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Dockets Management
Branch (HFA-305) Re: Comments of
The Society of the Plastics Industry, Inc. on FDA’s Request to OMB
for Extension of Authority to Collect Information from Applicants for
Exemptions under the Threshold of Regulation Rule, 21 C.F.R. Dear Madam or Sir: The Society of the Plastics Industry, Inc. (SPI), by its attorneys and through its Food, Drug, and Cosmetic Packaging Materials Committee, hereby respectfully submits these comments in response to the notice entitled "Agency Information Collection Activities: Proposed Collection; Comment Request; Extension" published in the Federal Register on December 10, 1996 (61 Fed. Reg. 65067). This notice provided the opportunity for public comment on the request by the Food and Drug Administration (FDA) to the Office of Management and Budget (OMB) for extension of FDA’s authorization under the Paperwork Reduction Act of 1995 to maintain the current requirements for information in support of applications for exemptions from premarket food additive clearance under the Threshold of Regulation rule. 21 C.F.R. § 170.39. As discussed more fully below, SPI fully supports and endorses FDA’s Threshold of Regulation rule allowing exemption of low-exposure food-contact substances from the food additive petition process. SPI believes, however, that the current requirement for an environmental assessment (EA) to accompany every request for an exemption is an undue paperwork burden. It is SPI’s position that an EA should be required only in extraordinary cases where significant adverse environmental impacts may occur that are not subject to regulation by other authorities. I. The Threshold of Regulation Is a Positive Step by FDA to Reduce the Regulatory Burden on Food-Contact Substances SPI fully supports, and commends FDA on, the issuance and implementation of the Threshold of Regulation rule. 21 C.F.R. § 170.39 (August 16, 1995). This rule benefits the public, FDA, and industry by reducing the resources devoted to regulation of food-contact substances that will not migrate to food, if at all, in more than trivial, insignificant amounts. The Threshold of Regulation rule allows FDA to devote its resources to issues that are of real public health significance. In addition, the rule results in safe food-contact materials reaching the market more quickly. This rule resulted from careful scientific analysis by FDA officials, which established a reasonable certainty of safety with respect to materials that involve only very low potential consumer exposure. This principle also was supported by scientific work sponsored by SPI and shared with FDA. The outcome of these parallel efforts has been beneficial to all parties. We note that FDA has been able to reduce the backlog of pending indirect food additive petitions from 112 in 1994 to 100 by the end of 1996. This reduction is undoubtedly due, in part, to companies using the Threshold of Regulation process instead of filing food additive petitions. SPI supports the continuation of the Threshold of Regulation process, including FDA’s collection of the information that is truly needed to support requests for exemptions. As SPI has commented in another proceeding (Docket No. 96N-0057 "National Environmental Policy Act: Proposed Revision of Policies and Procedures; Proposed Rule"), however, FDA should not routinely require information on the environmental impact of exemptions requested under the Threshold of Regulation. In most, if not all cases, other laws, regulations, and other regulatory authorities are in place to protect against significant adverse environmental effects. II. Environmental Assessments Are Unnecessary for Most Threshold of Regulation Requests FDA currently requires environmental assessments as part of all requests for Threshold of Regulation exemptions. 21 C.F.R. § 170.39(c)(6). The Agency has proposed that this requirement be eliminated for repeated-use articles and functional components of food-contact materials that are present at five percent or less by weight of the finished material. 61 Fed. Reg. 14922 (April 3, 1996). Furthermore, FDA has proposed to eliminate from all environmental assessments the requirement for information on possible environmental effects at the site of manufacture. Id. As SPI stated in its comments on FDA’s proposed reduction in the scope of environmental assessments, these assessments should not be required routinely, but should be reserved for extraordinary situations. In most cases, any potential environmental effects from the issuance of a Threshold of Regulation exemption will be minimal, and will be controlled adequately by other federal, state, or local environmental laws, regulations, and enforcement authorities. FDA should become involved only in the rare case where there are significant environmental impacts that are not subject to regulation by others. The burden of proof should rest with FDA to establish that a proposed action presents a real risk of adverse environmental impacts not controlled by other regulatory authorities. Unfortunately, preparation of an EA is at least as burdensome, more so in many cases, as compiling information on the level of exposure and the safety of the food-contact material. It is unreasonable to devote this level of effort to a part of the application that has no connection to the basic eligibility of a material for a Threshold of Regulation exemption. The considerable effort involved in preparing an EA also is grossly out of proportion to any minimal increment in the protection of the environment that may be gained. * * For these reasons, SPI urges FDA and OMB to eliminate the requirement for environmental assessments for all Threshold of Regulation requests except those deemed to present potential environmental risks not addressed by other regulatory authorities. While supporting FDA’s request for the authority to collect information truly needed for Threshold of Regulation exemptions, SPI believes that the purpose of the Paperwork Reduction Act should be fulfilled by the elimination of unnecessary filings concerning the environmental impact of an exemption. SPI appreciates this opportunity to comment on the information requirements for issuance of Threshold of Regulation exemptions by FDA. Respectfully submitted, THE SOCIETY OF THE
PLASTICS Ralph A. Simmons
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