SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
July 16, 1997 Newsletter

* * * For Members Only * * *

Table of Contents

1. FDA Reform Bill Reported Favorably by Senate Committee

2. Biomaterials Bills Still Active on Capitol Hill

3. FDA Fares Well in FY 1998 Budget Process

4. USDA Creates Difficulties by Refusing to Accept Self-Determined GRAS and No Migration Positions

5. FDA Releases Exposure Estimates for Bisphenol A

6. Industry Presses European Union to Revise Draft Directive on Use of Recycling Symbols

7. Reporting Requirements under the Chemical Weapons Treaty

In Brief

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

Dear Ladies and Gentlemen:

The purpose of this letter is to update you on recent developments in Congress on legislation containing the SPI-FDA agreed upon premarket notification (PMN) provisions for food-contact substances and on other developments concerning the laws and regulations administered by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). In Congress, the Senate Committee on Labor and Human Resources favorably reported the FDA reform bill introduced by Senator Jim Jeffords (R-VT), S.830, that contains the PMN provisions we have long supported. The bill now is headed to the Senate floor for debate, and a similar bill is expected to be introduced in the House of Representatives in July. Also in Congress, the pending product liability and stand-alone biomaterials bills that include protections for biomaterials suppliers are still moving forward in the House, although Senator John Breaux (D-LA) recently introduced a competing bill focused solely on biomaterials suppliers that, in our opinion, does not go as far as the other proposals in protecting companies from potential law suits. In addition, FDA's 1998 fiscal year budget is faring well in the Congressional appropriations process, and has passed the House Appropriations Subcommittee with a funding level higher than many expected.

Outside of Congress, USDA's policy of refusing to accept manufacturers' self-determinations regarding their products' FDA status has raised concerns among many food- contact material suppliers. For materials used in meat and poultry facilities, the Department's policy often results in the need for filing Threshold of Regulation requests or food additive petitions that otherwise would not be required.

At FDA, the Agency recently released exposure estimates for bisphenol A (BPA). We believe FDA relied heavily on original data supplied by SPI's Inter-Industry Group on Bisphenol A and Alkyl Phenols (IIG) in making these estimates, but did not consider revised data the IIG submitted demonstrating a lower potential migration of BPA from its use in food-contact applications. As soon as possible, we hope to discuss the IIG's refined data with FDA so that the Agency's exposure estimates can be revised.

Internationally, the American Chamber of Commerce in Brussels has asserted that the European Union's (EU) draft marking directive on the use of recycling symbols on packaging materials may create a trade barrier by prohibiting the use of non-EU approved recycling marks. At this time, it is unclear how the draft directive will be interpreted by EU officials, or whether marks such as SPI's resin identification code may be used if the directive is adopted in its current form. These and other issues of interest are discussed below.

1. FDA Reform Bill Reported Favorably by Senate Committee

We are pleased to report that the Senate Committee on Labor and Human Resources favorably reported the "Food and Drug Administration Modernization and Accountability Act of 1997" (S.830) to the full Senate and that the reported version of the bill continues to contain the SPI-FDA agreed upon premarket notification (PMN) language for food-contact substances. The bill cleared the Senate Committee by a vote of 14 to 4 after a June 18 "mark up" hearing, and is now scheduled to be debated by the full Senate within the next few weeks. Moreover, despite competing priorities, Senate Majority Leader Trent Lott (R-MS) has identified FDA reform as a major legislative priority.

In addition to the PMN provisions in S.830, the legislative history language upon which SPI and FDA also have agreed has been included in the Senate Committee report that will accompany the bill to the floor. (See our letter of January 3, 1997 for the legislative history language). For those who have reviewed the special July 4, 1997 issue of FDA Week that preprinted parts of the Committee report, we confirmed that a printing error resulted in the accidental deletion of a number of paragraphs of legislative history language in the food-contact section of the report. These paragraphs are included in the actual Committee report, and we understand that FDA Week intends to reprint the full legislative history section for food-contact substances to correct this printing error.

