Standards and Guidance Update

1. Standards and Guidance Update Jim Maddux OSHA Directorate of Standards and Guidance Dallas Fort Worth AIHA/ASSE Seminar September 15, 2009

2. Standards and Guidance Update OSHA�s regulatory process Regulatory activities Guidance work Answer questions

3. What I�d like to do this afternoon is cover some of the topics on our regulatory agenda that might be of interest to you. Starting with a very brief description of the analyses that needs to be done before we can actually issue a rule. We�ve discovered recently that a lot of people are really not aware of the analytical requirements and that there have been added requirements. The process of developing a new regulation is complex and time consuming. It has become more complex over time and includes a series of technical analyses. . What I�d like to do this afternoon is cover some of the topics on our regulatory agenda that might be of interest to you. Starting with a very brief description of the analyses that needs to be done before we can actually issue a rule. We�ve discovered recently that a lot of people are really not aware of the analytical requirements and that there have been added requirements. The process of developing a new regulation is complex and time consuming. It has become more complex over time and includes a series of technical analyses. .

4. The preliminary rulemaking activities include preparing Requests for Information (RFIs), literature research, site visits, stakeholder meetings and other activities needed to develop rules that address important health and safety hazards in the most cost effective way possible. In addition, for major rules, (those with compliance costs in excess of a $100 million dollars or that have a major impact on small businesses) OSHA conducts SBREFA panels to get input on small business impacts. Small Business Regulatory Enforcement Fairness Act Based on this information OSAH develops the regulatory text, the preamble explaining the standard, and publish it in the Federal Register. OSHA then accepts written comment from the public and, in most cases, conducts informal public hearings. OSHA then analyzes the record, prepares the final rule and preamble and published the final rule in the Federal Register. At various steps in the process, rules are reviewed by OSHA and DOL management and OMB. The preliminary rulemaking activities include preparing Requests for Information (RFIs), literature research, site visits, stakeholder meetings and other activities needed to develop rules that address important health and safety hazards in the most cost effective way possible. In addition, for major rules, (those with compliance costs in excess of a $100 million dollars or that have a major impact on small businesses) OSHA conducts SBREFA panels to get input on small business impacts. Small Business Regulatory Enforcement Fairness Act Based on this information OSAH develops the regulatory text, the preamble explaining the standard, and publish it in the Federal Register. OSHA then accepts written comment from the public and, in most cases, conducts informal public hearings. OSHA then analyzes the record, prepares the final rule and preamble and published the final rule in the Federal Register. At various steps in the process, rules are reviewed by OSHA and DOL management and OMB.

5. Public Involvement The public is invited to comment on rules, often several times Stakeholder meetings (pre-proposal) Advance Notice of Proposed Rulemaking (ANPR) or Request for Information (RFI) Written comment following publication of proposal (mandatory) Hearings (if requested) Post hearing comments and briefs

6. Legal Requirements for Rulemaking OSH Act Administrative Procedures Act Regulatory Flexibility Act Paperwork Reduction Act (PRA) Small Business Regulatory Enforcement Fairness Act (SBREFA) National Environmental Policy Act (NEPA) Unfunded Mandates Reform Act (UMRA) Congressional Review Act Information Quality Act

