The Commonwealth of Massachusetts

Executive Office of Health and Human Services

Department of Public Health

250 Washington Street, Boston, MA 02108-4619

TO: Commissioner Monica Bharel and Members of the Public Health Council

FROM: Jan Sullivan, Acting Director, Bureau of Environmental Health

DATE: March 8, 2017

RE: Informational Briefing on Proposed Rescission of 105 CMR 515.000:

Action Levels for Poisonous or Deleterious Substances In Food

INTRODUCTION

This regulation, 105 CMR 515.000 Action Levels for Poisonous or Deleterious Substances In Food, creates action levels for poisonous or deleterious substances in food. Over time, the regulation has become outdated and inconsistent with federal action levels and therefore should be rescinded. The underlying statute, G.L. c.94 §192, provides the Department of Public Health with discretion to promulgate standards or action levels for hazardous substances, but further requires that those standards be consistent with the federal Food, Drug & Cosmetic Act and associated regulations.

BACKGROUND

The Department promulgated 105 CMR 515.000 in 1984, and amended it in 1986, to establish action levels for three chemicals in food: polychlorinated biphenyls (PCBs), daminozide (Alar), and ethylene dibromide (EDB). At the time, the state action levels were more stringent than federal levels and there were no federal action levels for daminozide. Massachusetts established a program to sample a limited number of food products for EDB and ALAR, but the program to collect and test foods for these two specific substances has since ended.

The US EPA banned the use of the pesticide daminozide on food crops in 1989 and the US FDA has established action levels and/or tolerances for PCBs and EDB. Therefore the action levels contained in 105 CMR 515.000 for these substances are no longer needed and recession of this regulation as it applies to these substances will not jeopardize the safety of the food supply.

In addition, the US FDA and US EPA have established action levels and tolerances for many more substances than are covered by 105 CMR 515.000. If, in the future, MDPH has a need to establish an action level for a poisonous or deleterious substance in food not addressed by US FDA or US EPA standards, it could do so under MGL c.94 §192.

PROPOSED RESCISSION

The proposed rescission to the regulations conforms the Massachusetts action levels with the federal action levels established in the federal Food, Drug and Cosmetic Act, 21 U.S.C. §321, et seq. and associated regulations, consistent with the directive in the Governor’s Executive Order 562.

CONCLUSION

The Department plans to hold a public hearing to solicit feedback from the public and other interested organizations. All comments will be evaluated. The testimony and any proposed changes will be summarized and presented to the Public Health Council at a future meeting. Unless a different course of action is determined following public comment, the Department will request approval from the Public Health Council to rescind the regulation.