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To: Members of the Carcinogen Identification Committee (CIC) and
Developmental and Reproductive Toxicant (DART) Identification Committee
From: (original signed by) Colleen Murphy, Chief Counsel
Date: July 20, 1998
Subject: "Authoritative Bodies" Mechanism for Listing
Chemicals Pursuant to Proposition 65
Background
At the "Authoritative Bodies" workshop conducted by the
Office of Environmental Health Hazard Assessment (OEHHA) on June
11, 1998, members of both the DART Committee and CIC raised several
questions regarding the interaction of the "State’s qualified
experts" authority to list chemicals under Proposition 65 (adopted
by initiative statute as the Safe Drinking Water and Toxic Enforcement
Act of 1986) and the "Authoritative Bodies" mechanism
for listing chemicals under Proposition 65. This memorandum explores
the relationship between these two mechanisms for listing chemicals
and the "primacy", if any, between various means of listing
chemicals. In addition, it contains an analysis of different or
potentially conflicting decisions made by different authoritative
bodies. The memorandum also examines "delisting" of a
chemical by an authoritative body and criteria that the CIC and
DART Committees should be using to select and evaluate authoritative
bodies.
Authorities
Statute
Health and Safety Code Section 25249.8 (b) sets forth the three
independent bases for determining whether a chemical is "known
to the State to cause cancer or reproductive toxicity" within
the meaning of Proposition 65. That provision reads as follows:
(b) A chemical is known to the State to cause cancer or reproductive
toxicity within the meaning of this chapter [6.6]
[1] if in the opinion of the State’s qualified experts
it has been clearly shown through scientifically valid testing
according to generally accepted principles to cause cancer
or reproductive toxicity, or
[2] if a body considered to be authoritative by such experts
has formally identified it as causing cancer or reproductive
toxicity, or
[3] if an agency of the state or federal government has
formally required it to be labeled or identified as causing
cancer or reproductive toxicity." (emphasis added)
It should be noted from the above that the standard for assessing
whether a chemical is "known to the State to cause cancer or
reproductive toxicity" is different for each of the three distinct
methods of listing chemicals. It should also be noted that the means
of identifying chemicals for listing under Proposition 65 is phrased
in the disjunctive. That is, a chemical need only meet one of the
three ways of being identified as causing cancer or reproductive
toxicity in order to be listed. Also pursuant to [2] above, it should
be pointed out that the Committees do not directly decide which
chemicals go on the Proposition 65 list. Rather, as is explored
further below, the Committees select the authoritative bodies and
OEHHA determines if a chemical has been formally identified by such
an authoritative body in a manner that it should go on the list.
Regulations
Title 22, California Code of Regulations, Section 12306 (hereafter
Section 122306) is the regulation adopted by the lead agency (previously
the Health and Welfare Agency, currently OEHHA) for implementing
Health and Safety Code Section 25249.8 (b), set forth above. Section
12306 specifies the standards that must be met for an "authoritative
bodies" listing of a chemical under Proposition 65. It
also sets forth the roles of the various parties (DART Committee,
CIC, and OEHHA) in this process and makes more specific the procedures
to be followed in reviewing and listing a chemical via the authoritative
bodies listing mechanism.
The basic structure of Section 12306 is as follows. First of all,
the CIC and DART Committees each separately designate entities that
are "authoritative" for the identification of chemicals
that cause cancer and chemicals that cause reproductive toxicity,
respectively.
OEHHA reviews activities of designated authoritative bodies to
find candidate chemicals for listing based on strict criteria for
"formally identified." Finally, there is a public process
for review of the authoritative body action to determine if there
was "sufficient evidence" for formally identifying the
chemical as causing cancer or reproductive toxicity.
Section 12306 provides in pertinent part as follows:
"(a) Pursuant to Health and Safety Code, Section 25249.8 (b),
a chemical is known to the State to cause cancer or reproductive
toxicity if a body is considered to be authoritative by the State’s
qualified experts and the lead agency has determined that the body
has formally identified the chemical as causing cancer or reproductive
toxicity, as described in this section.
(b) A ‘body considered to be authoritative’ is an agency
or formally organized program or group which utilizes one of the
methods set forth in subsection (c), paragraph (1) for the identification
of chemicals as causing cancer or reproductive toxicity. For purposes
of this section, ‘authoritative body’ means either a ‘body
considered to be authoritative’ in the identification of chemicals
as causing cancer by the Carcinogen Committee or a ‘body considered
to be authoritative’ in the identification of chemicals as
causing reproductive toxicity by the DART Committee. The Carcinogen
Committee and the DART Committee shall have the authority to revoke
or rescind any determination that a body is authoritative on the
grounds that the respective Committee no longer considers the body
to have expertise in the identification of chemicals as causing
cancer or reproductive toxicity, respectively in which case chemicals
listed pursuant to this section prior to the effective date of the
revocation shall remain on the list. Nothing in this section shall
be construed to limit or otherwise interfere with such authority."
(c) The lead agency shall determine which chemicals have been formally
identified by an authoritative body as causing cancer or reproductive
toxicity.
