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 September 21, 2000
(202) 434-4120 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: In this letter we discuss a clarification we have obtained from the Food and Drug Administration (FDA) to the effect that the Proposed Rule for Food Contact Notifications (FCNs) is not intended to change the start of the 120 day review period for FCNs to the date of FDA's acceptance of the FCN, rather than the date of FDA's receipt of the filing as provided in the statute. We also report that FDA's direct final rule extending to FCNs the existing categorical exclusions of certain food additive petitions from the need for Environmental Assessments became effective as planned on August 24th. Finally, we bring you up-to-date on the status of the National Uniformity for Food Act of 2000, and provide information on other matters of interest to the Committee
Table of Contents
1. FDA Official Clarifies Agency's Intent Regarding Beginning of FCN 120-Day Review Period In our last letter to the Committee, we provided an overview of FDA's Proposed Rule for implementation of the Food-Contact Notification (FCN) program. In particular, we discussed a potentially significant issue with Proposed Section 170.104, which states that A[i]n order for the 120-day review period to begin FDA must accept that notification@ (Emphasis added). It appeared from this language that FDA was proposing to start the 120-day review period from FDA's acceptance of the notification, rather than receipt of the FCN as required by statute. An FDA official, however, has informed us that Section 170.104 is not intended to create a starting point for the review period different from the one provided in the statute. FDA fully intends to begin the 120?day period from receipt of the FCN, unless the Agency determines that the notification is not acceptable on its face for one or more of the reasons set forth in the Proposed Rule, including the absence of essential information. Therefore, acceptance of an FCN by FDA actually will not begin the 120-day review period, but will allow it to continue to run, retroactive to the date of original filing. Although we have received informal guidance from the Agency on this matter, we plan, in our comments to the Agency, to request that they revise this provision of the regulation to make their intent clear on this point. 2. FDA Rule on Categorical Exclusions of FCNs from Environmental Assessments Becomes Effective. We have been informed by FDA officials that, on August 24th, the direct final rule became effective extending to notifications the existing categorical exclusions from Environmental Assessments (EAs) that have been applicable to food additive petitions and requests for Threshold of Regulation exemptions. You may recall from previous letters that FDA published the direct final rule in the May 11, 2000 Federal Register (65 Fed. Reg. 30352). The exclusions, which are set forth in 21 C.F.R. ' 25.32, eliminate the need for an EA in the case of substances present in finished food packaging material at not greater than 5% by weight and expected to remain with the packaging through use by consumers, components of coatings for food packaging, and components of permanent and semipermanent equipment and of other repeated-use articles. As expected, the Agency did not receive any significant adverse comments to the direct final rule by the deadline, thereby allowing the rule to go into effect. The Agency plans to publish a confirmation of the direct final rule's effective date in the Federal Register. 3. National Uniformity for Food Act of 2000 Appears Dead for this Year In our last letter, we discussed The National Uniformity for Food Act of 2000 (AAct@) (H.R. 2129, S. 1155), which seeks to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for national uniformity in food safety warning requirements. The Act would have preempted state warning requirements, such as California's Proposition 65, unless they were identical to FFDCA provisions with respect to food or any component or package of the food. After passing through the Senate Agriculture Committee two months ago, there were rumors that the legislation would be attached as a rider to an appropriations bill when Congress returned after Labor Day. However, a letter penned by the Association of Food and Drug Officials (AFDO) expressing concerns about the legislation has caused the bill to lose some of its momentum in Congress. The AFDO letter, sent to the Food Processors Institute (FPI), charged that the legislation as written could have serious adverse impacts on public health, federal-state relations and interstate commerce. AFDO strongly recommended that the bill be referred to the Senate Judiciary Committee for a full and open discussion. While a lot of AFDO's concerns could be addressed, it is unlikely that there is sufficient time in the four weeks left of the current Congress to do so. The Grocery Manufacturers of America (GMA), which helped draft S. 1155, stated that they were surprised by AFDO's position, as AFDO changes had been made to the bill to address issues raised by AFDO. In a letter to current and potential sponsors of the bill, GMA criticized AFDO for changing its position Awithout a word to the industry, or more importantly, the bill sponsor who accommodated their request. 