[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Proposed Rules]
[Pages 75045-75057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

RIN 0920-AA04


Quality Assurance Requirements for Respirators; Notice of 
Proposed Rulemaking

AGENCY: Centers for Disease Control and Prevention.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS) proposes to 
update existing quality assurance requirements under 42 CFR Part 84 for 
the manufacture of all respirators approved by the National Institute 
for Occupational Safety and Health (``NIOSH'') of Centers for Disease 
Control and Prevetion (CDC), HHS. The proposed new requirements would 
require respirator manufacturers to be compliant with a widely adopted 
voluntary consensus standard for quality management systems, would 
update technical requirements particular to quality assurance for 
manufacturing of NIOSH-approved respirators, and would establish 
requirements governing the related quality assurance oversight 
activities of NIOSH.

DATES: CDC invites comments on this proposed rule from interested 
parties. Comments must be received by February 9, 2009.

ADDRESSES: You may submit comments, identified by RIN: 0920-AA04, by 
any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: [email protected]. Include ``RIN: 0920-AA04'' 
and ``42 CFR pt. 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-AA04. All comments received will be posted 
without change to http://www.cdc.gov/niosh/docket, including any 
personal information provided. For detailed instructions on submitting 
comments and additional information on the rulemaking process, see the 
``Public Participation'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.cdc.gov/niosh/docket.

FOR FURTHER INFORMATION CONTACT: William Newcomb, NIOSH National 
Personal Protective Technology Laboratory (``NPPTL''), Pittsburgh, PA, 
(412) 386-4034 (this is not a toll-free number). Information requests 
can also be submitted by e-mail to [email protected].

SUPPLEMENTARY INFORMATION:

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this proposal.
    Comments submitted by e-mail or mail should be addressed to the 
``NIOSH Docket Officer'' , titled ``NIOSH Docket 109'', and 
should identify the author(s), return address, and a phone number, in 
case clarification is needed. Comments can be submitted by e-mail to: 
[email protected]. E-mail comments can be provided as e-mail text or 
as a Word or Word Perfect file attachment. Printed comments can be sent 
to the NIOSH Docket Office at the address above. All communications 
received on or before the closing date for comments will be fully 
considered by CDC.
    All comments submitted will be available for examination in the 
rule docket (a publicly available repository of the documents 
associated with the rulemaking) both before and after the closing date 
for comments. A complete electronic docket containing all comments 
submitted will be available on the NIOSH Web page at http://www.cdc.gov/niosh/docket, and comments will be available in writing by 
request. NIOSH includes all comments received without change in the 
docket, including any personal information provided.

II. Background

A. Introduction

    Under 42 CFR Part 84, ``Approval of Respiratory Protective 
Devices'' (``Part 84'') NIOSH approves respirators used by workers in 
mines and other workplaces for protection against hazardous 
atmospheres. The Mine Safety and Health Administration (``MSHA'') and 
the Occupational Safety and Health Administration (``OSHA'') require 
U.S. employers to supply NIOSH-approved respirators to their employees 
whenever the employer requires the use of respirators. In addition, 
MSHA co-approves with NIOSH all respirators used in mine emergencies 
and mine rescue.
    As provided under Subpart E of Part 84, NIOSH presently requires, 
as a condition of approval, that the manufacturer of a NIOSH-approved 
respirator maintain a quality control plan designed to ensure that the 
products manufactured are of adequate quality and perform to the 
specifications under which they were approved by NIOSH. To provide 
quality assurance oversight, NIOSH conducts audits of manufacturing 
facilities (site audits) and of finished products (product audits). 
Additionally, NIOSH investigates complaints from employers and users 
concerning the performance of approved respirators in their workplaces. 
These audits and investigations can result in a variety of compliance 
actions by NIOSH, including requesting product recalls, stop-sale 
orders, retrofits, advisories, and various remedial quality control 
actions.

B. Background and Significance

    Employers rely upon NIOSH-approved respirators to protect their 
employees from airborne toxic contaminants and oxygen-deficient 
environments. More than 3.3 million private sector employees in the 
United States wear respirators for certain work tasks. The most 
effective and reliable means of protecting workers from airborne 
contaminants is to prevent the workplace air from substantial 
contamination in the first place through enclosed processes and 
ventilation engineering. Similarly, the most effective and reliable 
means of protecting workers from oxygen-deficient environments is to 
prevent their causes or entry into them by workers. However, it is not 
technologically or economically feasible in all workplaces and 
operations to reduce airborne concentrations of

[[Page 75046]]

contaminants to safe levels and to prevent exposure to oxygen-deficient 
environments. In such cases, workers depend on respirators to protect 
them from asphyxiation or airborne contaminants that are known or 
suspected to cause acute and chronic health effects, such as heavy 
metal poisoning, acid burns, chronic obstructive pulmonary disease, 
silicosis, neurological disorders, and cancer.
    As immediate protection, respirators must not only be certified as 
safe, functional, and effective; they must also be manufactured to 
perform reliably. This is exceptionally important because in many 
circumstances, particularly involving chronic health effects that 
develop gradually or after a long latent period, the worker has no way 
of knowing if a respirator is failing to provide the protection for 
which it was certified. Occupational cancers, for example, typically 
become symptomatic decades following the toxic exposures. Even for 
acute health effects, the worker many not be able to detect defective 
performance of the respirator prior to the toxic exposure, upon which 
it might be too late to avoid serious injury or death.
    Respirator manufacturers and NIOSH have critical roles in assuring 
employers, other purchasers of respirators, and workers that their 
respirators will provide the protection that is implied by their NIOSH 
certification. This rulemaking, which has been identified as a priority 
among the policymaking needs of the NIOSH respirator certification 
program by respirator manufacturers, employers, and other stakeholders 
of the program, \1\ is intended to strengthen this assurance.
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    \1\ All Manufacturers Meeting--Application Log-in Time and 
flowchart of application process; March 22, 2000, NIOSH, Morgantown, 
WV.
    Private Sector Lab meeting to discuss improvement concepts for 
updating quality assurance and administrative requirements in the 
regulation (42CFR 84); June 12-13, 2000, ICS Inc., Brunswick, OH.
    Stakeholder and Public meeting concerning Quality Assurance and 
Administrative Requirements for Approval of Respirators, 
(FR65:129:41472), August 8, 2000, Quality Hotel and Suites, 
Arlington, VA; August 16, 2000, Embassy Suites, Burlingame, CA.
    NIOSH/NPPTL CBRN and Quality Assurance Public Meeting 
(FR68:107:33494-33495), June 25, 2003, Hilton Garden Inn, 
Canonsburg, PA.
    NIOSH/NPPTL Public Meeting--Quality Assurance Module for 
Respiratory Protective Equipments (FR 65:180:54458-54459), October 
16, 2003, Radisson Hotel, Morgantown, WV.
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C. Need for Rulemaking

