APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

• Citation: 42 CFR Part 84
• Sections: 175

§ 84.1 Purpose.

The purpose of the regulations contained in this part 84 is:

(a) To establish procedures and prescribe requirements which must be met in filing applications for approval by the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators;

(b) To establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part;

(c) To provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and

(d) To specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.

§ 84.2 Definitions.

As used in this part—

Applicant means an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator.

Approval means a certificate or formal document issued by the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this part, and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval.

Approved means conforming to the minimum requirements of this part.

Auxiliary equipment means a self-contained breathing apparatus, the use of which is limited in underground mine rescue and recovery operations to situations where the wearer has ready access to fresh air and at least one crew equipped with approved self-contained breathing apparatus of 2 hours or longer rating, is in reserve at a fresh-air base.

Compressed-breathing gas means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form.

dBA means sound pressure levels in decibels, as measured with the A-weighted network of a standard sound level meter using slow response.

Dust means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic.

A facepiece or mouthpiece is a respirator component designed to provide a gas-tight or dust-tight fit with the face and may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas source.

Final inspection means that activity carried out on a product after all manufacturing and assembly operations are completed to insure completeness and adherence to performance or other specifications, including satisfactory appearance.

Fume means a solid condensation particle, generally less than 1 micrometer in diameter.

Gas means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure.

Hazardous atmosphere means:

(1) Any atmosphere containing a toxic or disease producing gas, vapor, dust, fume, mist, or pesticide, either immediately or not immediately dangerous to life or health; or

(2) Any oxygen-deficient atmosphere.

A hood or helmet is a respirator component which covers the wearer's head and neck, or head, neck, and shoulders, and is supplied with incoming respirable air for the wearer to breathe. It may include a headharness and connection for a breathing tube.

Immediately dangerous to life or health means conditions that pose an immediate threat to life or health or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive materials, which are likely to have adverse cumulative or delayed effects on health.

Incoming inspection means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements.

In-process inspection means the control of products at the source of production and at each step of the manufacturing process, so that departures from specifications can be corrected before defective components or materials are assembled into the finished product.

Institute or NIOSH means the National Institute for Occupational Safety and Health, Department of Health and Human Services.

Liquefied-breathing gas means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form.

Loose fitting means respiratory inlet covering that covers the wearer's head and neck, or head, neck, and shoulders, or whole body (when integral to the design).

Mist means a liquid condensation particle with a size ranging from submicroscopic to macroscopic.

MSHA means the Mine Safety and Health Administration, U.S. Department of Labor.

National Personal Protective Technology Laboratory (NPPTL) means the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. NPPTL administers the NIOSH conformity assessment program for respiratory protective devices, replacing the former Certification and Quality Assurance Branch within the Division of Safety Research, Appalachian Laboratory for Occupational Safety and Health, NIOSH.

Not immediately dangerous to life or health means any hazardous atmosphere which may produce physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse physiological symptoms after prolonged exposure.

Oxygen-deficient atmosphere means an atmosphere which contains an oxygen partial pressure of less than 148 millimeters of mercury (19.5 percent by volume at sea level).

Powered air-purifying respirator means a device equipped with a facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, canister with filter, or cartridge with filter, and a blower.

Respirator means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere.

Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres.

Respirators for escape only means respiratory devices providing protection only during escape from hazardous atmospheres.

Respiratory inlet covering means that portion of a respirator that forms the protective barrier between the user's respiratory tract and an air-purifying device or breathing air source, or both.

( Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use.

Tight fitting means a respiratory inlet covering that forms a complete gas tight or dust tight seal with the face or neck.

Vapor means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure.

Warning device is a component of a respiratory protective device that informs the wearer to take some action.

§ 84.3 Respirators for mine rescue or other emergency use in mines.

(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), U.S. Department of Labor, shall jointly review and issue certifications for respirators used for mine emergencies and mine rescue, including any associated service-life plans, users' manuals and other supporting documentation.

(2) Each certification for a respirator designed for mine rescue or other emergency use in mines shall include, as a condition of approval, any use limitations related to mine safety and health.

(b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints or identified deficiencies involving any respirators used in the mining environment.

§ 84.10 Application procedures.

(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B.

