Document Vj5Dd41w70yyQnbXV308qJv5g

Visto Chemical Company 15990 North Barker's Landing Rood Post Office Box 19029 Houston, Texas 77224 Phone (713) 531-3200 March 29, 1988 Don McQuillen Henkel Corporation Organic Products Division 300 Brookside Avenue Ambler, PA 19002 Dear Don: As we discussed on the phone, I have enclosed a copy of the Proposition 65 regulations that were promulgated on February 16. in regards to the analytical methods for residual ethylene oxide, someone from our Lake Charles Chemical Plant laboratory will be contacting you with specific information on our methods. Please feel free to call me at 713/531-3445 if you have further questions. Sincerely, Thomas^u. Grumbles, C.I.H. Environmental Quality Manager ajo Attachment cc Mike Cox VVY 0{?00985i The following definitions shall apply to the regulations contained in this article: fa) The "Act11 refers to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et sea.) which was originally adopted bv California voters as Proposition 65 on November 4, 1986. fb) An "interpretive guideline" is a draft regulatory proposal which has been published for the information, comment, and guidance of California businesses, law enforcement agencies and others concerned. (c) A "safe use determination" is a written statement issued bv the lead agency to a person affected bv the Act or an authorized representative which interprets and applies the Act to a specific set of facts. fd) An "information letter" is a statement issued bv the lead aaencv which does no more than call attention to an established interpretation of the Act or a related principle, without applying it to a specific set of facts. fe) The "lead agency" refers to the Health and Welfare Aaencv as designated bv the Governor in Executive Order D-61-97. dated January 6. 1987, Authority: Health & Safety Code Section 25249.12 Reference: Health & Safety Code Section 25249.12 VVV 000009852 12103. Interpretive Guideline Request fa) Any interested person mav request the lead aaencv to issue an interpretive guideline concerning anv subject related to the Act. A request for interpretive guideline shall contain: f 1) A clear and concise a-P cnHe-l-a.os? ... CHAPTER 3 SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1936 ARTICLE 1 GUIDELINE AND SAFE USE DETERMINATION PROCEDURES 12101. General Practice fal it is the practice of the Health and Welfare Agency, as lead agency for implementing the Safe Drinking Water and Toxic Enforcement Act of 1986 fHealth and Safety Code section 25249.5 et sea.1 to answer inquiries of individuals and organizations, whenever appropriate, as to the application of the Safe Drinking Water and Toxic Enforcement Act of 1986 to their activities. One of Agency's functions is to issue public rulings on the requirements of the Act. fbl It is the practice of the lead agency to respond to inquiries concerning the Act as expeditiously as possible. Requests for consideration of an interpretive guideline, safe use determination or information letter ahead of its regular order or bv a specified date will be considered as circumstances warrant. However, persons or organizations making such requests should consider the time necessary to comply with public notice and hearing requirements specified in these procedures and anv additional delay that nav result from compliance with the California Environmental Quality Act (Public Resources Code Section 21000 et seq.K if necessary prior to issuing a guideline or determination. Therefore, no assurance can be given that anv request will be processed bv the time requested. Authority: Reference: Health & Safety Code Section 25249.12 Health & Safety Code Section 25249.12 vvv 000009853 12102. Definitions aaencv from making proposals for formal regulatory adoption which have not been published as interpretive guidelines. Authority; Reference: Health & Safety Code Section 25249.12 Health & Safety Code Section 25249.12 12104. Safe Use Determinations As a part of its overall responsibility to provide guidance to persons or organizations that are or wav be affected bv -the Act. the lead agency will consider the applicability of the Act or the exemptions specified in the Act: to business activities or prospective business activities. A safe use determination issued by the lead agency represents the state's best judgment concerning the application of the Act to the particular facts presented in the request. A safe use determination is advisory only. It does not affect the authority of the Attorney General, district attorneys, certain city attorneys and anv other person in the public interest to prosecute violations of the Act pursuant to Section 25249.7 nor does it affect the responsibility of courts to interpret the Act and apply the provisions of the Act to particular facts. rb^ Safe use determinations will not be issued under the following circumstances: VVV 000009854 fll where the subject matter of a request for safe use determination is at issue in a civil or criminal case pending in any court. (2) Where the individual or organization requesting the safe use determination is not directly required to enforce or comply with the provisions of the Act? provided, however, where two or more businesses which are members of the same trade association share A nature of the guideline requested; and (2) A description of the reason for the request. (b) Upon receipt of a.request for interpretive guideline, the lead agency shall notify the requester in writing of the receipt and provide an estimate of the time required to determine whether an interpretive guideline will be proposed or adopted. Except where the proposed guideline will be considered bv the panel of qualified experts referred to in Health and Safety Code section 25249.8. a decision on the request will normally be made within 60 davs. Where the proposed guideline is considered tav the panel of qualified experts, a decision will normally be made not later than 30 davs after the guideline is considered bv the panel fc) When appropriate, in the discretion of the lead agency, a request for interpretive guideline mav be treated as a request for a safe use determination under these procedures, or the lead acencv mav issue an information letter to the requester. (d) All interpretive guidelines issued bv the lead aaencv will be numbered and published either bv the lead agency or in the California Regulatory Notice Register. VVV 0000Q9Q55 fe^ Within a reasonable time after an interpretive guideline is published pursuant to paragraph . the lead aaencv mav rescind the interpretive guideline, propose that it be formally adopted as originally published, or modify it and either republish it as an interpretive guideline for further comment or propose formal regulatory adoption of the modified interpretive guideline. Nothing in this section shall preclude the lead Such facts include the names and addresses of all interested par-ties, a description of the business reason for the activity and a carefully detailed description.of the activity, (2) True copies of any contracts, agreements, instruments, reports, analyses or other documents directly related to the activity for which the safe use determination is requested and to the applicability of the Act to the activity. A clear statement of the issue or issues on which a safe use determination is sought. If the determination request includes references to a specific chemical, the request should include the chemical name and the Chemical Abstract Services fCASl Registry Number, if applicable. (5) If the activity for which the safe use determination is sought is only one step of a larger integrated process, the description of the activity shall include a description of the entire process. If the requester is contending for a particular result in the determination, the request shall include an explanation of the grounds for the contention together with an identification of any relevant authorities which support such view. Vyy 000009^5 ' (7) If the request for safe use determination contains any information which the requester claims should not be available for public inspection under the Public Records Act ^Government Code section 6250 et seq.). the reguest shall specifically identify the information and the basis for the claim. (A) If the request for determination contains a business practice which mav be the subject mattsr of a reouesc for a safe use determination, the request mav be made bv the trade association on behalf of such members. f3^ Where the request for determination concerns compliance with lavs other than the Act, or with regulations, permits, requirements or orders of anv federal, state or local agency. For example, questions concerning whether chemical discharges comply with the Water Code, state regulations and waste discharge requirements should be addressed to the appropriate Regional Water Quality Control Board. where the request for determination does not involve a current or Planned activity of the requester. Safe use determination will not be issued concerning