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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000037

Date: April 3, 2000

 

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

 

Subject: Premarket Notification FCN No. 000037 - Use of Di-methylolbutanoic Acid in the Production of Polyurethane Resins Intended for Use as a Component of Adhesives

 

Notifier: Nippon Kasei Chemical
c/o Keller and Heckman
Washington DC 20001

 

To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam
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

 

 



 



 

Environmental Assessment for FCN No. 000037

 

 

1. Description of the Proposed Action

The proposed action is to provide for the safe use of dimethylolbutanoic acid (DMBA) manufactured by Nippon Kasei Chemical Company, Ltd., for use in the production of polyurethane resins intended for use as components of adhesives used in food contact applications. The finished polyurethane resins may be used in adhesives subject to any specifications and limitations in 21 CFR 175.105. In particular, paragraph (a) of Section 175.105 requires that the adhesive be separated from the food by a functional barrier or be used so that (1) the quantity of adhesive in contact with dry food does not exceed the limits of good manufacturing practice, and (2) the quantity of adhesive that contacts aqueous and fatty food does not exceed trace amounts at seam and edge exposures between packaging laminates that may occur within the limits of good manufacturing practice.

This action was originally requested by Nippon Kasei Chemical Company, Ltd., in a food additive petition (FAP 0B4717), in which the petitioner claimed 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 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 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 petitioners were told that they could consider withdrawing such petition or request and resubmitting it as a PMN. FDA also said that it would be prepared to process notifications submitted to the agency beginning on January 18, 2000. The petitioner submitted FAP 0B4717 on January 14, 2000, just a few days before FDA said it would be ready to process new PMNs. In that same letter the petitioner requested that FAP 0B4717 be converted to a PMN.

At the time the petition was converted to a PMN, FDA had not determined whether the claim for categorical exclusion under 21 CFR 25.32(i) was warranted. We have reviewed the claim and have determined that, had the submission been treated as a food additive petition, the action would have qualified for this categorical exclusion. 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 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 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. These additives ordinarily have limited potential for causing any significant environmental effects as a result of their use and disposal. The principal routes of environmental introduction of the types of substances included under §25.32(i), whether reviewed in a food additive petition or in 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 use of the polyurethane adhesive resins in 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 0B4717, the petitioner stated that no extraordinary circumstances were expected that would preclude this use 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
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. 000037), submitted by Nippon Kasei Chemical Company, Ltd., to provide for the safe use of dimethylolbutanoic acid (DMBA) in the production of polyurethane resins to be used as components of adhesives for 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: April 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: April 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