(b) Applications must be submitted in accordance with the Standard Application Procedure for the Certification of Respirators under 42 CFR 84, ( Standard Application Procedure ) available on the NPPTL Web site, to Records Room, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(c) Except as provided in § 84.64, the examination, inspection, and testing of all respirators will be conducted or caused to be conducted by the National Personal Protective Technology Laboratory.

(d) Applicants, manufacturers, or their representatives may visit or communicate with the National Personal Protective Technology Laboratory in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge will be made for such consultation and no written report will be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation.

(e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059.

§ 84.11 Contents of application.

(a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.

(b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies.

(c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.

(d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and shall include the results of such tests.

(e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.

(The information collections contained in this section are approved under OMB control number 0920-0109)

§ 84.12 Delivery of respirators and components by applicant; requirements.

(a) Each applicant shall, when an application is filed pursuant to § 84.10, be advised by the Institute of the total number of respirators and component parts required for testing.

(b) The applicant will deliver, at his or her own expense, the number of completely assembled respirators and component parts required for their examination, inspection, and testing, to the National Personal Protective Technology Laboratory.

(c) Respirators and component parts submitted for approval must be made from materials specified in the application.

(d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

(e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

§ 84.20 Establishment of fees.

(a) This section establishes a system under which NIOSH charges a fee for services provided to applicants for conformity assessment activities conducted by NIOSH for respiratory protective devices under 42 CFR part 84. This section specifies the purposes for which fees will be assessed and the cost factors for such assessments.

(b) Fees will be charged for:

(1) Respirator certification application, approval, approval modification, records maintenance, and testing. Application processing under this Part by engineers, technicians and other specialists, including administrative review of applications, analysis of drawings, technical evaluation, testing, test set up and tear down, and consultation on applications, clerical services, computer tracking and status reporting, records control and security, and document preparation directly supporting application processing. This fee also contributes to a proportionate share of management, administration and operation of the NIOSH National Personal Protective Technology Laboratory;

(2) Maintenance of testing and approval facilities and test equipment. Amortization of facility improvements and depreciation of buildings and equipment used for testing and evaluation or otherwise directly associated with application processing;

(3) Site qualification. Initial review and approval, as specified under 42 CFR part 84 subpart E—Quality Control, of manufacturing facilities that may be used to manufacture respirators, principal components, and/or subassemblies;

(4) Quality assurance maintenance. Quality site audits to verify conformance to the requirements of §§ 84.33, 84.40, 84.41, 84.42, 84.43; and

(5) Maintenance of product performance. Product audits to verify the performance of commercially available respirators which have been granted a NIOSH certificate of approval.

(c) Fees will not be charged for:

(1) Technical assistance not related to application processing;

(2) Technical programs including development of new technology programs;

(3) Participation in research; and

(4) Regulatory review activities, including participation in the development of health and safety standards, regulations, and legislation.

§ 84.21 Fee calculation.

(a) This section explains the process NIOSH uses to calculate estimates of the direct and indirect costs of services provided in the course of application processing.

(b) Upon completion of an initial administrative review of the application, NIOSH will calculate a fee estimate for each application, including the maximum cost of conducting additional tests under § 84.24, and will provide that estimate, with payment details, to the applicant. The fee estimate will be derived using the current schedules of fees published by NIOSH in Part 84. NIOSH will begin the technical evaluation once the applicant accepts the terms of the fee estimate and authorizes payment.

(c) If NIOSH determines that actual costs for application processing and related testing will exceed the fee estimate provided to the applicant, NIOSH will provide a revised fee estimate for completing the application review before exceeding the previously-authorized fees. The applicant will have the option of either withdrawing the application and paying for services already performed or authorizing payment of the revised estimate, in which case NIOSH will continue the application review and testing.

(d) If the actual cost of processing the application is less than the fee estimate NIOSH provided to the applicant, NIOSH will charge the actual cost.

(e) If the applicant withdraws an application, the applicant will be invoiced for services already performed by NIOSH. Withdrawal of an application will be effective on the first business day following the date NIOSH receives a withdrawal notice from the applicant in writing. Withdrawal notices will be submitted to NIOSH in accordance with the Standard Application Procedure using the address specified in § 84.10.

§ 84.22 Fee administration.

