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Comments on OSHA's Proposal to Modify the Hazard Communication Standard (HCS) to Align with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), December 29, 2009

December 29, 2009

OSHA Docket Office
Docket No. OSHA-H022K-2006-0062
U.S. Department of Labor
Room N-2625
200 Constitution Avenue, NW
Washington, DC 20210

Re:  The following are comments submitted on behalf of the Industrial Minerals Association – North America (IMA-NA) regarding the proposed modifications to the Hazard Communication Standard

The Industrial Minerals Association – North America (IMA-NA) is pleased to present its comments on the Occupational Safety and Health Administration’s (OSHA) September 30, 2009, proposed Hazard Communication Rule.  IMA-NA represents companies which mine and process industrial minerals throughout the United States.  IMA-NA’s members primarily operate under the jurisdiction of the Mine Safety and Health Administration, but some of their operations—and the operations of most of their customers, where the industry’s products are used—are subject to the jurisdiction of OSHA.

OSHA is proposing to modify its existing Hazard Communication Standard (HCS) to align with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  The outcome for the proposed rule by OSHA should be the adoption of requirements that help achieve the goal of harmonization of hazard communication while minimizing the cost and burdens that aligning HCS with GHS will impose on producers and users substances and products including those from the industrial minerals industry.  With these objectives in mind, IMA-NA is providing the following observations as well supplemental comments attached as an appendix that address specific issues identified by OSHA in its proposal.

IMA-NA believes the burdens and costs (especially to small businesses) have been significantly underestimated in the proposed rule, and we concur with other submittals which have demonstrated this failing.  However, we do believe that the proposed rule should apply equally to all companies as any special provisions or alternative requirements for business entities of different sizes would only serve to dilute the overall effectiveness of developing a harmonized hazard communication standard.

The new rule is extensive and detailed.  Conceptually IMA-NA agrees with OSHA’s “preliminary determination that the proposed modifications will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures.”  But the “consistency” OSHA aims to accomplish through the new rule will not be achieved if pre-emption of state law tort claims is not incorporated into the standard. 

IMA-NA is particularly concerned with the failure of the new rule to make clear that state law tort claims are pre-empted relative to labels, warnings and other requirements.  IMA-NA submits that state law tort claims alleging failure to warn or failure to adequately warn should not be permitted against those who comply with GHS requirements, as such claims should be pre-empted.

The United States is a litigious society.  Our members have been the victims of thousands of frivolous lawsuits over decades.  These suits have been based on an alleged “failure to warn” concerning the potential health effects associated with respirable crystalline silica, even when labels and Material Safety Data Sheets have presented hazard information and precautions that have exceeded relevant standards.  In the absence of pre-emption, the adequacy of labels and warnings will be determined in the courtrooms of the United States.  Since the adequacy of warnings is a “fact” question, the authority of OSHA rules governing the adequacy of labels and warning will be superseded by decisions from juries.  The conclusion of any jury does not establish a “precedent”; in other words, the same labels and warnings can be adequate or inadequate, in the same county (depending on the jury), or in different counties within the same state, or in different states.

If the new HCS is to achieve its desired goal of “consistency,” then it must make clear that if a company has, in good faith, followed the requirements of the HCS, no additional burdens can be placed on the company by lawsuits alleging that the HCS compliant company failed to adequately warn.

The IMA-NA is hopeful that the new Standard will result in safer workplaces through a consistent protocol for labels and warnings, but we are confident this goal will not be achieved without a realization of the complications imposed by the American tort system.  We urge OSHA to include in the final standard a provision which pre-empts state law tort claims.

APPENDIX - RELEVANT ISSUES REQUESTED FOR COMMENT BY OSHA 

Issue #6. OSHA is proposing to adopt all of the physical and health hazard classes in the GHS. Among the physical and health hazard classes, OSHA is proposing to include all hazard categories in the GHS except Acute Toxicity Category 5 for oral, dermal, or inhalation exposures; Skin Corrosion/Irritation Category 3; and Aspiration Hazard Category 2. If you believe that the exclusion of these hazard categories is not consistent with the scope and/or level of protection provided by the current HCS, please describe any recommended changes to this proposal and the reasons you think these changes are necessary.

