OSHA Extends Deadline for Submitting Comments on MSD Rule by 15 Days

OSHA has just announced that it is extending by 15 days the public comment period for its proposal to add a separate column on the OSHA 300 log for employers to record work-related musculoskeletal disorders (MSDs).  Those wishing to comment on the proposed rule must now do so by March 30, 2010.  Four separate stakeholders had requested an extension of the comment period. 

Under the proposed rule, employers would be required to “check the box” in a separate column on the OSHA 300 log – an “MSD” column – for injuries and illnesses that fit within the agency’s definition. For purposes of the proposal, the agency defines MSDs as:

[D]isorders of the muscles, nerves, tendons, ligaments, joints, cartilage and spinal discs. MSDs DO NOT include disorders caused by slips, trips, falls, motor vehicle accidents, or other similar accidents. Examples of MSDs include: Carpal tunnel syndrome, Rotator Cuff syndrome, De Quervain’s disease, Trigger finger, Tarsal tunnel syndrome, Sciatica, Epicondylitis, Tendinitis, Raynaud’s phenomenon, Carpet layers knee, Herniated spinal disc, and Low back pain.

OSHA also is proposing to remove existing language from its recordkeeping compliance directive that “minor musculoskeletal discomfort” is not recordable as a restricted work case “if a health care professional determines that the employee is fully able to perform all of his or her routine job functions, and the employer assigns a work restriction for the purpose of preventing a more serious injury.” OSHA is concerned that this language creates confusion among employers about recording MSDs. OSHA’s proposal attempts to clarify that employers must record abnormal conditions resulting in minor musculoskeletal discomfort, regardless of whether the conditions include objective signs of an injury or illness – so long as all of the other criteria for recording are met.

This is an important rulemaking and all stakeholders are encouraged to participate in the rulemaking process.

OSHA Proposes to Restore MSD Column on "300 Log"

In a move sure to be viewed by some as a prelude to a new ergonomics rulemaking, OSHA has proposed adding a separate column on the OSHA 300 log for employers to record work-related musculoskeletal disorders (MSDs). (The initial 2001 recordkeeping final rule had included an MSD column, but OSHA later deleted that column before the provision ever became effective.) The rule also proposes the same definition of “MSDs” that OSHA had included in the initial 2001 final rule. 

This is an important and fast-moving rulemaking. Interested stakeholders are encouraged to review the proposal thoroughly and provide comments to the agency. The comment period ends on March 15, 2010; the agency is holding a public meeting on the proposal on March 9, 2010.

Under the proposed rule, employers would be required to “check the box” in a separate column on the OSHA 300 log – an “MSD” column – for injuries and illnesses that fit within the agency’s definition. For purposes of the proposal, the agency defines MSDs as:

[D]isorders of the muscles, nerves, tendons, ligaments, joints, cartilage and spinal discs. MSDs DO NOT include disorders caused by slips, trips, falls, motor vehicle accidents, or other similar accidents. Examples of MSDs include: Carpal tunnel syndrome, Rotator Cuff syndrome, De Quervain’s disease, Trigger finger, Tarsal tunnel syndrome, Sciatica, Epicondylitis, Tendinitis, Raynaud’s phenomenon, Carpet layers knee, Herniated spinal disc, and Low back pain.

OSHA also is proposing to remove existing language from its recordkeeping compliance directive that “minor musculoskeletal discomfort” is not recordable as a restricted work case “if a health care professional determines that the employee is fully able to perform all of his or her routine job functions, and the employer assigns a work restriction for the purpose of preventing a more serious injury.” OSHA is concerned that this language creates confusion among employers about recording MSDs. OSHA’s proposal attempts to clarify that employers must record abnormal conditions resulting in minor musculoskeletal discomfort, regardless of whether the conditions include objective signs of an injury or illness – so long as all of the other criteria for recording are met.

OSHA describes this proposed rule as a non-significant regulatory action involving only two small costs for employers. OSHA believes that:

1.      employers – and specifically a human resources specialist – will be required to spend 5 minutes familiarizing themselves with the rule; and  

2.      employers will need to spend one additional minute than they currently spend in analyzing an injury or illness to determine whether it should be classified as an “MSD” and put into the correct column on the new recordkeeping forms.