7. Analytical Requirements Significant risk determination Technological feasibility Economic feasibility/cost effectiveness Information collection requirements under the Paperwork Reduction Act Where there is impact on significant number of small businesses, Small Business Regulatory Enforcement Fairness Act (SBREFA) panel Peer review requirements As I said, OSHA conducts a lot of technical analysis during the rulemaking process. The first step, OSHA must determine that a significant risk is present (the Supreme Court in the Benzene decision provided guidance on significant risk and suggested that a 1/1000 risk of dying is significant). OSHA uses quantitative risk assessment for chemical hazards and analysis of injury and fatality records for safety standards. OSHA must demonstrate that a significant risk exists and that its proposed standard will reduce that risk. In addition to that we also have to establish that something is technologically feasible. Technological feasibility involves gathering data to assess the current compliance baseline and identifying feasible control methods for controlling exposure to workplace hazards which basically means capable of being done. We do site visits�go out and look at the types of controls that are currently in use in industry. The economic analysis includes estimating the costs of compliance, the benefits in terms of improved worker safety and health and the impact on affected businesses. We have to make sure that the requirements that we are thinking about doing are economically feasible for different industries. We also estimate the amount of time employers must spend complying with the any provisions of a standards that creates a paperwork burden as defined by the Paperwork Reduction Act. As I mentioned we must estimate the impact on small businesses through the SBREFA process, an interactive process involving review of preliminary drafts of regulatory text and economic information with a groups of affected small business representatives, SBA and OMB. This is a fairly new requirement from the late 1990s. It requires us to convene a panel of small business entity representatives to collect input from them on how the provisions that we are thinking about would affect these small businesses and then that information is folded into our preparations for the proposed rule. Finally, there are new requirements to conduct peer reviews of scientific information that supports our regulatory actions such as quantitative risk assessment and economic analyses. This is a new requirement, the past 2 months. We now have to peer review any scientifically influential information in our rulemakings. As I said, OSHA conducts a lot of technical analysis during the rulemaking process. The first step, OSHA must determine that a significant risk is present (the Supreme Court in the Benzene decision provided guidance on significant risk and suggested that a 1/1000 risk of dying is significant). OSHA uses quantitative risk assessment for chemical hazards and analysis of injury and fatality records for safety standards. OSHA must demonstrate that a significant risk exists and that its proposed standard will reduce that risk. In addition to that we also have to establish that something is technologically feasible. Technological feasibility involves gathering data to assess the current compliance baseline and identifying feasible control methods for controlling exposure to workplace hazards which basically means capable of being done. We do site visits�go out and look at the types of controls that are currently in use in industry. The economic analysis includes estimating the costs of compliance, the benefits in terms of improved worker safety and health and the impact on affected businesses. We have to make sure that the requirements that we are thinking about doing are economically feasible for different industries. We also estimate the amount of time employers must spend complying with the any provisions of a standards that creates a paperwork burden as defined by the Paperwork Reduction Act. As I mentioned we must estimate the impact on small businesses through the SBREFA process, an interactive process involving review of preliminary drafts of regulatory text and economic information with a groups of affected small business representatives, SBA and OMB. This is a fairly new requirement from the late 1990s. It requires us to convene a panel of small business entity representatives to collect input from them on how the provisions that we are thinking about would affect these small businesses and then that information is folded into our preparations for the proposed rule. Finally, there are new requirements to conduct peer reviews of scientific information that supports our regulatory actions such as quantitative risk assessment and economic analyses. This is a new requirement, the past 2 months. We now have to peer review any scientifically influential information in our rulemakings.

