General Counsel's Report To The Society of The Plastics Industry, Inc.'s Food, Drug, and Comestics Packaging Materials Committee

June 17-18, 1998
Jerome H. Heckman
Ralph A. Simmons

INTRODUCTION

Ladies and Gentlemen:

We are pleased to present this report on the status of matters in which we have been involved or which we have monitored on behalf of The Society of the Plastics Industry, Inc.'s (SPI's) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) since the December, 1997 meeting of the Committee.

TABLE OF CONTENTS

1. Legislative Activities
   1. Efforts Continue to Ensure that the Necessary Funding to Implement the Food-Contact Notification Program is Appropriated
   2. Legislation to Protect Biomaterials Suppliers Makes Slow Progress
   3. Single Food Agency Idea Still Being Debated
   4. Pallone FDA Enforcement Bill

2. Food and Drug Administration Activities
   1. CFSAN to Hold Public Meeting to Solicit Comments on the Priority of the Center's Programs
   2. Proposed Regulations for the Food-Contact Notification Program Submitted to FDA
   3. Update on the Continuing Issue of Potential Endocrine Disruptors
   4. Consortium Forming to Obtain Broader Clearance for Packaging Used to Hold Foods During Irradiation
   5. FDA Developing Guidelines for Testing Recycled Paper for Food-Contact Applications
   6. FDA Publishes Guidance on Making Non-Controversial Rules Final Immediately
   7. FDA Suggests New Claims for Latex Gloves

3. Activities of Other Federal Agencies
   1. EPA and FDA Close to Legislative Fix for Jurisdictional Dilemma Over Antimicrobials
   2. EPA Transfers Jurisdiction of Food Packaging Impregnated with Insect Repellents to FDA
   3. Working Group Established to Respond to Concerns Over USDA's Audit Procedures
   4. FSIS Announces Intent to Eliminate Prior Approval Requirement for All Non-Food Compounds

4. Update on International Issues
   1. Germany's BgVV Announces Elimination of Outdated Recommendation XL
   2. Prospective EU Ban on "Specified Risk Materials" Postponed Again
   3. The European Commission Releases Third Draft of the Fifth Amendment to the "Monomers Directive;" New Criticism Is Voiced
   4. Report on the Status of Food Packaging Issues at the Codex Alimentarius Commission
   5. A New Belgian Decree on Food-Contact Materials Goes Beyond Adopted EU Directives
   6. The United Kingdom Also Adopts EU Food-Contact Directives
   7. Korea Proposes New Packaging Standards
   8. The European Commission Sues Several Member States for Failure to Implement the EU Packaging and Packaging Waste Directive

In our December 1997 report to the Committee, we discussed the notification program for food-contact substances that was enacted as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA).¹ Section 309 (P.L. No. 105-115).² We had worked to change the law to permit such a notification program for many years, and we are looking anxiously forward to obtaining the full benefit for food packaging industry of this new faster and simpler system of clearing food-contact materials.

We also informed you in our December 1997 report of an unfortunate compromise that had to be made in order to assure the food-contact notification (FCN) program's passage. As you know, from the outset the industry was willing to pay user fees to fund the notification program, but because of certain political interests in Congress the new law requires the program to be funded from the Food and Drug Administration's (FDA's) budget. In February, the President submitted his version of the federal budget to Congress, and, although FDA had requested that the Administration include funding for the notification program, no such money was specifically included. Therefore, over the last few months we have returned to Capitol Hill to urge that Congress budget the $1.5 million identified in FDAMA as the minimum amount needed to implement the FCN program.

Although an argument can be made that FDA would still be required to commence the program even if Congress did not include these funds in FDA's budget,³ we have recently learned that FDA is taking the position that it has no legal obligation to implement the notification system unless funds are provided in the form of user fees that have been requested generally for FDA by the Administration or in FDA's budget appropriation. The Administration has directed FDA's Center for Food Safety and Applied Nutrition (CFSAN) to focus on the President's Food Safety Initiative (FSI), but it appears that full funding may not even be appropriated for this program. Faced with a budget that already does not cover all of its responsibilities, FDA officials will be extremely reluctant to implement the food-contact notification system without additional funds. The lack of funding will buttress the arguments of some within the Agency who already want to severely limit the application of the program, making it the exception rather than the rule for FDA clearance of food-contact substances.

Over the last few months, our work to obtain funding for this program has involved extensive effort from the SPI government affairs staff and a number of SPI member companies, as well as support from the Can Manufacturers Institute, the American Forest and Paper Association, and the Flexible Packaging Association. In addition, we are hoping that the Adhesives Manufacturers Association also will become involved in urging Congress to fund the program. Representatives from these groups have met with the members and staff of the two Subcommittees with jurisdiction over FDA's budget - the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and the Senate Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies.

With the help of this Washington representatives group, we were successful in encouraging Representatives Tom Bliley (R-VA) and Bart Stupak (D-MI), members of the House/Senate Conference Committee that recommended passage of the food-contact notification legislation, to send a letter to the members of the House Appropriations Committee urging support of funding for this program. A similar letter from Senator Kennedy, who also was on the Conference Committee, was sent to the members of the Senate Appropriations Subcommittee. In addition, our group persuaded Subcommittee members to submit questions to FDA at both the House and Senate Subcommittee hearings on FDA's budget to help build a record on the need for funding the program, and we have stimulated interest in both these Subcommittees to put language in their respective budget reports that would direct FDA to use $1.5 million of its budget for the notification program.

The House and Senate Subcommittees are scheduled to make their decisions on FDA's 1999 budget during the week of June 8. Accordingly, we are urging FDCPMC members to contact their Congressman and show their support for funding the notification program.

On April 1, 1998, the House Judiciary Committee reported out H.R. 872, which would shield suppliers of raw materials from liability in cases involving defective medical devices. Suppliers may be dismissed from lawsuits if the material they provide meets the specifications agreed upon with their customers. The bill allows suppliers to be brought back into liability cases if the evidence indicates that the supplier actually did something wrong.

There continues to be interest in creating a new single federal agency that would combine the regulation of food safety issues into one organization. Advocates of the proposal maintain that a single food agency would reduce regulatory duplication and allow for better regulatory monitoring and control. Critics suggest, however, that creating a new agency would produce regulatory confusion; what is needed, these opponents contend, is an increase in cooperation and communication between the existing agencies with responsibility for food safety, not the creation of a whole new system.

