See also Decisions for Petitions.
Date: December 8, 1995
From: Environmental Toxicologist, Environmental Impact Staff (HFS-246)
Subject: FAP 3B4380 - NOXOL for Use as an Antiscaling Agent in the Polymerization of PVC and Acrylic Polymers Intended for Food-Contact Articles
c/o AAC Consulting Group, Inc.
Washington, DC 20036
To: Indirect Additives Branch (HFS-216)
Attention: Vir D. Anand, Ph.D.
Through: Chief, EIS (HFS-246)
Attached is the Finding of No Significant Impact (FONSI) for this petition. When the petition is ready to be regulated, please forward the following information to the Dockets Management Branch:
1. This FONSI.
2. The petitioner's revised environmental assessment (EA) (in PDF,785Kb), dated May 24, 1995.
Please do not forward the confidential environmental assessment information attached to this EA (petition volume 4).
Layla I. Batarseh, Ph.D.
Finding of No Significant Impact
Food Additive Petition 3B4380, submitted by Compagnia Italiana di Ricerca e Sviluppo, srl (CIRS), to amend 21 CFR 178, Subpart D, to provide for the safe use of formaldehyde, polymer with 1-naphthylenol, as an antiscaling agent in the polymerization of polyvinyl chloride and acrylic polymers used in the manufacture of food-contact articles.
The Environmental Impact Staff, Center for Food Safety and Applied Nutrition, has determined that the approval of this petition 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 petitioner in an environmental assessment (in PDF,785Kb) prepared using the format described in 21 CFR 25.31a(a) and on the following analysis.
1. Only a very small amount of the subject additive is expected to enter the environment as a result of landfill disposal of food-packaging materials containing the subject additive. This finding is based on a) the market volume of the subject additive, provided in a confidential section of the petition; b) the percentage of the estimated market volume of the subject additive that will be disposed of in landfills; 1 c) the percentage of the subject additive that is extracted from foodpackaging materials; 2 and d) the Environmental Protection Agency's (EPA's) regulations governing municipal solid waste landfills. 3
2. Because of the very high estimated KOW, of the subject additive, 4 only an extremely small amount of the projected market volume of the subject additive is expected to enter surface waters as a result of its introduction at the site where it is used in polyvinyl chloride and acrylic polymers polymerization plants. Most of the subject additive will be removed from the wastewater generated in these plants by adsorption to sewage sludge either on-site or in publicly owned treatment works that receive wastewater from such polymerization plants. Because of its strong adsorption property, the additive would have limited mobility in agricultural environments receiving sewage sludge as a fertilizer.
3. Based on the elemental composition and the market volume of the subject additive provided in the petition, no significant change in incinerator emissions is expected to result from incinerating food-contact materials containing the subject additive.
4. The subject additive will not materially increase the market volume of polyvinyl chloride and acrylic polymers used in the manufacture of food-contact articles or change the potential uses of such articles because it will replace other additives that are already marketed for the same use.
Prepared by:______________________________Date: December 8, 1995
Layla I. Batarseh, Ph.D., Environmental Toxicologist
Environmental Impact Staff
Approved by:________________________________Date: December 8, 1995
Buzz L. Hoffman, Chief
Environmental- Impact Staff.
1 Characterization of Municipal Solid Waste in the United States: 1994 Update, EPA/530-S-94-042, Environmental Protection Agency, Office of Solid Waste and Emergency Response, Washington, DC 20460.
2 The percentage of the subject additive extracted from food-packaging materials was calculated from extraction data submitted by the petitioner using 3% acetone solution as an aqueous food simulant.
3 EPA's regulations require new municipal solid waste landfills and lateral expansions of existing landfills to have composite liners and leachate collection systems to prevent leachate from entering ground and surface water, and to have ground-water monitoring systems (40 CFR Part 258). Although owners and operators of existing active municipal solid waste landfills that were constructed before October 9, 1993, are not required to retrofit liners and leachate collection systems, they are required to monitor groundwater and to take corrective action as appropriate.
4 Log n-octanol/water partition coefficient of the subject additive (Log KOW) was estimated based on the chemical structure of the additive. The estimated Log KOW, for the monomer and the dimer of the subject additive were 8.45 and 13.3, respectively. Based on these values, we concluded that the Log KOW, for the subject additive would be greater than 13.3.