8. Regulatory Review Process The rule is written by a rulemaking team (at least one person each from DSG, DEA, SOL) The rule is then reviewed by: DSG management DEA management OSH Solicitor management OSHA Assistant Secretary DOL Solicitor DOL senior leadership OMB Federal Register As I said, OSHA conducts a lot of technical analysis during the rulemaking process. The first step, OSHA must determine that a significant risk is present (the Supreme Court in the Benzene decision provided guidance on significant risk and suggested that a 1/1000 risk of dying is significant). OSHA uses quantitative risk assessment for chemical hazards and analysis of injury and fatality records for safety standards. OSHA must demonstrate that a significant risk exists and that its proposed standard will reduce that risk. In addition to that we also have to establish that something is technologically feasible. Technological feasibility involves gathering data to assess the current compliance baseline and identifying feasible control methods for controlling exposure to workplace hazards which basically means capable of being done. We do site visits�go out and look at the types of controls that are currently in use in industry. The economic analysis includes estimating the costs of compliance, the benefits in terms of improved worker safety and health and the impact on affected businesses. We have to make sure that the requirements that we are thinking about doing are economically feasible for different industries. We also estimate the amount of time employers must spend complying with the any provisions of a standards that creates a paperwork burden as defined by the Paperwork Reduction Act. As I mentioned we must estimate the impact on small businesses through the SBREFA process, an interactive process involving review of preliminary drafts of regulatory text and economic information with a groups of affected small business representatives, SBA and OMB. This is a fairly new requirement from the late 1990s. It requires us to convene a panel of small business entity representatives to collect input from them on how the provisions that we are thinking about would affect these small businesses and then that information is folded into our preparations for the proposed rule. Finally, there are new requirements to conduct peer reviews of scientific information that supports our regulatory actions such as quantitative risk assessment and economic analyses. This is a new requirement, the past 2 months. We now have to peer review any scientifically influential information in our rulemakings. As I said, OSHA conducts a lot of technical analysis during the rulemaking process. The first step, OSHA must determine that a significant risk is present (the Supreme Court in the Benzene decision provided guidance on significant risk and suggested that a 1/1000 risk of dying is significant). OSHA uses quantitative risk assessment for chemical hazards and analysis of injury and fatality records for safety standards. OSHA must demonstrate that a significant risk exists and that its proposed standard will reduce that risk. In addition to that we also have to establish that something is technologically feasible. Technological feasibility involves gathering data to assess the current compliance baseline and identifying feasible control methods for controlling exposure to workplace hazards which basically means capable of being done. We do site visits�go out and look at the types of controls that are currently in use in industry. The economic analysis includes estimating the costs of compliance, the benefits in terms of improved worker safety and health and the impact on affected businesses. We have to make sure that the requirements that we are thinking about doing are economically feasible for different industries. We also estimate the amount of time employers must spend complying with the any provisions of a standards that creates a paperwork burden as defined by the Paperwork Reduction Act. As I mentioned we must estimate the impact on small businesses through the SBREFA process, an interactive process involving review of preliminary drafts of regulatory text and economic information with a groups of affected small business representatives, SBA and OMB. This is a fairly new requirement from the late 1990s. It requires us to convene a panel of small business entity representatives to collect input from them on how the provisions that we are thinking about would affect these small businesses and then that information is folded into our preparations for the proposed rule. Finally, there are new requirements to conduct peer reviews of scientific information that supports our regulatory actions such as quantitative risk assessment and economic analyses. This is a new requirement, the past 2 months. We now have to peer review any scientifically influential information in our rulemakings.

9. Semiannual Regulatory Agenda Provides each agency�s plans for regulatory activities over the next year Current agenda was published on 4/24/2006 The new agenda will be published in October 2006 Can be accessed through OSHA�s web page or on the web page for the Federal Register (www.gpoaccess.gov/fr) under �Unified Agenda� READ SLIDE The Semiannual regulator agenda. I�m sure most of you are familiar with this, it provides each Agency�s plans for regulatory activities over the next year. Published on 4/24/06. DSG has 20 projects on the Regulatory Agenda, including 2 completed action items. We are actively working on all of them. They address a variety of workplace hazards ranging from respiratory hazards addressed by the Assigned Protection Factors rulemaking to, hexavalent chromium, crystalline silica, electrical hazards and many others. It can be accessed through our website or on the webpage for the Federal Register. Remember to look under Unified Agenda, not Regulatory Agenda I will discuss several of the more visible projects and give you updates on our progress and plans for completing them. READ SLIDE The Semiannual regulator agenda. I�m sure most of you are familiar with this, it provides each Agency�s plans for regulatory activities over the next year. Published on 4/24/06. DSG has 20 projects on the Regulatory Agenda, including 2 completed action items. We are actively working on all of them. They address a variety of workplace hazards ranging from respiratory hazards addressed by the Assigned Protection Factors rulemaking to, hexavalent chromium, crystalline silica, electrical hazards and many others. It can be accessed through our website or on the webpage for the Federal Register. Remember to look under Unified Agenda, not Regulatory Agenda I will discuss several of the more visible projects and give you updates on our progress and plans for completing them.

