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The hazard classification procedures required by the standard are specification-oriented. The HCS has provided procedures on how to classify chemical in paragraph (d), and Appendix A and B of the standard. The term hazard classification is used to indicate not only the types of hazards presented by the chemical, but also the severity of the hazard. The hazard classification criteria are designed so the intrinsic hazardous properties of chemicals are considered for the known or intended use(s) of the products. Evaluation of the hazard classification incorporates three steps:
- Identification of relevant data regarding the hazards of a chemical;
- Subsequent review of those data to ascertain the hazards associated with the chemical;
- Determination of whether the chemical should be classified as hazardous and the degree of hazard.
Steps CSHOs Should Take When Evaluating Product SDSs
- The first step for CSHOs [Compliance Safety and Health Officers] when evaluating an SDS is to determine whether the chemical should be considered hazardous . The CSHO can determine this by reviewing the following sources:
- If the chemical or one or more of its ingredients are any of the following lists, then further investigation is warranted to determine whether it should be classified:
Any substance which the National Toxicology Program (NTP), https://ntp.niehs.nih.gov, or the International Agency for Research on Cancer (IARC), http://www.iarc.fr, has found to be a suspect or confirmed carcinogen or which
OSHA regulates as a carcinogen.
- CSHOs [Compliance Safety and Health Officers] may consult available sources in evaluating the chemical to see what has been published regarding the chemical. There are a number of databases online that can be consulted, such as the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS), http://www.epa.gov/IRIS, the Organisation for Economic Co- operation and Development (OECD) eChemPortal, http://www.oecd.org/chemicalsafety/risk-assessment/echemportalglobalportaltoinformationonchemicalsubstances.htm, or the European Chemical Agency's (ECHA) chemical database, http://echa.europa.eu/information-on-chemicals. Another helpful source could be Patty's Industrial Hygiene and Toxicology.
- Other sources that may be useful in determining whether a chemical is hazardous :
- Finally, for those chemicals where information is not readily available or where such available information is not complete, perform searches of bibliographic databases. In general, the National Library of Medicine (NLM) services should be used. These include the Toxicology Data Bank (TDB), TOXLINE, and MEDLARS. The information generated by these databases should be evaluated using the criteria in Appendix A of the standard. To evaluate whether a particular study would qualify as an acceptable study, it must be conducted according to established scientific principles (e.g., in animal studies, the number of subjects is adequate to do statistical analyses of the results; a control group is used, and the study must show statistically significant results indicating an adverse health effect). This evaluation obviously requires professional judgment. Any questions should be referred to the Regional Hazard Communication Coordinator, who may forward them, if necessary, to
the Health Response Team (HRT), a division of the Salt Lake Technical Center, under OSHA's Directorate of Technical Support and Emergency Management (DTSEM). A bulk sample of the chemical may be needed by the SLTC (HRT) to assist in their review.
- If an employer or manufacturer used their own test data as the basis for the hazard classification, the CSHO [Compliance Safety and Health Officer] should collect the test data used to classify the hazard and then request DTSEM to review the information. If the employer denies the CSHO access to the test and no other published data on the chemical can be found, the Regional Office shall be contacted for assistance in obtaining an administrative subpoena. The DTSEM in OSHA's National Office should be contacted if assistance is required in order to obtain unpublished chemical hazard information available from other Federal agencies such as the EPA.
- Published studies and test data should be evaluated using the HCS criteria in Appendix A for health hazards and in Appendix B for physical hazards in the standard. If needed, the DSG or DTSEM offices could assist in the review of the studies and test data.
- 6. In the event that there are any questions concerning the adequacy of the manufacturer's hazard classification, the CSHO [Compliance Safety and Health Officer] shall collect the information from the studies used to classify the chemical(s), and any justification the manufacturer or importer provided to support the classification. For example, this situation might arise when the CSHO has discovered scientific data indicating a hazard, but the chemical manufacturer's hazard classification has not classified the chemical as hazardous or two different manufacturers have classified the same chemical differently. In this case, the Area Director should then contact the Regional Hazard Communication Coordinator, who then may refer those findings to HRT for review, as necessary. HRT scientists will conduct a review of the hazard classification for conformance with 29 CFR 1910.1200(d) and AppendicesA and B. A bulk sample of the chemical may be needed by the SLTC (HRT) to assist in their review.
Examples of when a CSHO might refer a product SDS to HRT for review:
In general, if the CSHO [Compliance Safety and Health Officer] has found studies or other data to indicate that the product presents a health or physical hazard, but the manufacturer has not adequately addressed or has not provided a rationale on why they have not classified the product as hazardous , the CSHO should refer the SDS to HRT for review.
- Carcinogens:
- If the chemical is listed by IARC or NTP as a carcinogen and the chemical manufacturer or importer has not provided the determinations by IARC or NTP on the SDS; or
- The CSHO [Compliance Safety and Health Officer] has determined that there is at least one positive study for carcinogenicity but the manufacturer has not classified the chemical as a carcinogen or indicated the positive study on the SDS.
Appendix C of this Instruction provides more information concerning the evaluation of carcinogen classifications and a comparison of the HCS carcinogen classifications versus determinations by IARC and NTP. It also provides, in Table C.2, guidance for label and SDS notations for carcinogens.
- Germ Cell Mutagens/Reproductive Toxins:
If the CSHO's [Compliance Safety and Health Officer's] research finds one positive study and the result of the classification process by the chemical manufacturer or importer is non-classification. The HCS states that one positive study performed according to good scientific principles and with statistically and biologically significant results may justify classification as a germ cell mutagen or reproductive toxin.
Guidance for HRT Scientists' Review:
- Review the data and classification findings by the chemical manufacturer or importer.
- Evaluate the data for conformance with classification procedures set forth in 29 CFR 1910.1200(d) and Appendix A and Appendix B.
- Determine if the chemical manufacturer or importer has followed the appropriate classification procedures:
- Has the manufacturer or importer adequately addressed appropriate data (e.g., did not ignore data that disagreed with their conclusion)?
- Have they performed an appropriate weight of evidence analysis according to Appendix A.0 and the specific guidance in Appendix A for each hazard (in general, human evidence normally would carry more weight than animal studies or structural activity)?
- Have they applied the criteria and bridging principles (if applicable) appropriately for each individual hazard classes?
- Provide HRT's evaluation to the Area Office where they will determine whether a citation is warranted. For example, if HRT's evaluation finds the hazard evaluation to be incomplete or incorrect, a citation may be warranted.
- If necessary, the Regional Office may refer the hazard classification to DEP which will coordinate with DTSEM and the Directorate of Standards and Guidance (DSG) to review the data and classification findings.
Guidance for HRT Scientists' Review:
* See Table A.4.5 of the HCS 2012 standard for cut-off values for Category 1B ingredients.
** Note: If a Category 2 carcinogen ingredient is present in the mixture at a concentration between 0.1% and 1%, information is required on the SDS for a product. However, a label warning is optional. If a Category 2 carcinogen ingredient is present in the mixture at a concentration of ≥1%, both an SDS and a label is required and the information must be included on each.
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Entry last updated: Saturday, July 30, 2016.
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