To evaluate the benefits and drawbacks of creating a single food agency, Congress recently directed the National Academy of Sciences (NAS) to perform a study on the issue. As part of this study, Jerry Heckman was recently invited to speak at NAS on behalf of SPI regarding how the creation of a single food safety agency would affect the food packaging industry. Mr. Heckman mentioned that, over the years, the food packaging industry has been subjected to an undue burden as a result of the regulatory overlap among FDA, USDA, and the Bureau of Alcohol, Tobacco, and Firearms (BATF). Without taking a position on the merits of a single food agency, Mr. Heckman added that better communication and harmonization among the agencies would be a significant step in the right direction, especially in light of the prospective implementation of the new food-contact notification system. In addition, Mr. Heckman discussed the FCN program and stated his hope that agencies other than FDA, which have regulatory authority over food packaging, will be able to understand the new system. Mr. Heckman concluded by saying that it is important to preserve the FCN system and ensure that regulatory agencies understand how the system operates, regardless of what happens to the single food agency idea in the end.

On April 1, Rep. Frank Pallone (D-NJ) introduced the Consumer Food Safety Act of 1998 (H.R. 3676). The bill would enhance FDA's enforcement authority over both domestic and imported foods by requiring product registration, granting FDA mandatory recall and civil monetary penalty authority coupled with whistle blower protection, and increasing the number of inspections.

At last count, Pallone had gathered 29 co-sponsors in the House to support H.R. 3676; however, passage during this session of Congress seems unlikely at this time. The bill has growing popularity within the Democrat ranks, but the Republican leadership is unlikely to allow such controversial legislation to be considered before the election in November. Moreover, even though FDA has embraced and encouraged the food safety debate on Capitol Hill sparked by the introduction of H.R. 3676, the agency has distanced itself from the bill because of fears about the availability of resources to carry out additional responsibilities.

In a very recent and somewhat unusual development, the Center for Food Safety and Nutrition (CFSAN) published a notice in the June 3, 1998 Federal Register that a public meeting will be held on June 24-25, 1998 to solicit comments on what should be the Center's priorities in the coming year for the programs it administers. The Clinton Administration has dictated that the Food Safety Initiative will be the Center's first and foremost priority, but the Center is willing to accept comment on what areas it will focus its remaining resources. This is an unusual step by the Center, and shows the commitment of the new director to being more responsive to the Center's constituency. We believe the meeting presents a very good opportunity for us to reinforce our message that the Agency should give priority to promulgating regulations that will implement the new Food-Contact Notification program. Unless we receive comments from you suggesting another course of action, we intend, on behalf of the FDCPMC, to submit written comments advocating this position and also will make an oral presentation at the public meeting

With valuable input from many members of the Committee, we drafted and have now submitted to FDA our proposed regulations to implement the new food-contact notification system discussed above. Our aim is to encourage the adoption of a process that is as streamlined as possible, while still providing the Agency with sufficient information to determine the safety of the proposed food-contact substance. For example, we do not propose in our draft regulations that FDA reduce the amount of toxicology currently required to clear a substance. We have attempted, however, to more carefully delineate the toxicity data that is required for a given level of dietary exposure. In addition, our draft leaves open the possibility that the safety of a substance may be established by less than the full data set prescribed for the typical case.

Similarly, we have attempted to exclude FCNs from the requirements of filing an environmental assessment (EA). As many of you know, the EA can be the most time-consuming and troublesome aspect of any submission to the Agency.

Our proposed regulations also would allow a notifying party to claim confidentiality for the requested use level, the identity of the materials in which the food-contact substance will be incorporated, and the food types and temperatures of use of the food-contact substance. While this information still will be provided in the submission, we propose exempting this information from public disclosure. In the past, the Agency has required disclosure of this information when promulgating regulations in response to food additive petitions, or in exempting substances from the need for a food additive regulation under the Threshold of Regulation process. The Agency required disclosure due in part to the policy of allowing others to rely on the clearances granted by the regulation or exemption from regulation. In light of the proprietary nature of a food-contact notification, however, it seems to us that it will no longer be appropriate for the public to have access to this information.

We also have attempted to delineate the grounds upon which the Agency may object to a notification. Lack of time to review the submitted data would not be a valid ground for objection, nor would a request for additional data, provided at least the threshold level of properly developed data is submitted with the FCN. The only valid basis for objection is a determination that the food-contact substance has not been shown to be safe for the proposed use.

We trust that our draft will provide useful input to FDA as the Agency develops proposed regulations to implement the FCN system. The funding we discussed above is crucial for FDA's development of these regulations, among other steps needed to bring the notification into actual operation.

After 4 years, concerns regarding the effects of so-called "endocrine disruptors" are still surfacing both in the United States, Europe, and particularly of late in Japan. Endocrine disruptors are chemicals believed to cause effects on the endocrine systems of humans or wildlife, and are hypothesized to cause cancer or harm to the reproductive system or thyroid.⁴ In the next month, an EPA advisory panel is expected to finalize its recommendations for a screening and testing program that will assess the estrogenic, androgenic, and thyroid hormone effects of tens of thousands of chemicals. The recommendation may have a significant effect on many industries in the United States and abroad, including the food packaging industry.

In 1994, some scientific studies came to light which suggested that certain chemicals, some of which are used in the production of plastics, may act as environmental estrogen disruptors, or estrogen mimics, which could contribute to male infertility and/or other male reproductive disorders. The studies suggested that estrogen-like substances may activate female hormones in men, resulting in reproductive birth defects or an emasculation in affected males. The FDCPMC formed a group of members and interested non-members to investigate the possible connection between endocrine disruptors and food packaging materials to ensure that these materials could continue to be used in a safe manner.

The group formed by the Committee eventually became a self-funded entity known as the Inter-Industry Group (IIG) on Bisphenol A (BPA) and Alkylphenols. The IIG includes seven trade associations and over 43 companies, including epoxy resin formulators and suppliers, polycarbonate manufacturers, plastic films producers, can manufacturers, food companies, and other interested plastics manufacturers. A segment of the IIG, known as the Epoxy Can Enamels Work Group, surveyed the use of bisphenol A in food and beverage cans and conducted extraction tests to determine the possible dietary exposure to can coatings that contain BPA. Another segment of the IIG, the Polycarbonate Work Group, collected information on the potential migration of BPA from polycarbonate. A third group began work on the issue of exposure to alkylphenols. This Alkylphenols (AP) Work Group had a difficult task as alkylphenols are used in a wide range of material for a number of various food contact applications. The first task of the AP Work Group was to refine the list of alkylphenols that would be studied. Alkylphenols, including nonylphenol, are not used directly as components of plastics; rather, derivatives of alkylphenols, such as tris(nonylphenyl)phosphite (TNPP) and ethoxylated nonylphenols (NPEs) are employed.⁶

