# Hazard Communication (HazCom) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A00-24803 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** October 3, 2000 - **Citation:** 65 FR 59048 ## Text DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Parts 42, 47, 56, 57, and 77 RIN 1219-AA47 Hazard Communication (HazCom) AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION: Interim final rule; request for comments. SUMMARY: We (MSHA) are establishing this interim final rule entitled “Hazard Communication (HazCom)” (30 CFR Part 47) to reduce injuries and illnesses related to chemicals in the mining industry. The standard requires mine operators to assess the hazards of chemicals they produce or use and provide information to miners concerning chemical hazards by means of a written chemical hazard communication program; labeling containers of hazardous chemicals; providing access to material safety data sheets (MSDSs); and training miners. In response to the National Performance Review and President Clinton's subsequent Executive Memorandum on Plain Language in Government Writing, dated June 1, 1998, we wrote this interim final rule in a different style than the one used in the proposal. Most of the requirements in this interim final rule, however, are substantially the same as the proposed rule. This interim final rule reflects comments received on the Notice of Proposed Rulemaking, public hearings, and the notice published in the Federal Register on March 30, 1999 (64 FR 15144), requesting comments on the impact of certain regulatory mandates and related Executive Orders on the proposed rule. In response to the most recent re-opening of the record, commenters requested an opportunity to address the provisions of the whole rule. Although not legally required, we think the additional opportunity to comment on the interim final rule is appropriate given the new “plain English” format and the passage of time since the close of the original comment period. For these reasons, we are allowing the public an additional opportunity to comment. All comments received will become part of the rulemaking record. We will publish our response to the comments received during this additional comment period in the Federal Register . DATES: Effective date: This interim final rule is effective October 3, 2001. Comment period: Comments on this interim final rule must be received by November 17, 2000 to ensure consideration. ADDRESSES: Comments may be transmitted by electronic mail, fax, or mail, or dropped off in person at any MSHA office. Comments by electronic mail must be clearly identified as such and sent to this e-mail address: comments@MSHA.gov. Comments by fax must be clearly identified as such and sent to: MSHA, Office of Standards, Regulations, and Variances, 703-235-5551. Send mail comments to: MSHA, Office of Standards, Regulations, and Variances, 4015 Wilson Boulevard, Room 631, Arlington, VA 22203-1984, or to any MSHA district or field office. Interested persons are encouraged to supplement written comments with computer files or disks; please contact the Agency with any questions about format. FOR FURTHER INFORMATION CONTACT: Carol J. Jones, Director; MSHA Office of Standards, Regulations, and Variances; 703-235-1910. SUPPLEMENTARY INFORMATION: I. Introduction We identify our hazard communication standard as “HazCom” to abbreviate the term and to help readers distinguish it from the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS). In this interim final rule, “you” refers to production-operators and independent contractors, who have the primary responsibility for complying with our standards. Where needed, we use the terms “operator” or “independent contractor” to avoid confusion. HazCom's appearance is different from the 1990 proposed rule, which we modeled after OSHA's HCS. We have made a few substantive changes in the interim final rule where comments and information submitted to the record justified a change. Changes from the proposal are also meant to clarify intent, reduce burden, and eliminate unnecessary language and needless repetition. We have tailored provisions to better fit the mining industry. Despite the change of style, the substance of the requirements for most provisions remains the same as in the proposal. We tried to organize the standard in a way that optimized clarity, logic, and accessibility to the requirements. When HazCom was originally proposed as part 46 in 1990, a Congressional budget rider prohibited us from expending appropriated funds to enforce training requirements at surface nonmetal mines. The 1999 training rider, however, authorized us to expend funds to propose and promulgate a final training standard for surface nonmetal mines. We, therefore, promulgated new training standards on September 30, 1999, which address the exempted mining operations. We chose part 46 as the proper place in the Code of Federal Regulations for publication of this training rule so that it would be near our other training standards promulgated under section 115 of the Federal Mine Safety and Health Act of 1977. After publication of part 46, we determined that the proper place to publish the HazCom rule would be as a new part 47. This required us to move the existing part 47, National Mine Health and Safety Academy, to part 42 with other administrative provisions. The following is an outline of this HazCom preamble to help you find information more quickly. I. Introduction. A. Overview of Rulemaking. B. Regulatory History. II. Paperwork Reduction Act. III. Discussion of the Interim Final Rule. A. Subpart A—Purpose and Scope of HazCom. B. Subpart B—Hazard Determination. C. Subpart C—HazCom Program. D. Subpart D—Container Labels and Other Forms of Warning. E. Subpart E—Material Safety Data Sheet (MSDS). F. Subpart F—HazCom Training. G. Subpart G—Making HazCom Information Available. H. Subpart H—Trade Secrets. I. Subpart I—Exemptions. J. Subpart J—Definitions. K. Appendices. IV. Legal Authority and Feasibility. A. Statutory Requirements. B. Finding of Significant Risk. C. Finding of Feasibility. D. Petitions for Modification. V. The Regulatory Flexibility Act, the Small Business Regulatory Enforcement Fairness Act, and Executive Order 12866. A. Alternatives Considered. B. Consultation with SBA. C. Compliance Costs. D. Regulatory Flexibility Certification and Factual Basis. E. Benefits. VI. Other Regulatory Considerations. A. Unfunded Mandates Reform Act of 1995. B. The National Environmental Policy Act of 1969. C. Executive Order 12630: Government Actions and Interference with Constitutionally Protected Property Rights. D. Executive Order 12988: Civil Justice Reform. E. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks. F. Executive Order 13084: Consultation and Coordination with Indian Tribal Governments. G. Executive Order 13132: Federalism. A. Overview of Rulemaking MSHA's HazCom standard expresses two safety and health principles: miners have a right to know about the chemical hazards where they work and you have a responsibility to know about the chemical hazards at your mine. HazCom requires you to inform miners about chemical hazards. Chemically-related injuries and illnesses in the mining industry indicate that many operators and miners are not as aware of the presence and nature of hazardous chemicals as they should be. Injury and illness reports sent to us describe instances where miners— • Were using inadequate or improper personal protective equipment, • Did not know what they had been exposed to that caused their symptoms, • Failed to follow instructions because they misunderstood or were unaware of the consequences, and • Inadvertently misused a chemical from an unlabeled container. We expect the HazCom program—by increasing both knowledge and awareness—to bolster good work procedures, foster safer behavior, and reduce injuries and illnesses related to chemicals. When put into effect at a mine, HazCom should encourage better hazard identification and assessment; more consistent use of personal protective equipment; more informed process decisions; and greater awareness and care when working near hazardous chemicals. HazCom is an information and training standard about chemical hazards. To be successful in reducing accidents and injuries, your HazCom program must give miners an understanding of chemical hazards by informing them about mine processes and job procedures that can lead to chemical exposures. This can be a difficult technical subject using unfamiliar terms, scientific symbols, and complex physical laws. For the training to be credible, it must balance scientific accuracy against the miner's need to understand. 1. The Need for HazCom Our existing standards already require you to train miners in occupational health, hazard recognition, and the safety and health aspects of tasks, among other subjects. Except at underground coal mines, you must also label hazardous materials. Other HazCom provisions, however, are not currently required for mines. For example, currently you are not required to collect material safety data sheets (MSDSs), give copies of hazard information to miners, or keep a list of the hazardous chemicals at your mine. This rule is intended to ensure that your mine has a program that emphasizes chemical hazards. OSHA's HCS has evolved to apply to all industries in OSHA jurisdiction since it was originally promulgated in 1983 and, consequently, it already impacts some mines. Because of the HCS, manufacturers began sending labeled chemicals and providing MSDSs with product shipments to mines. Some mine operators began labeling their products and sending MSDSs with their products to help customers meet OSHA's HCS requirements. Many operators have segments of their business in OSHA jurisdiction and have created company-wide programs that brought their MSHA properties, as well as their OSHA properties, into compliance with the HCS. Some operators began complying with OSHA requirements in anticipation of a similar MSHA standard, using the unregulated interval as a time to assimilate the requirements into their mine's standard operating procedures. Although some operators on their own initiative have established programs that meet HazCom's provisions and goals, and have integrated OSHA's HCS requirements into the cultures of their mines, most have not made that effort or fully met those objectives. Coal mine example. In a 1997 case investigated by MSHA, an eastern Kentucky coal miner was periodically assigned to seal permanent brattices using a highly alkaline mortar. The miner had noticed after these assignments that his hands felt as if they were burning. He thought this resulted from the mortar. Although the operator assigned the miner other jobs for a while, the burning sensation did not go away and the miner was eventually returned to brattice work. On the Friday night after the reassignment, the miner's hands were burning painfully, and the raw, irritated skin eventually erupted in angry, oozing sores. On Sunday, the miner was hospitalized and placed on an intravenous antibiotic. He spent 6 days in the hospital and missed 2 weeks of work. During his recuperation, his physician referred the miner to a dermatologist, who asked the miner to get a copy of the mortar's MSDS in order to evaluate the problem and provide the proper treatment. When the miner asked the company for a copy of the MSDS, the safety director at first said he would have to arrange for it and then later refused to give it to him, saying that the miner had no right to the information. Metal and nonmetal mine example. In another recent case at a large Arizona copper mine, a tailings pond was so acidic it was damaging the system's pumps. The company hired a contractor to place lime in the pond to neutralize the acid and assigned a miner to the project, a job he had never done, and one presenting hazards the miner had never been trained for. About 4:00 p.m., the miner, trying to get the work done, walked down the slope of the pond and stepped onto an area of lime that appeared solid. His right leg sank into the lime up to his hips and he had to put his other leg into the material before he could get out. No emergency showers were available at the pond site for washing. Covered in wet lime, the miner drove himself 2 miles to the front gate while calling for help into a two-way radio. Through a series of unfortunate circumstances, the victim was not admitted to a hospital until 5:25 p.m. After stabilizing him, the hospital staff moved him the next day to the burn center, where he spent over a month with second- and third-degree burns over the lower half of both legs and the upper part of his right leg. He missed more than 2 months of work at the mine, returning to restricted duty while receiving a series of skin grafts. Chemical hazards in mining. Between 1984 and 1989, the National Institute for Occupational Safety and Health (NIOSH) surveyed almost 500 individual mines covering 70 commodities and about 60,000 miners for the National Occupational Health Survey of Mining (NOHSM). NOHSM documented over 10,000 individual hazardous chemicals and mixtures of hazardous chemicals to which miners could be exposed. Chemicals in the mining industry pose a range of hazards, from mild health effects to death. Some chemicals cause or contribute to chronic health problems, such as heart or kidney disease or cancer. The relationship between these injuries and illnesses and exposure to a chemical can be obscured by years of latency between the exposure and the onset of symptoms. Other chemicals cause acute injuries or illnesses such as dermatitis, burns, and poisonings. Some chemicals pose hazards by contributing to fires and explosions. In considering a HazCom standard, we reviewed reports of chemically-related injuries and illnesses reported to MSHA. From January 1990 through December 1999, the mining industry reported over 2500 chemical burns. More than 1,200 of these burns were lost work time cases, involving over 50 commodities, more than 60 job classifications, and exposures to chemicals at all sizes and types of mines. Bituminous coal mines reported the most chemical burns, and crushed and broken limestone mines reported the most in the metal and nonmetal industry. This same accident and injury data indicated more than 400 poisonings. This data takes into account only some of the acute effects reported as a result of chemical exposures and does not include the chronic effects that we know also occur. Some operators have a comprehensive HazCom program in place; others have some elements of a HazCom program; and some have none. We intend the HazCom standard to ensure that all operators give all miners the information, training, and access needed to protect themselves from chemically-related injuries and illnesses. HazCom unifies, focuses, and clarifies existing requirements and fills voids in miner protection. 