Regulatory Comments to OEHHA (Pre-regulatory proposal in response to Center for Environmental Health’s petition requesting repeal or amendment of the safe harbor level for lead, amendment to section 25805(b).
Date: October 28, 2015
Background:
California’s Proposition 65 or clean water initiative obligates the state to publish a list of chemicals “known to the State to cause cancer or reproductive toxicity” and provide an update at least annually to that list. The statute provided that the governor identify and consult with the state’s qualified experts to carry out his duties under the statute. Twelve persons were appointed as the state’s qualified experts to serve on what is today the Scientific Advisory Panel. The Scientific Advisory Board, organized into the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant Identification Committee, continues to meet, debate criteria, set levels, consider scientific data, and recommend chemicals for listing., Lead was added to the Prop 65 list on February 27, 1987 as known to the state to cause reproductive toxicity, pursuant to Labor Code Section 6382(d).
On July 3, 2015, OEHHA received an electronic copy of the “Petition by Center for Environmental Health (CEH) for Administrative Rulemaking to repeal or amend Proposition 65 regulations pertaining ot the Maximum Allowable Dose Level [MAD] for lead,” which was filed pursuant to Government Code section 11340.6. OEHHA has the authority to adopt, amend and repeal regulations related to the Safe Drinking Water and Toxic Enforcement Act of 1986, including the adoption of new safe harbor levels for listed chemicals. In response to the CEH petition, OEHHA drafted pre-regulatory language to adopt a new set of MADLs for lead on its website at www.oehha.ca.gov/prop65. The regulatory amendments are designed to:
- Clarify OEHHA’s intent that all the existing MADLs for listed chemicals are set as the highest exposures that can occur in a single day. These values. When multiplied by 1000, are deemed to cause no observable effect, and hence are exempt from the Proposition 65 warning requirements pursuant to Health and Safety Code section25249.10.
- They would create a new subsection 25805(b)(2) that would establish MADLs for certain chemicals for intermittent exposures that, when multiplied by 1000, are deemed to pose no observable effect.
- They would repeal and replace the existing MADL for lead with MADLs in the new subsection (25805(b)(2)). The levels are expressed as maximum levels of exposure to lead that could occur for different exposure frequencies. For example, one MADL value is for an exposure that occurs every day and a different value when an exposure occurs once every 7 days.
Many, if not most, NPA members conduct business in California and will therefore be significantly impacted by mandated use of the arithmetic mean to calculate chemical exposure. Thank you for the opportunity to comment.
Action:
The Proposed MADL for Lead Will Be Lowered Far Below FDA’s Actionable Lead Limit, Set To Protect Consumers
OEHHA’s Proposed Lead Level Seeks To Overturn 2015 “Beach-Nut” Appellate Court Ruling
The Proposed MADL for Lead Will Be Lowered By 60% And Create Overwarning and Increased Litigation
Prop 65 could be considered the most stringent standard on the planet as it requires warnings for chemicals even if present at levels well below federal PTTILs. How could food be considered safe to eat because it is well within the good manufacturing practices and limits on contaminants but not meet a state safe harbor level? Lowering the lead safe harbor level does not serve to protect public health but instead encourages increased litigation, fosters an environment of useless warnings, and ensures future settlements over lead levels in consumer products. Lead has produced more pre-litigation notices than any chemical listed among the 800 chemicals on the Prop 65 list.
OEHHA Lead MADL Vs Federal Limits on Contaminants: A Case for Federal Regulations Preempting The States
NPA supports warnings on products when they exceed a federal standard (e.g. the Food and Drug Administration (FDA), charged to protect consumer health. The US FDA, Environmental Protection Agency (EPA), Institute of Medicine (IOM), and World Health Organization (WHO) have extensive research on the health impact and toxicity of common chemicals and set reasonable guidelines for total tolerable intake and exposure levels. Violation of federal levels set for contaminants can result in a warning letter from FDA, a ban of the product from store shelves, recalls for the product, detention of the ingredient or product at US ports, or some other enforcement action to protect the public health. Federal authorities like FDA’s actionable limits on contaminants are based upon sound science, an intent to protect public health, and a thorough review of the scientific literature. FDA’s actionable limits on contaminants are based upon well-established provisional total tolerable intake levels (PTTILs) set for contaminants. OEHHA should adopt a federal standard such as FDA’s PTTILs until federal laws preempt these state levels. In many cases, California’s safe harbor levels are inappropriate and several-fold lower than established federal levels. For example, the existing Prop 65 requires a warning statement for food products found to contain greater than 0.5 μg per serving per day of lead, but the federal level prompting action based upon a safety concern is 75 μg per serving per day of lead if the product has conditions of use that limit it to be consumed by adults and excludes pregnant women. This safe harbor level for lead is 150 times lower than the serving level of the federal standard. This pre-regulatory draft would make California’s safe harbor level 750-fold lower than the current federal standard. Even if you looked at food products which do not exclude children, which have a lower federal actionable level, California’s lead safe harbor level remains 30-fold lower than the federal standard for foods.
Application of Safety Factors in Regulatory Toxicology
NPA requests an amendment to Article 6 to contain a discussion regarding the proper application of safety factors and a revision of Section 25349.10 Exemptions from Warning Requirement. The Safe Drinking Water and Toxic Enforcement Act of 1986 exempts exposures when they “will have no observable effect assuming exposure at one thousand (1000) times the level in question”. In other words, the exemption, provided in Proposition 65 for exposures to reproductive toxicants, is that the exposure will result in no observable effect at 1,000 times the level in question. Safety factors, also called uncertainty factors, are designed to address risk in exposure models to chemical in the course of food consumption. For example, the safety factor applied in traditional regulatory toxicology for commonly encountered contaminants or chemical when human studies are available is 100, assuming only subchronic studies are available.
