Food

Environmental Decision Memo for Food Contact Notification No. 000100

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Date: December 6, 2000

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

Subject: FCN No. 100 - Polyvinyl Alcohol for Use in Coatings for Fruits and Vegetables with Inedible Peels

Notifier: Agway, Inc
Syracuse, NY 13221-4933

To: Division of Petition Control (HFS 215)
Attention: Julius Smith
Through: Team Leader, ERT (HFS-246)

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification and a supplemental environmental assessment (EA) that we prepared. When this notification becomes effective, this FONSI, the notifier's August 17, 2000, EA, and our supplemental EA may 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.

Elizabeth Ann Cox

2 Attachments
FONSI
Supplemental EA


Finding of No Significant Impact

Premarket notification FCN No. 100, submitted by Agway, Inc, to provide for the safe use of polyvinyl alcohol as a component of coatings applied to fruits and vegetables with inedible peels, except on citrus fruits.

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 information submitted by the notifier in an environmental assessment dated August 17, 2000, and on the attached supplement to the environmental assessment prepared by the Environmental Review Team.

Prepared by________________________________________ Date: December 6, 2000
Elizabeth Ann Cox, Environmental 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: December 6, 2000
Buzz L. 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


Supplement to the Environmental Information for Food Contact Notification No. 100

This document incorporates by reference the notifier's environmental assessment (EA) dated August 17, 2000.

In the environmental assessment (EA) for this notification, the notifier does not address the potential for introduction of polyvinyl alcohol into the environment at sites where this chemical is coated onto fruits and vegetables. The Environmental Review Team has determined that these introductions are of low concern based on the following:

In the process whereby polyvinyl alcohol is coated onto fruits and vegetables, some of this chemical adheres to these fruits and vegetables and some drips off to waste. In response to our question, the notifier has explained that no more than 1% of the coating (containing 3-5% polyvinyl alcohol) will be lost at the sites of use and that this lost amount will go to conventional waste treatment facilities. Thus, the concentrations of polyvinyl alcohol that will be introduced into the environment at use sites are likely to be low because almost all of it adheres to the fruits and vegetables. We do not, however, have quantitative estimates for these concentrations.

The toxicity of polyvinyl alcohol to organisms that may be exposed in the environment was predicted using EPA's ECOSAR. The molecular weight for polyvinyl alcohol ranges from 30,000 to 50,000. ECOSAR will not yield meaningful results for compounds with a molecular weight greater than 1000. Therefore, we used ECOSAR to predict the toxicity of an oligomer of polyvinyl alcohol, i.e., a compound with the same structure but with a molecular weight of 999.26. The ECOSAR predicted low toxicity to fish, daphnids, and green algae for this oligomer with an EC50 >1000 milligrams per liter (mg/L). Extrapolating toxicity from these results for this oligomer indicates that the toxicity of polyvinyl alcohol will also be low, with an EC50 >1000 mg/L. Even though we do not have quantitative estimates for the concentration of polyvinyl alcohol in the environment, we believe that such concentrations are likely to be well below 1000 mg/L and, therefore, we predict its toxicity to aquatic organisms to be of low concern.

In addition to having low toxicity, polyvinyl alcohol is biodegradable. This means that the polyvinyl alcohol that is introduced into the environment, if any, will not accumulate because it will be degraded.

Thus, the polyvinyl alcohol that enters the environment at use sites as a result of this action is very unlikely to have adverse effects on exposed organisms.

Prepared by:__________________________________________ Date: December 6, 2000
Elizabeth Ann Cox, Environmental 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

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