September 4, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: California Proposes to Update Proposition 65 Regulations - Lead and Arsenic Focus
In July 2015, JPA staff notified members that the Center for Environmental Health (CEH) had petitioned the California Environmental Protection Agency's (EPA's) Office of Environmental Health Hazard Assessment (OEHHA) to repeal or amend the maximum allowable dose level (MADL) or safe harbor level for lead, which is currently 0.5 micrograms (μg) per day. The CEH petition is available here. In August 2015, members were notified that OEHHA had announced the Agency would initiate rulemaking to update the current MADL for lead. OEHHA recently announced several proposed revisions to the Proposition 65 regulations including regulations related to lead and arsenic. While this communication is lengthy, it provides important details regarding proposed changes to the Proposition 65 regulations.
JPA members were earlier notified that the Environmental Law Foundation (ELF) had filed a lawsuit against food processors, including some JPA members alleging lead was found in certain baby foods, processed fruits and juices and violated California’s Proposition 65 warning requirements.
In 2013, the court ruled in favor of the defendants and found that it is appropriate to average exposure to lead over more than one day. ELF subsequently filed an appeal and this year, the court ruled on the appeal finding it is acceptable to average the lead concentration by calculating the geometric mean of the product’s lead level. The court also affirmed it was appropriate to average consumer consumption frequency data over a fourteen-day period.
OEHHA published a notice advising that CEH petitioned the Agency to repeal or amend the maximum allowable dose level (MADL) or safe harbor level for lead. The CEH noted that the current MADL is not protective of public health. In part, CEH referred to the ELF court cases regarding lead in processed fruits and juices, and noted that due to the courts' ruling that producers could average lead exposures from their products over a 14-day period, the MADL for lead would be increased from 0.5 μg/per day to up to 7 μg/per day. According to CEH, a single day exposure of 7 μg averaged over 14 days would result in an exposure of 0.5 μg/per day.
CEH also noted that the MADL for lead was never scientifically valid, and decades of peer-reviewed studies conducted since the limit was established in 1989 have shown that the level is not sufficiently protective. CEH urged OEHHA to publish a regulation establishing that the MADL for lead is a single day exposure limit and averaging exposure over time is not allowed when assessing compliance to the regulatory limit.
In response to the petition, OEHHA is proposing a number of revisions to the regulations as detailed below.
Proposed MADLs for Lead
In response to the CEH petition, OEHHA has announced that the Agency will initiate rulemaking to update the current MADL for lead, codified in Title 27 California Code of Regulations, Section 25805(b). OEHHA announced that the Agency will hold a hearing on October 14, 2015 (10 a.m. – 12 p.m.) to consider the CEH petition. In part, the Agency is proposing to establish levels of lead exposure for periods of time ranging from one day to as many as 120 days that would be exempt from the warning requirements of Proposition 65. OEHHA has published a document, available here, explaining the rationale for proposing multiple MADLs for lead rather than maintaining the current MADL of 0.5 μg/per day. The draft regulatory language, available here, includes, in part, the following proposed MADLs for lead.
- 0.2 micrograms every day (i.e., this MADL represents an exposure to lead that occurs on a daily basis)
- 0.3 micrograms one day in every 2 days (i.e., this MADL represents an exposure to lead that occurs once every 2 days)
- 0.5 micrograms one day in every 3 days (i.e., this MADL represents an exposure to lead that occurs once every 3 days)
- 0.7 micrograms one day in every 4 days (i.e., this MADL represents an exposure to lead that occurs once every 4 days)
See the draft regulatory language for the complete list of proposed MADLs. The Agency notes the potential MADLs provide a new approach for determining if a given lead exposure requires a Proposition 65 warning.
The deadline to submit comments to OEHHA related to the proposed lead MADLs is October 28, 2015.
Measuring Concentrations of Chemicals in Products
OEHHA is also proposing to amend the Proposition 65 regulations, codified in Title 27 California Code of Regulations, Section 25821, concerning the calculation of the concentration of listed Proposition 65 chemicals in foods. The Agency recently announced a workshop will be held on October 19, 2015 (1 p.m. – 4 p.m.) to consider draft regulatory language, available here, and explanatory information, available here, for a possible new regulation.
