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CFSAN/Office of Food Additive Safety
April 5, 2000
Date: April 5, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No.000024 for a Tin-based Alloy for Filling Bearings made from Extruded or Molded Carbon and Graphite
Notifier: Graphite Metallizing Corporation
1050 Nepperhan Avenue
Yonkers, NY 10702
To: Division of Petition Control (HFS-215)
Attention: Ellen M. Waldron
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 following information should be made available to the public:
1. The FONSI
2. The EA we have prepared.
3. The EA originally prepared for the TOR exemption request.
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
1. Description of the Proposed Action
The proposed action submitted by Graphite Metallizing Corporation is to provide for the safe use of a tin-based alloy for filling bearings made from extruded or molded carbon and graphite. The tin-based alloy is ASTM B32-49 Grade 1, which has the following components: antimony, copper, lead, iron, aluminum, zinc, arsenic, bismuth, and tin. The bearings are intended for use in pumps, baking ovens, and equipment for transporting or handling of food products. This action was originally submitted as a Threshold of Regulation (TOR) exemption request (No. 225). The TOR exemption request contained an environmental assessment (EA) prepared in accordance with previous 21 CFR part 25.
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 a new use of a food additive that is a food contact substance (FCS). Section 409(h)(6) of the FFDCA 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 for the use of a food contact substance, that the petitioned or requested action might be eligible for a PMN under section 409(h) of the FFDCA. The sponsors were told that they could consider withdrawing such a request and resubmitting it as a PMN. In an letter dated December 8, 1999, Graphite Metallizing Corporation requested that TOR exemption request No. 225 be converted to a PMN. On January 7, 2000, the agency mistakenly requested that the notifier submit a claim of categorical exclusion under 21 CFR 25.32(j). Responding to the January 7, 2000, request, Graphite Metallizing Corporation submitted a claim of categorical exclusion on January 14, 2000. We evaluated the claim and have determined that, had the submission continued to be treated as a TOR exemption request, the action would have qualified for the categorical exclusion under 21 CFR 25.32(j). However, even though 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 TOR exemption request, or a PMN, 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, because the sponsor's original EA,submitted with the TOR exemption request, was not complete, we have prepared this EA for the subject notification.
2. Environmental Consequences of the Proposed Action
This notification involves an FCS that is a component of an article intended for repeated use. The notifier has stated that the tin-based alloy filled carbon bearings are to be used for food contact articles, including pumps and ovens. 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 (see 61 FR 19476 at 19481-82, May 1, 1996). The basis for the Agency's decision to establish the categorical exclusion in §25.32(j) for food additive petitions and TOR exemption requests 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 potential environmental introduction of the types of substances included under 25.32(j), whether in a food additive petition, a TOR exemption request, or a PMN, results from their disposal after use. The likelihood for significant introduction of substances to the environment due to disposal is very low because of the long service life of the food contact equipment of which the food contact substance is a component (See the EA submitted by the notifier) and the limited market volumes of the food contact substance.
In the claim of categorical exclusion and in a subsequent clarification of information in the claim, the notifier has said that there are no extraordinary circumstances such that the production, use, and disposal of the food contact substance will significantly affect the environment. We do not believe that the conversion of this TOR 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
A Premarket Notification (FCN No. 000024), submitted by Graphite Metallizing Corporation, to provide for the safe use of tin-based alloy (ASTM B32-49 Grade 1) for filling bearings made from extruded or molded carbon and graphite for use in repeat use food contact articles including pumps, baking ovens, and equipment for transporting or handling of food products.
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 5, 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 5, 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
