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 November 11, 2001
(202) 434-4120 The Society of the Plastics Industry, Inc. Dear Ladies and Gentlemen: In this letter, we report on the Food and Drug Administration's (FDA) interim final rules implementing the prior notice of food imports and food facilities registration provisions of the Bioterrorism Act. As many of you already know, FDA changed the rules that were originally proposed to now exclude food-contact materials and articles from the requirements, thanks in large part to the efforts of this Committee. FDA held a satellite conference to discuss the revised rules. We also discuss the Committee's submission of comments to FDA on the Agency's proposed rules with regard to recordkeeping and administrative detention of food products. Also on the bioterrorism front, we provide information on changes FDA has made in its Center for Food Safety and Applied Nutrition (CFSAN) to help the Agency deal with potential terrorism. We also discuss FDA's issuance of a guidance document on claims of categorical exclusions and preparing environmental assessments for Food-Contact Notifications and Food Additive Petitions, and FDA's change in the required signed commitments in Drug Master Files (DMFs). In addition, we also provide information on California's consideration of lowering the exposure limit for acrylamide under Proposition 65. Irradiation of food continues to make the news, and we have included in this letter an account of a Consumer Reports article discussing the efficacy of meat irradiation and the United States Department of Agriculture's (USDA) publication of technical requirements for the purchase of irradiated ground beef for the Minnesota school lunch program. Finally, in international news, we report on the release of a new version of the European Union's draft Super Directive on food-contact plastics, the adoption of two laws in the European Union (EU) that will allow for the traceability and labeling of genetically modified foods, and the European Food Safety Authority's report of a risk assessment on semicarbizide concluding that there is no reason for consumers to change dietary habits due to possible presence of the chemical in foods. Table of Contents
1. FDA Issues Interim Final Rules on Prior Notice of Import and Registration of Food Facilities under Bioterrorism Act; Food-Contact Materials Exempt from Both Rules On October 9, 2003, FDA made available its interim final rules governing food facility registration and prior notice of imported food shipments under the Bioterrorism Act. Most notably, the rules specifically exempt food-contact materials and articles from these two rules by changing the definition of the word "food" for purposes of the Bioterrorism Act to exclude food-contact substances as they are defined in Section 409(h)(6) of the Federal Food, Drug and Cosmetic Act ("the Act"). 1 This result was obtained through extensive work by SPI, through this Committee and in cooperation with other trade associations representing packaging industries. The Committee obtained expressions of Congressional intent not to cover packaging. When FDA nevertheless covered packaging in the proposed regulations, the Committee filed comments with FDA and the Office of Management and the Budget (OMB), met with officials of FDA, OMB, and the Department of Health and Human Services (HHS) (FDA's parent Agency), and worked in an industry coalition to obtain additional help from Congress. The rules, which were published in the Federal Register on October 10, will go into effect December 12, 2003. A comment period will remain open until December 23, 2003; this comment period will be reopened for an additional 30 days beginning in March 2004. The Agency then plans to issue the final rules for these two provisions sometime next spring. FDA held a satellite downlink conference on October 28 to discuss the rules. A transcript of the conference should be available on FDA's website soon. Of particular interest to container manufacturers, FDA stated that, with regard to facilities that maintain food on-site for test packs, these facilities will need to register if the food is being manufactured, processed, packed or held for U.S. consumption. Interim final rules implementing the administrative detention and recordkeeping provisions of the Bioterrorism Act are expected by December 12th. As proposed, both of these rules would cover all food packaging materials and articles. Given the result with respect to import notification and facility registration, we are hopeful that the final regulation on recordkeeping will not apply to manufacturers of food-contact materials, as urged by SPI. The Committee, however, did not ask for exemption of packaging materials from the rule on administrative detention, which allows FDA to detain products only based upon credible evidence of a threat of serious injury or death. Our comments on these proposed rules are discussed below. The registration and prior notice of import rules and the Agency's talk papers on these rules are available on FDA's website at http://www.fda.gov/oc/bioterrorism/furls/. 