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Environmental Decision Memo for Food Contact Notification No. 000064

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: June 8, 2000

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

Subject: Premarket Notification FCN No. 000064 - for the use of diallyldimethyl ammonium chloride and acrylamide copolymers in paper and paperboard

Notifier: Nalco Chemical Company
One Nalco Center
Naperville, IL 60563-1198

To: Division of Petition Control (HFS-215)
Attention: Edward Machuga, Ph.D.
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 PMN submission. When this notification becomes effective, the EA and FONSI 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.

John L. Dennison

Environmental Assessment for FCN No. 000064

1. Description of the Proposed Action

The proposed action is to provide for the safe use of diallyldimethylammonium chloride polymer with acrylamide, produced by the copolymerization of diallyldimethylammonium chloride with acrylamide in weight ratios ranging from 85/15 to 50/50 diallyldimethyl-ammonium chloride/acrylamide, for use as a drainage and/or retention aid prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard, and used in a 1 percent by weight aqueous solution at a level not to exceed 0.05 percent by weight of the finished paper or paperboard. This action was originally requested by Calgon Corporation in a food additive petition (FAP 3B3677), as announced in the Federal Register on December 17, 1982 (47 FR 56556). When the petition was filed, it contained an environmental assessment (EA). On July 27, 1997, FDA published revised regulations under 21 CFR Part 25, which became effective on August 28, 1997. These revised regulations contain categorical exclusions for actions that do not require the preparation of an EA or an Environmental Impact Statement, including the type of action that was the subject of FAP 3B3677. Because the environmental review had not been completed, the agency contacted the petitioner on April 12, 1999, and explained that the categorical exclusion in 21 CFR 25.32(i) might apply to the proposed action. In a letter dated May 5, 1999, Calgon Corporation submitted a claim of 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 the PMN process as the primary method for authorizing new uses of food additives that are food contact substances (FCS). Section 409(h)(6) of the 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 involving the use of an FCS, that the petitioned or TOR exemption request might be eligible for premarket notification under section 409(h) of the FFDCA. The sponsors were told that they could consider withdrawing the petition or TOR exemption request and resubmitting it as a PMN.

Calgon Corporation transferred the petition to Nalco Chemical Company (Calgon's letter dated March 24, 2000). The same day, Nalco Chemical Company sent a letter to FDA requesting that FAP 3B3677 be converted to a Premarket Notification (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 TOR exemption request, 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) and that remains with the packaging, in this case paper or paperboard, 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 route for potential environmental introduction of the types of substances included under §25.32(i), whether reviewed in a food additive petition, or a PMN, results 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. 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 for FAP 3B3677 (letter dated May 5, 1999), the original petitioner, Calgon, stated that no extraordinary circumstances exist that would require submission of an EA. 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.

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

John L. Dennison
Environmental Review Team
Division of Product Manufacture and Use
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Finding of No Significant Impact

A Premarket Notification (FCN No. 000064), submitted by Nalco Chemical Company, to provide for diallyldimethylammonium chloride polymer with acrylamide in weight ratios ranging from 85/15 to 50/50 diallyldimethylammonium chloride/acrylamide to be used only as a draining and/or retention aid employed prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard.

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: June 8, 2000
John L. Dennison, 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: June 8, 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

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