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 SPI
- Food, Drug, and * * * For Members Only * * * Table of Contents
To: SPI Food Drug and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: This letter reports on several issues that we believe are of special interest to the Committee. Of particular note are the recent additional staff changes at FDA's Center for Food Safety and Applied Nutrition (CFSAN), following the appointment of Mr. Joseph Levitt as the Center's new Director. FDA has announced that Dr. Alan Rulis, formerly head of the Office of Premarket Approval (OPA), will now become the Center's Acting Director for Programs, and Dr. Laura Tarantino will move into the leadership position at OPA as Acting Director. The letter also provides updates on matters of continuing interest, including our efforts to secure funding for the new Food-Contact Notification (FCN) system. As many of you know from our previous letters, we are working with the Washington representatives of SPI member companies to urge Congress to appropriate the necessary funds for this program. In this regard, we thought you would be interested in the enclosed copy of a recent letter that Representatives Bliley (R-VA) and Stupak (D-MI) sent to the House Appropriations Committee in support of funding for the program. In other news, this letter contains information on a consortium that is forming to seek a broader clearance for packaging which can be used to hold foods during radiation treatment, so that industry can take full advantage of FDA's recent approval of the irradiation of meat. In addition, we report on USDA's elimination of the requirement for the preclearance of non-food compounds and proprietary substances in federally-inspected meat and poultry facilities. The letter also discusses EPA's announcement of a new rule regarding food packaging that is impregnated with insect repellents and the Agency's release of draft proposals to modify the so-called "treated article" exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Finally, at the request of Dr. Luigi Rossi, chief staff member of the European Union's (EU's) food-packaging regulatory program, we are passing along his letter regarding the new policy on incomplete or incorrect submissions to the Scientific Committee on Food (SCF).
1. Rulis Named Acting Deputy Director for Programs at CFSAN; Tarantino Takes Over as Acting Director of OPA Dr. Alan Rulis, head of FDA's Office of Premarket Approval, was named Acting Deputy Director for Programs for the entire Center for Food Safety and Applied Nutrition on February 23. In his new position, Dr. Rulis will likely play a major role in the development of the very influential Codex General Standard for Food Additives and is the lead candidate to become the permanent Deputy Director for Programs at CFSAN. Dr. Rulis will oversee the operation of seven offices in CFSAN, including OPA. Assigning these new responsibilities to Dr. Rulis will allow CFSAN's other deputy director, Janice Oliver, to concentrate on the Food Safety Initiative (FSI) and other related matters. Dr. Laura Tarantino will become acting OPA Director. Dr. Rulis will remain involved with certain OPA matters, but it is expected that he will mainly concentrate on his CFSAN appointment. Dr. Tarantino and the other OPA division directors will handle the bulk of the food additive petition load. Bob Lake will remain as Director of Policy for CFSAN. It has also been reported that Dr. Rulis may become the primary advocate for funding the parts of CFSAN that are likely to face budget cuts in (fiscal year) FY 98 and subsequent years. The Administration strongly supports FSI and will ensure sufficient funds for FSI-related programs. However, CFSAN officials are expecting the rest of the Center to face budget cuts. Some CFSAN offices under Dr. Rulis' management that are not part of the FSI may receive funding cuts of over 10% for FY 99.
