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: January 23, 2014
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: FCN No. 1398 – Polymer of 3-hydroxybutyric acid with up to 25% 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid, 3-hydroxyoctanoic acid, and/or 3-hydroxydecanoic acid. The FCS is intended for use in the manufacture of repeat-use (primarily housewares) and single-use (food service) food contact materials.
Notifier: Meredian, Inc.
To: Marla D. Swain, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Leah Proffitt, Environmental Reviewer, Office of Food Additive Safety (HFS-255)____
Attached is the Finding of No Significant Impact (FONSI) for FCN 1398. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 25, 2013, may be made available to the public. We will 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.
Attachment: Finding of No Significant Impact
File: FCN No. 1398
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1398), submitted by Meredian, Inc., to provide for the safe use of a Polymer of 3-hydroxybutyric acid with up to 25% 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid, 3-hydroxyoctanoic acid, and/or 3-hydroxydecanoic acid. The FCS is intended for use in the manufacture of repeat-use (primarily housewares) and single-use (food service) food contact materials.
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, will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated Nov. 25, 2013, and confidential business information (CBI) provided in several appendices attached to the EA.
The FCS is intended for use at levels up to 100% in the manufacture of food contact articles. The primary end-use applications for the polymer are housewares applications, such as disposable cutlery and utensils, outer plastic bags, and other disposable containers. Other applications may include films, coatings, and thermoformed or injection molded articles.
Polyhydroxyalkanoate (PHA) polymers similar to the FCS for use in the manufacture of food-contact articles are the subject of effective FCNs 943 and 1119. The environmental introduction, fate, and effects of these food contact substances have been discussed in detail in the EAs and internal memoranda of the Environmental Review Team. All of the environmental decisions for use in food-contact articles are FONSIs.
There are no extraordinary circumstances suggesting an adverse environmental impact as a result of the manufacture of the FCS.
No environmental release is expected when the subject polymer is used in the manufacture of food contact articles. The polymer will be entirely incorporated into the finished article. Any waste material generated in this process, e.g., plant scraps, is expected to be disposed as part of the packaging manufacturer’s overall nonhazardous solid waste in accordance with established procedures.
The uses of the FCS in the subject notification are identical and substitutional to uses already authorized under existing effective FCNs. For example, the FCS is expected to substitute for polyolefin, polystyrene or polylactic acid (PLA) in single-use food service articles.
Food-contact articles produced with the FCS will be utilized in patterns corresponding to the national population density and will be widely distributed across the country. Thus, it is anticipated that disposal of the food-contact articles containing the FCS will occur nationwide.
The EA and the attached confidential documents contain information on biodegradation of the FCS when exposed to microbial activity in soil, marine, or aerobic environmental sludge media. The FCS is biodegradable, however commercial composting is available on a very limited basis in the U.S. such that it is not considered a likely route of disposal. Therefore food-contact materials manufactured using the subject polymer are primarily expected to be disposed of either by conventional rubbish disposal (i.e., sanitary landfill) or incineration.
The subject copolymers consist of carbon, oxygen, and hydrogen. No toxic combustion products are expected as a result of incineration of the polymers in municipal waste combustors operating in compliance with applicable emission laws and regulations (i.e., 40 CFR Part 60 and/or relevant state and local laws). Additionally, only extremely small amounts, if any, of the polymer’s constituents are expected to enter the environment as a result of the U.S. EPA regulatory compliant (40 CFR Part 258) landfill disposal of food-contact articles.
The FCS is not intended for use in the production of bottles and would not compete with, for example, the polyethylene terephthalate (PET) bottle market. Current competitive products (i.e., quick service food contact articles including disposable utensils, plates, clamshells, and home storage bags) are manufactured using polystyrene, polyolefins, and PLA. While we understand that the recovery and recycling of these types of articles have increased in recent years , the majority of these items still are not routinely recycled . Any items containing the FCS, which would otherwise be disposed of by conventional landfilling, inadvertently ending up in the recycling process stream are expected to be easily removed as part of every company’s source control practices. Additionally, the emergence of near-infrared recycling equipment is enabling the sorting of plastics using each material’s unique spectral signature. This technology facilitates the effective separation of recyclable and non-recyclable polymers according to each plant’s capabilities. Given the low recycling rate we do not at this time believe that the proposed use of the FCS would result in adverse impact on recycling of polymers.