10. Recent Standards Activities Final rule, longshoring & marine terminals- vertical tandem lifts (December 2008) Final rule, clarification on training and PPE for each employee (December 2008) Final rule, welding definitions consensus standards (March 2008)

11. Recent Standards Activities Final action, Bitrex� respirator fit testing (June 2009) Direct final rule, acetylene consensus standards (August 2009) Final rule, PPE consensus standards (August 2008)

12. Recent Standards Activities Withdrawal of the ANPRM for diacetyl Initiate diacetyl SBREFA panel Add combustible dust to the Regulatory Agenda Initiate peer review of crystalline silica health effects and risk assessment Within a few weeks of arriving at the Department of Labor Secretary Solis made clear her commitment to worker safety and health and the need to move forward quickly with standards development by withdrawing the ANPRM for diaceytyl on March 17th. She believed that an ANPRM in this rulemaking was an unnecessary step and wanted to move more quickly to convene the SBREFA review panel. We formally convened the panel on May 5th. The Secretary also announced on April 28th that OSHA will be adding combustible dust to our regulatory agenda. The agenda states that we will develop an ANPRM in August. This activities clearly signal that this administration is interested in moving forward with rulemaking. Peer review on silica was initiated on May 22nd. Within a few weeks of arriving at the Department of Labor Secretary Solis made clear her commitment to worker safety and health and the need to move forward quickly with standards development by withdrawing the ANPRM for diaceytyl on March 17th. She believed that an ANPRM in this rulemaking was an unnecessary step and wanted to move more quickly to convene the SBREFA review panel. We formally convened the panel on May 5th. The Secretary also announced on April 28th that OSHA will be adding combustible dust to our regulatory agenda. The agenda states that we will develop an ANPRM in August. This activities clearly signal that this administration is interested in moving forward with rulemaking. Peer review on silica was initiated on May 22nd.

13. Regulatory Agenda Projects Health Standards Hazard communications (GHS) Diacetyl Beryllium Silica Hexavalent chromium remand Portacount respirator fit testing method The Spring Regulatory Agenda has the following actions for these projects: HazCom/GHS � publish an NPRM in October 2009 Diacetyl � Complete SBREFA report in July 2009 Beryllium � initiate peer review in December 2009 Silica � initiate the peer review in June 2009. Peer Review was initiated on May 22nd.The Spring Regulatory Agenda has the following actions for these projects: HazCom/GHS � publish an NPRM in October 2009 Diacetyl � Complete SBREFA report in July 2009 Beryllium � initiate peer review in December 2009 Silica � initiate the peer review in June 2009. Peer Review was initiated on May 22nd.

14. Globally Harmonized System of Classification and Labeling of Chemical - GHS A common, coherent approach to classifying and communicating chemical hazards Includes: Harmonized definitions of hazards Specific criteria for labels Harmonized format for safety data sheets GHS is not a proposed standard GHS is not a standard but a set of criteria and provisions that a regulatory body can incorporate into existing systems. GHS is not a standard but a set of criteria and provisions that a regulatory body can incorporate into existing systems.

15. How does the GHS advance safety and health? The goal: All domestic and international systems Using the same definitions of hazard for the same chemical Providing the same basic information on labels Providing the same SDS format Protection/Health & Safety Reduce confusion/Increase comprehension of hazards Better downstream risk management Facilitates training Helps address literacy problems

16. Proposed Modifications to the HCS Performance-oriented to specification standard Hazard Classifications (not specifically relevant to construction) Labels and Safety Data Sheet format Scope and Application will not change All current exemptions will apply No testing required Implementation Revised provisions � 3 years Training � 2 years

17. Proposed Modifications to the HCS Designation of Categories of Hazard Determines Label Elements Pictogram � Hazard Statement � Signal Word Precautionary Statements