The results of the studies performed by the Epoxy Can Enamels Work Group and the Polycarbonate Work Group showed minimal exposure to BPA from its use in food-contact applications. The Can Enamel Work Group studies showed a maximum potential dietary concentration of bisphenol A from its use in cans of 2.1 ppb. Reports of these studies were provided to FDA and the National Academy of Science/ National Research Council's (NAS/NRC's) Committee on Hormone-Related Toxicants in the Environment. In addition, two papers describing the can enamel studies have been published in the Journal of Coatings Technology.⁷ The studies conducted by the Polycarbonate Work Group showed no detectable migration of bisphenol A in any of the food simulants, using analytical methodology with a limit of detection of 5 parts per billion (ppb). Using these data, the group determined the potential dietary concentration of BPA from its use in polycarbonate food-contact materials to be less than 0.25 ppb. Reports of these studies also were provided to FDA and the NAS/NRC Committee. In addition, a paper describing these findings has been published in Food Additives and Contaminants.⁸

The Alkyl Phenol (AP) Task Group is composed of companies that produce TNPP and/or NPE, or incorporate these substances in their resins or other packaging materials. The AP Task Group identified the principal packaging applications that incorporate these materials, and developed analytical methodology to determine the potential migration of nonylphenol as well as TNPP from food packaging materials. Extraction studies were performed, and the results, combined with use information, were used to develop a dietary exposure estimate for nonylphenol of 19 ppb. A report of this work was provided to FDA in April 1998. With regard to potential exposure to NPE and to nonylphenol from the use of NPE, the Task Group elected a different approach. In this case, the Group performed worst-case calculations based on an assumption of 100% migration to the contacted food, along with NPE use information, to develop an estimate of maximum potential exposure to NPE and nonylphenol of 504 ppb and 0.89 ppb, respectively. A report of this work also was provided to FDA.

In 1996, attention was again drawn by the press to the endocrine disruptor issue as a result of the publication of Our Stolen Future written by Theo Colburn, Dianne Dumanoski, and John Peterson Myers which raised questions about the endocrine effects of a number of chemicals including BPA. though the book did not create the firestorm originally feared and the credibility of its scientific conclusions has been called into question, the book still served to increase public attention to this issue and was one of the major reasons for Congress including provisions dealing with endocrine disruptors in legislation that was passed later that year.

The publication of Our Stolen Future led to concerns over the possible endocrine effects of styrene as well. Although the book was not specific in identifying the styrenic substances of concern, it was believed that these allegations were directed at styrene dimers and trimers. To address these concerns, the FDCPMC Polystyrene Task Group decided to study the potential estrogen effect of polystyrene extracts that simulate the most severe anticipated use of polystyrene in food-contact applications. The Group also began discussions with the Styrene Screening Committee of CEFIC (Conceil Europen des Confederation de l'Industries Chimique), the European trade association of the chemical industry, which also was undertaking a similar testing program. The Group conducted both in vivo and in vitro tests for estrogenic effects from styrene extracts under exaggerated conditions and no response was shown. The Group intends to publish these results in a scientific journal in the near future. Currently, the Group is working with the Japanese Styrene Industry Association and the Ministry of Health and Welfare in Japan to assist them in planning their own studies.

In August of 1996, Congress passed the Food Quality Protection Act (FQPA) and the Safe Drinking Water Amendments (SDWA). Both of these statutes require EPA to develop a screening program to evaluate the estrogenic effects of pesticides and, at its option, evaluate nonpesticidal substances as well, if those substances have a cumulative (e.g., synergistic) effect with pesticides. FQPA required EPA to develop a program using appropriately validated tests to determine whether certain substances may have an effect in humans similar to the effect produced by a naturally occurring estrogen or other endocrine effects as the Administrator may designate. If a substance is found to have an endocrine effect on humans, EPA is required to take appropriate action as necessary to protect public health. EPA must report to Congress on the findings of the screening program in August 2000.

To assist the Agency with implementing the endocrine screening requirements of FQPA and the SDWA, EPA empaneled an advisory committee, known as the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), to develop a conceptual framework and strategy for the program. EDSTAC is composed of 45 members from a number of different stakeholder groups. In addition, EDSTAC is composed of four working groups which have additional members to address specific tasks. EDSTAC will finalize its report to EPA in June. This report will be submitted to the Agency's Scientific Advisory Board and the FIFRA Science Advisory Panel who will provide their comments to EPA.

On April 3, 1998, EDSTAC issued a draft of its report. A full discussion of the draft report, including detailed information regarding the prioritization scheme and the types of screening and testing recommended by EDSTAC is discussed in Dr. Lester Borodinsky's Technical Advisors report for this meeting of the FDCPMC. Among other issues, the EDSTAC report sets forth a conceptual framework for the program and a priority schedule for testing specific chemicals or classes of chemicals, and identifies the types of testing that EDSTAC recommends. In the draft report, EDSTAC defines an endocrine disruptor as "an exogenous chemical substance or mixture that alters the structure or function(s) of the endocrine system and causes adverse effects - at the level of the organism, its progeny, populations, or subpopulations of organisms - based on scientific principles, data, weight-of-evidence, and the precautionary principle." Chemicals will be tested for estrogenic, androgenic, and thyroid receptor effects. EDSTAC recommends that EPA adopt a process involving priority setting for which chemicals should be tested first, followed by screening to determine which chemicals may have endocrine effects, and then testing to establish the effects of chemicals identified by the screening program.

The draft report indicates that approximately 86,000 chemicals that should be considered for screening. Importantly for the plastics industry, under the priority scheme set up in the draft report, polymers having molecular weights above 1000 Daltons would not be screened unless tests on their monomeric or oligomeric components indicated an effect. The monomers and oligomers used to manufacture these polymers would be prioritized for testing. Chemicals that are produced in quantities that exceed 10,000 pounds per year also would be prioritized. Six specific mixtures that have high exposure or particular exposures to infants also will be examined.

The chemicals in the priority group established by the criteria discussed above, which number approximately 15,000, will all then be screened initially using automated technology in a High Throughput Pre-Screening (HTPS). After chemicals are prioritized further based on the results of the HTPS studies, the chemicals with highest priority will undergo Tier 1 testing to detect potential estrogenic effects. Tier 1 studies involve eight in vitro and in vivo tests that are supposed to be sensitive so as to minimize the possibility of false negative results. All in vitro tests are intended to be conducted at multiple doses, while the in vivo tests would be performed at one level. Those substances that are determined to warrant additional consideration from the results of Tier 1 tests will undergo additional consideration in Tier 2 testing. Tier 2 is intended to involve definitive tests to determine the estrogenic, androgenic or thyroid hormone disrupting activity of a substance. The Tier 2 tests will be quite expensive, with the cost estimated at $1 million dollars per chemical in many cases.