hypothetical situations or on each of several alternative plans in a proposed activity. (5) Where, in the discretion of the lead agency, issuance of a safe use determination will not further the public interest, or is otherwise inappropriate under the circumstances presented in or related to a particular request for safe use determination. For example, where the subject matter of the request is at issue in an administrative proceeding before a government agency or does not concern a chemical listed pursuant to Health and Safety Code section 25249.8. yyy 000009857 (c) A request for a safe use determination shall be submitted in writing to the lead agency and shall contain the following: m A complete statement of all relevant facts related to da-termination. Where the request is made bv an authorized representative for an individual or organization, the request shall indicate the source of the authority to make the request. fdT Each request for a safe use determination shall be accompanied bv a nonrafundable processing fee of 5500. In addition, the requester shall be assessed a charge in the amount of anv costs to the lead agency or other state agency which are necessarily incurred in considering the request and vhich exceed S5Q0. Such additional assessment shall be made only after the requester has been provided an estimate of the amount, has elected to proceed with the request for safe use determination and has agreed to pav the additional assessment. All or part of the processing fee or other charges assessed pursuant to this section may be waived if the lead agency determines that payment of the fee would present a hardship to the requester or that it is otherwise in the public interest to proceed with the request without payment of such fees or charges. fe^ Anv request for safe use determination that does not comply with these procedures will be acknowledged in writing within 30 davs of receipt bv the lead agency, with an indication of the requirements that have not been met. If the request lacks essential information, the requester will be advised that the request will be closed if the additional information is not received within 30 davs. If the information is received after the request is closed, the request will be reopened and treated as a new request as of the date of receipt. 000009S5B ff) A request for safe use determination that appears to information which the requester claims should not be available for public inspection, it shall be accompanied bv a copy of the request and anv supporting documents on which shall be indicated, bv the use of brackets, the material which the requester contends should be deleted. (B) All requests for safe use determination shall be open for public inspection except as otherwise specifically identified bv the requester under this section. If the lead agency determines that information which the requester claims should not be available for public inspection must be released to the public under the Public Records Act, it will promptly notify the requester bv telephone or in writing of this determination and provide a reasonable opportunity for the requester to submit additional justification for the claim or to contest the determination in an appropriate proceeding. If the requester claims that fees or other charges for the safe use determination should be waived, the request shall include an explanation of the basis for the claim. A statement concerning whether to the best of the requester^ knowledge the subject matter of the request is: fAl An issue in a civil or criminal case pending in anv court. VVV 000009359 fAn issue in anv administrative proceeding pending before a federal, state or local agency. (C\ The subject of a notice of violation to the Attorney General, a district attorney or a city attorney as described in Health and Safety Code section 25249.7fd). on the request. ri 'i Safe use determinations issued bv the lead agency are limited to the particular facts on which they are based and they reflect the lead agency*s view of the best interpretation of the Act and the state of scientific knowledge at the time they are issued. Whenever the issuance of a safe use determination requires the performance bv a state agency of a risk assessment of the carcinogenicity or reproductive toxicity of a chemical, such assessment shall be performed pursuant to the methodologies adopted bv the lead agency. A safe use determination found to be in error or not in accord with the best interpretation of the Act or the current state of scientific knowledge mav be modified or revoked. Modification or revocation of a safe use determination mav be effected bv a notice to the individual or organization that requested the ruling along with notice in the California Notice Register or bv the issuance of an interpretive guideline. fk^ A safe use determination shall be issued to a particular individual or organization with respect to the application of particular provisions of the Act to particular facts. Determinations are not intended to affect other individuals or organizations, or other activities of the requesters vvv 000009860 Authority: Reference: Health & Safety Code Section 25249.12 Health & Safety Code Sections'25249.10 and 25249.12 ARTICLE 2 DEFINITIONS 12201. In The Course of Doing Business (a) For purposes of Health and Safety Code sections 25249.5 ........ ruA-J. . - -g 1 -------A - n ...1-- ' .................................................................. .......... ..................... ...................................... comply with these procedures will be acknowledged in writing within 30 davs of receipt bv the lead agency and a public notice of the receipt of the request will be published in the California Notice Register and sent to interested persons. The public notice will include the text or a summary of the request as appropriate. It will advise interested parties that they can comment on the request in writing or in person at a public hearing which shall be held on a date not less than 30 davs after the notice is published. (a) At anv time while a request for a safe use determination is pending, the lead agency or anv other state agency that is considering the request mav ask for anv additional information or explanation from the requester as necessary to complete a consideration of the request. (h) After considering the request, anv comments of the public received in writing or at the public hearing, and the comments of anv other state agencies that have considered the request, the lead agency shall in response to the request: fll Issue a safe use determination. (2) Decline to issue a safe use determination because the facts are insufficient to clearly establish the basis for an the requested determination or for anv other reason s'll Issue an information letter to the requester. VVV 000009861 Issue an interpretive guideline, fil The lead aqencv<s response to the request shall be sent to the requester and the text or a summary of the response shall be published in the California Notice Register and sent to counted. Thus, the prohibitions on discharge car release and exposures to certain chemicals will apply to anv person who has ten or more full-time or part-time employees on the date in question. fcl Knowingly "Knowingly11 refers only to knowledge of the fact that a discharge of. release of. or exposure to a chemical listed pursuant to Health and Safety Code section 25249.8 fal is occurring. No knowledce that the discharge, release or exposure is unlawful is required. However, a person in the course of doing business who, through misfortune or accident and without evil design, intention or negligence, commits an act or omits to do something which results in a discharge, release or exposure has not violated Health and Safety Code sections 25249.5 or 25249.6. (d\ Discharge or Release to Water or Land The term "water" includes both surface and groundwater. (2) A discharge or release into water or onto or into land which is in hydraulic continuity with a source of drinking water "probably" will pass to that source whether or not it is upqradient or upstream. Tor purposes of this paragraph, the ocean, saline bavs. the Salton Sea, and Mono Lake, are not in hydraulic continuity with anv source of drinking water unless such saline bodies are identified or designated in a water quality control plan adopted bv a regional board as being suitable for domestic or municipal uses. VVV 000009862 (2) "Discharge or release into water or onto or into land" includes a discharge or release to air that is directly and omission, whether or not for profit, except: as excluded bv subdivision (b) of section 25249.11 of the Health and Safety Code; or (1\ when caused bv acts of war or grave and irresistible natural disasters^ fbT "In the course of doing business" includes anv act or omission of anv employee which furthers the purpose or operation of the business, or which is expressly or immlicitv authorized, except for the personal use, consumption or production of listed chemicals bv an employee on the business premises or while performing activities for the business, unless the employer knows or should know of such use, consumption or production and knows or should know that such use, consumption or production will expose other individuals within the meaning of Health and Safety Code section 25249.6 to a listed chemical. Employee The term "employee11 shall have the same meaning as it does in Unemployment Insurance Code section 621 and in Labor Code section 3351. Generally, and without limiting the applicability of the definitions in these two statutes. this means that an employee is a person who performs services for remuneration under anv appointment or contract of hire or apprenticeship, express or implied, oral or written, whether lawfully or unlawfully employed. yW O0OOQ9S63 In computing whether a person employs ten or fever employees in his business, all full-time and part-time employees on the date on which the discharge, release or exposure occurs must be (el Expose The term "expose11 means to cause to ingest, inhale, contact via body surfaces or otherwise come into contact: with a chemical. An individual mav come into contact with a chemical through water, air, food, consumer products and anv other environmental exposure as well as occupational or workplace exposures * (fl Threatened Illegal Discharge A. "threatened illegal discharge" means the creation of a condition or the taking of an action which is intended to or will foreseeablv create a substantial probability that an illegal discharge will occur^ (ol Substantial Injury The term "substantial iniurv" means a real and immediate physical iniurv or a resulting adverse physical condition of a substantial nature to one or more persons. (h^ General Public Knowledge The term "general public knowledge11 means knowledge which has been disseminated to the general public, including information in newspapers of general circulation or radio or television reports in the geographic area affected bv the discharge. In order to demonstrate general public knowledge, it shall not be necessary to prove that any members of the public have actually acquired such knowledge but only that the information has been disseminated. VVV 000009864 Authority; Reference: Health & Safety Code Section 25249.12 Health & Safety Code Sections 25180.7, 25249.5. 25249.6. 25249.9. 25249,10 and 25249.11 f4> Except as provided in paragraphs (3^ and ^61. "discharge or release into water or onto or into land" includes the direct or indirect transfer by any person in the course of doing business of anv listed chemical to anv person within the meaning of Health and Safety Code section 25249.11 fa^ for the curcose of discharging or releasing the chemical to land or water in a manner which, if committed bv the transferor, would violate Health and Safety Code $ 25249.5. (5} "Discharge or release into water or onto or into land" does not include the sale, exchange or other transfer of a chemical to a solid waste disposal facility as defined in sections 66714 and 66719 of the Government Code, or a hazardous waste facility as defined in section 25117.1 provided that the disposal to such facility complies with all applicable state and federal statutes, rules, regulations, permits, requirements and orders. "Sale, exchange or other transfer", as used in this paragraph, does not include disposal to a facility owned or operated bv the transferor. VVV 00000^965 (6> "Discharge or release into water or onto or into land" does not include the sale, exchange or other transfer of a chemical to anv treatment works as defined in 33 United States Code section 1292 provided that the discharge or release to such treatment works complies with all applicable standards and limitations imposed, and permits required, under federal law or an approved state program. "Sale, exchange or other transfer", as used in this paragraph, does not include disposal to a facility owned or operated bv the transferor. members a Chairperson who will call and preside over meetings, and an Executive Secretary who shall be a state employee who has expertise in one or more of the areas of specialization listed in subsection (b). The Chairperson, with ^the consent of the other Panel members, shall designate from among the Panel members such subcommittees as mav be appropriate in fully discharging the responsibilities of the Panel. fd^ Except as otherwise expressly authorized bv statute, all meetings of the Panel and all subcommittee meetings shall be open to the public and convened only after reasonable public notice of the meeting, including the date, time, location and an agenda of items of business to be transacted or discussed, has been provided. All official correspondence to or from the Panel, anv subcommittee, or anv member of the Panel shall be available for public inspection as provided in the Public Records Act. (el Panel members mav be asked to provide advice and counsel both at formally convened Panel and subcommittee meetings and individually in response to written materials submitted to them bv lead agency, the Executive Secretary, or the Governor. The Panel shall act as a body in making recommendations to the Governor or the lead agency. Questions posed to the members of the Panel shall be decided bv a majority of those voting. However, no official action of the Panel mav be taken unless at least one-half of the authorized number of members has voted on a question. VVV 000009866 Authority: Health & Safety Code Section 25249.12 Reference: Health & Safety Code Section 25249.8 12303 . Compensation_______________________________________________________________ 12301. Definitions fa^ The "Scientific Advisory Panel" or -the "Panel" refers to the Safe Drinking Water and Toxic Enforcement Act Scientific Advisory Panel. rb^ The "Act" refers to the Safe Drinking Water and Toxic Enforcement Act of 1986 fHealth and Safety Code section 25249.5 et saq.1 which was originally adopted bv California voters as Initiative Measure Proposition 65 on November 4, 1986. The "lead agency" refers to the Health and Welfare Aaencv as designated bv the Governor in Executive Order D-61-37. dated January 6, 1987. Authority: Health & Safety Code Section 25249.12 Reference: Health & Safety Code Sections 25249.12 and 25249.8 12302. Scientific Advisory Panel fa^ There is created in the Health and Welfare Agency a Scientific Advisory Panel to advise and assist the Governor in the implementation of Health and Safety Code Section 25249.8. The Panel shall be the "state's qualified experts" as the term is used in that section. 000009867 The Panel shall be composed of twelve members. The members shall include experts in each of the following areas of specialization: epidemiology, oncology, pathology, reproductive toxicology, teratology. and toxicology. The members of the Panel shall be appointed bv the Governor and shall serve at the pleasure of the Governor. Vacancies which occur on the Panel shall be filled only bv the Governor. fc^ The Panel shall meet not less than once in anv six- fa) Determine whether specific chemicals are "known to tha state to causa cancer or reproductive toxicity" pursuant to Health and Safety Code Section 25249.3fb) . (h) Identify bodies which are considered to be authoritative and which have formally identified carcinogens or reproductive toxicants. fc) Identify specific chemicals that are required bv state or federal law to have been tasted for potential to cause cancer or reproductive toxicity but which have not been adequately tested, fd) Review or propose standards and procedures for determining carcinogenicity and reproductive toxicity of chemicals, (&) Review or propose standards, procedures and definitions related to the implementation, administration or interpretation of the Act upon reguest bv the lead agency. Authority: Health & Safety Code Section 25249.12 Reference: Health & Safety Code Section 25249.3 ARTICLE 5. EXTENT. OF EXPOSURE o0000<?868 12501. Exposure To Food Human consumption of food shall not constitute an exposure to anv chemicals in the food to the extent that the person responsible for the contact can show that: fa) The chemical is present in food as a result of washing, or preparing, or processing the food with drinking water which is received from a public water system as defined in Health and Safety Code section 4010.1 or from * rnwmarpj-a]-----i ------------- Panel members shall be entitled to reimbursement for actual and necessary expenses incurred while attending meetings or otherwise carrying out the duties of the Panel. In addition, a Panel mg-mfagr who is not an officer or employee in the State Civil Service or an appointed state official shall be entitled to compensation for time spent on attending -the Panel meetings and other actual and necessary work of the Panel, as determined by the lead agency and pursuant to a consulting services contract executed prior to appointment of the member to the Panel. Authority; Health & Safety Code Section 25249.12 Reference: Health & Safety Code Section 25249.8 