E7-13208. Regulatory Flexibility Act Review of the Methylene Chloride Standard

AGENCY:

Occupational Safety and Health Administration, Labor.

ACTION:

Request for comments.

SUMMARY:

The Occupational Safety and Health Administration (OSHA) is conducting a review of its Methylene Chloride Standard under Section 610 of the Regulatory Flexibility Act and Section 5 of Executive Order 12866 on Regulatory Planning and Review. In 1997, OSHA promulgated the Standard to protect workers from occupational exposure to methylene chloride. The purpose of this review is to determine whether there are ways to modify this Standard to reduce regulatory burden on small business and to improve its effectiveness. Written comments on these and other relevant issues are welcomed.

DATES:

Written comments to OSHA must be sent or postmarked by October 9, 2007.

ADDRESSES:

You may submit comments by any of the following methods:

Electronically: You may submit comments and attachments electronically at http://www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions on-line for making electronic submissions.

Fax: If your submissions, including attachments, are not longer than 10 pages, you may fax them to the OSHA Docket Office at [phone].

Mail, hand delivery, express mail, messenger and courier service: You must submit three copies of your comments and attachments to the OSHA Docket Office, Docket No. OSHA-2007-0024, U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210. Deliveries (hand, express mail, messenger and courier service) are accepted during the Department of Labor's and Docket Office's normal business hours, 8:15 a.m.-4:45 p.m., Eastern Time.

Instructions: All submissions must include the Agency name and the OSHA docket number for this rulemaking, (OSHA-2007-0024). Submissions are placed in the public docket without change and may be available online at http://www.regulations.gov. Therefore, do not include private materials such as social security numbers.

Docket: To read or download submissions or other material in the docket, go to http://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through the Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT:

Joanna Dizikes Friedrich, Directorate of Evaluation and Analysis, Occupational Safety and Health Administration, Room N3641, 200 Constitution Avenue, NW., Washington, DC 20210, Telephone [phone], Fax [phone].

SUPPLEMENTARY INFORMATION:

Background

OSHA adopted the first Methylene Chloride (MC) Standard in 1971 pursuant to Section 6(a) of the OSHA Act, 29 U.S.C. 655, from an existing Walsh-Healy Federal Standard. The original MC Standard was intended to protect workers from injury to the neurological system and from irritation. It required employers to ensure that employee exposure did not exceed 500 parts per million (ppm) as an 8-hour time weighted average (TWA), 1,000 ppm as a ceiling concentration, and 2,000 ppm as a maximum peak for a person not to exceed five minutes in any two hours (29 CFR 2920.1000, Table Z-2). In February 1985, the National Toxicology Program reported the results of animal testing studies indicating that MC is a potential cancer causing agent. In July 1985, several unions petitioned OSHA to reduce worker exposure to MC. In response, OSHA agreed to commence development of a permanent standard, issuing an Advanced Notice of Proposed Rulemaking on November 24, 1986 (51 FR 42257).

Based on its review of human and animal data, OSHA determined that the existing permissible exposure limit (PEL) for MC did not adequately protect employee health, and on November 7, 1991, OSHA issued a Notice of Proposed Rulemaking (NPRM) to address the significant risk of MC induced health effects (56 FR 57036). OSHA also presented the proposal to the Advisory Committee on Construction Safety and Health (ACCSH). Based on input from ACCSH, OSHA issued a supplemental notice (57 FR 36964, August 17, 1992) which raised the MC use, exposure, and control issues specific to the construction industry. OSHA conducted informal public hearings in 1992, reopened the record in 1994 for comments to address engineering controls and carcinogenicity issues, and reopened the record again in 1995 to request public input on the Halogenated Solvents Industry Alliance studies addressing the use of animal data to estimate human cancer risk from MC.

On January 10, 1997, OSHA promulgated the Methylene Chloride (MC) Standard as 29 CFR 1910.1052 (62 FR 1494). OSHA concluded that MC exposure created a significant risk of cancer and that 25 ppm was the lowest feasible level. There is extensive discussion of these issues and risk assessment issues in the final preamble.

The Standard covers occupational exposures to MC in all workplaces in general industry, shipyard employment, and construction. Employers are required to ensure that no employee is exposed to an airborne concentration of MC in excess of 25 ppm as an 8-hour TWA, or short-term exposure limit (STEL) in excess of 125 ppm during a sampling period of 15 minutes. The action level for a concentration of airborne MC is 12.5 ppm calculated as an 8-hour TWA. Reaching or exceeding the action level signals that the employer must begin compliance activities, such as exposure monitoring and medical surveillance.

The Standard also requires the establishment of a regulated area and procedures for determining employee exposure to MC. The employer is required to notify employees of monitoring results and to allow employees or their designated representative to observe monitoring. Employers also must establish a medical surveillance program for employees exposed to MC. The Standard provides specific requirements depending on the nature of the exposure and health status of the employee. If a medical professional determines that exposure to MC may aggravate or contribute to an employee's existing skin, heart, liver, or neurological disease, the Standard provides for temporary medical removal and protection of benefits during removal.

The Standard provides that employers must control exposures to MC to the PEL or below using engineering controls and work practices as the primary methods, unless the employer can demonstrate that these controls are infeasible. In these cases, respirators are permitted in combination with engineering controls and work practices. The Standard also provides minimum requirements for respiratory protection. However, air filtration respirators are not very effective for MC. Finally, the Standard includes requirements for protective clothing and equipment, maintaining records of exposure measurements and medical surveillance, providing information and training to employees, and providing facilities for washing MC off of persons or clothing.