Comment – IMA-NA supports the exclusion of the above hazard categories as mandatory under the current proposal which would be consistent with the scope and/or level of protection provided by the current HCS.  This approach would also be consistent with that taken elsewhere including European Commission that excluded certain hazard categories including Acute Toxicity Category 5 from its Classification, Labeling and Packaging ("CLP") regulation as part of its adoption of GHS.  Business entities however, should not be specifically prohibited from including the above categories on their labels if they seek standardized labeling information contained on products intended for both domestic and export use.

Issue #7. OSHA has proposed a definition for unclassified hazards be added to the HCS to ensure that all hazards currently covered by the HCS – or new hazards that are identified in the future – are included in the scope of the revised standard until such time as specific criteria for the effect are added to the GHS and subsequently adopted by OSHA. Will this approach provide sufficient interim coverage for hazards such as combustible dust? Are there other hazards for which criteria should be developed and added to the GHS? Please provide information regarding these hazards, and the information available to characterize them.

Comment – The term “unclassified hazard” appears to be broad and ambiguous, and ultimately may be confusing to workers as any accompanying precautionary statements and warnings for a hazard yet to be classified or defined.  We encourage OSHA to adopt only hazard endpoints that can be clearly classified based upon well defined criteria for establishing and complying with these endpoints.  Where a known hazard exists that does not currently fit clearly into a classification, appropriate definitions or clarification can be added to the GHS guidance.  Case in point, it appears that the example given by OSHA of combustible dust could fall under the current UN GHS guidelines under physical hazards for flammable solids under readily combustible solids which are defined as “powdered, granular or pasty substances which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly.”   For clarity, the inclusion of the NFPA definition of a combustible dust could be included in the above section of the GHS guidelines: “Any finely divided solid material that is 420 microns or smaller in diameter (material passing a U.S. No. 40 Standard Sieve) and presents a fire or explosion hazard when dispersed and ignited in air."

Issue #9. In order to help to ensure that health hazard determinations are properly conducted under a performance-oriented approach, the HCS includes a "floor" of chemicals that are to be considered hazardous based on several cited reference lists. In addition, the existence of one toxicological study indicating a possible adverse effect is considered sufficient for a finding of hazard for any health effect. Under the GHS, there is no floor of chemicals cited, nor is there an across-the-board provision such as the one-study criterion. Instead, specific, detailed criteria are provided for each type of health hazard to guide the evaluation of relevant data and subsequent classification of the chemical. The proposed modifications to the HCS would align the standard to the GHS approach, and thus do not include the floor of chemicals nor the universal one-study rule. Would the proposed detailed criteria provide sufficient guidance for a thorough hazard evaluation?

Comment – IMA-NA supports the proposal by OSHA to remove the “floor” of chemicals that are considered hazardous based on several cited reference lists.  We also support the removal of the “one-study rule.”  Removal of both these provisions clearly would be a positive change while their inclusion would only serve to detract from an evaluators ability to perform a true weight-of-evidence approach which ideally should be based on an equitable and balanced consideration of all relevant study findings to determine the appropriate hazard for relevant health effect(s).  The experience of our member companies from working in other countries that have adopted GHS is that the proposed criteria provide sufficient guidance for a thorough hazard evaluation.

Issue #10. OSHA has edited the chapters in the GHS for classification of physical and health hazards to remove material not directly related to classification and to otherwise streamline the text. OSHA anticipates providing the decision logics separately to serve as guidance, but has not included them in the regulatory text. Are there any additions, subtractions, or clarifications of the classification criteria from the GHS that OSHA needs to consider?

Comment – IMA-NA does not currently have any additions, subtractions, or clarifications to offer regarding the classification criteria from the GHS that OSHA needs to consider. We do however, encourage OSHA to seek additional public input/comments at that time in which it develops the anticipated decision logics that will serve as guidance as noted above in the description of this issue.    