(a) Applicants will be invoiced for all fees incurred in the processing of an application when all required reviews, analyses, evaluations, and tests are completed or the application is withdrawn. Invoices will contain specific payment instructions and identify authorized methods of payment.

(b) Applicants who hold active and/or obsolete certificates of approval will be invoiced by NIOSH annually for applicable maintenance fees, in accordance with the fee schedule published in Appendix A of this part.

(c) NIOSH reserves the right to impose sanctions for any missed payment, and will administer such penalties after assessing the circumstances of the manufacturer and the needs of other stakeholders. Sanctions may include but are not limited to:

(1) Refusal to accept future applications for approval;

(2) Stop-sale of all approved product; and

(3) Engaging appropriate government authorities to initiate debt collection procedures for the unpaid fees.

§ 84.23 Fee revision.

(a) Each fee schedule will remain in effect for at least 2 years and will be revised as needed to reflect cost increases identified in biennial reviews.

(b) Fee schedule updates will be proposed in a notice of proposed rulemaking published in the Federal Register .

(c) The current fee schedules will be published in Appendix A and Appendix B of this part and will remain in effect until the effective date of the new fee schedules published in the Federal Register .

§ 84.24 Authorization for additional examinations, inspections, tests, and fees.

NIOSH will conduct or cause to be conducted any additional examinations, inspections, or tests it deems necessary to determine the quality and effectiveness of any respirator submitted to NIOSH for the purposes of seeking a certificate of approval. The costs of such examinations, inspections, or tests will be paid by the applicant prior to issuance of a certificate of approval for the subject respirator.

§ 84.30 Certificates of approval; scope of approval.

(a) The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable.

(b) The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly.

(c) The Institute shall not issue an informal notification of approval. However, if the application for approval, submitted in accordance with § 84.11, states that the submitted respirator and component parts are only prototypes, the Institute will examine, inspect, and test such respirator and component parts in accordance with the provisions of this part. If, upon completion of such examinations, inspections and tests, it is found that the prototype meets the minimum requirements set forth in this part, the Institute may inform the applicant, in writing, of the results of the examinations, inspections, and tests, and may require him to resubmit respirators and component parts made on regular production tooling, with no operations included which will not be incorporated in regular production processing, for further examination, inspection, and testing, prior to issuance of the certificate of approval.

(d) Applicants required to resubmit respirators and component parts made on regular production tooling, with no operation included which will not be incorporated in regular production processing, shall be charged fees in accordance with subpart C of this part.

§ 84.31 Certificates of approval; contents.

(a) The certificate of approval shall contain a classification and a description of the respirator or combination of respirators for which it is issued, as provided in this part.

(b) The certificate of approval shall specifically set forth any restrictions or limitations on the respirator's use in hazardous atmospheres.

(c) Each certificate of approval shall be accompanied by the drawings and specifications (and lists thereof) submitted by the applicant in accordance with § 84.11. These drawings and specifications shall be referenced in the certificate of approval, and shall be maintained by the applicant. The drawings and specifications listed in each certificate of approval shall set forth in detail the design and construction requirements which shall be met by the applicant during commercial production of the respirator.

(d) Each certificate of approval shall be accompanied by a reproduction of the approval label design to be employed by the applicant with each approved respirator, as provided in § 84.33.

(e) No test data or specific laboratory findings will accompany any certificate of approval, however, the Institute will release pertinent test data and specific findings upon written request by the applicant, or as required by statute or regulation.

(f) Each certificate of approval shall also contain the approved quality control plan as specified in § 84.42.

§ 84.32 Notice of disapproval.

(a) If, upon the completion of the examinations, inspections, and tests required to be conducted in accordance with the provisions of this part, it is found that the respirator does not meet the minimum requirements set forth in this part, the Institute shall issue a written notice of disapproval to the applicant.

(b) Each notice of disapproval shall be accompanied by all pertinent data or findings with respect to the defects of the respirator for which approval was sought with a view to the possible correction of any such defects.

(c) The Institute shall not disclose, except to the applicant or as required by statute or regulation, any data, findings, or other information with respect to any respirator for which a notice of disapproval is issued.

§ 84.33 Approval labels and markings; approval of contents; use.

(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval.

(b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:

Respirator type

Label type

Location

Self-contained breathing apparatus

Entire

Harness assembly and canister (where applicable).