2. Committee Submits Comments on FDA Recordkeeping and Administrative Detention Proposals under the Bioterrorism Act On behalf of the Committee, we submitted comments to OMB and FDA regarding FDA's proposed rule to require the establishment and maintenance of records by persons who handle food products. We also submitted comments to FDA on the proposed rule regarding administrative detention of food for human and animal consumption. Again, these proposals were drafted by FDA to implement provisions in the Bioterrorism Act. With regard to the recordkeeping proposal, we opposed the application of the provision to suppliers and transporters of packaging or other food-contact articles on the basis that it is in contravention of Congressional intent and will unduly burden industry while providing no significant protection against terrorism. Furthermore, FDA misinterpreted the language of Section 306 of the Bioterrorism Act with regard to the applicability of the provision to the packaging industry. On the subject of recordkeeping, the Bioterrorism Act states that FDA may implement regulations to require recordkeeping by persons (excluding farms and restaurants) who "manufacture, process, pack, transport, distribute, receive, hold, or import food," to the extent such records are needed to allow FDA to identify the "immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals" (emphasis added). Based on the language of the statute and our knowledge of the underlying Congressional intent (through discussions with those involved in drafting the law), we are confident that Congress was using "food" according to the ordinary understanding of the word, meaning edible food, not packaging. Furthermore, the reference to "packaging" in addition to "food," indicates a distinction between the two terms in the view of the drafters. The law and Congressional intent would be satisfied by just the food processor maintaining records identifying the source of the finished packaging for the food product. We also stated that including food-contact materials in the regulation beyond the limited extent described above will impose burdens on manufacturers (and transporters) of such materials that are disproportionate to any minimal reduction in risk and that will provide no significant protection against terrorism. Regardless of whether or not the recordkeeping requirement would apply only to finished food packaging (as indicated by FDA in meetings but not so limited in the language of the proposed regulation), it would impose an ongoing, significant burden on the companies involved. We also pointed out the difficulty companies will have responding to requests for records by FDA within the amount of time required under the proposal. The proposal requires that companies make information available to FDA within 4 hours of a request made by the Agency between 8 a.m. and 6 p.m., Monday through Friday, or within 8 hours if requested at any other time. Even if the information is available from existing records, the 4 - 8 hour window for response certainly will require many companies to establish a procedure dedicated to the records required by FDA, as opposed to relying on existing systems. In addition, we argued, requiring suppliers of food-contact materials to keep these records would have limited usefulness in satisfying the purpose of the Bioterrorism Act, which is to "expand FDA's powers to prevent and respond effectively to terrorist threats against the food supply." It seems unlikely that terrorists would take such an indirect approach to contaminating the food supply. At the least, this prospect seems sufficiently remote so as not to justify the additional burden that would be imposed on suppliers and transporters of food-contact materials. We also asked for clarification as to what food-contact materials FDA is proposing to be subject to the rule. As we have explained, the proposal as drafted could be interpreted as applying to literally all food-contact articles and materials. The preamble to the proposed regulation and FDA's public statements, however, suggest that the Agency only intends for "finished" food packaging, not all food-contact substances, to be subject to the rule. We included in the comments language FDA could use to exempt food-contact materials from the rule, and language FDA could use to limit the proposed regulation to finished packaging for direct contact with food. We stressed that the proposed regulation should be revised to implement the intent of the Congress, which was not to extend the Bioterrorism Act to any packaging or packaging materials not yet containing food. Finally, we pointed out that FDA's estimate of the burden on industry is low. In attempting to estimate the number of food packaging companies affected by the proposal, FDA used counts of facilities found in the County Business Patterns (CBP), which was created by the U.S. Census Bureau. Data in the CBP is tabulated by industry as defined in the North American Industry Classification System (NAICS) Codes. A particular NAICS Code corresponds to a specific industry or subset of industry. In the discussion