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Proposed Rule

Total Inward Leakage Requirements for Respirators

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Information about this document as published in the Federal Register.

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Centers for Disease Control and Prevention, Department of Health and Human Services.


Notice of proposed rulemaking; reopening of comment period.


The Centers for Disease Control and Prevention (CDC) is reopening the comment period for the notice of proposed rulemaking by the National Institute for Occupational Safety and Health (NIOSH) of CDC, entitled “Total Inward Leakage Requirements for Respirators,” published in the Federal Register on October 30, 2009 (74 FR 56141). The comment period on this proposed regulation closed on March 29, 2010 (74 FR 66935) and is being reopened until September 30, 2010.


All written comments must be received on or before September 30, 2010.


You may submit comments, identified by RIN: 0920-AA33, by any of the following methods: Start Printed Page 20547

  • Fe deral eRulemaking Portal: Follow the instructions for submitting comments.
  • E-mail: Include “RIN: 0920-AA33” and “42 CFR Part 84” in the subject line of the message.
  • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.

Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking, RIN: 0920-AA33. All comments received will be posted without change to​niosh/​docket, including any personal information provided.

Docket: For access to the docket to read background documents or comments received, go to​niosh/​docket.

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Jonathan V. Szalajda, NIOSH, National Personal Protective Technology Laboratory (NPPTL), Post Office Box 18070, 626 Cochrans Mill Road, Pittsburgh, Pennsylvania 15236, telephone (412) 386-5200, facsimile (412) 386-4089, e-mail

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I. Background

On October 30, 2009, the Department of Health and Human Services proposed a rule to establish total inward leakage (TIL) requirements for half-mask air-purifying particulate respirators approved by NIOSH. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g., influenza A (H5N1), Bacillus anthracis, severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis). The agency held a public meeting on December 3, 2009 to take comments on the proposed regulation (74 FR 59501). Based on requests to extend the comment period submitted in writing and made orally at the public meeting, the agency extended the comment period until March 29, 2010 (74 FR 66935).

II. Reopening of Comment Period

Prior to the close of the comment period on March 29, 2010, two commenters requested the comment period be extended for up to one additional year because they are conducting independent research into scientific requirements of the proposed rule and/or its economic impact. The commenters stated that they needed this amount of time to complete this research before they can fully comment.

Due to the fact that the proposed rule contains only one new performance requirement that the commenters need to analyze and that the comment period has already been extended once, the Centers for Disease Control and Prevention (CDC) has determined that an additional reopening of the comment period to September 30, 2010 provides sufficient time to allow for public comment.

III. Public Meeting

NIOSH will conduct a public meeting in June or July 2010 to hear from stakeholders on the preliminary results of their independent research. A formal notice will be published in the Federal Register announcing the date and location of that meeting.

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Kathleen Sebelius,

Secretary, Department of Health and Human Services.

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[FR Doc. 2010-9085 Filed 4-19-10; 8:45 am]