2. The Major Provisions of HazCom Hazard determination. You must identify the chemicals at your mine and determine if they can present a physical or health hazard to miners. If you produce a chemical, such as gold, molybdenum sulfide, calcium oxide (lime), sand, and phosphates, among others, you must review available scientific evidence to determine if the material is hazardous. Some of the chemicals you produce that result from a chemical reaction, such as nitrogen oxides from blasting, may already be addressed on the MSDS for the original chemical. In this example, the original chemical is the explosive. For a chemical or mixture brought to your mine, such as diesel fuel, lubricants, solvents, and paints, you can rely on the evaluation performed by the chemical's manufacturer or supplier. HazCom program. You must develop, implement, and maintain a written comprehensive plan to formalize a HazCom program. The program must include provisions for container labeling, collection and availability of MSDSs, and training of miners. It also must contain a list of the hazardous chemicals known to be present at the mine; how you will inform miners of the hazards of non-routine tasks and of chemicals in unlabeled pipes. If your mine has more than one operator or has an independent contractor onsite, it must also describe how you will inform them about the chemical hazards and protective measures needed. Container labeling. A label is an immediate warning about a chemical's most serious hazards. You must ensure that containers of hazardous chemicals are marked, tagged, or labeled with the identity of the hazardous chemical and appropriate hazard warnings. The label must be in English and prominently displayed. We are not requiring you to label mine products that go off mine property though you must provide the information if a customer asks for it. Material safety data sheet (MSDS). A chemical's MSDS provides comprehensive technical and emergency information. It serves as a reference document for operators, exposed miners, health professionals providing services to those miners, and firefighters or other public safety workers. You must have an MSDS for each hazardous chemical at your mine. The MSDS must be accessible in the work area where the chemical is present or in a central location readily accessible to miners in an emergency. HazCom training. You must establish a training program to ensure that miners understand the hazards of each chemical in their work area, the information on MSDSs and labels, how to access this information when needed, and what measures they can take to protect themselves from harmful exposure. You may already cover some of this information in your current training program. If so, you do not have to re-train miners in topics they have already been trained in. Making HazCom information available. You must provide miners, their designated representatives, MSHA, and NIOSH with access to the materials that are part of the HazCom program. These include the HazCom program, the list of hazardous chemicals, labeling information, MSDSs, training materials, and any other material associated with the HazCom program. You do not have to disclose the identity of a trade secret chemical except when there is a compelling medical need. 3. The Basis for the HazCom Interim Final Rule In addition to the requirements in the Federal Mine Safety and Health Act of 1977 (Mine Act) and other applicable legislation, we based our interim final rule primarily on comments received in response to the Advance Notice of Proposed Rulemaking (ANPRM), the Notice of Proposed Rulemaking, and the public hearings. We also considered— • The comments received in response to our recent Notice in the Federal Register ; • Our experience in the mining industry; and • The related standards of other Federal agencies. To the extent practical, the substance of our HazCom requirements is the same as that in OSHA's HCS. We developed some provisions to be consistent with other MSHA standards, such as the retention period for training records. Two areas where our standard significantly differs from OSHA's are in the inclusion of hazardous waste among the chemicals of concern and the omission of a requirement to label products going off mine property. OSHA's HCS exempts certain hazardous wastes because there are employee protections in other rules which address these hazards, such as 29 CFR 1910.120, Hazardous Waste Operations and Emergency Response (Hazwoper) and EPA's regulations under the Resource Conservation and Recovery Act of 1976 (RCRA). Because we do not have standards that address miners' exposure to hazardous waste, we needed supplemental requirements to ensure that miners working with hazardous waste understand the associated hazards and take precautions. HazCom does not require you to label products that go off mine property. When the product leaves mine property, however, you must comply with the OSHA HCS which requires hazardous chemicals to be labeled. With few exceptions, if your HazCom program complies with OSHA's HCS, it also will comply with this interim final rule. We will publish a Compliance Guide to help you understand the application of this rule. It will contain numerous examples, suggestions, and explanations of how we interpret the interim final rule. B. Regulatory History Petition for Rulemaking. On November 2, 1987, the United Mine Workers of America (UMWA) and the United Steelworkers of America (USWA) jointly petitioned us to adapt OSHA's HCS in both coal and metal and nonmetal mines and to propose it for the mining industry. They based their petition on the need for miners to be better informed about chemical hazards. In their petition, the UMWA and USWA argued that miners deserve protection equal to that of other workers. To support their position, the petition cited an incident in which miners at an iron ore mine were experiencing adverse health effects. These miners asked the operator for MSDSs for the flotation chemicals used at the mine to determine the identity of the chemical causing the symptoms. Although the State in which the mine was located had a right-to-know law, this law did not cover mines. Because we did not have a standard to require the operator to provide MSDSs to miners, the operator refused several times to provide the requested MSDSs. The operator finally provided the MSDSs after lengthy negotiations. The local union used the information provided in the MSDSs to discuss safeguards with the company. The petition also specifically noted that work at both surface and underground coal and metal and nonmetal mines exposes miners to a variety of hazardous chemicals. For example, the petition stated that explosives contain organic nitrates that produce nitrogen oxides and ammonia when detonated; roof bolting systems contain plastic resins and reactants; solvents used in equipment maintenance are both toxic and flammable; and mill reagents can release hydrogen sulfide, cyanide, or other dangerous chemicals. Preliminary rulemaking. In response to this petition, we issued an advance notice of proposed rulemaking (ANPRM) on hazard communication on March 30, 1988 (53 FR 10256). In the ANPRM, we indicated that we would use the OSHA HCS as a basis for our standard and requested specific comments on a number of related issues. We published a notice of proposed rulemaking on hazard communication for the mining industry on November 2, 1990 (55 FR 46400). We also held three public hearings in October 1991—one each in Washington, DC; Atlanta, GA; and Denver, CO. The record closed on January 31, 1992. Public response . We received a wide variety of comments on our ANPRM and proposed rule. Commenters included both small and large mining companies; a variety of trade associations, including those representing specific minerals; State mining associations; chemical and equipment manufacturers; national and local labor unions; a member of Congress; and two Federal Agencies. There were a combined total of 121 written comments submitted in response to the ANPRM (50), the proposed rule (63), and the re-opening of the record (8), as well as oral testimony presented at public hearings. Limited reopening of the record . While we were working to finalize this rulemaking, Congress passed several laws which affected our rulemaking procedures. These statutory mandates and related Executive Orders require us to evaluate the impact of a regulatory action on small mines; 1 State, local, and tribal governments; 2 and the health and safety of children. 3 1 The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) Amendments to the Regulatory Flexibility Act of 1980, Pub. L. No. 96-354, 94 Stat. 864 (1980) (codified as amended at 5 U.S.C. 601-612). 2 The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq. ); and Executive Order 13084, Consultation and Coordination with Tribal Governments. 3 Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. In addition, we requested comments on the information collection and paperwork requirements of certain provisions of the proposal, now considered as an information collection burden under the expanded definition of “information” under the Paperwork Reduction Act of 1995. 4 4 Pub. L. No. 104-13, 109 Stat. 163 (1995) (codified as amended at 4 U.S.C. 3501-3520). When we published the HazCom proposal, the information collection and paperwork requirements were not an information collection burden under the 1980 Paperwork Reduction Act because they were third-party disclosures. Under the Paperwork Reduction Act of 1995, agency rules that require businesses or individuals to maintain information for the benefit of a third-party or the public, rather than the government, are covered by the Act under the definition of “information.” Most MSHA regulations do not require an evaluation of their impact on the environment. Health standards do, however. This was brought to our attention and we took this opportunity to remedy the oversight. We requested comments on the effect of the proposed rule on the environment because the proposal had not. 5 5 The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq. ). We reopened the rulemaking record on March 30, 1999 (64 FR 15144) to receive comments on the impact of the proposed rule in accordance with these regulatory mandates and Executive Orders. The record closed on June 1, 1999. Public response to limited reopening. We received seven comments, mostly from trade associations and labor organizations, on this limited reopening of the rulemaking record. The National Mining Association (NMA) urged us to reopen the rulemaking record in its entirety because the information in the record is outdated since the proposal was published on November 2, 1990. The NMA indicated this action would improve the effectiveness and quality of the HazCom standard because sectors of the mining industry that have incorporated OSHA's HCS can provide us with their experience under such program. Consol, Inc., a large mining company, stated that we need to address in the HazCom standard recent changes in the OSHA HCS regarding electronic access to MSDSs and microfiche maintenance of these documents. The National Stone Association (NSA) commented on the need to promulgate a HazCom standard in light of our new miner training regulations applicable to surface aggregate mines. Finally, the United Mine Workers of America (UMWA), and Jim Weeks, a consultant to the UMWA, objected to the delay in promulgating a final standard. We disagreed with commenters on the need to reopen the rulemaking record in its entirety. Unlike general industry, the mining industry is narrowly composed of two sectors, coal and metal and nonmetal. Because of our frequent presence on mine properties, we have determined that there are no substantial changes in the mining industry which would require changes in the provisions of this final standard. Changes experienced by the mining industry since the publication of the HazCom proposal in 1990 do not rise to a level of change in “core” circumstances so material in nature as to entail a modification of the final standard. Substantive rulemaking issues and regulatory alternatives have not changed since the record closed in 1992 and, consequently, the evidence in the rulemaking record is current. We understand commenter's desire to provide more information regarding their experience under the OSHA HCS standard. Our rulemaking record, however, contains numerous comments concerning the mining industry's experience with OSHA's HCS. We have considered all these comments, and the final standard reflects the public's recommendations where they do not undermine the ultimate issue of protecting the safety and health of miners. For example, some commenters indicated their experience regarding OSHA's MSDS requirements and suggested that we include a provision on electronic access to MSDSs; simplify the proposal regarding the content of MSDSs; use terms that are consistent with the Mine Act instead of the OSH Act; simplify the requirements regarding inclusion of MSDSs with initial shipment of product; and require retention of MSDSs for a period of less than 30 years. In response to these comments, the HazCom final standard provides for electronic access to MSDSs; uses terms such as “miner” and “mine operator” instead of “employee” and “employer” to be more consistent with the language of the Mine Act; streamlines and clarifies the provisions on the format and content of MSDSs; and requires the operator to keep the MSDS at the mine for as long as the chemical is known to be present at the mine, instead of 30 years as OSHA requires. While MSHA's HazCom standard is generally consistent with OSHA's HCS, we made changes to the final standard from the proposal in recognition of comments received from the mining industry concerning their experience under OSHA's HCS. These changes also recognize that the affected regulated community is smaller and more homogeneous than the industries regulated by OSHA. On the applicability of the new part 46 training standard, we concluded that hazard communication can best be accomplished by establishing miner training requirements separate from part 46. The new part 46 training regulations are broad, covering many different training needs. Part 46 does not cover all of the specific aspects of training required under this final standard. For example, part 46 does not require training about how to read an MSDS. We developed the training aspects of HazCom to be fully compatible with existing standards. HazCom does not require you to revise your part 46 training program or plan in order for it to be credited toward complying with the more specific hazard communication training requirements in this interim final rule. The training required under HazCom is directly