12304. Financial Disclosure Upon appointment and annually thereafter, panel members shall make a public disclosure on forms provided of investments in. income from or business positions in any partnership, corporation or other entity that imports, manufactures, distributes, sells, buys or uses chemicals that are or may be considered carcinogens or reproductive toxicants. The disclosure made upon appointment shall cover the two-vear period immediately prior to the date of appointment. Individuals serving in academic appointments shall also provide a description of funding sources for all significant research undertaken during the two years immediately prior to their appointment. Authority: Health & Safety Code Section 25249.12 Reference: Health & Safety Code Section 25249.8 0000Q9869 12 3 05. Duties As an advisory body to the Governor and the lead agency, the Reference; Health & Safety Code 5 25249.6 12503. Environmental Exposures (a\ A person otherwise responsible for an exposure to a listed chemical in water, including water in anv consumer product, does not "expose11 an individual within the meaning of 25249.6 ho tha extent that the person can show that the listed chemical was contained in water which was received from; m a public vater system, as defined in Section 4010.1 of the Health and Safety Code? (2) a commercial supplier of drinking water? or (2\ a source of drinking vater in compliance with all state or federal primary drinking vater standards and the chemical is the result of treatment of the vater in order to achieve such compliance; and the person did not add a listed chemical, in excess of the no significant risk level, to the vater. (h) A person otherwise responsible for an exposure to a listed chemical does not "expose" an individual within the meaning of Health and Safety Code 9 25249.6 to the extent that the person can show that the chemical was contained in vater which the person discharged or released in the manner described in $ 12401 fbl Nothing in this subdivision shall be interpreted to affect the responsibility for an exposure which occurs before such discharcre or release. O0000`?8'r0 fc) A person otherwise responsible for an exposure to a listed chemical in air does not "expose11 an individual within the meaning of Health and Safety Code 3 25249.6 to the extent that the person can show that: drinking water, or which meets state or federal primary drinking water standards for -the chemical, provided that the responsible person has not added a listed chemical in excess of the no significant risk level to the drinking water? or fb^ The chemical present in food is naturally occurring. (11 For the purposes of this section, a chemical is "naturally occurring" if it is a natural constituent of a food, or if it is present in a food solely as a result of natural absorption or accumulation of the chemical which is naturally present in the environment in which the food is raised, or grown, or obtained; for example, mineral present in the soil solely as a result of natural geologic processes, or toxins produced bv the natural growth of fungi. (2) The "naturally occurring1* level of a chemical in food mav be established bv determining the natural background level of the chemical in the area in which the food is raised, or grown, or obtained, based on reliable local or regional data. WV 000009871 (3) A chemical is naturally occurring only to the extent that the chemical did not result from anv known human activity other than ordinary cultivation practices. Where a food contains a chemical, in part naturally occurring and in part added as a result of human activity. " exposure" can only occur as to that portion of the chemical which resulted from such human activity. (41 Where a chemical contaminant can occur naturally in food, the chemical is naturally occurring only to the extent that it was not avoidable bv good manufacturing practices or other intervening measures. Nothing in this section shall be construed -to preclude a person from providing warnings other than those specified in subdivisions (b^ . fcl. and fdl which satisfy the requirements of this subdivision, or to require that warnings be provided separately to each exposed individual. (b\ Warnings for consumer products exposures which include the methods of transmission and the warning messages as specified bv this subdivision shall be deemed to be clear and reasonable. A "consumer products exposure" is an exposure which results from a person's accuisition. purchase, storage, consumption, or other reasonably foreseeable use of a consumer good, or anv exposure that results from receiving a consumer service, m The warning mav be provided by using one or more of the following methods singly or in combination: A. A warning that appears on a products label or other labeling. The term "label" means a display of written, printed or graphic matter upon a product or its immediate container. The term "labeling" means anv label or other written, printed or graphic matter affixed to or accompanying a product or its container or wrapper. VVV 000009872 B. Identification of the product at the retail outlet in a manner which provides a warning. Identification mav be through shelf labeling, signs, menus, or a combination thereof. C. A system of signs, public advertising identifying the system and toll-free information services, or anv other system, that provides clear and reasonable warnings. p. For alcoholic beverages, including, without limitation. received from the ambient air, and (2) The responsible person did not add the listed chemical at a significant level to the ambient air. Authority: Health & safety Code 3 25249.15 Reference: Health & Safety Code 25249.6. 25249.11 12505. Miscellaneous. fa) Where a product washed, prepared or processed with drinking water, a chemical may be established to be present in the product as a result of that water by reliable scientific evidence and shall be deemed to be present as a result of that water to the extent that the amount of that chemical does not exceed the primary drinking water standard. fb) Where a product contains a chemical in part from water or natural sources and in part from other sources, "exposure" occurs only as to that portion of the chemical present in the product from the other sources. Authority: Health & Safety Code 5 25249.12 Reference: Health & Safety Code $$ 25249.6, 25249.11 12601. ARTICLE 6. CLEAR AND REASONABLE WARNING? Clear and Reasonable Warnings wv 00000987 fa) Whenever a clear and reasonable warning is required under section 25249.6 of the Health and Safety Code, the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure. The message must clearly communicate that the chemical in Question is known to the state to cause cancer, or birth defects or other reproductive harm. b p -H p(0 d) G o> TrHJ V) 0) G uGrl in > & G b r| G in p0) u GH in p (V0) 0) rH p (TJ in o> H XpIdI --i rH iHd Pp id 4J V) XJ3I in TJ c<tj Hf"H -<H4 P PGid V) XI p tn in id *rGO-l in c01 HE TJ C bH in o P b G V tO p in TJ G id 0) -NH in 0) p P p o GO -H P G 0 pGoi P *GPin r--1 GO P G0J E id G o P P TJ CJ u id i--i p G O rH9 o g ipd G o id G id p G H TIdJ GH G O in 0) TJ TJ G id Grl 0J G G 0) in Pd a) Hu G 0J tn G to P G PO u 0) GP G 01 >O G b oP G GP T<Ju P P XHI G Pin H TJ G O TrHJ otn m G Pid G bid G id P cH G pG <OM P to in in GOH P id urH rH u 0) pin to G p b -cH P 00)) E c Hb in 01 Go P in id a) rH o in p c 01 E G tn H i-H Gid Pin op -HH id POP G 0) G P GH TOJP u id rH a G O rl in rl >H TJ G Pin Htn GP <M O H o G Q> P G PO o rH tH id OE G TidJ a> G OP G O P r>H to rXHH TJ C id a> rH G id TJ id OP G iHn p H P(d XJ P orH l--1 G P P OP GP O P 1--011 Gid rH H id >id in G orH P id V o r-1 r--in ai Gri--d in id G u iPn iHin -HId OGP pid E b GH PG id 5 0) rH Gid uH P uid G P P G0) p X0P 0) GP o E-* fM w o G OP b id XU id P G o GOP u p TOJ GP G OP G PP U id iPGd E a) GP G T0J) THJ >O G D 01 G rH rH id G in th e consum er p ro d u c t, ra th e r than bv th e r e ta il s e lle r. or r- CO eh b G o ^ TJ 03 *H 5 o ai G G So ^ G OP P 0 0) e .