In the House of Representatives, the Commerce Committee is expected to discuss a bill soon that likely will be substantially similar, if not identical, to S.830. This bill has yet to be introduced in the House, but Committee staffers have reportedly promised to mark up an FDA reform bill within the next few weeks. As in the Senate, FDA reform is reportedly a top priority in the House and it is expected to have little trouble getting on the House calendar for full debate on the floor once it has been introduced. We are now working to ensure that the legislation to be introduced in the House contains the same SPI-FDA agreed upon PMN provisions that are in the Senate bill.

As we reported in our June 6 letter, the driving force behind the reform legislation is the reauthorization of the Prescription Drug User Fee Act (PDUFA), which provides industry financing for expedited FDA review of prescription drug applications. PDUFA reauthorization is considered by many in Congress to be "must pass" legislation this session. Without reauthorization of PDUFA, FDA will be forced to lay off or reassign approximately 600 personnel. It was recently reported, however, that the Agency has squirreled away nearly $28 million that will keep these personnel employed for a few months in case PDUFA reauthorization is not passed on time. FDA's fiscal planning, however, has raised the ire of at least one Member of Congress: Representative Joe Barton (R-IN) sent a letter to Donna Shalala, the Secretary of Health and Human Services, requesting that FDA provide information on the source of this money and whether other programs were financially neglected to save it. FDA has responded to Representative Barton indicating that the $28 million was not saved for the contingency that PDUFA reauthorization would be delayed, but to continue processing partially completed drug applications past the September 30, 1997 PDUFA expiration date.

Nevertheless, S.830 as a whole has broad bipartisan support. Only four Democratic senators voted against the bill in the Committee markup hearing (Senators Edward Kennedy (D-MA), Tom Harkin (D-IA), Jeff Bingaman (D-NM), and Jack Reed (D-RI)). Furthermore, there was no debate (or even discussion) of the PMN provisions for food-contact substances during the Senate Committee hearing. The chief concern now is that, if some of the non-PDUFA portions of the bill become controversial and appear to threaten the passage of PDUFA reauthorization, the bill may be stripped of all its FDA reform provisions, including the non-controversial provisions such as the PMN program, to ensure passage of PDUFA reauthorization. In particular, although Senator Kennedy withheld a threatened all-out attack on S.830 during the June 18 markup hearing, he is still considering either a filibuster when the bill reaches the Senate floor or attempting to amend the bill to death if some of the controversial provisions involving third party review for medical devices, nutrition labeling statements, and health claims are not removed or substantially modified. We are very encouraged, however, by the following statement in the minority views on the bill recently issued by Senator Kennedy (also representing the positions of Senators Bingaman and Reed): "We support the inclusion of a consensus provision on food contact substances that has been endorsed by both the FDA and the food industry."

In addition to the PMN provisions of S.830, two provisions of the bill relating to health claims and national uniformity also may be of interest to the Committee. Specifically, the health claims provisions are similar in many ways to the PMN program for food-contact substances. The health claims language, which was approved (although contested) by the Senate Committee in the June 18 mark up, would establish a premarket notification system for health claims that have been substantiated by an authoritative scientific body in the federal government (e.g., the National Academy of Sciences, the National Institutes for Health, or the Center for Disease Control and Prevention (CDC)). A company could use a substantiated health claim after submitting a premarket notification to FDA if the Agency does not object to the notification within 120 days. Obviously, this program is based on the same philosophy as the PMN program for food contact substances, and we are encouraged to see this type of reform moving forward in other regulatory areas.

The other area of interest in S.830 is national uniformity provisions that would apply to over-the-counter drugs. Although not directly applicable to food-contact substances, the amendment, sponsored by Senator Judd Gregg (R-NH) and adopted during the June 18 markup, could increase the chances for obtaining national uniformity legislation in other areas, such as product labeling laws (e.g., Proposition 65). However, the national uniformity language in S.830 was opposed by two Democrats on the Committee, Senators Kennedy and Patty Murray (D-WA), and one Republican, Tom DeWine (R-OH), and may face additional controversy on the Senate floor and in the House.