applicable to the training in 30 CFR part 46 that involves hazard recognition and avoidance, mandatory health and safety standards, and warning labels. Hours spent on HazCom training can be credited to part 46, as well as part 48, training as appropriate. II. Paperwork Reduction Act When we published the HazCom proposal in 1990, its information collection and paperwork requirements were not an information collection burden under the 1980 Paperwork Reduction Act because they were third-party disclosures. In August 1995, the Office of Management and Budget (OMB) published its final rule (60 FR 44978) implementing the new Paperwork Reduction Act of 1995 (PRA 95). These OMB rules expanded the definition of “information” to clarify that PRA 95 also covered Agency rules that required businesses or individuals to maintain information for the benefit of a third-party or the public, rather than the government. The requirements for information collection and dissemination in HazCom are now an information collection burden because of this expanded definition. Almost all HazCom provisions fit this definition: §§ 47.11, 47.21, 47.22, 47.31, 47.32, 47.33, 47.41, 47.42, 47.43, 47.44, 47.45, 47.51, 47.52, 47.53, 47.61, 47.62, 47.63, 47.71, 47.72, 47.73, 47.74, 47.75, 47.76, and 47.77. The interim final rule also removes the labeling requirements from existing §§ 56.16004, 57.16004, and 77.208. We have submitted the interim final rule to OMB for its review and approval under § 3507 of PRA 95. Request for public comments. Send your comments on the information collection requirements in this interim final rule to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for MSHA, 725 17th Street NW., Room 10235, Washington, DC 20503 by December 4, 2000. Description of requirements. HazCom is primarily an information collection and dissemination rule. The annual information collection burden includes the time to inventory chemicals, determine the hazards of chemicals present, develop a HazCom program, develop or obtain labels or MSDS's as necessary, prepare training materials and train miners, and provide copies of HazCom materials. The information collection and paperwork burden encompasses each section of this part, as summarized in Table 1. Table 1.—Description of Information Collection Provisions Provision Information collection burden Written HazCom Program Prepare, administer, and review annually; determine hazards of chemicals; list hazardous chemicals at the mine. Labels or other warnings Prepare for hazardous chemicals produced; maintain legibility and accuracy. Material Safety Data Sheets Develop for hazardous chemicals produced; obtain for other hazardous chemicals; maintain availability and accuracy. Training Program Develop or obtain training courses and materials; conduct initial training for miners; train miners about changing hazards; administer program. Copies of HazCom information Distribute written HazCom program information to miners, miners' representatives, and customers when requested; distribute to other operators. All written information can be either paper or electronic format provided that you meet access requirements. Description of respondents. The respondents are operators, including independent contractors. The interim final HazCom rule will be applicable to all 21,166 operations under MSHA jurisdiction: 2,459 surface and underground coal mines; 3,801 coal contracting firms; 11,337 surface and underground metal and nonmetal (M/NM) mines; and 3,569 M/NM contracting firms. We estimate that 33% of small mines and 43% of large mines (15% of coal and 19% of M/NM mines employing <20 miners, 17% of coal and 33% of M/NM mines employing 20 to 500 miners, and 100% of coal and M/NM mines employing >500 miners) have an existing hazard communication program that complies with all or part of the provisions of HazCom. The percentage of mines complying with a specific HazCom requirement varies depending on the type of mine and the specific provision. For example, some mines label containers and keep MSDSs, but do not have a written program or provide HazCom information to miners. As a matter of corporate policy or to comply with State hazard communication or right-to-know laws, most existing HazCom programs are modeled on OSHA's HCS. For these reasons, we believe that you can adjust your existing program to comply fully with HazCom with little effort and few resources. We assumed that most independent contractors conduct some work at locations under OSHA jurisdiction and would have an existing hazard communication program. The contractor's program, however, may need modification for a particular mine. The magnitude of the burden for any individual mine operator or independent contractor, therefore, will vary greatly by the size, type, and location of the operation. For the purpose of estimating burden, we assumed that there are existing hazard communication programs at 65% of small (<20 miners) coal contractors, 75% of large (≥20 miners) coal contractors, 70% of small (<20 miners) M/NM contractors, 74% of large (20-500 miners) M/NM contractors, and 100% of M/NM contractors employing >500 miners. Information Collection Burden. The greater portion of HazCom's burden accrues when you are developing and implementing the program. We annualized this initial burden. We summarize the total first-year, start-up information collection burden for HazCom in Table 2. We summarize the total annually recurring information collection burden in Table 3. Table 2.—First-Year Information Collection Burden* Provision Number of respondents Number of responses Responses/ respondent Hours/ response Total hours Associated costs** Develop Program 14,239 14,239 1 12.2 173,366 $446,826 Review Existing Program 7,620 7,620 1 6.3 48,144 125,416 Develop MSDS 3,544 3,894 1.1 2.9 10,222 26,074 Develop Training Program 13,007 13,007 1 6.9 89,196 229,257 Prepare Initial Training 13,007 13,007 1 2.0 26,014 83,632 Total 51,767 6.7 346,942 911,205 * Discrepancies due to rounding. ** Adjusted first-year costs annualized (See Regulatory Economic Analysis, Chapter VII.) Table 3.—Annual Information Collection Burden \*\ Provision Number of respondents Number of responses Responses/ respondent Hours/ response Total hours Associated costs** Update Program 14,239 14,239 1 1.7 24,767 $911,890 New Operators Develop Program 889 889 1 13.2 11,772 437,982 Label Containers 1,717 6,712 3.9 0.20 1,343 62,309 Update MSDS 3,544 974 0.27 1.5 1,460 53,211 Maintain MSDS 14,239 637,720 44.8 0.05 31,886 568,744 New Operators Develop MSDS 889 1,019 1.1 3 3,057 113,578 Manage Training Program 13,007 13,007 1 1.7 22,299 818,776 New Operators Prepare Training 889 889 1 8.6 7,664 301,063 Training Records 13,007 187,149 14.4 0.05 9,365 167,518 Provide Info to Miners 14,239 21,961 1.5 0.20 4,395 78,817 Providing Info to Customers 14,239 233,860 16.4 0.20 46,772 832,582 Total 1,118,419 0.15 164,780 4,346,470 * Discrepancies due to rounding. ** Adjusted first-year costs annualized (See Regulatory Economic Analysis, Chapter VII.) III. Discussion of the Interim Final Rule In preparing this interim final rule, we attempted to address the concerns of all commenters, while ensuring that miners and operators have the information necessary to work in a safe and healthful environment. Commenters supported widely different ideas about a HazCom rule for the mining industry. Some said we do not need one because existing standards require hazard training and labeling; others said it is vital to allow miners to exercise their right-to-know. Some said the rule would be a great burden; others said that they already have such a program. Some said they want a rule just like OSHA's; others said we should resist the temptation to duplicate OSHA's HCS. Some wanted a separate standard for the coal mining industry; others recommended that we establish separate standards for mine operators and independent contractors; others wanted a single Federal standard. Some urged us to include specific language to ensure that individual States do not promulgate or enforce any requirements related to hazard communication that conflict with the Federal standard. Commenters recommended that the final rule be practical, strike a balance between providing too much information and too little, and allow for global harmonization with international standards. In response to the different needs for hazard communication in the mining industry, and the broad range of comments, the provisions of the interim final rule are performance-oriented and flexible enough that operators, including contractors, can comply using a single program to meet OSHA's HCS and our HazCom standard. We considered adopting the OSHA HCS in its entirety, but some requirements of OSHA's HCS are not relevant to mining. OSHA's HCS is supplemented by other OSHA standards for which we have no parallel. OSHA, for example, has comprehensive standards specifically covering hazardous waste operations, laboratories, and medical records. To the extent practical, the substance of our interim final rule is the same as that in OSHA's HCS. We added provisions where needed, however, to give miners the same protection as employees in general industry. A. Subpart A—Purpose and Scope of HazCom The proposed rule included a “scope and application” section stating where HazCom applied and listing exemptions from coverage. In the interim final rule, we renamed this section “operators and chemicals covered.” We moved the exemptions, which were a part of the scope in the proposal, to the end of the HazCom interim final rule so that the substantive requirements would be up front where they are more accessible. (See § 47.81 and § 47.82, Exemptions.) We will discuss exemptions later in the preamble, consistent with their placement in the interim final rule. 1. § 47.1 Purpose of a HazCom Standard A few commenters suggested that we include a “purpose and intent” section in our HazCom interim final rule, in addition to the “scope and application” section. In response, the interim final rule adds language to clarify our intent. The purpose of HazCom is to reduce chemically-related injuries and illnesses by ensuring that you— • Know what chemicals are at your mine; • Determine which are hazardous and the nature of their hazards; • Establish a HazCom program; and • Inform each miner who can be exposed, and other on-site operators whose miners can be affected, about those hazards and appropriate protective measures. 2. § 47.2 Operators and Chemicals Covered The proposal would have applied “to all operators who produce or use hazardous chemicals in their workplaces” and to “any chemical which is known to be present in the workplace in such a manner that employees are exposed * * *.” The interim final rule applies “to any operator producing or using a hazardous chemical to which a miner can be exposed * * *.” By modifying the language in the interim final rule, we clarify our intent that you must find out what hazardous chemicals are present at your mine and evaluate whether it is possible for miners to be exposed under normal conditions of use or in a foreseeable emergency. You do not have to determine that miners are exposed or the level of their exposure. The interim final rule is consistent with the purpose of HazCom and OSHA's HCS. Although the proposed rule seemed to apply only where there was an actual exposure, the proposal defined “exposed” as “subjected, or potentially subjected, to a hazardous chemical * * *.” The preamble to the proposal further explained that this definition included “current and potential (accidental and possible) exposures.” The potential for exposure to a hazardous chemical, such as diesel fuel, motor or hydraulic oils, lubricants, paints, and solvents, occurs at virtually every mining operation although exceptions do exist. While considering HazCom, we reviewed data and documents from inspections and investigations, chemical inventories, technical reports, accident and injury data, and sampling data confirming that exposure to chemicals occurs in all types and sizes of mines. If you have already implemented a HazCom program at the mine, and that program complies with the requirements of OSHA's HCS, it should also comply with our HazCom interim final rule. You will still have to check your existing HazCom program to make sure it complies with the interim final rule. Potential exposure. The interim final rule retains the proposal's intention concerning the potential for exposure. Although we interpret the term “foreseeable” broadly in the context of this rule, we also intend HazCom to be practical. NIOSH commented on our HazCom proposal and stated that the scope should not limit coverage of HazCom only to hazardous chemicals “under normal conditions of use or in a foreseeable emergency.” NIOSH stated that HazCom should cover all hazardous chemicals present on mine property, regardless of intended or expected exposures. Specifically, NIOSH stated that: All workers should be informed about the nature of the risks associated with the hazardous materials found in their workplace. “When working in the presence of a hazardous material, hazards are always present even under work situations most carefully designed to eliminate risk” (NIOSH 1974a). The informed worker is prepared to minimize the impact of a hazardous materials incident. The uninformed worker is at risk of causing a hazardous materials incident or contributing to adverse health effects. We partly agree with NIOSH's comment. But we also agree with those commenters who expressed concern that by addressing remote or trivial hazards, the purpose of HazCom would be defeated and its effectiveness diluted. If miners are flooded with warnings about all chemical hazards, including those they perceive as remotely possible, they may be more likely to ignore warnings for the more probable hazards. We also believe that it would be unnecessarily burdensome to require you to address every conceivable chemical hazard, regardless of how unlikely that hazard is to materialize. For example, suppose a chemical liquor, or caustic, is only present in a certain area of your bauxite mill and you have miners in this area working near pipes carrying the caustic. You have other miners who work in the farthest area of your operation who never go near the mill or the caustic. Although you could conceive of circumstances where the miner who does not work near the pipes can be exposed, it would not be reasonably foreseeable. On the other hand, you can conceive of circumstances where the miner who works daily near the pipes can be exposed. The caustic can eat through a pipe; a truck can back into a pipe; pressure can cause joints to leak. Exposure is foreseeable under these circumstances: strong caustics can eat through pipes; trucks have run into pipes before; and pressure often causes leaks. Almost