-1 P id in G p u bl o bi C Q) p OP G >u P > P id p rH H p p TJ p H P 0) > G O o in tn o f--1 -r P id G 0P id E G - QP QP to G P W p H aP ai G 0 G 0J GGG id p tn - id S <--i P O rH in id P 0 P TJ p to rH GEo P *"H a) C QP rH OP G O c U id XJ id H G u O U 01 in id o p P id tn G G in 0P <H H id Vl > P to o P TJ 5 nj p G *d P o P G OP G o H p O in rH in id OP G id G TJ p id H b id id G pp P o E G p rH Q) b G p TJ rH G p OP G id b G id H u G > a> 0J P TJ G p G id id td --i G G OP rH TJ <d E <w p > H O P G P TJ pCP , rH id O O ap H id TJ G G 0) P in 0) rH 4-J cS o G id to rH a> p P p Gp id E rH o G b id c Q G G id H in rH G H rH OP O OP P P OP id 0) in P id G TJ f-H p G G P PG in P U P w u id OP P p G rH QP OP id in OP w G p rl <M fti G TJ OP G u O OP id in E P ap O ap P id G rH G H 0) TJ rH G P rH > P rH P p tn G rH p PP id b H P O > u o TJ H O G TJ 0P in Ur o id p QJ OP i--1 P in ai G u o GG TJ G H TJ OP P D p TJ H PGP 0) rH 0) G to > rH in V) o E id >GP 0 o P Op in to <0 TJ in 0) E to 0 G in G u in G u H P 01 P QP o bp o G p O in G HH P id H > id o P G P <M G O rH P OP a) TJ P o rH OP o in rH G GG p G O G o rl G > 01 in G O -- id GG id u P p G O 01 rH P 0) in H 0) P rH G G o H P a in G rH G G b TJ G OP OP id H OP H P G A OP P P in > G PP G --1 G p TJ o p f-H 0 id Go O 0) in TJ G U a) in tn L> id tn H V) rH G H id P P OP c id in TJ tM H TJ rH <d H 0) id G in P D id QP G P P On o t 1. primarily intended for consumption off -the premises where sold or distributed, at least one square notice or sign, no smaller than 10 inches vide bv 10 inches high, and bearing the warning message set forth In paragraph (41 E. of this subdivision. For signs 10 inches high bv 10 inches wide, the word "warning11 shall be centered three-quarters of an inch from the top of -the sign in ITC Garamond bold condensed type face all in one-inch capital letters. Three-sixteenths of an inch from the base of the word "warning" shall be a line extending from left to right across the width of the sign one-sixteenth of an inch in thickness. Centered one-half inch below the line shall be the body of the warning message in 54/60 ITC Garamond bold condensed type face with the initial letter of each word, other than the conjunctive "and11. capitalized. For the body of the warning message, left and right margins of at least three-quarters of an inch, and a bottom margin of at least one and one-cruarter inch shall be observed. Larger signs shall bear substantially the same proportions of type size and spacing to sign dimension as the sian IQ inches high bv 10 inches wide. Such sian shall be placed in the retail establishment so as to assure that it is readable and likely to be read either at the retail point of sale or each point of display. Signs or notices placed at the point of display shall be placed no more than ten feet from anv display of anv alcoholic beverage container in a manner associating the sign or notice with the display. VVV G000Q9875 2. provided for consumption on the premises at tables served bv food or beverage persons, a notice or sign displayed at each of cause cancer, or birth defects or other reproductive harm." E. For alcoholic beverages, including, without limitation, beer, malt beverages, vine and distilled spirits: "WARNING: Drinking Distilled Spirits. Beer, Coolers, wine and other Alcholic Beverages During Pregnancy Can Cause Birth Defects." f 51 A person in the course of doing business, who manufactures, produces, assembles, processes, handles, distributes, stores, sells or otherwise transfers a consumer product which he or she knows to contain a chemical known to the state to cause cancer cr reproductive toxicity in an amount which requires a warning shall provide a warning to any person to whom the product is sold or transferred unless the product is packaged or labeled with a clear and reasonable warning. fcl Warnings for occupational exposures which include the methods of transmission and the warning messages as specified bv this subdivision shall be deemed clear and reasonable. An "occupational exposure" is an exposure, in the workplace of the employer causing the exposure, to anv employee. fll The method employed to transmit the warning must include one of* the following alternative methods: vW 000009876 A. A warning that appears on the label or labeling of a product or substance present or used in the workplace. The label or labeling shall be prominently displayed on the product or substance and the product or substance shall be used under circumstances which make it likely that the warnings will be read...... labeling or displayed at the retail outlet with such conspicuousness, as compared with other words, statements, designs, or devices in the label, labeling or display as to render it likely "to be read and understood bv an ordinary individual under customary conditions of purchase or use. The warning message must include the following language: A. For consumer products -that: contain a chemical known to the state to cause cancer: "WARNING; This product contains a chemical known to the State of California to cause cancer." B. For consumer products that contain a chemical known to the state to cause reproductive toxicity: "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm." C. For food, other than alcoholic beverages, sold, served, or otherwise provided in food facilities, as defined in Health & Safety Code Section 27521faK which is intended for immediate consumption: "WARNING: Chemicals known to the State of California to cause cancer, or birth defects or other reproductive harm mav be present in foods or beverages sold or served here." D. For fresh fruits, nuts and vegetables: Oooo0*?at7 "WARNING: This product mav contain a chemical known to the State of California to reproductive toxicitv: "WARNING: This area contains a chemical known to the State of California to cause birth defects or other reproductive harm." fd) Warnings for environmental exposures which include the methods of transmission and the warning messages as specified bv this subdivision shall be deemed clear and reasonable. An "environmental exposure11 is an exposure which mav foreseeably occur as the result of contact with an environmental medium, including, but not limited to. ambient air, indoor air, drinking water, standing water, running water, soil, vegetation, or manmade or natural substances, either through inhalation, ingestion, skin contact or otherwise. Environmental exposures include all exposures which are not consumer products exposures. or occupational exposures. (1) The method employed to transmit the warning must include the most appropriate of the following alternative methods under the circumstances: A. A warning that appears on a sign in the affected area. The term "sign" means a presentation of written, printed or graphic matter. The term "affected area11 means the area in which an exposure to a chemical known to the state to cause cancer or reproductive toxicitv is at a level that requires a warning. A posting of signs in the manner described in section 6776. re) ri) of Title 3 of the California Code of Regulations shall be sufficient for purposes of this paragraph. yyy 000009878 B. A warning which is in a notice mailed or otherwise delivered to each occupant in the affected area. 28 Such notice shall be and understood bv employees or other individuals prior to the exposure for which the warning is given. B. A warning that appears on a sign in the workplace posted in a conspicuous place and under conditions that make it likely to be read and understood bv employees and other individuals prior to the exposure for which the warning is given, c. A warning to the exposed employee about the chemical in question which complies with all information, training and labeling requirements of the federal Hazard Communication Standard f29 CFR 5 1910.1200), the California Hazard Communication Standard (8..CCR 5194), or, for pesticides, the Pesticides and Worker Safety requirements authorized in Food and Agricultural Code section 12980 and following (3 CCR 6700, et sea.) (2) For purposes of paragraph fUA. of this subdivision, the warning shall be provided in terms which would provide a clear warning for a consumer product as specified above. For purposes of paragraph (1)B. of this subdivision, the following specific warning messages shall be deemed to clearly communicate that an individual is being exposed to a chemical known to the state to cause cancer, or birth defects or other reproductive harm. A. For exposure to a chemical known to the state to cause cancer: VVV 000009679 "WARNING: This area contains a chemical known to the State of California to cause cancer." B. For exposure to a chemical known to the state to cause chemical known to the state to cause cancer noses no significant risk for purpose of Health and Safety Code section 25249.10fc^ shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of the chemical as known to the state to cause cancer. Nothing in this article shall preclude a person from using evidence, standards or levels not described in this article to establish that a level of exposure to a listed chemical poses no significant risk. mi rne aeieoinat:ion mat exn osure to a iistea cnemica! poses no sicmificant risk under this article mav be made: rn Bv means of a quantitative: risk assessment that meets the standards described in section 127 03 (21 3v application of section 12707 (Routes of Exposure^ : or Bv one of the following, as applicable: A. If a specific regulatory level has been established for the chemical in question in section 12705. bv application of that leV'e'''' 000009880 B. If no specific level is established for the chemical in question in section 12705. bv application of section 12709 fEXPOSure to Trace Elements^ . 