(d) For purposes of this section, a chemical is ‘formally
identified’ by an authoritative body when the lead agency determines
that: . . .
Subsections (e), (f), (g) and (h) of Section 12306 further define
"as causing cancer," and "as causing reproductive
toxicity", as well as setting forth grounds when the lead agency
(OEHHA) shall not make a finding regarding "as causing cancer"
or "as causing reproductive toxicity."
Subsection (i) of Section 12306 specifies the procedure that OEHHA
as the lead agency for implementation of Proposition 65 must follow
in adding chemicals via the authoritative bodies mechanism to the
Proposition 65 list. It provides as follows:
"(i) At least 60 days prior to adding a chemical determined
to have been formally identified by an authoritative body as causing
cancer or reproductive toxicity to the list of chemicals known to
the State to cause cancer or reproductive toxicity, the lead agency
shall cause to be published in the California Regulatory Notice
Register a notice identifying the authoritative body and the chemical,
and stating the lead agency’s intention to cause the chemical
to be added to the list. Copies of the notice shall be provided
to the Carcinogen Committee or the DART Committee, as appropriate,
to permit the appropriate Committee at least 30 days to review and
comment or the proposed action. Within 30 days following the publication
of the notice, interested parties, including any member of the appropriate
committee, shall submit to the lead agency their written objections
to the addition of the chemical to the list of chemicals known to
cause cancer or reproductive toxicity, along with any supporting
documentation. Objections shall be made on the basis that there
is no substantial evidence that the criteria identified in subsection
(e) or in subsection (g) have been satisfied. The lead agency shall
review such objections. If the lead agency finds that there is no
substantial evidence that the criteria in subsection (e) or in subsection
(g) have been satisfied, the lead agency shall refer the chemical
to the appropriate Committee to determine whether, in the Committee’s
opinion, the chemical has clearly been shown through scientifically
valid testing according to generally accepted principles to cause
cancer or reproductive toxicity."
Subsection (j) of Section 12306 sets forth the criteria for the
lead agency, OEHHA, to use in reconsidering a determination that
a chemical has been formally identified by an authoritative body
as causing cancer or reproductive toxicity. It also provides that
while a chemical is under reconsideration by the lead agency, it
shall be referred to the appropriate committee for a recommendation
concerning whether the chemical should continue to be included on
the list of chemicals known to the State to cause cancer or reproductive
toxicity. Pending such reconsideration, the chemical remains on
the list.
Finally, subsection (k) sets forth authority for the CIC or DART
Committee to condition its determination that a body is considered
to be authoritative upon the subsequent application of the controls
set forth in Section 12306.
Questions Presented
(1) What happens
if one authoritative body formally identifies a chemical as
causing cancer or reproductive toxicity and a different authoritative
body reviews the chemical and does not formally identify it
as causing cancer or reproductive toxicity?
(2) What effect, if any, does a determination by an authoritative
body to not formally identify a chemical as causing cancer or
reproductive toxicity have on the authority of the CIC or DART
Committee to render an opinion regarding listing under Proposition
65?
(3) What effect, if any, does a determination by the CIC or
DART Committee to not identify a chemical for listing under
Proposition 65 have on the authority of the lead agency to list
a chemical as causing cancer or reproductive toxicity on the
basis of an authoritative body formal identification?
(4) What happens if a chemical is formally identified by an
authoritative body as causing cancer or reproductive toxicity
and is added by the lead agency to the Proposition 65 list and
later the pertinent authoritative body no longer identifies
the chemical as causing cancer or reproductive toxicity?
(5) What criteria should the CIC and DART Committees be using
to identify and evaluate authoritative bodies?
Answers/Analysis
(1) If any one authoritative body formally identifies a chemical
as causing cancer or reproductive toxicity that is sufficient
for OEHHA, as the lead agency for implementation of Proposition
65, to initiate the proceedings to have the chemical added to
the Proposition 65 list. Again, as Health and Safety Code Section
25249.8 (b) provides, "if a body considered to be authoritative
by such [State’s qualified] experts has formally identified
it as causing cancer or reproductive toxicity . . ." (emphasis
added) it is a chemical known to the State to cause cancer or
reproductive toxicity.
It may well be that different determinations by various authoritative
bodies reviewing the same chemical may, after the notice of
intent to list, lead to submittal of objections to the proposed
listing, as was discussed above (Section 12306 (i)). However,
upon receipt of any objections, it is up to the lead agency
to determine if the regulatory criteria in either Section 12306
(e) (as causing cancer") or 12306 (g) ("as causing
reproductive toxicity") have been satisfied. The evidence
that led another authoritative body to conclude that the chemical
did not cause cancer or reproductive toxicity could provide
the basis for a determination by OEHHA that the regulatory criteria
for listing are not met. Again, however, there is no per se
barrier to listing a chemical under Proposition 65 via the authoritative
body mechanism because a different authoritative body did not
formally identify it as causing cancer or reproductive toxicity.