all miners are exposed to crystalline silica, but the potential for illness is related to their exposure to the respirable fraction of dust. For example, your miners work on a concrete floor and there is silica in the concrete. If no cutting, grinding, or other activities happen to the floor that would release the respirable fraction, the potential for exposure to respirable crystalline silica is remote, and the miners are not potentially exposed to a hazard. If you must remove the floor through grinding, cutting, or crushing, the potential for exposure is foreseeable and the concrete would become a hazardous chemical subject to HazCom. Base your decision to include a chemical in your HazCom program on its hazards and the potential for miner exposure, not the risk. A chemical's hazard is in its inherent characteristics. Risk is the likelihood of expression of that hazard in a given situation. The interim final rule sets boundaries on the chemicals and operators covered by HazCom. It is our judgment that these boundaries provide miners the protections intended by the Mine Act without causing you to expend resources on remote possibilities. Significance of exposures. One of the most frequent suggestions received on the HazCom proposal was that it should apply only where significant exposure to a chemical occurs. These commenters asserted that a significant exposure involved a likelihood of material impairment of health to a miner, such as when a miner was overexposed to a hazardous chemical. HazCom's most misunderstood concept was its relationship to risk and significant exposure. Miners are frequently and seriously harmed by chemicals in their work area, but HazCom is not a risk-based health standard for measuring exposures, requiring controls, or providing personal protective equipment. Other standards address the problems of significant risk and the methods of controlling it. HazCom is an information and training standard intended to diminish risk by ensuring that operators provide miners with a level of knowledge that allows them to reduce their exposures by recognizing potential hazards and by following safe work practices. HazCom is based on the premise that chemicals can have inherent characteristics that pose hazards and miners have a right to know what those hazards are and what their employer is doing to protect them. Many chemicals are considered to be hazardous because evidence indicates that they can threaten a miner's physical well-being or harm the miner. Determining that a chemical is hazardous is not the same as determining that there is a significant risk of any specific physical or health effect occurring from its use under a particular set of circumstances at the mine. HazCom is being promulgated to anticipate the possibility of harm or loss from chemical exposures and provide information on ways to avoid them. It is not to regulate chemical use. It does not prohibit or limit the use of chemicals in the mining industry or prescribe controls to reduce exposures. HazCom's effectiveness is dependent on the operator's and miner's knowledge and awareness of hazards. Like any training or information standard, it is through hazard identification and awareness that HazCom addresses hazardous chemical exposure and prevents injuries and illnesses. B. Subpart B—Hazard Determination A hazardous chemical is any chemical whose properties can pose a physical or health hazard. It can be a pure substance (an element or chemical compound), a mixture, or an ingredient in a mixture. A hazardous chemical can be in any physical form: Solid, liquid, or gas. The likelihood of harm may be greater under some circumstances than others, but the potential to do harm is inherent in the chemical's properties. We discussed exposure and its significance under “purpose and scope” in this preamble. HazCom's definition of hazardous chemical is consistent with the proposal and OSHA's HCS. We arranged the criteria for determining whether a chemical is hazardous in Table 47.11 and re-stated the proposal's language in a simpler way. 1. § 47.11 Identifying Hazardous Chemicals HazCom is most effective when the criteria for determining the hazards of a chemical are applied consistently. Most physical hazards of elements and compounds are well-known and can be verified in a laboratory through testing. Physical hazards of mixtures can be determined the same way. Health hazards, however, are generally more complex, requiring studies of living systems, and can take much longer. Most health hazards of chemicals are determined through animal studies by extrapolating data from the effects on animals to predict the effects on humans. We consider a chemical to be a physical hazard when there is scientifically valid evidence that it is combustible; a compressed gas or liquid; an explosive; a flammable aerosol, gas, liquid, or solid; an organic peroxide; an oxidizer; a pyrophoric (capable of spontaneously igniting); unstable and reactive; or water-reactive. Scientifically valid evidence means that a study was conducted or data obtained in a highly reliable manner that takes into consideration the margin of accuracy and consistency. We consider a chemical to be a health hazard when there is statistically significant evidence that it can cause acute or chronic health effects. Statistically significant evidence supports a conclusion with a high level of confidence, typically 90% to 95%. This means that there is only a 5% to 10% probability that the observed results are due to chance. Health hazards include chemicals that cause cancer; irritate or corrode tissues; or cause a sensitization reaction. It also includes chemicals that damage the reproductive system, the liver, the kidneys, the nervous system (including psychological or behavioral problems), the blood or lymphatic systems, the digestive system, or the lungs, skin, eyes, or mucous membranes. Hazard determination methods. The final HazCom rule, like the proposal, includes two basic ways for determining whether or not a chemical is hazardous: One for chemicals brought to the mine and the other for chemicals produced at the mine. In every instance we reviewed, operators producing chemicals also brought chemicals to their mines. We intend that the hazard determination provisions of HazCom apply to all hazardous chemicals produced at the mine or brought onto mine property, even if they are not covered under other MSHA standards. A number of commenters wanted the hazard determination requirement in the proposal changed to read: “Operators who ship chemicals shall determine the chemicals’ hazards under conditions of intended use based on our standards in 30 CFR parts 56, 57, 71, and 75.” A number of commenters wanted operators who received chemicals to determine their hazards based solely on whether the chemical is regulated by us and whether it presents a physical or health hazard under conditions of intended use. The interim final rule does not use the word “ship” instead of “produce”; does not add the phrase “under conditions of intended use”; and does not limit the chemicals covered to those listed in our existing standards. We enforce exposure limits for chemicals listed by the American Conference of Governmental Industrial Hygienists (ACGIH) in their list of Threshold Limit Values (TLV). This list does not address all chemicals known to be present on mine property. These suggestions would have significantly changed the intent and scope of HazCom. It would emphasize the hazards associated with the manner or process in which chemicals are used by persons off mine property, instead of emphasizing the hazards to miners. 2. Chemicals Brought to the Mine The interim final rule is substantively the same as the proposal in its requirements for a chemical brought to a mine. Under the interim final rule, you must review the chemical's label for any hazard warning and its MSDS for more detailed information. If the label or MSDS indicates a hazard, consider it hazardous. You must then include the chemical on the list of hazardous chemicals at the mine; keep a copy of the MSDS accessible to miners; and train miners about the hazards, what you are doing to control these hazards, how to prevent or reduce the exposure, and how to protect themselves from injury or illness. If you do not want to rely on the chemical manufacturer or supplier, you may evaluate the chemical yourself. If you do, we will require you to demonstrate that you have conducted a thorough evaluation of the available evidence. The number and types of different hazardous chemicals brought to the mine depends on the size and type of the operation. These chemicals can range from bulk raw materials, such as ammonium nitrate for use in blasting agents, to small quantities of highly hazardous chemicals used in quality control laboratories. Diesel fuel, antifreeze, motor or hydraulic oil, brake fluid, lubricants, adhesives, paints, and solvents are a few of the materials commonly brought to mining operations that would require you to ask the question: Is this a hazardous chemical? The interim final rule requires you to make a hazard determination for each chemical at your mine to which miners can be exposed regardless of how the chemical is used. Based on your experience, we expect you to anticipate any likely misuse of the chemical, as well as accidents. This intention is further emphasized in the written HazCom program, which requires you to document how you determined the hazards of the chemicals at your mine and to make a list of those found to be hazardous. For a chemical brought to the mine, you need to review its label and MSDS. If, however, you intend to use the chemical in a manner not intended by the manufacturer or supplier, you must determine if your conditions of use create any different hazards. 3. Hazardous Waste Hazardous waste can be either brought to the mine or produced at the mine. Hazardous waste regulated by the Environmental Protection Agency (EPA) under the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, was exempt from the labeling and MSDS requirements under the proposal. If a hazardous waste is brought to the mine without an MSDS, however, and you could not obtain one, the proposal would have required you to determine its hazards using the same methods as if it had been produced at the mine: You would either have had to test it or have had to use any valid, available, scientific information. We expect that, in most cases, the shipping manifest or EPA permit accompanying the waste will say what it is. Even if the ingredients are listed generically, you should request that the supplier provide you with hazard information. We did not propose to exempt EPA-regulated hazardous waste from the training and other requirements of HazCom. Because the proposal would have required you to have information on the hazards of this waste, and because there is no specific format for the MSDS, it follows that a compilation of such information could be considered an MSDS. You can use this information to develop a label. For this reason, we did not specifically exempt EPA-regulated hazardous waste from the labeling and MSDS requirements in the interim final rule. Rather, we address such waste separately in § 47.43, MSDS for hazardous waste. You must make sure that miners have the best information you can find about the waste's chemical hazards. We suggest for the sake of consistency that you put the hazard information in the same MSDS format as you use for other chemicals. 4. Chemicals Produced at the Mine The interim final rule, as in the proposal, defines a chemical as any element, chemical compound, or mixture of these and requires you to identify what chemicals you produce at your mine. Chemicals produced at your mine include— • Those that you mine or process to sell, such as coal or crushed stone; • The mixtures you create, such as flotation reagents or blasting agents; • The by-products of mining and milling, such as diesel exhaust, hydrogen sulfide, or gases from combustion or blasting; and • The materials discarded from mining operations, such as tailings. Every mine product is a chemical, but not all are hazardous for the purposes of HazCom. You must determine if the chemical has any harmful properties that could pose a physical or health hazard. You must determine what the hazards and protective measures are so that you can prepare an appropriate label and MSDS. Again, HazCom does not require you to take additional protective action, as might be required by a risk-based rule. HazCom requires you to inform miners about scientifically valid evidence concerning a chemical's hazards, from either your own testing or the published results of other testing or studies. For example, if your product is sand and gravel or crushed limestone, crystalline silica is likely to be the only hazardous component, and you are already training your miners about its hazards. Because respirable silica is so prevalent in mine products, we will be producing a generic MSDS for you to use if you do not want to prepare one yourself. You will have to ensure that your label identifies the product as containing crystalline silica, which is a human carcinogen. It is only respirable crystalline silica, however, that is a human carcinogen. Sources for identifying hazardous chemicals. The interim final rule requires that, if you produce a chemical, you must determine its physical hazards based on available evidence or testing. You must determine its health hazards based at least on the findings of the following four recognized authorities or sources: • Title 30 Code of Federal Regulations (30 CFR) chapter 1. • American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV's) and Biological Exposure Indices (latest edition). • National Toxicology Program (NTP) Annual Report On Carcinogens (latest edition). • International Agency for Research on Cancer (IARC) Monographs or Supplements. These sources are basically identical to those listed in the proposal and the OSHA HCS, with the exception that MSHA standards regulating exposure to and use of hazardous substances are referenced instead of OSHA standards. The proposed rule intended that you would not have to look beyond these sources to determine if a chemical was a health hazard. In addition, you must consider a chemical a suspected or confirmed carcinogen if it has been evaluated and listed as such by ACGIH, NTP, or IARC. HazCom does not require you to determine whether the concentration of the chemical in the mine environment exceeds a limit recommended by one or more of these four sources. If there is a potential for harm and a potential for exposure, the chemical is hazardous for the purposes of HazCom. You must tell your miners about the hazards that are known and give them information relevant to the safe performance of their tasks. Some commenters recommended