12711 (Levels Based on State or Federal Standards) or 12713 (Exposure to Food. Drugs. Cosmetics and Medical Devices^. fc) The chemicals, routes of exposure and conditions nf use provided at least once in anv three-month pericd. C. A varnina provided bv public media announcements which target the affected area. Such announcements shall be made at least once in anv three-month period. (2) Environmental exposure warnings shall be provided in a conspicuous manner and under such conditions as to make it likely to be read, seen or heard and understood bv an ordinary individual in the course of normal daily activity, and reasonably associated with the location and source of the exposure. r:n For purposes of paragraph fUA. of this subdivision, the following specific warning messages shall be deemed to clearly communicate that an individual is being exposed to a chemical known to the state to cause cancer, or birth defects or other reproductive harm. A. For exposure to a chemical known to the state to cause cancer: "WARNING: This area contains a chemical known to the State of California to cause cancer." B. For exposure to a chemical known to the state to cause reproductive toxicity: "WARNING: This area contains a chemical known to the State of California to cause birth defects or other reproductive harm." VVV 000009881 Authority: Health and Safety Code section 25249.12 Reference: Health and Safety Code sections 25249.6. 25249.11 ARTICLE 7. No Significant Risk Levels 12701. General. (2) The quality and suitability of available epidemiologic data should be appraised to determine whether the study is appropriate as the basis of a guantitative_risk assessment, considering such factors as the selection of the exposed and reference croups, reliable ascertainment of exposure, and completeness of follow up. Biases and confounding factors should be identified and quantified. (2) Risk analysis should be based on the most sensitive study deemed to be of sufficient quality. f4> The results obtained for the most sensitive study deemed to be of sufficient crualitv shall be applicable to all routes of exposure for which the results are relevant. (5) The absence of a carcinogenic threshold dose should be assumed and no-threshold models shall be utilized. In the absence of other scientifically appropriate extrapolation models, methods utilizing the linearized multistage model for extrapolation from high to low doses, with the upper 95 percent confidence limit of the linear term the most appropriate for expressing the upper bound of potency are preferred. Time-to- tumor models mav be appropriate where data are available on the time of appearance of individual tumors, and particularly when survival is poor due to competing toxicity. yyy 000009032 Human cancer potency mav be derived from data on human or animal cancer potency. Potency shall be expressed in milligrams of chemical oer kilogram of bodweiaht per dav. Interspecies specifically listed in this article do not include all chemicals, routes of exposure and conditions of use that mav pose no significant risk. The fact that a chemical, route of exposure or condition of use does not appear in this article does not mean that it poses a significant risk. fd) This article establishes exposure levels posing no significant risk solely for purposes of Health and Safety Code section 25249.lore). Nothing in this article shall be construed to establish exposure or risk levels for other regulatory purposes 12703. Quantitative Risk Assessment. fa) Where a Quantitative risk assessment is used for the purpose of establishing the level at which a chemical poses no significant risk, it shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for listing the chemical as known to the state to cause cancer. In the absence of anv more scientifically appropriate principles or data. the following default assumptions should be considered in anv such assessment: VVV 000009883 fl) Animal bioassav studies for Quantitative risk assessment should meet generally accepted scientific principles, including the thoroughness of experimental protocol, the degree to which dosing resembles the expected manner of human exposure, the temporal exposure pattern, the duration of study, the purity of test material, the number and size of exposed groups, the route of exposure, and the extent of tumor occurrence. v fa) Exposure to a chemical at a level which does not exceed the level sat forth in subsection fb) for such chemical poses no significant risk within the meaning of Health and Safety Code section 25249.10(c). fh) (reserved) (c) whenever the lead agency.proposes to formally adopt a level at which a chemical known to the state to cause cancer which, poses no significant risk established solely for the purposes of the Safe Drinking Water and Toxic Enforcement Act of 1936. it shall provide to each member of the Scientific Advisory Panel notice of the proposed action, a copy of the proposed level, and a copy of initial statement of reasons supporting the proposal. The close of the public comment period for anv such proposal shall be scheduled bv the lead agency so as. to permit the Scientific Advisory Panel the opportunity to review such proposal and provide comment to thei lead agency. Anv :such comment by the Scientific Advisory Panel shall become a part of thei formal rulemaking file. Nothing in this subdivision shall be construed to prevent members of the Scientific Advisory Panel from providing comments individually on anv such proposal, or to require the Scientific Advisory Panel to submit anv comment. 12707. Routes of Exposure VVV 000009884 (a) Where scientifically valid absorption studies conducted according to generally accepted standards demonstrate that absorption of a chemical through a specific route of exposure can be reasonably anticipated to present no significant risk of conversion of animal cancer potency to human cancer potency may be determined bv multiplying bv a surface area scaling factor equivalent to the ratio of human to animal bodweiqht. taken to the one-third power. Alternatively, a scaling factor of 14 may be used when extrapolating from mouse data, and a scaling factor of 6.5 mav be used when extrapolating from rat data. (7) When available data are of such quality that physiologic, pharmacokinetic and metabolic considerations can be taken into account with confidence, they may be used in the risk assessment for inter-species. inter-dose, and inter-route extrapolations (81 When the cancer risk applies to the general population, human body weight of 70 kilograms should be assumed. When the cancer risk applies to a certain subpopulation, the following assumptions should be made, as appropriate: Subpopulation Kilograms of Body Weight Man <18+ years of age) Woman (18+ years of aqe} Women with cenceotus Adolescent (11-18 years of Child (2-10 years of aqe^ Infant: (0-2 years of age) aoe^ 70 58 58 40 20 (bl For chemicals assessed in accordance with this section, the risk level which represents no significant risk shall be one which is calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question, except where sound considerations of public health support an alternative level. VVV 00000988.5 12705. Specific Regulatory Levels Posing No Significant Risk or 12713. levels of no significant risk mav be determined as (H Where a state or federal agency has developed a regulatory level for a chemical known to the state to cause cancer which is calculated to result in not more than one excess case of cancer in an exposed population of 100.000, such level shall constitute the no significant risk level. (21 The following levels based on state or federal risk assessments shall be deemed to pose no significant risk: Chemical Name Level (microarams/dav^ Acrylonitrile Asbestos 1 100 fibers inhaled/dav 140 million fibers inaested/dav Benzene Benzidine Bsnzo ra 1tvrene Bis(chloromethyllether 20 0.003 Q 06 0.6 Carbon tetrachloride Chloroform Chromium fhexavalentl Coke oven emissions 5. 9 0.001 0.3 DDT 3-3'-Dichlorobenzidine Epichlorohvdrin Ethvlene dibromide Ethvlene dichloride Ethvlene oxide 2 0.4 70 3. 9 2 Hexachlorobenzene 0.4 Hexachlorocvclohexane (technical grade) 0.4 Nickel refinery dust Nickel subsulfide N-Nitrosodi-n-butvlamine N-nitrosodiethvlamine N-nitrosodimethvlamine N-Nitrosopyrrolidine N-nitroso-N-ethvlurea -NcjiitrQSQ-N-Tnethvlurea 0.8 0.4 0.l 0.02 0.03 0.3 0.02 n nm WV 000009886 cancer at levels of exposure not in excess of current regulatory levels, the lead agency may identify the chemical as presenting no significant risk bv that route of exposure. Any exposure, discharge or releas_e__Q-f__a chemical so identified shall be deemed to present no significant risk to the extent that it results in exposure to humans by the identified route, and does not exceed the level established in any other applicable federal or state standard, regulation, guideline^ action level, license, permit, condition, requirement or order. ffcO The following chemicals present no significant risk of cancer bv the route of ingestion: (I'i Beryllium and beryllium compounds (2\ Cadmium and cadmium compounds f31 Chromium fhexavalent compounds^ 12709. Exposure To Trace Elements. ra^ Except where a specific regulatory level is established in 12705. exposure to a trace element listed in rbl poses no significant cancer risk so Iona as the reasonably anticipated level of exposure to the chemical does not exceed the level set forth in fbl . Element No Significant Risk Level in microarams per dav Arsenic (inorganic) 10 Beryllium Q. 1 Cadmium 1 12711. Levels Based on State or Federal Standards. 