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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000087

Date: August 18, 2000

 

From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

 

Subject: Premarket Notification FCN No. 000087 for use of 1,4-cyclo-hexanedimethanol(CHDM) for coatings that contact food

 

Notifier: Eastman Chemical Company
P.O. Box 511
Kingsport,TN 37662-5054

 

To: Division of Product Policy (HFS-206)
Attention: Hortense S. Macon
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 PMN becomes effective, the EA/FONSI may 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

 

 



 



 

Environmental Assessment for FCN No. 000087

1. Description of the Proposed Action

The proposed action is to provide for the safe use of 1,4-cyclohexanedimethanol(CHDM) as a polyhydric alcohol for use in polyester resins, intended for coatings, with all food types. This action was originally requested by Eastman Chemical Company in Food Additive Petition (FAP) 7B4547, as announced in the Federal Register on July 11, 1997 [62 FR 37266]. On September 4, 1997, Eastman Chemical Company amended the petition by requesting 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. In a September 25, 1997, memorandum to the administrative file, FDA scientists concluded that the claim of categorical exclusion for FAP 7B4547 was warranted.

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 (FCSs). 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 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 threshold of regulation exemption requests involving the use of an FCS 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 In a letter dated June 9, 2000, Eastman Chemical Company requested that FAP 7B4547 be converted to a PMN.

Since 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 Environmental Assessment (EA) for the subject notification.

2. Environmental Consequences of the Proposed Action

This action involves an FCS that is a component of a coating of finished food-packaging materials. The FCS is also 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 route of environmental introduction of the types of substances included under §25.32(i), whether reviewed in a food additive petition 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. 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.

Eastman Chemical Company's letter of September 4, 1997, stated that no extraordinary circumstances exist that preclude the subject petition from 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



 



 

 

Finding of No Significant Impact

A Premarket Notification (FCN No. 000087), submitted by Eastman Chemical Company, to provide for the safe use of 1,4-cyclohexanedimethanol(CHDM), as a polyhydric alcohol for use in polyester resins intended for coatings with all food types.

 

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: August 18, 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: August 18, 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