CALIFORNIA REGULATORY NOTICE REGISTER 2018, VOLUME NO. 40-Z
 1760the Department would be more ef fective in carrying out
the purpose for which the action is proposed, would be
as effective and less burdensome to af fected private per-
sons than the proposed regulatory action, or would be
more cost−effective to affected private persons and
equally effective in implementing the statutory policyor other provisions of law . Interested persons are invited
to present statements or arguments with respect to any
alternatives to the changes proposed at the scheduled
hearing or during the written comment period.
A V AILABILITY OF PROPOSED TEXT AND
INITIAL STATEMENT OF REASONS
The Department has prepared and will make avail-
able the text and the Initial Statement of Reasons
(ISOR) of the proposed regulations. The rulemaking
file for this regulatory action, which contains thoseitems and all information on which the proposal is based
(i.e., rulemaking file) is available to the public upon re-
quest directed to the Department’s contact person. The
proposed text, ISOR, and Notice of Proposed Actionwill also be made available on the Department’s web-site: www.cdcr.ca.gov
.
A V AILABILITY OF THE FINAL
STATEMENT OF REASONS
Following its preparation, a copy of the Final State-
ment of Reasons may be obtained from the Depart-ment’s contact person.
A V AILABILITY OF CHANGES TO
PROPOSED TEXT
After considering all timely and relevant comments
received, the Department may adopt the proposed regu-
lations substantially as described in this Notice. If the
Department makes modifications which are sufficient-
ly related to the originally proposed text, it will make
the modified text, with the changes clearly indicated,
available to the public for at least 15 days before the De-
partment adopts, amends or repeals the regulations asrevised. Requests for copies of any modified regulation
text should be directed to the contact person indicated in
this Notice. The Department will accept written com-ments on the modified regulations for at least 15 daysafter the date on which they are made available.TITLE 27.  OFFICE OF
ENVIRONMENTAL HEALTH
HAZARD ASSESSMENT
SAFE DRINKING WATER AND TOXIC
ENFORCEMENT ACT OF 1986
PROPOSITION 65
PROPOSED AMENDMENT TO
SECTIONS 25821(a) AND (c)
LEVEL OF EXPOSURE TO CHEMICALS
CAUSING REPRODUCTIVE TOXICITY:
CALCULATING INTAKE BY THE A VERAGE
CONSUMER OF A PRODUCT
NOTICE IS HEREBY GIVEN that the Office of En-
vironmental Health Hazard Assessment (OEHHA) pro-
poses to amend Title 27, Cal. Code of Regulations, Sec-
tion 25821, subsections (a) and (c)(2), Level of Expo-
sure to Chemicals Causing Reproductive T oxicity. This
proposed regulatory action would amend subsection (a)
to clarify that where a business presents evidence for the
“level in question” of a chemical listed as causing repro-
ductive toxicity 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 manufac-turers or producers, or that were manufactured in differ-
ent facilities from the product at issue. The proposed
regulatory actions would also modify subsection (c)(2)
to clarify that, when determining whether exposure to areproductive toxicant in a consumer product requires a
warning, the reasonably anticipated rate of intake or ex-
posure from consumer products to a chemical listed as
causing reproductive toxicity be calculated as the arith-
metic mean of the rate of intake or exposure for product
users.
PUBLIC PROCEEDINGS
In order to be considered, OEHHA must receive
comments by 5:00 p.m. on November 19, 2018, the
designated close of the written comment period. All
comments will be pos ted on the OEHHA website at the
close of the public comment period.
The public is encouraged to submit written informa-
tion electronically, rather than in paper form. Com-
ments may be submitted electronically through our
website at https://oehha.ca.gov/comments
. Comments
submitted in paper form can be mailed, faxed, or deliv-
ered in person to the address below.CALIFORNIA REGULATORY NOTICE REGISTER 2018, VOLUME NO. 40-Z
 1761Monet V ela
Office of Environmental Health Hazard Assessment
1001 I Street, 23rd FloorP.O. Box 4010
Sacramento, California 95812−4010
Telephone: 916−323−2517
Fax: 916−323−2610
E−mail comments may be sent to P65Public.