On May 5-6, 1998, EPA's advisory groups, the Scientific Advisory Board and the FIFRA Science Advisory Panel met to begin discussions on the EDSTAC draft report. The comments of the panel members at this meeting also have been summarized in this Spring's Technical Advisor's report. The two panels will provide their recommendations to EPA based on the report produced by EDSTAC in December 1998. After this, EPA will make decisions on the screening program in early 1999 and will report to Congress in August 1999. An initial pilot testing program of a number of chemicals is already underway. It is important to note that EDSTAC and the advisory boards just make recommendations to EPA, and that the Agency is free to adopt whatever program it sees fit. Nevertheless, it seems clear that EPA will adopt a testing and screening program, at least philosophically along the lines of the EDSTAC report; so endocrine screening is likely to become a reality in the near future.

Endocrine disruptors are not only the subject of debate in the United States; the possible effects of these chemicals are also the subject of attention in Europe and Japan. Our Stolen Future was published recently in Japan, and this has led to a great detail of media attention to the endocrine disruptor issue, the removal of at least two products from the market, and possibly some consumer deselection of plastic materials. Most of the stories in the public press have focused on polystyrene noodle cups and polycarbonate dinnerware. Several Japanese trade groups are working to address this issue and to ensure that real scientific findings are used to make determinations regarding the safety of these items. In addition, the major Japanese beer producers have undertaken testing that demonstrates that BPA is not detected even at low levels in their products.

As a final note, the results of scientific studies conducted to determine whether certain substances are or are not endocrine disruptors have become only more confusing over the past several years. Recent studies suggest that earlier evidence that some chemicals produced estrogenic-like effects from use in food packaging or pesticides may not be as reliable as once thought. Effects reported in earlier studies have not been able to be reproduced and new studies have shown that there appear to be other causes for the effects that have been detected. Moreover, some members of the EDSTAC committee, like pharmacologist/toxicologist Christopher Bogert, president of Applied Pharmacology and Toxicology, have questioned if we are putting our resources toward the most significant health problems. In a recent Food Chemical News article, Bogert noted that EPA eventually will test over 70,000 chemicals for endocrine effects; if further testing is needed the cost will exceed $1 million per chemical. Regardless of the outcome, product deselection of these chemicals may occur by the public and formulators of consumer products. Jerry Heckman, in a recent letter to Plastics News, recently highlighted the problem of language in even well-intentioned press reports on this issue suggesting that plastics present a risk to consumers, even though no such risk has been established. What is most needed now is more research to determine whether the alleged endocrine disruptors really present a health and safety problem for humans and wildlife.

As many of you know, late last year, FDA published its long-awaited final rule providing for the safe use of radiation to treat refrigerated or frozen uncooked meat, meat byproducts, and certain meat food products to control foodborne pathogens and extend product shelf life. 62 Fed. Reg. 64107 (December 3, 1997). Section 179.45 of the food additive regulations lists a limited number of materials as permitted for packaging food to be irradiated, as well as the source of the irradiation and dosage level. Legally, it can be argued that any packaging material with a suitable FDA status may be used for irradiated food, as long as the radiation does not affect the packaging material in a way that is significant from a regulatory standpoint. In practice, however, we understand that many companies prefer the "safe harbor" of materials listed in Section 179.45.

The fact that Section 179.45 lists only limited types of food packaging has caused some consternation in the meat and packaging industries. Consequently, a number of companies are now interested in broadening the variety of food-contact materials with explicit FDA sanction for holding prepackaged meats intended to be treated with electron beam, gamma, or X-radiation. Several of these companies met in February at a meeting organized by the American Meat Institute and the Illinois Institute of Technology's National Center for Food Safety and Technology (NCFST) and are now looking into the possibility of putting together an industry consortium to address this issue.

FDA is developing guidelines for assuring that paper made from reclaimed pulp is of a suitable purity for use in food-contact applications. The guidelines are expected to be patterned after "Points To Consider for the Use of Recycled Plastics in Food Packaging," the document that the Agency developed several years ago with assistance from SPI for establishing the safety of recycled plastics. Like "Points To Consider," the recycled paper testing guidelines are expected to recommend studies with surrogate contaminants to determine whether a particular process is sufficient to remove the range of unwanted substances that might be present in recycled paper.

In the case of polymeric material, FDA was concerned that reclaimed plastic containers might be contaminated as a result of consumers storing hazardous substances in containers prior to placing them in the recycling stream. While recognizing that paper is not expected to be contaminated in the same way as plastics, FDA still feels that surrogate contaminant testing is appropriate to represent the following classes of substances that might be present in reclaimed pulp as a result of the feedstock including paper that had not been cleared originally for use in contact with food: (1) inks, (2) photoinitiators, (3) defoamers, (4) slimicides, (5) optical brighteners, (6) coating materials, (7) adhesives, and (8) polynuclear aromatic hydrocarbons. FDA is expected to identify "spiking" levels and particular substances that may be used as surrogates for each contaminant class in the forthcoming guidance document. In addition, the Agency is expected to recommend that both virgin and recycled paper products be tested for the presence of the following substances: (1) polychlorinated biphenyls (PCBs), (2) heavy metals, (3) dioxins, and (4) microbiological contaminants.

In our experience, paper recycling often relies on excluding undesirable components from the feedstock as much or more than processing the recycled pulp to remove contaminants. Since the potential contaminants in paper are more readily identifiable than in plastics, we believe it is more appropriate to test recycled pulp for certain substances of concern and to compare the recycled pulp to virgin pulp. The American Forest and Paper Association is working to persuade FDA not to adopt the surrogate approach, as presently contemplated by the Agency. So far, however, FDA seems committed to surrogate removal testing. A draft guidance document is expected to be available this summer, at which point FDA officials plan to meet with interested parties to discuss the document.

On November 21, 1997, FDA published a Guidance for FDA and Industry: Direct Final Rule Procedures that explains the Agency's new process for expedited rulemaking. The direct final rule procedure allows FDA to use a process faster than the normal notice-and-comment rulemaking for rules that will be routine or noncontroversial. When a rule is promulgated using the direct rule process, it may become effective in 135 days provided that FDA does not receive any significant adverse comments.

The FDA Guidance document states that FDA can use direct rulemaking when it does not anticipate receiving any significant adverse comment or when a rule may qualify for exemption from notice-and-comment rulemaking. Once FDA makes the determination that the proposed rule is eligible for this process, it will publish the full text of the rule in the Federal Register along with all the material that would be required in a preamble to a regularly promulgated rule.

After the rule is published, FDA must accept comments for 75 days. If no adverse comments are received, the rule will go into effect 60 days after the end of the comment period. FDA will publish a notice confirming the effective date within 30 days of the end of the comment period. If "significant adverse comment" is received, FDA must withdraw the rule and also must publish a notice within 30 days of the end of the comment period. When a rule is withdrawn any comments received will be considered in developing the final rule using the normal procedure.

FDA defines "significant adverse comment" as comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or why the rule would be ineffective or unacceptable without a change. In general, the test is whether a comment would require a substantive response from the Agency in a normal notice-and-comment rulemaking. Comments recommending a rule change in addition to the rule that was published will not be considered a significant adverse comment. In addition, if the comment only applies to part of a rule, and that part can be severed, FDA may adopt as final those parts of the rule that are not the subject of the adverse comment.

As we have reported in earlier letters, natural rubber latex allergy has become recognized increasingly as a problem in the United States, particularly in the health care industry. In recent years, to protect against allergic reactions, manufacturers have developed allergen-reduced latex gloves. FDA encouraged the production of these alternative gloves in a final rule on latex labeling the agency published on September 30, 1997. 62 Fed. Reg. 51021. The rule requires manufacturers to state that the product contains natural rubber latex on the label and allows for a "hypoallergenic" claim to be used for allergen-reduced products. However, FDA has since determined that the "hypoallergenic" claim is misleading because there are several types of latex-related reactions not covered by the allergen-reduction steps. Thus, FDA plans to disallow the claim after September 30, 1998.

To address the upcoming change, FDA released a draft guidance on May 4 which contains modifications to the claims allowed in an earlier draft guidance that was released last summer. 63 Fed. Reg. 24559. The new claims will aid industry to develop proper labeling warnings since the "hypoallergenic" claim will soon be prohibited. One of the revised claims that the draft suggests is the following: "Testing has shown that this product probably will not cause a contact skin reaction in people who are not known to be sensitized to the chemical additives in natural rubber latex products. CAUTION: Do not use this product if you have a known chemical or protein sensitivity. This product has not been tested for protein sensitization." To make these assertions, companies should conduct a negative skin sensitization study (Modified Draize-95 Test) on a minimum of 300 nonsensitized human subjects.

The second revised claim is as follows: "Testing has shown that this product is less likely than many other types of natural rubber latex products to produce an allergic contact skin reaction in persons with known contact sensitivity to [name of chemical sensitizer(s)]. WARNING: Do not use this product if you have a known protein allergy. This product has not been tested for protein sensitization." To make these assertions, companies should conduct a negative Modified Draize-95 Test and negative patch test in 25 persons who are allergic to the major chemical sensitizers present in natural rubber latex products.

FDA is also close to approving a new skin reagent test for sensitivity to latex products, which may eventually be used by companies to make the revised alternative claims listed above. The Agency is accepting comments on the draft guidance until August 3, 1998.

The Environmental Protection Agency (EPA) and FDA have been progressing slowly toward a resolution of the jurisdictional quandary brought about by the passage of the Food Quality Protection Act (FQPA), which, as we have explained previously, is interpreted by EPA as having transferred FDA's jurisdiction over antimicrobials in food-contact materials to EPA. While EPA and FDA have been working on a rulemaking that would largely restore the status quo prior to FQPA, an industry group, in which we are participating, has been developing a partial legislative solution. EPA and FDA have signaled their support for the legislative "fix," which has now been favorably reviewed by the House Commerce Committee. The technical correction language would amend the Federal Food, Drug and Cosmetic Act's definition of pesticide chemical in Section 201(q)(1) as follows:

(q)(1)(A) The term, "pesticide chemical," means any substance that is a "pesticide" within the meaning of the Federal Insecticide, Fungicide and Rodenticide Act, including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term "pesticide" includes ethylene oxide and propylene oxide when such substances are used on food. The term "pesticide chemical," however, does not include the following uses of substances identified in the previous two sentences:

(i) any use of a substance to prevent, destroy, repel, or mitigate any microbiological organisms, including but not limited to, bacteria, viruses, fungi, protozoa, algae, and slime, in or on food, or water that comes into contact with food, where such food is prepared, packed, or held for commercial purposes; and

(ii) any use of a substance as a "food contact substance," as defined in section 409(h)(6), to prevent, destroy, repel, or mitigate any microbiological organisms, including but not limited to, bacteria, viruses, fungi, protozoa, algae, and slime. Such uses shall include uses of food contact substances in the manufacture or treatment of food packaging.

(B) Notwithstanding any other provision under this section, the term "pesticide chemical" includes any use of a substance to prevent, destroy, repel, or mitigate any microbiological organisms, including, but not limited to, bacteria, viruses, fungi, protozoa, algae, and slime, if such use:

(i) is on raw agricultural commodities, or in water used on such commodities, (I) in the field, or (II) in a facility where only one or more of the following activities occur, washing, waxing, fumigating, and packing of raw agricultural commodities, or (III) during transportation of raw agricultural commodities between the field and a facility described in (II); or

(ii) is on semi-permanent or permanent food contact surfaces other than food packaging . . . .

(emphasis added). Since early May, the amended technical language has been slated for the fast-track Corrections Day process in the House, and from there will be forwarded to the Senate Labor Committee for similar Corrections Day treatment. Currently, no date has been set for Corrections Day in the House of Representatives or the Senate.

Meanwhile, as the technical correction moved forward in May, the interim "fix" devised by EPA and FDA broke down. The proposed "fix," a Memorandum of Understanding between the two Agencies, would have decreed that EPA would receive the antimicrobial petitions, and the Center for Food Safety and Applied Nutrition at FDA would review the petitions for a fee that would be paid by EPA. EPA would then follow through on any work necessary after FDA's review, but a notice of proposed rulemaking or notice of availability was never published on the subject and is unlikely to be published now. Negotiations on the proposed "fix" broke down when CFSAN learned that it would receive only 11% of the $4,000 that EPA was to pay for each petition review, with the remainder going to the general FDA budget. For this reason, CFSAN has discontinued review of all antimicrobial petitions. Thus, the legislative technical correction appears to be the only option which, at this time, has a chance of solving the problems raised by FQPA.