18. Modifications to Labels Sample Hazard Statements Fatal if in contact with skin Extremely flammable aerosol May cause cancer The left of this slide provides examples of hazard statements that may be included on a label and the two signal words. (A hazard statement is a phrase assigned to a hazard class and category that describes the nature of hazards of a hazardous product, including, where appropriate, the degree of hazard. A signal word is a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label.) On the right of this slide is all 9 GHS pictograms. A pictogram consists of a hazard symbol surrounded by a red square set at a point. The pictograms in the first two columns may look familiar, as they have symbols that are taken from the Transport sector. The three pictograms in the last column are new and consist of an exclamation point, which is just supposed to be an attention getter, the dead tree and fish for environmental hazards and the �star man� for health hazards. Column 1 pictograms: Flame, Flame over circle, Exploding bomb Column 2 pictograms: Gas cylinder, Corrosion, Skull and Crossbones Column 3 pictograms: Exclamation mark, Environment, Health Hazard The left of this slide provides examples of hazard statements that may be included on a label and the two signal words. (A hazard statement is a phrase assigned to a hazard class and category that describes the nature of hazards of a hazardous product, including, where appropriate, the degree of hazard. A signal word is a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label.) On the right of this slide is all 9 GHS pictograms. A pictogram consists of a hazard symbol surrounded by a red square set at a point. The pictograms in the first two columns may look familiar, as they have symbols that are taken from the Transport sector. The three pictograms in the last column are new and consist of an exclamation point, which is just supposed to be an attention getter, the dead tree and fish for environmental hazards and the �star man� for health hazards. Column 1 pictograms: Flame, Flame over circle, Exploding bomb Column 2 pictograms: Gas cylinder, Corrosion, Skull and Crossbones Column 3 pictograms: Exclamation mark, Environment, Health Hazard

19. Labeling

20. SDS Format 16 Section Format Modeled after ANSI OSHA is proposing: Sections 1 -11 and section 16 would be mandatory Sections 12 -15 would be non-mandatory

21. Other OSHA Standards All substance specific standards will contain a generic hazard communication statement: The employer shall include cadmium in the workplace hazard communication program established to comply with the Hazard Communication Standard (HCS) (29 CFR 1910.1200). The employer shall ensure that employees have access to labels on containers of cadmium and�safety data sheets, and are trained in accordance with the provisions of 29 CFR 1910.1200 and paragraph (m)(4) below.� The employer shall provide information on at least the following hazards:� Cancer, lung and kidney effects, and acute toxicity effects

22. Other OSHA Standards 1926.152 Flammable and Combustible Liquids Harmonizing the definitions of flammable liquids with GHS definitions Removing the term combustible liquid Maintaining scope by combining flashpoint cutoffs with the GHS categories

23. Silica Rulemaking Update �Current Activities Developing Notice of Proposed Rulemaking (NPRM) Conducting peer review of health effects analysis and quantitative risk assessment OSHA has made the silica rulemaking a priority, and the Agency is devoting the resources necessary to move promptly to develop a silica standard The SBREFA process for the rulemaking was completed in late 2003 A separate regulatory text for construction was developed at that time We are now developing revised regulatory text and supporting analyses for a proposed rule We have also initiated the peer review process for our health effects literature review and quantitative risk assessment OSHA has made the silica rulemaking a priority, and the Agency is devoting the resources necessary to move promptly to develop a silica standard The SBREFA process for the rulemaking was completed in late 2003 A separate regulatory text for construction was developed at that time We are now developing revised regulatory text and supporting analyses for a proposed rule We have also initiated the peer review process for our health effects literature review and quantitative risk assessment

24. Silica Rulemaking Update Next Steps Completion of peer review reports and revisions to health and risk analyses Complete development and clearance of NPRM Our next steps will lead us to publication of a proposed rule As I just mentioned, the Agency will receive reports from peer reviewers and make any appropriate revisions to the health effects and risk analyses We will also complete development and clearance of the other portions of the NPRM, including our economic and technological feasibility analyses We will consult with our advisory committees as appropriate No target date has been established for issuing a proposal at this time Our next steps will lead us to publication of a proposed rule As I just mentioned, the Agency will receive reports from peer reviewers and make any appropriate revisions to the health effects and risk analyses We will also complete development and clearance of the other portions of the NPRM, including our economic and technological feasibility analyses We will consult with our advisory committees as appropriate No target date has been established for issuing a proposal at this time

