California’s Office of Environmental Health Hazard Assessment (OEHHA) released several new pre-regulatory draft proposals that may profoundly affect Proposition 65 compliance at the end of August.
The new pre-regulatory draft proposals, do not appear to ease compliance for manufacturers or retailers. If anything, they seem to complicate issues where clarity is dearly needed.
One such issue is the developments a new Safe Harbor Level for Lead. This proposal comes in response to petitions filed by the Center for Environmental Health (CEH) and previously by Mateel Environmental Justice Foundation earlier this year.
The petitioners argue that when OEHHA reclassified the listing of Lead in late 2013, the new listing also triggered a duty to update the science supporting the Safe Harbor Level. The petitioners note that the background data from the 1992 Maximum Allowable Dose Level (MADL) was derived from OSHA air exposure studies in the late 1980s. Both petitioners contend there is no safe level for lead exposure.
The current Safe Harbor Level of 0.5 micrograms per day remains the strictest lead standard in the world.
OEHHA’s draft proposal would adopt a modified method of calculation that would work on a sliding scale for various exposure periods. For example the current MADL of .05 Ug/L per day would be reduced to 0.2 ug/L for single day exposures to lead. If the exposure were to occur once a week the safe harbor exposure level would increase to 1.0 Ug/L.
Surprisingly, OEHHA is not proposing the sliding scale to other reproductive toxicants, however.
Instead the agency has proposed that other reproductive toxicants would be subject to a single day exposure scenario.
The argument about whether exposures should be limited to a single day, or averaged over time has been hotly contested for more than a decade.
The California Court of Appeal has ruled in favor of averaging these exposures, while the California Attorney General and citizen enforcement groups argue that exposures to reproductive toxicants can have devastating teratogenic effects in a single day.
Many see the petition as a means to nullify the decision in ELF v. Beech-Nut, 235 Cal. App. 4th 307 (2015) and to reduce the Safe Harbor Level for Lead to zero.
OEHHA is holding a public workshop on the proposals on October 14, 2015. The agency will accept public comments through October 28, 2015.
OEHHA is also proposing to change regulations about how to average rates of exposure
o listed chemicals by calculating the reasonable anticipated rate of intake of exposure.
The agency’s proposal would change the method of calculation to use the arithmetic mean instead of the geometric mean.
The agency will host a workshop on this proposal on October 19, 2015 and accept public comments on the proposal through November 2, 2015.
In addition, OEHHA is proposing a new regulation that would require the “level in question” of a reproductive toxicant to be based on a single lot when applied to food products. This requirement would limit the averaging of reproductive toxicants to products manufactured by a single manufacturer in a single production run. OEHHA will also host a workshop on this proposal on October 19, 2015 and accept public comments on the proposal through November 2, 2015.
OEHHA has also proposed to use naturally occurring allowances for lead and arsenic in unprocessed foods. The agency has determined lead and arsenic that would be considered naturally occurring in certain food products such as rice, fruit, meat, seafood, eggs and leafy vegetables. The agency developed these background levels from data on lead and arsenic levels occurring in regions of California where crops are cultivated. “The concentrations derived in section 25501.1(a) take into account the possible contribution of anthropogenic sources in deriving the naturally occurring safe harbor values for the section,” the proposal notes.
Below are proposed “naturally occurring” levels for various food crops:
Inorganic arsenic in white grain rice – 60 parts per billion (ppb)
Inorganic arsenic in brown grain rice – 130 ppb
Lead in Seafood – 6.2 ppb
Lead in Eggs – 6.2 ppb
Lead in Meat – 6.2 ppb
Fresh Milk – 6.2 ppb
Fruits – 6.2 ppb
Non-Leafy vegetables – 8.8 ppb
OEHHA will conduct a pre-regulatory workshop on this proposal on October 14, 2015. The agency will accept public comments through October 28, 2015.
Lead Safe Harbor Workshop
The workshop will be held on October 19, 2015 from 1 p.m. to 4 p.m. in the Auditorium at the Elihu Harris State Building at 1515 Clay Street in Oakland, California.