Issue #11. Certain physical hazard classification criteria (i.e., for self-reactive chemicals, organic peroxides, self-heating chemicals, explosives) either directly reference packaging or quantity, or rely on test methods that reference packaging or quantity. The criteria were developed for transport concerns. Clearly, quantity and packaging can greatly affect safe transport of chemicals that pose hazards such as those listed above. However, OSHA seeks comments on whether the criteria as stated in the GHS are appropriate for the workplace. Does use of these criteria present any obstacles to classification or create any difficulties for suppliers or users of chemicals? Describe any difficulties these criteria may present and any suggestions for addressing these issues, particularly recommendations that would be consistent with the GHS and maintain the GHS level of safety for these chemicals.

Comment –The classification, labeling, handling and storage of chemicals related to transport concerns should remain aligned with the principles of HCS.   OSHA should seek where possible to reduce incompatibilities between HCS criteria and US DOT transportation requirements. 

Issue #12. The GHS gives countries guidance on a cut-off or concentration limit for chemical mixtures containing target organ toxicity hazards. In Appendix A, Section A.8.3, OSHA is proposing to make the suggested 20% concentration limit mandatory so that label preparers are clear on what needs to be done. Please comment on whether this mandatory concentration limit is appropriate. If you have an alternative, please provide it along with the rationale.

Comment – It should be noted that setting 20% as the mandatory cut-off or concentration limit for chemical mixtures containing target organ toxicity hazards is an arbitrary value as the hazard endpoint for difference chemicals within a mixture may occur at higher or lower levels.  We encourage OSHA to adopt a weight-of-evidence approach for identifying the target organ toxicity of mixtures – particularly where data exists for making sound scientific decisions by evaluators.  This should include consideration of each mixture and its component based on the toxicology of the each of the components of the mixture, which includes a dose response assessment.  It should be noted that the 20% limit appears to apply only to Specific Target Organ Toxicity – Single Exposure since it refers to Category 3 ingredients.  Category 3 ingredients are those substances associated with transient target organ effects, and only consist of respiratory tract irritants and narcotic effects. If OSHA proceeds with adopting this portion of its proposal it should develop clear guidance on how to comply including identifying the target endpoints captured by the cut-off or concentration.  . 

Issue #13. The proposal would require pictograms to have a red frame. As discussed in Section V, OSHA believes that use of the color red will make warnings more noticeable and will aid in communicating the presence of a hazard. However, the GHS gives competent authorities such as OSHA the discretion to allow use of a black frame when the pictogram appears on a label for a package which will not be exported. For packages that will not be exported, should the modified standard allow black frames on pictograms, or should the pictogram frame be required to be presented in red?

Comment – IMA-NA member companies produce product labeling intended for both domestic consumption as well as import/export to and from the United States.  Flexibility should be provided that allows industry to use either red or black borders on their labels in order to standardize their global approach where desired based on their own production and distribution needs.  This approach would be consistent with the UN Purple Book which provides for this provision.  Awareness of this distinction can be apart of downstream employee training which would further foster the original intent of using borders to make warnings more noticeable to communicating hazard.

Issue #14. In addition to the pictograms, signal word and hazard statements, GHS labels must include precautionary statements. OSHA is proposing to require the text in the precautionary statements in the GHS to be on HCS labels. As discussed in Section XV Summary and Explanation of the Proposed Standard, these statements are codified under the GHS, meaning that numbers have been assigned to them. In addition, the appropriate statements to use for each hazard class and category have been indicated in the GHS annexes. This means that label preparers will know exactly what precautionary statements to apply once they complete their hazard classification, and chemical users will see consistent language on labels to indicate the necessary precautionary measures. However, the statements are not yet considered to be part of the harmonized text like hazard statements are; rather they are included in the GHS as a suggested language. OSHA expects that other countries may adopt the codified precautionary statements when they put GHS in place. For example the EU has required that labels use the GHS codified precautionary statement text in adapting the GHS. Since OSHA did not previously require the use of precautionary statements, and had no such recommended statements to provide, the Agency is proposing to use those currently in the GHS as the mandatory requirements with the option of consolidating statements where appropriate (See Appendix C). OSHA anticipates this approach will provide the maximum benefit. OSHA is also seeking comment on whether any of these statements should be modified or if other precautionary statements should be included.

