Proposed Rulemaking Addressing Globally Harmonized System Update to Hazard Communication Health (Horcher)

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1 Page 1 of 15 TO: FROM: Occupational Safety and Health Standards Board 2520 Venture Oaks Way, Suite 350 Sacramento, CA American Chemistry Council American Coatings Association Associated General Contractors of California California Chamber of Commerce California Construction and Industrial Materials Association (CalCIMA) California Framing Contractors Association California Grape and Tree Fruit League California Manufacturers and Technology Association California Professional Association of Specialty Contractors Chemical Industry Council of California Consumer Specialty Products Association Industrial Environmental Association International Fragrance Association Motion Picture Association of America, Inc. Residential Contractors Association Styrene Information and Research Center Vulcan Materials Company Western States Petroleum Association Western Steel Council DATE: November 9, 2012 SUBJECT: Proposed Rulemaking Addressing Globally Harmonized System Update to Hazard Communication Health (Horcher) Dear Board Members: Thank you for providing an opportunity to comment on the proposed rule to address Globally Harmonized System updates to the Hazard Communication Standard (HCS). We are a coalition representing employers, distributors and manufacturers impacted by the proposed rule and in full agreement with its stated purpose: to classify and communicate chemical hazards in a manner consistent with the provisions of the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Revision 3 (Proposed Section 5194(a)). Our analysis has identified significant inconsistencies between the federal standard adopted on March 26, 2012, and the proposed California standard. Our primary concern is with the definitions of health hazard and hazardous substances in proposed Section 5194(c) and some of the criteria specified in proposed Section 5194(d) for determining hazard classifications. The proposed standard has substantial deviations from the federal standard that defeat the

2 Page 2 of 15 purpose of global harmonization and exceed the editorial and format differences allowed under CCR Title 8, Section for the Horcher exemption from normal rulemaking procedures. The disharmony exists where the proposed standard omits new federal language (OSHA HCS 2012) and retains existing California language that was deleted from the federal standard (OSHA HCS 1994). This is clearly illustrated in the attached side by side comparison of key California and federal changes (Attachment 1). The proposed standard creates an incompatible mix of new and old criteria for health hazard determinations. THE CHEMICAL TEST REQUIREMENT [PROPOSED SECTION 5194(d)(2)] One substantial difference in proposed Section 5194(d)(2) is the omission of this sentence added to the new federal standard: There is no requirement to test the chemical to determine how to classify its hazards. The omission creates an ambiguity. Will Cal/OSHA require additional testing not required by the federal standard? If yes, how will Cal/OSHA determine when additional testing is appropriate? If no, why not mirror the federal standard and say so? THE SUFFICIENCY OF ONE POSITIVE STUDY [PROPOSED SECTION 5194(d)(2)] Another substantial difference in proposed Section 5194(d)(2) is the retention of the following sentence which was deleted from the federal standard: For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section. The proposed one positive study rule conflicts with the new GHS health hazard criteria summarized in OSHA HCS 2012, Appendix A (Mandatory), Subsection A.0.3.5: Both positive and negative results are considered together in the weight of evidence determination. However, a single positive study performed according to good scientific principles and with statistically and biologically significant positive results may justify classification. Under the mandatory GHS health hazard criteria in federal Appendix A, one positive study may justify classification. Under proposed Section 5194(d)(2), one positive shall justify classification, regardless the weight of contrary evidence. That is a substantial difference that would make