OSHA’s action takes the agency back a decade to the end of the Clinton Administration, when OSHA completed its revised recordkeeping rule with a separate MSD column. Of course, many stakeholders will ask if this move signals a return to the other Clinton Administration rulemaking on MSDs: ergonomics. That rule was rescinded by Congress and President Bush under the Congressional Review Act.  OSHA’s leadership has insisted that this rulemaking is totally separate from any ergonomics initiative and should not be interpreted as a first step to a new ergonomics rule. However matters may develop on ergonomics, this rulemaking is important in its own right as it affects – by OSHA’s own count – approximately 1.5 million workplaces around the country.

OSHA in 2010: What to Expect!

In mid-December 2009, Professor David Michaels was sworn in as the new Assistant Secretary of Labor for OSHA.  Shortly after being sworn in as Assistant Secretary, Professor Michaels gave an interesting speech at the National Institute for Occupational Safety and Health (NIOSH) Going Green Workshop.  The speech was entitled “Making Green Jobs Safe: Integrating Occupational Safety and Health into Green and Sustainability,” and provides a good glimpse as to where he would like to take OSHA in 2010 and beyond.

Professor Michaels’ speech touched on many important issues with respect to occupational safety and health.  In particular, he emphasized the need for workers to be heavily involved in workplace safety, to know the hazards they may face, and to work with their employers to identify and correct hazards in the workplace.  “To get us up to date and move into a safer, healthier future, it’s . . . clear that workers must have a stronger voice in workplace safety than they have now.”  Professor Michaels has always been a strong proponent of safety and health management systems, whereby employers and employees deal proactively with workplace hazards through management leadership, employee participation, hazard identification and control, and system evaluation.  His speech certainly suggests that he will continue to push this as head of OSHA.

Professor Michaels also mentioned OSHA’s “substantial” budget increase, which will “significantly increase the number of inspectors” OSHA puts in the field and the need to update many of OSHA’s outdated standards.  Translation:  the Agency must do everything it can to increase enforcement and engage in smart rulemaking to “to create good standards.”

So what does all this boil down to as a practical matter?  In 2010, employers should expect OSHA to continue to push forward aggressively on enforcement and regulatory initiatives.  Some specific initiatives to watch out for include a:

Final Cranes and Derricks in Construction rule. OSHA staff have been working diligently to finalize a rule addressing hazards associated with crane operations.  If the rule is finalized as proposed, it would be one of the largest overhauls of the nation’s safety regulations in the Agency’s history.  OSHA’s existing rules for cranes in construction take up only a few pages of the Code of Federal Regulations with several cross-references to outdated national consensus standards.  The proposed rule and preamble, in contrast, fill out 250 densely packed pages of the Federal Register.  The proposal contains over 40 separate sections of detailed requirements in such areas as crane assembly, crane operation, inspections, and operator training and certification.

Crystalline Silica Proposed Rule.  Crystalline silica is ubiquitous, comprising a substantial percentage of the Earth’s crust.  OSHA has evidence that exposure to crystalline silica at the current permissible exposure limit (PEL) causes silicosis and lung cancer.  It has been seeking to comprehensively regulate the substance – and reduce the PEL – for over a decade and the Agency seems poised to take that next step in 2010.  Expect a proposed rule on silica to be released sometime this year, as OSHA pushes forward on this longstanding initiative.

New Approach on Ergonomics.  For the last year, various administration officials have stressed the importance of OSHA dealing with WMSDs and ergonomics.  WMSDs still comprise a significant percentage of workplace injuries every year.  WMSDs occur in every industry and in every job throughout the country.

Almost a decade ago, the Clinton Administration finalized an ergonomics standard that would have required all general industry employers to implement an ergonomics program, including the elements of management commitment, employee participation, hazard assessment and control, and medical management.  It also would have mandated “work restriction protection,” which would have required that certain pay and benefits for employees be maintained for periods of time they are out of work due to a work-related injury.

Congress and President Bush disapproved of the final standard, however, and in 2001 it was rescinded under the Congressional Review Act (CRA).  As a result, OSHA is prohibited from promulgating an ergonomics standard that is “substantially the same” as the rescinded standard.  No one knows precisely what those words mean, but they are sure to be hotly debated over the next several months.