Comments@oehha.ca.gov (link sends e−mail) .
Please include “Calculating Intake” in the subjectline when submitting emailed comments.
Please be aware that OEHHA is subject to the Cali-
fornia Public Records Act and other laws that requirethe release of certain information upon request. If youprovide comments, please be aware that your name, ad-
dress and e−mail may be available to third parties.
A public hearing on this proposed regulatory amend-
ment will be scheduled on request. To request a hearing,
send an e−mail to Monet Vela at monet.vela@oehha.
ca.gov  or to the address listed above by no later than
November 5, 2018. OEHHA will mail a notice of the
hearing to the requester and interested parties on theProposition 65 mailing list for regulatory public hear-
ings. The notice will also be posted on the OEHHA
website at least ten days before the public hearing date.
The notice will provide the date, time, and location of
the hearing.
CONTACT
Please direct inquiries concerning the proposed regu-
latory action described in this notice to Monet Vela at
(916) 323−2517, or by e−mail to monet.vela@oehha.
ca.gov . Mario Fernandez is a back−up contact person
for inquiries concerning processing of this action and is
available at (916) 323−2635 or mario.fernandez@
oehha.ca.gov .
AUTHORITY
Health and Safety Code section 25249.12.
REFERENCE
Health and Safety Code sections 25249.5, 25249.6,
25249.9, 25249.10, 25249.11 and 25249.12.INFORMATIVE DIGEST/POLICY STATEMENT
OVERVIEW
BACKGROUND
OEHHA is the state entity responsible for the imple-
mentation of Proposition 651. Proposition 65 prohibits
a person in the course of doing business from knowing-ly and intentionally exposing any individual to a chemi-cal that has been listed as known to the state to cause
cancer or reproductive toxicity, without first giving
clear and reasonable warning to such individual
2. The
Act also prohibits a business from knowingly dis-charging a listed chemical into water or onto or into land
where such chemical passes or probably will pass into
any source of drinking water
3. Warnings are not re-
quired and the discharge prohibition does not apply
when exposures are insignificant4. The Act requires a
warning for a consumer when the level of exposurefrom a consumer product exceeds a specific amount for
a given chemical. OEHHA has the authority to adopt
and modify regulations as necessary to implement and
further the purposes of Proposition 65
5.
For purposes of Section 25249.10(c) of the Act, Title
27, Cal. Code of Regulations, Section 25821 requires
that the level of exposure to a chemical listed as causing
reproductive toxicity be determined by multiplying the
level in question (stated in terms of a concentration of a
chemical in a given medium) times the reasonably an-
ticipated rate of exposure for an individual to a given
medium. For exposures to consumer products, the level
of exposure is calculated using the reasonably anticipat-
ed rate of intake or exposure from a product for average
users of the consumer product. This proposed actionwould amend Section 25821(a) to clarify that where abusiness presents evidence for the “level in question” of
a chemical listed as causing reproductive toxicity in a
food product based on the average of multiple samplesof that food, the level in question may not be calculatedby averaging the concentration of the chemical in food
products from different manufacturers or producers, or
food products that were manufactured in different facil-
ities. This proposed action would also amend Section
25821(c)(2) to clarify that for exposures to chemicals
listed as causing reproductive toxicity from consumerproducts, the reasonably anticipated rate of intake or ex-
1 The Safe Drinking Water and Toxic Enforcement Act of 1986,
codified at Health and Safety Code section 25249.5 et seq., com-
monly referred to as “Proposition 65”. Hereafter referred to as“Proposition 65” or “the Act”.
2 Health and Safety Code section 25249.6.
3 Health and Safety Code section 25249.5.
4 Health and Safety Code sections 25249.9 and 25249.10.
5 Health and Safety Code section 25249.12.CALIFORNIA REGULATORY NOTICE REGISTER 2018, VOLUME NO. 40-Z
 1762posure to the chemical must be calculated as the
arithmetic mean of the rate of intake or exposure for
product users.