If finished food-contact articles made with the FCS are introduced into commercial composting sites or otherwise into the environment, the polymer is expected to biodegrade ultimately to CO2. In this regard, the FCS has been shown to fulfill the evaluation criteria for material characteristics, biodegradation, disintegration and compost quality as defined by the American Society of Testing Materials (ASTM) Standards D6400-042 (municipal compost facility biodegradable plastics), D5511 (mesophilic anaerobic digestion), 6691-09 (aerobic marine), D7081-05 (non-floating aerobic/anaerobic marine), and other biodegradation standards. These assertions are supported by environmental certifications attached to the EA.
None of these potential releases present any toxicological concern at the low levels at which they could occur upon use and disposal of food-contact materials containing the FCS when disposed in accordance with applicable laws and regulations (e.g., the U.S. Environmental Protection Agency’s regulations in 40 CFR Part 60 that pertain to municipal solid waste combustors and Part 258 that pertain to landfills).
The FCS is a bio-based polymer, produced through batch fermentation. A discussion of the use of feedstock resources is provided in Confidential Appendix F to the EA. The notifier provided sufficient evidence that no significant diversion of food-grade oils is anticipated. With regard to energy use, as with other food packaging materials, the production, use, and disposal of the FCS involves the use of natural resources such as petroleum products and coal. The notifier’s FCS is expected to compete with, and to some degree replace, similar food contact polymers already on the market, such as polystyrene, polyolefins, and PLA. In terms of the use of energy and resources for these polymers, the production of the PHA polymer is expected to be most similar to the production of PLA polymers, because lactic acid monomer is produced through fermentation of foodstuffs. There is relatively little similarity (or equivalence) in the production of PHA as compared to polystyrene or polyolefins. The raw material for PHA is plant-based triacylglycerol, as compared to the derivatives of petroleum. Polystyrene and polyolefins are produced in high temperature, high pressure environments, which would be expected to require greater energy usage than is needed for the PHA fermentation process. Therefore, the partial replacement of such polymers by the notifier’s FCS is not expected to have any adverse impact on the use of energy and resources.
Finally, the subject polymer is not expected to replace glass bottles or jars, aluminum cans, polyethylene terephthalate (PET) bottles for carbonated beverages, or high-density polyethylene milk jugs, nor occur as a significant recycling stream ‘impurity’ for these types of articles. Therefore impacts on energy resources related to recycling are expected to be minimal.
The intended use of the FCS is not reasonably expected to create adverse environmental impacts that would require mitigation measures of any kind.
No potential adverse effects are identified which would necessitate alternative actions to that proposed in the notification.
Prepared by __________________________________________Date: ____________
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: ____________
Robert I. Merker
Supervisory Consumer Safety Officer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 A minimum of 934 million pounds (0.47 million tons) of postconsumer non-bottle rigid plastic was recovered in 2011. This represents an increase of 13% over 2010. Sixteen percent of this amount (151 million pounds = 0.08 million tons) was designated as ‘other resin / mixed resins / unknown resins’ which includes polymers such as the FCS. 2011 National Postconsumer Non-Bottle Rigid Plastic Recycling Report. Prepared by Moore Recycling Associates Inc. for the American Chemistry Council (http://plastics.americanchemistry.com/Education-Resources/Publications/2011-National-Report-on-Post-Consumer-Non-Bottle-Rigid-Plastic-Recycling.pdf).
 0.03% of total U.S. total municipal solid waste = 0.08 million tons of recovered ‘other resins’ (see footnote 1) / 250 million tons 2011 U.S. total municipal solid waste (Source: U.S. EPA Municipal Solid Waste Report EPA-530-F-13-001, May 2013, http://www.epa.gov/wastes/nonhaz/municipal/pubs/MSWcharacterization_508_053113_fs.pdf) x 100.