SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
June 8, 1998 Newsletter

* * * For Members Only * * *

1. Efforts Continue to Persuade Congress to Fund the Food-Contact Notification Program

2. Proposed Regulations for the FCN Program Submitted to FDA

3. CFSAN Priority Meetings Provide Opportunity to Push the FCN Program

4. EPA and FDA Close to Legislative Fix for Jurisdictional Dilemma Over Antimicrobials

5. FDA Status of Diethylene Glycol and Ethylene Glycol

6. Update on Recent Developments with Regard to Potential Endocrine Disruptors

7. Germany’s BgVV Announces Elimination of Outdated Recommendation XL

8. Henney Expected to be Nominated for FDA Commissioner; Senator Coats Begins Inquiry

9. Report on the Status of Food Packaging Issues at the Codex Alimentarius Commission

10. Legislation to Protect Biomaterials Suppliers Makes Slow Progress

11. FDA Suggests New Claims for Latex Gloves

12. Single Food Agency Idea Still Being Debated

13. Pallone FDA Enforcement Bill

14. Mandatory Food Recall Idea Debated at FDLI Conference

15. In Brief

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

Dear Ladies and Gentlemen:

This letter reports on several issues in the United States and abroad that we feel are of significant interest to the Committee. In particular, we want to bring you up to date on our efforts to persuade Congress to appropriate the funds necessary to implement the new notification program for food-contact substances. Continuing with the notification theme, we also recently provided the Food and Drug Administration (FDA) with our proposed regulations for the program in an effort to ensure that the result is a simpler, more efficient regulatory scheme for food packaging materials. In addition, we intend to impress upon FDA the importance and benefits of implementing the notification systems at public meetings scheduled for June 24 and 25 to solicit comments on the appropriate priorities for the Center for Food Safety and Applied Nutrition (CFSAN).

In other matters, the Environmental Protection Agency (EPA) is getting closer to adopting a screening and testing program for potential endocrine disruptors. At the same time, the local media in Japan is exaggerating fears regarding endocrine disruptors after the publication of Theo Colburn’s Our Stolen Future in that country. This letter contains information on a number of important issues in Europe as well.

On a solemn note, we are sad to report to those on the Committee not already aware of it that John Modderman, a staff scientist with Keller and Heckman and former FDA employee, died suddenly on April 25, 1998. John was an active member of the Codex Alimentarius Commission and sat on its Food Additives and Contaminants Committee (CCFAC). John worked diligently during his ten years with Keller and Heckman to monitor and protect the interests of the food packaging industry on the Codex Committee. Shortly before his death, John reported on the developments at the March 1998 meeting of the Codex Committee on Food Additives and Contaminants and its impact on the food packaging industry; his report appears in this letter. John is survived by his wife and four teenage children. He will be missed by everyone at Keller and Heckman and, we are sure, by the many members of the FDCPMC who knew him.

1.Efforts Continue to Persuade Congress to Fund the Food-Contact Notification Program

We are working intensively to obtain Congressional funding for the food-contact notification (FCN) system as the House and Senate Appropriations Subcommittees with responsibility for the Food and Drug Administration (FDA) prepare to vote on the Agency’s funding for the 1999 fiscal year (FY) on June 9. As you will read below, obtaining full funding of this program is now more important than ever, and it is extremely likely that the program will only be implemented by FDA if Congress appropriates $1.5 million for the program in FDA’s FY99 budget. We have contacted those of you on our e-mail lists to ask for support in the form of contacts with your company’s Congressional representatives to urge funding for the FCN system. We will soon see whether all of your and our efforts obtain the desired result.

As you know, the industry was willing to pay user fees to fund the notification program, but, because of certain political interests in Congress, the new law which enacted the FCN system requires the program to be funded from FDA’s budget. In our last letter, we mentioned that, if Congress does not appropriate the $1.5 million, an argument can be made that FDA still would be required to commence the program. However, we 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 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, 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 FCN program, making it the exception rather than the rule for FDA clearance of food-contact substances. Indeed, high-level contacts at FDA have indicated that, even if Congress includes funding for the FCN system in FDA’s budget, the Agency will view that funding as having been taken from other FDA programs, reducing the enthusiasm for full implementation of the FCN process.