SPECIFIC BENEFITS OF THE
PROPOSED REGULATION
The Act and its existing implementing regulations are
not specific about how the intake or exposure of an av-erage consumer is to be determined. Lack of clarity can
lead to incorrect determinations whether product−
related exposures are exempt from Proposition 65
warnings pursuant to Health and Safety Code section24549.10(c).
Section 25821(a) does not specify procedures for de-
termining the concentration of a listed chemical, or the
“level in question”, in a food product. Lack of clarity on
this issue has led to the incorrect conclusion that the ex-
isting regulations allow averaging of the measured con-
centrations of a listed chemical in a food product across
products manufactured by dif ferent manufacturers, and
from manufacturing facilities in different states and
countries. This proposed regulatory action would
amend Section 25821 to clarify that the level in question
in a food product may not be calculated by averaging
the concentration of the chemical in food products from
different manufacturers or producers, or that were man-
ufactured in different facilities from the product at is-sue. In addition, the proposed regulatory action would
amend Section 25821(c)(2) of the existing regulation to
clarify how rates of intake and exposure are calculated
for consumer product exposures. The existing regula-tion is not clear about whether an average consumer’s
intake is to be characterized by the geometric mean, the
median level, some other percentile, or the arithmeticmean of consumer intakes. Clarifying that the arith-metic mean of the intake or exposure level for users of a
consumer product is the appropriate approach helps the
responsible business to correctly determine the rate ofintake or exposure for average users of the consumer
product and properly decide whether a warning is re-
quired for a given exposure.
NO INCONSISTENCY OR INCOMPATIBILITY
WITH EXISTING REGULATIONS
After conducting an evaluation for any related regu-
lations in this area, OEHHA has determined that theseare the only regulations dealing with calculating thelevels of exposure to Proposition 65 chemicals listed as
causing reproductive toxicity.
Therefore, the proposed amendment is neither incon-
sistent nor incompatible with other existing state regu-lations. The regulatory amendment will not change theexisting mandatory requirements on those businesses
or state or local agencies, and does not address compli-
ance with any other law or regulation.
LOCAL MANDATE/FISCAL IMPACT
Because Proposition 65 by its terms
6 does not apply
to local agencies or school districts, OEHHA has deter-mined the proposed regulatory action would not impose
a mandate on local agencies or school districts; nor does
it require reimbursement by the State pursuant to Part 7
(commencing with Section 17500) of Division 4 of the
Government Code. OEHHA has also determined thatno nondiscretionary costs or savings to local agencies,
state agencies, or school districts will result from the
proposed regulatory action, nor will there be any costsor savings in federal funding to the state because of the
proposed regulatory action.
EFFECT ON HOUSING COSTS
OEHHA has initially determined that the proposed
regulatory action will have no effect on housing costs
because it does not impose any new mandatory require-
ments on any business.
SIGNIFICANT STATEWIDE ADVERSE
ECONOMIC IMPACT DIRECTLY AFFECTING
BUSINESS, INCLUDING ABILITY TO COMPETE
The proposed regulatory action provides compliance
assistance to businesses subject to the Act by clarifying
an existing regulation and does not impose any manda-
tory requirements on those businesses. OEHHA hastherefore made an initial determination that the adop-tion of this action will not have a significant statewide
adverse economic impact directly af fecting businesses,
including the ability of California businesses to com-pete with businesses in other states.
RESULTS OF ECONOMIC IMPACT ANALYSIS
(Gov. Code section 11346.3(b))
OEHHA finds there will be no economic impact re-
lated to the clarifying regulatory amendment. The
amendment does not impose any costs because it mere-
ly clarifies how the level of exposure of a listed chemi-cal in a food product be calculated and specifies that the
arithmetic mean of the intake or exposure level among
consumer product users must be used to calculate the
rate of intake or exposure for users of a consumerproduct.
