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Environmental Decision Memo for Food Contact Notification No. 000733

Date: July 16, 2007
From: Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 733 - Polyester-polyurethane for use as an adhesive in laminate structures that are intended for use at retort temperatures
Notifier: Dainippon Ink and Chemicals, Inc.
Tokyo 174-8520
JAPAN
To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 733. When this notification becomes effective, the FONSI and the notifier's environmental assessment (in PDF, 347Kb), dated April 23, 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.*

The supplement to the environmental record contains confidential business information that should not be released to the public. A redacted copy of the document may still serve to inform the public and we will make it available on the internet.

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
Confidential Supplement to the Environmental Record for Food Contact Notification No. 733


Finding of No Significant Impact

A food contact notification (FCN No. 733), submitted by Dainippon Ink and Chemicals, Inc., to provide for the safe use of polyester-polyurethane for use as an adhesive in laminate structures that are intended for use at retort temperatures.

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, 347Kb), dated April 23, 2007, and our supplement to the environmental record for FCN 733.

Prepared by__________________________________________Date: July 16, 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: July 16, 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. 733

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, 347Kb) (EA), dated April 23, 2007, and confidential market volume information submitted in Attachment 12. 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 and to assist the public in understanding the agency's basis for preparing a finding of no significant impact (FONSI).

Clarification of Information in the EA

Under Format Item 6, the EA states, "The lack of any leaching is especially true considering that the subject substance is a high molecular weight adhesive resin that contains only low levels of low molecular weight resin components, the portion of the resin that can potentially be leachable." We note that what is leachable from a food package into food is not necessarily the same as what is expected to leach into a landfill.

Under Format Item 7, the EA states, "The products of complete combustion of the adhesive resin are carbon dioxide and water, along with small amounts of nitrogen oxides; the concentration of these substances in the environment will not be significantly altered by the proper incineration of the resin in the amounts utilized for food packaging applications." We agree that the proper incineration of the FCS will not significantly alter current emissions from properly operating incinerators. However, some incomplete combustion will occur and emissions other than those listed are expected (1).

Under Format Item 7, the EA states, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the polymer, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of the polymer components." We understand that the term migration in the EA refers to movement of substances out of the food contact article into food and not to data on the movement of substances out of the food contact article 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 food contact article 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 (2-4). 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 (2-4).

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 (5). 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 Packaging in pounds
B = Percent N in packaging
C = 3.28 lb NO2/lb N
D = Percent MSW not recovered for recycling that is combusted (roughly 20%)

A = | | | || | | || | | |
B = | | % Nitrogen, estimated by notifier

| | | lbs FCS x | | | lb N/lb FCS x 3.28 lb NO2/lb N x 0.20 = | | | || | | short tons

| | | || | | lbs FCS x 0.036 lb N/lb FCS x 3.28 lb NO2/lb N x 0.20 = | | | | lbs or | | | | short tons

Total in NO2 emissions in U.S. and Japan assuming total requested market volume was disposed of in the U. S. = | | | | lbs or | | short tons NO2

The notifier assumed that 13.6% of MSW is combusted in the calculations estimating NO2 emissions in Attachment 12 of the FCN. This number is correct when MSW is considered as a whole, with some being recycled. However, none of the FCS is expected to be recycled. Of the amount of MSW that is not recovered for recycling or composting, 20% is expected to be combusted with energy recovery and 80% will be discards to landfill and other disposal (6). 1 Discards to landfill and other disposal may be incinerated without energy recovery (6). However, we believe that the combustion for energy recovery provides a good estimate of the total percentage of MSW combusted because most of the MSW combustion practiced in this country incorporates energy recovery and we do not have a good source of data on the amount of MSW disposed of without energy recovery that is incinerated (6).

In 2000, NOx emissions from large MWC units were 46,500 short tons/yr (7). The emissions from approval of FCN 733 would increase this number by | | | % (| | | | short tons 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 the FCS will not result in a significant increase in current NOx emissions.

Literature Cited

  1. Sullivan, P. M.; Hallenbeck, W. H.; Brenniman, G. R. Municipal Solid Waste Combustion; University of Illinois at Chicago: Chicago, IL, 1993.
  2. Solid Waste Landfills, http://www.epa.gov/epaoswer/non-hw/muncpl/landfill/sw_landfill.htm (accessed Apr. 4, 2007).
  3. 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).
  4. 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).
  5. 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).
  6. Municipal Solid Waste in the United States: 2005 Facts and Figures; EPA530-R-06-011; U.S. Environmental Protection Agency; Office of Solid Waste: Washington, D.C., Oct, 2006. http://www.epa.gov/msw/msw99.htm (accessed Feb. 8, 2007).
  7. Stevenson, W. Memorandum to Docket A-90-45; Document ID EPA-HQ-OAR-2003-0072-0017; Jun 20, 2002.

Prepared by__________________________________________Date: July 16, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety


1 33,400 thousands of tons MSW combusted with energy recovery/ (33,400 thousands of tons MSW combusted with energy recovery + 133,310 thousands of tons MSW discards to landfills) x 100 = 20.03%


*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.