Both Houses of Congress are making slow progress toward enacting legislative protection from legal liability for biomaterials suppliers. On June 12, 1997, the House Judiciary Subcommittee on Commercial and Administrative Law held hearings on a biomaterials bill introduced by Rep. George Gekas (R-PA), H.R. 872. (See our June 6, 1997 letter). These hearings underscored the need for liability protection, and, hopefully, increased support for this cause.

In the Senate, Senator John Breaux (D-LA) introduced a new liability reform bill, S.669, that focuses only on biomaterials suppliers. Compared to the other pending bills, we feel that the liability limitations in S.669 offer more limited protection to companies that supply materials to the medical device market. For instance, the Breaux bill departs from the other biomaterials measures in that it does not immunize suppliers that negligently fail to warn of potential risks associated with the use of their materials. In addition, we believe that language in the bill regarding a supplier's liability for failure to meet published specifications is too broad (and potentially confusing). Specifically, where a supplier has published more than one set of specifications, the bill may cause factual disputes over which specifications are binding on the supplier. The Breaux bill also protects only suppliers of raw materials (not suppliers of component parts), and does not cover suppliers of materials used in silicone gel breast implants.

In addition to action on Capitol Hill, a White House task force formed to advise President Clinton on product liability legislation has prepared an "options paper" for the President regarding the bills now pending in Congress (S. 648, H.R. 872, and S. 364). The task force includes representatives from the Small Business Administration, the Department of Justice, and the Department of Commerce. The paper, which has yet to be publicly released, is expected to include support for a provision protecting biomaterials suppliers. The President has indicated that he is willing to support a biomaterials provision, and the task force hopes to find compromise language with Congress on the other areas of product liability to produce a legislative package the President will sign.

FDA's 1998 fiscal year budget is currently going though the appropriations hearing process on Capitol Hill, and is faring better than many had expected. The House Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies recommended approximately $944 million for FY 1998. This amount includes the revenue the Agency expects from user fees collected under the Prescription Drug User Fee Act (PDUFA), which is expected to be reauthorized this summer. The $944 million recommended by the Committee is greater than last year's budget of approximately $921 million, although less than the $987 million FDA requested. FDA's request, however, included substantial additional user fees that are not part of the budget approved by the Subcommittee. The House Subcommittee report is due to be released shortly, and the full House is expected to take up the matter soon.

The House Subcommittee included $91 million in expected user fees for the Agency's work under PDUFA. Some members of Congress and industry representatives worried that the Appropriations Subcommittee would recommend less than the minimum amount of funding the PDUFA law requires FDA to expend on PDUFA activities for the Agency to collect user fees, thus effectively killing the PDUFA program. Therefore, the Subcommittee's $91 million recommendation (enough to continue PDUFA) demonstrates crucial support for the continuation of the PDUFA user fee program, which expires by its own terms on September 30, 1997 unless the law is "reauthorized" by Congress. As discussed above, this reauthorization is currently pending in the Senate as part of S.830.

Following up on a report in our May 12, 1997 letter, we want to explain further the problems presented by the United States Department of Agriculture (USDA) policy of not accepting manufacturers' self-determinations of the FDA status of their products that are used in federally-inspected meat and poultry plants. Specifically, USDA is not recognizing a product's suitable FDA status if there is not a specific food additive regulation, Threshold of Regulation letter, or "no objection" letter from the Agency covering the intended use.

As many of you know, properly based self-determinations that a substance will not migrate to food or is generally recognized as safe (GRAS) for its intended use can form an appropriate and legal basis to conclude that the material is suitable for food-contact use and is not a "food additive" that requires premarket clearance by FDA. USDA, however, is not accepting these perfectly legitimate self-determinations when conducting random audits of supplier assurances of FDA compliance in the files of USDA-inspected facilities.

Unfortunately, USDA is requiring companies that are marketing materials based on these positions to obtain official concurrence from FDA. As many of you know, FDA will not provide written confirmation of a self-determined "no migration" position, and will only "concur" in a GRAS determination under the recently proposed GRAS notification process (See related story below). Therefore, USDA's position is forcing companies to file requests for Threshold of Regulation exemptions or food additive petitions, or possibly GRAS notifications.

