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Environmental Decision Memo for Food Contact Notification No. 000178

Date: November 27, 2001

 

From: Environmental Scientist, Environmental Review Group
Division of Chemistry Research and Environmental Review

 

Subject: FCN No. 178 - Polylactide (PLA) for Use in Fabricating Food contact Articles.

 

Notifier: Cargill Dow LLC
c/o Keller and Heckman
Washington, DC 20001

 

To: Division of Food Contact Notification
Attention: Edward Machuga
Through: Supervisor, Environmental Review Group

 

 

Attached is the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for this premarket notification. When this notification becomes effective, the following documents may be made available to the public:

 

1. the FONSI;
2. the notifier's September 4, 2001, EA; and
3. our Supplement to the EA.

 

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.

 

 

 

Jonathan L. Chappell

 

2 Attachments

 

 



 



 

 

Finding of No Significant Impact

A food contact notification (FCN No. 178), submitted by Cargill Dow LLC, to provide for the use of polylactide (PLA) for use in manufacturing food contact articles.

 

The Environmental Review Group 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 September 4, 2001, and in our supplement to that EA.

 

 

 

Prepared by_________________________________________ Date: November 27, 2001
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by________________________________________ Date: November 27, 2001
Jeanette Glover Glew, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 



 



 

 

Supplement to the Environmental Information
for Food Contact Notification No. 178

This document incorporates by reference the notifier's environmental assessment (EA) dated September 4, 2001 and a letter from the notifier dated October 8, 2001, which was based on a telephone conversation between FDA and the notifier.

 

Most of the environmental issues associated with this Food Contact Notification (FCN) are addressed in the notifier's EA and in the above cited telephone conversation. However, two points need further clarification. In previous submissions for plastics that have enhanced degradation properties, FDA has asked that information about the littering and toxicity of adjuvants be included in the EA. Since these two points were not addressed in the EA for FCN 178, they are discussed here.

 

Littering

 

We previously have asked for information on littering in submissions for food packaging materials with enhanced degradation characteristics for two reasons: First, we believed that people may be more inclined to litter materials labeled as 'degradable.' Second, we had concerns over the potential for environmental effects of substances that enter the environment as a result of littered materials. Both of these issues will be addressed here.

 

1. Potential for increased littering

 

While all sorts of materials are littered, objects labeled as >degradable= might be littered more readily. For example, in the past, manufacturers have claimed that their new materials were photodegradable, that is, the material readily degrades in sunlight. If consumers think that such materials will photodegrade, they may be more inclined to litter them than materials not so labeled. Consumers may get the impression that littering will not have an environmental effect because the material will readily degrade under conditions associated with litter, such as sunlight. However, in a telephone conversation the notifier said that products manufactured from polylactide (PLA) would be labeled as '#7' plastic, which stands for 'Other.' A #7 label has nothing to do with the degradability of a polymer. This label alone should not lead to a public misconception about the consequences of littering articles made from PLA. As a result, we do not anticipate an increase in the littering of articles made from PLA as compared to articles made from other types of plastics.

 

In our telephone conversation, the notifier also said that its customers may label products made from PLA as 'compostable' if the final product meets the criteria for compostability under the Federal Trade Commission's requirements for environmental marketing claims. Labeling a material as compostable does not indicate that it will degrade under the environmental conditions associated with litter. Composting is a process that requires specific conditions in order for the materials to biodegrade. For example, commercial composting facilities generally operate at elevated temperatures and involve mixing and aeration in order to accelerate the composting process. That being the case, it does not appear that labeling this material as compostable would lead to an increase in littering when compared to other types of plastics.

 

2. Environmental effects of degradation products

 

FDA previously has asked for information on the potential toxicity of breakdown products of littered articles in submissions for polymers with enhanced degradation characteristics. While no information on littering rates is included in the notifier's EA, it is reasonable to assume that some amount of products made from this material will be littered. While the notifier claims that its material is compostable under municipal composting conditions, the potential for products made from PLA to degrade under conditions associated with littered materials, i.e. roadsides, city streets, is not addressed. Since we do not know how readily this material degrades under these conditions, we cannot predict the precise environmental effects. However, either one of two situations will result.

3. If the material is littered and does not degrade, then there is no potential for adverse environmental effects resulting from degradation products.

4. If the material is littered and does degrade, then we do not expect the degradation products to be toxic based on the results of the notifier's ecotoxicity tests.

 

Adjuvants

 

We assume that adjuvants typically migrate very slowly from intact polymers after proper disposal. However, the potential exists for adjuvants used in the preparation of polymers with enhanced degradation properties to leach into the environment. As a result, we routinely ask for toxicity information for adjuvants of polymers with enhanced degradation properties. In the case of PLA, no such information was provided for the adjuvants used in the manufacturing process. However, we believe that toxicity information of adjuvants is not needed in this case for the following reasons:

1. The notifier provided toxicity data for the degredation product of the entire finished polymer. Any adjuvants present in the finished polymer would presumably be included in this test.

 

2. The notifier claims that finished food packaging materials manufactured from PLA generally will be disposed of by means of landfill and incineration. We believe that environmental introduction of adjuvants through these routes would be extremely low, if any. Our belief is based on the extremely low levels of adjuvants from the proposed use of PLA polymers expected to be in municipal solid waste and on EPA regulations governing emissions from landfills and municipal waste incinerators outlined in 40 CFR part 258 and in 40 CFR Part 60, respectively.

 

 

 

Prepared by_________________________________________ Date: November 27, 2001
Jonathan L. Chappell, Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration