Honorable Greg Watchman
Acting Assistant Secretary
for Occupational Safety and Health
200 Constitution Avenue
Washington, DC 20210
Docket No. H-200-C, Section 610 Review of the Occupational Exposure to Ethylene Oxide Standard
Dear Mr. Watchman:
The Small Business Administration's Office of Advocacy is submitting comments to the Occupational Safety and Health Administration (OSHA) for the agency's review of two existing standards under Section 610 of the Regulatory Flexibility Act (RFA) (1). These comments are in response to OSHA's review of the Control of Hazardous Energy Sources (Lockout/Tagout) Standard and the Occupational Exposure to Ethylene Oxide Standard.
The Office of Advocacy was established by Congress under Public Law No. 94-305 to represent the views of small business before Federal agencies and Congress. Advocacy is required to monitor and report to Congress on Federal agencies compliance with the RFA, including compliance with Section 610 requiring periodic review of existing regulations.
Section 610 Review
The RFA's Section 610 period review offers the agency an excellent opportunity to identify rules that are outdated, require clarification, or should be revised. Congress has consistently raised concerns that Federal agencies are not reviewing existing rules (for such elements as feasibility and effectiveness) and not making subsequent efforts to revise or update regulations. The RFA offers an appropriate mechanism to address these concerns. For instance, a rule that has reached its ten year anniversary and is a candidate for Section 610 review is the full general industry standard for hazard communication (2).While the RFA's objective is to minimize the impact of regulations on small businesses, nonprofit organizations and small governmental jurisdictions, the analytical processes it prescribes helps produce sound regulations applicable to all entities. In its review, the agency should solicit government and industry data in order to measure and compare the injury and illness rate savings to the costs for specific industries and different size businesses to determine if a rule effectively contributes to worker safety.
Advocacy recommends that OSHA broadly publicize its intent to review a rule under Section 610 as early as possible. With regard to the particular rulemakings now under review, we applaud OSHA's use of public meetings. However, we believe OSHA would have received more input from various sectors, including small businesses, if the agency had asked trade associations or publications serving the affected industries (manufacturing, medical sterilization, etc.) to publicize the upcoming review of these rules. The agency published its intent in the semi-annual agenda (3) but more outreach in the early stages would have been helpful. Advocacy tried to identify and encourage industries to participate during the 60 day comment period, but many were just learning of the review and did not have the resources to explore the issue in a short time frame. For instance, most trade associations that have resources to follow regulations focus mostly on rules under development.
To improve this process, we believe that industry representatives will be able to alert and collect information from businesses if they are aware of the rule much earlier. In trade associations, regulations and legislation are often discussed with members in annual or semi-annual meetings. In addition, periodicals have deadlines that are often 30 to 60 days before publication. Obviously the semi-annual agenda is one way to contact affected parties, but early and targeted outreach should result in more meaningful comments from small businesses and their representatives. Although not yet published, the agency has identified the next two rules for Section 610 review - cotton dusting and grain handling. We urge OSHA to identify trade associations and other organizations (e.g., agricultural cooperatives) that can help the agency identify small entities to comment on these rule. Advocacy also will attempt to identify affected industries. Small entities have few resources, but with sufficient time, their representatives can explore the impact of a rule and identify recommendations for the agency.
Control of Hazardous Energy Sources (Lockout/Tagout)
The Office of Advocacy commends OSHA for conducting a Section 610 review of the standard for the Control of Hazardous Energy Sources. This standard is used daily by the small business community to protect employees from hazardous energy exposure.
The Office of Advocacy has been contacted by representatives of small businesses who are concerned that the standard is being inconsistently enforced by compliance personal who may not be adequately trained in industry specific procedures and processes. The Office of Advocacy recommends that the agency evaluate its implementation of the standard for inconsistencies with the intent of the final rule. Resources should be made available to small business that may need consultation assistance to comply with the existing rule.
The agency should use this review process to evaluate the standard for processes and energy sources that were not included in the final rule. The agency should also assess the burdensome annual review requirement for its true contribution to workplace safety. Supplemental OSHA guidance on generic equipment procedures might be beneficial to facilitate compliance among small businesses.
The agency should assure that recommended changes in the standard or its enforcement accommodate the needs of industries that use both modern equipment and those that continue to use older equipment. OSHA should recognize that engineering controls can be costly and recommendations for equipment alterations should be analyzed prior to changes.
At OSHA's public meeting held on June 30, 1997, an individual from E.I. Dupont De Nemours testified and made recommendations for the rule's application to small business. (While no small businesses testified at the meeting, it is unclear what credentials this individual had with regard to small business operations.) This individual recommended that the agency adopt an industry consensus-based standard and expand the standard to include the construction industry. Whenever such standards are recommended, the agency should evaluate the degree of small business participation in the process for developing such standards. In addition, the agency must consider the impact that mandatory industry standards would have on small businesses and their competitiveness. The Office of Advocacy does not believe that Fortune 500 companies are the appropriate spokespeople for small businesses. OSHA should be cautious when reviewing testimony and supplemental materials on small business concerns submitted by representatives of big business or other constituencies. The Office of Advocacy encourages OSHA to examine the record fully for specific concerns and recommendations for changes to the standard submitted by and in application to small businesses.
Occupational Exposure to Ethylene Oxide
The Office of Advocacy commends OSHA for conducting a Section 610 review of the standard for the Occupational Exposure to Ethylene Oxide. The Office of Advocacy is, however, concerned that the Section 610 review may not have had meaningful small businesses participation. When reviewing the docket and testimony from OSHA's public meeting (June 30, 1997) the agency should recognize this void. As the agency moves forward to address specific recommendations to accommodate new sterilization processes; engineering controls; medical and monitoring protocols; and the permissible exposure limit (PEL) the agency should analyze the impact of proposed alternatives on regulated small business entities. The analysis should address small and/or niche industries that might rely heavily on a particular substance or process which would have to be addressed in the case of a change to the rule. Small businesses often do not have adequate access to technological or capital resources to make process and product alterations.
The Office of Advocacy commends OSHA for coordinating with the Environmental Protection Agency on the Occupational Exposure to Ethylene Oxide Standard. At the August 4, 1997 meeting of the National Advisory Committee for Occupational Safety and Health OSHA indicated that consultation had occurred. The Office of Advocacy, however, could find no record of this exchange in the public docket. Interagency coordination is recommended to facilitate good public policy, but these activities, to the extent possible, should be made part of the public record.
If we can provide assistance, please contact me or Sarah Rice of my staff at (202) 205- 6533.
Sincerely,
Jere W. Glover
Chief Counsel for Advocacy
cc: Honorable Sally Katzen
ENDNOTES
1. 5 U.S.C. §§601-612
2. This rule was subject to review under the Paperwork Reduction Act in 1996 but changes to the rule have not been implemented.
3. Federal Register Vol. 61, No. 231 (November
29, 1996).
* Last Modified: 6/14/01