We are continuing to work intensively for support in Congress to fund the FCN program, which is our only hope at this point of achieving any meaningful implementation of the program. This campaign involves 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 will become involved in urging Congress to fund the program. With the help of the Washington representatives group, we have stimulated interest in both the House and the Senate Appropriations Subcommittees to put language in the Subcommittee budget reports that would direct FDA to use $1.5 million of its budget for the notification program. We hope to see these efforts bear fruit after the June 9 Subcommittee votes.

2. Proposed Regulations for the FCN Program Submitted to FDA

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. 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 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 for 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.

In addition, we 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.

3. CFSAN Priority Meetings Provide Opportunity to Push the FCN Program

In a very recent and somewhat unusual development, the Center for Food Safety and Nutrition 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. As we stated earlier, 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.

4. EPA and FDA Close to Legislative Fix for Jurisdictional Dilemma Over Antimicrobials

When we reported on this issue in our last letter, the Environmental Protection Agency (EPA) and FDA were progressing slowly toward a resolution of the jurisdictional quandary brought about by the passage of the Food Quality Protection Act (FQPA), which, as you know, 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 reviewed favorably 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 then would 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.

5. FDA Status of Diethylene Glycol and Ethylene Glycol

The Division of Health Effects Evaluation (DHEE) of the Office of Premarket Approval (OPA) at FDA has very recently begun to hold up all food additive petitions which involve diethylene glycol (DEG), whether as a food additive or as an impurity. Reportedly, DHEE will be requesting additional data concerning a Japanese study (circa 1990) that apparently did not evaluate the possibility of bladder tumors, despite the fact that an earlier study indicated that DEG may cause bladder tumors. The earlier study which indicated a possibility of bladder tumors was known to have been performed using diethylene glycol with a large amount of unidentified contaminants. Therefore, FDA could not rely upon the findings. Both of these studies have been known by toxicologists at FDA for some time, but are for some unexplained reason now being reexamined by DHEE.

DHEE now wants additional data from the later Japanese study to determine, if possible, why they did not consider possible bladder tumors, or whether there is more data that were not reported. The level of data that will be requested may be as little as summary data for petitions with diethylene glycol as an impurity to a complete (translated) copy of all the study data where the DEG itself is the food additive.

Currently no new studies on ethylene glycol are under review by FDA. Some personnel in DHEE have suggested orally that ethylene glycol contamination of diethylene glycol could be the source of bladder tumors reported in the study referenced above. However, we know of no other studies that suggest that ethylene glycol may be a carcinogen, and we are perplexed as to why FDA would have concerns with this substance. At present, petitions with ethylene glycol as an impurity or for use as a food additive are very much at the mercy of the individual DHEE reviewers. There has been no hold placed on reviews of petitions with ethylene glycol, but ethylene glycol could easily be pulled into the general inquiry on DEG.

6. Update on Recent Developments with Regard to Potential Endocrine Disruptors

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 ¹. 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.

1. EDSTAC Screening and Testing Recommendations

   In August of 1996, Congress passed the Food Quality Protection Act (FQPA) and the Safe Drinking Water Amendments (SDWA). These statutes require EPA to develop a screening program to evaluate the estrogenic effects of pesticides and some nonpesticidal substances. EPA is required 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 naturally-occurring estrogen or other endocrine effects as the Agency deems appropriate. 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 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 scheduled to finalize its report to EPA this month. This report then 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 will be provided in Dr. Lester Borodinsky’s Technical Advisor’s Report for the upcoming FDCPMC meeting. 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.

   Under the screening program outlined in the draft report, 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 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 indicate an effect. The monomers and oligomers used to manufacture these polymers would be given priority for testing. In addition, chemicals that are produced in quantities that exceed 10,000 pounds per year also would be given priority. Six specific mixtures that have high exposure or particular exposures to infants also are candidates for early screening.