6 See Health and Safety Code section 25249.11(b).CALIFORNIA REGULATORY NOTICE REGISTER 2018, VOLUME NO. 40-Z
 1763Creation or Elimination of Jobs within the State of
California
The proposed regulatory action will not impact the
creation or elimination of jobs within California. Theaction merely clarifies how the level of exposure to alisted chemical in a food product be calculated and
specifies that the arithmetic mean of the intake or expo-
sure level among consumer product users must be used
to calculate the rate of intake or exposure for users of aconsumer product.
Creation of New Businesses or Elimination of
Existing Businesses within the State of California
The proposed regulatory action will not impact the
creation of new businesses or the elimination of exist-ing businesses within California. The action simplyclarifies how the leve l of exposure to a listed chemical
in a food product be calculated and specifies that the
arithmetic mean of the intake or exposure level among
consumer product users must be used to calculate therate of intake or exposure for users of a consumerproduct.
The Expansion of Businesses Currently Doing
Business within the State
OEHHA will not have a major impact on the expan-
sion of businesses currently doing business within thestate. The proposed action provides clarification onhow the level of exposure to a listed chemical in a food
product be calculated and specifies that the arithmetic
mean of the intake or exposure level among consumerproduct users must be used to calculate the rate of intake
or exposure for users of a consumer product.
Benefits of the Pr oposed Regulation
Affected businesses will likely benefit from the pro-
posed regulatory action because the amendment clari-fies existing regulation and provides guidance for busi-
nesses that choose to determine the anticipated expo-sure level for users of a consumer product in order to
take advantage of established safe harbor levels. This
amendment will add more certainty in assessingwhether reproductive toxicants in a consumer productresult in exposures that require a warning under Propo-
sition 65. The amendment will contribute to publichealth and safety by providing additional guidance tobusinesses about how to calculate the level of exposure
of a chemical listed as causing reproductive toxicity in a
food product for purposes of determining whether a
warning is required under the Act, and thus benefit Cali-
fornia residents by ensuring that warnings are provided
for significant exposures to reproductive toxicants,thereby improving the public’s ability to make in-formed decisions concerning the foods and consumerproducts they may choose to purchase.CONSIDERATION OF ALTERNATIVES
Pursuant to Government Code section
11346.5(a)(13), OEHHA must determine that no rea-
sonable alternative considered by OEHHA, or that hasotherwise been identified and brought to the attention of
OEHHA, would be more effective in carrying out the
purpose for which the action is proposed, would be aseffective and less burdensome to affected private per-sons than the proposed action, or would be more cost−
effective to affected private persons and equally effec-
tive in implementing the statutory policy or other provi-
sion of law.
EFFECT ON SMALL BUSINESSES
The proposed regulatory action will not adversely
impact very small businesses because Proposition 65 is
limited by its terms to businesses with 10 or more
employees
7.
COST IMPACTS ON REPRESENTATIVE PERSON
OR BUSINESS
OEHHA is not aware of any cost impacts that a repre-
sentative private person or business would necessarily
incur in reasonable compliance with the proposed regu-
latory action. The action does not impose any new re-quirements upon private persons or business.
A V AILABILITY OF STATEMENT OF REASONS
AND TEXT OF PROPOSED REGULATIONS
OEHHA has prepared and has available for public re-
view an Initial Statement of Reasons for the proposed
regulation, all the information upon which the regula-tion is based, and the text of the proposed regulation.These documents are available on OEHHA’s website at
www.oehha.ca.gov
.
A V AILABILITY OF CHANGED OR
MODIFIED TEXT
The full text of any proposed regulation that is
changed or modified from the express terms of this pro-
posed action will be made available at least 15 days pri-
or to the date on which OEHHA adopts the resulting
regulation. Notice of the comment period on the revised
proposed regulation and the full text will be mailed toindividuals who testified or submitted oral or writtencomments at the public hearing, whose comments were
received by OEHHA during the public comment peri-
7 Health and Safety Code section 25249.11(b).CALIFORNIA REGULATORY NOTICE REGISTER 2018, VOLUME NO. 40-Z
 1764od, and anyone who requests notification from OEHHA
of the availability of such change. Copies of the notice
and the changed regulation will also be available on theOEHHA website at www .oehha.ca.gov
.
