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CFSAN/Office of Food Additive Safety
May 10, 2000
Date: May 10, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000045 - Quaternary Amine Cellulose Ion Exchange Resins Used to Isolate and Purify Protein Concentrates and Isolates from Aqueous Process Streams for Food Processing
Notifier: Life Technologies, Inc.
Grand Island, NY 14072
To: Division of Petition Control (HFS-215)
Attention: Martha Peiperl
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.
Hardy J. Chou, Ph.D.
1. Description of the Proposed Action
The proposed action is to provide for the safe use of two GibcoCel quaternary amine (QAE) cellulose ion exchange resins (IXRs): (1) high substitution capacity QAE cellulose IXR (1.5 -2.5 milliequiv. quaternary ammonium per dry g resin); and (2) high protein capacity QAE cellulose IXR (1.0-1.5 milliequiv. quaternary ammonium per dry g resin) for use in the isolation and purification of protein concentrates and isolates from aqueous process streams for food processing. This action was originally requested by Life Technologies, Inc. in a food additive petition (FAP 9A4659). The notice of filing, which was published in the Federal Register on April 30, 1999 [64 FR 23338], contained the agency's decision that approval of the petition would qualify for categorical exclusion under 21 CFR 25.32(j). This exclusion is for actions when the substance is 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.
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 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 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 requesters who had pending food additive petitions or threshold of regulation (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. On February 10, 2000, Life Technologies, Inc. requested that FAP 9A4659 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, (TOR), 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 in treating aqueous process streams for food processing. 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 19481-19482, 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 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 FCS is a component and because of the limited market volumes of the food contact substance. The claim of categorical exclusion in FAP 9A4659 states that no extraordinary circumstances exist. 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
Hardy J. Chou, Ph.D., 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. 000045), submitted by Life Technologies, Inc. for two GibcoCel quaternary amine (QAE) cellulose ion exchange resins (IXRs): (1) high substitution capacity QAE cellulose IXR (1.5-2.5 milliequiv. quaternary ammonium per dry g resin); and (2) high protein capacity QAE cellulose IXR (1.0-1.5 milliequiv. quaternary ammonium per dry g resin) for use in the isolation and purification of protein concentrates and isolates from aqueous process streams for food processing.
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: May 10, 2000
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
Approved by: ____________________________________________ Date: May 10, 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
