§ 25821. Level
of Exposure to Chemicals Causing Reproductive Toxicity
(a) For purposes of
the
Act, “level in question” means the chemical concentration
of a listed chemical for the exposure in question. The exposure in question
includes the exposure
for which the person in the
course of doing business is responsible, and does not
include exposure to
a listed
chemical from any other
source or product. For purposes
of this section, where a business presents evidence fo r
the “level
in qu e stio n ”
of a listed
chemical in a food product
based on the average
of multiple
samples of that food,
the level in question may not be calculated
by averaging
the concentration of the chemical
in food products from different manufacturers or producers, or that
were manufactured in different
manufacturing facilities from the
product at issue.
This proposed
rule bars a producer from calculating an average exposure level from multiple
samples based on food from different manufacturers or producers or from
different manufacturing facilities. OEHHA stated that they believe that it is inconsistent with the purposes of
[Prop. 65] to average concentrations of chemicals in products manufactured over
extended periods, and “based on concentrations measured
in samples of foods from different manufacturers or producers, or from different manufacturing facilities, because these are not necessarily representative of the levels of the
chemical in products an individual
would typically be exposed to when consuming a particular product in California.”
Initial Statement of Reasons https://oehha.ca.gov/media/downloads/crnr/isor25821100518.pdf
at p.9.
OEHHA also made proposed changes to the way the rate
of intake or exposure is calculated:
§ 25821.(c)(2) For exposures
to consumer products,
the
level of exposure shall be calculated
using the reasonably anticipated rate of intake or exposure for average
users of the consumer
product, and not on a per capita
basis for the general
population. This rate of intake or exposure is calculated as the
arithmetic mean of the
rate of intake or
exposure for users of the product. The
rate of intake or exposure shall be based on data for
use of a general category or categories
of
consumer products,
such as the United States Department of
Agriculture Home Economic Research Report, Foods Commonly Eaten
by Individuals: Amount Per Day and Per
Eating Occasion, where such data
are available.
In this section 27 CCR § 25821(c)(2), OEHHA attempts to define the method of calculating the reasonably anticipated rate of intake by using the arithmetic mean of differing
exposure rates. According to OEHHA the arithmetic mean best captures that
variability because it, unlike a geometric mean or median methodology it “accounts
for consumption levels at both the low and the high end of the range, weighing
the intake of each consumer equally.” Initial Statement of Reasons at p.8.
These amendments would arguably abrogate the state
appellate court decision in Environmental
Law Foundation v. Beech-Nut Nutrition. et al., (2015) 235 Cal.App.4th 307, (“Beech-Nut”)
in which the Court allowed exposure calculations based on the average lead
levels across different manufacturers and facilities. It also permitted the use
of the geometric mean to calculate rates of rather than the arithmetic as these
proposed rules require.
OEHHA in the Initial Statement or Reasons makes it clear that they believe that the Court in Beech-Nut was wrong:
Neither [of the
Court] finding[s] is consistent with the
intent of OEHHA’s regulations or Proposition 65, which is focused on an
individual exposure from a specific product. Therefore, OEHHA believes that the
regulations should be clarified so that businesses and courts can apply the
correct analysis in the future. It should be noted that it is also inconsistent
with the purposes of the Act to average concentrations of chemicals in products
manufactured over extended periods. OEHHA considered including a time element
in this regulation. Initial Statement of Reasons at p.11
The consequence of these new rules would be to make it more difficult for food producers to support a decision to forego labeling certain food products, as the proposed rule makes the Prop 65 threshold more difficult to calculate because of the inherent variability of constituents in foods with respect to the levels in the foods and the variability of the rate of exposure to consumers.
The Public comment cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.Public comments cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.
The Public comment cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.Public comments cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.