of the estimate of firms affected, FDA references twenty NAICS Codes for the food packaging industry. See 68 Fed. Reg. 25201. These codes correspond to general categories of finished packaging manufacturers, such as "Plastics Bottle Manufacturing," "Paperboard Container Manufacturing," and "Glass and Glass Product Manufacturing." Thus, many manufacturers of the materials used in the production of food packaging are not included in the estimate. As a result, FDA's estimate of the burden is unrealistically low if the regulation remains as drafted, meaning that it applies to all domestic and foreign manufacturers and domestic transporters of food-contact materials. In comments to OMB and FDA on the administrative detention provision, we did not oppose the applicability of the proposal to food-contact materials, because, as discussed above, this FDA authority to detain products would only come into play in the event of credible evidence of a threat of serious harm or death. We simply asked for clarification as to which materials FDA intends to be subject to the provision. As is the case with the other proposals drafted to implement provisions of the Bioterrorism Act, the administrative detention provision could be interpreted as applying to all food-contact articles and materials. On the other hand, the Agency has expressed an intent to limit administrative detention to finished packaging that is in immediate contact with food. We also provided suggested language FDA could use to limit the provision to finished packaging. 3. FDA Issues Draft Guidance Document on Preparing Environmental Assessments and Claims of Categorical Exclusions In the September 17, 2003 Federal Register, FDA announced the availability of a draft guidance document providing information on how to prepare claims of categorical exclusion and environmental assessments (EAs) for submission to CFSAN. As you probably know, Food-Contact Notifications and Food Additive Petitions are required to contain information on the environmental impact of the substance that is the subject of the submission, pursuant to the National Environmental Policy Act of 1969 (NEPA). In certain cases, however, an environmental assessment is not required. These "categorical exclusions" are described in 21 C.F.R. Part 25 of FDA's regulations. The following topics are covered in the draft guidance: (1) the types of industry-initiated actions that are subject to a claim of categorical exclusion; (2) what a claim of categorical exclusion must include by regulation; (3) what an EA is; (4) when an EA is required by regulation and the format that should be used; and (5) suggestions CFSAN has for preparing an EA. A section of the document that is intended to provide specific guidance on preparing an EA for food-contact materials present at more than 5% by weight is not yet complete, and, therefore, not included in this draft. The Agency plans to issue this section of the guidance at a later date. Comments on the guidance may be submitted to FDA at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be filed at http://www.fda.gov/dockets/ecomments. Since the draft does not yet contain specific guidance on preparing EAs for food-contact materials present at more than 5% by weight, those wishing to comment on the draft may wish to wait until the guidance is complete. The document in its current form is available on the Agency's website at http://www.fda.gov/OHRMS/DOCKETS/98fr/03D-0379-GDL00001.pdf. 4. FDA Reorganizes CFSAN to Address Food Security and Obesity Joseph A. Levitt, Director of FDA's CFSAN, announced in late June that several management changes in the Center took place to make it easier to deal with potential terrorism. Dr. Robert Brackett, Director of Food Safety, and his staff are responsible for coordinating food security and counter-terrorism activities within CFSAN, FDA, other state and federal agencies, and industry. The name of the Food Safety Staff was changed to "Food Safety and Security Staff" to reflect the department's new focus. A new position, "Senior Advisor for Applied Nutrition," was created to coordinate and respond to growing issues surrounding nutrition, obesity and dietary supplements. Dr. Alan Rulis, Director of the Office of Food Additive Safety (OFAS), fills this new role while a search is conducted to find a permanent Senior Advisor for Applied Nutrition. In the meantime, Dr. Laura Tarantino, Deputy Director of OFAS, is the Acting Director of OFAS. 5. FDA Changes Statements of Commitment Required for All DMFs Staff at FDA's Center for Drug Evaluation and Research (CDER) is now requiring in all Drug Master Files (DMFs) a signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in the DMF. FDA recommended that this type of statement be included in DMFs in its September 1989 "Guideline for Drug Master Files," but it now appears that the statement is a requirement. This statement of commitment can be worded as follows: "[Company] certifies that the information contained in this Drug Master File (DMF) submission is current, and that [Company] will comply with the statements made in this DMF." A separate Environmental certification still must be included as well. No changes have been made to this statement, which should read : "[Company] certifies that our facilities will be operated in substantial compliance with all applicable environmental laws relating to the manufacture of the products identified in the Drug Master File." We also have become aware that FDA Dockets is now scrutinizing incoming DMF filings to ensure that the following various documents include original inked signatures: the cover letter, the statements of commitment, any agent letters, and all authorization letters. This does not appear to be the result of any particular problem, merely the practice of the current staff. 