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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000943

Date: April 12, 2010
From: Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 943 - Polyhydroxyalkanoates as components of polymers used in articles that may contact food.
Notifier: Telles LLC
650 Suffolk Street, Suite 100
Lowell, MA 01854
To: Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

The food-contact substance (FCS) is butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid at 4-10 wt% and butanoic acid, 3-hydroxy, homopolymer at 90-96 wt%.

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 943. After this notification becomes effective, copies of the FONSI, the notifier's environmental assessment, dated October 12, 2009, and the supplement to the environmental record may be made available to the public. We shall post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

Please let us know if there is any change in the identity or use of the food-contact substance.

 

Hoshing W Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 943


Finding of No Significant Impact

A food-contact notification (FCN No. 943), submitted by Telles LLC, to provide for the safe use of butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid at 4 - 10 percent-by-weight of the polymer and butanoic acid, 3-hydroxy, homopolymer at 90 - 96 percent-by-weight of the polymer as components of articles that may contact food.

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 information, submitted by the notifier, in an environmental assessment, dated October 12, 2009, our supplement to the environmental record for FCN 943, and other information known to the agency.

 

Prepared by __________________________________________Date: April 12, 2010
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: April 12, 2010
William H Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 943

This document incorporates by reference the notifier's environmental assessment (EA), dated October 12, 2009.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI).

The production of the food-contact substance (FCS) is an innovative technology. In topic 5, the EA reports that D-glucose (dextrose) is metabolically converted by fermentative polymerization into the FCS. (See also a series of patents describing details about the process to produce and extract the FCS.1) Because the primary feedstock, dextrose, is derived from corn,2 the potential impact from land that may be converted into agricultural use for cultivation of corn to support the manufacture of the FCS needs consideration to determine whether any extraordinary circumstances exist consequent on the manufacturing capacity and commercial demand.

The FCS will be produced in a commercial scale plant at Clinton, IA.3 Environmental considerations of the context and intensity of localized effects, specifically, changes in land use in Iowa, establish "the significance of an action" on the "the affected region, the affected interests, and locality."4 If we assume all corn available for refining to support the manufacture of the FCS is locally from IA, then we can estimate the percentage of current land use devoted to cultivate the quantity of corn needed for manufacture of the FCS. The estimation is based on 1) a public disclosure that the annual production capacity of the facility in Clinton, IA, is about 110 million pounds, 2) a public presentation of research5 from which the amount of corn required to produce one pound of FCS can be derived, 3) United States' agricultural data,6 and 4) corn industry statistics.7 A rudimentary estimation is calculated below.

  • Amount of corn needed annually to support production of the FCS:

    110 x 106 lbs FCS/year[3] x 5 lbs corn/lb FCS (a derived statistic[5] for the amount of corn required to produce one pound of FCS) = 550 x 106 lbs corn/year

  • Area of corn required to support the manufacture of the FCS:

    550 x 106 lbs corn/year x 1 bu corn/70 lbs corn[6] x 1 acre/166 bu corn[6-7] = about 60,000 acres

  • Percentage of land use to support the manufacture of the FCS in IA:

    60,000 acres/12.6 x 106 acres (land used to cultivate corn in IA)[6] x 100% = about 0.5%

Therefore, we understand that, because only about 0.5% or less of currently cultivated land is needed to support the anticipated manufacturing capacity and near-future commercial demand of the FCS, the proposed action is not anticipated to alter significantly land use. Moreover, we understand that, because the increase, if any, of land area to cultivate corn is small, the environmental burdens associated with corn cultivation, which include concomitant use of resources (for example, water or chemical fertilizers and other agricultural materials) and energy (direct and indirect), are also not anticipated to increase significantly to accommodate the demand placed upon corn as a raw source of manufacturing feedstock for the FCS.

A consideration about compostability of the FCS is not a significant basis for the agency to make its final environmental decision because, as stated in the EA, the ultimate disposal location after use of the FCS is primarily in landfills. Without a compulsory or an incentive-based collection system for the FCS at the end of its service life, compostability is a minor consideration.

The EA proposes that the FCS holds promise for commercial applications because its polymeric characteristics are functionally equivalent to synthetic petrochemical-based plastics that presently dominate the commodity plastics' market. Nonetheless, the EA recognizes that commercial development and demand of the FCS as an alternative to petrochemical-based plastics is not yet certain, and the projected market is focused on presenting the FCS "as a premium priced specialty material catering to customers who want to match the functionality of petroleum-based plastic, but add the dimension of environmental responsibility to their products and brands."3

Thus, the extent of environmental impact, if any, is related to added economic value for the FCS as a finished product. The environmental impact, which stems chiefly from raw material production and fermentative manufacturing processes, is moderated or inhibited by the acknowledged expense of the FCS, which is three-fold more expensive than petrochemical plastics.8 Therefore, any relative environmental advantages described in the EA about the FCS contrasted with competitive petrochemical plastics is correspondingly inhibited as well.

 

Prepared by __________________________________________Date: April 12, 2010
Hoshing W. Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

1 For example, to produce the polymer, see GW Huisman, FA Skraly, DP Martin, and OP Peoples, US Patent 7229804 (June 12, 2007), "Biological systems for manufacture of polyhdroxyalkanoate polymers containing 4-hydroxyacids," and, to extract the polymer, see J Van Walsen, L Zhong, and SS Shih, US Patent 7252980 (August 7, 2007), "Polymer extraction methods."

2 S Kim and BE Dale, "Life cycle assessment study of biopolymers (polyhydroxyalkanoates) derived from no-tilled corn," Int J LCA, 10(3), 200-210 (2005).

3 Metabolix, Inc., Annual Report on Form 10-K for fiscal year 2007 filed March 13, 2008, with the United States Securities and Exchange Commission.

4 40 Code of Federal Regulations 1508.27.

5 S Kim and BE Dale, "Life cycle assessment of integrated biorefinery-cropping systems: all biomass is local," in Agriculture as a Producer and Consumer of Energy, JL Oulaw, KJ Collins, and JA Duffield (Eds.), CAB International, Wallingford, Oxfordshire, UK, 2005, conference proceedings of Farm Foundation and USDA Office of Energy Policy and New Uses, Arlington, VA, June 24-25, 2004.

6 United States Department of Agriculture, Agricultural Statistics, 2008, National Agricultural Statistics Service, United States Government Printing Office, Washington, DC, 20402 (2008).

7 Corn Refiners Association, Corn: Part of a Sustainable Environment, Corn Refiners Association Annual Report 2006, Washington, DC, 20006.

8 BE DiGregorio, Chemistry & Biology, 16(1), 1-2 (2009), "Biobased performance bioplastic: Mirel."