These forced filings not only involve additional expense and other burdens, but also result in compelled public disclosure of information that some companies consider highly confidential. In the case of a food additive petition, the process results in a regulation published in the Federal Register and, ultimately, in the Code of Federal Regulations that identifies the complete chemical composition of the material and the conditions under which it may be used, including limitations on use level, temperature of use, types of food that may be in contact with the material, and other materials with which the substance may be used. This same type of information also is disclosed by FDA for Threshold of Regulation exemptions in the list of exemptions granted by the Agency that is maintained (and made available to the public) by FDA's Dockets Management Branch. Similarly, in its GRAS notification proposal, FDA has indicated that it will presume information provided in a notification is publicly disclosable (and may even make that information available over the Internet). Thus, the combination of USDA's insistence on written FDA confirmation of a food-contact material's regulatory compliance and FDA's unwillingness to provide that confirmation except through the three formal regulatory procedures described above is compelling the public disclosure of confidential business information as a condition of continuing to supply material for USDA-regulated uses.

The one saving grace in this situation is that USDA is currently allowing materials to continue to be used in meat and poultry facilities while FDA concurrence is being sought, provided there are no health or safety concerns with the continued use.

We also understand that USDA is not accepting general representations that a packaging material, such as a film, complies with a particular FDA food additive regulation clearing the film (or the base polymer). Instead, USDA inspectors now commonly request that all components of a packaging material (including all additives) be identified by chemical name. When complying with USDA's requirements, we caution that there is a danger in providing unnecessary detail about the composition of a material. For example, unless specifically requested, we feel that it is unnecessary to provide the identity of solvents, catalysts, or other production aids that are used in manufacturing the material but that are considered part of the basic resin and not independent components of the finished product. As you know, these types of materials generally do not require food additive clearance, but listing them for USDA will cause Agency personnel to look for the materials in the food additive regulations and, upon not finding them listed there, to demand FDA confirmation of compliance.

On a related topic, Mark Reo, a chemistry reviewer in USDA's Compounds Review Branch who was responsible for evaluating food-contact materials used in meat and poultry applications, recently moved to a new area of USDA. His work has now been distributed among other Agency personnel. At this time, the change in personnel has not altered USDA's procedures in connection with auditing supplier assurances of the FDA compliance of food-contact materials. This process remains under the supervision of John DamarJ at USDA, which suggests that Mr. Reo's reassignment may not signal any significant shift in the current situation.

The Food and Drug Administration (FDA) has released a March 13, 1997 memorandum by Allan Bailey of the Agency's Office of Premarket Approval (OPA) that estimates the dietary exposure of adults and infants from the use of Bisphenol A (BPA) in can enamels and polycarbonates. Unfortunately, FDA's exposure estimates appear to be based on the first set of data that SPI's Inter-Industry Group on Bisphenol A and Alkyl Phenols (IIG) submitted to the Agency in 1995, and not on the revised data the IIG submitted in 1996. As many of you know, the IIG collected data to assess the potential exposure to BPA from food-contact materials. These data were assembled largely to address concerns raised by media attention that BPA may have endocrine modulating capabilities. The FDA memo concluded that the potential dietary exposure to BPA for adults from food contact can enamels and polycarbonates is no greater than 3.7 parts per billion (ppb) of the daily diet, which corresponds to an estimated daily intake (EDI) of 11 micrograms/person/day. For infants, FDA estimated the potential exposure to BPA from can enamels and polycarbonate infant bottles to be less than 8.3 ppb, with an EDI of 7 micrograms/person/day.

Using the 1995 data, the IIG's calculations of potential exposure to BPA and EDI were very close to FDA's. However, in 1996, the IIG submitted revised data based on additional extraction studies conducted because the earlier studies did not resolve interfering signals from other materials that were originally thought to be BPA. The IIG's 1996 data indicate a lower level of potential BPA migration. Efforts are now underway to persuade FDA to use the revised data to calculate more accurate exposure estimates.

