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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000131

Date: February 26, 2001


From: Environmental Scientist, Chemistry and Environmental Review Team (HFS-207)


Subject: FCN No. 131 - 2-methyl-4-isothiazolin-3-one for use as an antimicrobial agent


Notifier: Rohm and Haas Company
Philadelphia, PA 10106

To: Division of Petition Control (HFS-215)
Attention: Mark Hepp



I have reviewed the claim of categorical exclusion under 21 CFR 25.32(q) for the above referenced notification, and have concluded that it is warranted. The food-contact substance will be used

1) as an antimicrobial agent for polymer latex emulsions in paper coatings at a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one), and

2) as an antimicrobial agent for finished coating formulations and for additives used in the manufacture of paper and paperboard including latex emulsions, fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 150 ppm (based on 2-methyl-4-isothiazolin-3-one) in the individual additives and not to exceed 150 ppm in the finished coating formulation.


The claim of categorical exclusion cites the section under which the categorical exclusion is claimed, includes a statement of compliance with the categorical exclusion criteria and states that no extraordinary circumstances exist that require submission of an environmental assessment. Therefore, neither an environmental assessment nor an environmental impact statement is required.


Please let me know if there is any change in the identity or use of the food-contact substance that would render the categorical exclusion inappropriate.




Jeanette Glover Glew