3 Page 3 of 15 some health hazard determinations different under the California standard. Cal/OSHA could determine that a federally compliant safety data sheet does not meet the California standard. Appendix A contains more language confirming the weight of evidence approach in which one positive study may, not shall, justify classification. (Appendix A has been reproduced through Subsection A.0.3 Classification based on weight of evidence as Attachment 2 to this letter.) THE INTERNAL AMBIGUITY The proposed standard adopts Appendix A to OSHA Section (HCS 2012) as Appendix A to Cal/OSHA Section 5194 without change. This means that the retained one study issufficient language creates an ambiguity within the proposed standard as well as a conflict with the federal standard. We see this conflict in the whole of proposed Section 5194(d)(2): Manufacturers, importers, or employers evaluating classifying chemicals substances shall identify and consider the full range of available scientific literature and other evidence concerning such the potential hazards. For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section. Appendix A to section 5194 shall be consulted for the scope of classification of health hazards covered, and Appendix B to section 5194 shall be consulted for the criteria to be followed with respect to the completeness of the evaluation, and the data to be reported. classification of physical hazards. The first sentence has amendments that conform the proposed standard to the federal GHS updates. It suggests a weight of evidence approach amended to emphasize the inclusion of all relevant data in the evaluation. The second sentence has the old federal (existing California) language that does not conform to the federal GHS updates. It arguably turns the weight of evidence mandate into a mandate to search all available data for that one positive study which shall justify classification. The third sentence has new conforming language that refers to Appendix A for classification criteria. Appendix A requires the weight of evidence approach denied by the second sentence. In short, California s one study is sufficient language substantially changes the meaning of the federal standard and creates ambiguity within the proposed rule.

4 Page 4 of 15 THE DEFINITION OF HEALTH HAZARD [PROPOSED SECTION 5194(c)] The one study is sufficient concept in proposed Section 5194(d)(2) also appears in the definitions of health hazard found in Section 5192 (Hazardous Waste Operations and Emergency Response) and Section 5194 (Hazard Communication). They say: A health hazard is a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in expose employees. Like Section 5194(d)(2), these definitions also refer to Section 5194 Appendix A for the criteria for determining whether a chemical is classified as a health hazard under which one study may be sufficient for classification. By retaining the one study is sufficient language in definitions of health hazard, they too create ambiguity within the proposed standard as well as a conflict with the federal standard. The internal ambiguity extends to the proposed definition of health hazard found in Section 5191 (Occupational Exposure to Hazardous Chemicals in Laboratories) which does not retain the one study is sufficient language. So the definitions conflict with each other, with the federal standard, and with California and federal Appendix A. OTHER LEGACY CLASSIFICATION CRITERIA [PROPOSED SECTIONS 5194(d)(3 5)] Proposed sections 5194(d)(3 5) also retain classification criteria, deleted from the federal standard, that conflict with the new federal standard and create ambiguity within the proposed California standard. Proposed Section 5194(d)(3) provides a list of source lists (such as the American Conference of Governmental Industrial Hygienists list of Threshold Limit Values) deemed sufficient to establish that a chemical poses an unspecified health hazard. The corresponding section in OSHA HCS 1994 was deleted in OSHA HCS 2012 in favor of detailed classification criteria for each health hazard in Appendix A and each physical hazard in Appendix B. A problem arises when the classification criteria of the retained source lists do not match the new GHS classification criteria in the Appendices. This problem can be solved by conforming to the federal standard and eliminating the list of source lists. The exception to this statement may be Subsection 5194(d)(3)(A), which implements California Labor Code section 6382 otherwise known as the Director s list of hazardous substances. This California statute has its own list of lists for purposes of hazard classification and communication. The statute provides an independent foundation for rulemaking and retention of the Director s list for purposes of hazard classification and communication. Nonetheless, the Director s list will generate the problem of competing classification criteria. The means of compliance in that instance need to be carefully considered and clearly spelled out in the hazard communication standard.