    The current requirements of Part 84 for a quality control plan 
(Subpart E) were established in 1972. Since that time, the quality 
management practices employed in manufacturing and other industries 
have developed substantially and have become more effective. Quality 
management systems have developed and become widely diffused. These 
systems direct the work of an organization regarding the quality of its 
products and services through a highly focused system of processes, 
documentation, resources, and monitoring. Central to this progress, 
particularly in manufacturing industries, are quality assurance methods 
that have improved through the increasing application of statistical 
process control methods (monitoring methods for achieving consistent 
satisfactory performance of each process involved in the manufacture of 
a final product). This progress has enabled manufacturers in many 
industries to reduce levels of product nonconformance with design and 
performance standards to a diminishingly small fraction of their total 
product output.
    Revising Part 84 to incorporate up-to-date requirements for quality 
management is a necessary step to facilitate progress in respirator 
manufacturing that has been achieved in other manufacturing concerns. 
Although most respirator manufacturers maintain effective quality 
management systems, more than eight percent of NIOSH audits of 
manufacturing facilities since 1999 have found nonconformances in 
product quality requiring a cessation of sales and remedial actions by 
the approval holder. Approximately 40 percent of NIOSH product audits 
conducted since 1999 have identified a nonconformance with 
certification requirements and five percent have resulted in a product 
recall or retrofit. In addition, of the 40 field problem investigations 
NIOSH conducts per year, 45 percent require corrective actions, 20 
percent result in a recall request, and 2.5 percent result in NIOSH 
issuing a stop-sale request. The levels of nonconformance indicated by 
these statistics, although they cover a small number of the 7,100 
respirators approved by NIOSH, suggest that some respirator 
manufacturers can make substantial advances in product quality by 
instituting improved quality management systems.
    In addition to facilitating quality management in respirator 
manufacturing, this proposed rule provides NIOSH with the opportunity 
to more efficiently deploy its auditing resources to focus on quality 
matters that are highly specific to assuring respirator performance. 
Over the past decade, the number of approved respirators has increased 
substantially. NIOSH has issued more than 5,100 of the 7,100 active 
approvals since 1995. In October 2007, there were 87 approval holders 
operating manufacturing facilities in the United States and foreign 
countries. The growth of the industry, the diversity of its products, 
and the globalization of its operations, have strained NIOSH resources 
applied to providing adequate quality assurance audits and related 
services.
    This proposed rule would incorporate into Part 84 the ISO 
Q9001:2000 standard: Quality management systems--Requirements, 3rd 
Edition, established by the International Organization for 
Standardization (ISO),\2\ which is a national and international 
consensus standard widely adopted by leading manufacturers in many 
industries. All respirator manufacturers holding or seeking a NIOSH 
approval would have to be compliant with this standard. Presently, 
approximately 77 percent of approval holders are voluntarily registered 
as compliant with this standard, having undergone auditing to establish 
compliance, and most of the remaining approval holders claim also to be 
compliant.
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    \2\ ISO Q9001:2000 is available from the American National 
Standards Institute (ANSI), 25 West 43rd St., New York, NY 10036; 
Web page: http://www.ansi.org; phone 212-642-4900.
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    Incorporation of the ISO standard would elaborate and enhance the 
existing Part 84 quality control requirements. The existing 
requirements are general except for those governing the use of product 
inspection sampling plans. The ISO standard, by contrast, requires the 
use of a clearly specified, comprehensive, systematic, quality 
management system, providing specific parameters for quality management 
system documentation, management responsibilities, resource management, 
product realization, and measurement, analysis and quality management 
improvement. Incorporation of the ISO standard would foster better 
quality management consistently throughout this critical safety product 
market.
    With respect to quality control activities governed by the current 
provisions of Part 84, the proposed rule would also update the existing 
requirements governing the inspection sampling plans used by respirator 
manufacturers (42 CFR 84.41(b)). The existing requirements constrain 
manufacturers to conducting extensive inspection regardless of the 
design and sophistication of their quality management systems. The 
proposed rule would enable manufacturers to establish product 
inspection approaches suited to their quality management

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systems and the degree of process control they achieve. The change 
would save inspection resources and costs for manufacturers achieving 
high levels of process control in any elements of their production 
processes.

D. Public Meetings for Discussion and Comment

    NIOSH held public meetings to discuss underlying issues and 
technical matters addressed in this proposed rule on August 8, 2000, at 
the Quality Hotel and Suites, Arlington, VA; on August 16, 2000, at the 
Embassy Suites, Burlingame, CA; June 25, 2003, at the Hilton Garden 
Inn, Canonsburg, PA; and on October 16, 2003, at the Radisson Hotel, 
Morgantown, WV.\3\ Official transcripts of the meetings are available 
from the NIOSH Docket Office at the address provided above. Most 
comments were generally supportive of the need to update the quality 
assurance and control provisions of Part 84.
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    \3\ Notice of these meetings were published in the Federal 
Register (FR65:129:41472) (FR68:107:33494-33495) (FR 65:180:54458-
54459). NIOSH also sent a letter announcing the meetings to known 
stakeholders and posted it on the NIOSH Web page http://www.cdc.gov/niosh/npptl.
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    NIOSH will convene public meetings to provide to stakeholders an 
opportunity to comment orally on this rulemaking during the comment 
period. The meetings will be in the vicinities of Washington DC and Los 
Angeles, CA and are announced in a separate notice in this issue of the 
Federal Register.

III. Summary of Proposed Rule

    This proposed rule would establish new quality assurance and 
control requirements for manufacturers of respirators approved by 
NIOSH, or NIOSH and MSHA, under 42 CFR Part 84--Approval of Respiratory 
Protective Devices. The current provisions of Subpart E would be 
replaced almost entirely. In addition, some related provisions of 
several other subparts of Part 84 would be revised, added, or removed. 
The following is a section-by-section summary which describes and 
explains the provisions of the rule. The public is invited to provide 
comment on any aspect of the proposed rule. The complete regulatory 
text for this proposed rule is provided in the last section of this 
notice.