that we rewrite this provision to require that “operators who produce chemicals must determine the chemicals' hazards” and not specify the basis for the determination. These commenters felt that this language would make the requirement more performance oriented, would avoid incorporation by reference, and would allow operators to choose the best methods for this assessment based on the best available sources at the time of the assessment. Although the hazard determination criteria rely on the findings of respected and authoritative scientific organizations, these are minimal requirements. The interim final rule allows and encourages you to use the best methods and sources available. Using ACGIH, NTP, and IARC to determine if a chemical is hazardous. Many commenters strongly opposed including ACGIH, NTP, or IARC in the hazard determination section of the interim final rule. These commenters also objected to our use of IARC and NTP publications as authoritative sources for identifying certain chemicals as carcinogens. Some of these commenters felt that these organizations may identify a substance as a possible human carcinogen based upon the results of a single animal study and that animal studies alone should not be relied on to identify human carcinogens. Others felt that these organizations only considered positive studies (those showing an adverse health effect) and not negative studies (those that were inconclusive or did not show a health effect) when determining that a chemical is a carcinogen or a suspected carcinogen. Commenters opposed our reliance on an automatic trigger, such as a hazard determination made by one of these organizations, to deem a chemical as hazardous without considering the risk posed in a given situation. One commenter stated that any reference to ACGIH, NTP, or IARC in the rule is inappropriate because these institutions make determinations based on “strength of evidence analysis” and defer “weight of evidence determinations” to regulatory authorities. This commenter felt that, as in our proposed air quality rule, we should adhere to the guidelines of the Office of Science and Technology Policy (OSTP) because HazCom ultimately would reference our final air quality standard. OSTP guidelines address the use of “strength of evidence” and “weight of evidence” analysis in quantitative risk assessment. Most commenters on our use of these publications opposed such use, stating that including references to these would be an incorporation-by-reference without following the proper rulemaking procedures. They stated that ACGIH's, NTP's, and IARC's decision-making processes are deficient because they restrict public or peer input. They further stated that the absence of public comment and external peer review raises significant questions regarding the quality of any science-based decision-making process. These commenters added that our rulemaking, because it goes through an established process, provides the only basis for establishing valid references for hazard determination purposes. Some commenters also strongly objected to referencing either the latest edition or subsequent monographs or supplements of these sources because such references fail to advise the regulated community of the standard of conduct to which they are expected to conform. They commented further that we may only incorporate-by-reference materials in existence at the time we promulgate a final rule. In response to these comments, we wish to re-emphasize that HazCom is not a risk-based rule. A risk-based rule requires us to limit a miner's exposure to a toxic substance or harmful physical agent. This is an information-providing standard to ensure that operators are aware of potential hazards so that they can take appropriate actions to train miners and provide them with information about ways the operator, miners, and others can protect themselves from these hazards. We believe that miners have a fundamental right to know about the hazards in their work area and that operators have a fundamental duty to provide this information. For example, warnings concerning the presence of a radiation source or high-voltage electricity are commonplace, whether or not a person is likely to be exposed or injured. We address risk assessment and risk management in other standards. Referring to IARC, ACGIH, and NTP documents, in one sense, does incorporate them by reference. We refer to these sources because they contain lists of known hazardous chemicals. Using these lists as a screening tool reduces the resources you would otherwise have to devote to determining if a chemical is hazardous and poses no increased compliance obligations on you. The use of these references was supported by some commenters because the sources are renowned scientific authorities. Using the latest editions of the referenced sources of information to establish that a chemical is hazardous is appropriate because it contains the most recent information. We also believe it will be easier for you than requiring a continual, exhaustive literature search, conducting your own chemical testing, or trying to locate a document that is outdated or out-of-print. If the commenters objecting to the use of these references meant to address whether or not the chemicals are known to be hazardous, the chemicals are listed in the four sources because scientific studies have indicated that they are hazardous. We expect most hazardous chemicals produced at mines to be listed. Other sources not cited in the proposal or interim final rule also can provide valuable information. You can check other reputable sources of scientific information, such as the NIOSH “Registry of Toxic Effects of Chemical Substances,” the NIOSH “Pocket Guide to Chemical Hazards,” OSHA standards, or chemical databases on the internet. The alternative to using these four sources as a screening tool would be for you to conduct a thorough search of available literature to determine if the chemical is hazardous in addition to finding any statistically significant, scientifically valid studies that report the chemical's hazards. By using these sources as a screening tool, we intend to minimize the number of literature searches and, thus, the burden. Using ACGIH, NTP, and IARC to determine a chemical's hazards. If the commenters objecting to the use of the references meant to address the nature of the harm, the circumstances under which the chemical can cause harm, or the level of exposure at which harm becomes likely, we recognize that there may be conflicting information in the scientific literature. We agree that relying solely on the information from these four sources may not be sufficient to determine the health hazards of a chemical. Except for identifying certain chemicals as either carcinogens or suspected carcinogens, these sources contain little specific information on the types of health hazards posed. Some commenters stated that it would be a great burden on the mining community to find out if recent scientific studies show their product to be a carcinogen or other type of chemical hazard. Although determining the hazards of a chemical you produce could be more time consuming, we do not believe that it is overly burdensome, infeasible, or impractical. An entire segment of the publishing industry exists to inform the mining industry about new production equipment, legislative and regulatory affairs, commodity pricing, changes in construction specifications, bid proposals, and scientific studies that can affect the commercial value of mining products. We expect that the media, trade associations, or unions will also provide the mining industry with any significant new information concerning the hazards of their products. Proposed Table 1. To simplify your access to the information from these sources, we compiled a table of all the chemicals listed in them and included this table in the proposal. The table indicated which of the four sources would give you more information about a chemical's health hazards and carcinogenicity. Operators could use the proposed table to determine quickly if the chemical they produced was a health hazard rather than having to refer to the four sources. We thought this would save resources if the chemical was not hazardous. We intended to spare operators from the need to look beyond this table to determine whether a chemical posed a health hazard. We had intended to update this table as needed. Several commenters agreed that we should allow operators to use proposed Table 1 to determine if the chemicals they produce are hazardous. One of these commenters felt that we should publish this table as an appendix to the rule and that it should state explicitly that operators may use this table to determine whether a chemical is a health hazard rather than having to refer to the four sources. Another of these commenters suggested that we include Chemical Abstract Service (CAS) registry numbers in the table to help operators identify the chemical. Some commenters asked that we not include the table in the final rule. One commenter felt that the average person would find this list of hazardous chemicals difficult and impractical to use. Others expressed concern that the list may not indicate all the potentially hazardous materials produced or used at the mine and favored the OSHA HCS's one-study approach. One commenter objected to the proposal's reference to a table in the proposed air quality standard before we published the air quality standards as a final rule. Some commenters supported our intention to reference the final air quality standards in the hazard determination provision. That support, however, was contingent upon our establishing permissible exposure limits (PELs) at levels that prevent material impairment of health or functional capacity. These commenters further stated: PEL's and carcinogens validated through the rulemaking process will enable operators who ship chemicals to evaluate whether those chemicals present a health hazard under conditions of intended use. When proposed 30 CFR Parts 58 and 72 are validly promulgated, MSHA should amend proposed 30 CFR Part 46.3(a) to incorporate those provisions. Although the interim final rule continues to reference NTP, IARC, and ACGIH, it does not include a table of hazardous chemicals. Upon further consideration, we concluded that the list will quickly become outdated as new hazardous chemicals come on the market or new information becomes available, and we could not readily update it. The constant need to update the table would reduce the effectiveness of HazCom because the update would require rulemaking. Instead, we will put a list of chemicals known to be hazardous in the Toolbox that supplements the Compliance Guide for this interim final rule. We intend to place both of these references on our website and provide links to other websites, such as university collections of MSDSs. Access to internet news services, libraries, and databases will allow you to obtain the most recent and reliable information soon after it becomes available. 5. Mixtures Produced at the Mine The best way to determine the hazards of a mixture is to test the mixture as a whole. You would then use the results of that testing to make a determination as to whether or not the mixture poses a hazard and the nature of the hazard. We recognize that most operators do not have the facilities and equipment to conduct this testing. For mixtures not tested as a whole, the interim final rule establishes the same criteria as the OSHA HCS (and as proposed) for determining the hazards of the mixture based on its ingredients. You must use available scientifically valid evidence to determine the mixture's physical hazards and rely on available health hazard information for the mixture's ingredients to determine its health hazards. • You must conclude that the mixture is a health hazard if at least 1% of the mixture is a chemical that is a health hazard. • You must conclude that the mixture is a carcinogenic hazard if at least 0.1% of the mixture is a chemical that is a known or suspected carcinogenic hazard. Determining the hazards of mixtures. A number of commenters wanted the final rule to allow you to determine the hazards of mixtures of chemicals in the same way you would determine the hazards of individual chemical compounds or elements, i.e., under conditions of intended use. They believed that mixtures should not be treated differently from other chemicals, although they may present additional health or physical hazards. These commenters stated that you should— (1) test the mixture as a whole; (2) if not tested as a whole, determine whether a component of the mixture presents a health hazard under conditions of intended use and if it constitutes a physical hazard; or (3) assume that a component presents a health hazard under conditions of intended use and that the mixture presents the same hazard, and use whatever scientifically valid evidence is available on the components of the mixture to determine the mixture's physical hazards. Several commenters objected to the requirement that if a mixture has not been tested as a whole, you must assume that it will pose the same health hazards and carcinogenic hazards as each of its components. Other commenters recommended that the health hazards of mixtures be based on either experimental evidence or weight of experience and, if known, dosage and exposure. Others argued that the concentration levels of 1.0% for hazardous components of a mixture, and 0.1% for carcinogenic components, had been chosen arbitrarily and that there are no studies showing relevance to these levels with regard to health hazards. Although we did not choose these levels arbitrarily, we agree that they are not based on specific scientific studies. The interim final rule sets concentration levels of 1.0% for hazardous components of a mixture and 0.1% for carcinogenic components, to be consistent with OSHA's HCS. By being consistent, HazCom reduces your burden by allowing you to use the label and MSDS for hazardous chemicals brought to the mine. Trace ingredients. The proposal stated that, if you have evidence indicating that a component of the mixture could be released in concentrations that would exceed an established MSHA PEL or ACGIH TLV, or could present a health risk to miners, you must assume that the mixture presents the same hazard. A number of commenters opposed the proposal's reference to the ACGIH TLVs and suggested that the final rule reference only MSHA health standards. Commenters expressed concern that the resources spent on determining the potential release of a hazardous trace component of a mixture dilutes the resources available to address real hazards. We contend, however, that if a trace ingredient can be released from the mixture at concentrations that can pose a health risk