A V AILABILITY OF THE FINAL
STATEMENT OF REASONS
A copy of the Final Statement of Reasons may be ob-
tained, when it becomes available, from Monet Vela at
the e−mail or telephone number indicated above. The
Final Statement of Reasons will also be available onOEHHA’s web site at www .oehha.ca.gov
.
TITLE 27. OFFICE OF
ENVIRONMENTAL HEALTH
HAZARD ASSESSMENT
SAFE DRINKING WATER AND TOXIC
ENFORCEMENT ACT OF 1986
PROPOSITION 65
AMENDMENT TO SECTION 25805
SPECIFIC REGULATORY LEVELS:
CHEMICALS CAUSING
REPRODUCTIVE TOXICITY
MAXIMUM ALLOWABLE DOSE LEVELS FOR
n−HEXANE, ORAL AND
INHALATION ROUTES
NOTICE IS HEREBY GIVEN that the Office of En-
vironmental Health Hazard Assessment (OEHHA) pro-
poses to establish two Proposition 651 Maximum Al-
lowable Dose Levels (MADLs) for exposure to
n−hexane by amending Section 25805(b) of Title 27 of
the California Code of Regulations. The proposed oralMADL for n−hexane is 28,000 micrograms per day and
the proposed inhalation MADL for n−hexane is 20,000
micrograms per day.
PUBLIC PROCEEDINGS
Any written comments concerning this proposed ac-
tion, regardless of the form or method of transmission,
must be received by OEHHA by 5:00 p.m. on Novem-
ber 19, 2018, the designated close of the written com-
ment period. All comments received will be posted on
1 The Safe Drinking Water and Toxic Enforcement Act of 1986,
codified at Health and Safety Code section 25249.5 et seq., re-ferred to herein as “Proposition 65” or “The Act.”the OEHHA website at the close of the public comment
period.
We encourage you to submit comments in electronic
form, rather than in paper form. Comments may be sub-
mitted electronically through our website athttps://oehha.ca.gov/comments
. Hard−copy comments
may be mailed, faxed, or delivered in person to the ap-
propriate address below.
Mailing Addr ess: Ms. Monet Vela
Office of Environmental Health Hazard AssessmentP.O. Box 4010, MS−2311F
Sacramento, California 95812−4010
Fax: (916) 323−2517
Street Address: 1001 I Street
Sacramento, California 95814
Please be aware that OEHHA is subject to the Cali-
fornia Public Records Act and other laws that require
the release of certain information upon request. Com-ments on all regulatory and other actions are routinely
posted on our website. By sending us your comments
you are waiving any right to privacy you may have in
the information you provide. Individual commenters
should advise OEHHA when submitting documents torequest redaction of home address or personal tele-
phone numbers. Names of commenters will not be
redacted.
A public hearing on this proposed regulatory amend-
ment will be scheduled on request. To request a hearing,
send an e−mail to Monet Vela atmonet.vela@oehha.ca.gov
 or to the address listed
above by no later than November 5, 2018, which is 15
days before the close of the comment period. OEHHAwill send a notice of the hearing to the requester and in-
terested parties on its Proposition 65 email list for regu-
latory public hearings. The notice will also be posted on
the OEHHA website at least ten days before the public
hearing date. The notice will provide the date, time, and
location of the hearing.
CONTACT
Please direct inquiries concerning the proposed regu-
latory action described in this notice to Monet Vela, in
writing at the address given above, via e−mail to
monet.vela@oehha.ca.gov
 or (916) 323−2517. Mario
Fernandez is the back−up contact. He can be reached at
(916) 323−2635 or mario.fernandez@oehha.ca.gov .