On March 4, 1998, the Environmental Protection Agency (EPA) published a direct final rule which transfers to FDA the responsibility for issuing clearances for inert ingredients in food packaging materials impregnated with insect repellants. 63 Fed. Reg. 10,718. Currently, FDA regulates food-contact materials which are reasonably expected to become non-exempt components of food as food additives under Section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA). When an insect repellent is added to food packaging, however, the entire package becomes a pesticide and any potential residues in food require clearance as pesticide chemical residues under Section 408. Furthermore, the treated packaging, per se, requires registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Rather than issue clearances for inert packaging compounds that would duplicate existing FDA clearances for use of the same components when the package is not a pesticide, EPA decided that these materials should be excluded from the definition of pesticide chemical and, thus, not regulated by EPA under Section 408 of the FFDCA (the materials may still require registration under FIFRA). EPA will still be responsible for issuing tolerances or exemptions from tolerance under Section 408 for any residue on food created by the insect repelling ingredient in the product (the active ingredient).

The promulgation of this rule was prompted by an application EPA received to register an insect repellent, methyl salicylate, that was intended to be impregnated into food packaging material. Methyl salicylate is a synthetic version of wintergreen oil. A request for an exemption from tolerance for methyl salicylate was submitted by Tenneco Packaging on June 13, 1997. On November 19, 1997, EPA issued an exemption from tolerance for the use of this insect repellent on food packaging and animal feed packaging provided that the application rate of methyl salicylate does not exceed 0.2 mg/in2. 62 Fed. Reg. 61635. In granting this exemption from tolerance, EPA realized that the clearing of each component of the packaging material as a pesticide chemical would duplicate FDA's regulatory clearance with no benefit for public health. The authority for EPA to exempt the packaging components from the definition of pesticide chemical is provided in Section 201(q)(3) of the FFDCA as amended by FQPA. The exemption is based on the conclusion that the packaging materials, per se, are not used primarily for a pesticide purpose.

Under the new rule, EPA may still regulate the impregnated food packaging material as a pesticide product; therefore, manufacturers will be required to obtain a registration for the impregnated package under Section 3 of FIFRA before marketing the product, unless the package qualifies for the treated article exemption. It is important to note, however, that the inert ingredients must be authorized or permitted for use in food packaging by FDA, otherwise EPA will not issue a registration for the product under FIFRA.

USDA and FDA have established a working group to address issues raised in our October 1, 1997 letter to both Agencies regarding USDA's policy of requiring upon an audit of the records of a federally-inspected meat or poultry plant, that food-contact substances used in the plant have some type of official sanction from FDA. The working group will be headed by John Damaré of USDA's Food Safety and Inspection Service. A date for the first meeting of the group has not yet been set.

As was reported in our last General Counsel's report, last year, on behalf of FDCPMC, we wrote officials at both USDA and FDA in an attempt to resolve a problematic situation involving USDA's inspections and audits of meat and poultry facilities. Specifically, our letter addressed the issue that, although a supplier guarantee of FDA compliance is legally sufficient for a USDA-inspected facility to use a food-contact material, upon auditing these records, USDA typically will demand that there be a food additive regulation or other official FDA sanction for every component of a food-contact material. In light of FDA's recent policy to require submission of a publicly disclosable Food Additive Petition or Threshold of Regulation request, this USDA policy forces companies to reveal sensitive confidential information about their products, as well as bear the time and costs associated with submitting unnecessary requests to FDA.

In our letter to the Agencies, we suggested, as an alternative to the current situation, that USDA ensure that facially valid supplier assurances of compliance exist for food-contact materials, but not necessarily require FDA confirmation of these assurances. John Damaré responded to our request and wrote that the working group is intended to "ensure the timely exchange of information, and facilitate uniform and consistent interpretations relating to food-contact applications." We have requested the opportunity to provide input to the working group.

USDA's Food Safety and Inspection Service (FSIS) announced in a February 13 Federal Register notice its intent to eliminate the prior approval system for all non-food compounds and proprietary substances used in federal-inspected meat and poultry plants. 63 Fed Reg. 7319 (February 13, 1998). FSIS has determined that the prior approval program is redundant and inconsistent with the new FSIS pathogen reduction/Hazard Analysis Critical Control Point (HACCP) regulations. Under HACCP, the burden is placed on federally-inspected meat and poultry facilities, not FSIS, to determine whether non-food compounds and proprietary substances are safe and effective. FSIS intends to redirect the resources saved from the elimination of the prior approval system to the implementation program for the new HACCP regulations. FSIS will, however, maintain a limited staff with expertise in non-food compounds and proprietary substances that will follow developments in the area and issue technical guidance when necessary.

FSIS has requested that interested parties propose alternatives to the prior approval system. A review of the notice, however, indicates that the only alternative really open for comment is whether the prior approval could continue through independent laboratories. The alternative of keeping the current system has been rejected as incompatible with HACCP. Furthermore, this is being presented as a decision that has been made, not as a proposed rule subject to reconsideration based on public comment. On August 25, 1997, USDA published a proposed rule that would abolish 9 C.F.R. § 381.60, which is the regulation that governs the use of all nonfood compounds in federally-inspected meat an poultry plants, including products such as sanitizers and lubricants. See 62 Fed. Reg. 45045. A subsequent notice indicated that the proposal was aimed only at sanitizers and that lubricants and other nonfood compounds would be considered later. See Fed. Reg. 55996 (October 28, 1997). Since the August 25 proposal would abolish the regulation relating to prior approval of all compounds, however, USDA is taking the position that prior approval of nonfood compounds currently is being conducted only as a matter of policy and can be eliminated at the discretion of the Agency (even thought the August 25 proposal has not yet resulted in a final rule).

Other than the alternative of keeping the current system, rejected by USDA, the February 13 notice indicated that the Agency considered a system based on user fees charged to chemical manufacturers and distributors to cover the costs of review, but USDA lacks statutory authority to levy such charges. The one alternative that really appears to be under consideration at this time is allowing the industry to use recognized, non-governmental organizations or laboratories to test and certify non-food compounds and proprietary substances. This alternative has received criticism because of the possibility of conflict of interest and the difficulty associated with evaluating 16,000 -20,000 products per year.

In April 1998, the Bundesinstitut für Gesundheitlichen Verbraucherschutz und Veterinärmedizin (BgVV) announced its official withdrawal, effective immediately, of Recommendation XL, "Varnishes and Coatings for Food Containers and Packaging," which provides a list of materials approved for use in food-contact coatings. Information about this pending action first came to our attention when, during an international conference held in London in December, an industry speaker indicated that he believed this action would not be totally unwelcome, at least to the extent that it might enhance the willingness of global customers to rely on FDA's coatings regulation in 21 C.F.R. § 175.300.