2. Efforts Continue to Obtain Funding for the Food-Contact Notification Program We expect that many of you are interested in being updated on our continuing efforts to ensure that Congress will fully fund the recently enacted food-contact notification (FCN) system. As you undoubtedly know, the Food and Drug Administration Modernization Act of 1997 (FDAMA) provides that $1.5 million dollars (or an amount equal to that requested in the President's budget) needs to be appropriated in FY 99 for the FCN program to be implemented. We are working with the Washington representatives of a number of FDCPMC member companies to educate the members of the Congressional Appropriations Committees on the importance of this new regulatory program to the food-packaging industry. FDCPMC representatives have now met with nearly every member (or their staff) of the Senate and House Appropriations Subcommittees that deal with FDA's budget. Members of the FDCPMC group also attended hearings on the FDA budget which were held by the House Appropriations Subcommittee on Agriculture, FDA, Rural Development, and Related Agencies. At the hearing, acting Commissioner Michael Friedman and other FDA officials answered many questions about the Agency's regulatory priorities and defended the President's budget. Due to a number of votes on the House floor, however, few of the Subcommittee members were in attendance at any one time, and the hearings did not proceed smoothly. FDCPMC member company representatives had contacted some of the Subcommittee members before the hearing about asking questions on the FCN program, but, because of the limited time that the Subcommittee was actually in session due to floor votes, no questions were asked. After the hearing, however, Rep. Marcy Kaptur (D-OH) submitted written questions to FDA on the funding needed for the FCN program, and FDA's answers will be placed in the record. As many of you know, the President's budget request contains several provisions for funding FDA's programs, including the FCN system, through user fees. It is interesting to note that, in his opening remarks at the hearing, Chairman Skeen (R-NM) stated in no uncertain terms that the Subcommittee would not consider, or even discuss, the option of new user fees. The FDCPMC working group was successful in getting 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 copy of this letter is attached. We understand that a similar letter, which is being organized by Senators who were on the Conference Committee, will be sent to the members of the Senate Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies. This Subcommittee is scheduled to hold hearings on FDA's budget on March 31. The critical phase of the appropriations process is now beginning, so it is most important that we demonstrate to Congress as much constituent support as possible for the FCN program. Several companies have asked their plant managers to write letters to members of the House or Senate representing their facility's location urging support for funding. Additional letters would be very helpful. You may wish to provide your Congressional contacts with a copy of the attached letter from Representatives Bliley and Stupak to assist them in drafting their own letter. Please let us know of any contacts you may make on behalf of support for the FCN funding measure, so that we can best focus our resources. We, of course, will continue to keep you fully informed of our efforts and of any developments that may occur.
3. EPA Transfers Jurisdiction of Food Packaging Impregnated with Insect Repellents to FDA 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. See 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. See 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. See related story on page 8. 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. Under the direct final rule procedure, this regulation will go into effect within 60 days if no relevant adverse comments are received by EPA in the next 30 days. Although we are still considering the implications of this change, we believe EPA's proposal is basically sound. We are slightly concerned that as written the new 40 C.F.R. § 180.4 states that inert ingredients are "subject to regulation by the Food and Drug Administration as food additives under FFDCA Section 409." This language does not take into account the fact that not all food-contact materials are regulated under Section 409. For instance, the materials may be GRAS, prior sanctioned, or not reasonably expected to become a component of food. Also, a favorable Threshold of Regulation determination constitutes a decision that a Section 409 clearance is not required, although it is not clear whether EPA would consider such a determination to constitute a regulation under Section 409. As a practical matter, the new FCN system will be available to establish clearances for substances that do not already have a formal Section 409 clearance. The new notifications should be acceptable to EPA as evidence of a satisfactory FDA status, since such notices will be submitted under Section 409.
4. Consortium Forming to Obtain Broader Clearance for Packaging Used to Hold Foods During Irradiation As many of you know, FDA recently 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). A second meeting organized by NCFST was held on March 10 with the purpose of developing a collaborative strategy toward obtaining a broader approval of materials permitted for use under Section 179.45. Any companies that may be interested in such an effort should call either George Misko at Keller and Heckman (202-434-4170) or George Sadler at NCFST (708-563-8170).
Food irradiation is also receiving attention in the European Union (EU) where the European Parliament met last week and approved two European Council proposals on food irradiation. These proposals aim to harmonize the national laws regarding irradiation in the EU, which is no small feat considering that only France, Belgium and The Netherlands permit food irradiation as a commercial practice and radiation treatment is banned in Germany and Sweden. Despite strong differences of opinion among Parliamentary members over the last several years, it now appears that the EU may be moving towards establishing a framework directive that would cover the general and technical aspects of the irradiation of food and food ingredients. A second proposal would establish a positive list of foods and food ingredients that could be treated with radiation.
5. FSIS Announces Intent to Eliminate Prior Approval Requirement for All Non-food Compounds USDA's Food Safety and Inspection Service (FSIS) recently 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. See 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 its Federal Register notice, however, FSIS requests comments on whether this alternative is, in fact, feasible. Comments on the FSIS proposal must be received on or before April 14. Please let us know if you have interest in submitting comments to FSIS regarding this proposed rule. Although USDA appears to have limited the scope of comments severely, we would recommend that any companies concerned about the elimination of the prior approval process include such concerns in their comments so that USDA is at least made aware of your position.
6. EPA "Clarifies" FIFRA Treated Articles and Formulations Exemption Recently, the U.S. Environmental Protection Agency (EPA) released a draft Federal Register notice and a draft Pesticide Registration (PR) notice intended to clarify the criteria that pesticide products must meet to be eligible for the FIFRA "treated article" exemption and to set forth the Agency's current and future enforcement policy with regard to claims that may be made for "treated articles and formulations" that are exempt from FIFRA registration requirements. By way of background, although "treated articles" are pesticides within the meaning of FIFRA, under 40 C.F.R. § 152.25(a), an article (or formulation) treated with or containing a pesticide to protect the article itself is exempt from all requirements of FIFRA, including the often costly registration requirements, provided the pesticide used to protect the article is registered for such use. This exemption was created to save EPA resources by assuring that EPA would not have to review the same safety and efficacy data twice -- once to register the pesticide and a second time to register the treated article. However, as evidenced by these draft notices and EPA's recent enforcement activities, EPA is continuing to narrow the interpretation of the "treated article" exemption to limit, where possible, the use of products containing antimicrobials. As EPA is now interpreting the "treated article" exemption, many unregistered articles currently on the market are illegal. EPA will not bring enforcement action against such products as long as the following restrictions are observed: 1) claims concerning the presence of a pesticide in the treated article are limited solely to protecting the treated article; 2) no implied or explicit public health claims of any kind are made; and 3) when such claims involve antibacterial properties (i) the words antibacterial, antimicrobial, or germicidal, or related terms are not a part of the name of the product, and (ii) the claims are qualified by statements indicating that the antibacterial properties do not protect users and others against disease and that users should follow prudent hygienic measures. In its Federal Register notice, EPA warns that it will pursue enforcement against manufacturers of treated articles that are not marketed in accordance with this policy. In the draft PR notice, EPA revealed its current view that the treated article exemption is even more restrictive than the interim enforcement policy noted above. Assuming the PR Notice is finalized as presented on the draft and that the validity of EPA adopting these "clarifications" in the absence of rulemaking is not successfully challenged, terms such as antibacterial, antimicrobial, and germicidal may not be used in labeling and advertising materials at all, and claims of aesthetic significance attributable to a pesticide component may not be made. The only permitted pesticidal claim would be the following specific language: This product contains a preservative (fungicide, insecticide) built in (or applied as a coating) only to protect the product. Any other claim would require registration of the treated article itself.
7. NIEHS Releases Study on the Reproductive and Developmental Effects of Nonylphenol As you may recall from previous reports, the Alkyl Phenol Working Group of SPI's Inter-Industry Group on Bisphenol A and Alkyl Phenols (IIG) focuses its efforts on the alleged endocrine modulating effects of several classes of alkyl phenols, one of which, nonylphenol, is a starting material for such components of plastics as ethoxylates (emulsifiers) and trisnonylphenylphosphite (TNPP) (stabilizers). Recently, the National Institute of Environmental Health Sciences (NIEHS) completed a study on nonylphenol that indicates that the material is not a reproductive or developmental toxicant at levels below those that cause general toxicological effects. The NIEHS study, which evaluated reproduction in three generations of laboratory rats (30 male and 30 female rats), found that dosing the rats' diet with nonylphenol had "no consistent effect on fertility," and that any changes in the subjects' reproductive parameters could be traced to body and organ weight changes, not to any reproductive or developmentally toxic properties of nonylphenol. According to the study, the "No Observed Effect Level" (NOEL) for reproductive toxicity could be set at 15 milligrams of nonylphenol per kilogram of body weight in rats, based on a dosage of 200 parts per million (ppm) for rats. In addition, the study determined that the maximum tolerated dose for adverse effects on fertility in rats could be set at 2,000 ppm, indicating that the No Observed Adverse Effect Level (NOAEL) for fertility effects could be set at greater than 150 milligrams of nonylphenol per kilogram of body weight in rats. The Alkyl Phenol Working Group has been studying the dietary exposure to nonylphenol from its use in ethoxylates and TNPP in food-contact plastics. The results of this study are not yet available; however, they will appear in a report that is scheduled to be released next month. Preliminary indications of this study are that the dietary exposure to nonylphenol from its use in food-contact materials is several orders of magnitude below the effect levels for reproductive and developmental toxicity reported in the NIEHS study.