Subpart A

Definitions (Section 84.2)

    This section provides definitions for Part 84. It would be amended 
to add definitions of terms included in the proposed revision of 
Subpart E, to revise definitions related to Subpart E, and to make 
other clarifications. Definitions requiring explanation are identified 
in the following discussion.
    Under paragraph (a), the definition of ``applicant'' is revised to 
clarify that the applicant remains an applicant, for the purposes of 
the regulation, after receiving a product approval from NIOSH. This is 
necessary because Subpart E uses the term applicant with respect to 
quality assurance provisions that apply to the applicant during the 
manufacture of the approved product and subsequently.
    Paragraph (d) defines an ``Authorized NIOSH Representative'' to 
clarify that NIOSH contractors and their employees may serve as 
authorized representatives, as well as NIOSH employees. This is germane 
to the planned use of contractor employees by NIOSH in audits of 
manufacturing facilities.
    Paragraph (w) defines ``manufacturing facility'' to clarify that 
the buildings of any supplier whose quality system is a component of 
the applicant's quality system will be potentially subject to NIOSH 
facility audits under Subpart E. This is important for NIOSH efforts to 
oversee quality assurance for the increasing number of respirator 
manufacturers that are not vertically integrated manufacturing 
enterprises. While NIOSH does not have legal authority to mandate 
access and cooperation to conduct such facility audits, NIOSH 
respirator approvals are contingent on voluntary acceptance of such 
audits and necessary cooperation with the audits by all facilities 
involved in the respirator manufacturing process. If a supplier to an 
applicant whose quality system is integral to that of the applicant 
were to refuse to allow such an audit or refuse to cooperate 
sufficiently to permit the completion of such an audit, then NIOSH 
would either deny the associated application for approval or, if the 
respirator were already approved, NIOSH would revoke the approval.

Subpart B--Application for Approval

Application Procedures (Section 84.10).

    This section specifies procedures for applicants seeking the 
approval of a respirator under Part 84. It would be amended for 
administrative reasons, clarifications, and in support of the quality 
assurance requirements of Subpart E.
    Paragraph (b) would be added to notify potential applicants that 
complete application procedures are available on the NIOSH Web page as 
indicated.
    Paragraph (c) would be added to notify applicants who are holders 
of prior approvals that non-compliance with the quality assurance 
requirements of Subpart E would result in the suspension of processing 
of any new applications the applicant might have submitted. This is 
expected to provide incentive for the applicant to maintain adequate 
quality assurance and to remediate quality assurance problems 
identified by NIOSH in a timely fashion. Moreover, NIOSH believes it is 
sensible and efficient use of federal technical and administrative 
resources to require an applicant to remedy existing quality assurance 
problems prior to considering the approval of additions to the 
applicant's respirator product line which would extend the quality 
assurance responsibilities of the applicant.
    Paragraph (d) clarifies that NIOSH may use contractors as well as 
its own employees in its certification and auditing activities under 
Part 84.
    Paragraph (e) is not substantively changed. It would be revised to 
replace the specification of the ``Certification and Quality Assurance 
Branch'' with ``NIOSH''.

Contents of Application (Section 84.11)

    This section specifies key elements of the Standard Application 
Package for applicants seeking approval under Part 84. It would be 
amended to be consistent with new quality assurance provisions under 
Subpart E, to revise or remove provisions that are outdated, and to 
reflect current practice.
    Paragraphs (a) and (b) are current provisions of Part 84 that have 
been simplified since NIOSH now provides detailed instructions 
concerning application elements in the Standard Application Procedure 
available to applicants from the NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
    Paragraph (c) would require applicants to include a user 
instruction manual. Applicants currently include these, which contain 
information essential to NIOSH for testing to determine that a 
respirator will perform as certified and that users will have adequate 
relevant information, such as length of the service life of the 
respirator.
    Paragraphs (d) through (f) would provide for application contents 
that are consistent with the new quality assurance provisions of 
Subpart E. See the summary of Subpart E provisions for discussion of 
these contents.
    Paragraph (g) would require the applicant to provide a table that 
cross-references the certification requirements under this Part 
applicable to the respirator with the stage or stages in the 
manufacturing process in which the

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particular requirement is addressed by quality assurance and control 
procedures. This table would serve as a roadmap allowing NIOSH to 
efficiently evaluate the adequacy of the quality assurance program and 
would also reduce the time required of the applicant to guide NIOSH 
through quality assurance reviews during the application review and 
audits. NIOSH will include an example of such a cross-referencing table 
in the Standard Application Procedure to illustrate the degree of 
specificity sought.
    Paragraph (h) and (i) are revised but not substantially changed.
    Paragraph (j) would direct manufacturers to the information 
specified in the Standard Application Procedure, which provides 
instructions at a more detailed level than is appropriate for 
regulation and provides administrative information subject to periodic 
clarification and updating. As discussed above, the Standard 
Application Procedure is available on the NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.

Delivery of Respirators and Components by Applicant; Requirements 
(Section 84.12)

    This section would be revised to direct applicants to the Standard 
Application Procedure for instructions on where to submit respirators 
and component parts for testing by NIOSH. The substantive requirements 
with respect to such submissions would remain without change.

Subpart D--Approval and Disapproval

Revocation of Certificates of Approval (Section 84.34)

    This section, which provides NIOSH with authority to revoke 
certificates of approval for cause, would be revised to be consistent 
with the new quality assurance provisions of Subpart E by specifying 
that failure to maintain or cause to be maintained the quality 
assurance or quality control requirements of the certificate of 
approval would constitute a valid cause for a revocation. The existing 
provision is identical except that it specifies solely quality control 
requirements. The existing provisions of Subpart E are limited to 
activities termed as quality control activities, whereas the broader 
nomenclature of ``quality assurance'' would also be applied to the 
proposed new provisions of Subpart E.

Changes or Modifications of Approved Respirators; Issuance of 
Modification of Certificate of Approval (Section 84.35)

    This section provides a procedure for applicants who seek approval 
from NIOSH for modifying features of an approved respirator. Paragraph 
(c) of the current provisions includes requirements for quality control 
information germane to the modifications. These provisions would be 
revised to also comprise the new quality assurance requirements 
proposed for Subpart E.

