OSHA CPL 02-02-079, Appendix BCPL 02-02-079, App B
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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;
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 for which OSHA has a permissible exposure limit (PEL) in 1910.1000 or a comprehensive substance-specific standard in Subpart Z. If OSHA has included cancer as a health hazard to be considered by classifiers in a substance specific hazard, the substance must be classified as a carcinogen. If such a substance is an ingredient in a mixture, the mixture must be classified as a carcinogen if it is present at a concentration of 0.1% or more, or at a lower concentration if it would present a health risk.
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'sDirectorate 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.
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.
If the CSHO's [Compliance Safety and Health Officer's] research finds one positive study and the result of the classification process by the chemicalmanufacturer 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.
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.
* 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.