March 4, 2014
Erik C. B***
Washington, DC 20005
Re: Request for Interpretation OSHA's Amended Hazard Communication Standard (HCS 2012) regarding Petroleum Streams
Dear Mr. B***:
This letter is being issued to API to provide guidance on how to apply the March 26, 2012, revisions to OSHA's Hazard Communication Standard (HCS 2012). Classifiers may rely on the following guidance in applying the classification and SDS requirements of HCS 2012 to petroleum streams.
For purpose of this letter, a petroleum stream includes crude oil and anything derived from crude oil that is:
- a well-defined chemical compound defined by a Chemical Abstracts
Service Number, such as butane or propane, aside from impurities and
- a Substance of Unknown or Variable composition, Complex reaction
products or Biological materials (UVCBs) defined by a Chemical Abstracts
Petroleum Stream Classification
The obligation to classify the health hazards of petroleum streams under the Hazard Communication Standard may be satisfied by following the below guidance, in conjunction with the general guidance found in A.0.1-A.0.3, in the application of the classification criteria in Appendix A of the standard.
- For hazard classes other than carcinogenicity, germ cell
mutagenicity, and reproductive toxicity ("CMR"), a petroleum stream
shall be classified as follows:
(a) Where test data are available for the petroleum stream, the classification of the stream will always be based on those data.
(b) Where test data are not available for the stream itself, the classification may be based on a toxicologically appropriate read across from test results of a substantially similar stream. A substantially similar stream is one that has a similar starting material, production process, and range of physico-chemical properties (e.g., boiling point and carbon number) and similar constituent compositions.
(c) If test data are not available either for the stream itself or a substantially similar stream, then the method(s) described in each chapter of Appendix A for estimating the hazards based on the information known will be applied to classify the stream (i.e., application of cut-off values/concentration limits).
- For the CMR hazard classes:
(a) When reliable and good quality data are available to classify a petroleum stream-based on testing of the stream or the toxicologically appropriate read-across to a substantially similar stream-a weight of evidence analysis supported by that data may be relied upon for classification regardless of whether a CMR constituent is present in the stream. A substantially similar stream is one that has a similar starting material, production process, and range of physico-chemical properties (e.g., boiling point and carbon number) and similar constituent compositions.
(b) To be reliable and good quality test data, the data must be from one or more tests that reflect appropriate study design and performance. The study or studies must appropriately take into account dose and other factors such as duration, observations, and analysis (e.g. statistical analysis, test sensitivity) so as to conclusively exclude the possibility that the lack of effect(s) is due to a poor study design, e.g., insufficient dose or number of subjects. A study (or studies) is conclusive in this sense if, when viewed in conjunction with all relevant information about the chemical, its results are consistent with the relevant information and allow a strong inference that the lack of effects is not due to a poor study design.
(c) Where reliable and good quality data are not available on the stream or a substantially similar stream, then the method(s) described in each chapter of Appendix A for estimating the hazards based on the information known will be applied to classify the stream (i.e., application of cut-off values/concentration limits).
Safety Data Sheet Disclosure
Many petroleum streams are of unknown or variable concentration, and cannot be represented by unique structures, molecular formulas, or fixed concentration percentages. In addition, petroleum industry test data are largely based on the testing of streams rather than the hundreds or thousands of individual constituents of those streams. In light of these facts, application of the disclosure requirements in Section 3 of table D.1 to petroleum streams may be infeasible and/or undermine the usefulness of the SDS. Thus, SDSs for petroleum streams that are in accordance with the following guidance will be considered to be in compliance with the standard for enforcement purposes.
- When dealing with petroleum streams, it may be more important for
the user to know the concentrations of particular groups of constituents
that are toxicologically similar. For example, in the classification
of a petroleum stream, it may be more relevant to know the total
concentration of a class of constituents such as polycyclic aromatic
hydrocarbons (PAH) to understand the health hazards of the stream,
rather than knowing the concentration of each particular PAH. Further,
information about the presence and concentration of particular
constituents of the group might not be available, or even if it were,
inclusion of every one could lead to the listing of hundreds of
constituents. This is likely to undermine the effectiveness of the
disclosure requirements in Section 3. Thus, where the classifier can
show that it is toxicologically appropriate to treat a particular set of
constituents as a group, and all of the toxicologically useful
information about the constituents in that group is conveyed by treating
them as a group, SDS need only include the name and concentration of
that group in Section 3 if present above the cut-off/concentration limit
(or if the group presents a health risk below the cut-off/concentration
limit). The foregoing example of PAHs is designed to assist in better
understanding the concept of this paragraph. It is not intended to
limit the application of this approach to any particular type or group
- Other constituents, such as benzene or n-hexane, that are known to
be present in the stream, and that present classified health hazards,
must be listed individually in Section 3 along with their concentrations
if present above the cut-off/concentration limit (or if the constituent
presents a health risk below the cut-off/concentration limit).
- Where there is "reliable and good quality" data supporting a weight
of evidence determination that a constituent in a petroleum stream
poses no health risk (as per A.0.4.3.3) in a downstream use of the
stream, it need not be disclosed on the SDS.
- Where the classifier does not know the exact concentration of a constituent or group of constituents included in Section 3 of the SDS, it may use a range of concentrations instead. Concentration ranges, if used, must be based on the information available to the classifier, such as analysis results, product specifications, or nature of the process, and the high end of the range reported may not affect the reported hazard classification.