Gas mask

Entire

Mask container and canister.

Supplied air respirator

......do

Respirator container or instruction card.

Particulate respirator

......do

Respirator container and filter container.

Abbreviated

Filters.

Chemical-cartridge respirator

Entire

Respirator container, cartridge container, and filter containers (where applicable).

Abbreviated

Cartridges and filters and filter containers.

(f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.

(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.

§ 84.34 Revocation of certificates of approval.

The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.

§ 84.35 Changes or modifications of approved respirators; issuance of modification of certificate of approval.

(a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of the original certificate of approval issued by the Institute for such respirator by filing an application for such modification in accordance with the provisions of this section.

(b) Applications shall be submitted as for an original certificate of approval, with a request for a modification of the existing certificate to cover any proposed change.

(c) The application shall be accompanied by appropriate drawings and specifications, and by a proposed quality control plan which meets the requirements of subpart E of this part.

(d) The application for modification, together with the accompanying material, shall be examined by the Institute to determine whether testing will be required.

(e) The Institute shall inform the applicant of the fee required for any additional testing and the applicant will be charged for the actual cost of any examination, inspection, or test required, and such fees shall be submitted in accordance with the provisions of subpart C of this part.

(f) If the proposed change or modification meets the requirements of this part, a formal certificate of modification will be issued, accompanied, where necessary, by a list of new and revised drawings and specifications covering the change(s) and reproductions of revised approval labels.

(The information collections contained in this section are approved under OMB control number 0920-0109)

§ 84.36 Delivery of changed or modified approved respirator.

An approved respirator for which a formal certificate of modification has been issued shall be delivered, with proper markings and containers, by the applicant to the National Personal Protective Technology Laboratory, as soon as it is commercially produced.

§ 84.40 Quality control plans; filing requirements.

As a part of each application for approval or modification of approval submitted pursuant to this part, each applicant shall file with the Institute a proposed quality control plan which shall be designed to assure the quality of respiratory protection provided by the respirator for which approval is sought.

§ 84.41 Quality control plans; contents.

(a) Each quality control plan shall contain provisions for the management of quality, including:

(1) Requirements for the production of quality data and the use of quality control records;

(2) Control of engineering drawings, documentations, and changes;

(3) Control and calibration of measuring and test equipment;

(4) Control of purchased material to include incoming inspection;

(5) Lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant;

(6) Audit of final inspection of the completed product; and

(7) The organizational structure necessary to carry out these provisions.

(b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. The procedure of Military Standard MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. Incoming bulk raw material inspection or verification of specification, and in-process inspection shall be sufficient to ensure control of product quality through the manufacturing cycle.

(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.

(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:

(1) Critical. A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to life or health for individuals using or depending upon the respirator;

(2) Major A. A defect, other than critical, that is likely to result in failure to the degree that the respirator does not provide any respiratory protection, or a defect that reduces protection and is not detectable by the user;

(3) Major B. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is detectable by the user; and

(4) Minor. A defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the respirator.

(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.

(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.

(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:

(1) Major A. 1.0 percent;

(2) Major B. 2.5 percent; and

(3) Minor. 4.0 percent.

(h) Except as provided in paragraph (i) of this section, inspection level IV as described in MIL-STD-414, 11 June 1957, including Change Notice No.1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an equivalent procedure, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. Inspection level II as described in MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent procedure.

(i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to ensure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.

(The information collections contained in this section are approved under OMB control number 0920-0109)

§ 84.42 Proposed quality control plans; approval by the Institute.

(a) Each proposed quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for which an approval is sought.

(b) If the Institute determines that the proposed quality control plan submitted by the applicant will not ensure adequate quality control, the Institute shall require the applicant to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate of approval.

(c) Approved quality control plans shall constitute a part of and be incorporated into any certificate of approval issued by the Institute, and compliance with such plans by the applicant shall be a condition of approval.

§ 84.43 Quality control records; review by the Institute; revocation of approval.

(a) The applicant shall keep quality control inspection records sufficient to carry out the procedures required in MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure. MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an approved equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(b) The Institute reserves the right to have its representatives inspect the applicant's quality control test methods, equipment, and records, and to interview any employee or agent of the applicant in regard to quality control test methods, equipment, and records.

