Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1761

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

FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1761, submitted by Perstorp Holding AB, for use of polycaprolactone (CAS Reg. No. 24980‐41‐4) in blends with authorized polylactide polymers and thermoplastic starch polymers intended for use as components of articles in contact with food. The FCS may be used in blends with the identified polymers at levels up to 35%. Finished articles may contact all food types under Conditions of Use B through H, as described in Tables 1 and 2, respectively.^[1] The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

The Office of Food Additive Safety has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated March 7, 2017. The EA was prepared in accordance with 21 CFR 25.40. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below.

The FCS is intended for use as a component in blends with polylactide polymers and thermoplastic starch polymers; these blends are then used to make food-contact articles. Manufacture of the FCS is not expected to result in adverse environmental impact. Once the FCS-containing food contact articles are made, they will be used and disposed of by conventional rubbish disposal. The food contact articles in which the FCS will be used are not expected to be recycled. Consequently, the FCS is expected to be primarily land disposed (80.4% of the FCS) and secondarily, incinerated (19.6% of the FCS) based on disposal trends for municipal solid waste (MSW), as reported by the U.S. Environmental Protection Agency (EPA). Based on confidential market volume information provided in a confidential attachment to the EA, the FCS will make up a very small portion of the total MSW landfilled and incinerated.

Because of EPA's regulations governing landfills (40 CFR Part 258) and the marginal amount of the FCS that would be landfilled, the FCS is not expected to be introduced to land or water when disposed via landfill. Similarly, when combusted, the EA explains there is nothing to suggest the FCS would threaten a violation of 40 CFR 60, the regulations governing MSW combustion facilities (based on the composition of the FCS and the marginal amount of FCS compared to all combusted MSW). The EA also considered the impact of greenhouse gas (GHG) emissions in a confidential attachment. The GHG carbon dioxide is anticipated to be released upon combustion of the FCS. MSW combustion facilities that emit 25,000 metric tons carbon dioxide equivalents (CO2-e) or more per year are required to report their GHG emissions per the EPA's Greenhouse Gas Reporting Program (GHGRP) described in 40 CFR 98.2. If an FCN was expected to contribute such a level of GHG, more analysis would be necessary to determine if it constituted a significant environmental impact. However, based on the information provided in the confidential attachment to the EA, total estimated GHG emissions resulting from the use of the FCS per FCN 1761 is below 25,000 metric tons carbon dioxide equivalents (CO2-e). In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1761.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS, nor do we expect adverse environmental effects, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of the materials which the FCS would otherwise replace; such action would have no environmental impact. Furthermore, as the use and disposal of the FCS is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.

As evaluated in the EA, the use of the FCS, as described in FCN 1761, as a component in blends with polylactide polymers and thermoplastic starch polymers that are made into food-contact articles, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 06-27-2017
Sarah C. Winfield
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 06-27-2017
Mariellen Pfeil
Biologist / Acting Lead, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] https://www.fda.gov/food/ingredientspackaginglabeling/packagingfcs/foodtypesconditionsofuse/default.htm, accessed 5/25/17

U.S. Food and Drug Administration
Revision Sheet for the March 7, 2017 EA for FCN 1761

Dated: June 27, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of March 7, 2017 for food contact notification (FCN) 1761 concluded that the action will not constitute a significant impact. The revision is issued to make a minor change and update of an editorial nature that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI).

The revision is necessary to explain the following:

There is a discrepancy in the EA versus the regulatory language: Item 4. a. of the EA describes the requested action, and then indicates the food contact substance (FCS) will not be used in applications that would contact "breast milk." However, the final regulatory language, as described in the March 17, 2017 Acknowledgement Letter uses the term "human milk," not "breast milk." The reader is advised that "breast milk" is a typographical error and should be "human milk," per the regulatory language.
The EA includes irrelevant information: The paragraph that starts with "Indeed, in its Guidance for Industry:..." and ends with "current commercial recycling processes." under Item 6. b. of the EA is not relevant to determining whether the FCS will impact recycling. We reached the conclusion the FCS will not impact recycling based on the information provided in footnote 4 of the EA, which cites data from the Environmental Protection Agency indicating negligible recycling of a relevant polymer. The identified paragraph should be disregarded by the reader.
The EA includes a typo: Under Item 13 of the EA, the year in the date is written as "2016." This is a typographical error and should be "2017."

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the March 7, 2017 EA for FCN 1761

U.S. Food and Drug Administration
Revision Sheet for the March 7, 2017 EA for FCN 1761