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Environmental Decision Memo for Food Contact Notification No. 000731

Date:June 6, 2007
From:Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 731 - Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine for use as a component of films intended to contact food.
Notifier:BASF Aktiengesellschaft
KS/KS-E100
D-67056
Ludwigshafen
To:Division of Food Contact Notifications (HFS-275)
Attention: Julie N. Mayer, M.F.S.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



 

Attached are the Finding of No Significant Impact (FONSI) and our confidential supplement to the environmental record for FCN 731. When this notification becomes effective, the FONSI and the notifier's environmental assessment (in PDF, 251Kb), dated April 5, 2007, may be made available to the public in response to a FOIA request and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

Katrina E. White, Ph.D.

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 731


 

Finding of No Significant Impact

A food contact notification (FCN No. 731), submitted by BASF Aktiengesellschaft, to provide for the safe use of hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine for use as a component of films intended to 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 the notification, including an environmental assessment (in PDF, 251Kb), dated April 5, 2007, and our supplement to the environmental record for FCN 731.

Prepared by__________________________________________Date: June 6, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: June 6, 2007
Layla I. Batarseh, Ph.D., 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. 731

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.

This document incorporates by reference the notifier's environmental assessment (in PDF, 251Kb), dated April 5, 2007, and confidential market volume information submitted in an e-mail message on May 21, 2007. This supplement contains confidential business information that SHOULD NOT be released to the public.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record.

Clarification of Information in the EA

The EA states in Item 7, "Furthermore, the very low production of nylon 6/66 polymers for use in food-contact applications, as indicated in Attachment 11 of this Notification." The submission did not contain an Attachment 11. The market volume was submitted in an e-mail message to the FDA on May 21, 2007.

The EA discusses migration of polymer components in support of little or no introduction of substances into the environment. We understand that the term migration in the EA refers to movement of substances out of the film into food and not to data on the movement of substances out of the package/film into a landfill or movement of the substance out of a landfill. In general, migration studies or calculations on these food-packaging materials, which are performed to demonstrate the safety of polymeric packaging, indicate only low levels of migration of substances from the package/film into food. Even if small amounts leach from a package into landfill leachate, the United States Environmental Protection Agency's regulations governing landfills (40 CFR Part 258) will minimize migration of the leachate into the natural environment (1-3). Municipal solid waste (MSW) landfills must comply with the federal regulations in 40 CFR Part 258 or equivalent state regulations. The federal standards include composite liner requirements, leachate collection and removal systems, groundwater monitoring requirements, and closure and post closure care requirements (1-3).

Nitrogen Oxide Emissions

The food contact substance (FCS) contains nitrogen. Combustion of MSW containing nitrogen has the potential to produce nitrogen oxides (NOx) which can cause adverse environmental effects by contributing to acid precipitation (4). We estimated potential nitrogen dioxide (NO2) emissions produced from combustion of the food contact substance (FCS) and compared that to the amount of NOx emissions from large municipal waste combustion (MWC) units.

NO2 emissions = A × B × C × D

Where: A = Market Volume of FCS in pounds
B = Percent nitrogen in packaging/film
C = 3.28 lb NO2/lb nitrogen
D = Percent MSW not recovered for recycling that is combusted (roughly 20%)1

A = | | | | | in 2011, estimated by notifier in email dated May 21, 2007
| | | | | x 2204.62 lbs/metric ton = | | | | | lbs

B = 13.25 % Nitrogen, estimated by the environmental group in FCN 502 (5)

| | | | | lbs FCS x 0.136 lb N/lb FCS x 3.28 lb NO2/lb N x 0.20 = | | | | | lbs NO2 emissions

| | | | | lbs NO2 x 0.0005 short tons/lb = | | | | | NO2 emissions

Total in NO2 emissions in U.S. = | | | | | lbs or | | | | | NO2

In 2000, NOx emissions from large MWC units were 46,500 short tons/yr (6). The emissions from approval of FCN 731 would increase this number by | | % (| | | NOx /46,500 short tons/yr x 100 = | | %). The estimated amount of NO2 that could be emitted as a result of incinerating municipal solid waste containing the FCS would be a very small fraction of the total nitrogen oxides emitted from large MWC units. Based on the above analysis, we determined that approval of FCN 731 will not result in a significant increase in current NOx emissions.

Literature Cited

  1. Solid Waste Landfills, http://www.epa.gov/epaoswer/non-hw/muncpl/landfill/sw_landfill.htm (accessed Apr. 4, 2007).
  2. Solid Waste Disposal Facility Criteria; EPA530-R-93-017; U.S. Environmental Protection Agency: Washington, D.C., Nov, 1993. http://www.epa.gov/epaoswer/non-hw/muncpl/landfill/techman/index.htm (accessed May 24, 2007).
  3. Decision Maker's Guide to Solid Waste Management, Volume II. Chapter 9. Land Disposal.; EPA530-R-95-023; University of Wisconsin-Madison/Extension; Sold and Hazardous Waste Education Center: 1995. http://www.epa.gov/garbage/dmg2/chapter9.pdf (accessed May 24, 2007).
  4. Combustion Modification Control of Nitrogen Oxides; EPA/600/F-95-012; U. S. Environmental Protection Agency; Office of Research and Development, National Risk Management Research Laboratory: Research Triangle Park, NC, Aug, 1995. http://www.epa.gov/appcdwww/aptb/pia.pdf (accessed May 14, 2007).
  5. McCarthy, A. M.; Batarseh, L. I. Confidential Supplement to the Environmental Record for FCN 502; Food and Drug Administration; Office of Food Additive Safety: May 2, 2005. http://www.cfsan.fda.gov/~rdb/fnce0502.html* (accessed May 24, 2007).
  6. Stevenson, W. Memorandum to Docket A-90-45; Document ID EPA-HQ-OAR-2003-0072-0017; Jun 20, 2002.

Prepared by__________________________________________Date: June 6, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety


1 In 2005, 54.3% of all MSW in the United States was deposited in land disposal sites, 13.6% was combusted with energy recovery, and 32.1% was recovered for composting and recycling (1). Of the municipal solid waste that was not recovered for composting and recycling, (33,400,000 tons combusted + 133,310,000 tons landfilled = 166,710,000 tons), 20% was combusted with energy recovery and 80% was land disposed (1). It is also expected that 20% of the FCS will be combusted and 80% will be land disposed. We note that the some of the 80% that is land disposed may be incinerated without energy recovery.


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.