(c) The Institute reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's quality control test methods, equipment, or records do not ensure effective quality control over the respirator for which the approval was issued.

(The information collections contained in this section are approved under OMB control number 0920-0109)

§ 84.50 Types of respirators to be approved; scope of approval.

Approvals shall be issued for the types of respirators which have been classified pursuant to this subpart F, have been inspected, examined and tested by the Institute, in accordance with the provisions of subparts G through L of this part, and have been found to provide respiratory protection for fixed periods of time against the hazards specified in such approval.

§ 84.51 Entry and escape, or escape only; classification.

Respirators described in subparts H through L of this part shall be classified for use as follows:

(a) Entry and escape. Respirators designed and approved for use during entry into a hazardous atmosphere, and for escape from a hazardous atmosphere; or

(b) Escape only. Respirators designed and approved for use only during escape from a hazardous atmosphere.

§ 84.52 Respiratory hazards; classification.

Respirators described in subparts H through L of this part shall be classified as approved for use against any or all of the following respiratory hazards:

(a) Oxygen deficiency;

(b) Gases and vapors; and

(c) Particles, including dusts, fumes and mists.

§ 84.53 Service time; classification.

(a) Respirators described in subparts H through L of this part shall be classified, where applicable, as approved for use during the following prescribed service times:

(1) Four hours;

(2) Three hours;

(3) Two hours;

(4) One hour;

(5) Forty-five minutes;

(6) Thirty minutes;

(7) Fifteen minutes;

(8) Ten minutes;

(9) Five minutes; or

(10) Three minutes.

(b) Other service times may be prescribed by the Institute.

§ 84.60 Construction and performance requirements; general.

(a) The Institute shall issue approvals for the types of respirators described in subparts H through O of this part which have met the minimum requirements set forth for such respirators in this part.

(b) In addition to the types of respirators specified in subparts H through L of this part, the Institute shall issue approvals for other respiratory protective devices not specifically described in this part subject to such additional requirements as may be imposed in accordance with § 84.63(c).

§ 84.61 General construction requirements.

(a) Respirators will not be accepted by the Institute for examination, inspection and testing unless they are designed on sound engineering and scientific principles, constructed of suitable materials and evidence good workmanship.

(b) Respirator components which come into contact with the wearer's skin shall be made of nonirritating materials.

(c) Components replaced during or after use shall be constructed of materials which will not be damaged by normal handling.

(d) Mouthpieces, hoods, helmets, and facepieces, except those employed in single-use respirators, shall be constructed of materials which will withstand repeated disinfection as recommended by the applicant in his instructions for use of the device.

§ 84.62 Component parts; minimum requirements.

(a) The component parts of each respirator shall be:

(1) Designed, constructed, and fitted to insure against creation of any hazard to the wearer;

(2) Assembled to permit easy access for inspection and repair of functional parts; and

(3) Assembled to permit easy access to parts which require periodic cleaning and disinfecting.

(b) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the respirator.

§ 84.63 Test requirements; general.

(a) Each respirator and respirator component shall when tested by the applicant and by the Institute, and meet the applicable requirements set forth in subparts H through O of this part.

(b) Where a combination respirator is assembled from two or more types of respirators, as described in this part, each of the individual respirator types which have been combined shall, as applicable, meet the minimum requirements for such respirators set forth in subparts H through O of this part, and such combination respirators, except as specified in § 84.70(b)(2), will be classified by the type of respirator in the combination which provides the least protection to the user.

(c) In addition to the minimum requirements set forth in subparts H through O of this part, the Institute reserves the right to require, as a further condition of approval, any additional requirements deemed necessary to establish the quality, effectiveness, and safety of any respirator used as protection against hazardous atmospheres.

(d) Where it is determined after receipt of an application that additional requirements will be required for approval, the Institute will notify the applicant in writing of these additional requirements, and necessary examinations, inspections, or tests, stating generally the reasons for such requirements, examinations, inspections, or tests.

§ 84.64 Pretesting by applicant; approval of test methods.

(a) Prior to making or filing any application for approval or modification of approval, the applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of respirator performance which are equal to or exceed the severity of those prescribed in this part.