6. California Panel Advises Against Placing Acrylamide Warnings on Foods California's Carcinogen Identification Committee (CIC) has completed its review of acrylamide's potential health risks and advised against placing acrylamide warnings on certain foods. The panel review was performed at the behest of the Office of Environmental Health Hazard Assessment (OEHHA), which is considering the warnings in the wake of recent research indicating that acrylamide, a suspected carcinogen, can form during the cooking of certain foods at high temperatures. As we have been reporting to you, studies have found that certain foods, such as some potato chips, french fries and cookies, contain relatively high levels of the substance. The CIC's recommendations are not binding on OEHHA, which now must decide whether to go forward with the food labeling plan. OEHHA also is investigating whether its exposure limit for acrylamide should be modified, and the CIC agreed that the exposure limit should be changed. Currently, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as "Prop. 65"), the No Significant Risk Level (NSRL) for the substance is 0.2 micrograms per day. As you may know, Prop. 65 requires the Governor of California to publish a list of chemicals that are known to the state to cause cancer, birth defects or other reproductive harm. The food industry opposes the move by OEHHA to place acrylamide warnings on food. Henry Chin, a vice president with the National Food Processors Association (NFPA), argued that acrylamide warnings on food would be "unwarranted" and would not be of benefit to consumers. Mr. Chin further pointed out that a link between acrylamide and human health risk has not yet been established. OEHHA spokesman Allan Hirsch countered that Prop 65 provides Californians with "the right to be informed" that their food contains carcinogens. It is being reported that FDA even weighed in on the controversy, asking California's OEHHA to reconsider its move toward requiring companies to include warnings on foods containing acrylamide above certain levels because there is not currently a scientific justification for such warnings, in FDA's view. The consumer group Center for Science in the Public Interest (CSPI) quickly disparaged FDA for what it calls "discouraging state governments from actively protecting the public health." 7. Consumer Reports Article Discusses Effectiveness of Irradiating Meat in Reducing Pathogens An article in the August, 2003 issue of Consumer Reports discusses the safety of irradiated meats and the results of a study examining the efficacy of irradiation in reducing pathogens. The efficacy study was conducted on irradiated and nonirradiated chicken and ground beef. The results of the efficacy study showed that bacteria levels in the irradiated, uncooked meat were much lower than levels in the nonirradiated meat. However, not surprisingly, the irradiated meat still contained some bacteria, prompting the organization to conclude that there's no reason for consumers to purchase irradiated meat if they cook their meats thoroughly. Although the story does acknowledge that the use of irradiated meats in institutions such as cafeterias could reduce the incidence of foodborne illness, it also states that, given concerns about the toxicological safety of irradiated foods, there should be more focus on preventing the contamination of foods rather than on processes used to kill bacteria once its in the food. The meat industry has taken issue with several statements in the Consumer Reports article, most notably the comment that the irradiated meat still contained some bacteria. In a letter to Consumer Reports, Minnesota Beef Council Director Ronald Eustice noted that irradiation companies do not claim that all pathogens are killed in the irradiation process. Mr. Eustice pointed out that irradiation can reduce the level of pathogens in meat by more than 99 percent, a huge benefit from the use of irradiation. 8. USDA Publishes Technical Requirements for Purchase of Irradiated Ground Beef for School Lunch Program USDA has published technical requirements for the purchase of irradiated ground beef for the Minnesota school lunch program. Information on the specifications can be found on USDA's website at http://www.usda.gov/news/releases/2003/05/0172.htm. Included in the requirements are specifications for packaging. Irradiated ground beef must be vacuum packaged in tamper proof plastic containers, and the packaging must be made from materials that have been "approved" by FDA (USDA's terminology) for use with irradiation. 