Changes in Device or Applicant Ownership (Section 84.36)

    This section would specify requirements for an applicant acquiring 
the manufacturing rights to one or more devices (either respirators or 
specific respirator configurations) that has received NIOSH approval 
under this Part. Ownership change of NIOSH-approved devices might occur 
through the sale of a product line from one manufacturer to another or 
through a merger, buy-out, or other means of corporate acquisition or 
divestiture. The representative of the new owner must submit an 
Application for Modification of Certificate of Approval for such 
devices, pursuant to Sec.  84.36, detailing the change in ownership and 
the impact on the approved manufacturing and quality processes 
documented in the respirator certification files at NIOSH. 
Documentation of the change in ownership status from the original 
applicant to whom the NIOSH certificates of approval were issued to the 
new owner must be included by the new owner in the application. The new 
owner would be required to complete such application submissions and 
receive a modified certificate of approval from NIOSH for each approved 
device prior to placing a NIOSH approval label or otherwise 
representing any respirators produced by the new owner as having been 
approved by NIOSH. Sales of an approved device that was manufactured by 
the original applicant prior to the change in ownership can continue 
after ownership of the device or the applicant has changed.
    Ownership turnover in the respirator industry has increased in 
recent years. This has elevated the importance of ensuring that 
acquiring applicants provide timely notification to NIOSH of such 
changes, such that NIOSH can provide timely reviews to verify that 
required quality assurance activities and resources are maintained 
under the new ownership. It is in the interest of all parties, 
including the original applicant and the prospective new owner, to seek 
approvals from NIOSH as soon as possible once a change of ownership is 
decided, to avoid any interruption in the manufacture or sales of an 
approved product pending such approvals.

Changes in Manufacturing Facility or Quality System (Section 84.37)

    This section would ensure that applicants obtain approval from 
NIOSH when they update their quality system, including updates made 
necessary by the addition of a new manufacturing facility. Approval by 
NIOSH is necessary to ensure that the quality system remains in 
compliance with the quality assurance provisions of Subpart E and to 
ensure that NIOSH has correct information for audits that it conducts 
pursuant to Subpart E.

Delivery of Changed or Modified Approved Respirator (Section 84.38)

    This section authorizes NIOSH to obtain from the applicant, for 
inspection and retention, a unit of a respirator whose modification had 
been approved by NIOSH and is being commercially produced. The proposed 
revision is non-substantive, redesignating the section and replacing 
the specification of the ``Certification and Quality Assurance Branch'' 
with ``NIOSH''.

Subpart E--Quality System

Quality System, General Requirements (Section 84.40)

    Paragraph (a) of this section would require that each applicant be 
compliant with the ISO standard for Quality Management Systems \4\, 
which is an international consensus standard widely adopted by leading 
manufacturers in many industries. All respirator manufacturers holding 
or seeking a NIOSH approval would have to be compliant with this 
standard. The standard includes requirements for the following elements 
of a quality management system:
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    \4\ ISO Q9001:2000 is the International Standard: Quality 
management systems--Requirements, 3rd edition, approved on December 
15, 2000, and available from the International Organization for 
Standardization (ISO) and the American National Standards Institute 
(ANSI).
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    a. Quality Policy and Management Responsibility (management's 
stated commitment to the development and implementation of the quality 
management system and its continual improvement and related 
responsibilities, authorities, and communications)
    b. Organization (clear assignment of a structure by which 
management of quality is overseen and implemented)

[[Page 75049]]

    c. Quality Program Documents (a system governing the creation, 
control, and maintenance of documents related to quality management)
    d. Resource Management (a framework for ensuring that physical and 
human resources required to implement the management of quality are 
identified and provided)
    e. Customer-related Processes (procedures to identify and address 
customer requirements and ensure customer satisfaction)
    f. Design Assurance (a framework for ensuring that design work 
involves appropriate planning, controls, inputs, outputs, review 
processes, and validation of results)
    g. Purchases and Subcontracts (requirements for ensuring that 
purchased products conform to specified requirements)
    h. Production and Servicing (requirements for the control and 
validation of these processes and for related policies)
    i. Control of Monitoring and Measuring (requirements and processes 
for monitoring to assure product conformity with quality 
specifications, including internal and external audits)
    j. Control of Nonconforming Products (procedures for the 
identification and processing of nonconforming products)
    k. Corrective Actions and Improvement (procedures for identifying, 
evaluating, and implementing corrective actions to ensure product 
conformity with requirements and for continually improving the quality 
management system)
    Incorporation of the ISO standard would elaborate the related 
existing Part 84 quality control requirements substantially. These 
existing requirements are general, except for the requirements 
governing the use of product inspection sampling plans.
    As discussed under section II-C of this preamble, requiring ISO 
compliance by all respirator manufacturers would foster better quality 
management overall without substantial involvement of NIOSH and would 
promote a higher and more consistent level of quality in this critical 
safety product market. As manufacturers increasingly become ISO 
registered, this will also improve the efficiency and coverage of NIOSH 
manufacturing facility audits. To the extent that ISO registrars are 
effective in addressing generic quality management issues, NIOSH 
auditors will be able to focus their efforts on the most technical 
factors in quality management for assuring the supply of high quality 
respirators, especially the design and implementation of effective 
product inspection sampling plans. This increased technical focus would 
allow NIOSH, over time, to extend the scope of the audit program to 
achieve more timely audits of manufacturing facilities and coverage of 
more products.
    Subsection (b) of this section would authorize NIOSH to conduct an 
audit of an applicant who is registered as compliant with the ISO 
standard or claims to be compliant, to assess or reassess the 
compliance of the applicant.
    The purpose of the NIOSH audit would be to evaluate compliance with 
the ISO standard as it applies to the requirements of this Part. Such 
audits would be conducted only when NIOSH has reason to seek assurance 
of the adequacy of the basis of an applicant's ISO registration or 
statement of compliance. Past evaluations by NIOSH of ISO-registered 
manufacturer's quality plans have indicated to NIOSH that some ISO 
audits have not provided an adequate basis for the resulting ISO 
registrations.
    Subsection (c) of this section would require each applicant and 
approval holder to submit to NIOSH documentation of compliance with the 
ISO standard. The applicant can provide either a copy of registration 
under the ISO standard (or any update to the standard), if the 
applicant is registered as compliant, or a statement of compliance if 
the applicant has not undergone an audit for such compliance by an ISO 
registrar.

Quality Manual Requirements (Section 84.41)

    This section would require applicants to submit to NIOSH a copy of 
their quality manual, which should meet the specifications of the ISO 
standard and should address all quality assurance elements specified in 
the Standard Application Procedure. The applicant would submit a copy 
of the manual with each initial application for approval of a product 
and upon substantial revisions of the manual or, at minimum, once every 
four years, and upon a request by NIOSH.
    The quality manual is a critical source of information by which 
NIOSH evaluates the adequacy of the applicant's quality management 
system. It documents the structure, resources, and policies of the 
quality management system.