Noting that Recommendation XL had not been amended since 1968, when it was first published in Communication on Health Assessment of Plastics in the Framework of the Food and Consumer Products Law, the BgVV reasoned that Recommendation XL no longer reflects modern scientific and technical knowledge, current safety requirements, and analytical capabilities, or even the chemical composition of coatings now used in food-contact applications. Further, the BgVV rejected Recommendation XL's approach of defining overall listings covering an entire substance class instead of individual compounds.

The BgVV, however, is currently considering a recommendation to replace Recommendation XL, and has requested that manufacturers and users of coatings submit data to the Agency regarding the components of modern coatings and safety data on their use. In the interim, while the BgVV considers a replacement recommendation, or prior to the adoption of a harmonized European Union (EU) recommendation on the subject, the BgVV suggests that industry rely upon listings in FDA regulations or the Council of Europe Resolution AP (96) 5, "Surface Coatings for Food-Contact Applications," or, alternatively, have the coating materials evaluated by internationally recognized scientists of the Scientific Committee on Food (SCF) or the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

9	The BgVV handles industry requests for approval of food-contact materials, issuing such approvals in the form of "Recommendations." While the Recommendations are not legally binding, they are highly regarded and are respected by many German manufacturers as if they were law.

The European Union (EU) decided to postpone for the second time the effective date of Decision 97/534/EC prohibiting the use of specific risk materials (SRMs) that could spread bovine spongiform encephalopathy (BSE) and other transmissible spongiform encephalopathies (TSE's). This ban would affect the plastics industry as the Decision includes in the list of SRMs tallow and tallow derivatives, commonly used as additives and processing aids for certain plastic resins or articles.

The Decision had been adopted in July 1997 and was originally scheduled to take effect January 1, 1998. Its effective date was first postponed until April 1, 1998. On March 31, 1998, the EU Agricultural Ministers unanimously decided to further defer the effective date until January 1, 1999. In the meantime, national measures will continue to apply.

The EU Ministers invited the European Commission to make a new proposal that would satisfy both Member States and their trading partners. In substance, the new proposal is expected to be country specific, so that "BSE free" countries may be partly exempted from the ban. With respect to tallow and tallow derivatives, the Commission may follow the April 3, 1998 opinion of the Scientific Steering Committee (the principal new scientific body advising the EU) in permitting their use, provided they have undergone defined purification processes.

On February 6, 1998, the European Commission released the long awaited third draft of the Fifth Amendment to the so-called "Monomers Directive" (90/128/EEC), which governs the use of plastics in food-contact applications. The draft proposes various small technical adjustments to the existing lists of monomers and additives of the Monomers Directive. It also proposes the addition of new monomers and additives that are perceived to be noncontroversial that is, substances that have been reviewed by the Scientific Committee on Food (SCF) and either do not have a Specific Migration Limit (SML) or have an SML that is accepted by the sponsor.

As expected, the proposed draft Fifth Amendment does not include reference to a Threshold of Regulation program, the Concept of Functional Barrier or the use of Consumption Factors, all U.S. concepts that are also being considered in the EU. All parties seem to agree that some or all of these concepts should be included in the subsequent (Sixth) Amendment to the Monomers Directive. Also, the Commission has suggested that the Sixth Amendment will serve to consolidate this Directive and all of its amendments to form a single, up-to-date regulation.

The third draft of the Fifth Amendment has been criticized by member states' representatives and members of the SCF as giving up too much to Industry. Critics question why the proposed Amendment does not list all substances reviewed by the SCF with their established SML, if any, but only those for which the SML is accepted by the sponsor. Some member states, including Belgium, impressed on the Commission that the content of the new legislation should reflect the scientific consensus reached by the SCF and not be dictated by industry.

Accordingly, it is not clear if the final Fifth Amendment to the Monomers Directive will resemble the draft currently being considered or when it will be finally adopted. All parties will meet at the end of June 1998 to discuss the proposed Amendment. If they agree on how to proceed, the Fifth Amendment could be presented by the Commission to the Standing Committee on Foodstuffs in September 1998 and officially adopted before the end of the year. If the Amendment is not presented in September, its adoption will certainly be postponed until 1999. In the meantime, as described below, member states continue to implement previous amendments to the Monomers Directive and related directives.

The following is Dr. Modderman's report of the March meeting of the Codex Alimentarius Codex Committee on Food Additives and Contaminants (CCFAC) at The Hague, Netherlands. Generally, the interests of CCFAC have remained quiet with regard to developing international standards for food packaging and with regard to specific migrants into food as "contaminants." This is in part because of Dr. Modderman's regular attendance at Codex sessions and our consistent urging that the Committee not involve itself in indirect additives issues. At least as of this time, our position on this point has always been supported by FDA's delegates like Dick Ronk, and now Alan Rulis; however, we believe continued diligence is warranted.

The Codex Alimentarius Commission develops technical standards for food-related subjects through subsidiary bodies such as the Codex Committee on Food Additives and Contaminants. Codex standards became significant in international trade with specific reference in the Sanitary and Phytosanitary (SPS) measures regulated by the World Trade Organization (WTO). Currently, the Codex definition of food additives does not include indirect additives or food packaging, but only pertains to direct additives. Although government delegates at Codex meetings have asked for standardization of food packaging, i.e., formats such as the U.S. regulations or the European Union directives, we discourage such approaches due to the limited public health benefit versus the amount of effort.

The Codex system has ceased their development of "vertical" standards, that is, standards of food identity, and they are now developing "horizontal" standards. The General Standard for Contaminants and Toxins in Foods (GSC) is one of these horizontal standards. It will establish contaminant levels for specific foods. If there is any action of the CCFAC regarding food packaging matters, it will first appear as work on the GSC for migrants from packaging into food. The GSC has annexes that are priority lists and data status reports for a wide list of potential contaminants that may be placed into the GSC. These annexes address potential contaminants by chemical class and toxicological structure-activity assignment. Several potential migrants are in this contaminant priority list and candidates for MCLs, although, there is no explicit category of contaminants listed by a title such as "food packaging concerns".

The GSC is being developed in priority fashion with several elemental contaminants such as lead and cadmium being addressed first. Further, the GSC is being developed with a policy where significant sources of exposure are assigned MCLs and lesser sources of exposure are not assigned a maximum level. By this process, a matter such as lead or cadmium from packaging or food utensils should be very minor sources of exposure compared to major food commodities and the CCFAC should not be setting MCLs for food packaging articles. We will continue to monitor the CCFAC work on MCL for packaging migrants, especially since the amount of time devoted to direct food additives matters will decline and the time devoted to contaminant matters will greatly increase.