9. EU Releases New Draft of the "Super Directive" On September 23, 2003, the European Commission (EC) released a new draft of the EU "Super Directive" on plastics. As we have been reporting to you, this directive is intended to revise and replace the current Plastics Directive (2002/72/EC) and its forthcoming first amendment, as well as two directives on migration testing (82/711/EEC and 85/575/EEC) and three directives on vinyl chloride monomer (78/142/EEC, 80/766/EEC and 81/432/EEC). Important regulatory developments included in the draft are (1) changing the scope of the Plastics Directive to apply to multilayer materials not made entirely of plastics, where the plastic layer contacts food; (2) introducing into the Plastics Directive the concept of functional barrier; (3) the introduction of fat consumption reduction factors; (4) the finalization of the "positive list" of plastic additives; (5) the transformation of all QM and QMA (residual limits) into SML (migration limits); and (6) clarifying provisions related to the content of the declaration of compliance and creating a new recordkeeping obligation. This past spring, on behalf of the Committee, we submitted comments on an earlier draft of the Super Directive. The EC had at one point indicated its intent to finalize the directive in 2004, but that most likely will be delayed, due in part to the many issues raised by the draft text that are being discussed between industry and the EC. One issue relates to the proposal that the Super Directive cover multilayer materials where one or more layers is not made entirely of plastic and the food-contact layer consists of plastic. This proposal would expand significantly the scope of the current Plastics Directive, which applies only to materials that are made exclusively of plastic. In our comments to the Commission, we pointed out that this expansion could raise problems for those marketing materials consisting of layers of different types of materials (e.g. plastic and paper) if no transitional period is planned to ensure that companies have time to petition for the listing of the substances they are using that did not have to be (and may not yet be) listed in the Plastics Directive. Also, by deleting the words "exclusively made of plastics," the Super Directive would extend to materials that are made of a single layer of plastic together with other non-plastic materials, again with no transition period. Another point of contention is the introduction of the "functional barrier" concept, and the definition of when there is a functional barrier and how this must be established. The draft Super Directive specifies that multilayer materials falling within the scope of the Directive must comply with the overall migration and specific migration requirements of the Directive and, further, that all layers must be made of positively listed substances. Multilayered materials, however, will be exempt from those requirements if there is a "functional barrier" that prevents migration of unauthorized substances to food. Earlier drafts of the Super Directive proposed that a material be considered a "functional barrier" if the migration of a substance, not otherwise listed in the Directive, would not be detectable at levels exceeding 0.0015 mg/kg (1.5 parts per billion (ppb)), a level that we felt was too low to be of practical significance. The September version of the draft raises this level to 0.01mg/kg (10 ppb). There also has been controversy surrounding the proposal to finalize a positive list of additives. The current Plastics Directive (2002/72/EC) only contains a provisional list of additives that are authorized at the EU level; other additives may continue to be used subject to national legislation. The previous draft Super Directive incorporates the provisions of the draft first amendment to the Plastics Directive 2002/72/EC, also issued by the Commission, which would require companies to file petitions for unlisted additives by December 31, 2004 and would compel the Commission to announce the date of completion and publication of a positive list of additives before December 31, 2005. Once the EU list of additives is a "positive list," only those additives that are listed on the EU list could be used in food-contact plastics. The most recent version of the draft Super Directive, however, would give petitioners until December 31, 2006 to file the additives petitions, and the Commission would then have until December 31, 2007 to establish the date when the list of additives will become a positive list. While there is some relief that there will be additional time to file petitions for unlisted additives, industry remains concerned with the Commission's intent to include polymer production aids (such as emulsifiers, surfactants and buffering agents, with the exception of solvents, colorants and adhesives) in the positive list of additives. Industry feels that these substances should not be subject to the positive listings. Also, the