Environmental Decision Memo for Food Contact Notification No. 000007
Date: February 4, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification (FCN No. 000007) for Wool Felt as a Component of Conveyor Belts in Contact with Raw Dough Bakery Products
Notifier: Applied Fabric Technologies , Inc.
Orchard Park, NY 14127-0575
To: Division of Petition Control (HFS-215)
Attention: Edward Machnga, 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 Premarket Notification. 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.
Environmental Assessment for FCN No. 000007
1. Description of the Proposed Action
The proposed action is to provide for the use of wool belts as a component of conveyor belts in contact with raw dough bakery products such as bread and croissants. This action was originally requested by Applied Fabric Technologies, Inc. in a threshold of regulation (TOR) exemption request dated May 20, 1999. The requester submitted a claim of categorical exclusion under 21 CFR 25.32(j) in the facsimile dated December 15, 1999. This exclusion is for actions for substances to be used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intend for repeat use.
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 a 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 FCS that is the subject of a premarket notification, 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 TOR exemption requests involving the use of a food contact substance, that the petitioned or requested action might be eligible for premarket notification under section 409(h) of the FFDCA. The sponsors were told that they could consider withdrawing the petition or TOR request and resubmitting it as a PMN. Applied Fabric Technologies, Inc., requested in a letter, dated November 19, 1999, that the TOR exemption 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(j) 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 premarket notification. 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(j). Therefore, we have prepared this Environmental Assessment (EA) for the notification.
2. Environmental Consequences of the Proposed Action
This action involves a FCS to be used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intended for repeated use. 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 19482, May 1, 1996). The basis for the agency's decision to establish the categorical exclusion in §25.32(j) for food additive petitions is the same basis as 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. These additives ordinarily have limited potential for causing any significant environmental effects as a result of their use and disposal. The principal route for potential environmental introduction of the types of substances included under §25.32(j), whether in a food additive petition or a PMN, results from their disposal after use. The likelihood for significant introductions of substances to the environment due to disposal is very low because of the long service life of food-contact equipment or other repeat-use articles, of which the subject FCS is a component, and the limited market volumes of these substances.
In the claim of categorical exclusion in the TOR exemption request, the requester certified that no extraordinary circumstances were expected that would require the preparation of an EA. 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
Hardy J. Chou, Ph.D., 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