrence letters should not be needed. Mr. Damare further informed us that he is meeting with Dr. George Pauli of FDA's Center for Food Safety and Applied Nutrition (CFSAN) to discuss additional ways of resolving this problem. Dr. Rulis, too, is taking this matter under advisement and has promised to get back to us on it. We believe it would be useful to meet with the Agencies in the near future to provide industry input on the list of categories to be provided to USDA and on other potential approaches to resolving this matter. In the meantime, we are preparing a list of the types of materials we believe should be included among the categories of excluded substances.

6. Food Groups and Flavor and Extract Manufacturers Association Comment Favorably on FDA's Proposed GRAS Notification Procedure

     The National Food Processors Association (NFPA), the Grocery Manufacturers Association (GMA), and other food groups, as well as the Flavor and Extract Manufacturers Association (FEMA), have filed comments supporting FDA's proposed generally recognized as safe (GRAS) notification procedure. The proposal would establish a voluntary notification procedure for substances claimed to be GRAS, and would offer a simpler and potentially faster alternative for obtaining FDA's recognition that a substance is GRAS than does the lengthy GRAS petition process. (See our May 12, 1997 letter for a detailed discussion of FDA's GRAS proposal).

     In addition to supporting FDA's proposal, NFPA and the American Dairy Products Institute (ADPI) commented that the Agency should respond in writing to GRAS notifications within a 90-day proposed time frame. ADPI also commented that the Agency's response should indicate to some degree that FDA has accepted the GRAS status of the substance. According to these groups, responses from FDA will serve as a important tools in marketing GRAS products. On the other side, GMA and the American Bakers Association commented that FDA should respond in writing only when notifiers request it. These groups point out that any response from FDA within the short 90-day time frame will probably not provide a useful marketing tool because it will likely indicate only that the proper GRAS notification procedures were followed, and will not likely provide clear concurrence in the notifier's GRAS determination.

     The comments by NFPA and GMA also indicate a concern that we noted in the comments we filed on behalf of SPI regarding the potential release of confidential or trade secret information. In the proposal, FDA states that all information submitted in a notification will become publicly available, and cautions notifiers not to submit information they consider confidential. The problem with this procedure is that notifications are expected to contain information on manufacturing methods and levels of intended use, information that may be considered confidential. As with other filings such as food additive petitions and Threshold of Regulation requests, FDA has a responsibility to protect such information from public disclosure.

     NFPA, also noted in its comments that it does not expect the number of GRAS notifications that are filed with the Agency to be significantly higher than the number of current GRAS affirmation petitions. Although we can only speculate, it would appear to us that the number of notifications may be quite a bit higher than the number of petitions if manufacturers of food packaging materials and other sectors of the food industry not involved in direct food additives decide to use the notification procedure. For example, FEMA's comments supporting the GRAS proposal indicate that the food flavor industry could benefit from the new procedure. The majority of new flavor substances, over 1800 in all, have been marketed pursuant to a FEMA determination that the substance is GRAS. Manufacturers of new flavors may use FDA's GRAS notification procedure in lieu of, or in addition to, a FEMA GRAS determination, greatly increasing the number of notifications FDA would receive. We are particularly interested in FDA's development of procedures for processing notifications for GRAS notifications on food-contact substances, as they may provide precedents and clues as to the Agency's approach to establishing procedures for the premarket notification provisions in the pending FDA reform bill, S.830, discussed above.

7. Polystyrene Cups Not Likely to Require Warning Labels If Styrene Were to be Listed as a Reproductive Toxicant under California's Proposition 65

     California's Environmental Protection Agency (Cal EPA) is currently evaluating the possible listing of styrene, among other substances, as a reproductive toxicant under the state's Safe Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. For substances listed as reproductive toxicants, Cal EPA establishes permissible daily exposure limits; products resulting in exposures to listed substances above these limits must bear warning labels regarding the potential hazards of the exposures. Even though it is not certain that styrene will be listed under Proposition 65, and Cal EPA has not established a permissible daily exposure limit for styrene, SPI's Styrene Information and Research Center (SIRC) recently requested that we evaluate whether polystyrene cups would likely require warning labels if Cal EPA to list styrene as a reproductive toxicant. As discussed below, we concluded that these cups likely would not require such warnings.

