On Friday, August 28, 2015, the California Office of Environmental Health Hazard Assessment (“OEHHA”) released four pre-regulatory proposals under Prop 65 that, if passed, would likely significantly expand the overall obligations of certain businesses to meet Prop 65 warning label requirements. Prop 65, known officially as The Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings for an exposure to a listed chemical known by the state to cause cancer or reproductive toxicity.
Specifically, the OEHHA pre-regulatory proposals released Friday would (1) update the existing Maximum Allowable Dose Level (“MADL”) for lead; (2) require use of the arithmetic mean to calculate the reasonably anticipated rate of intake or exposure to a chemical listed as causing reproductive toxicity; (3) restrict chemical concentration calculations for food products to single lots; and (4) establish background levels for certain ubiquitous chemicals, such as lead, that are naturally present in unprocessed foods. Each of these proposed regulatory changes is briefly described below, and links for further information are provided.
- New MADL for Lead: Currently, the maximum MADL for lead is set at .5 micrograms per day. Any exposure within this limit does not require a warning. Under the newly proposed regulations, however, the permissible MADL for lead will no longer be set at one daily maximum. Instead, the MADL will vary based upon the number of times a person is exposed to lead within a certain period. Thus, for example, the MADL for persons exposed to lead on a daily basis would drop to just .2 micrograms. The MADL for a person exposed to lead only once every 116 days, however, would rise to 8 micrograms. Thus, businesses should consult with the draft list of exposure levels calculated by the OEHHA to determine what new warnings, if any, would need to be provided. A hearing on the proposed regulations, and the initial petition prompting revision, will be held on October 14, 2015 from 10:00 a.m. to 12:00 p.m.at CalEPA Headquarters in Sacramento. More information, including the draft regulatory language and underlying rationale, is available at: http://www.oehha.ca.gov/prop65/CRNR_notices/082815CEHHearing.html.
- Arithmetic Mean for Intake/Exposure to Listed Chemicals Causing Reproductive Toxicity: The pre-regulatory proposals released Friday also include a proposed clarification that would require use of the arithmetic mean to calculate the reasonably anticipated rate of intake or exposure for users of a particular product to a listed chemical that causes reproductive toxicity. Businesses will no longer be able to use other calculation methods, such as the geometric mean. The geometric mean, determined the OEHHA, will, in most cases, produce a lower average consumption amount than the arithmetic mean, as the geometric mean underweights the rate of exposure of those people who consume significantly more of a food or product than more typical consumers. Thus, businesses previously relying upon the geometric mean to determine intake or exposure to certain listed chemicals may be required to provide new warnings using the arithmetic mean. A workshop on the proposed regulatory language will be held on October 19, 2015 at 10:00 a.m. in the Elihu Harris State Building in Oakland. More information, including the draft regulatory language and underlying rationale, is available at: http://www.oehha.ca.gov/prop65/CRNR_notices/082815WorkshopSafeHarborcalculations.html.
- Single Lot Calculations for Listed Chemicals in Food Products: In another significant clarification proposed Friday, businesses in food production would no longer be able to determine the concentration of a listed chemical in a food product by averaging the presence of that chemical across lots from different locations, manufacturing runs, or time periods of production. Instead, the concentration of a listed chemical in a food product would have to be determined on the basis of a single lot of a product in the form it would likely be sold to the end-consumer. In an effort, no doubt, to reassure businesses that this requirement will not be unduly burdensome, the OEHHA makes clear that food manufacturers are intended to rely upon existing quality-control testing to address any responsibilities to provide Prop 65 warnings. A workshop on the proposed regulatory language will be held on October 19, 2015 from 1:00 p.m. to 4:00 p.m. in the Elihu Harris State Building in Oakland. More information, including the draft regulatory language and underlying rationale, is available at http://www.oehha.ca.gov/prop65/CRNR_notices/082815lotsandbatchesworkshop.html.
- Default Calculations for Naturally Occurring Arsenic and Lead: Finally, the OEHHA has proposed establishing default calculations for naturally occurring concentrations of lead in certain fresh foods and of arsenic in dry rice grain. Such goods would be exempt from Prop 65 warning requirements if the levels of the lead or arsenic detected fall within naturally occurring levels. The naturally occurring levels presently calculated by the OEHHA for lead are 8.8 ppb in leafy vegetables and 6.2 ppb in non-leafy vegetables. The levels calculated for arsenic are 60 ppb for white rice and 130 ppb for brown rice. A workshop on the proposed regulatory language will be held on October 14, 2015 from 1:00 p.m. to 4:00 p.m. at CalEPA Headquarters in Sacramento. More information, including the draft regulatory language and underlying rationale, is available at http://www.oehha.ca.gov/prop65/CRNR_notices/082815WorkshopBackgroundLevels.html. In the future, the naturally occurring levels of other chemicals may also be added to this list.