Quality Control Plan Content (Section 84.42)

    The current Sec.  84.41 of Part 84 specifies elements that must be 
established in the applicant's quality control plan, which documents 
all manufacture, assembly, inspection, testing, and servicing processes 
applicable to the respirator submitted to NIOSH for approval. The 
section would be redesignated Sec.  84.42 and revised to eliminate 
redundancy with information covered in the quality manual (e.g., 
information on organizational structure), to clarify and generalize the 
required elements, and to distinguish clearly between those elements 
that must be submitted to NIOSH and those that must be made available 
upon request to NIOSH. NIOSH has retained the framework used to 
classify nonconformances (termed ``defects'' under the current 
provisions of this section) according to their potential effect with 
respect to the safety of the user and the usability and performance of 
the respirator. Most important to this revision, NIOSH would replace 
the current product inspection sampling requirements of the quality 
control plan with quality assessment requirements appropriate to the 
variety of present day quality management approaches and appropriate to 
a consumer-oriented statistical weighting of ``producer and consumer 
risks,'' as explained further below.
    The proposed quality assessment requirements reflect the range of 
possible quality management approaches, from the use of more intensive 
inspection regimens, appropriate when processes are not highly 
controlled or the degree of control is unknown (paragraph (a)(5)(i) of 
this section), to the use of statistical process control for highly 
controlled production processes (paragraph (a)(5)(iii) of this 
section). The flexibility in sampling plans proposed would 
progressively reward manufacturers who can achieve high levels of 
quality management performance by allowing increasing economy in their 
product quality inspection time and effort.
    The three sampling plans specified in this section are 
statistically equivalent and are moderately more stringent than the 
current requirements of this section. The sampling requirements under 
the current Sec.  84.41 were designed to limit producer risk, which is 
the statistical ``risk'' or probability that the manufacturer would 
erroneously reject a conforming product as nonconforming. The proposed 
new sampling requirements would shift the emphasis to limiting consumer 
risk, the latter being the statistical probability that the 
manufacturer would fail to reject a nonconforming product. This shift 
in emphasis results in a greater likelihood that non-conforming 
products will be identified and rejected by the manufacturer. A more 
technical analysis

[[Page 75050]]

of the proposed sampling plans, their statistical equivalence, and a 
comparison with the sampling plans covered by the existing requirements 
of Sec.  84.41, is available from the NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
    Paragraph (a)(5)(iv) would allow applicants to devise, with NIOSH 
approval, alternative sampling plans that are statistically equivalent 
to those specified in this section. Under paragraph (a)(6), applicants 
would also be allowed to continue to use the inspection plan under 
which their respirator was approved by NIOSH prior to the effective 
date of the final rule, with the exception that a more stringent 
performance requirement would be applied to ``Major A'' 
nonconformances. NIOSH has proposed a three-year grandfather period for 
this provision, after which all quality assurance plans would have to 
comply with the proposed new requirements. Finally, paragraph (a)(7) 
would continue to allow applicants to use other sampling plans they 
might devise, with NIOSH approval, for destructive inspection or test 
sampling.

Proposed Quality Control Plans; Approval by NIOSH (Section 84.43)

    This section, currently designated as Sec.  84.42 in Part 84, 
authorizes NIOSH to review, require modifications, and approve the 
applicant's quality control plans; requires the applicant to comply 
with the plans; and makes such compliance a condition of approval. This 
section further authorizes NIOSH to revoke approvals of the applicant 
as a consequence of noncompliance. Paragraph (c) would be revised to 
clarify the possible response by NIOSH to a case of noncompliance and 
paragraph (d) would be added to provide a procedure for applicants to 
revise and obtain NIOSH approval of revised quality control plans as 
necessary.

Respiratory Device Complaints (Section 84.44)

    This section would elaborate the requirements of the ISO standard 
for Quality Management Systems to govern the applicants' management of 
complaints they receive concerning their NIOSH-approved respirators. 
Paragraphs (a)(3)(A) and (B) would impose on applicants special 
requirements for timeliness of response and for the timely reporting of 
complaints of a particularly serious nature that potentially involve 
health endangerment. The requirement for reporting of these cases would 
enable NIOSH to monitor and facilitate investigations of safety and 
health importance and to involve NIOSH and other federal resources in 
efforts to notify respirator users and take other actions necessary to 
remediate an identified hazardous condition involving a NIOSH-approved 
respirator.

Audit Programs (Section 84.45)

    This section would replace and elaborate current provisions of 
Sec.  84.43 under Part 84, which authorize NIOSH to inspect and 
evaluate the quality control program of an applicant and, if necessary, 
to revoke for cause an approval on the basis of such evaluation. Under 
these current provisions, NIOSH presently conducts audits of 
manufacturing facilities and of manufactured products, as discussed in 
section II.C. of this preamble. The proposed new subsection Sec.  
84.45(a) largely reflects the current practices of these NIOSH audit 
programs. The purpose of the audits is to provide assurance of the 
safety, performance, functionality, and reliability of approved 
respirators that have been produced.
    Paragraph (a)(1)(i) would require the applicant to provide to the 
NIOSH representative conducting a facility audit, upon request, any 
documents or records germane to the auditing of facilities or products 
as provided for under this section.
    Paragraph (a)(1)(ii) would limit the frequency of NIOSH facility 
audits, except for cause, to balance the need for such evaluation 
against the burden to applicants of hosting such audits and responding 
to the related informational requests.
    Paragraph (a)(2)(i) would require an applicant to provide NIOSH-
approved respirator or respirator component samples as necessary during 
the facility or product audit and would specify the timeliness with 
which such samples must be provided. Evaluation of these products is an 
essential, existing element of NIOSH audits. The paragraph would also 
allow for alternative schedules for the provision of such samples, as 
provided for by other sections of Part 84 that cover requirements for 
specific types of respirators.
    The proposed new subsection Sec.  84.45(b) would require applicants 
to conduct an annual quality control audit on each approved respirator 
or respirator family (set of respirators assembled using a subset of 
common components) for which the respirator or respirator family is not 
manufactured and sold as a complete device. Some applicants sell 
certain respirators unassembled and sell respirator components 
separately. The requirement that applicants annually audit such 
respirators or families of respirators is important to ensure that the 
components continue to assemble to produce an effective respirator as 
approved under NIOSH certification testing. Presently, such assembly 
and evaluation is required only once, at the time the applicant submits 
the respirator for approval by NIOSH. It is possible, however, that 
over time, changes in manufacturing materials and processes could 
affect the compatibility of components and the performance of the 
completely assembled respirator. NIOSH has observed such circumstances 
through NIOSH product audits. This required annual quality control 
audit would ensure that the quality assurance programs of applicants 
that produce such respirators periodically address this quality factor.