5 Page 5 of 15 Proposed Section 5194(d)(4) provides a list of source lists (such as the National Toxicology Program Annual Report on Carcinogens) deemed sufficient to establish that a chemical is a carcinogen or potential carcinogen for hazard communication purposes. The corresponding section in OSHA HCS 1994 was deleted in OSHA HCS 2012 in favor of detailed criteria in Appendix A, though the criteria for carcinogens allow the use of the same source lists in lieu of applying the Appendix A criteria for carcinogens. Making the source lists compulsory creates the same problem described for proposed Section 5194(d)(3). The classification criteria of the source lists may not match the GHS classification criteria in the Appendices. The proposed rule does not provide any guidance on how to deal with a substantial difference in classification criteria. Also, there is a legal question whether California can defer to the latest editions of those lists when that deference has been removed from the federal standard. Proposed Section 5194(d)(5) retains this provision deleted from the federal standard: If the manufacturer, importer, or employer has evidence to indicate that a component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established permissible exposure limit or ACGIH Threshold Limit Value, or could present a health hazard to employees in those concentrations, the mixture shall be assumed to present the same hazard. This conflicts with corresponding GHS criteria for mixtures found in the new federal, proposed California, Appendix A. In addition to the conflict and ambiguity created by retaining this provision, there is again the legal question of whether California can defer to unknown future determinations by ACGIH when that deference has been removed from the federal standard. The potential for conflicts and ambiguity created by these legacy provisions deserve careful consideration. The rulemaking documents do not provide a rationale for any of these deviations from the federal standard. THE DEFINTION OF HAZARDOUS CHEMICAL [PROPOSED SECTION 5194(c)] Proposed Section 5194(c) contains another definition with substantial differences that could affect the classification of certain hazards and therefore the content of their safety data sheets. The federal definition of hazardous chemical was amended as follows: "Hazardous chemical" means any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified. The proposed California standard adds combustible liquid and water reactive to the list between combustible dust and pyrophoric gas. The two additions were not in the old federal definition, nor are they in the existing California definition. Further, the definitions of combustible liquid and water reactive were deleted from Section (c) of the new federal standard. The same hazards are now dealt with in OSHA 2012 Mandatory Appendices A

6 Page 6 of 15 and B using the new GHS classification criteria. For example, many liquids fitting the deleted federal definition of combustible liquid now fit the new Appendix B definition of flammable liquid. Proposed Section 5194(c) retains the deleted federal (existing California) definitions of combustible liquid and flammable liquid creating yet another conflicting and confusing mix of criteria. (See the side by side comparison in Attachment 1 for more details.) These substantial differences should be carefully considered before adoption. We note in the Notice of Proposed Changes, Informative Digest, that federal changes to OSHA 2012 Section , Flammable and combustible liquids, will be considered in future rulemaking using the state s normal public notice and comment period procedures in order to assure that more protective state standards are preserved and to afford stakeholders with an opportunity to evaluate and comment on the proposed changes. That seems the appropriate time and method to consider these California changes to the definition of hazardous chemical. SUMMARY AND SUGGESTIONS REGARDING HAZARD CLASSIFICATION The federal side by side comparison of OSHA HCS 1994 versus OSHA HCS 2012 had this to say about GHS updates to hazard classification: The hazard classification approach in the GHS is quite different from the performanceoriented approach in the HCS The GHS has specific criteria for each health and physical hazard, along with detailed instructions for hazard evaluation and determinations as to whether mixtures of the substance are covered. OSHA has included the general provisions for hazard classification in paragraph (d) of the revised rule, and added extensive appendixes that address the criteria for each health or physical effect. Mandatory Appendices A and B provide classification guidance for Health Hazards and Physical Hazards, respectively. The hazard classification criteria contained in the HCS 2012 is test method neutral. That is, the person classifying a chemical or substance should use available data and no additional testing is required to classify a chemical. This OSHA explanation confirms that the omitted testing language must be restored, the retained one study language must be deleted, and the other legacy criteria must be thoroughly vetted to resolve all the substantial differences between the federal and state standards. Resolving these differences would achieve the purpose stated in the Board s Notice of Proposed Changes, Informative Digest: to be consistent with the United Nations GHS classification. This resolution of differences would further substantiate the claim that proposed regulations are substantially the same as the federal standards (Informative Digest, pg. 1, para.4) and strengthen the basis for exempting the Board from the provisions of Article 5 (commencing with Section 11346) and Article 6 (commencing with Section 11349) of Chapter 3.5, Part 1, Division 3 of Title 2 of the Government Code that would otherwise govern this rulemaking.