Endocrine modulators also continue to be the subject of discussions outside FDA. Recent studies conducted by researchers at the University of Cincinnati and Indiana University highlight the continuing uncertainty as to whether the use of BPA (or other alleged endocrine modulators) in food-contact materials poses a safety concern. In particular, although the Cincinnati and Indiana University studies appear to indicate that BPA has some estrogenic effect, many scientists (including Allan Bailey) have criticized the studies because the method of exposure, injecting capsules of BPA under the skin of test animals, is not realistic or predictive of potential exposure from ingestion. George Pauli, Director of OPA's Division of Product Policy, recently pointed out that the results of tests reviewed by FDA have not changed the Agency's position on BPA's acceptable regulatory status and that he believes the scientific community is still working through the existing data on the subject. In addition, Stanford University Professor David S. Feldman, a well-known researcher in the endocrine disrupter area, recently reiterated his belief that the current studies are not conclusive with respect to the endocrine disrupting potential of BPA.

The American Chamber of Commerce (Amcham) in Belgium issued a statement cautioning the European Union (EU) that implementing the EU's draft directive on the marking of packaging materials in its present form could raise barriers to international trade. As it stands now, the draft directive would prohibit the use of symbols, other than EU-approved recycling symbols, on packaging to indicate the recycling status or recycling potential for a product. This could result in a trade barrier if it requires packaging producers to use one set of marks for products marketed in the EU and another for products marketed in the rest of the world. The EU symbols are an inverted "C" with an upward pointing arrow to indicate recycled or recyclable packaging, and two horizontal arrows pointing in opposite directions to indicate reusable materials.

Rather than the two currently designated symbols, the Amcham is calling on the EU to adopt the Mobius Loop (the commonly used chasing arrows symbol). The EU earlier rejected this option due to potential copyright problems. Nonetheless, the Amcham also is urging the International Standards Organization (ISO) to adopt the Mobius Loop as the international symbol for recycled or recyclable materials. An ISO standard for such a symbol is expected to be published in 1999. If the Mobius Loop is chosen, the EU may consider permitting its use pursuant to a provision of the draft directive that permits the directive to be revised to comply with international standards.

The status of SPI's resin identification code under the draft directive is not clear. The code may not be permitted under the directive if it is found to indicate the recycled or recyclable nature of the packaging. However, the intent of establishing the resin identification code was to provide a means to distinguish containers by type of resin, not to indicate the recycled content or recycling potential of the material. Because the SPI code is used in Australia, Canada, Japan, and has been adopted into law by forty states in the U.S., a significant trade barrier could be created if the code is prohibited by the directive. The Amcham has recommended that the EU modify the existing draft directive to include a clause specifically permitting the use of other codes along with the appropriate EU symbol, provided there is no conflict. These and other recycling issues are to be discussed in a meeting of the ISO in August, 1997 in Stockholm, Sweden.

On April 24, 1997, the United States ratified the Chemical Weapons Convention Treaty, joining 87 other countries that have now ratified the Treaty. Bills are now being considered in both houses of Congress to implement the Treaty's requirements for private parties. The Treaty focuses on banning the manufacture of chemical weapons and requiring the destruction of existing weapons. Because chemical weapons can be manufactured from chemicals that also have non-weapons uses, the Treaty's implementing legislation will require some manufacturers and consumers not involved in the chemical weapons industry to keep records and make annual reports. A few manufacturers also will be subject to inspections by an international compliance team, and the export of certain chemicals will be restricted.

Whether a company is subject to record keeping and reporting under the Treaty is based on the amount and type of chemicals it produces or consumes. Industry groups worked hard to ensure that thresholds were established so that only information necessary to the Treaty's purpose of restricting chemical weapons is collected. In addition, the Treaty exempts several types of chemicals from reporting requirements entirely, including all polymers and oligomers. The Chemical Manufacturers Association (CMA) estimates that, as a result of these thresholds and exemptions, about 2,000 companies in the United States will be affected, and only 200 of these will be subjected to regulatory burdens above submitting a single-page form once a year.

As an overview, the Treaty lists chemicals under four general categories, depending on the risk of their use in chemical weapons. Schedule 1 chemicals can be used as actual weapons agents, and, accordingly, are the most regulated. Schedule 1 chemicals include substances like sulfur and nitrogen mustards, and Lewisites. Export of these chemicals is restricted to Treaty signatories, and manufacturers have stringent record keeping and reporting requirements and may face frequent and detailed inspections. (Extremely small amounts of these chemicals also are used in medical research.) Schedule 2A and Schedule 2B chemicals are direct precursors to chemical weapons agents. Companies that produce or consume 100 kilograms or more per year of a Schedule 2A chemical, or at least one metric ton per year of a Schedule 2B chemical, are subject to record keeping and reporting obligations. Companies that produce or consume more than one metric ton of a Schedule 2A chemical or more than 10 metric tons of a Schedule 2B chemical also may be subject to inspections. CMA estimates that 65 U.S. companies currently produce listed chemicals in amounts above the inspection threshold levels.

Schedule 3 chemicals are higher volume materials that can be indirect precursors to chemical weapons. Substances included in Schedule 3 include phosgene, certain cyanide compounds, and ethanalomines. Manufacturers that produce at least 30 metric tons a year of these chemicals will be subject to reporting and record keeping requirements. Consumers of Schedule 3 chemicals do not have regulatory obligations under the Treaty. The broadest category of chemicals covered by the Treaty is Discrete Organic Chemicals (DOCs). DOCs are chemicals that are several steps removed from being used in chemical weapons and include all chemical compounds containing carbon, except for its oxides, sulfides, and metal carbonates. However, the Treaty exempts all polymers and oligomers, including those that could be considered DOCs. Monomers that meet the definition of a DOC are subject to the Treaty, although only manufacturers that produce more than 200 metric tons a year of a DOC (or 30 metric tons a year of a DOC containing phosphorus, sulfur, or fluorine) are covered. These manufacturers are required to keep records and submit a two-page form once a year. The information required to be submitted consists of the name and CAS Registry Number of the chemical, the amount produced, the amount imported or exported, and a brief statement of the purpose for which the chemical is produced.

Industry groups in the U.S. are working to ensure that the implementing legislation will protect the confidentiality of information required to be submitted under the Treaty. There is already in place a process to protect trade secret and confidential business information collected as a result of the Treaty's inspection and reporting obligations. In addition, the implementing legislation for the Treaty is expected to include a provision to prohibit the federal government from releasing reports and other information that otherwise would be obtainable through Freedom of Information Act (FOIA) requests. Once the legislation becomes law, the Commerce Department, the federal body that will be responsible for administering the Treaty's requirements, will promulgate regulations and publish the forms to be used by affected companies. With regard to inspections, inspection teams will be composed of an international group of civil servants from the various signatory countries. These inspectors are bound by contractual obligations regarding secrecy and future employment. In the US, the implementing legislation currently pending in Congress is expected to exclude officials from the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) to allay concerns regarding backdoor enforcement of other laws through treaty-related inspections.

In Brief . . .

• Nomination of FDA Commissioner Appears Imminent

President Clinton is reported to have on his desk for decision, perhaps within the next week, a list of three candidates from which he will choose a nominee to succeed Dr. David Kessler as FDA Commissioner. The candidates (all medical doctors, in the FDA tradition) have been identified as Dr. Michael Friedman (currently Acting Commissioner), Dr. Jane Henney (currently Vice President of Health Science at the University of New Mexico and formerly FDA Deputy Director for Operations), and Dr. Eve Slater (Senior Vice President, Clinical and Regulatory Development, Merck & Co.).

All three candidates have impressive qualifications. Dr. Friedman, however, actually has a track record in the job of Commissioner, and has acquainted himself well, particularly in handling food safety issues in a way that has avoided undue public concern. Under his leadership, the Agency also has continued to actively support the premarket notification system for food-contact substances.

This will be the first time the nominee for FDA Commissioner will go through the Senate confirmation process. Formal confirmation hearings probably will occur in September or October, but informal "courtesy visits" by the nominee to influential Senators will begin soon after the President announces the nomination.