to miners, such as concentrations exceeding its PEL or TLV, this trace component is considered a hazard. Another commenter recommended that the final rule be more performance oriented and suggested that we reword this section to state: If the operator has reason to believe that lesser amounts than listed in item (2) could reasonably present a health risk they will be assumed to present the same hazard. In response to comments, we used more performance-oriented language in the interim final rule. It requires you to assume that a mixture presents the same hazard as a component if you have evidence that the component could be released from the mixture in a concentration that could present a health risk to miners. For example, the MSDS may indicate that a particular trace component reacts with other components, diffuses into the packaging, or evaporates over time. In this example, if the trace component is hazardous, you must inform miners about this information and its implications for them, and comply with the applicable HazCom provisions. We do not intend that you conduct research for chemicals brought to the mine; however, you must obtain an MSDS for them to determine whether or not a trace component can be released from the mixture in a hazardous concentration. Our intent is that, if you determine the trace ingredient to present a hazard, then you must include this information in your HazCom training. However, you must determine potential hazards from trace ingredients in hazardous chemicals you produce, including mixtures and by-products of mining activities. This is consistent with MSHA's HazCom proposal and OSHA's HCS. The interim final rule eliminates unnecessary language but retains generally the same requirement as the proposal. This provision recognizes that even trace components of a mixture could cause harm if a sufficient quantity is released from the mixture. Crystalline silica. A number of commenters expressed concern that IARC has designated respirable crystalline silica as a probable human carcinogen. Several commenters were concerned that the requirements for determining the hazards of mixtures that had not been tested as a whole did not take into account that a chemical is hazardous only when it is encountered in a specific physical state or form. Specifically, they felt that the proposed rule would have required you to determine that any untested mixture that contains 0.1% or greater of crystalline silica is carcinogenic, even when the concentration of respirable crystalline silica in the mixture is less than 0.1%. They pointed out that IARC's Monograph No. 42 and Supplement 7 and NTP's proposal to add this substance to its list in its 6th Edition address only the respirable crystalline form of silica as a human carcinogen and not other forms of crystalline silica. We agree that it is the respirable form of crystalline silica that is designated as a human carcinogen in the sources listed in the interim final rule. Therefore, if the mixture contains 0.1% or greater of crystalline silica, you must determine the percentage that is respirable or capable of being liberated. Any required label and MSDS for products containing concentrations of 0.1% or more of respirable crystalline silica must indicate this potential health hazard. This is consistent with OSHA's HCS. HazCom also requires you to inform miners about the carcinogenic hazard from exposure to respirable crystalline silica. Physical hazards. Comments on the proposal indicated that you may find it difficult to categorize the physical hazards of some mixtures because of the stratification or deterioration that may occur in these mixtures during storage and handling. To ensure that all hazards of a mixture are properly addressed, this commenter felt that we should require you to use persons who are qualified by education, experience, and training to determine the hazards of a mixture with respect to its use in mines. We expect that most of the information necessary to determine the hazards of a mixture are available in MSDSs or other publications. Because you are the person responsible for making this determination, and often the most qualified, we expect that you will make the determination yourself or select a competent person to do it. The proposed rule stated that if a chemical is not tested as a whole, you must use “whatever” scientifically valid evidence is available to determine the mixture's physical hazard. The word “whatever” was removed from the interim final rule at the request of commenters. 6. Hazardous Chemical One commenter felt that “chemical” may be interpreted restrictively to mean that only the chemicals you produce require a hazard determination. This commenter felt that we should state clearly that all mining products, including minerals, ore, and miscellaneous materials, require a hazard determination. Another commenter recommended that we use the term “hazardous material” rather than “hazardous chemical” because operators and miners are more likely to associate that term with minerals, ores, and other materials that occur naturally. We use the term “hazardous chemical” in HazCom to be consistent with its use in OSHA's HCS. It is used by a wide variety of industries and has been the subject of much clarification in the 15 years since OSHA promulgated its HCS. We believe that the definition of “chemical” in the proposed and interim final rules is more widely applicable and less open to misinterpretation than the alternatives suggested. C. Subpart C—HazCom Program All mines must have a written HazCom program, even if it only documents that you looked at each chemical at the mine, made a hazard determination, and found none to be hazardous. The written program does not have to be lengthy or complicated, and some operators may be able to rely on existing HazCom programs to comply with the requirements of the interim final rule. As mining processes change and as new chemicals are brought onto mine property, you must update your written program to reflect these changes. 1. § 47.21 Requirement for a HazCom Program This section of the interim final HazCom rule is substantively the same as the proposal and consistent with OSHA's HCS. It requires you to develop, establish, and maintain a written HazCom program. You must ensure that you have an effective method to communicate hazards to miners and other operators at the mine if their miners can be exposed to your hazardous chemicals. You must also retain the written program for as long as a hazardous chemical is known to be at the mine and exposure is possible. The scope of HazCom, § 47.2, clearly states that the interim final rule applies to all operators with miners who can be exposed to a hazardous chemical “under normal conditions of use or in a foreseeable emergency.” The scope applies to all sections of HazCom and all operators at a mine, including contractors. Therefore, we did not need to repeat the language of the scope in the requirements for the contents of the written program. You must make the written program available to miners, their designated representatives, and MSHA and Department of Health and Human Services (HHS) personnel. In the interim final rule, the provisions on access and copies are in a new, separate subpart on making HazCom information available. Generic programs. Some commenters stated that development of the written HazCom program was beyond the capabilities of most operators and would impose a technological and financial burden. Other commenters suggested that we develop a generic written HazCom program for use as an example. You are responsible for developing a HazCom program for the chemicals that you produce or bring to the mine. Your written program must include all the information that you need— • To implement the HazCom program; • To provide hazard information to miners so that they will know what is expected and can participate in supporting the protective measures in place; and • To ensure that other operators at the mine receive the HazCom information they need. Although the development and implementation of a HazCom program may pose a technological and financial burden on some small operators, we determined that the interim final rule is feasible. We discuss the issue of technological and economic feasibility in the Regulatory Economic Analysis (REA) for this rule. This preamble includes a summary of the REA as Section IV. Of this preamble. The REA is posted on our website ( www.msha.gov ). You can download it or request a hard copy from the MSHA Office of Standards, Regulations, and Variances at the address in the front of this preamble. To relieve the burden for small operators, we have planned an extensive outreach effort, developed a wide variety of compliance aids, and delayed the effective date of the rule for 1 year. As part of these efforts, we will provide several examples of a written HazCom program in the HazCom Toolbox for this rule. You can adapt the programs developed to meet OSHA's HCS because the two standards are similar. You also may obtain assistance from organizations that have developed generic guides to meet OSHA's HCS. The availability of generic programs reduces your technical and financial burden. 2. § 47.22 HazCom Program Contents Under the interim final rule, like the proposal, your HazCom program has to describe how you meet the HazCom standard for hazard determination, labels and other forms of warning, MSDSs, and training. It also must include a list of the hazardous chemicals that you produce or bring to the mine and use the same identity for the chemical on this list, the label, and the MSDS. Exchanging HazCom information. Where more than one operator works at a mine, your HazCom program also has to describe— • How you inform these other operators about the chemical's hazards and any protective measures for both normal work and foreseeable emergencies; • How you provide other operators with access to your written HazCom materials, especially MSDSs; and • How you identify hazards on labels and other warnings (the system or symbols you use). Several commenters expressed concern about how information would be exchanged between operators. One commenter wanted the final rule to give the primary operator at the mine the latitude to determine how to exchange information. Another commenter wanted us to prescribe how operators exchange information. The interim final rule deliberately uses performance-oriented language to give you the flexibility to establish how to exchange information with other operators and tailor your written program. At many mines, contractors, service personnel, and production miners are exposed to hazards of chemicals from many sources. For example, when independent contractors bring hazardous chemicals onto mine property, it is their responsibility to provide the primary operator and other operators (such as other independent contractors at the same site) with a written plan containing information about those chemicals. Likewise, it is the responsibility of the primary operator to inform these independent contractors about the chemical hazards at the mine. A systematic and orderly transfer of information ensures that all miners are informed. Specific, detailed requirements could reduce flexibility and become unnecessarily burdensome. Hazard determination procedures. One commenter wanted the final rule to require you to describe, in writing, the procedures you use to determine the hazards of the chemicals you evaluate and to maintain these written procedures. This commenter stated that these detailed written procedures would be a valuable source of information for workers, their representatives, and the government. This commenter also stated that such a record is the means to determine if you are following procedures to assess the hazards associated with a chemical's inherent properties and not how you use it. Another commenter said that we do not need to know the basis of your hazard determination. The interim final rule requires that your HazCom program include how you are putting the provision for hazard determination into practice at your mine. This requirement is performance oriented; it does not specify format or criteria. Although we agree with commenters that detailed procedures are valuable, HazCom does not require them. We expect your description of your hazard determination procedures to be sufficient to allow others to understand how you made the determination. Hazardous chemical list. The interim final rule requires you to compile a list of hazardous chemicals and maintain it for as long as a hazardous chemical is at the mine. You are responsible for listing only the hazardous chemicals that you produce or bring to your work areas. The list, or inventory, of hazardous chemicals is a quick reference so that you, miners, other operators working at your mine, and MSHA and HHS personnel can see what hazardous chemicals are present. It also must use a chemical identity that permits cross-referencing between the list, a chemical's label, and its MSDS. For example, if a chemical is identified by a trade name on the MSDS or the label, the list must be indexed and the chemical identified using the same trade name. You can compile the list for the mine as a whole or you can compile lists for individual work areas. For example, if few chemicals are used in one work area, such as a mine's quarry, and many are used in another work area, such as its shop, lists for the individual work areas would avoid confusing the miners in the quarry who would have no exposure to most of the chemicals that would be on a comprehensive list. You are in the best position to judge the most effective and efficient way to maintain this list. In maintaining this list, you must keep it up-to-date, whether for the whole mine or a specific work area. D. Subpart D—Container Labels and Other Forms of Warning Labeling containers of hazardous chemicals is a major provision of HazCom. A label is an immediate source of information about a hazardous chemical in the work area, providing the identity of the chemical and a brief summary of the chemical's most serious hazards. The labeling requirements in the interim final rule are substantively the same as in the proposal and consistent with OSHA's HCS. Labels that comply with OSHA's HCS will meet HazCom's requirements. The proposed rule contained the labeling exemptions under the “Scope and Application” and again under “Labels and Other Forms Of Warning.” In response to comments, we eliminated this repetition. We also put the labeling exemptions in a table, so that they are visually more accessible, and restated the proposal's provisions using clearer language. We moved the table to a separate Exemptions subpart near the end of the rule rather than placing them in the “Scope” section at the front of the rule. Except for “raw materials being mined or processed while on mine property,” the chemicals listed are exempt from labeling under HazCom because they are covered by the labeling requirements of other Federal agencies. These exempt chemicals, therefore, are already labeled when you receive them at the mine. We will discuss these exemptions in detail later in the section called “Exemptions from Labeling” (§ 47.82). The proposal contained provisions addressing a miner's and designated representative's right to examine the labeling information and have a copy without cost. In response to comments, we consolidated HazCom's provisions on access and cost for copies in a new, separate subpart, Making HazCom Information Available (§ 47.61 through § 47.63). The interim final rule does not include proposed § 46.5(d), which would have required you to ensure that the label for a hazardous chemical complies with the labeling requirements in an MSHA substance-specific standard, rather than the labeling requirements in HazCom. We do not currently have a substance-specific standard that requires labeling. Upon consideration of the comments, we determined that this provision was premature. If we promulgate such a standard, we will reconcile any differences from those in HazCom. 