Commission indicated that the exception for solvents, colorants and adhesives is provisional pending the presentation of an inventory of these substances. Industry also is concerned with the provision remaining in the draft Super Directive requiring that the "declaration of compliance" that currently must accompany plastic materials up to the retail stage include certain additional information considered necessary for enforcement purposes, and be complemented by "supporting documentation" that would have to be made available to enforcement authorities upon demand. Industry feels that they should be allowed to organize the content and circulation of these documents. Industry also does not want the Commission to require the inclusion of information that is confidential and/or would not bring any value to the recipient, such as the identity of the substances used behind a functional barrier. There are also a few other changes in the recent draft worth noting. First, under the current Plastics Directive, impurities and oligomers of cleared materials are considered to be cleared under the listing for the cleared materials. A previous version of the draft Super Directive required that companies keep in their files justification that these impurities and oligomers are safe. The most recent version of the draft indicates that impurities and oligomers of listed materials are presumed to be safe if they were declared in the Scientific Committee for Food (SCF) dossier; otherwise, they can still be present if justified to be safe. Second, the metal zinc was removed from the list of metals in the Plastics Directive for which the corresponding salts also are considered listed. This was the result of a recent evaluation of zinc by the SCF. Third, the new draft establishes specific migration limits (SMLs) for some common monomers. Finally, the current draft of the Super Directive proposes to lower the SML for non-detects to 10 mg/kg. 10. EU Passes GMO Labeling Laws On July 2, the European Parliament passed two new labeling and traceability laws that will require labeling of all bioengineered food and restrict the accidental presence of bioengineered crops to 0.9%. One measure establishes a system to trace and label genetically modified organisms (GMOs), while the other will regulate the marketing and labeling of food and feed products derived from GMOs. The Council of Ministers formally adopted the proposals on July 22, and the regulations were published in the Official Journal of the European Union on October 18. The regulations entered into force November 7, and food processors have 6 months to comply with the regulations. While the law will pave the way for the lifting of the EU-wide moratorium on GMO products, the restrictiveness of the law will make it extremely difficult for the U.S. agricultural industry to market its products in the EU. The U.S. currently is challenging the EU GMO moratorium through World Trade Organization (WTO) channels. Most recently, in August, the U.S. asked for a WTO dispute settlement panel to consider the moratorium. Now that the EU laws officially are going into effect, it is likely that the U.S. will consider a WTO case against them based on the charge that the new rules violate the Technical Barriers to Trade Agreement, which prohibits unjustifiable trade barriers by foreign governments. 11. EFSA Advises Consumers against Changing Diet Due to Semicarbazide in Foods Packaged in Jars Following reports that semicarbazide, a chemical that may cause cancer, may be present in food packaged in jars, the European Food Safety Authority (EFSA) conducted a risk assessment to determine what, if any, risk the chemical may pose to consumers. Preliminary studies indicate that the chemical may be migrating from plastic sealing gaskets used in the lids of jars used to package certain foods, such as fruit juices, jams, honey, baby food, mayonnaise and ketchup. In assessing the risks associated with semicarbazide, experts considered the most recent toxicological information on the substance, the levels found in foods, and the estimated dietary intakes of the chemical by babies, children and adults. After analyzing this data, EFSA concluded that semicarbazide is present in certain foods in very small quantities. Further, the risk to consumers, if any, is considered to be very small, even for infants. As a result, EFSA advises that there is no reason to change current dietary habits. For more details on this risk assessment, see EFSA's press release on its website at http://efsa.eu.int/pdf/pressrel20031015_en.pdf. * * * As always, if you have any questions on the above, please do not hesitate to contact Jerry Heckman, Deborah Ziffer, or me. Cordially yours, Ralph A. Simmons 1. Section 409(h)(6) of the Act defines a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food." Note that this definition includes some substances known by FDA as "secondary direct additives," which are used in food processing, but may not have a technical effect in the food. Back to TopMore 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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