   The chemicals in the priority group, which number approximately 15,000, will all be screened initially using automated technology in a High Throughput Pre-Screening (HTPS). After chemicals are further prioritized 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 studies are intended to be conducted at multiple doses, while the in vivo studies 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. Initial pilot testing 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 intends to adopt a testing and screening program, at least philosophically, along the lines of the EDSTAC report; so endocrine screening may become a reality in the near future.

2. Endocrine Issues Hot Topic in Japan

   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 as well. Theo Colburn’s book Our Stolen Future was published recently in Japan, and this has led to a great deal 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.

   The publication of Our Stolen Future in this country in 1996 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 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. Currently, the Group is working with the Japanese Styrene Industry Association and the Ministry of Health and Welfare in Japan to assist these groups in planning their own studies.

7. Germany’s BgVV Announces Elimination of Outdated Recommendation XL

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 is a list of materials approved for use in food-contact coatings ². 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 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 such listings as 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).

8. Henney Expected to be Nominated for FDA Commissioner; Senator Coats Begins Inquiry

Dr. Jane Henney is reportedly the Clinton Administration’s lead choice to be nominated for the position of FDA Commissioner, a position that has been vacant for over a year since the departure of Dr. David Kessler. Dr. Henney is currently Vice President for Health Services at the University of New Mexico, but she previously was a high-level official at FDA. Dr. Henney’s previous service at the Agency is now the subject of an inquiry by Senator Dan Coats (R-IN), Chairman of the Labor Committee which will review the Administration’s nomination for Commissioner. Senator Coats has sent two letters to Health and Human Services Secretary Donna Shalala requesting that the FDA provide information on Henney’s past FDA actions regarding tobacco, the abortion pill RU-486, breast implants, folic acid, and the Temple Commission report.

The Temple Commission report set up what is referred to as the “drug model” for the regulation of medical devices and has received sharp criticism by the industry because many feel it failed to take into account the important differences in the appropriate regulation of devices and drugs. Dr. Henney’s involvement with the Temple Commission has led the device industry to openly question her appointment as FDA Commissioner.

Senator Coats asked that FDA respond to his request by May 18, and speculation is that this information will be used against Dr. Henney during confirmation hearings in the event she is nominated. Reportedly, the announcement of Dr. Henney’s nomination is awaiting the completion of her FBI clearance, but the announcement is expected to be made soon.

9. Report on the Status of Food Packaging Issues at the Codex Alimentarius Commission

John Modderman attended the recent meeting of the Codex Alimentarius Commission in March of this year. The following is Dr. Modderman’s report of the meeting. Generally, the interests of the Codex Committee on Food Additives and Contaminants (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, inevitably will 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 this CCFAC meeting, 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. Migration of substances 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 significance.

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 fora 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.

10. Legislation to Protect Biomaterials Suppliers Makes Slow Progress

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.

11. FDA Suggests New Claims for Latex Gloves

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.

12. Single Food Agency Idea Still Being Debated

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 The Society of the Plastics Industry, Inc. (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 implementation in the near future (we hope) 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.

Kay Holcombe, Executive Vice President of Policy Directions, Inc. and former FDA Deputy Commissioner for Legislative Affairs from 1991-1993, made comments regarding the single food agency idea at the April 20-21 Food Update ‘98. Many of you may recall that Ms. Holcombe was most recently on the minority staff of the House Commerce Committee where she was extremely helpful to us in getting the food-contact notification program enacted this past fall. Holcombe argued that the debate in Congress will not focus on whether a single food agency is necessary, but on who will be in charge in Congress. Because eight agencies and multiple Congressional committees have some type of food safety authority, there will likely be significant confusion and tension over consolidation into a single agency. Holcombe added that, since this is an election year, neither the Administration nor Congress will be willing to say that the U.S. food supply is unsafe, thus, the idea may lack sufficient justification in the eyes of lawmakers. Moreover, while some industry groups are supporting the idea, it appears that the overall industry is split. For instance, agriculture groups are currently happy with the USDA and do not want an FDA-like presence in their business. On the other hand, many consumer groups are happy with FDA because of its perceived consumer-friendly approach. With the interested parties taking a number of different positions, Holcombe concluded that single food safety agency legislation would only be considered in Congress if either a major food safety crisis developed, or the White House started to apply pressure on Congress so that Members might be able to deflect criticism from their constituents.