     We were assisted in our evaluation by Dr. George Cruzan, SIRC's scientific consultant. Specifically, Dr. Cruzan reviewed the toxicology information on styrene to determine a no observable effect level (NOEL) from which we could calculate a permissible daily exposure limit following the same methods that Cal EPA would employ. Although Dr. Cruzan determined that a NOEL for human effects would be difficult to identify based on the available toxicology information, he suggested that 100 mg/kg/day NOEL for mice could be used as a "worst-case" figure for calculating a Proposition 65 permissible daily exposure limit. Applying a thousand fold safety factor to this value (as Cal EPA would do) yields a permissible exposure limit of 0.1 mg/kg/day for mice, or 7 mg/kg/day for humans. To determine potential exposure to styrene from polystyrene cups, we relied on data developed over the past 15 years by FDA, the United Kingdom's Ministry of Agriculture, Fisheries and Food, and, as many of you know through your participation, by the FDCPMC itself. These data show estimated daily intake (EDI) values for food-contact materials composed of styrene polymers (including polystyrene cups) ranging from approximately 0.6 ug/day to 5 ug/day. Even the highest exposure value, 5 ug/day (or 0.005 ug/day) is orders of magnitude below the 7 mg/kg/day possible "worst-case" permissible daily exposure limit that we concluded Cal EPA could establish. Therefore, Proposition 65 warning labels would not be required for these products

     The priority setting workgroup of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which was created by the Environmental Protection Agency (EPA) under the recently-enacted Food Quality Protection Act (FQPA) and Safe Drinking Water Act to advise the Agency in establishing screening and testing procedures for potential endocrine disrupting chemicals, has advanced a plan to eliminate approximately 30,000 substances from its review. Specifically, the EDSTAC committee proposed to eliminate substances with a molecular weight greater than 1000 Daltons because such substances are too big to pass through the gills of aquatic animals or the intestines of terrestrial animals, the most critical pathways for exposure. Not all members of the full EDSTAC group, however, concurred with the recommendation. During a July 15-16, 1997 meeting in Chicago, EDSTAC opponents claimed that substances with molecular weights greater than 1000 Daltons could become bioavailable through other pathways, and that children's intestines might be able to absorb larger molecules than those of adults. Despite disagreement over the 1000 Daltons molecular weight cut-off, the EDSTAC members did all agree that eliminating some subset of chemicals is a scientifically sound principle that should be explored.

     On a related topic, in the July 25, 1997 issue of Science, Dr. John McLachlan of the Tulane-Xavier Center for Bioenvironmental Research withdrew a report originally published in the June 7, 1996 issue of Science on the possible synergistic effects of estrogenic chemicals. The original report suggested that some alleged endocrine modulating substances could act synergistically, thereby creating toxicological effects more significant than the effects of such substances acting alone. Dr. McLachlan withdrew the original work after a number of other laboratories, including the Chemical Industry Institute of Technology, Duke University Medical School, the National Institute of Environmental Health Sciences, Texas A&M University, and Zeneca Central Toxicology Laboratory in the United Kingdom, could not reproduce the findings originally reported.

In Brief . . .

• Michael Friedman May be Front Runner for FDA Commissioner
  

     Dr. Michael Friedman, who was appointed FDA's Lead Deputy Commissioner after Dr. David Kessler resigned as the Agency's Commissioner this February, is rumored to be President Clinton's front runner for the now-vacant Commissioner's position. Other names reportedly on the "short list" of candidates include Dr. Janet Woodcock, chief of FDA's Center for Drug Evaluation and Research, Dr. Jane Henney, Vice President of Health Sciences at the University of New Mexico and former FDA Director of Operations, and Dr. Eve Slater, Senior Vice President of Clinical and Regulatory Development at Merck Company. In addition to being appointed by the President, the FDA Commissioner must be approved by the Senate. By all accounts, an appointment and confirmation hearings are not likely to take place soon.

• FDA Inspectors Accused of Bribery
  

     A 10-month undercover U.S. Customs investigation has culminated in the indictment of at least two West Coast FDA inspectors and two Customs brokers on bribery charges. The inspectors allegedly took bribes for allowing importers to bypass health and safety inspections of Asian seafood, herbs, and delicacies that were unsafe, filthy, or produced under unsanitary conditions. USDA, FDA, and the Internal Revenue Service cooperated in the investigation.

Cordially yours,

Jerome H. Heckman

August 1, 1997
(202) 434-4110
heckman@khlaw.com

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