The Office of Environmental Health Hazard Assessment (OEHHA) today announced it has revised its proposed regulation establishing a No Significant Risk Level (NSRL) for 4-Methylimidazole (4-MEI), and augmented the regulatory record with dozens of additional scientific references.
On Jan.7, OEHHA first proposed a NSRL of 16 micrograms per day for 4-MEI. OEHHA’s proposal triggered a public comment period that was extended as a result of the high level of interest and volume of contents received. A public hearing on this regulatory proposal was held on March 10. Written comments from the public and scientific peer reviewers were received during the comment period which ended March 24, 2011.
After reviewing the public comments concerning the proposed NSRL, OEHHA revisited the scientific basis for its calculations, and revised its cancer potency calculations to derive a new NSRL.
OEHHA’s revised NSRL has been increased to 29 micrograms per day.
According to the agency, the reason for the increase is that it has recently adopted methods developed in 2005 by the U.S. Environmental Protection Agency for the conversion of animal to human cancer potency which accounted for the difference. Previously, OEHHA used the default methods established by Proposition 65 regulations in 1989. According to OEHHA, the updated EPA guidance for calculating conversion of animal to human cancer potency is a widely accepted method in the scientific community.
4-MEI is used in the manufacture of pharmaceuticals, photographic chemicals, dyes and pigments, cleaning and agricultural chemicals, and rubber. 4-MEI is also formed as a fermentation by–product in ammoniated livestock feed. A main source of 4-MEI exposure to the general public is the presence of 4-MEI in food products resulting from the direct addition of particular types of caramel coloring. Reactions between carbohydrates and ammonia used to produce these caramel colorings form by-products, including 4-MEI. Caramel colorings containing 4-MEI are directly added to some commonly consumed beverages and sauces, including cola, beer, wine coolers, and soy and other sauces. The main opposition to OEHHA’s first proposed NSRL was largely from the food industry.OEHHA has extended the public comment period for the proposed NSRL for 4-MEI after receiving a request from the American Beverage Association and the International Technical Caramel Association for an extension of the comment period. OEHHA will accept written comments on these amendments to the proposed regulation between October 7, 2011, and November 7, 2011. Comments should be addressed to:Fran Kammerer Office of Environmental Health Hazard Assessment P. O. Box 4010 1001 I Street Sacramento, California 95812-4010 Fax No.: 916-324-1786 E-mail: firstname.lastname@example.org