• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 001194

 

August 13, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
 
Subject: FCN No. 1194 – Methyl formate as a blowing agent for polystyrene food-contact articles.
 
Notifier: Pactiv, LLC.
 
 Attached is the Finding of No Significant Impact (FONSI) for FCN 1194. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated July 10, 2012, 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.
 
 
Leah D. Proffitt
 
 
 
 
 
 
 
Attachment:         Finding of No Significant Impact
 
           


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1194), submitted by Pactiv, LLC., to provide for the safe use of methyl formate as a blowing agent for polystyrene food-contact articles.
 
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, dated July 10, 2012, as discussed below.
 
Using confidential manufacturing information, EPA’s EPI Suite Tier III fugacity tool was applied to model environmental fate across air, water, sediment and soil. Air pollution control devices at the facility remove 99% of emissions.  The FCS preferentially partitions into water, therefore, soil and sediment contain only trivial concentrations of the FCS. Using the EPI Suite default evaluative water volume of 2 x 1011  m3, to examine potential watershed-wide impacts, the methyl formate (MF) concentration in water was estimated as 3.67 x 10-7 mg/L.
 
EPA’s E-FAST (Exposure and Fate Assessment Screening Tool) was used to obtain a more localized estimate of aquatic emissions. Using the General Population and Ecological exposure module in E-FAST, 0% wastewater treatment removal, 0% adsorption to treatment sludge, and 0% drinking water treatment removal were assumed. E-FAST calculates concentrations for four stream flow conditions, including 30Q5, 7Q10 and 1Q10 (lowest 30-day average flow that occurs once every 5 years, and lowest 7-day and 1-day average flow that occurs once every 10 years). In order to determine the likelihood of adverse acute impacts, the 1Q10 10th percentile value was chosen as being representative of the worst case scenario as it was the highest predicted aquatic concentration. These values are reflected below.
Aquatic Exposure Estimates – Surface water (mg/L)
Percentile
Harmonic Mean
30Q5
7Q10
1Q10
10
1648
5.35
9.152
9.866
50
55.5
0.121
0.182
0.224
 
The lowest ecotoxicity endpoint for MF reported in the EA is 115 mg/L LC50 for the fish species Leuciscus idus (golden orfe). The EPI-Suite result of 3.67 x 10-7 mg/L results in a level of concern (RQ=EEC/ LC50) of 3 x 10-9. The E-FAST result of 9,866 µg/L (= 9.8 mg/L) results in a level of concern of 0.085. EPA defines a risk quotient of 0.5 (0.05 for endangered species) for aquatic animals and an RQ of 1 for aquatic plants as “Acute Risk” which may warrant regulatory action.[1] While the RQ value of 0.085 exceeds the Acute Risk level of 0.05 for endangered species, it represents a number that is expected to be attained only during the lowest 1-day average flow that occurs once every 10 years.  The difference in predicted environmental concentrations between the models also suggests that the predicted value could be highly conservative, and not a realistic estimate of actual concentrations. Therefore, due to the transient nature of such an event, any impacts are expected to be temporary with no significant adverse effects are expected for aquatic organisms. No regulatory action is required.
 
Methyl formate hydrolyzes to form formic acid and methanol (half-life 2.9 days at pH 7). The EA provides ecotoxicity data for these degradation products, but no EEC results. In the absence of EEC values for the breakdown products, we conservatively use the EEC of MF to evaluate the impacts of both formic acid and methanol. Ecotoxicity values reported for formic acid range from EvC50 24.7 mg/L for green algae[2] to LC50 68 mg/L for golden orfe fish. The highest aquatic concentration reported for MF, used as the EEC for formic acid. is the EPI-Suite result of 9.8 mg/L.  The lowest LC50 value for formic acid is 68  mg/L for green algae. This results in an RQ of 0.14.   While the RQ exceed the Acute Risk level of 0.05 for endangered species it is highly conservative in nature, as it assumes 100% conversion of MF to formic acid, and because it represents an exposure that is likely to occur only once every 10 years. Given these factors, no significant long term impacts are predicted.
  
Reported ecotoxicity data for methanol range from >10,000 mg/L for Daphnia magna (EC50)[3], to 29,000mg/L for fish (LC50). Using the EEC of 9.8 mg/L estimated for MF, we calculated an RQ for methanol of 3.4 x 10-4.   An RQ of this level represents no concern for any species. No toxic effects from methanol are expected at the very low concentrations anticipated from the proposed use.
 


 

 
 
 
Prepared by     __________________________________________Date: August 13, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: August 13, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


[1] U.S EPA Appendix F: the Risk Quotient Method and Levels of Concern, August 29, 2007
[2] Growth inhibition expressed as “yield” (Ey) see p. 104 SIDS Initial Assessment Report for SIAM 26, Formic acid and Formates, OECD, April 16 2008
[3] See p. 35 of SIDS Initial Assessment Report for SIAM 19 Methanol, OECD, October 2004: “In a reliable standard static test with Daphnia magna no adverse effects were reported at 10,000 mg/L after 48-h exposure (Kuehn, 1989). A QSAR calculation performed with ECOSAR (v0.99) indicates a LC50 (48 h) for daphnids of 9375 mg/L.”