13. Pallone FDA Enforcement Bill

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 whistleblower protection, and increasing the number of inspections. H.R. 3676 also would require FDA to work with the Center for Disease Control and Prevention to heighten surveillance and tracking of foods, particularly imported fruits and vegetables.

With respect to the registration provision in the bill, H.R. 3676, would for the first time require existing and new food producers to register their products with FDA before being able to market them. Under this new approach, FDA would be able to collect additional information on food producers, which would allow the Agency to keep tabs on the overall track records of registering companies and help FDA to prioritize its inspections by focusing on companies with lackluster histories.

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 Republican leadership will be hesitant to take up any controversial legislation 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.

14. Mandatory Food Recall Idea Debated at FDLI Conference

The idea of giving FDA authority to require recalls of food products, as Rep. Pallone has proposed, was the subject of a panel discussion at a Food and Drug Law Institute (FDLI) conference held on April 27. At the conference, consumer groups advocated that FDA desperately needs the authority to recall foods. Caroline Smith DeWaal, Food Safety Director for the Center for Science in the Public Interest (CSPI), voiced concern over the fact that companies often move too slowly or fail to follow through on FDA recall requests entirely. In light of this type of company behavior, Smith DeWaal argued that FDA needs stronger authority to force food recalls.

On the other side, John Goldberg, staff member for the House Agriculture Committee, questioned whether there was a need to change a system that is already apparently working. FDA must show Capitol Hill a good rationale for Congress to consider such a legislative change, in particular, why FDA mandatory recall authority would enhance food safety. Representatives of the food industry also weighed in on the topic at the conference and stated that the current recall system is adequate and that any legislation at this time is unnecessary.

So far, FDA officials appear to be ambivalent towards the idea. FDA sources stated that many within the Agency believe that the current system is working well and that legislation would only create a larger bureaucracy and other burdensome tasks for FDA. As we reported to you in our letter last year, FDA had planned to draft mandatory recall legislation, but has not followed through with a draft to date. The reluctance on FDA’s part to develop draft legislation has further slowed the legislative process in this area. It is very likely that, until FDA moves forward and offers draft legislation, any mandatory recall legislation will remain stalled in Congress.

15. In Brief

• On April 30, FDA officially suspended the voluntary reporting program, the consumer assistance program, and laboratory studies for cosmetics within the Office of Cosmetics and Color Additives (OCCA). The only functions at the OCCA that will continue with respect to cosmetics will be compliance programs and responses to Freedom of Information Act requests. FDA is shifting its resources away from the already limited regulatory attention to cosmetics and into higher priority Agency activities, such as the Food Safety Initiative.

• Since FDA proposed the elimination of the GRAS petition affirmation procedure in favor of a notification system, CFSAN’s Office of Premarket Approval (OPA) has received a total of five GRAS notices; all for direct additives. The proposed rule encouraged the submission of GRAS notices during the period between publication of the proposed and final rules and FDA has used this opportunity to evaluate their proposal. One of the major concerns voiced by OPA now that personnel have had a chance to work on the GRAS notices is whether 90 days is sufficient time for FDA to respond. FDA had requested comments on the appropriateness of that time frame and it seems that the final rule may reflect a change to a longer review period. FDA had planned to issue a final rule this Summer, but recently indicated that this schedule would not be met and did not provide an alternative deadline. Recent contacts with the Agency have suggested concern about programs with automatic effectiveness after defined periods as imposing priorities on FDA that may detract from other programs.

We look forward to seeing each of you at the FDCPMC meeting in June. In the meantime, should you have any questions or comments regarding any of these subjects, please do not hesitate to let us know.

Cordially yours,

Ralph A. Simmons

(202) 434-4120
simmons@khlaw.com
http://www.khlaw.inter.net Back to Top

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