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CFSAN/Office of Food Additive Safety
May 3, 2000
Date: May 3, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000049 for the use of Benzoic Acid used as a Blocking Agent in the Manufacture of Nylon 6 Food Contact Polymers
Notifier: Unitika, Ltd.
c/o Center for Regulatory Services
Woodbridge, VA 22192
To: Division of Petition Control (HFS-215)
Attention: Edward Machuga
Through: Team Leader, ERT
Attached is the Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. When this notification becomes effective, the EA and FONSI should be made available to the public. Please let us know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.
John L. Dennison
1. Description of the Proposed Action
The proposed action is to provide for the safe use of benzoic acid as a blocking agent in the manufacture of Nylon 6 food contact polymers described in 21 CFR § 1500(a)(6), at a maximum use level of 0.15% by weight of the polymer. This action was originally requested by Unitika, Ltd., on June 1, 1999, in a request for exemption from regulation as a food additive under 21 CFR §170.39 (threshold of regulation or TOR exemption request No. 220).
The Food and Drug Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a premarket notification (PMN) process as the primary method for authorizing new uses of food additives that are food contact substances. Section 409(h)(6) of the FFDCA 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. Under the PMN process, a notification becomes effective 120 days after the date of receipt by FDA, unless FDA determines that, based on the data and information before the agency, the use of the substance is not safe and FDA objects to such notification within the 120-day period. If FDA does not object within 120 days to the use of a food contact substance that is the subject of a PMN, the substance may be legally marketed for the notified use.
In a letter dated October 26, 1999, the Agency told petitioners and requesters who had pending food additive petitions or TOR exemption requests involving the use of a food contact substance, that the petitioned or requested action might be eligible for notification under section 409(h) of the FFDCA. The petitioners were told that they could consider withdrawing such petition or request and resubmitting it as a PMN.
The notifier requested that the TOR exemption request be converted to a PMN in a letter dated December 15, 1999. The TOR exemption request contained neither an environmental assessment nor a claim of categorical exclusion. Therefore, in a letter dated February 9, 2000, the notifier requested a categorical exclusion under 21 CFR 25.32(i) This exclusion is for actions for substances present in food-packaging material at not greater than 5 percent-by-weight and that are expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.
The types of substances and the uses of such substances under the categorical exclusion in 21 CFR 25.32(i) are the same whether a sponsor submits a food additive petition, a TOR exemption request, or a PMN. However, a categorical exclusion for allowing a PMN to become effective is not currently one of the enumerated types of actions listed in §25.32(i). Therefore, we have prepared this Environmental Assessment (EA) for the subject notification.
2. Environmental Consequences of the Proposed Action
This action involves a food contact substance that is a minor component of finished food-packaging materials (<5% by weight of the finished packaging material) and that remains with the packaging through use by consumers. FDA has found that the very small quantities of substances that could potentially enter the environment from this type of use are highly unlikely to have a significant effect on the environment (61 FR 19476 at 19481-19482, May 1, 1996). The basis for FDA's decision to establish the categorical exclusion in §25.32(i) for food additive petitions or TOR exemption requests is the same basis that would be applicable to PMNs. Therefore, FDA's experience with the food additive petitions that it reviewed to support a categorical exclusion for such actions is relevant to PMNs. The principal route for potential environmental introduction of the types of substances included under §25.32(i), whether reviewed in a food additive petition, a TOR exemption request, or a PMN, results from their disposal in municipal solid waste combustors or landfills. These routes of disposal are governed by the regulations of the Environmental Protection Agency (EPA) in 40 CFR part 60 (combustors) and part 258 (landfills). Based on the low levels of use of these substances in packaging material, the introduction of combustion products or introductions at landfill sites are not environmentally significant. Because of the nature of this type of action, we do not expect that any limited increase in environmental introductions resulting from this proposed action will threaten a violation of EPA's regulations governing combustors and landfills or have any other adverse environmental effects.
In the claim of categorical exclusion for the PMN, the notifier stated that no extraordinary circumstances were expected that would preclude this use from categorical exclusion. We do not believe that the conversion of this TOR exemption request to a PMN would alter the fact that no extraordinary circumstances are likely to occur as a result of this action.
3. Alternatives to the Proposed Action
Alternatives to the proposed action need not be considered, because no potential adverse environmental effects have been identified.
4. List of Preparers
John L. Dennison
Chemist
Environmental Review Team
Division of Product Manufacture and Use
Center for Food Safety and Applied Nutrition
Food and Drug Administration
A Premarket Notification (FCN No. 000049), submitted by Unitika Ltd., to provide for the safe use of benzoic acid as a blocking agent in the manufacture of Nylon 6 food contact polymers to be used in food packaging.
The Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on an environmental assessment prepared by a scientist on the Environmental Review Team.
Prepared by: ______________________________________________ Date: May 3, 2000
John L. Dennison, Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by: _____________________________________________ Date: May 3, 2000
Buzz Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
