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Environmental Decision Memo for Food Contact Notification No. 000035

Date: April 21, 2000

 

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

 

Subject: Premarket Notification FCN No. 000035 for use of Dimethyl Dicarbonate as an Antimicrobial in Noncarbonated Juice Beverages

 

Notifier: Bayer Corporation
c/o McKenna & Cuneo, L.L.P.
Washington, DC 20006

 

To: Division of Petition Control (HFS-215)
Attention: Martha Peiperl
Through: Team Leader, Environmental Review Team

 

 

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 FONSI.

 

 

 

Jeanette Glover Glew

 

 



 



 

Environmental Assessment for FCN No. 000035

 

 

1. Description of the Proposed Action

The proposed action is to provide for the safe use of dimethyl dicarbonate (DMDC), manufactured by Bayer Corporation and intended for use as a microbial control agent in non-carbonated juice beverages containing up to and including 100% juice. No more than 250 ppm of DMDC may be added to non-carbonated juice beverages containing up to and including 100% juice. The DMDC complies with the requirements listed in §172.133(a) and (c). The beverages must be produced under good manufacturing conditions and their microbial load must first be reduced by current technologies such as heat treatment, filtration, etc., prior to the addition of DMDC.

This action was originally requested for Bayer Corporation by McKenna & Cuneo, L.L.P., in a food additive petition (FAP) 0A4718. The notice of filing, which contained the agency's decision that approval of the petition would qualify for a categorical exclusion under 21 CFR 25.32(k), was published in the Federal Register on March 7, 2000 (65 FR 12014). This exclusion is for actions for substances added directly to food that are intended to remain in food through ingestion by consumers and that are not intended to replace macronutrients in food. DMDC is unstable in aqueous solution and breaks down almost immediately after addition to beverages. The principal breakdown products are methanol and carbon dioxide. These substances are the same as products of digestion and metabolism resulting from the consumption of human food. Since the breakdown products remain with food through ingestion, this clearly falls within the original intent of the exclusion (see "Section 2, Environmental Consequences of the Proposed Action" below), even though DMDC is neither present nor functioning in the finished food.

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 (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 requesters who had pending food additive petitions or threshold of regulation (TOR) 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 February 10, 2000, the petitioner's representative requested that FAP 0A4718 be converted to a PMN.

The types of substances and the uses of such substances under the categorical exclusion in 21 CFR 25.32(k) are the same whether a sponsor submits a food additive petition 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(k). Therefore, we have prepared this Environmental Assessment for the subject notification.

2. Environmental Consequences of the Proposed Action

This action involves an FCS that is added directly to food, is intended to remain in food through ingestion by consumers, and that is not intended to replace macronutrients in food. 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 19482-19483, May 1, 1996). The basis for FDA's decision to establish the categorical exclusion in §25.32(k) 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. The agency's evaluation of the environmental effects of substances added directly to food included consideration of the potential for impacts from the disposal of human waste products containing the petitioned substance and/or its products of digestion and metabolism. After ingestion, these substances are either digested and/or metabolized to other substances or excreted largely intact. Food substances with these use and disposal patterns are not expected to be toxic to organisms in the environment at the expected levels of exposure. Thus, use and disposal of such substances are not expected to result in significant environmental effects. The Agency also found that for substances in this class, there was no potential for significant impacts on energy and natural resources. These findings relied on one or more of the following scenarios: 1) the substances were expected to compete with and replace other already regulated substances with no significant change in the overall use of natural resources or energy; 2) the substances are also used in non-food contact situations and the food-contact usage represented a small increase in the overall production and usage of the substance such that the small increase in the uses of natural resources and energy was not significant; or 3) the predicted market volumes for the substances were very small so that the use of natural resources and energy for the substances was very limited. The Agency found that it was not likely that there would be any effects on threatened or endangered species.

In the claim of categorical exclusion in FAP 0A4718, the petitioner stated that DMDC is added directly to food, is intended to remain in food through ingestion by consumers, and is not intended to replace a macronutrient. The petitioner also stated that no extraordinary circumstances were expected that would preclude this use from categorical exclusion. We do not believe that converting 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

Jeanette Glover Glew
Environmental Scientist
Chemistry and Environmental Review Team
Division of Product Policy
Center for Food Safety and Applied Nutrition
Food and Drug Administration



 



 

 

Finding of No Significant Impact

A Premarket Notification (FCN No. 000035), submitted by Bayer Co., to provide for the safe use of dimethyl dicarbonate (DMDC) intended for use as a microbial control agent in non-carbonated juice beverages containing up to and including 100% juice.

 

 

The Chemistry and Environmental Review Team and 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 Chemistry and Environmental Review Team.

 

 

 

Prepared by: ____________________________________________ Date: April 21, 2000
Jeanette Glover Glew, Environmental Scientist
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by: ___________________________________________ Date: April 21, 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