For several years, there has been a lack of CCFAC interest in international standardization of food packaging. This is due, in large part, to the high priority placed on completing the General Standard on Food Additives (GSFA). The GSFA will have one more year of high effort, then the CCFAC will turn its attention to new work. The matter of harmonizing food packaging laws, i.e., creation of a food packaging standard, will, inevitably, be raised again and the industry should prepare to participate in this discussion. Our principal argument should be that any significant food packaging-related public health matter is dealt with in the GSC and that a separate standard for food packaging materials is not necessary.

Under the pressure of Codex standards being reference points by the WTO, the Codex also has undertaken a program to develop guidelines for their risk assessment policies. At the CCFAC meeting this past March, the Government of The Netherlands presented a document on international risk assessment policies. This document reported on a meeting of government and academic scientists. We had some preliminary conversations with some of the U.S. individuals that took part in this meeting and encouraged some of the recent policy initiatives such as threshold of regulation. As a result, the report mentions that certain issues may be below a "threshold of toxicological concern" and therefore require a less detailed risk assessment. Substances migrating from food packaging was mentioned as one of those areas of low toxicological concern. There will be further work on this report and we will encourage the continuation of policies based on public health concern.

One CCFAC action is the development of the "Codex Priority List," which is a list of food additive and contaminant subjects for which there is priority attention by the toxicological advisory body, the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In an earlier CCFAC meeting, the delegate of the International Organization of Consumers Unions (IOCU), now Consumers International, had desired a toxicological evaluation for endocrine disruptor substances. When this subject came up again at this meeting, John Modderman and other delegates spoke to say that the information on this subject was premature for evaluation by the JECFA. As a consequence of this intervention, this matter is no longer on the Codex Priority List.

The Codex meetings are becoming larger due to their WTO status. This growth is based on formation of non-governmental organizations (NGOs) to represent specific interests. In looking to the future, the Committee may be interested in forming a NGO that would uniquely represent their interests at Codex meetings. With this NGO status, the Committee would able to present information and speak at Codex meetings without having to ask a government delegation to speak on its behalf.

In February 1998, a new Belgian Royal Decree of November 24, 1997 on materials and articles intended to contact food was adopted. This Decree implements the Third and Fourth Amendments to the Monomers Directive (Directives 95/3/EEC and 96/11/EC, respectively). Importantly, the new decree also includes additives that have been reviewed and approved for food-contact use by the SCF but that have not yet been listed or proposed by the Commission for listing in any amendment to the Monomers Directive. This is in line with the Belgian critique of the draft Fifth Amendment, as mentioned above. It is also an implicit criticism of the whole EU legislative process as applied to food-contact materials.

In February 1998, the United Kingdom's Ministry of Agriculture, Fisheries and Food distributed for consultation a proposed Plastic Materials and Articles in Contact with Food Regulations 1998, designed to implement the EC Directive 97/48/EC on testing food-contact plastics for chemical migration. Importantly, the regulations would also consolidate the Monomers Directive and all of its adopted amendments. The regulations are scheduled to be adopted in June 1998.

We have received a translation of a proposal by the South Korean Ministry of Health and Welfare for new specifications and standards for materials used in food-contact applications. The new regulations are intended to broaden and clarify the existing standards for materials as well as to harmonize the Korean regulations with international standards.

As proposed, the new regulations will expand the number of materials covered by standards from 5 to 30. Specifically, the thirty standards cover food-contact equipment, containers, and packaging made from the following materials (set forth in the terminology used in the English-language version of the Korean proposal): polyvinyl chloride (PVC), polyethylene (PE), fluorinated polyethylene, polypropylene (PP), polystyrene (PS), polychlorovinylidene (PVdC), polyethylene terephthalate (PET), phenolformaldehyde (PF), melamine formaldehyde (MF), urea formaldehyde (UF), polyacetal, polyoxymethylene (POM), polyformaldehyde, polymethylmethacrylate (PMMA), polyamide/nylon, polymethylpentene (PMP), polycarbonate (PC), polyvinylalcohol (PVA), polyurethane, polybutene-1 (PB), butadiene resin, acrylonitrile-butadiene styrene (ABS) and acrylonitrile styrene (AS), polymethacrylstyrene (MS), polybutyleneterephthalate (PBT), polyarylsulfon (PASF), polyarylate (PAR), hydroxybutyl polyester (HBP), polyacrylonitrile (PAN), flurororesins (FR), ionomer resins, ehtylenevinylacetate (EVA), methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), polyethylenenaphthalate (PEN), cellophane, rubber materials, paper or processed paper materials, metals, woods, and glass, ceramic, enamel, and pottery.

Most of these standards consist of fairly general compositional definitions for the materials, maximum lead and cadmium limitations, limitations on the amount of heavy metals in general, evaporation residue, and limitations on certain residual monomers and by-products that are specific to the material that is the subject of the specification. The proposed regulations prohibit the use of dioctyl phthalate.

The European Commission started proceedings against several Member States for failure to implement Directive 94/62/EC on packaging and packaging waste. This Directive has two objectives: (1) to prevent and reduce the environmental impact of packaging and packaging waste, and (2) to ensure that the management of packaging and packaging waste does not hinder the smooth functioning of the internal market. In particular, the Directive sets out measures to prevent the production of packaging waste and promotes reusing, recycling, or recovery of packaging waste.

Members States were expected to adopt all provisions of the Directive and communicate their national legislation to the Commission by June 30, 1996. However, they largely failed to do so. According to the Commission, only six Members States (Austria, Denmark, Germany, Italy, The Netherlands, and Sweden) have correctly transposed the Directive. The other Members States have either partially transposed the Directive (this is the case for Portugal and Belgium), or are still completing the process. Also, the Commission has not received any information from Greece. Finally, Finland has adopted a national legislation following the Directive with respect only to part of its territory.

The Commission started proceedings against Finland before the European Court of Justice. It also started proceedings (by issuing "reasoned opinions") against Portugal and Belgium in December 1997 and against the UK in April 1998. These actions are starting to bear fruit as Finland, Portugal, and the UK have since submitted new proposed legislation that is being assessed by the Commission.

These actions reflect the will of the Commission to ensure that the implementation of the Directive is complete before the end of 1998. The uncertainty caused by these legal actions adds complexity to the challenge that companies face in monitoring the implementation of the Directive in each EU Member State and identifying their specific obligations under each national scheme.

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