Food

Environmental Decision Memo for Food Contact Notification No. 000011

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: March 8, 2000

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

Subject: Premarket Notification FCN No. 000011 - 4,5-dichloro- 2-n-octyl-3(2H)-isothiazolone in paper and paperboard intended to contact aqueous and fatty food

Notifier: Rohm and Haas Co.
Philadelphia, PA 19106

To: Division of Product Policy (HFS-205)
Attention: Hortense Macon
Through: Team Leader, Environmental Review Team
Division of Product Manufacture and Use (HFS-246)

Attached is the Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. Also attached is a copy of the Environmental Protection Agency (EPA) FIFRA label. 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.

Jeanette Glover Glew

 

3 Attachments:
Environmental Assessment
Finding of No Significant Impact
EPA FIFRA label


Environmental Assessment for FCN No. 000011

1. Description of the Proposed Action

The proposed action is to provide for the safe use of 4,5-dichloro-2-n-octyl-3(2H)-isothiazolone in paper and paperboard intended to contact aqueous and fatty food as follows: 1) as a mold-proofing agent applied to the surface of uncoated paper and paperboard and in coatings for paper and paperboard, in compliance with 21 CFR 176.170(b), at a level not to exceed 100 parts per million (ppm) based on dry fiber weight; 2) as a preservative in wet lap and sheet pulp, in compliance with 21 CFR 176.170(a) prior to repulping to produce paper and paperboard, at a level not to exceed 100 ppm based on dry fiber weight; 3) as a preservative in pigment dispersions in compliance with 21 CFR 176.170(b), at a level not to exceed 50 ppm and as a slimicide in compliance with 21 CFR 176.300 at a maximum level of 0.034 pound per ton of dry paper or paperboard. This action was originally requested by Rohm and Haas Co., in Food Additive Petition (FAP) 9B4645. The notice of filing for this petition was published in the Federal Register on April 19, 1999 [64 FR 19182]. The notice of filing contained the Agency's decision that approval of the petition would qualify for a categorical exclusion under 21 CFR 25.32(q). This exclusion is for actions for substances registered by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the same use requested in the petition.

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 (the act) to establish a premarket notification (PMN) process as the primary method for authorizing a new use of a food additive that is a food contact substance. 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 sponsors were told that they could consider withdrawing such a petition or request and resubmitting it as a PMN. The petitioner=s representative requested, in a letter dated November 22, 1999, that FAP 9B4645 be converted to a PMN.

The types of substances and the uses of such substances under the categorical exclusion in 21 CFR 25.32(q) 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(q). Therefore, we have prepared this EA for the subject notification.

2. Environmental Consequences of the Proposed Action

This notification involves a food contact substance that is registered by EPA under FIFRA for the same use requested in the original petition (see attached FIFRA label). The Agency's experience with antimicrobial substances that were the subject of food additive petitions or threshold of regulation exemption requests has been that, when an antimicrobial substance is intended for the same use, FDA's assessment of the environmental risk of antimicrobial substances is the same as EPA's assessment of the environmental risk of pesticides; therefore, the food additive use will be subsumed under EPA's environmental review of the substance as a pesticide registered under FIFRA (62 FR 40583). The basis for the Agency's decision to establish the categorical exclusion in §25.32(q) for food additive petitions is the same basis that would be applicable to PMNs. Therefore, the Agency's experience with the food additive petitions that it reviewed to support a categorical exclusion for such actions is relevant to PMNs and additional environmental analysis by FDA for FCN No. 000011 is not needed.

In the claim of categorical exclusion in FAP 9B4645, the petitioner certified 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.

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. 000011), submitted by Rohm and Haas Co., to provide for the safe use of 4,5-dichloro-2-n-octyl-3(2H)-isothiazolone in paper and paperboard intended to contact aqueous and fatty food as follows: 1) as a mold-proofing agent applied to the surface of uncoated paper and paperboard and in coatings for paper and paperboard, in compliance with 21 CFR 176.170(b), at a level not to exceed 100 parts per million (ppm) based on dry fiber weight; 2) as a preservative in wet lap and sheet pulp, in compliance with 21 CFR 176.170(a) prior to repulping to produce paper and paperboard, at a level not to exceed 100 ppm based on dry fiber weight; 3) as a preservative in pigment dispersions in compliance with 21 CFR 176.170(b), at a level not to exceed 50 ppm and as a slimicide in compliance with 21 CFR 176.300 at a maximum level of 0.034 pound per ton of dry paper or paperboard.

The Chemistry and Environmental Review Team and the Environmental Review Team have 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 6. 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 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

Page Last Updated: 05/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.