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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000041

Date: March 31, 2000

 

From: Environmental Scientist, Chemistry and Environmental Review Team (CERT)
Scientific Support Branch (HFS-207)

 

Subject: Premarket Notification FCN No. 000041 for use of Silicone Acrylate Resins as Coatings on Polymers and Paper and Paperboard Intended to Contact Food

 

Notifier: Goldschmidt Chemical Corp.
c/o Keller and Heckman
Washington, DC 20001

 

To: Division of Product Policy (HFS-205)
Attention: Hortense Macon
Through: Team Leader, Environmental Review Team

 

 

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 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.

 

 

 

Jeanette Glover Glew

 

 



 



 

Environmental Assessment for FCN No. 000041

 

 

1. Description of the Proposed Action

The proposed action is 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, manufactured by Goldschmidt Chemical Corporation and 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 resins shall be cured by the use of electron beam or ultraviolet light such that the finished coating, when extracted with 50 % ethanol at 100 C for 2 hours, yields total chloroform-soluble nonvolatile extractives not to exceed 0.02 milligram per square inch (mg/in2). The cured resins may include substances permitted for use by regulation in 21 CFR 170-189, substances generally recognized as safe, substances used in accordance with prior sanction approval, and the following substances as photoinitiators: 2-hydroxy-2-methyl-1-phenyl-1-propanone ( CAS Reg. No. 7473-98-5) and/or oligomeric-2-hydroxy-2-methyl-1-[4-(1-methylvinyl)phenyl]-1-propanone (CAS Reg. No. 163702-01-0). The total photoinitiator levels shall not exceed 3 percent by weight of silicon acrylate resin in coatings.

This action was originally requested for Goldschmidt Chemical Corporation by Keller and Heckman, in a food additive petition (FAP) 9B4658. The notice of filing, which contained the agency's decision that approval of the petition would qualify for a categorical exclusion under 21 CFR 25.32(i), was published in the Federal Register on June 23, 1999 (64 FR 33488). This exclusion is for actions for substances present in food-packaging material at not greater than 5 percent-by-weight and that are expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.

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 new uses of food additives that are food contact substances. Section 409(h)(6) of the FFDCA defines a food contact substance (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 requesters who had pending food additive petitions or threshold of regulation (TOR) exemption requests involving the use of an FCS, that the petitioned or requested action might be eligible for notification under section 409(h) of the FFDCA. The petitioners were told that they could consider withdrawing such petition or request and resubmitting it as a PMN. In a letter dated February 4, 2000, the petitioner's representative requested that FAP 9B4658 be converted to a PMN.

The types of substances and the uses of such substances under the categorical exclusion in 21 CFR 25.32(i) are the same whether a sponsor submits a food additive petition, a request for exemption from regulation as a food additive (threshold of regulation or TOR) 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(i). Therefore, we have prepared this Environmental Assessment for the subject notification.

2. Environmental Consequences of the Proposed Action

This action involves an FCS that is a minor component of finished food-packaging materials (<5% by weight of the finished packaging material) that remains with the packaging through use by consumers. FDA has 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 (61 FR 19476 at 19481-19482, May 1, 1996). The basis for FDA's decision to establish the categorical exclusion in § 25.32(i) for food additive petitions is the same basis that would be applicable to PMNs. Therefore, FDA's experience with the food additive petitions that it reviewed to support a categorical exclusion for such actions is relevant to PMNs. The principal routes of environmental introduction of the types of substances included under § 25.32(i), whether reviewed in a food additive petition or in a PMN, result from their disposal in municipal solid waste combustors or landfills. These routes of disposal are governed by the regulations of the Environmental Protection Agency (EPA) in 40 CFR part 60 (combustors) and part 258 (landfills). Based on the low levels of use of these substances in packaging material, the introduction of combustion products or introductions at landfill sites are not environmentally significant. The petitioner states that the proposed maximum use of the silicone acrylate resins in food packaging material is not greater than 5 percent-by-weight and that it is expected to remain with the finished food-packaging material through use by consumers, or are used only in coatings for finished food packaging materials. Moreover, the resins were expected to constitute less than 5% of the finished food package weight due to the restriction on the maximum coating weight. Because of the nature of this type of action, we do not expect that any limited increase in environmental introductions resulting from this proposed action will threaten a violation of EPA's regulations governing combustors and landfills or have any other adverse environmental effects.

In the claim of categorical exclusion in FAP 9B4658, the petitioner stated that no extraordinary circumstances were expected that would preclude this use from categorical exclusion. 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

Jeanette Glover Glew
Environmental Scientist
Chemistry and Environmental Review Team
Division of Product Policy
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