Quality System Records Retention (Section 84.46)

    This section would complement the ISO standard for Quality 
Management Systems, which covers recordkeeping practices for records 
providing evidence of conformity to requirements and of the effective 
operation of the quality management system. The section would further 
specify that the applicant retain such quality management system 
records relevant to the manufacture of NIOSH-approved respirators for a 
period that is at least as long as the expected life of the 
respirator's major components and for a minimum of two years.
    Some NIOSH evaluations of respirator problems have been stymied 
because of the lack of appropriate recordkeeping or accessibility. The 
proposed specifications for records retention will ensure that relevant 
records are available for NIOSH audits and for evaluation in case 
potential problems are identified through complaints to either the 
applicant or directly to NIOSH. Ensuring the availability of these 
records is essential for NIOSH to determine the cause and extent of a 
problem and will assist the applicant in rectifying problems 
identified.

IV. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether a regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the executive order. Under section 3(f), 
the order defines a

[[Page 75051]]

``significant regulatory action'' as an action that is likely to result 
in a rule (1) Having an annual effect on the economy of $100 million or 
more, or adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local, or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in this executive order.
    This proposed rule is not being treated as a ``significant 
regulatory action'' within the meaning of the executive order. The 
proposed rule is not considered economically significant, as defined in 
section 3(f)(1) of the executive order and does not raise novel policy 
issues or have any of the other effects specified in sections 3(f)(2)-
(4).
    For the leading U.S. respirator manufacturers who obtain approvals 
from NIOSH, the most substantial elements of the proposed new 
requirements are already standard practice. Approximately three-
quarters of these manufacturers are already registered as compliant 
with the ISO Q9001-2000 standard and virtually all of the manufacturers 
with NIOSH approvals appear to be complying already with the most 
essential requirements of the ISO standard, according to NIOSH quality 
assurance audits conducted in recent years. Substantial additional 
quality improvement costs are unlikely to be incurred by any NIOSH 
approval holders. NIOSH expects this rule will allow some respirator 
manufacturers to achieve quality control cost savings, as discussed 
below.
    The new sampling plan performance requirements proposed in Sec.  
84.42(a)(5) will be the most important change for respirator 
manufacturers, particularly to those manufacturers with either the 
least or most stringent quality management systems. The proposal would 
require respirator manufacturers that have not developed stringent 
quality control of their production processes to either tighten the 
quality performance of their production processes or to increase their 
quality control inspection regimen. These changes would enable such 
manufacturers to provide greater assurance of the performance of their 
products by reducing the level of consumer risk currently allowed under 
existing quality control plan requirements of Subpart E, as explained 
under section III of this preamble. On the other hand, manufacturers 
who already operate stringent quality management systems would be able 
to reduce their inspection regimen substantially under the proposed new 
requirements, since the current regulations, which are more than three 
decades old, require all respirator manufacturers to continue a system 
of inspections appropriate to much lower levels of process control than 
is achieved by some manufacturers today. Hence, high-performing 
respirator manufacturers are likely to be conducting redundant product 
quality inspections, maintaining compliance with current regulatory 
requirements but achieving little benefit in terms of quality 
assurance.
    NIOSH would welcome information from respirator manufacturers on 
costs and cost savings that might be associated with compliance with 
proposed new sampling plan requirements. NIOSH recognizes that 
manufacturers who are not already achieving compliance with the 
performance requirements associated with the proposed sampling plan 
options would have difficulty estimating costs and cost savings 
associated with implementing more stringent process controls. However, 
if such a manufacturer planned to simply increase its inspection 
regimen, which is an option under the proposed requirements, the 
manufacturer could estimate the costs of an increased rate of product 
inspections and perhaps also estimate the potential cost savings of 
avoided product recalls. On the other hand, manufacturers that are 
already achieving the proposed performance requirements might be able 
to provide insight into other potential effects of this rule, 
particularly if they have retained documentation of relevant quality 
improvement costs and the resulting quality performance improvements. 
Cost savings related to the latter that might be documented include 
reduced inspection costs resulting from well controlled production 
processes; reduced losses associated with nonconforming materials, 
components, and final assembled products; and reduced losses associated 
with product recalls. At minimum, for companies that have well 
controlled production processes, it should be relatively 
straightforward to estimate the cost savings associated with 
eliminating redundant inspections presently conducted to maintain 
compliance with the current, outdated sampling plan requirements.
    The proposed rule would not interfere with State, local, and tribal 
governments in the exercise of their governmental functions.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities, including small businesses, small 
governmental units, and small not-for-profit organizations. The 
Department of Health and Human Services (``HHS'') certifies that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities within the meaning of the RFA.
    The majority of respirator manufacturers are small businesses as 
defined under the Small Business Act (Pub. L. 85-536) for this industry 
sector (NAICS 339112--Medical Instruments and Equipment Manufacturers), 
employing fewer than 500 employees. For these manufacturers, the 
proposed rule would establish new quality assurance requirements 
applicable to respirators approved by NIOSH for use in potentially 
hazardous work atmospheres of every type, including toxic gases; 
radiological, toxic, obstructive, and carcinogenic dusts; oxygen 
deficient atmospheres; and biological aerosols. Workers don these 
respirators for their protection in a wide variety of goods production 
industrial sectors, such as mining, manufacturing, construction, and 
agriculture. NIOSH-approved respirators are also worn by workers in 
service sectors, such as firefighters and other emergency responders in 
public safety, maintenance workers in public utilities, and nursing and 
medical staff exposed to pharmaceutical and biological aerosols in 
health care.
    The new quality assurance requirements would replace requirements 
that are considerably less specific in part, and where specific, are 
out-of-date with typical quality control and assurance practices of 
today's respirator manufacturing industry. As discussed under section 
IV.A of this preamble, most of the respirator manufacturers that seek 
and maintain approvals from NIOSH are essentially in compliance already 
with most or all of the proposed new requirements. The requirements 
most likely to require changes in the quality assurance practices of 
some of these manufacturers are the new set of options for quality 
control sampling plans and their