If OEHHA determines the criteria are met, the chemical will
be added to the Proposition 65 list. If after issuing a notice
of intent to list, OEHHA determines there is no substantial
evidence that the criteria in subsection (e) or (g) have been
satisfied, then OEHHA shall refer the chemical to the appropriate
Committee, DART or CIC, for determination whether, in the Committee’s
opinion, the chemical has been clearly shown through scientifically
valid testing according to generally accepted principles to
cause cancer or reproductive toxicity. (Section 12306 (i)).
Quite simply, there really is no problem with "dueling"
authoritative bodies. There is no obligation on the part of
the CIC or DART Committee to determine "primacy".
Rather, OEHHA will examine any chemical identified listed by
a recognized authoritative body and determine if it has been
formally identified as causing cancer or reproductive toxicity
and if the sufficiency of the evidence supports the identification.
Upon notice of intent to list, the CIC and DART Committee as
well as the public may object to such determination on the grounds
set forth above. If OEHHA agrees with the objection, it then
refers the chemical to the appropriate committee for review
and consideration under the State’s qualified experts listing
mechanism.
(2) A determination by an authoritative body to not formally
identify a chemical as causing cancer or reproductive toxicity
is not a legal impediment to the authority of the CIC or DART
Committee to have the chemical added to the Proposition 65 list.
Quite clearly, Health and Safety Code, Section 25249.8 (b) sets
up three distinct means of listing. Each means is of equal weight.
Accordingly, although there may be some practical and scientific
considerations posed by the fact that an authoritative body
chose not to formally identify a chemical as causing cancer
or reproductive toxicity, it is not a bar to the CIC or DART
Committee making a different determination under the standards
applicable to the State’s qualified expert authority and
method of listing and deciding to list the chemical. Much of
the analysis set forth in answer to the first question applies
here. That is, there is no real " primacy" problem.
If a chemical qualifies for the Proposition 65 list under any
of the three independent means specified in Section 25249.8
(b) it may be added to the list despite the fact that it may
not qualify for listing under either of the other listing methods.
(3) The answer to Question #1 and #2 serve to answer this question,
as well. That is, each of the three listing mechanisms is independent
of the other methods and has its own authority. Accordingly,
a determination by the CIC or DART Committee to not identify
a chemical for listing under the "State’s qualified
expert" listing procedure is no bar or limitation on the
authority of an authoritative body to formally identify a chemical
as causing cancer or reproductive toxicity. Again, the Statute
(Section 25249.8 (b)) is framed in the disjunctive--"or".
If a chemical meets any one of the three listing methods, it
may be added to the list.
(4) The answer to this question is contained in Section 12306
(j). More specifically, pursuant to subsection (j), if the authoritative
body that formally identified a chemical as causing cancer or
reproductive toxicity no longer identifies the chemical as such,
then OEHHA is required to reconsider its determination that
the chemical has been formally identified as causing cancer
or reproductive toxicity.
As subsection (j) of Section 12306 further specifies, OEHHA’s
reconsideration may be initiated by OEHHA on its own motion,
or on a request of an interested party, including any member
of the CIC or DART Committee. Under this procedure, OEHHA is
required to refer the chemical under reconsideration in this
context to the appropriate Committee (CIC or DART) for a recommendation
concerning whether the chemical should continue to be included
on the list of chemicals known to the State to cause cancer
or reproductive toxicity. Pending such reconsideration, the
chemical shall remain on the list.
(5) The applicable statute, Health and Safety Code, Section
25249.8 (b), and regulation, Section 12306, do not provide very
specific criteria for identifying and/or evaluating potential
or existing authoritative bodies. However, there is some direction
provided by Section 12306. In subsection (b), an authoritative
body is defined as "an agency or formally organized program
or group which utilizes one of the methods set forth in subsection
(c), paragraph (1) [since renumbered to (d)] for the identification
of chemicals and which the Carcinogen Committee or the DART
Committee has identified as having expertise in the identification
of chemicals as causing cancer or reproductive toxicity."
In addition, the definitions of "formally identified"
in subsection (d) and of "as causing cancer" in subsection
(e) and of "as causing reproductive toxicity" in subsection
(g), as well as the exclusions from the definition of"
"as causing cancer"’ in subsection (f) and "as
causing reproductive toxicity" in subsection (h) all help
to shed light on the types of activities that are engaged in
by authoritative bodies and the methods used by them in their
work.
While it has been pointed out that the "formal identification"
determination is one specifically reserved to OEHHA, this does
not prevent the CIC or DART Committees from taking into account
the scientific methodology and type of decision-making that
occurs at a potential authoritative body when the CIC or DART
Committee is determining whether to designate a body as authoritative.
In fact, the reference in subsection (b) to use of the methods
in subsection (c) (1) (since renumbered to (d)), emphasizes
that these are the factors that the CIC and DART Committees
should examine in determining whether or not a body is "authoritative".
However, once the designating Committee, CIC or DART, is satisfied
the authoritative body uses one of the appropriate methods for
formal identification of chemicals as causing cancer or reproductive
toxicity, the pertinent committee need not specify which method
satisfied the requirement in subsection (d) this in making the
designation. This is so because under Section 12306 only
those acts of an authoritative body that follow the appropriate
methods will result in the listing of chemicals based on the
authoritative body mechanism.
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