OSHA cannot keep avoiding the issue of ergonomics and likely will start to take on the issue in 2010 of what it can and cannot do under the CRA.  It will also likely increase ergonomics enforcement under the General Duty Clause.
 

No matter what happens in 2010, we will keep you up-to-date in this space on the latest OSHA developments.

OSHA: A Review of 2009

In 2009, OSHA emerged from the regulatory and enforcement shell that had shrouded it during the eight years of the Bush Administration. Once confirmed, Secretary of Labor Hilda Solis announced that a “new Sheriff” was in town, who would refocus the Department of Labor – including OSHA – on tough enforcement and aggressive rulemaking. In both areas, OSHA delivered on Secretary Solis’s promise.

            OSHA Increases Enforcement

Many critics of OSHA during the Bush Administration focused on the seeming “emphasis” on cooperative programs and compliance assistance, at the expense of strong enforcement. In response, the Department of Labor announced in 2009 the hiring of hundreds of additional compliance officers (CSHOs) to refocus the Agency on what many believe is its core mission – enforcing occupational safety and health standards. It also initiated or revamped several new National Emphasis Programs (NEPs) to further focus CSHOs on certain safety and health issues and hazards:

Chemical Facilities National Emphasis Program. OSHA initiated a new NEP to focus enforcement resources on process safety management (PSM) hazards in chemical facilities across the country. The NEP, effective July 27, 2009, is billed as a “new approach for inspecting PSM covered facilities” and “allows for a greater number of inspections by better allocation of OSHA’s resources.”  In its instructions to compliance officers regarding the scope of inspections, OSHA emphasizes implementation of the PSM standard over documentation. Paper programs are not enough and OSHA will make sure that employers are fully implementing their PSM programs.

Recordkeeping National Emphasis Program. In the fall of 2009, OSHA launched its long-awaited Recordkeeping NEP. The NEP subjects employers in certain industries to comprehensive injury and illness records reviews. The purpose of the NEP is to ascertain whether, and to what extent, employers are under-recording injuries and illnesses at the worksite. OSHA cites several recent studies in the NEP asserting under-recording by employers on OSHA 300 logs. The NEP is designed to “identify and correct under-recorded and incorrectly recorded cases.” Employers subjected to an NEP inspection will face what are likely to be the most comprehensive inspections in the history of the Agency, with detailed records reviews, interviews of numerous employees, and an analysis of employer safety incentive programs and the effect of these programs on the reporting of injuries and illnesses.

Facilities that Manufacture Food Flavorings Containing Diacetyl National Emphasis Program. After focusing for years on the hazards of occupational exposure to diacetyl in microwave popcorn production, OSHA finally shifted its focus with respect to diacetyl to employers who manufacture food flavorings containing diacetyl. OSHA cites a Centers for Disease Control (CDC) study finding seven cases of bronchiolitis obliterans – a lung disease associated with exposure to diacetyl – in employees working in facilities where flavorings are manufactured. As part of the NEP, OSHA identifies eighty three facilities for inspection and provides detailed guidance for compliance officers to determine the extent to which these facilities are in overall compliance with their obligations.

Perhaps the most eagerly anticipated – and discussed – enforcement initiative was not an NEP at all, but was related to OSHA enforcement procedures for high to very high occupational exposure to the 2009 H1N1 virus. H1N1 captivated the world this past year, and OSHA spent significant resources addressing the occupational safety and health side of the issue. In the spring and summer of 2009, OSHA responded to the H1N1 outbreak by reissuing and repackaging guidance documents on pandemic influenza that had been previously developed. In November, however, OSHA went further and announced inspection procedures for certain high-hazard H1N1 workplaces, including hospitals, emergency medical centers, doctors’ and dental offices and clinics.

A More Active Regulatory Agenda

In 2009, OSHA also set a course for more activity in the rulemaking arena. As with enforcement, many stakeholders were critical of the Bush Administration’s perceived lack of investment in OSHA’s regulatory agenda. The two most significant regulatory accomplishments during the Bush Administration were the final Hexavalent Chromium rule and the final Employer Payment for PPE rule. Many stakeholders, however, argued that even these accomplishments were essentially forced on the Agency by the federal courts. Whether this is true or not, the first year of the Obama Administration saw the announcement of several new regulatory initiatives and what is even more stunning is that these initiatives were announced without a permanent political head of the Agency.