7 Page 7 of 15 The proposed differences in classification criteria present serious legal and policy issues that call for meaningful deliberation. None of the public documents provided for this rulemaking present any rationale for omitting the test language or retaining any legacy criteria, including the one study is sufficient language. Nor do they answer two threshold questions applicable to substantial differences in the regulation of products (Occupational Safety and Health Act of 1970, Section 18(c), the Product Clause). Are the differences compelled by local conditions? Do they unduly burden interstate commerce? We urge the Board to adopt the federal language on these matters. If the Board desires to retain some of the proposed differences, they should be deferred to future rulemaking as was done with seven other federal updates due to significant differences with state standards. (Notice of Proposed Changes, Informative Digest, pg.3) PROCESS CONCERNS AND SUGGESTIONS [PROPOSED SECTION 5194(f)(11), SECTION 5194(j) AND OTHER] We also have some concerns and suggestions related to process. Proposed Section 5194(f)(11) requires that Manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within three months of becoming aware of the new information The time for compliance granted in the federal standard (OSHA HCS (f)(11)) was amended from three months to six months. (See Attachment 1 for sideby side comparison.) California should extend the time period to six months to avoid conflict with the federal standard and confusion for the regulated public. The rulemaking documents do not provide a rationale for this substantial difference. We note that proposed Section 5194(j) conforms to OSHA HCS 2012 Section (j) regarding the effective dates of these new hazard communication standards. This conformance is vitally important to avoid any confusion and foster compliance by the regulated public. The coalition also urges the Board and the Division of Occupational Safety and Health to: Expedite rulemaking on the seven standards not included in the current proposal (including Process Safety Management). Make available the federal standards on Cal/OSHA websites until such time as California adopts corresponding standards since California employers will be subject to the new federal standards as well as California s existing standards. Reach out and explain the new requirements and compliance deadlines to California s business community. Thank you for giving these comments your careful consideration.

8 Page 8 of 15 ATTACHMENT 1 SIDE BY SIDE OF KEY PROVISIONS OF OSHA HCS SECTION AND PROPOSED CAL/OSHA SECTION 5194 OSHA HCS 1994 (DELETIONS) OSHA HCS 2012 (ADDITIONS) Cal/OSHA HCS 2012 (AMENDMENTS) (c) Definitions: Health (c) Definitions: 5194(c) Definitions: Health hazard hazard Health hazard "Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard. "Health hazard" means a chemical which is classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); or aspiration hazard. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A to Health Hazard Criteria. Health hazard. A chemical substance for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term health hazard includes substances which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. chemicals which are classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); or aspiration hazard. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A to this section Health Hazard Criteria. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a substance is to be considered hazardous for purposes of this standard.

