10.30.15
A coalition of organizations headed by the California Chamber of Commerce—including the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and the Personal Care Products Council (PCPC)—has expressed concerns about California Office of Environmental Health Hazard Assessment's (OEHHA's) proposed revisions to the Proposition 65 safe harbor Maximum Allowable Dose Levels (MADLs) for lead.
OEHHA has proposed a draft safe harbor MADLs range from 0.2 micrograms (mcg) per day for daily exposures to a cap of 8 mcg one day in every 116 days or more. OEHHA also proposed to define all other safe harbor MADLs other than lead as single-day limits. These are pre-regulatory proposals that could change substantially prior to the commencement of a formal rulemaking.
"The approach taken by OEHHA is problematic from both a policy and scientific standpoint and the draft MADL proposal should not be adopted in its current form," said AHPA President Michael McGuffin. "The substantial reduction in the safe harbor MADL for lead, coupled with OEHHA's draft proposals to require the arithmetic mean for determining average consumption and to prohibit averaging of concentration levels across 'lots,' will further arm private enforcers with even more opportunities to challenge businesses under Prop 65."
The comments highlight specific issues with OEHHA's proposals, including:
· Increased warnings and litigation risk
· Inadequate justification for the proposed 15 mcg per deciliter (dL) target blood lead level (BLL) as the lowest BLL with no observed effect
· The target BLL of 15 mcg/dL is not appropriate for exposures lasting less than 14 days
· Lack of explanation for why an overall 10-year period of exposure is appropriate for all types of exposures
· The model OEHHA developed to predict human absorption, distribution, metabolism and excretion of chemical substances is inaccurate due to uncorrected errors
· OEHHA's use of a 1,000-fold uncertainty factor to derive the draft safe harbor MADLs for lead is unjustified
· Draft MADL Proposal should use the same prefatory language as used for existing safe harbor levels
· OEHHA's Single-Day Proposal is not scientifically appropriate
AHPA and the coalition of more than 80 organizations urge OEHHA to reconsider the proposal and not move forward with the levels or concepts currently proposed. The coalition's letter also states that OEHHA has not provided sufficient time for adequate review and feedback on the highly technical proposal. The organizations request OEHHA allow the coalition to submit additional comments to be considered before issuing any formal regulatory proposal.
The coalition’s comments can be found here.
OEHHA has proposed a draft safe harbor MADLs range from 0.2 micrograms (mcg) per day for daily exposures to a cap of 8 mcg one day in every 116 days or more. OEHHA also proposed to define all other safe harbor MADLs other than lead as single-day limits. These are pre-regulatory proposals that could change substantially prior to the commencement of a formal rulemaking.
"The approach taken by OEHHA is problematic from both a policy and scientific standpoint and the draft MADL proposal should not be adopted in its current form," said AHPA President Michael McGuffin. "The substantial reduction in the safe harbor MADL for lead, coupled with OEHHA's draft proposals to require the arithmetic mean for determining average consumption and to prohibit averaging of concentration levels across 'lots,' will further arm private enforcers with even more opportunities to challenge businesses under Prop 65."
The comments highlight specific issues with OEHHA's proposals, including:
· Increased warnings and litigation risk
· Inadequate justification for the proposed 15 mcg per deciliter (dL) target blood lead level (BLL) as the lowest BLL with no observed effect
· The target BLL of 15 mcg/dL is not appropriate for exposures lasting less than 14 days
· Lack of explanation for why an overall 10-year period of exposure is appropriate for all types of exposures
· The model OEHHA developed to predict human absorption, distribution, metabolism and excretion of chemical substances is inaccurate due to uncorrected errors
· OEHHA's use of a 1,000-fold uncertainty factor to derive the draft safe harbor MADLs for lead is unjustified
· Draft MADL Proposal should use the same prefatory language as used for existing safe harbor levels
· OEHHA's Single-Day Proposal is not scientifically appropriate
AHPA and the coalition of more than 80 organizations urge OEHHA to reconsider the proposal and not move forward with the levels or concepts currently proposed. The coalition's letter also states that OEHHA has not provided sufficient time for adequate review and feedback on the highly technical proposal. The organizations request OEHHA allow the coalition to submit additional comments to be considered before issuing any formal regulatory proposal.
The coalition’s comments can be found here.