25. Regulatory Agenda Projects Safety Standards Consensus standards-acetylene Electric power generation Standards improvement project III General working conditions for shipyards Walking/working surfaces Combustible dust We are currently perparing final rules for Consensus Standards for PPE and Acetylene, and Electric power generation (subpart V). Both PPE and Acetylene have completion dates of August in the reg agenda. Consensus Standards: PPE Final Rule--It is anticipated that OMB will clear the final next week, making way for final Acting A/S signature, and publication in the Federal Register. Consensus Standards: Acetylene DFR/NPRM--Cleared by OMB 07/23/09/ Being prepared for final signature and publication in Federal Register. We are developing proposals for working conditions in shipyards, mechanical power presses, explosives, walking & working surfaces, tree care operations and the standards improvement project phase III. We are currently perparing final rules for Consensus Standards for PPE and Acetylene, and Electric power generation (subpart V). Both PPE and Acetylene have completion dates of August in the reg agenda. Consensus Standards: PPE Final Rule--It is anticipated that OMB will clear the final next week, making way for final Acting A/S signature, and publication in the Federal Register. Consensus Standards: Acetylene DFR/NPRM--Cleared by OMB 07/23/09/ Being prepared for final signature and publication in Federal Register. We are developing proposals for working conditions in shipyards, mechanical power presses, explosives, walking & working surfaces, tree care operations and the standards improvement project phase III.

26. Recently Published Guidance Combustible dust fact sheet Combustible dust web page Control of safety and health hazards in metal scrap recycling Occupational exposure to noroviruses We have published a variety of guidance products ranging from written publications, videos, fact sheets, web pages and posters. We have published a variety of guidance products ranging from written publications, videos, fact sheets, web pages and posters.

27. Recently Published Guidance Nanotechnology web page Barge safety guidance PSM poster & quick card Shipyard industry digest Hazard communication for combustible dust We have published a variety of guidance products ranging from written publications, videos, fact sheets, web pages and posters. We have published a variety of guidance products ranging from written publications, videos, fact sheets, web pages and posters.

28. Guidance developed under the American Recovery and Reinvestment Act (ARRA) Silica control guidelines for construction Ethylene oxide guidance in health care Under the ARRA OSHA will be issuing new guidance to support stimulus projects being conducted in various sector especially construction and possibly health care. These are just a few of the things we have completed. There may be more to come. Under the ARRA OSHA will be issuing new guidance to support stimulus projects being conducted in various sector especially construction and possibly health care. These are just a few of the things we have completed. There may be more to come.

29. Influenza Guidance Pandemic Influenza Guidance on preparing workplaces for an influenza pandemic Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers Proposed guidance on workplace stockpiling of respirators & facemasks for pandemic influenza As you know, over the last few weeks, there has been a lot of discussion in the news about pandemic influenza, notably the H1N1 virus. DSG and other directorates in OSHA have been working hard to get information out to the employers and employees in the workplace, especially to those in the healthcare industry. Above is a list of documents that have been release by OSHA to help keep employers and employees safe within the workplace if there is a pandemic influenza outbreak. As you know, over the last few weeks, there has been a lot of discussion in the news about pandemic influenza, notably the H1N1 virus. DSG and other directorates in OSHA have been working hard to get information out to the employers and employees in the workplace, especially to those in the healthcare industry. Above is a list of documents that have been release by OSHA to help keep employers and employees safe within the workplace if there is a pandemic influenza outbreak.

30. Influenza Guidance H1N1 Guidance Materials How to protect yourself in the workplace What employers can do to protect workers High exposure risk occupations Respiratory protection Respirators vs. surgical masks

31. Future Guidance Final stockpiling of respirators and facemasks for pan flu Booklet on hexavalent chromium Longshoring quick cards Respirator video Safety and health management systems

32. Questions?