9 Page 9 of (c) Definitions: Hazardous chemical, Combustible liquid, and Flammable liquid. "Hazardous chemical" means any chemical which is a physical hazard or a health hazard. "Combustible liquid" means any liquid having a flashpoint at or above 100 deg. F (37.8 deg. C), but below 200 deg. F (93.3 deg. C), except any mixture having components with flashpoints of 200 deg. F (93.3 deg. C), or higher, the total volume of which make up 99 percent or more of the total volume of the mixture. "Liquid, flammable" means any liquid having a flashpoint below 100 deg. F (37.8 deg. C), except any mixture having components with flashpoints of 100 deg. F (37.8 deg. C) or higher, the total of which make up 99 percent or more of the total volume of the mixture. "Water reactive" means a chemical that reacts with water to release a gas that is either flammable or presents a health hazard (c) Definitions: Hazardous chemical, Combustible liquid, and Flammable liquid. "Hazardous chemical" means any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified. [Note from commenter. Combustible liquid no longer defined in this section. See the new definition of flammable liquid.] [Note from commenter. Liquid, flammable now defined in Mandatory Appendix B: Flammable liquid means a liquid having a flash point of not more than 93 C (199.4 F).] [Note from commenter. Water reactive no longer defined in this section.] 5194(c) Definitions: Hazardous chemical, Combustible liquid, and Flammable liquid. Hazardous chemical. Any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, combustible liquid, water reactive, pyrophoric gas, or hazard not otherwise classified Hazardous substance. Any substance which is a physical hazard or a health hazard or is included in the List of Hazardous Substances prepared by the Director pursuant to Labor Code section Combustible liquid. Any liquid having a flashpoint at or above ( C), but below F ( C), except any mixture having components with flashpoints of F ( C), or higher, the total volume of which make up 99 percent or more of the total volume of the mixture. Liquid, flammable. Any liquid having a flashpoint below F ( C), except any mixture having components with flashpoints of F ( C) or higher, the total of which make up 99 percent or more of the total volume of the mixture. Water reactive. A substance that reacts with water to release a gas that is either flammable or presents a health hazard (d)(2) (d)(2) 5194(d)(2) Chemical manufacturers, importers or employers evaluating chemicals shall identify and consider the available scientific evidence concerning such hazards. For health hazards, evidence which is statistically significant and which is based on at least one positive study Chemical manufacturers, importers or employers classifying chemicals shall identify and consider the full range of available scientific literature and other evidence concerning the potential hazards. There is no Manufacturers, importers, or employers evaluating classifying chemicals substances shall identify and consider the full range of available scientific literature and other evidence concerning such the potential hazards. For health hazards, evidence which is statistically significant and which is based on at least one positive study

10 Page 10 of 15 conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section. Appendix A shall be consulted for the scope of health hazards covered, and Appendix B shall be consulted for the criteria to be followed with respect to the completeness of the evaluation, and the data to be reported. requirement to test the chemical to determine how to classify its hazards. Appendix A to shall be consulted for classification of health hazards, and Appendix B to shall be consulted for the classification of physical hazards. conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section. Appendix A to section 5194 shall be consulted for the scope of classification of health hazards covered, and Appendix B to section 5194 shall be consulted for the criteria to be followed with respect to the completeness of the evaluation, and the data to be reported. classification of physical hazards (d)(3) (d)(3). 5194(d)(3) (d)(3) The chemical manufacturer, importer or employer evaluating chemicals shall treat the following sources as establishing that the chemicals listed in them are hazardous: (d)(3)(i) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration (OSHA); or, (d)(3)(ii) "Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment," American Conference of Governmental Industrial Hygienists (ACGIH) (latest edition). The chemical manufacturer, importer, or employer is still responsible for evaluating the hazards associated with the chemicals in these source lists in accordance with the requirements of this standard. [Note from commenter. The content of previous section (d)(3) was deleted from the new federal standard without amendment. New section (d)(3) corresponds to previous section (d)(5).] (3) The manufacturer, importer, or employer classifying chemicals evaluating substances shall treat any of the following sources as establishing that the chemical substances listed in them are hazardous: (A) The list of hazardous substances prepared by the Director pursuant to Labor Code section 6382 and as promulgated in title 8, California Code of Regulations, section 339. The concentrations and footnotes which are applicable to the list shall be understood to modify the same substance on all other source lists or hazard determinations set forth in sections 5194(d)(3)(B) 5194(d)(5)(CD). (B) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration (OSHA). (C) Threshold Limit Values for Chemical Substances in the Work Environment, American Conference of Governmental Industrial Hygienists (ACGIH) (latest edition). The manufacturer, importer, or employer is still responsible for classifying evaluating the hazards associated with the chemicals substances in these source lists in accordance with the requirements of the standard.