8. EU Announces New Policy Regarding Incomplete/Incorrect Submissions Dr. Luigi Rossi, chief staff member of the section of the European Commission that is responsible for the regulation of food packaging, wrote to us on March 5, 1998 and asked for our assistance in notifying those companies who submit technical dossiers to the European Commission about a new policy under which submissions to the Scientific Committee on Food will be returned to the petitioners. Dr. Rossi's letter is reprinted below in its entirety. Dear Sir/Madame, It has been noted that some petitioners do not make correct use of the guidelines for the submission of a petition. In practice they continue to make all the mistakes underlined in page 27 of the Practical Guide No. 1 which remains in use. One of the more common mistakes is not to use the appropriate model letters (see the "compilation of all amendments to the Practical Guide" (CS/PM/2604 Rev. 2)) as well as not sending the full dossier to RIVM, or the Commission or to TNO (the dossier to TNO should not contain toxicological data). These mistakes can no longer be tolerated by the EC services, which are put to a great deal of trouble by the non compliance of these guidelines. Therefore, it has been decided that all incorrectly submitted petitions will be sent back to the petitioner. I would like to take this occasion to stress that the Commission services only manage the cellulose and plastic directives (see Articles 1, paragraph 2, of Directive 90/128/EEC, for the field of application in plastics). From now on, any submission related to all other products, not yet regulated by a positive list (e.g. substances for surface coatings, colorants, inks, adhesives, catalysts etc.), will no longer be considered and will be sent back with a negative AAP. I would be grateful if you could distribute this message to all the petitioners associated to your organisations, as well as to any other professional organisation directly or indirectly concerned by this information in Europe and outside. Yours sincerely,
In previous letters we have reported that Dr. Jane Henney was a leading contender for the nomination of FDA Commissioner. Dr. Henney is currently Vice President of Health Sciences at the University of New Mexico. Apparently, she is another step closer to being nominated as, reportedly, the White House has sent her name to the Federal Bureau of Investigation for final clearance before announcing her nomination. As we reported last year, on April 17, 1997, FDA proposed a new generally recognized as safe (GRAS) notification procedure which would replace the GRAS affirmation process. 62 Fed. Reg. 18938. Under the new rule, FDA would no longer affirm that the use of a substance is GRAS, rather the Agency would respond to the notifying party within 90 days that the Agency either objected to the notification (because the submission was inadequate or the company's GRAS determination was unsupported), or by stating that the Agency found the notification acceptable. In the proposed rule, FDA invited the submission of GRAS notifications and the conversion of GRAS affirmation petitions to GRAS notifications in accordance with the procedures outlined in the proposal; however, the Agency specifically reserved the right to take longer than 90 days to act on notifications before the rule is finalized. FDA recently received its first GRAS notifications. Both the notifications were for additives directly added to food. Archer Daniels Midland submitted a notification for isoflavones derived from soybeans and United Grain Growers Limited converted its pending GRAS affirmation petition for refined solin oil as a cooking or frying ingredient to a notification. Linda Kahl will be the leader of FDA's new GRAS notification team. The team is reportedly proceeding cautiously with the first few notifications, but Kahl expects that, after the first few petitions are filed, the GRAS notification system will be running smoothly. Apparently, no decision has yet been made regarding whether FDA will respond to every notification or just those to which the Agency objects, and what form the Agency's response will take. We have previously reported on FDA's concerns regarding latex sensitivities. It has now come to our attention that FDA is exploring the option of reclassifying latex gloves from a Class I medical device to a Class II device. As we reported on February 18 to the Committee, rubber latex products were recently included on a "reserve list" of Class I medical devices that still require 501(k) PMN requirements under the streamlined regulatory scheme implemented as part of the Food and Drug Administration Modernization Act amendments. Class II devices are considered by FDA to require special controls to ensure their safety and effectiveness and, hence, are subject to stricter regulation than Class I devices. With regard to latex gloves, FDA is apparently considering specials controls which would limit the exposure of latex gloves to sensitized individuals. The controls may include requiring medical facilities to adopt standard operating procedures (SOPs) for the use and distribution of the gloves. FDA is also suggesting new stronger warning labels on gloves and expiration date labeling.
As always, should you have any questions or comments about these subjects, please do not hesitate to let us know. Cordially yours, Ralph A. Simmons (202) 434-4120 More About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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