California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 3.2 - California Occupational Safety and Health Regulations (Cal/OSHA) › Subchapter 1 - Regulations of the Director of Industrial Relations › Article 5 - Hazardous Substances Information and Training › Section 337 - Development and Maintenance of List

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Establishment of Initial List. Substances
					 designated in the sources specified in Labor Code section
					 6382(b)
					 shall be considered in formulating the initial list.
The Director shall presume all such substances to be
						potentially hazardous to human health when present occupationally except those
						which the Director determines do not pose any adverse acute or chronic risk to
						human health as present occupationally. Those substances which do not pose any
						risk shall be removed from the list. Evidence of risk shall include any
						immediate or long-term adverse effect which causes impairment of function,
						alteration of structure, or increased susceptibility to disease or contributes
						to adverse effects of other substances. In making a determination of risk, the
						Director shall consider available scientific data including, but not limited
						to, data from human epidemiological studies, data from short-term in vitro
						studies, and data from animal bioassay tests.
Animal bioassay data is admissible and generally
						indicative of potential effects in humans.
For purposes of this regulation, substances are present
						occupationally when there is a possibility of exposure either as a result of
						normal work operations or a reasonably foreseeable emergency resulting from
						workplace operations. A reasonably foreseeable emergency is one which a
						reasonable person should anticipate based on usual work conditions, a
						substance's particular chemical properties (e.g., potential for explosion,
						fire, reactivity), and the potential for human health hazards. A reasonably
						foreseeable emergency includes, but is not limited to, spills, fires,
						explosions, equipment failure, rupture of containers, or failure of control
						equipment which may or do result in a release of a hazardous substance into the
						workplace.
(b)
					 Administrative Procedure Followed by the Director for the Development of the
					 Initial List. The Director shall hold a public hearing concerning the initial
					 list. The record will remain open 30 days after the public hearing for
					 additional written comment. Requests to exempt a substance in a particular
					 physical state, volume, or concentration from the provisions of Labor Code
					 sections
					 6390 to
					 6399.2 may be
					 made at this time. If no comments in opposition to such a request are made at
					 the public hearing or received during the comment period, or if the Director
					 can find no valid reason why the request should not be considered, it will be
					 incorporated during the Director's preparation of the list.
After the public comment period the Director shall
						formulate the initial list and send it to the Standards Board for approval.
						After receipt of the list or a modified list from the Standards Board, the
						Director will adopt the list and file it with the Office of Administrative
						Law.
(c) Concentration
					 Requirement. In determining whether the concentration requirement of a
					 substance should be changed pursuant to Labor Code section
					 6383, the
					 Director shall consider valid and substantial evidence. Valid and substantial
					 evidence shall consist of clinical evidence or toxicological studies including,
					 but not limited to, animal bioassay tests, short-term in vitro tests, and human
					 epidemiological studies. Upon adoption, a regulation indicating the
					 concentration requirement for a substance shall consist of a footnote on the
					 list.
(d) Procedures for Modifying
					 the List. The Director will consider petitions from any member of the public to
					 modify the list or the concentration requirements, pursuant to the procedures
					 specified in Government Code section
					 11347.1.
					 With petitions to modify the list, the Director shall make any necessary
					 deletions or additions in accordance with the procedures herein set forth for
					 establishing the list. The Director will review the existing list at least
					 every two years and shall make any necessary additions or deletions in
					 accordance with the procedures herein set forth for establishing the
					 list.
(e) Criteria for Modifying
					 the List. Petitions to add or remove a substance on the list, modify the
					 concentration level of a substance, or reference when a particular substance is
					 present in a physical state which does not pose any human health risk must be
					 accompanied with relevant and sufficient scientific data which may include, but
					 is not limited to, short-term tests, animal studies, human epidemiological
					 studies, and clinical data. If the applicant does not include the complete
					 content of a referenced study or other document, there must be sufficient
					 information to permit the Director to identify and obtain the referenced
					 material. The petitioner bears the burden of justifying any proposed
					 modification of the list.
The Director shall consider all evidence submitted,
						including negative and positive evidence. All evidence must be based on
						properly designed studies for toxicological endpoints indicating adverse health
						effects in humans, e.g., carcinogenicity, mutagenicity, neurotoxicity, organ
						damage/effects.
For purposes of this regulation, animal data is
						admissible and generally indicative of potential effects in humans.
The absence of a particular category of studies shall not
						be used to prove the absence of risk.
Negative results generally indicate the absence of
						statistically positive results in appropriate studies. As all tests for
						toxicological effects have inherent insensitivities, negative results must be
						reevaluated in light of the limits of sensitivity of each study, its test
						design, and the protocol followed.
In evaluating different results among proper tests, as a
						general rule, positive results shall be given more weight than negative results
						for purposes of including a substance on the list or modifying the list in
						reference to concentration, physical state or volume, so that appropriate
						information may be provided regarding those positive results. In each case, the
						relative sensitivity of each test shall be a factor in resolving such
						conflicts.
1. New
						article 5 (section
						337) filed 11-5-81; effective
						thirtieth day thereafter (Register 81, No. 45).
2. Amendment of
						subsection (d) filed 1-15-87; effective upon filing pursuant to Government Code
						section
						11346.2(d)
						(Register 87, No. 3).
3. Editorial correction of HISTORY 2.
						(Register 91, No. 19).
Note: Authority cited: Section
						  6380, Labor
						  Code. Reference: Sections
						  6361,
						  6380,
						  6380.5,
						  6382 and
						  6383, Labor
						  Code.