11 Page 11 of (d)(4) (d)(4). 5194(d)(4) (d)(4) Chemical manufacturers, importers and employers evaluating chemicals shall treat the following sources as establishing that a chemical is a carcinogen or potential carcinogen for hazard communication purposes: (d)(4)(i) National Toxicology Program (NTP), "Annual Report on Carcinogens" (latest edition); (d)(4)(ii) International Agency for Research on Cancer (IARC) "Monographs" (latest editions); or (d)(4)(iii) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration. Note: The "Registry of Toxic Effects of Chemical Substances" published by the National Institute for Occupational Safety and Health indicates whether a chemical has been found by NTP or IARC to be a potential carcinogen. [Note from commenter. The content of previous section (d)(4) was deleted from the new federal standard without amendment.] (4) Manufacturers, importers, and employers classifying chemicals evaluating substances shall treat any of the following sources as establishing that a chemical substance is a carcinogen or potential carcinogen for hazard communication purposes: (A) National Toxicology Program (NTP), Annual Report on Carcinogens, (latest edition). (B) International Agency for Research on Cancer (IARC) Monographs (latest editions). (C) 29 CFR Part 1910, Subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration. Note to (d)(4): The registry of Toxic Effects of Chemical Substances published by the National Institute for Occupational Safety and Health indicates whether a substance has been found by NTP or IARC to be a potential carcinogen (d)(5) (d)(3) 5194(d)(5) (d)(5) The chemical manufacturer, importer or employer shall determine the hazards of mixtures of chemicals as follows: (d)(5)(i) If a mixture has been tested as a whole to determine its hazards, the results of such testing shall be used to determine whether the mixture is hazardous; (d)(5)(ii) If a mixture has not been tested as a whole to determine whether the mixture is a health hazard, the mixture shall be assumed to present the same health hazards as do the components which comprise one percent (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a (d)(3) Mixtures. (d)(3)(i) Chemical manufacturers, importers, or employers evaluating chemicals shall follow the procedures described in Appendices A and B to to classify the hazards of the chemicals, including determinations regarding when mixtures of the classified chemicals are covered by this section. (d)(3)(ii) When classifying mixtures they produce or import, chemical manufacturers and importers of mixtures may rely on the information provided on the (5) The manufacturer, importer, or employer shall determine the hazards of mixtures of substances as follows: Mixtures. (A) Manufacturers, importers, or employers evaluating chemicals shall follow the procedures described in Appendices A and B to section 5194 to classify the hazards of the chemicals, including determinations regarding when mixtures of the classified chemicals are covered by this section. (B) When classifying mixtures they produce or import, manufacturers and importers of mixtures may rely on the information provided on the current safety data sheets of the individual ingredients except where the manufacturer or importer knows, or in the exercise of reasonable diligence should know, that the safety data sheet misstates

12 Page 12 of 15 carcinogenic hazard if it contains a component in concentrations of 0.1 percent or greater which is considered to be a carcinogen under paragraph (d)(4) of this section; (d)(5)(iii) If a mixture has not been tested as a whole to determine whether the mixture is a physical hazard, the chemical manufacturer, importer, or employer may use whatever scientifically valid data is available to evaluate the physical hazard potential of the mixture; and, (d)(5)(iv) If the chemical manufacturer, importer, or employer has evidence to indicate that a component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees in those concentrations, the mixture shall be assumed to present the same hazard. current safety data sheets of the individual ingredients except where the chemical manufacturer or importer knows, or in the exercise of reasonable diligence should know, that the safety data sheet misstates or omits information required by this section. or omits information required by this section. (A) If a mixture has been tested as a whole to determine its hazards, the results of such testing shall be used to determine whether the mixture is hazardous; (B) If a mixture has not been tested as a whole to determine whether the mixture is a health hazard, the mixture shall be assumed to present the same health hazards as do the components which comprise one percent (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 percent or greater which is considered to be a carcinogen under section 5194(d)(4); (C) If a mixture has not been tested as a whole to determine whether the mixture is a physical hazard, the manufacturer, importer, or employer may use whatever scientifically valid data is available to evaluate the physical hazard potential of the mixture; and (CD) If the manufacturer, importer, or employer has evidence to indicate that a component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established permissible exposure limit or ACGIH Threshold Limit Value, or could present a health hazard to employees in those concentrations, the mixture shall be assumed to present the same hazard (f)(11) (f)(11) 5194(f)(11) f)(11) Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within three months of (f)(11) Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels (10)(11) Manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a substance chemical shall revise the labels for the substance chemical within three months of becoming aware of the new information.

