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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000017

Date: March 9, 2000


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


Subject: Premarket Notification FCN No.000017 for Perfluorocarbon Cured Elastomer Used as O-rings, Gaskets, Diaphragms and Seals in Repeat Use Food Processing Equipment


Notifier: PolyChem Consulting
Asheville, NC 28804


To: Division of Petition Control (HFS-215)
Attention: Julius Smith
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. 000017



1. Description of the Proposed Action

The proposed action is to provide for the safe use of perfluorocarbon cured elastomer in molded parts of food processing equipment including O-rings, gaskets, and diaphragms, which function primarily in sealing applications. The perfluorocarbon base polymer shall contain no less than 30 weight percent of polymer units derived from tetrafluoroethylene, no less than 60 weight percent of polymer units derived from perfluoro(2,5-dimethyl-3,6-dioxanonane vinyl ether) and no more than 4 weight percent of polymer units from perfluoro(6,6-dihydro-6-iodo-3-oxa-1-hexene). This action was originally requested on June 16, 1999, in a letter submitted by PolyChem Consulting in a threshold of regulation (TOR) exemption request (TOR #227). The letter also included a claim of categorical exclusion under 21 CFR 25.32(j). 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 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 (FFDCA) to establish a premarket notification (PMN) process as the primary method for authorizing a new use of food additives that are food contact substances (FCSs). Section 409(h)(6) of the act 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 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 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 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. Subsequently, in a letter dated November 22, 1999, PolyChem Consulting requested that the TOR exemption request No. 227 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 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 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 perfluorocarbon cured elastomer is used in the manufacture of molded parts of food processing equipment including o-rings, gaskets, diaphragms and the like which function primarily in sealing applications. 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.

These substances ordinarily have limited potential for causing any significant environmental effects as a result of their use and disposal. The principal route of potential environmental introduction of the types of substances included under § 25.32(j), whether in a food additive petition, in a TOR exemption request, or in 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 FCS is a component and because of the limited market volumes of the FCS.

The claim of categorical exclusion in the TOR exemption request, states that no extraordinary circumstances which would otherwise prevent the proposed use of the additive from being qualified for categorical exclusion were expected. 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