OEHHA states in the “explanatory” document that the Agency is proposing to “clarify that, for chemicals known to cause reproductive toxicity, the concentration of a listed chemical in a food product must be determined on the basis of a single lot of a product in the form it would likely be sold to the end-consumer.” The Agency notes that averaging concentrations of a listed chemical in food products that are manufactured in different locations or time periods is not consistent with the regulation’s purpose. According to the Agency, “The proposed amendment would clarify that the chemical concentration of a listed reproductive toxicant in a food product may not be averaged across lots from different locations, manufacturing runs or time periods of production.” OEHHA notes that if the concentration of a listed chemical is high in one lot and low in another lot, allowing the concentrations to be averaged over multiple lots could allow exposures to a listed chemical to occur without the required warning for reproductive toxicity. According to the Agency, the concentration of a given chemical in a single lot of product as sold to the end-consumer is the appropriate basis of determining the need for a warning.
As noted in the “Background” above, the courts earlier determined that is appropriate to average exposure to lead over more than one day. OEHHA is proposing to clarify that this practice is not acceptable.
The deadline to submit comments to OEHHA regarding proposed amendments on calculating the concentration of a listed chemical is November 2, 2015.
Arithmetic Mean for Calculating Intake or Exposure
As noted in the “Background” above, the courts also ruled in the ELF lawsuit that it is appropriate to calculate the exposure to a listed chemical using the geometric mean. OEHHA has announced that the Agency is considering amending the regulation, codified in Title 27 California Code of Regulations, Section 25821(c), to clarify that the rate of intake or exposure to a listed Proposition 65 chemical must be calculated as the arithmetic mean of daily intake or exposure for product users. The Agency notes the regulations are not specific regarding how the intake or exposure of a consumer is to be determined. A workshop is scheduled to be held on October 19, 2015 (10 a.m. – 12 p.m.) to consider the draft regulatory language, available here, and the explanatory information, available here.
The deadline to submit comments to OEHHA regarding the proposed method for calculating intake or exposure is November 2, 2015.
Proposed Safe Harbor Levels for Naturally Occurring Levels of Lead and Arsenic in Certain Foods
OEHHA is also proposing to add a new regulation, codified in Title 27 California Code of Regulations, Section 25501.1, which would establish safe harbor values for lead and arsenic naturally occurring in certain unprocessed foods. Both lead and arsenic are naturally occurring elements in the environment. OEHHA’s notice is available here. The Agency has announced that a workshop will be held on October 14, 2015 (1:00 p.m. – 4:00 p.m.) to consider the draft regulatory language, available here, and the explanatory information, available here.
OEHHA is proposing a naturally occurring concentration of lead of 0.0088 parts per million (ppm) (or 8.8 parts per billion (ppb)) in leafy vegetables and 0.0062 ppm (or 6.2 ppb) in non-leafy vegetables, fruit, meat, seafood, eggs, and milk. According to the Agency, research has shown that leafy vegetables tend to have higher concentrations of lead than non-leafy vegetables even when grown in the same area. Of particular note, OEHHA includes data from the Food and Drug Administration's (FDA) Total Diet Study regarding lead in fruits. (See page 26 for details.)
OEHHA states, "In evaluating the exposure to a chemical in food for which the business is responsible, the naturally occurring concentration would be subtracted from the measured concentration in the food to determine if the food product is exempt from Proposition 65 warning requirements pursuant to Health and Safety Code section 25249.10(c)."
The proposed regulation would use these values to establish the background lead levels as noted in the example below, which was excerpted from the explanatory document.
“Suppose a given non-leafy vegetable is found to have a lead concentration equal to 0.01 ppm. Assuming a background lead level of 0.007 ppm for non-leafy vegetables, and multiplying that background level by the correction factor of 0.88 to obtain a naturally occurring lead level of 0.00616 ppm,, the remaining lead concentration is given by the difference 0.01 ppm – (0.00616 ppm) = 0.00384 ppm. Thus for the non-leafy vegetable in this example, 0.00384 ppm is the amount of lead that would be considered not to be naturally-occurring in the food.”
The Agency is also proposing a naturally occurring concentration of inorganic arsenic in white rice of 0.06 ppm (60 ppb) and 0.13 ppm (130 ppb) for brown rice. The Agency notes the safe harbor values applies to all rice, regardless of the location of where the rice is grown.
Comments must be submitted to OEHHA by October 28, 2015 regarding these proposed safe harbor values.
OEHHA notes the pre-regulatory documents are draft and could change substantially before rulemaking is initiated.
Please contact me with questions or comments.
(404) 252 - 3663