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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001252

 

Date:       February 11, 2013
From:      Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject:   FCN 1252 –Rutile Tin Zinc - doped with either potassium, sodium, or calcium (CAS Registry No.: 207691-99-4,389623-07-8, 389623-01-2, respectively) for use as a colorant in polymers and in printing ink for all food types under all temperature conditions as described in Tables 1 and 2 in 21 CFR 177.300. The FCS will be used at levels not to exceed 5 percent by weight in food-contact polymers and not to exceed 30 percent by weight in printing inks.
 
Notifier: Rockwood Pigments NA, Inc.
 
To: Thomas C. Zebovitz, Ph.D, Division of Food Contact Notifications (HFS-275)
 
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff__­___  
 
 
The notifier submitted claims of categorical exclusion under 21 CFR 25.32 (i) and (j) for the proposed use of the FCS as a component of food packaging materials and inks and for the use as a component of a food contact article intended for repeated use, respectively. An EA was submitted for the remaining uses as a component of articles that are not considered food packaging or coatings (e.g. freezer bags, freezer wrap, food wrap, high temperature polymers, utensils, and boots of PET bottles). 
 
We have reviewed the claims of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use of the FCS as a component of coatings, food packaging materials, inks, and in repeat-use articles.  The claims of categorical exclusion cite the sections, 21 CFR 25.32 (i) & (j), under which categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1252.  After this notification becomes effective, copies of this FONSI and the notifier’s environmental assessment, dated September 17, 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.
 
 
 
Talia A. Lindheimer
 
 
 
Attachment:   Finding of No Significant Impact
 



FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1252), submitted by Rockwood Pigments NA, Inc., to provide for the safe use of rutile tin zinc; doped with potassium, sodium or calcium when used as a color pigment in a variety of single- and repeat-use polymers. Examples of end use products that will contain the FCS include freezer bags, freezer wrap, food wrap, high temperature polymers, microwaveables, utensils, and PET bottle boots. When the pigment is incorporated into printing ink, the maximum rate will be 30% by weight of the ink formulation This FCS is intended for use in contact with all food groups.
 
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 September 17, 2012.
 
In the course of the review, it was noted that the EA lists all potential uses of the FCS and does not limit the scope of the EA to uses for which a categorical exclusion is not warranted. These end-use polymers include freezer bags, freezer wrap, food wrap, high temperature polymers, utensils, and PET bottle boots. The FONSI covers only those uses not already covered by a claim of categorical exclusion under 21 CFR 25.32 (i) or (j). 
 
Based on the information provided in the EA, disposal of the food-contact materials, which contain the FCS, will be by conventional trash disposal and primarily by incineration or sanitary landfills. The FCS is not combustible, and in the presence of high heat, the disposed consumer item will change color due to a change in its oxidation state (Sn (II) to Sn(IV)), but not release any hazardous substances. Therefore no toxic combustion products are expected as a result of the use and incineration of the FCS.
 
It is reasonably expected that there will not be leaching to the environment from disposal into landfills in light of the Environmental Protection Agency’s (EPA) regulations, which govern municipal solid waste landfills. Therefore, no extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, resulting from post-consumer disposal of these items addressed in the EA.
 
 
 
Prepared by     _________________________________________Date: February 11, 2013
Talia A. Lindheimer
Biologist
Office of Food Additive Safety        
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   _________________________________________Date: February11, 2013
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