Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Vinylidene Chloride

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65[1] No Significant Risk Level (NSRL) of 0.88 micrograms per day for vinylidene chloride, by amending Title 27, California Code of Regulations, section 25705(b)[2].  The office is concurrently providing notice of its intent to list vinylidene chloride as known to cause cancer for purposes of Proposition 65.  In the event OEHHA does not list the chemical, this rulemaking will be withdrawn.

PUBLIC PROCEEDINGS

Any written comments concerning this proposed action must be received by OEHHA by 5:00 p.m. on November 6, 2017, the designated close of the written comment period.  All comments received will be posted on 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 submitted electronically to P65Public.Comments@oehha.ca.gov.  Please include “Vinylidene Chloride NSRL” in the subject line.  Comments submitted in paper form can be mailed, faxed, or delivered in person to the address below.  Hard-copy comments may be mailed, faxed, or delivered in person to the address below.

Mailing Address:  Ms. Monet Vela
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-23B
Sacramento, California 95812-4010
Fax: (916) 323-2610
Street Address:  1001 I Street
Sacramento, California 95814

Please be aware that OEHHA is subject to the California Public Records Act and other laws that require the release of certain information upon request. Comments 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 to request redaction of home address or personal telephone numbers.  Names of commenters will not be redacted.

A public hearing on this proposed regulatory amendment 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 October 23, 2017, which is 15 days before the close of the comment period.  OEHHA will mail a notice of the hearing to the requester and interested parties on the Proposition 65 mailing list for regulatory 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. 

If a hearing is scheduled and you have special accommodation needs, please contact Monet Vela at (916) 323-2517 or monet.vela@oehha.ca.gov at least one week in advance of the hearing.  TTY/TDD/Speech-to-Speech users may dial 7-1-1 for the California Relay Service. 

CONTACT

Please direct inquiries concerning the proposed regulatory action described in this notice to Monet Vela at monet.vela@oehha.ca.gov  or by telephone at (916) 323-2517.  Fran Kammerer is a back-up contact person for inquiries concerning processing of this action and is available at fran.kammerer@oehha.ca.gov or (916) 445-4693. 

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW

Proposition 65 prohibits a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical 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[3]. The Act also prohibits a business from knowingly discharging a listed chemical into water or onto or into land where such chemical passes or probably will pass into any source of drinking water[4]. 

For carcinogens, an exemption from the warning requirement is provided by the Act when the exposure for which the person is responsible can be demonstrated to produce no significant risk or when a discharge which otherwise complies with all applicable requirements would not cause any significant amount of the discharged or released chemical to enter any source of drinking water[5].  A determination that a level of exposure poses no significant risk may be made utilizing regulations that have previously been adopted by OEHHA (Sections 25701-25721).  Section 25701 describes alternative methods for making such a determination.  Section 25705 sets forth the process for determining “no significant risk” levels for purposes of Proposition 65 and establishes those levels for certain listed chemicals. 

Details on the basis for the proposed NSRL for vinylidene chloride are provided in the Initial Statement of Reasons for this regulatory action, which is available on request from Monet Vela and is posted on the OEHHA website at www.oehha.ca.gov. 

This proposed amendment to section 25705 would add an NSRL for vinylidene chloride by amending Section 25705(b) as follows (addition in underline): 

Chemical

NSRL, in micrograms per day

Vinylidene chloride

0.88

To develop the proposed NSRL for vinylidene chloride, OEHHA relied on the National Toxicology Program (NTP) report entitled “Toxicology and Carcinogenesis Studies of Vinylidene Chloride (CAS No. 75-35-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)”[6] and Volume 71 in the series of International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans, entitled “Re-evaluation of Some Organic Chemicals, Hydrazine and Hydrogen Peroxide”[7].  These documents summarize the available data from rodent carcinogenicity studies, as well as other information relevant to the carcinogenicity of the chemical.  The NSRL is based upon the results of the most sensitive scientific study deemed to be of sufficient quality[8].  The derivation of the NSRL for vinylidene chloride is discussed in more detail in the Initial Statement of Reasons for this proposed regulatory amendment.