In 2009, OSHA announced new rulemakings for combustible dust hazards and airborne infectious diseases. OSHA also announced that it would revisit in a new rulemaking the definition of work-related musculoskeletal disorders (WMSDs) and how WMSDs should be recorded on OSHA 300 logs. This year OSHA also published its proposed rule to update its hazard communication standard. The hazard communication proposal is one of the most significant OSHA rulemakings in over a decade. OSHA is proposing to revise its hazard communication standard to align it with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS). If finalized, the rule would affect over 5 million business establishments across the country and potentially over 120 million employees. Over 40 million employees would need to be trained on hazard communication under the proposal. OSHA estimates the annualized compliance costs will be almost $100 million for employers. Annualized benefits are estimated to be approximately $850 million.

Finally, in 2009 OSHA made significant progress on its Cranes and Derricks in Construction proposed rule. OSHA’s proposal was over five years in the making. It was developed by the Agency through negotiated rulemaking, whereby representatives of employers and organized labor work together with OSHA to develop a draft rule. Consensus was reached by the negotiated rulemaking committee in 2004. OSHA held public hearings on the proposed rule in 2009 and Agency staff have been busy reviewing comments received with the goal of issuing a final rule in 2010.

All of this in just over 11 months. And yet, this is likely just the beginning for OSHA as 2010 is expected to bring greater enforcement and regulation. 

(More to come on what to expect in 2010 in the next blog post.)

OSHA Announces Informal Public Hearings on its Hazard Communication Proposed Rule

In a December 29, 2009 Federal Register notice, OSHA has announced three informal public hearings on its proposal to update its hazard communication standard. The hearings will begin at 9:30 am on the following dates:

  • March 2, 2010 in Washington, DC;
  • March 31, 2010 in Pittsburgh, PA; and
  • April 13, 2010 in Los Angeles, CA.

OSHA’s hazard communication proposal is one of the most significant rulemaking efforts in over a decade. Click here for a full description of the proposal. OSHA is proposing to revise its hazard communication standard to align it with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS). If finalized, the rule would affect over 5 million business establishments across the country and potentially over 120 million employees. Over 40 million employees would need to be trained on hazard communication under the proposal. OSHA estimates the annualized compliance costs will be almost $100 million for employers. Annualized benefits are estimated to be approximately $850 million.

Because of the broad scope of the proposed rule, all employers are encouraged to familiarize themselves with the requirements and participate in the informal public hearings. OSHA has announced that requests to appear at the hearings must be submitted by January 18, 2010, and testimony (if expected to be over 10 minutes in length) and documentary evidence must be submitted by February 1, 2010.

OSHA Releases Fall Regulatory Agenda: Focus is on Musculoskeletal Disorders and Airborne Infectious Diseases

OSHA has released its long-awaited Fall Regulatory Agenda.  The Regulatory Agenda lists the major rulemaking initiatives that the agency will be pursuing over the next 12 months.  The Agenda also provides a snapshot into the agency's priorities, as we enter the second year of the administration of President Obama.

Longstanding Rulemakings Remain on the Agenda

Most of the rulemaking items that started under President Clinton or Bush remain on OSHA's regulatory agenda.  OSHA continues to push forward with a silica rulemaking, which was initiated in the 1990s.  OSHA predicts that it will publish a proposed rule comprehensively regulating exposure to silica in the workplace in July, 2010.  Other rulemakings that continue to receive OSHA's attention include rulemakings on diacetyl, hazard communication, combustible dust, and tree care operations.

OSHA does announce in this regulatory agenda that it is abandoning its regulatory efforts to update its explosives rule.  This rulemaking had engendered some controversy during the Bush Administration over its proposed provisions related to storage of ammunition.

New Rulemakings Added

OSHA is also adding some new regulatory actions that are sure to be controversial.  First, OSHA is revisiting the issue of the definition of work-related musculoskeletal disorder (WMSD) and the need to identify specifically WMSDs in a separate recordkeeping column.  When OSHA developed its revised recordkeeping rule in the late 1990s, OSHA initially required employers to identify WMSDs separately on OSHA 300 logs.  This requirement, however, was abandoned by the Bush Administration in a follow-up regulatory initiative.  OSHA is now looking once again at the issue and it may reignite some of the controversy associated with past OSHA efforts related to WMSDs and ergonomics.