[[Page 75052]]

associated performance requirements, which provide a higher level of 
consumer protection than those they replace, by reducing ``consumer 
risk,'' as discussed under section III of this preamble. As discussed 
under section IV.A, manufacturers who are not currently achieving a 
sufficient degree of process control for critical characteristics of 
the respirators they produce would have to either increase the 
intensity of the product inspections or improve their production 
process controls. On the other hand, manufacturers with high degrees of 
process control will not have to make any changes in quality control 
practices and furthermore will be able to eliminate redundant product 
inspections required under the current, out-of-date regulations.
    NIOSH does not have access to information to estimate costs and 
cost savings associated with changes some manufacturers might make in 
response to the proposed sampling plan requirements. NIOSH is 
soliciting information from the manufacturers that might be useful in 
establishing such an estimate, but NIOSH expects that any companies 
that would be required to make changes would have difficulty estimating 
ex ante the potential economic impact of the changes.
    There are substantial difficulties in making such estimates for a 
company that lacks well-controlled production processes: First, the 
causes of quality problems must be identified; and second, once such 
cause or causes are identified, there are likely to be multiple 
alternatives for solving the problems identified. On the other hand, 
such a company would be in a position to estimate some of the possible 
cost savings associated with quality improvements, such as (1) reduced 
inspection costs; (2) avoided losses associated with nonconforming 
materials, components, and final assembled products; and (3) reduced 
losses associated with product recalls. As discussed in section IV.A of 
this preamble, most respirator manufacturers who obtain approvals from 
NIOSH operate quality assurance systems in line with current quality 
management practices and are likely to have the records needed for an 
analysis of potential cost savings.
    For the reasons provided, a regulatory flexibility analysis, as 
provided for under RFA, is not required.

C. What Are the Paperwork and Other Information Collection Requirements 
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?

    The Paperwork Reduction Act is applicable to the data collection 
aspects of this rule. Under the Paperwork Reduction Act of 1995, a 
Federal agency shall not conduct or sponsor a collection of information 
from ten or more persons other than Federal employees unless the agency 
has submitted a Standard Form 83, Clearance Request, and Notice of 
Action, to the Director of OMB, and the Director has approved the 
proposed collection of information. A person is not required to respond 
to a collection of information unless it displays a currently valid OMB 
control number.
    NIOSH has obtained approval from OMB to collect the information 
that NIOSH would collect from respirator manufacturers under this rule 
under OMB Control No. 0920-109 (Respiratory Protective Devices), which 
covers all information collection under 42 CFR part 84. The information 
NIOSH would collect under this rule does not differ substantially from 
the information presently collected by NIOSH from respirator 
manufacturers who obtain NIOSH certification of their products.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS would 
report to Congress the promulgation of a final rule, once it is 
developed, prior to its taking effect. The report would state that HHS 
has concluded that the rule is not a ``major rule'' because it is not 
likely to result in an annual effect on the economy of $100 million or 
more.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of federal regulatory 
actions on state, local, and tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
federal mandate that may result in increased annual expenditures in 
excess of $100 million by state, local or tribal governments in the 
aggregate, or by the private sector.

F. Executive Order 12988 (Civil Justice)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, Civil Justice Reform and will not unduly burden 
the federal court system. NIOSH has provided quality assurance 
requirements it would apply uniformly to all applications from 
manufacturers of respirators. This proposed rule has been reviewed 
carefully to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The proposed rule does not ``have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this proposed rule on 
children. HHS has determined that the proposed rule would have no 
effect on children.

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution, or use 
because it applies to the underground coal mining sector since coal 
mine operators are consumers of respirators. The proposed rule is 
unlikely to affect the cost of respirators used in coal mines and hence 
is not likely to have ``a significant adverse effect on the supply, 
distribution, or use of energy.'' Accordingly, this proposed rule does 
not constitute a ``significant energy action'' Under E.O. 13211 and 
requires no further Agency action or analysis.

List of Subjects in 42 CFR Part 84

    Incorporation by reference, Mine safety and health, Occupational 
safety and health, Personal protective equipment, Respirators.

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR Part 84 as follows:

[[Page 75053]]

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES [AMENDED]

    1. The authority citation for Part 84 continues to read as follows:

    Authority: 29 U.S.C. Sec.  651 et seq., and 657(g); 30 U.S.C. 3, 
5, 7, 811, 842(h), 844.

Subpart A--General Provisions

    3. Amend Sec.  84.2 by:
    A. Revising paragraph (a),
    B. Removing paragraph (e),
    C. Redesignating paragraphs (d), (f) through (u), (v) through (w), 
(x) through (z), (aa) through (bb), and (cc) as paragraphs (e), (g) 
through (v), (x) through (y), (bb) through (dd), (hh) through (ii), and 
(kk),
    D. Adding new paragraphs (d), (f), (w), (z), and (aa), and adding 
paragraphs (ee) through (gg) and (jj) to read as follows:


Sec.  84.2  Definitions.

    As used in this part--
    (a) 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 or 
who holds such an approval issued by NIOSH.
* * * * *
    (d) Authorized NIOSH Representative means an employee of NIOSH, a 
NIOSH contractor, or an employee of a NIOSH contractor acting on behalf 
of NIOSH.
* * * * *
    (f) Certified Equipment List means a list of approved respirators 
maintained and published by NIOSH.
* * * * *
    (w) Manufacturing facility means the building(s) where a respirator 
is manufactured or assembled, including any building used to 
manufacture or assemble the respirator that is operated by any supplier 
whose quality system is a component of the applicant's quality system.
* * * * *
    (z) NIOSH means the National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.
    (aa) Nonconformance means a failure to meet a requirement of this 
Part or of an approval under this part.
* * * * *
    (ee) Quality Assurance means the set of planned and systematic 
actions necessary to provide a high degree of confidence that a 
respirator will satisfy all design, quality, fitness-for-use, and 
performance requirements.
    (ff) Quality Control means the operational activities, processes, 
and techniques used to provide a high degree of confidence that 
individual units of an approved respirator that are produced will meet 
all safety, performance, and regulatory requirements.
    (gg) Quality System means the entire organizational structure, 
responsibilities, procedures, specifications, processes, and resources 
used or required for quality assurance and control.
* * * * *
    (jj) Standard Application Procedure means the detailed instructions 
provided by NIOSH on its Web page (http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html) for applicants requesting an 
approval, or modification of approval, for a device under this part.

Subpart B--Application for Approval

    4. Amend Sec.  84.10 by:
    A. Removing paragraph (b),
    B. Redesignating paragraphs (c) through (e) as (d) through (f),
    C. Adding new paragraphs (b) and (c), and
    D. Revising paragraphs (d) and (e), to read as follows:


Sec.  84.10  Application procedures.