Anticipated Benefits of the Proposed Regulation

Some businesses may not be able to afford the expense of establishing an NSRL and therefore may be exposed to litigation for a failure to warn or for a prohibited discharge of the listed chemical.  By providing an NSRL, this regulatory proposal spares businesses the expense of calculating their own NSRL and may also enable them to reduce or avoid litigation costs.  In addition, the NSRL does not require, but may encourage, businesses to lower the amount of the listed chemical in their product to a level that does not cause a significant exposure, thereby providing a public health benefit to Californians.  This in turn may reduce exposure to vinylidene chloride and reduce resident, worker and environmental exposures to chemicals that cause cancer.

No Inconsistency or Incompatibility with Existing Regulations

After conducting an evaluation on any related regulations in this area, the Office has found that these are the only regulations dealing with Proposition 65 Maximum Allowable Dose Levels for this specific chemical.  Therefore, OEHHA has determined that the proposed regulation is neither inconsistent nor incompatible with existing state regulations.  The proposed regulation does not impose any mandatory requirements on businesses, state or local agencies and does not address compliance with any other law or regulation.

RESULTS OF ECONOMIC IMPACT ANALYSIS

(Gov. Code section 11346.3(b))

Impact on the Creation, Elimination, or Expansion of Jobs/Businesses in California

This regulatory proposal will not affect the creation or elimination of jobs within the State of California.  Proposition 65 requires businesses with ten or more employees to provide warnings when they expose people to chemicals that are known to cause cancer.  The law also prohibits the discharge of listed chemicals into sources of drinking water.  Vinylidene chloride is listed under Proposition 65; therefore, businesses that manufacture, distribute or sell products with vinylidene chloride in the state must provide a warning if their product or activity exposes the public or employees to significant amounts of this chemical.  The regulatory proposal does not create additional compliance requirements, but instead provides a “safe harbor” value that aids businesses in determining whether a warning is required for a given exposure.

Because the proposed NSRL provides compliance assistance to businesses subject to the Act, but does not impose any mandatory requirements on those businesses, OEHHA has determined that the proposed regulatory action will not have any impact on the creation or elimination of jobs, the creation of new businesses or the elimination of existing businesses, or the expansion of businesses currently doing business within the State of California.

Benefits of this regulation include sparing businesses the expense of calculating their own NSRL and possibly enabling them to reduce or avoid litigation costs.  By providing an NSRL, it may encourage businesses to lower the amount of the listed chemical in their product to a level that does not cause a significant exposure, thereby providing a public health benefit to Californians.  This in turn may reduce exposure to vinylidene chloride and reduce resident, worker and environmental exposures to chemicals that cause cancer.

PEER REVIEW

This notice and the Initial Statement of Reasons are being provided to the OEHHA Science Advisory Board’s Carcinogen Identification Committee for review and comment.

AUTHORITY

Health and Safety Code Section 25249.12.

REFERENCE

Health and Safety Code Sections 25249.5, 25249.6, 25249.9, 25249.10 and 25249.11.

IMPACT ON LOCAL AGENCIES OR SCHOOL DISTRICTS

Because Proposition 65 expressly[9] does not apply to local agencies or school districts, OEHHA has determined 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 that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed regulatory action. 

COSTS OR SAVINGS TO STATE AGENCIES

Because Proposition 65 expressly[10] does not apply to any State agency, OEHHA has determined that no savings or increased costs to any State agency will result from the proposed regulatory action. 

EFFECT ON FEDERAL FUNDING TO THE STATE

Because Proposition 65 expressly[11] does not apply to any federal agency, OEHHA has determined that no costs or savings in federal funding to the State will result from the proposed regulatory action. 

EFFECT ON HOUSING COSTS

OEHHA has determined that the proposed regulatory action will have no effect on housing costs because it provides compliance assistance to businesses subject to Proposition 65, but does not impose any mandatory requirements on those businesses. 

SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE

Because the proposed regulatory level provides compliance assistance to businesses subject to Proposition 65, but do not impose any mandatory requirements on those businesses, OEHHA has made an initial determination that the adoption of the regulation will not have a significant, statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states. 

