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CFSAN/Office of Food Additive Safety
February 11, 2000
Date: February 11, 2000
From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000021 for use of 2,2'- Methylenebis (4,6-di-tert-butylphenyl)2-ethyl-hexyl phosphite as an antioxidant
Notifier: Asahi Denka Kogyo K.K.
Japan Technical Information Center
Arlington, VA 22202
To: Division of Petition Control (HFS-215)
Attention: Andrew Zajac, Ph.D.
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/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 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2) as an antioxidant and/or stabilizer in high-density polyethylene articles intended for contact with food. The additive shall be used at levels not to exceed 0.15 percent by weight of the high-density polyethylene polymers complying with §177.1520, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 and 5, and having a density of not less than 0.94 g/cc. The finished polymers may only be used in contact with food of the types identified in Table 1 of §176.170(c), under Categories I, II, IV-B, VI-B, VII-B, and VIII under conditions of use B through H described in Table 2 of §176.170(c) and with food of the type identified in Table 1 of §176.170(c), under categories III, IV-A,V, VI-A, VI-C, VII-A, and IX under conditions of use C through G described in Table 2 of §176.170(c). This action was originally requested for Asahi Denka Kogyo K.K., by Japan Technical Information Center, Inc., in Food Additive Petition (FAP) 8B4599, the notice of filing for which was published in the Federal Register on June 23, 1998 [63 FR 34188]. The notice of filing contained the agency's decision that approval of the petition would qualify for a categorical exclusion under 21 CFR 25.32(i). This exclusion is for actions for substances present in finished 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 Food and Drug Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) to establish a premarket notification (PMN) process as the primary method for authorizing a new use of a food additive that is a food contact substance. 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. 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 120 days. 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 requestors who had pending food additive petitions or threshold of regulation 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 sponsors were told that they could consider withdrawing such a petition or request and resubmiting it as a PMN. In a letter dated December 9, 1999, the petitioner's representative requested that FAP 8B4599 be converted to a PMN.
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 request for exemption from regulation as a food additive under 21 CFR §170.39, 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 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. We have 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 19481-82, May 1, 1996). The basis for the Agency's decision to establish the categorical exclusion in §25.32(i) for food additive petitions is the same basis that would be applicable to PMNs. Therefore, the Agency'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 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. The notifier states that the proposed maximum level of the additive in the food-packaging material will be not greater than 5 percent by weight and that it is expected to remain with the finished food packaging material through use by consumers. 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 in FAP 8B4599, the petitioner certified that no extraordinary circumstances were expected that would preclude this use from a categorical exclusion. We do not believe that the conversion of this petition 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
Environmental 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. 000020), submitted by Ashai Denka Kogyo, K.K. to provide for the safe use of 2,2'-methylenebis(4,6-di-tert-butylphenyl)2-ethylhexyl phosphite as an antimicrobial and/or stabilizer in linear low density polyethylene articles intended for food contact.
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: March 22, 2000
Hardy J. Chou, Ph.D., Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office for Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by: ________________________________________ Date: February 24, 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