(b) With the application, the applicant shall provide a statement to the Institute showing the types and results of the examinations, inspections, and tests required under paragraph (a) of this section and state that the respirator meets the minimum requirements of subparts H through O of this part, as applicable. Complete examination, inspection, and test data shall be retained on file by the applicant and be submitted, upon request, to the Institute.

(c) The Institute may, upon written request by the applicant, provide drawings and descriptions of its test equipment and otherwise assist the applicant in establishing a test laboratory or securing the services of a testing agency.

(d) No approval will be issued until the Institute has validated the applicant's test results.

§ 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; public demonstrations.

(a) All examinations, inspections, and tests conducted pursuant to subparts H through O of this part will be under the sole direction and control of the Institute.

(b) The Institute may, as a condition of approval, require the assistance of the applicant or agents of the applicant during the assembly, disassembly, or preparation of any respirator or respirator component prior to testing or in the operation of such equipment during testing.

(c) Only Institute personnel, persons assisting the Institute pursuant to paragraph (b) of this section, and such other persons as are requested by the Institute or the applicant to be observers, shall be present during any examination, inspection, or test conducted prior to the issuance of an approval by the Institute for the equipment under consideration.

(d) The Institute shall hold as confidential any analyses, drawings, specifications, or materials submitted by the applicant and shall not disclose any principles or patentable features of such equipment, except as required by statute or regulation.

(e) As a condition of each approval issued for any respirator, the Institute reserves the right, following the issuance of such approval, to conduct such public tests and demonstrations of the approved respiratory equipment as is deemed appropriate.

§ 84.66 Withdrawal of applications.

(a) Any applicant may, upon a written request submitted to the Institute, withdraw any application for approval of any respirator.

(b) Upon the receipt of a written request from the applicant for the withdrawal of an application, NIOSH will invoice the applicant based on the fee calculated, as specified under § 84.21(e).

§ 84.70 Self-contained breathing apparatus; description.

(a) Self-contained breathing apparatus, including all completely assembled, portable, self-contained devices designed for use as respiratory protection during entry into and escape from or escape only from hazardous atmospheres, are described as follows:

(1) Closed-circuit apparatus. An apparatus of the type in which the exhalation is rebreathed by the wearer after the carbon dioxide has been effectively removed and a suitable oxygen concentration restored from sources composed of:

(i) Compressed oxygen; or

(ii) Chemical oxygen; or

(iii) Liquid-oxygen.

(2) Open-circuit apparatus. An apparatus of the following types from which exhalation is vented to the atmosphere and not rebreathed:

(i) Demand-type apparatus. An apparatus in which the pressure inside the facepiece in relation to the immediate environment is positive during exhalation and negative during inhalation; or

(ii) Pressure-demand-type apparatus. An apparatus in which the pressure inside the facepiece in relation to the immediate environment is positive during both inhalation and exhalation.

(b) The following respirators may be classified as designed and approved for use during emergency entry into a hazardous atmosphere:

(1) A combination respirator which includes a self-contained breathing apparatus; and

(2) A Type “C” or Type “CE” supplied air respirator, where—

(i) The self-contained breathing apparatus is classified for 3-, 5-, or 10-minute service time and the air line supply is used during entry; or

(ii) The self-contained breathing apparatus is classified for 15 minutes or longer service time and not more than 20 percent of the rated capacity of the air supply is used during entry.

(c) Self-contained breathing apparatus classified for less than 1 hour service time will not be approved for use during underground mine rescue and recovery operations except as auxiliary equipment.

(d) Self-contained breathing apparatus classified for less than 30 minutes' service time will not be approved for use as auxiliary equipment during underground mine rescue and recovery operations.

§ 84.71 Self-contained breathing apparatus; required components.

(a) Each self-contained breathing apparatus described in § 84.70 shall, where its design requires, contain the following component parts:

(1) Facepiece or mouthpiece, and noseclip;

(2) Respirable breathing gas container;

(3) Supply of respirable breathing gas;

(4) Gas pressure or liquid level gages;

(5) Timer;

(6) Remaining service life indicator or warning device;

(7) Hand-operated valves;

(8) Breathing bag;

(9) Safety relief valve or safety relief system; and

(10) Harness.

(b) The components of each self-contained breathing apparatus shall meet the minimum construction requirements set forth in subpart G of this part.

§ 84.72 Breathing tubes; minimum requirements.