0000 09&07 subsection Chi of section 321 of Title 21 of the United States Code (21 USC 321 (h)). "Administrative standards" means all legal requirements that relate to safety bv the state or federal agencies responsible for administering state or federal statutes, including regulations, product approvals or licenses, enforcement action levels, and related requirements. fcl Except as otherwise provided in section 12705. exposure to a chemical known to the state to cause cancer and present in a food, drug, medical device, or cosmetic (including constituents and contaminants1 shall be deemed to pose no significant risk within the meaning of Health and Safety Code section 25249.10fc^ . provided that: (1) the chemical is a food additive within the meaning of section 321 of Title 21 of the United States Code, including anv food packaging material, approved for use at a specified level bv the federal Food and Drug Administration pursuant to section 348 of Title 21 of the United States Cede, or the California Department of Health Services, and is in compliance with all applicable administrative--s ^andards. WV 0GG0G9888 (2) the chemical is a food substance identified bv the federal Food and Drug Administration or the California Department of Health Services to be generally recognized, among experts qualified bv scientific training and experience to evaluate its safety, as having been adequately shown through scientific Polychlorinated Biphenyls (PCBs) 0.09 Tetrachlorodibenzo-o-dioxin (TCDD^ Toxaohene 2.4.6-Trichloroohenol 0.000005 Q.6 40 Vinvl chloride 0.3 12713. Exposure to Food, Drugs, Cosmetics and Medical Devices. The Health and Welfare Agency has determined, based on the recommendation of the Scientific Advisory Panel, that exposure to a listed chemical in a food, drug, cosmetic or medical device regulated under state and federal food safety lavs poses no significant risk as described in this section. This section is an interim standard. As quantitative risk assessments are performed or identified for listed chemicals and specific regulatory levels are adopted under section 12705. those levels will supersede the provisions of this section. (bl For purposes of this section: (1) "Food11 shall have the same meaning as set forth in subsection ff) of section 321 of Title 21 of the United States Code r21 USC 5 321 fffn (2\ "Cosmetic" shall have the same meaning as set forth in subsection fil of section 321 of Title 21 of the United States Code r 21 U5C 321 f in . VW 000009889 (3) "Drug11 shall have the same meaning as set forth in subsection (a) of section 321 of Title 21 of the United States Code f21 CSC 321 fa) )_. ''Medical device11 shall have the same meaning as set forth in u.s.c.. 135 - 135k) which is used in the production, storage or transportation of agricultural commodities within the meaning of section 321 of Title 21 of the United States Code and for which a specific tolerance level has been established and is in compliance with all applicable administrative standards. (7) the chemical is an animal drug within the meaning of section 321 of Title 21 of the United States Code approved for use at a specified level bv the federal Food and Drug Administration, or the California Department of Health Services, and is in compliance with all applicable administrative standards, (Q) the chemical is a drug within the meaning of section 321 of Title 21 of the United States Code, including a drug generally recognized, among experts qualified bv scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and is in compliance with all applicable administrative standards. Cd) If a chemical known to the state to cause cancer in a food, drug, medical device, or cosmetic (including constituents and contaminants) is not subject to a specific regulatory level set forth in section 12705. or paragraphs fl) through f8) of VVi/ r subdivision Cb) of this section, an exposure to such chemical shall be deemed to oose no significant risk within the meaning of Health and Safety Code section 25249.10(c). provided that the exposure is in compliance with all applicable administrative standards. procedures for in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food\ to be safe under the conditions of its intended use, and is in compliance with all applicable administrative standards. m the chemical is a food substance used in accordance with a sanction or approval granted prior to January 1, 1958 pursuant to the federal Food. Drug and Cosmetic Act, the Poultry Products Inspection Act (21 U.S.C. 451, et sea.), or the Meat Inspection Act of March 4, 1907 f34 Stat. 1260). as amended and extended (21 U.S.C. 71. et sea.), and is in compliance with all applicable administrative standards, f4^ the chemical is a color additive within the meaning of section 321 of Title 21 of the United States Code approved for use at a specified level by the federal Food and Drue Administration, or the California Department of Health Services, and is in compliance with all applicable administrative standards. VVV 000009891 (5) the chemical is a substance which is required in the production of food or which cannot be avoided by good manufacturing practice, and for which a specific tolerance level has been established by the federal Food and Drug Administration, or the California Department of Health Services, and is in compliance with all applicable administrative standards. (6) the chemical is a pesticide chemical within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act H_________ given medium of exposure measured over a lifetime of seven-tv years. (d) The following assumptions shall be used to calculate the reasonably anticipated rate of exposure -to a listed carcinogen, unless more specific and scientifically appropriate data are available: (1) For an exposure reasonably expected to affect the general population in anv geographic area: A. . The exposed individual ingests two liters of drinking water per dav. B. The exposed individual inhales twenty cubic meters of air per dav. C. The exposed individual has a lifespan of seventy years. (2) For an exposure reasonably anticipated to affect a certain subpopulation of the general population in anv geographic area, specific data (if available) relating to that subpopulation shall be used to determine..the level of exposure, tfyv 000009a92 A. In the absence of more specific and scientifically appropriate data, the following assumptions should be made as appropriate: subpopulation Water liters/dav ______________Air cubic Tneters/dav Man f18 + years of age) Woman (18 t vears of aae) Mother with conceptus Adolescent (10-18 vears of Child (2-10 vears of age) Infant (0-2 vears of age) aae) 2 2 2 2 2 1 2 ZQ. 20 20 XI 4 Be For an exposure reasonably expected to affect.the conceptus rel This section shall not apply to anv drug -the labeling of which contains a statement that the drug is carcinogenic. (f'i Paragraphs (c) and fd) of this, section are intended to establish safe levels of exposure_to chemicals present in foods, drugs, medical devices, or cosmetics, and are based on assumptions about the level and tvoe of exposures occurring in these media. 12721. Level of Exposure to Carcinogens. ra) For the purposes of the Act, "level in question*1 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 anv other source or product. (b) For purposes of the Act, "lifetime exposure11 means the reasonably anticipated rate of exposure for an individual to a given medium of exposure measured over a lifetime of seventy years. VVV 000009893 (c) For purposes of Health and Safety Code section 25249.10fc), the level of exposure to a listed carcinogen, assuming lifetime exposure at the level in question, shall be determined bv multiplying the level in question (stated in terms of a concentration of a chemical in a given medium^ times the reasonably anticipated rate of exposure for an individual to the ARTICLE 8. No Observable Effect Levels 12801. General. fa) The determination of whether a level of exposure to a chemical known to the state to cause reproductive toxicity has na observable effect for purposes of Health and Safety Code section 25249.10fc) shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of a chemical as known to the state to cause reproductive toxicity. Nothing in this article shall preclude a person from using evidence, s-tandards or levels not: described in -this article to establish that a level of exposure has no observable effect at one thousand f1,000) times the level in question. fb) The determination that exposure to a listed chemical has no observable effect for purpose of Health and Safety Code section 25249.10fc) mav be made under this article bv: (1) conducting an assessment that meets the standards described in section 12803 to determine the