4. U.S. Codex Office Revises Comments Concerning the Precautionary Principle As we have been reporting to you, the Precautionary Principle has been a central topic in European discussions of food safety. This principle, which has been promoted by environmental and consumer groups and some European government authorities, basically stands for the proposition that it is better to require a full set of toxicology data and a complete assessment of all possible risks before allowing new technology or products on the market. On March 2, 2000, the European Commission (EC) issued a communication on the Precautionary Principle to further its discussions on the management of food safety. The communication, intended to explain how the EC intends to apply the principle, was debated at the April 10-14, 2000 session of the Codex Alimentarius Committee on General Principles held in Paris, France. During the meeting, the United States delegation took somewhat ambivalent positions, to the dismay of industry, but ended by expressing concerns over the EC communication and the lack of definition ascribed to the Principle and its implementation. At the end of the April session, the Codex Committee agreed that a drafting group would continue to develop the proposal and further clarify how it would be applied in situations where scientific evidence is insufficient to fully assess risk. In addition, the risk assessment document was re-circulated for comments. On August 11, the U.S. Codex Office, which is located in the Food Safety and Inspection Service at the U.S. Department of Agriculture, released revised draft comments to the Codex Committee on General Principles regarding risk analysis principles, including the Precautionary Principle, and requested comment by August 18. The revised comments indicate that it may be appropriate in certain situations to exercise precaution and adopt provisional measures to protect the public health. However, the comments go on to state further that member countries are encouraged to fully disclose the basis of the provisional measures and seek further scientific support for their actions. U.S. industry has been critical of these draft comments as not being rigorous enough on issues such as the need for real scientific evidence of a risk to public health before invoking the Precautionary Principle, the proposition that governments should move conscientiously and quickly to develop additional data once the Principle is invoked, and the position that the Principle must be applied in an objective and evenhanded manner. Industry representatives also objected to the short comment period. The U.S. Codex Office declined to extend the brief comment period, based on the need to get comments to the Codex Committee, but promised to consider any comments filed after the deadline. 5. Health Canada Seeks Public Input on Meat Irradiation Health Canada intends to consult with consumers regarding the proposals it has received concerning the irradiation of ground beef and poultry, a practice that already is permitted in the United States. Irradiation currently is approved in Canada for potatoes, flour and herbs. This plan to consult with the public on irradiation follows on the heels of two major recalls this summer of meat products contaminated with E. coli. Health Canada has been accused by the Canadian Cattlemen's Association of not acting fast enough on approving irradiation for meat and poultry. However, Canadian officials indicate that they are reviewing all of the information on irradiation as well as considering how this practice will affect the food inspection system in Canada. 6. Public Citizen Requests that FDA Revoke Ruling on Irradiation of Eggs On August 17th, Public Citizen submitted a Citizens Petition to FDA requesting a formal public evidentiary hearing on whether the Agency should consider revoking its ruling permitting the use of ionizing radiation for the reduction of Salmonella in fresh eggs. In its petition, Public Citizen charges that FDA misrepresented studies used as the basis for the irradiation regulations and ignored recommendations of the FDA Bureau of Foods Irradiated Food Committee (BFIFC). The BFIFC stated that foods irradiated at doses above 1 kGy and comprising more than 0.01% of the diet may contain a sufficient quantity of Unique Radiolytic Products (URPs) to warrant toxicological evaluation. FDA's regulations permit a maximum of 3 kGy, and Public Citizen is concerned that there has been no testing to show whether irradiation at that level would cause the formation of URPs that are harmful to human health. * * * As always, if you have any comments or if we can provide further information on any of the issues discussed above, please do not hesitate to contact us. Cordially yours, Ralph A. Simmons Back to TopMore About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . 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