Source: http://www.fda.gov/Food/IngredientsPackagingLabeling/EnvironmentalDecisions/ucm154071.htm
Timestamp: 2016-09-29 20:32:21
Document Index: 685331004

Matched Legal Cases: ['§177', '§175', '§170', '§25', '§25', 'art 60', 'art 258']

Environmental Decision Memo for Food Contact Notification No. 000036 Skip to main page content
Environmental Decision Memo for Food Contact Notification No. 000036
Subject: Premarket Notification FCN No. 000036 for use of gum rosin as a reactant in the production of polyester resins as a component of coatings applied to polypropylene films
Notifier: Resinall Corporation
Attached are 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.
Environmental Assessment for FCN No. 000036
The proposed action is to provide for the safe use of gum rosin, CAS No. 8050-09-7, manufactured by Resinall Corporation and intended for use as a reactant in the production of polyester resins used as a component of coatings applied to polypropylene films complying with §177.1520. The polyester resin may be used at levels not to exceed 0.05 milligrams per square inch in coating applied to the film surface area. The coated films may be used in contact with all types of food and under all conditions of use in accordance with §175.320.
This action was originally requested for Resinall Corporation by Keller and Heckman LLP, in a food additive petition (FAP) 0B4715, in which the petitioner requested a categorical exclusion under 21 CFR 25.32(i). 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 act defines a food contact substance 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 threshold of regulation exemption requests involving the use of a food contact substance, 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. FDA also said that it would be prepared to process notifications submitted to the agency beginning on January 18, 2000. The petitioner's representative submitted FAP 0B4715 on January 14, 2000, just a few days before FDA said it would be ready to process new PMNs. In a telephone conversation on February 4, 2000, the petitioner's representative requested that FAP 0B4715 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 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 (EA) for the subject notification.
This action involves a food contact substance 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. These additives ordinarily have limited potential for causing any significant environmental effects as a result of their use and disposal. 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 gum rosin in food packaging material will be not greater than 5 percent-by-weight and that it is expected to remain with the finished food-packaging material through use by consumers. 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 0B4715, the petitioner stated that no extraordinary circumstances were expected that would preclude this use from categorical exclusion. We do not believe that the conversion of this petition to a PMN would alter the fact that no extraordinary circumstances are likely to occur as a result of this action.
A Premarket Notification (FCN No. 000036), submitted by Keller and Heckman LLP, on behalf of Resinall Corporation, to provide for the safe use of gum rosin as a reactant in the production of polyester resins used as a component of coatings applied to polypropylene films which may be used in contact with all types of food and under all conditions of use.
Prepared by: _________________________________________ Date: March 20, 2000
Approved by: ________________________________________ Date: March 20, 2000