Flexible breathing tubes used in conjunction with breathing apparatus shall be designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces and mouthpieces;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

§ 84.73 Harnesses; installation and construction; minimum requirements.

(a) Each apparatus shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the apparatus in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of apparatus parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.

§ 84.74 Apparatus containers; minimum requirements.

(a) Apparatus may be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains, and all appropriate approval labels.

(b) Containers supplied by the applicant for carrying or storing self-contained breathing apparatus will be inspected, examined, and tested as components of the respirator for which approval is sought.

(c) Containers for self-contained breathing apparatus shall be designed and constructed to permit easy removal of the apparatus.

§ 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum requirements.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes, either:

(1) By providing more than one facepiece size; or

(2) By providing one facepiece size which will fit varying facial shapes and sizes.

(b) Full facepieces shall provide for the optional use of corrective spectacles or lenses which shall not reduce the respiratory protective qualities of the apparatus.

(c) Apparatus with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or apparatus and provide an airtight seal.

(d) Facepieces shall be designed to prevent eyepiece, spectacle, and lens fogging.

§ 84.76 Facepieces; eyepieces; minimum requirements.

(a) Facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.

(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

§ 84.77 Inhalation and exhalation valves; minimum requirements.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.

(b) Exhalation valves shall be—

(1) Protected against external influence; and

(2) Designed and constructed to prevent inward leakage of contaminated air.

§ 84.78 Head harnesses; minimum requirements.

(a) Facepieces shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during suspension and an even distribution of pressure over the entire area in contact with the face.

(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.

§ 84.79 Breathing gas; minimum requirements.

(a) Breathing gas used to supply apparatus shall be respirable and contain no less than 19.5 (dry atmosphere) volume percent of oxygen.

(b) Oxygen, including liquid oxygen, shall contain not less than 99.0 percent, by volume, of pure O 2 , not more than 0.03%, by volume, carbon dioxide, and not more than 0.001%, by volume, carbon monoxide. Methods for making these determinations can be found in the U.S. Pharmacopeia National Formulary. Containers used for oxygen must not be treated with any toxic, sleep-inducing, narcosis-producing, or respiratory tract irritating compounds.

(c) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

§ 84.80 Interchangeability of oxygen and air prohibited.

Approvals shall not be issued by the Institute for any apparatus, combination of respirator assemblies, or any apparatus or respirator component which is designed or constructed to permit the interchangeable use of oxygen and air.

§ 84.81 Compressed breathing gas and liquefied breathing gas containers; minimum requirements.

(a) Compressed breathing gas and liquefied breathing gas containers shall meet the minimum requirements of the Department of Transportation for interstate shipment of such containers when fully charged.

(b) Such containers shall be permanently and legibly marked to identify their contents, e.g., compressed breathing air, compressed breathing oxygen, liquefied breathing air, or liquefied breathing oxygen.

(c) Containers normally removed from apparatus for refilling shall be equipped with a dial indicating gage which shows the pressure in the container.

(d) Compressed breathing gas contained valves or a separate charging system or adapter provided with each apparatus shall be equipped with outlet threads specified for the service by the American Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections, B57.1-1965. B57.1-1965 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

§ 84.82 Gas pressure gages; minimum requirements.

(a) Gas pressure gages employed on compressed breathing gas containers shall be calibrated in pounds per square inch.

(b) Liquid-level gages shall be calibrated in fractions of total container capacity, or in units of liquid volume.

(c) Gas pressure gages other than those specified in paragraphs (a) and (b) of this section shall be calibrated in:

(1) Pounds per square inch; or

(2) In fractions of total container capacity; or

(3) Both in pounds per square inch and fractions of total container capacity.

(d)(1) Dial-indicating gages shall be reliable to within ±5 percent of full scale when tested both up and down the scale at each of 5 equal intervals.

(2) The full-scale graduation of dial-indicating gages shall not exceed 150 percent of the maximum rated cylinder pressures specified for the container in applicable Department of Transportation specifications or permits.

(e)(1) Stem-type gages shall be readable by sight and by touch and shall have a stem travel distance of not less than one-fourth inch between each graduation.

(2) A minimum of five graduations shall be engraved on the stem of each gage and these graduations shall include readings for empty, one-quarter, one-half, three-quarters, and full.