COST IMPACTS ON REPRESENTATIVE PRIVATE PERSONS OR BUSINESSES

The proposed NSRL was developed to provide compliance assistance for these businesses in determining whether a warning is required or a discharge is prohibited.  The NSRL provides a level of exposure at or below which a warning is not required and a discharge is not prohibited.  Use of the NSRL is not mandatory.  The implementing regulations allow a business to calculate its own level and provide guidance in order to assist businesses in doing so[12].  However, conducting such a process can be expensive and time consuming, and the resulting levels may not be defensible in an enforcement action.  OEHHA is not aware of any cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action.

EFFECT ON SMALL BUSINESSES

OEHHA has determined that the proposed regulation will not impose any mandatory requirements on small business.  Rather, the proposed NSRL will provide compliance assistance for small businesses subject to Proposition 65 because it will help them determine whether or not an exposure for which they are responsible is subject to the warning requirement or discharge prohibition of Proposition 65. 

CONSIDERATION OF ALTERNATIVES

Government Code section 11346(a)(13) requires that OEHHA must determine that no reasonable alternative considered by the OEHHA or that has otherwise been identified and brought to the attention of the OEHHA would be more effective in carrying out the purpose for which the action is proposed, would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost-effective to affected private persons and equally effective in implementing the statutory policy or other provision of law than the proposal described in this Notice.

AVAILABILITY OF STATEMENT OF REASONS AND TEXT OF PROPOSED REGULATIONS

OEHHA has prepared and has available for public review an Initial Statement of Reasons for the regulation, all the information upon which the regulation is based and the text of the regulation.  A copy of the Initial Statement of Reasons, the text of the regulation and the documents relied on to develop the proposed regulation are available upon request from OEHHA at the address and telephone number indicated above.  These documents are also posted on OEHHA’s website at www.oehha.ca.gov. 

AVAILABILITY OF CHANGED OR MODIFIED TEXT

The full text of any regulation which is changed or modified from the express terms of this proposed action will be made available at least 15 days prior to the date on which OEHHA adopts the resulting regulation.  Notice of the comment period on changed regulations and the full text will be mailed to individuals who testified or submitted written comments at the public hearing, if held, or whose comments were received by OEHHA during the public comment period, and anyone who requests notification from OEHHA of the availability of such changes.  Copies of the notice and the changed regulation will also be available on the OEHHA website at www.oehha.ca.gov.

FINAL STATEMENT OF REASONS

A copy of the Final Statement of Reasons for this regulatory action may be obtained, when it becomes available, from OEHHA at the address and telephone number indicated above, and on the OEHHA website at www.oehha.ca.gov. 

OFFICE OF ENVIRONMENTAL
HEALTH HAZARD ASSESSMENT
Allan Hirsch
Chief Deputy Director

Dated: September 22, 2017

Downloads

Footnotes and References

[1] The Safe Drinking Water and Toxic Enforcement Act of 1986, codified at Health and Safety Code section 25249.5 et seq., referred to herein as “Proposition 65” or “The Act.”

[2] All further regulatory references are to sections of Title 27 of the California Code of Regulations unless otherwise indicated. 

[3] Health and Safety Code section 25249.6.

[4] Health and Safety Code section 25249.5.

[5] Health and Safety Code sections 25249.9 and 25249.10

[6] National Toxicology Program (NTP, 2015). Toxicology and Carcinogenesis Studies of Vinylidene chloride (CAS No. 75-35-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 582. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

[7] International Agency for Research on Cancer (IARC, 1999). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 71, Re-evaluation of Some Organic Chemicals, Hydrazine and Hydrogen Peroxide. IARC, World Health Organization, Lyon, France.  Available from: http://monographs.iarc.fr/ENG/Monographs/vol71/index.php

[8] Section 25703(a)(4)

[9] See Health and Safety Code section 25249.11 (b)

[10] See Health and Safety Code section 25249.11 (b)

[11] See Health and Safety Code section 25249.11 (b)

[12] Title 27, Cal. Code of Regs., section 25801 et seq.