1. Labeling Requirement in General Among those commenters supporting a HazCom labeling requirement, many urged us to be consistent with OSHA's HCS. Several of these commenters, especially those with operations in both mining and general industry, said that it would be extremely burdensome if they had to comply with two significantly different requirements. For example, they said that it would be a great burden if you had to re-label incoming containers of hazardous chemicals to meet unique MSHA requirements. The interim final rule is consistent with the proposal, as well as OSHA's HCS. Labels that comply with OSHA's HCS will meet our labeling requirements because HazCom requires the same information on a label as OSHA's HCS. Likewise, we expect that labels meeting MSHA's HazCom criteria will meet OSHA's requirements for labels under its HCS. Among those commenters generally opposed to labeling requirements under HazCom, many stated that our existing labeling standards are adequate and HazCom is redundant. Other commenters stated that they already are providing labeling information and MSDSs consistent with OSHA's standard because their customers are asking for them. By unifying labeling requirements for hazardous chemicals in HazCom, we intend to clarify requirements for all mines and to help you understand your compliance responsibilities. 2. § 47.31 Requirement for Container Labels The interim final rule, consistent with the proposal, requires that each container of a hazardous chemical be labeled, tagged, or marked with the identity of the hazardous chemical and appropriate hazard warnings. You should only have to deal with three categories of labels: labels on containers of hazardous chemicals brought to the mine; labels on mixing, storage, or transport containers on mine property; and labels on the containers that you use to ship a hazardous chemical that you produce. Existing container labels. MSHA believes that hazardous chemicals brought to the mine will arrive with labels or labeling information. We expect that the label on the original container of a hazardous chemical provides adequate information about its hazards. The Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), OSHA, and other Federal agencies have rules addressing the labeling of hazardous chemicals. For this reason products or chemicals subject to their standards are exempt from labeling under HazCom. Commenters' suggestions about label content and format indicated that they perceived the proposed rule as requiring much more operator labeling than we intended. Some seemed to think that we required operators to evaluate and label containers of hazardous chemicals brought to the mine. One commenter pointed out that manufacturers may not identify new information on the label and MSDS they provide and stressed that operators should not have to update existing labels. The interim final rule also contains exemptions from labeling. The interim final rule does not require you to re-label containers of hazardous materials that are labeled in accordance with other Federal standards or are otherwise marked or tagged with the required information. You are not responsible for inaccurate information on a label prepared by the chemical's manufacturer or supplier, which you accept in good faith. We do not expect, and HazCom does not require, you to update the hazard warnings on labels you did not prepare. We do expect, however, that as you replace your inventory, you will do so with containers already labeled by the manufacturer with the new information. If the manufacturer sends you a new label with instructions to replace the existing label, you must do so. Labels on mine products. Commenters expressed concern that some operators might be unable to prepare the label for their mine's products because they lack the technical knowledge to do so. You should already know the hazard information for the chemicals produced at your mine because our existing standards require you to label hazardous materials and train miners about the safety and health aspects of their job. While underground coal mines are not required to label hazardous materials, they do conduct miner training. In the HazCom Toolbox, we will provide language that you can copy for labels for hazardous chemicals commonly produced at mines, such as respirable crystalline silica and ammonium nitrate-fuel oil (ANFO) mixed on mine property. A commenter asked that we clarify whether the requirement to update the label with significant new hazard information within 3 months applied to small quantities of hazardous chemicals in transfer containers. The availability of significant new hazard information on a hazardous chemical is a relatively infrequent occurrence. Most new information confirms, clarifies, or expands knowledge about the hazards already known. If you have to label the container of a hazardous material, it is our intent that you ensure that the label is accurate and update the label when you become aware of significant new hazard information. Maintenance. Some commenters stated that labels would be difficult to maintain in a mining environment or that they would be difficult for miners to read and understand. Although it may be difficult to maintain labels in some areas of the mining environment, these labeling requirements are realistic and achievable. OSHA's HCS provisions are successfully met at heavy and highway construction sites as well as at tunneling operations, situations that are comparable to mining sites. Many of the containers coming onto mine property will have permanent labels affixed, suitable for use in the mining environment, and effective training will help miners to understand the labeling information. HazCom requires you to check the label on a chemical brought to the mine to determine if it is hazardous so you will know whether you need to obtain and keep an MSDS, list the chemical on the list of hazardous chemicals, and train miners about the chemical. You also must ensure that the labels and other forms of hazard warning are legible. You do not have to re-label these containers unless there is no label or it is unreadable. Likewise, you must not remove or deface the labels on hazardous chemicals brought to the mine unless you immediately mark the container with the chemical's identity and its hazards. You must also ensure that the container remains labeled as long as you use it to contain a hazardous chemical. 3. § 47.32 Label Contents HazCom requires that you label containers of the hazardous chemicals you produce. Although the hazard warnings on the labels should be concise and easy to see, they also must convey the chemical's identity and its physical and health hazards. The label, tag, or other marking that you prepare must communicate enough information to users of your product and other employers so that they can recognize the hazards and make correct decisions about safe procedures and protective equipment. We do not intend the label to be the only or most complete source of information on the hazardous chemical. We recognize that it may not be feasible to include every hazard on the chemical's label that is listed in the MSDS. We expect, however, that you will address all hazards in the training program. The selection of hazards to be highlighted on the label will involve some assessment of the weight of the evidence regarding each hazard. This does not mean, however, that only acute hazards are to be covered on the label or that well-substantiated hazards can be omitted from the label because they appear on the MSDS. As one commenter stated: We urge you to consider the possible effects of a world in which every conceivable threat is labeled, stickered, highlighted until the senses are saturated and the desired effect of the entire message is lost. We are rapidly creating such a world, and we caution you against needlessly furthering this unnerving trend. For those chemicals posing multiple hazards, we expect you to prioritize the hazards and use that as the basis for the warnings. At a minimum, you must specify all serious hazards on the label. For example, if chromium (VI) in a welding fume is carcinogenic, causes liver and kidney damage, and blood abnormalities, as well as respiratory irritation, perforation of the nasal septum, damage to the eyes, sensitization dermatitis, and skin ulcers, the label could say: “Causes cancer, liver and kidney damage, blood abnormalities, and irritation of the skin, eyes, and mucous membranes.” The warning about it causing sensitization dermatitis, respiratory irritation, skin ulcers, perforation of the nasal septum, or conjunctivitis could be covered by the less specific phrase, “irritation of the skin, eyes, and mucous membranes.” You may have to reconcile inconsistent information in different sources by evaluating the evidence used in making the hazard classification. For example, if the chemical causes severe burns upon contact with skin, eyes, or mucous membranes, you would not also have to say that some evidence reported it to be a skin irritant. You also may need to distinguish between acute and chronic hazards. For example, some chemicals present a hazard only from prolonged exposure to high concentrations. When you determine what hazard information to include on a label, you should make an assessment of the information you report on the MSDS and coordinate the two documents. Hazard warning. The definition of “hazard warning” states that the warning must convey the specific hazard of the chemical. Consistent with the proposal, the hazard warning can be any type of message, words, picture, or symbol that provides at least general information regarding the hazards of the chemical in the container such as “flammable” or “suspected human carcinogen”. If applicable, the warning must include the organs affected. For example, if the chemical causes lung damage when inhaled, then “causes lung damage” is the appropriate warning. “Lung damage” would be the hazard and “do not inhale” would be the protective measure. Phrases such as “caution,” “danger,” or “harmful if inhaled” are precautionary statements. Some commenters suggested that the labels would need to state the container's contents and provide a general hazard warning, using words like “combustible,” “flammable,” or “poison.” A general statement, however, would not convey enough information to enable miners to adequately protect themselves. Other commenters believed that only a precautionary statement, such as “Danger!” would be needed. Some suggested that we require operators to include precautionary statements on the label, in addition to the other information. A few commenters stated that warning labels should summarize acute and chronic health effects and safety hazards and should provide advice and a phone number in case of emergency. Others recommended that labels include the target organ(s) affected by the chemical. We intend that the label include the target organ effects, if such information is available. There are some situations where the specific target organ effect is not known. When this is the case, you can use a more general warning statement. For example, if the only information available is an LC 50 test result, “harmful if inhaled” is appropriate. (An LC 50 , or the lethal concentration by inhalation for 50% of the animals tested, is the exposure concentration at which half of the animal test subjects died.) Our existing standards (§§ 56/57.16004; §§ 56/57.20012; § 77.208) require you to label hazardous materials appropriately. In addition to the required information, we encourage you to include other helpful information on the label. For example, the symbols on the label representing precautionary measures or safe work practices, such as “chemical goggles,” “respiratory protection,” or “use only in a well-ventilated area,” serve as reminders about the hazard and increase the likelihood that miners will use these measures. Label format . Many commenters suggested various format criteria and coding schemes for labels, affirming the benefits of uniformity. Consistent with the proposal, we recognize that there are a variety of different labeling systems to warn persons of chemicals and their hazards. Some systems rely on numeric codes and specific colors to convey the hazards of chemicals. These systems, however, usually convey the degree of risk that a chemical poses and not specific hazard information. You can use these types of systems for labels used at the mine if you communicate the specific physical and health hazards of the chemicals through other parts of the HazCom program, such as MSDSs and training. These systems are appropriate for labels to downstream users if you also provide them the other labeling information and the way to understand your labeling system. Recognizing that a specific system is not necessary to communicate the chemical's identity and its hazards, and that some mine operators already have a labeling system, HazCom's labeling requirements are performance oriented. The interim final rule is deliberately flexible to allow for the adoption of an international system for classifying and displaying hazard information, when it becomes available. Although the interim final rule does not require a specific labeling system, we encourage you to adopt a label format that is in accordance with an established standard. In its comments on the proposal, the Chemical Manufacturers Association (CMA) suggested that operators use the “American National Standard for Industrial Chemicals—Precautionary Labeling” (ANSI Z129.1-1988) for their labeling