In addition, as discussed in Section IV, OSHA has presented other alternatives with regards to precautionary statements, and OSHA is soliciting comment on these options as well. Specifically, OSHA is seeking feedback on whether the Agency should include the GHS precautionary statements as nonbinding examples, through a non mandatory appendix or guidance, rather than as required statements, or whether OSHA should allow label preparers to develop their own precautionary statements rather than specifying the text to be used.

Comment – IMA-NA encourages OSHA to adopt required text in the precautionary statements in the GHS to be on HCS labels.  While we recognize that the proposed precautionary statement text found within the GHS are offered as suggested language, we expect much like OSHA that other countries will adopt the codified precautionary statements when they put GHS in place.  The standardization of precautionary statements will also allow for the development and adoption of accurate translations.  The alternative will be the need to develop duplicate labels with different precautionary language in order to comply with either domestic and export regulatory commitments based on non-standardized global requirements.  

As noted in our above introductory remarks, IMA-NA is particularly concerned with the failure of the new rule to make clear that state law tort claims are pre-empted relative to labels, warnings and other requirements.  IMA-NA submits that state law tort claims alleging failure to warn or failure to adequately warn should not be permitted against those who comply with labeling requirements including precautionary statements as implemented by OSHA, as such claims should be pre-empted.

Issue #16. In the current HCS, OSHA has a provision that requires labels to be updated within three months of obtaining new and significant information about the hazards. The Agency has not been enforcing this provision for many years, and there has been an administrative stay on enforcement. OSHA is including the provision in this proposal, and inviting comment on it with the intention of including it in the final rule and lifting the stay. Is three months the appropriate time interval for updating? Are there any practical accommodations that need to accompany this limit (for example, related to stockpiles of chemicals)? Provide any alternatives you consider appropriate, as well as documentation to support them.

Comment – IMA-NA recognizes the need to provide new and relevant information on the product labels in a timely manner.  However, practical barriers exist within the supply chain that would limit the ability of entities to comply with such a short compliance interval resulting in considerable burdens and costs (especially to small businesses).  This impact includes potential disruption to the supply chain and burden to downstream customers that may need to shoulder responsibility for removing or repackage existing products.  These limitations are echoed in part by the fact the OSHA itself is not currently enforcing this provision under HCS.  These challenges do not account for the fact that a large portion of the available time will be consumed during the evaluation phased to decide whether new information is relevant for triggering a label revision not to mention the period of time required to develop/revise the hazard classification and/or updated revisions required for the label(s).  It should also be noted that new information when available typically does not apply to a single product or substance but rather impacts a wide array of products and their labels which compounds the impact and amount of time needed to implement changes. 

Issue #17. As discussed in Section XV, the Agency is proposing to require that OSHA permissible exposure limits (PELs) be included on the SDS, as well as any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet. OSHA welcomes comments on this approach, along with an explanation of the basis for your position.

Comment – IMA-NA supports the inclusion of OSHA Permissible Exposure Limits (PEL) within SDS documents as a mandatory requirement.  However, information concerning exposure limit levels from other sources should not be required under the proposed rule.  This is particularly relevant to guidelines and recommendations from organizations or agencies that do not meet the requirements of U.S. law under the Data Quality Act ("DQA") and its legally binding guidelines.  For example, the HCS (29 CFR 1910.1200) currently requires SDS documents to include Threshold Limit Values (TLVs) developed by ACGIH and cancer hazard evaluations developed by the Internal Agency for Research on Cancer (IARC) “Monographs” both of which do not meet current Data Quality Act guidelines.  Rather the inclusion of any additional information such as that mentioned above should be optional and left to the professional judgment of qualified individuals responsible for developing and implementing SDS documents to make informed decisions concerning the relevancy of related information.  

Issue #18. OSHA is proposing that Section 15 of the SDS be non-mandatory. As indicated in Appendix D, Section 15 addresses regulatory information concerning the chemical. OSHA is considering requiring the substance specific standards be referenced in this section, which would make Section 15 mandatory. Would employers and employees benefit from having this information in this section of the SDS?