(3) Stem gage readings shall not vary from true readings by more than one-sixteenth inch per inch of stem travel.

(f) The loss of gas through a broken gage or severed gage connection shall not exceed 70 liters per minute when the cylinder pressure is 6,900 kN/m.

2 (1,000 pounds per square inch gage) or when the liquid level is at one-half.

(g) Where gages are connected to the apparatus through a gage line, the gage and line shall be capable of being isolated from the apparatus except where the failure of the gage or line would not impair the performance or service life of the apparatus.

(h) Oxygen pressure gages shall have the words “Oxygen” and “Use No Oil” marked prominently on the gage.

(i)(1) Apparatus using compressed breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining gas content in the container.

(2) Apparatus using liquefied breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining liquid content in the container; however, where the liquid content cannot be rapidly vented, and the service time of the device begins immediately after filling, a timer shall be provided in place of a visible gage.

§ 84.83 Timers; elapsed time indicators; remaining service life indicators; minimum requirements.

(a) Elapsed time indicators shall be provided for apparatus with a chemical oxygen source, except:

(1) Apparatus used for escape only; or

(2) Liquefied breathing gas apparatus equipped with gages visible to the wearer which indicate the remaining liquid content in the container.

(b) The timer or other indicator shall be accurately calibrated in minutes of remaining service life.

(c) Timers shall be readable by sight and by touch during use by the wearer.

(d) Timers shall be equipped with automatically preset alarms which will warn the wearer for a period of 7 seconds or more after the preset time has elapsed.

(e) Remaining service-life indicators or warning devices shall be provided in addition to a pressure gage on compressed gas self-contained breathing apparatus, except apparatus used for escape only, and shall operate automatically without preadjustment by the wearer.

(f) Each remaining service-life indicator or warning device must give an alarm when the remaining service life is reduced to a minimum of 25 percent of its rated service time or any higher minimum percent value or values as specified in the approval. Open-circuit demand and pressure-demand respirators must alarm continuously until depletion of the breathing air supply. The percent value set for indicator activation must be identified by labels and/or markings on each respirator unit.

§ 84.84 Hand-operated valves; minimum requirements.

(a) Hand-operated valves shall be designed and constructed to prevent removal of the stem from the valve body during normal usage to insure against a sudden release of the full pressure of the container when the valve is opened.

(b) Valves shall be designed or positioned to prevent accidental opening and closing, and damage from external forces.

(c) Valves operated during use of the apparatus shall be installed in locations where they can be readily adjusted by the wearer.

(d) Main-line valves, designed and constructed to conserve gas in the event of a regulator or demand valve failure, shall be provided in addition to gas container valves, except when such failure will not affect performance.

(e) Hand-operated bypass systems designed and constructed to permit the wearer to breathe and to conserve his gas supply in the event of a regulator or demand valve failure, shall be provided where necessary.

(f) Valves installed on apparatus shall be clearly distinguishable from one another by sight and touch.

(g) The bypass system valve control shall be colored red.

(h) A main-line or bypass valve or system will not be required on apparatus for escape only.

(i) Safety relief valves or systems, designed and constructed to release excess pressure in the breathing circuit, shall be provided on closed-circuit apparatus, and shall meet the following requirements:

(1) The relief valve or system shall operate automatically when the pressure in the breathing circuit on the inhalation side of the breathing bag reaches 13 mm. (one-half inch) water-column height of pressure above the minimum pressure required to fill the breathing bag, within the breathing resistance requirements for the apparatus.

(2) The relief valve or system shall be designed to prevent external atmospheres from entering the breathing circuit.

(3) The relief valve or system shall be designed to permit manual overriding for test purposes and in the event of a failure in the valve or system.

§ 84.85 Breathing bags; minimum requirements.

(a) Breathing bags shall have sufficient volume to prevent gas waste during exhalation and to provide an adequate reserve for inhalation.

(b) Breathing bags shall be constructed of materials which are flexible and resistant to gasoline vapors.

(c) Breathing bags shall be installed in a location which will protect them from damage or collapse by external forces, except on apparatus classified for escape only.

§ 84.86 Component parts exposed to oxygen pressures; minimum requirements.

Each applicant shall certify that the materials employed in the construction of component parts exposed to oxygen pressures above atmospheric pressure are safe and compatible for their intended use.