system. Uniformity in the format, content, and terminology of MSDSs and labels aids understanding and simplifies their development. It also allows miners and others to find critical information quickly. Consistent domestic labeling requirements between MSHA and OSHA will make communication among industries more effective and will make it easier for them to adopt global hazard communication standards. Other languages . The interim final rule, consistent with OSHA's HCS and the proposal, requires that the label be in English. If a significant number of your miners do not read English, or if their English is poor, you should provide the labeling information in another language in addition to English or add symbols to communicate the chemical's hazards. For example, if your workforce speaks Spanish, you should add a label in Spanish that gives the chemical's identity and hazard information or provide a translation of the labeling information to the affected miners. If your workforce speaks several different languages, or there are other literacy issues, you should add symbols to the label to communicate the chemical's hazards. You must ensure that the workforce understands the meaning of the symbols. Carcinogen labeling. As discussed under “Identifying Hazardous Chemicals,” the HazCom proposal, interim final rule, and OSHA's HCS all require that the employer consider a chemical to be hazardous if it is listed in the specified ACGIH, NTP, or IARC publications or regulated under agency standards. You must include a carcinogenic warning on the label if one of these sources classifies the hazardous chemical as a potential or confirmed carcinogen. Many commenters suggested that we allow operators to determine what should be listed on the label based on an assessment of the weight of the evidence. Several pointed out that both IARC and NTP acknowledge that their classification evaluations are not complete hazard assessments. IARC and NTP use a strength-of-evidence approach that does not take into consideration negative studies for evaluating a chemical's carcinogenic hazard. In regard to the use of ACGIH, one commenter stated: ACGIH lists chemicals identified as carcinogens from “other sources” without identifying these sources. The ACGIH documentation of TLV's and BEI's lists five sources of information on carcinogens (IARC, MAK, NTP, NIOSH, and TLV). Since these sources often use each other as their reference point rather than come to independent conclusions, we believe that the “carcinogen” tag can be inappropriate unless there is conclusive evidence of carcinogenicity. While fuller explanations may be given on an MSDS, we believe that automatic triggers should not be used to determine warnings on labels. Although some commenters specifically objected to using IARC, NTP, or ACGIH as a trigger for cancer labeling, others supported carcinogen labeling based on the judgment of these organizations, but only for those chemicals identified as known human carcinogens. Another commenter objected to carcinogen labeling for those chemicals listed in IARC Group 2A. Group 2A carcinogens (probably carcinogenic) are known to induce cancer in animals, but the evidence of human carcinogenicity is limited. These commenters believed that requiring carcinogen labeling for potential or probable carcinogens would result in “over-labeling” and detract from the focus that should be given to more serious hazards. In addition, one pointed out that “over-labeling” could have the adverse marketplace consequence of encouraging shifts to unlabeled products, typically without an assessment of whether the unlabeled product is, or is not, safer than the labeled product. Several commenters supported including IARC, NTP, and ACGIH's carcinogenicity findings on the MSDS, but not on the label. A few commenters, however, recommended that we require labeling for all carcinogens, including those listed as potential or probable. In considering the comments, we find that IARC, NTP, and ACGIH base their cancer classifications on valid scientific evidence. This evidence warrants informing miners of the cancer hazard associated with any chemical on these lists. Miners have a right to know about this hazard information. If one or more of these organizations has associated a potential, probable, or confirmed carcinogenic hazard with a chemical at the mine, you must inform the miners who can be exposed. A fuller discussion about the use of these organizations as sources is in the Hazard Determination section of this preamble. Silica labeling. IARC is one of the authoritative sources listed in HazCom for establishing whether a chemical is a carcinogen. In 1997, IARC classified inhaled (respirable) crystalline silica as Group 1, a confirmed human carcinogen. A number of commenters expressed concern that the proposal would have required the labeling of silica as a carcinogen. Several argued that labeling silica as a carcinogen was both impractical and unnecessary. One of these commenters stated: Silica is, as MSHA recognizes, a natural substance occurring in the great majority of the earth's crust and labeling over one billion tons annually of naturally occurring stone produced by American quarries would clearly be impractical and unnecessary by the standards of good science. Some commenters stressed that the labeling requirement should apply to respirable silica because the size of the silica particle determines whether or not it is a health hazard. One commenter stated: OSHA has taken the position in interpreting its HCS that it applies only to crystalline silica available for respiration. * * * Mr. Gerald F. Scannel, Assistant Secretary of Labor for OSHA, stated that kaolin dust products containing less than 0.1% respirable crystalline silica would be exempt from coverage under the provision of paragraph (d) of the [OSHA's] HCS, “Hazard Determination.” In addition, this commenter cited a statement by Dr. David Rall of the NTP that, “Only crystalline silica in respirable form will be added to the list of substances in the [NTP] 6th annual report.” The interim final rule does not address the labeling of containers of hazardous chemicals off mine property. You will have to label containers of any product containing 0.1% or more of respirable crystalline silica as a carcinogen to meet OSHA's HCS labeling requirements for your customers. The HazCom interim final rule exempts the raw material being mined or processed from labeling while on mine property. For example, if you operate a silica flour mill, you do not have to label containers of the raw material, such as crushers, bins, or hoppers. Under HazCom's hazard determination criteria, you must consider crystalline silica to be a human carcinogen when it is in respirable form and capable of being released in the work area or when an activity, such as crushing, would create respirable dust. Although you do not have to label it for purposes of HazCom, you must train miners about silica's carcinogenicity. Providing copies. The proposal would have required you to provide a copy of the labeling information with the initial shipment of a hazardous chemical to an employer. You could include this labeling information with the chemical's shipping papers rather than attach it to each container. If you became aware of any significant new information concerning the hazards of the chemical, you had to incorporate this new information, as appropriate, into a new label within 3 months and provide it with the next shipment of the chemical to the employer. In addition to the identity of the hazardous chemical and appropriate hazard warnings, the proposal also would have required you to provide the employer with your name and address or the name and address of a responsible party who could provide additional information about the hazardous chemical. The proposal did not specifically address customers who were not employers. Some commenters said that HazCom should require this labeling information on all containers shipped from the mine. They stated that it would be easier to label each shipment to avoid the extra recordkeeping associated with tracking which shipments to employers must contain labeling information. Several commenters stated that 3 months is too long and that you should inform miners immediately of significant new hazard information. These commenters suggested 5 days, 30 days, and 45 days as adequate time for you to incorporate the new information into a new label. Several commenters wanted us to cover hazardous chemicals shipped from a mine in a way that was consistent with the OSHA HCS. Some questioned our authority to require you to provide labels on products leaving mine property. The interim final rule requires you to make label information available upon request. Our experience indicates that mine products are already labeled and MSDSs are sent in a manner consistent with OSHA's HCS. We believe that market forces and the requirements of other agencies will serve to ensure that you label your product appropriately for downstream users. Although you are responsible for the accuracy of the information on any label you prepare, you are not responsible for the accuracy of labels a manufacturer prepared for a hazardous chemical brought to your mine. We agree with those commenters who felt that you should inform miners immediately of any significant new information about the hazards of the chemicals in their work area, whether or not you have to update the label. 4. § 47.33 Label Alternatives HazCom requires that the hazardous chemical's label warn miners about the presence, chemical identity, and specific health and physical hazards of the chemical. Neither the proposal nor the interim final rule includes specific criteria for the format of the label. The interim final rule requires that the label be prominently displayed, legible, accurate, and in English; display appropriate hazard warnings; and use a chemical identity that permits cross-referencing between the list of hazardous chemicals, a chemical's label, and its MSDS. In the case of a trade secret, you must comply with the requirements of §§ 47.71 through 47.77 (trade secrets). Commenters supplied a wide variety of suggestions for a label format. Several recommended that we require a standardized label format. Some commenters suggested that a coding or rating system might be helpful. Some requested that we permit flexibility in our labeling requirements and allow batch labeling, color coding, standardized containers, or stenciling a generic name on the container. Others did not support the use of a coding or rating system on labels because they thought that miners would find such a system confusing. Some commenters suggested that we require labels to have large bold print with pictorial or color warnings. Another suggested that operators could label containers using markers or paint. The label requirements in the interim final rule are performance-oriented, flexible, and consistent with the proposal and OSHA's HCS. Labels made with markers or paint are acceptable as long as they identify the hazardous chemical and its hazards and are maintained in legible condition. Any name may be used to identify the chemical contents of a container as long as it can be cross-referenced with the MSDS and the hazardous chemical list. You may substitute various types of standard operating procedures, process sheets, batch tickets, blend tickets, and similar written materials for container labels on stationary process equipment. The alternative, however, must identify the container to which it applies, communicate the same information as required on the label, and be readily accessible throughout each work shift to miners in the work area. You can post signs or placards that convey the hazard information if there are a number of stationary containers within a work area that have similar contents and hazards. 5. § 47.34 Temporary, Portable Containers The interim final rule, consistent with the proposal and OSHA's HCS, does not require you to label a portable container into which a hazardous chemical is transferred from a labeled container, if the portable container is for the immediate use of the miner who performs the transfer. To clarify compliance responsibilities, we replaced the word “immediately” with the phrase “during the same work shift” in the interim final rule. Most commenters supported the proposed portable container exemption, but some claimed that it was too restrictive. These commenters recommended that we not require labeling of portable containers if they are subject to operating procedures that provide a means of alerting miners to their contents. Other commenters recommended that we expand this exemption to include any designee of the miner who performs the transfer. One of these commenters stated that adding the word designee would allow those individuals working with the miner who transferred the hazardous chemical, also to use that chemical. Otherwise, each miner working on the job would need his or her own portable container, perhaps creating a bigger hazard. Another commenter opposed expanding the portable container exemption to include the miner's designee because of concern that the miners would not communicate the hazard information to each other. Other commenters opposed our proposal to exempt portable containers, believing that it was too lenient and could create a serious hazard. Commenters expressed concern— • That unattended, misplaced, or forgotten unlabeled portable containers could present a high risk of exposure to hazardous materials due to inappropriate handling or disposal by other workers; • That unlabeled portable containers could be potentially dangerous because of the residues left in them; • That if the chemical in the portable container was not completely used by the end of the shift, we should require that the unused portion be returned to a labeled container; • That all containers of hazardous chemicals be labeled under this law or other applicable laws; and • That this section should be clarified because it seems to imply that you have no responsibility to maintain labeling information if a product is repackaged or transferred to another container at the mine site. After considering the comments and observing the use of portable containers in mining, we determined that allowing the miner who performs the transfer to use a hazardous chemical from an unlabeled container will not reduce that miner's protection. One common use of temporary, portable containers is when a miner transfers a lubricant from a 55-gallon drum into a small plastic or galvanized container in order to safely access and properly service machinery. We recognize that it would be impractical, or at least inconvenient in some instances, [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A00-24803. Public record. Not legal advice.