maximum dose level having no observable effect, and dividing that level bv one thousand (1.000) to arrive at the maximum allowable dose level: or VVV 000009894 (2) bv application of a specific recralatorv level for the chemical in question as provided in section 12805. fc) For purposes of this article. ">TOEL" shall mean that no observable effect level, which is the maximum dose level at which a chemical has no observable effect. fembrvo or fetus) , the gestation period for -the exposed conceotus is nine months. (3^ For workplace exposures, the exposed worker inhales ten cubic meters of workplace air per eight-hour dav. forty hours per week, fifty weeks per year over, a fortv-year period. The exposed individual from the general population who occasionally enters a workplace inhales 1.25 cubic meters of workplace air for one hour per month for a seventv-vear lifetime. r4^ "or exposures to consumer products. lifetime exposure shall be calculated using the average rate of intake or exposure for users of the consumer product, and not on a per capita basis for the general population. The average rate of in-take 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 bv Individuals: Amount Per Dav and Per Eating Occasion, where such data are available. VVV 000009895 (2\ Animal bioassav studies for assessment should meet generallY accented scientific principles, including the -thoroughness of experimental protocol, the degree .to which dosing resembles the expected manner of human exposurethe temporal exposure pattern, the duration of study, the puritv_of test material, the number and size of exposed groups, and the route of exposure and the extent of occurrence of effects. (4) The NOEL should be based on the most sensitive study deemed to be of sufficient crualitv. (5^ The results obtained for the most sensitive study deemed to be of sufficient quality shall be applicable to all routes of exposure for which the results are relevant. (6^ When available data are of such crualitv that anatomic, physiologic, pharmacokinetic and metabolic considerations can be taken into account with confidence, thev mav be used in the assessment. (!) When data do not allow the determination of a NOEL, the lowest obseryable effect level (LOEL'I shall be divided bv 10 to establish a NOEL for purposes of assessment. VVV 00000989t> The NOEL shall be converted to a milligram per dav dose level bv multiplying the assumed human body weight bv the NOEL. When the applicable reproductive effect is upon the male, human body weight of 7Q kilograms shall be assumed. When the applicable reproductive effect is upon the female or eoncsotus. 12803. Assessment. (a.) Where an assessment is conducted for the purposes of establishina the NOEL, such assessment shall be based on evidence ana stanaaras or com para. re scientiric vanaitv to tne evidence and standards which form the scientific basis for listing the chemical as known. to the state to cause reproductive toxicity Tn the absence of anv more scientifically appropriate principles or data, the; following default assumptions should be considered in anv such assessment: (1) only studies producing the reproductive effect which provides the basis for the determination that a chemical is known to the state to cause reproductive toxicitv should be utilized for the determination of the NOEL. Where multiple reproductive pffprt.s provide the basis for the determination that a chemical is known to the state to cause reproductive toxicitv. the reproductive effect for which studies produce the lowest NOEL shall be utilized for the determination of the NOEL. The NOEL shall be the highest dose level which results in no observable reproductive effect. expressed in milligrams of chemical per kilogram of bodweicht per dav. VVV 000009897 (2) The quality and suitability of available epidemiologic data should be appraised to determine whether the study is appropriate as the basis of an assessment considering such factors as the selection of the exposed and reference croups, the reliable ascertainment of exposure, and completeness of follow-up. Biases and confounding factors should be identified and -quantified. of a concentration of a chemical in a given medium) times the reasonably anticipated rate of exposure for an individual to a given medium. The reasonably anticipated rate of exposure shall be based on the pattern and duration of exposure that is relevant to the reproductive effect which provided the basis for the determination that a chemical is known to the state to cause reproductive toxicity, (For example, an exposure of short duration is appropriate for a teratogenic chemical. whereas a chronic or protracted exposure is appropriate for one that retards fetal growth.) (c^ The following assumptions shall be used to calculate the reasonably anticipated rata of exposure to a listed reproductive toxicant, unless more specific and scientifically appropriate data are available: (1) The assumptions set forth in subdivision fdl of section 12721 shall be used to calculate the reasonably anticipated rate of exposure to a listed reproductive toxicant, unless more specific and scientifically appropriate data are available, VVV 000009896 (2) For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for users of the consumer product, and not cn a per capita basis for the general population. The rate of intake or exposure shall he 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 bv Individuals: Amount Per Day and Per 12805. Specific Regulatory Levels: Reproductive Toxicants, fa) Exposure to a chemical at a level which does not exceed -the level set forth in subsection fb) for such chemical has no observable effect assuming exposure at one thousand flOQO) times that level. m Chemical Name LevelfMicrograms/dav) Ethvlene Oxide Lead 20.0 0.5 (c) Unless a specific level is otherwise provided in this section, an assessment bv an agency of the state or federal government that is the substantial equivalent of the assessment described in subdivision fa) of section 12803. and establishes a maximum allowable dailv dose level in the manner orovided in naraoranh fb) I'D of section 12801. shall constitute the allowable dailv dose level having no observable effect within the meaning of Health and Safety Code Section 25249.10fc). 12821. Level of Exposure to Reproductive Toxicants, VVV 000009899 fa^ 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 anv other source or product. fb) For purposes of Health and Safety Code section 25249.10(c). the level of exposure to a listed reproductive toxicant shall be determined bv multiplying the level in question f-stated in terms has been adopted, is employed or is generally accepted bv the scientific community, and a scientifically valid analytical method has been developed for the detection or measurement of a listed chemical in a specific medium, including, but not limited to. water, air, food or soil, such method shall be the analytic*! method for that chemical in that medium. Where more than one method has been developed for a chemical in a specific medium. each mav be utilized as the method of analysis, fd^ In performing a laboratory analysis to determine the concentration of a chemical known to the state to cause cancer or reproductive toxicity in a given medium, generally accepted laboratory standards and practice for sampling, collection, storage, preparation, chemical analysis, statistical analysis of data, and interpretation of results shall be observed. vw 000009900 Eating Occasion, where such data are available. f31 Where a maternal exposure to a listed reproductive toxicant has an effect on the conceptus .(embryo or fetus^ . the level of exposure shall be _based on the__reas_gnablv anticipated rats of exposure for the mother during the nine-month gestation period. ARTICLE 9. MISCELLANEOUS 12901. Methods of Detection For purposes of section 25249.11. subdivision (c). of the Health and Safety Codethe term "anv detectable amount** means a level detected using the methods of sampling and analysis referred to in this section. rbl Where the California Department of Health Services, the California Department of Food and Agriculture, the Air Resources Board, a local air pollution control district, or a federal aaencv has adopted or employs a method of analysis, or where a method of analysis is generally accepted bv the scientific community, as evidenced by^its_publication in compilations by professional and scientif ic__associations or societies, such as the Association of Officia_l ^Analytical Chemists, or in peer- reviewed technical journals published bv such associations or societies, for the detection or measurement of a listed chemical in a specific medium, including, but not limited, to water, air. food or soil, such method shall be the analytical method for that chemical in that medium. Where more than one method has been so adopted, is so employed, or is generally accepted, each mav be utilized as the method of analysis. VVV 00000^901 fc^ Where no method of analysis as described in subsection fbl 49