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CFSAN/Office of Food Additive Safety
May 9, 2000
Date: May 9, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000058- ADK STAB HP-10 for Use in Contact with Food
Notifier: Asahi Denka Kogyo K.K.
Japan Technical Information Center
Arlington, VA 22202
To: Division of Petition Control (HFS-215)
Attention: Andrew Zajac
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 EA and FONSI.
John L. Dennison
1. Description of the Proposed Action
The proposed action, requested by Asahi Denka Kogyo K.K., is to provide for the safe use of 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2) as an antioxidant and/or stabilizer in styrene-butadiene block polymers for food contact materials used at a maximum rate of 0.20% by weight. The notifier submitted a claim of 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. A categorical exclusion for allowing a Premarket Notification (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) 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 and threshold of regulation (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 routes of 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, result 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. Further, we do not expect any limited increase in environmental introductions resulting from this proposed action to threaten a violation of EPA's regulations governing combustors and landfills or have any other adverse environmental effects.
In the claim of categorical exclusion, the notifier stated that no extraordinary circumstances exist that would preclude this use from qualification for a categorical exclusion under §25.32(i). Although the categorical exclusion is not warranted for this action, we do not believe that accepting this PMN would alter the fact that no extraordinary circumstances are likely to occur as a result of the production, use, and disposal of the food contact substance.
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. 000058), submitted by Asahi Denka Kogyo K.K., to provide for the safe use of 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite, as a antioxidant and/or stabilizer in styrene-butadiene block polymers that contact food.
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 9, 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 9, 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
