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Environmental Decision Memo for Food Contact Notification No. 000002

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: February 11, 2000

From: Environmental Scientist, Chemistry and Environmental Review Team (CERT)
Scientific Support Branch (HFS-207)

Subject: Premarket Notification FCN No. 000002 for use of N,N-Dialkyl-N-methylamine oxide as an antioxidant

Notifier: General Electric Company
c/o Keller and Heckman
Washington, DC 20001

To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam
Through: Team Leader, Environmental Review Team
Division of Product Manufacture and Use

Attached is the Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. These documents supersede our previous EA and FONSI, dated December 22, 1999. 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.

Jeanette Glover Glew


Environmental Assessment for FCN No. 000002

1. Description of the Proposed Action

The proposed action is to provide for the use of N,N-Dialkyl-N-methylamine oxide, manufactured by GE plastics, intended for use as an antioxidant at levels not to exceed 0.1 weight percent polypropylene complying with 21 CFR 177.1502. This action was originally submitted as a Threshold of Regulation (TOR) exemption request. In the TOR request, the requestor submitted a claim of 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 (FCS). Section 409(h)(6) of the act defines an FCS 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 an FCS 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 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 sponsors were told that they could consider withdrawing such a petition or request and resubmitting the petition or request as a notification. In a letter dated November 4, 1999, the requestor asked that the TOR request 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 an EA for the subject notification.

2. Environmental Consequences of the Proposed Action

This action involves an FCS 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, TOR exemption request or 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's (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 additive is intended for use at a level not to exceed 0.1 percent by weight of polypropylene that is used in contact with aqueous, acidic and dry foods, and alcoholic beverages containing up to 15% of alcohol, in applications involving use with food at temperatures up to 100°C. 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 9B4662, the petitioner certified that no extraordinary circumstances were expected that would cause adverse effects on human health or the environment as a result of the use of the additive. 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

Buzz L. Hoffmann, Ph.D.
Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Jeanette Glover Glew
Environmental Scientist
Petition Contract Work Group
Division of Product Policy
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Finding of No Significant Impact

Premarket Notification FCN No. 000002, submitted by General Electric Company, to provide for the safe use of sn,N-Dialkyl-N-methylamine oxide as an antioxidant at levels not to exceed 0.1 weight percent polypropylene complying with 21 CFR 177.1520.

The Chemistry and Environmental Review Team and Environmental Review Team have 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 scientists in the Office of Premarket Approval.


Prepared by: _________________________________________ Date: February 10, 2000
Jeanette Glover Glew, Environmental Scientist
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center of Food Safety and Applied Nutrition
Food and Drug Administration


Approved by:_________________________________________ Date: February 10, 2000
Buzz Hoffmann, Ph.D., Team Leader
Environmental Impact Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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