Second, OSHA is seeking information from the public on the need for a federal Aerosol Infectious Diseases standard.  Specifically, "OSHA is considering the need for a standard to ensure that employers establish a comprehensive infection control program and control measures to protect employees from airborne infectious disease exposures to pathogens that can cause significant disease."  California recently adopted its own aerosol transmissible disease standard and this rulemaking initiative suggests that federal OSHA is exploring the need for such a standard nationwide.

OSHA continues to be active on both regulatory and enforcement initiatives.  We will continue to keep you apprised in this space on the latest OSHA developments.              

OSHA Proposes Major Changes to its Hazard Communication Standard

In one of the most significant rulemaking efforts in over a decade, OSHA is proposing to revise its hazard communication standard to align it with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS). If finalized, the rule would affect over 5 million business establishments across the country and potentially over 120 million employees. Over 40 million employees would need to be trained on hazard communication under the proposal. OSHA estimates the annualized compliance costs will be almost $100 million for employers. Annualized benefits are estimated to be approximately $850 million.

Because of the broad scope of the proposed rule, all employers are encouraged to familiarize themselves with the requirements and participate in the rulemaking process. Comments on the proposal must be submitted to OSHA by December 29, 2009.

Attached is a Special Report on the proposed rule that summarizes its key provisions.

OSHA's Combustible Dust ANPR to be Issued Soon

OSHA’s Advance Notice of Proposed Rulemaking (ANPR) on combustible dust should be published soon in the Federal Register. The ANPR is currently under review by the Office of Management and Budget, the final step in the intergovernmental review process. Employers with combustible dust hazards in their worksites are encouraged to participate in the rulemaking process.

Combustible dusts are solids ground into fine particles, which can cause a fire or explosion when suspended in air under certain circumstances. Common examples of combustible dusts include metal (aluminum and magnesium), wood, plastic, rubber, coal, flour, sugar, and paper, among others. OSHA has identified  a number of industries with combustible dust hazards, including agriculture, chemicals, food, grain, plastics, wood, paper, textiles, pharmaceuticals, tire and rubber manufacturing, and metal processing. While certain OSHA standards provide some protection against combustible dust, for example, Housekeeping (29 CFR 1910.22) and Electrical Equipment in Hazardous Locations (29 CFR 1910.307), OSHA does not have a single comprehensive rule to protect employees from combustible dust explosions.

Secretary of Labor Solis, in announcing the combustible dust rulemaking, stated that “OSHA is reinvigorating the regulatory process to ensure workers receive the protection they need while also ensuring that employers have the tools needed to make their workplaces safer.” We will continue to monitor closely developments in this area and update this blog when the ANPR is finally published in the Federal Register.

OSHA Publishes Hazard Communication Proposal

OSHA's long-awaited proposed rule updating its Hazard Communication standard will be published in tomorrow's Federal Register (September 30). Here is an advance version of the proposal.

We will provide more information on this important rulemaking in an upcoming post.

OSHA Issues Final Rule Updating PPE Standards

In a move widely applauded by both employer and employee groups, OSHA has updated its general industry and maritime personal protective equipment (PPE) standards to specifically allow the use of certain PPE designed according to current national consensus standards. OSHA’s final rule, “Updating OSHA Standards Based on National Consensus Standards; Personal Protective Equipment,” will bring greater certainty to compliance with OSHA’s PPE standards for head, eye, and foot protection and further encourage use of the latest protective technology. This final rule is the third in a series of updates OSHA is making to its rules to reflect the latest versions of national consensus standards.

With this final rule, employers are expressly allowed to use head, eye, and foot protection built in accordance with these recent national consensus standards:
 

  • ANSI Z89.1-2003 for head protection;
  • ANSI Z87.1-2003 for eye protection; and
  • ASTM F-2412-2005 and ASTM F-2413-2005 for foot protection.