• FDCPMC Forms Workgroup to Comment on FDA's Proposed GRAS Notification Program

At the June, 1997 FDCPMC business meeting, the Committee formed a workgroup to draft comments on FDA's proposed generally recognized as safe (GRAS) notification proposal (62 Fed. Reg. 18938, April 17, 1997). (For an in-depth discussion of the GRAS notification proposal, see our May 12, 1997 letter.) Comments were developed by the workgroup and filed today. The comments support FDA's proposal as another step to streamline the regulatory process, in line with the Premarket Notification system for food-contact substances that SPI and FDA are seeking to create through legislation. In addition, the comments support FDA's proposal to allow (but not require) electronic filing of GRAS notifications and electronic dissemination (such as through the Agency's Internet homepage) of disclosable information about filed notifications. Copies of the comments can be obtained from SPI.

Other comments have been filed supporting the notification concept. Technical Assessments Systems, Inc. has recommended that FDA respond to all notifications in writing because these responses will be valuable internationally and will serve as an end-point to the notification process. Technical Assessments Systems also commented that FDA should make the non-confidential portions of the notification and the Agency's response available to the public. The second set of comments was filed by Wyeth Nutritionals International. Wyeth commented that companies should be able to submit GRAS notifications for infant formula ingredients. As currently drafted, FDA's proposal specifies that such substances are not eligible for notification treatment.

• FDA Establishes Special Project Team for Color Additives

In an attempt to update the color additive regulations and expedite review of petitions requesting listing as a certification-exempt color additive, or an amendment of such a listing, FDA's Office of Premarket Approval formed the Color Additive Special Project Team (called the "CASPT"). To expedite review, the CASPT will eliminate a number of middle-level review stages that had occurred after the reviewing team issued a draft regulation for a certification-exempt color additive. In addition, the CASPT will review, and possibly propose to correct, the existing regulations for certification-exempt color additives so that the compositions of the additives listed in the regulations match the compositions actually in commerce.

Although the CASPT is modeled after the Special Project Team that expedites food additive petitions, its impact is expected to be much less due to the small number of certification-exempt color additive petitions that are filed. As a reminder, color additives are substances that impart color to food, drugs, cosmetics, or the human body; colorants for food-contact materials are not color additives (assuming, of course, they do not color the food).

• Nestle Proposes Adding Plastic Articles to Confectionery

Nestle, Inc. has proposed to market a new chocolate product in the United States that would contain an imbedded hollow plastic ball with a plastic toy character inside. Although the product is currently marketed in Europe, FDA has expressed concern over a potential violation of Section 402(d)(1) of the Federal Food, Drug, and Cosmetic Act, which prohibits confectionary from containing non-nutritive substances that do not have a functional purpose.

• European Commission Amends Migration Testing Rules

 On June 25, 1997, the Second amendment to Directive 82/711/EEC ("Basic rules for migration testing,") was adopted by the European Commission with no changes to the draft dated December 17, 1996. The amendment calls for a more flexible approach to migration testing requirements, particularly with regard to fatty food testing when the standard testing (with e.g., olive oil or other official simulants) is not appropriate or feasible. The amendment also establishes 10% ethanol as the simulant for alcoholic foods, making it the same as FDA's simulant for non-fatty foods.

• USDA to Propose to End to Authorization Process for Lubricants

We have been advised that USDA intends to discontinue the requirement (and the opportunity) to obtain the Agency's H1 and H2 authorizations for lubricants on machinery for processing meat and poultry products. Our experience indicates that these authorizations may have a significant role in marketing lubricants, and interested companies may want to make their views known to USDA.

• New Procedure for Filings with FDA's Office of Premarket Approval

Filings to be hand-delivered to the Office of Premarket Approval (located on Vermont Avenue in Washington, D.C.) must now be delivered to the FDA offices at 200 C Street, N.W. The material is x-rayed there and subsequently forwarded (twice a day) to Vermont Avenue.

As always, should you have any questions or comments about any of these subjects, please do not hesitate to let us know.

Cordially yours,

Ralph A. Simmons
202/434-4120
July 16, 1997
simmons@khlaw.com

More About SPI:   Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use