13 Page 13 of 15 becoming aware of the new information. Labels on containers of hazardous chemicals shipped after that time shall contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importers, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again. for the chemical within six months of becoming aware of the new information, and shall ensure that labels on containers of hazardous chemicals shipped after that time contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importer, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again. Labels on containers of hazardous chemicals substances shipped after that time shall contain the new information. If the substance chemical is not currently produced or imported, the manufacturer, importer, distributor, or employer shall add the information to the label before the substance chemical is shipped or introduced into the workplace again.

14 Page 14 of 15 ATTACHMENT 2 APPENDIX A TO HEALTH HAZARD CRITERIA (MANDATORY) A.0 GENERAL CLASSIFICATION CONSIDERATIONS A.0.1 Classification A The term "hazard classification" is used to indicate that only the intrinsic hazardous properties of chemicals are considered. Hazard classification incorporates three steps: (a) identification of relevant data regarding the hazards of a chemical; (b) subsequent review of those data to ascertain the hazards associated with the chemical; (c) determination of whether the chemical will be classified as hazardous and the degree of hazard. A For many hazard classes, the criteria are semi quantitative or qualitative and expert judgment is required to interpret the data for classification purposes. A.0.2 Available data, test methods and test data quality A There is no requirement for testing chemicals. A The criteria for determining health hazards are test method neutral, i.e., they do not specify particular test methods, as long as the methods are scientifically validated. A The term "scientifically validated" refers to the process by which the reliability and the relevance of a procedure are established for a particular purpose. Any test that determines hazardous properties, which is conducted according to recognized scientific principles, can be used for purposes of a hazard determination for health hazards. Test conditions need to be standardized so that the results are reproducible with a given substance, and the standardized test yields "valid" data for defining the hazard class of concern. A Existing test data are acceptable for classifying chemicals, although expert judgment also may be needed for classification purposes. A The effect of a chemical on biological systems is influenced, by the physico chemical properties of the substance and/or ingredients of the mixture and the way in which ingredient substances are biologically available. A chemical need not be classified when it can be shown by conclusive experimental data from scientifically validated test methods that the chemical is not biologically available. A For classification purposes, epidemiological data and experience on the effects of chemicals on humans (e.g., occupational data, data from accident databases) shall be taken into account in the evaluation of human health hazards of a chemical.

15 Page 15 of 15 A.0.3 Classification based on weight of evidence A For some hazard classes, classification results directly when the data satisfy the criteria. For others, classification of a chemical shall be determined on the basis of the total weight of evidence using expert judgment. This means that all available information bearing on the classification of hazard shall be considered together, including the results of valid in vitro tests, relevant animal data, and human experience such as epidemiological and clinical studies and well documented case reports and observations. A The quality and consistency of the data shall be considered. Information on chemicals related to the material being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be considered together in a single weight of evidence determination. A Positive effects which are consistent with the criteria for classification, whether seen in humans or animals, shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification. Reliable, good quality human data shall generally have precedence over other data. However, even well designed and conducted epidemiological studies may lack a sufficient number of subjects to detect relatively rare but still significant effects, or to assess potentially confounding factors. Therefore, positive results from well conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data. A Route of exposure, mechanistic information, and metabolism studies are pertinent to determining the relevance of an effect in humans. When such information raises doubt about relevance in humans, a lower classification may be warranted. When there is scientific evidence demonstrating that the mechanism or mode of action is not relevant to humans, the chemical should not be classified. A Both positive and negative results are considered together in the weight of evidence determination. However, a single positive study performed according to good scientific principles and with statistically and biologically significant positive results may justify classification.

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