Before promulgation of this final rule, OSHA’s PPE standards required employers to provide head, eye, and foot protection built in accordance with outdated national consensus standards (e.g., the 1986 ANSI standard for head protection). This caused confusion for employers and employees as the national consensus standards were continually updated and PPE available for purchase no longer reflected the outdated design specifications. Employers who provided the latest PPE to their employees could be subject to a de minimis notice by OSHA – a technical violation of OSHA’s standards not adversely impacting the safety and health of employees. While employers are still able to use certain older equipment, as a result of this final rule, employers now can use the latest technology in head, eye, and foot protection, certain in the knowledge that they will be in compliance with OSHA’s standards.

OSHA Soon to Issue Hazard Communication Proposal

OSHA’s Hazard Communication/Globally Harmonized System proposed rule has been cleared by the Office of Management and Budget, paving the way for the agency to publish it for public comment. The proposed rule has been in the works for several years and the Obama Administration has made finalizing it a priority. If finalized, the proposed rule could significantly change the labels and Material Safety Data Sheets (MSDSs) that currently appear and accompany hazardous chemicals in the workplace.

OSHA’s existing Hazard Communication rule (“Haz Com”) requires chemical manufacturers and importers to analyze the hazards of the chemicals they produce or import, and prepare labels and MSDSs to inform downstream users of the hazards and needed protective measures. Haz Com also contains the core OSHA training requirements for informing employees about chemical hazards in the work environment.

Other countries also have developed labeling and MSDS requirements. While these rules are often similar to Haz Com, they differ in various ways, including the specificity of information required to be conveyed to end users. The differing requirements can cause confusion for chemical manufacturers, importers, and employers and employees.

As a result, in 2003 the United Nations adopted the Globally Harmonized System of Classification and Labeling of Chemicals, which standardizes and harmonizes these requirements. Countries are now adopting the Globally Harmonized System and OSHA, through this proposed rule, is looking to do the same.

Many employers are in favor of the rulemaking, seeing it as an opportunity to facilitate international trade and improve the effectiveness of communicating hazard information to employees. Others have raised concerns about having to re-learn a “new” Haz Com rule when many have grown accustomed to complying with the existing requirements.  For its part, OSHA has claimed that adoption of the Globally Harmonized System will:

  • Provide consistent information and definitions for hazardous chemicals;
  • Address stakeholder concerns regarding the need for a standardized format for MSDSs; and
  • Increase understanding of hazardous chemicals by using standardized pictograms and harmonized hazard statements.

We will continue to monitor the status of the proposal and pass along any further updates.

Q&A on Workplace Safety and Health

Click here to read a Q&A on workplace safety and health issues that appeared recently in Employment Law 360. 

OSHA to Regulate Combustible Dust

Signaling its renewed focus on regulatory means to address occupational hazards, OSHA is pursuing comprehensive rulemaking to prevent combustible dust explosions. The Agency announced it will be issuing an Advance Notice of Proposed Rulemaking (ANPR) and convening stakeholder meetings to evaluate approaches to regulating combustible dust. Employers with combustible dust hazards in their worksites are encouraged to participate in the rulemaking process.

Combustible dusts are solids ground into fine particles, which can cause a fire or explosion when suspended in air under certain circumstances. Common examples of combustible dusts include metal (aluminum and magnesium), wood, plastic, rubber, coal, flour, sugar, and paper, among others. OSHA has identified a number of industries with combustible dust hazards, including agriculture, chemicals, food, grain, plastics, wood, paper, textiles, pharmaceuticals, tire and rubber manufacturing, and metal processing. While certain OSHA standards provide some protection against combustible dust, for example, Housekeeping (29 CFR 1910.22) and Electrical Equipment in Hazardous Locations (29 CFR 1910.307), OSHA does not have a single comprehensive rule to protect employees from combustible dust explosions.

OSHA’s announcement was expected. Over the last several years, the Agency has published non-mandatory guidance on combustible dust hazards and the prevention of combustible dust explosions. Furthermore, there has been significant congressional interest in the issue. In the last Congress, the House of Representatives passed a bill to force OSHA to issue an interim and final combustible dust standard within 3 and 18 months, respectively. On February 4 of this year, Representatives George Miller, Lynn Woolsey, and John Barrow re-introduced this bill.

Secretary of Labor Solis, in announcing the combustible dust rulemaking, stated that “OSHA is reinvigorating the regulatory process to ensure workers receive the protection they need while also ensuring that employers have the tools needed to make their workplaces safer.” Employers must remain alert to OSHA’s regulatory initiatives and participate in the rulemaking process.