The Standard had phased-in start-up dates commencing on April 10, 1997. In response to petitions, OSHA delayed until August 31, 1998 the requirement to use respirators to achieve the PEL and to December 10, 1998 the requirement to achieve the PEL and STEL through engineering controls.

Methylene chloride is a powerful solvent with a number of uses. Major uses include metal degreasing and aircraft paint removal. It is used to strip finishes from furniture prior to refinishing, a use carried out by very small businesses. MC is used in the manufacturing of some plastics, adhesives, inks, and ink solvents. It also is used as the expansion agent in the manufacture of flexible polyurethane foam, and to manufacture polycarbonates. Another major, but diminishing, use is in the manufacture of film base. Other uses of MC are as an aerosol in spray cans, as a cleaning agent for semiconductors, and in the manufacture of some pesticides and pharmaceuticals.

Regulatory Review

OSHA is reviewing the MC Standard under Section 610 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and Section 5 of Executive Order 12866 (58 FR 51735, Oct 4, 1993).

The purpose of a review under Section 610 of the Regulatory Flexibility Act:

“(S)hall be to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant impact of the rules upon a substantial number of such small entities.”

“[T]he agency shall consider the following factors:

(1) The continued need for the rule;

(2) The nature of complaints or comments received concerning the rule from the public;

(3) The complexity of the rule;

(4) The extent to which the rule overlaps, duplicates or conflicts with other Federal rules, and, to the extent feasible, with state and local governmental rules; and

(5) The length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.”

The review requirements of Section 5 of Executive Order 12866 require agencies:

“To reduce the regulatory burden on the American people, their families, their communities, their state, local and tribal governments, and their industries; to determine whether regulations promulgated by the [Agency] have become unjustified or unnecessary as a result of changed circumstances; to confirm that regulations are both compatible with each other and not duplicative or inappropriately burdensome in the aggregate; to ensure that all regulations are consistent with the President's priorities and the principles set forth in this Executive Order, within applicable law; and to otherwise improve the effectiveness of existing regulations.”

Requests for Comments

An important step in the review process involves the gathering and analysis of information from affected persons about their experience with the rule and any material changes in circumstances since issuance of the rule. This notice requests written comments on the continuing need for the MC Standard, its small business impacts, its effectiveness in protecting workers and all other issues raised by Section 610 of the Act and Section 5 of the Executive Order. It would be particularly helpful for commenters to suggest how the applicability or requirements could be changed or tailored to reduce the burden on employers while maintaining employee protection. Comments concerning the following subjects also would assist the Agency in determining whether to retain the Standard unchanged, to initiate rulemaking for purposes of revision or rescission, and/or to develop improved compliance assistance.

New Developments and Compliance

1. Do any provisions of the MC Standard at 29 CFR 1910.1052, such as medical surveillance or respiratory protection, need to be updated as a result of recent technological or scientific developments?

2. In cases where firms fail to comply with the MC Standard, is non-compliance more commonly the result of (1) a lack of information (e.g. about the dangers or the requirements), (2) inadequate supervision, (3) cost pressures, or (4) other factors? How could OSHA encourage improved compliance?

3. Are OSHA's MC requirements known to all firms that use MC, including small firms and firms that use MC only occasionally? How could awareness be increased for such firms?

4. Have better respirator filters been developed for MC? Are there actions OSHA or NIOSH could take to encourage the development of better filters?

5. Have safer alternatives been developed for high exposure uses such as foam blowing?

6. Have small furniture refinishers implemented the low cost engineering controls developed by NIOSH? Are there ways OSHA could improve outreach to these small businesses?

7. Have new studies been completed since 1996 on the health effects of MC?

Costs and Impacts

8. How many employees are exposed to MC, generally, or in your business; what are current exposures, and how much have they been reduced since 1996? Please provide data.

9. Does any part of the MC Standard impose an unnecessary or disproportionate burden to small businesses, or to industry in general? How might OSHA modify the MC requirements to reduce costs without jeopardizing protections to workers?

10. How much does it cost annually to comply with specific provisions of the MC Standard (e.g., exposure monitoring, medical surveillance, etc.)? Provide data if possible.

11. How have changes in technology, the economy, or other factors affected the amount of MC used, the use of substitutes, and compliance costs associated with the MC Standard since 1997?

Clarity/Duplication

12. Are any provisions of the MC Standard unclear, needlessly complex, or duplicative?

13. Have standards relating to MC issued by OSHA, EPA, other Federal agencies, or States caused overlap problems. If so, how could these issues be addressed to reduce the burden on industry without reducing worker protection?

Comments must be submitted by October 9, 2007. Comments should be submitted to the addresses and in the manner specified at the beginning of the notice.

Authority: This document was prepared under the direction of Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue, NW., Washington, DC 20210. It is issued under Section 610 of the Regulatory Flexibility Act (5 U.S.C. 610) and Section 5 of Executive Order 12866 (58 FR 51735, October 4 1993).

Signed at Washington, DC on July 2, 2007.

Edwin G. Foulke, Jr.,

Assistant Secretary of Labor for Occupational Safety and Health.