Comment – IMA-NA believes that there is value in retaining the requirement for inclusion of Sections 12-15 within SDS documents.  Regardless of its decision, IMA-NA strongly believes that the information content should be optional as OSHA has proposed.  And any requirements for inclusion of substance specific standards in Section 15 should be clearly delineated in rule make decision. 

Issue #23. In determining the health hazards that need to be considered by manufacturers, importers and distributors when classifying chemicals regulated by the substance-specific standards, OSHA is proposing to primarily rely on the determinations made by the Agency in each rulemaking, the NIOSH Pocket Guide to Chemical Hazards (2005) and the International Chemical Safety Cards, and use as a secondary source the health effects identified by the European Commission (2007). OSHA is proposing to include a health hazard only if it is identified as such by two or more of these organizations. Are there other sources of information that OSHA should consult?

Comment – IMA-NA does not support the proposal to include a health hazard only if it is identified as such by two or more of the organizations identified nor the use of other sources of information.  Reliance upon determinations of health hazards for chemical classification chemicals made by the Agency in each rulemaking, the NIOSH Pocket Guide to Chemical Hazards (2005) and the International Chemical Safety Cards, and use as a secondary source the health effects identified by the European Commission (2007) would run counter to the weight-of-evidence approach articulated in the principles of GHS.  Significant concern also exists from the potential use organizations or non-US based agencies which do not meet requirements of U.S. law under the Data Quality Act ("DQA") and its legally binding guidelines.

Issue #25. OSHA has proposed to require that employers train employees regarding the new labels and safety data sheets within two years after publication of the final rule to ensure they are familiar with the new approach when they begin to see new labels and SDSs in their workplaces. Is the proposed time appropriate?

Comment - Member companies of IMA-NA routinely include employee training as part of its work health safety programs.  Thus, we support proposal to mandate training on GHS.  The timeline required for implementation however, should be correlated with the decision buy OSHA (see Issue #26 below) concerning timing for chemical manufacturers, importers, distributors, and employers to be required to comply with all provisions of the modified final rule.  This is because the effectiveness of employee training will be reduced if it is decoupled from the actual appearance of related items within the workplace.  Additionally, OSHA should provide clear guidelines concerning which industries (i.e. business entities) are required to train its employees as well as requirements for demonstrating that employee training has been completed.

Issue #26. OSHA has proposed that chemical manufacturers, importers, distributors, and employers be required to comply with all provisions of the modified final rule within three years after its publication. Does this allow adequate time to review hazard classifications and amend them as necessary, and to revise labels and safety data sheets to reflect the new requirements? Would a shorter time frame be sufficient?

Comment – The implementation of new/revised hazard classifications, SDS documents, and product labeling will be a significant task for our members.  A three year implementation period following adoption of the Hazard Communication Rule by OSHA would be a stretch target for our members but would be achievable under the best circumstances.  That would mean implementation of the GHS would truly reduce the need for testing and evaluation of chemicals, since classification would be based on existing data and would only need to be performed once for each substance.

IMA-NA strongly encourages OSHA to provide interim guidance for those entities that choose to implement GHS compliant labels and SDS documents. Thus, three years following the issuance of the final rule should be adequate time for companies to begin issuing new compliant SDS documents and labels. Allowances should be provided for product labels issued prior to the target implementation date but remain within downstream customer inventories beyond this target date.

Issue #27. Are there any other factors that should be considered in establishing the phase-in period?

See comment provide above under Issue #26. 

Issue #29. OSHA received a number of comments that suggested that a database of chemical classifications should be developed and maintained to assist chemical manufacturers and importers in performing hazard classifications. This approach has been adopted in some other countries. Would such a data base be helpful? Who would be responsible for doing the classifications and maintaining them? How would the data base be kept aligned with other countries' classifications?

Comment – It is not clear how a database of chemical classifications would be developed and maintained.  Although such a database could be helpful as a reference, it is not clear how the classifications within the database would be populated especially since GHS is principally based on self-classification.  And would such a database hinder the ability to perform future weight-of-evidence based hazard classifications in future assessments?

IMA-NA is pleased it had the opportunity to comment on the proposed modification to the HCS, and we stand ready to assist in a constructive manner.

Sincerely,

Mark G. Ellis
President