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Environmental Decision Memo for Food Contact Notification No. 000043

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: April 6, 2000

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

Subject: Premarket Notification FCN No.000043 - Nickel Iron Alloy to be Used in Seals for Food-Processing Equipment

Notifier: Marlen Research Corporation
Overland Park, Kansas 66214

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 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. 000043

1. Description of the Proposed Action

The proposed action, requested by Marlen Research Corporation, is to provide for the safe use of a nickel-iron alloy to be used in seals for food-processing equipment. The metal, which is manufactured by Ametek Specialty Metal Products Division, would be used in a fine powder form in acrylonitrile-butadiene resin contacting meat products at up to 35E F, and contacting fruit and vegetable products at up to 180E F. The components of the alloy are as follows: nickel, iron, molybdenum, sulfur, and carbon. This action was originally considered to be a Threshold of Regulation (TOR) exemption request (TOR No. 218).

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 an FCS 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 petition or TOR exemption request and resubmitting it as a PMN.

In a letter dated February 1, 2000, Marlen Research Corporation requested that TOR No. 218 be converted to a PMN. The letter contained a claim of categorical exclusion under 21 CFR 25.32(j) from the need to prepare an environmental assessment. This exclusion is for actions for substances used as a component of a food contact surface of permanent or semi-permanent equipment or of another food contact article intended for repeated use.

We have reviewed the sponsor's claim of categorical exclusion and have determined that, had the submission been reviewed as a TOR exemption request, the action would have qualified for categorical exclusion under 21 CFR 25.32(j). The types of substances and the uses of such substances under this categorical exclusion are the same whether a sponsor submits a food additive petition, a TOR exemption request, 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(j). Therefore, we have prepared this environmental assessment (EA) for the notification submitted by Marlen Research Corporation.

2. Environmental Consequences of the Proposed Action

This action involves an FCS that is a component of an article intended for repeated use. The notifier said that the nickel-iron alloy will be used in acrylonitrile-butadiene seals for food-processing equipment. 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 19482, 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, 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 and because of the limited market volume of the food contact substance.

The claim of categorical exclusion in the February 1, 2000, letter also stated that there are no extraordinary circumstances such that the use of the FCS will significantly affect the environment. The notifier subsequently clarified that the word "use" may be interpreted broadly to include the production, use, and disposal of the FCS. Therefore, 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

John L. Dennison
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. 000041), submitted by Goldschmidt Chemical Corp., to provide for the safe use of silicone acrylate resins produced by the addition of omega-hydroxyalkenes and/or propenyloxy-2,3-dihydroxypropane, mono- or diester with acrylic acid, acetic acid or other saturated monocarboxylic acid, to dimethyl polysiloxane, methylhydrogen polysiloxane, or dimethyl-methylhydrogen polysiloxane intended for use as coatings or components of coatings on polymeric substrates and on paper and paperboard, at a maximum level of 1.3 milligram per square inch (mg/in2), in contact with all food types under conditions of use E, F, G, and H as defined in 21 CFR 176.170, Table 2.

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: March 31, 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: March 31, 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

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