* * * * *
    (b) Applications may be submitted to NIOSH following the 
instructions provided in the Standard Application Procedure on the 
NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
    (c) NIOSH reserves the right to suspend the processing of 
applications of any applicant who NIOSH has found to be noncompliant 
with any provisions of Subpart E. This suspension of processing shall 
remain in effect until such time as NIOSH finds that the applicant is 
complying with such provisions.
    (d) Except as provided in Sec.  84.64, the examination, inspection, 
and testing of all respirators and the auditing of manufacturer 
facilities shall be conducted by NIOSH or an authorized NIOSH 
representative.
    (e) Applicants, manufacturers, or their representatives may visit 
or communicate with NIOSH to discuss the requirements for approval of 
any respirator or the proposed designs thereof. NIOSH shall not charge 
for such consultation nor issue any written report to applicants, 
manufacturers, or their representatives as a result of such 
consultation.
* * * * *
    5. Revise Sec.  84.11 to read as follows:


Sec.  84.11  Contents of application.

    Each application shall include the following elements:
    (a) A complete written description of the respirator for which 
approval is requested;
    (b) Drawings or specifications that depict or describe the 
respirator assembly and all of it major components, including 
accessories;
    (c) User instructions;
    (d) Evidence of compliance with or current registration under ISO 
Q9001:2000 \5\ for the quality system under which the respirator will 
be manufactured, as specified in Subpart E of this part.
---------------------------------------------------------------------------

    \5\ ISO Q9001:2000, the International Standard: Quality 
management systems--Requirements, 3rd edition. This standard is 
incorporated by reference under Sec.  84.40(a) of this Part.
---------------------------------------------------------------------------

    (e) A copy of the current quality manual, as specified in Subpart E 
of this part.
    (f) A quality control plan flowchart, as specified in Subpart E of 
this part.
    (g) A table that lists each section and paragraph of this Part with 
which the respirator complies and that cross-references the stage or 
stages in the manufacturing process during which compliance with the 
listed section or paragraph is evaluated through quality assurance or 
control procedures.
    (h) A statement that the respirator has been pre-tested by the 
applicant as specified in Sec.  84.64 and documentation of the results 
of such tests;
    (i) A statement that the respirator and component parts submitted 
for approval are not prototypes and were made using regular production 
tooling, with no operation included that will not be incorporated in 
regular production processing; and
    (j) Applicants may obtain detailed guidance specified in the 
Standard Application Procedure on the NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html. (The 
information collections contained in this section are approved under 
OMB control number 0920-0109.)
    6. Amend Sec.  84.12 by revising paragraph (b) to read as follows:


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

* * * * *
    (b) The applicant shall deliver, at his own expense, the number of 
completely assembled respirators and component parts required for 
testing, to the location

[[Page 75054]]

designated in the Standard Application Procedure on the NIOSH Web page 
at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
* * * * *

Subpart D--Approval and Disapproval

    8. Revise Sec.  84.34 to read as follows:


Sec.  84.34  Revocation of certificates of approval.

    NIOSH 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, or failure to maintain or cause to be 
maintained the quality assurance or quality control requirements of the 
certificate of approval.
    9. Amend Sec.  84.35 to revise paragraph (c) to read as follows:


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

* * * * *
    (c) The application shall be accompanied by appropriate drawing(s) 
and by a proposed quality control plan and quality assurance provisions 
that meet the requirements of Subpart E of this part.
* * * * *


Sec.  84.36  [Redesignated as Sec.  84.38]

    10. Redesignate Sec.  84.36 as Sec.  84.38.
    11. Add a new Sec.  84.36 to read as follows:


Sec.  84.36  Changes in device or applicant ownership.

    (a) When there is a change in either the ownership of the 
manufacturing rights to a device approved by NIOSH under this Part or 
the ownership of an applicant that holds a NIOSH approval for one or 
more devices under this Part, as might occur through the sale of a 
product line from one manufacturer to another or through a merger, buy-
out, or other means of corporate acquisition or divestiture, the new 
owner acquiring the rights to the manufacture of the device or 
acquiring the applicant that holds the approval for the device shall 
submit an Application for Modification of Certificate of Approval for 
each approved device, pursuant to the requirements of Sec.  84.35. The 
new owner making or having made such an acquisition shall complete the 
application submissions and must receive a modified certificate of 
approval from NIOSH for each device prior to any continued manufacture 
of the device after ownership of the device or applicant is changed.
    (b) The new owner making or having made an acquisition as described 
under paragraph (a) of this section shall submit to NIOSH documentation 
of the resulting change in ownership with the Application for 
Modification of a Certificate of Approval.
    (c) Units of an approved device manufactured by an applicant prior 
to a change in ownership, as described in paragraph (a) of this 
section, may continue to be sold as NIOSH-approved devices following 
the change in ownership.
    (d) The failure by an owner that has made an acquisition, as 
described in paragraph (a) of this section, to obtain approval from 
NIOSH prior to the continued manufacture of a related NIOSH-approved 
device, may be deemed as sufficient cause for revocation of the 
relevant approval(s).
    11. Add a new Sec.  84.37 to read as follows:


Sec.  84.37  Changes in manufacturing facility or quality system.

    (a) The applicant shall notify NIOSH in writing, within 20 work 
days, of a final decision to change the location of a manufacturing 
facility or of a final decision to make any substantive change in the 
quality system associated with one or more approved devices. Failure to 
notify NIOSH within this deadline may be deemed cause for revocation of 
the relevant approval(s).
    (b) Prior to implementing a change specified under paragraph (a) of 
this section, the applicant shall submit to NIOSH for approval a 
revised quality manual, revised quality control plans, and revisions of 
any other materials and information previously submitted to NIOSH under 
Subpart E of this part that require revision to incorporate the 
reported change. Failure to obtain such approval from NIOSH prior to 
implementing the change or changes may be deemed cause for revocation 
of the relevant approval(s).
    12. Revise newly designated Sec.  84.38 to read as follows:


Sec.  84.38  Delivery of changed or modified approved respirator.

    Upon request, the applicant shall deliver to NIOSH, as soon as it 
is commercially produced, one unit of an approved respirator for which 
NIOSH has issued a formal certificate of modification. The unit must 
include all required markings and be provided in its customary 
commercial container.
    13. Revise Subpart E to read as follows:
Sec.

Subpart E--Quality System

84.40 Quality system, general requirements.
84.41 Quality manual requirements.
84.42 Quality control plan content.
84.43 Proposed quality control plans; approval by NIOSH.
84.44 Respiratory device complaints.
84.45 Audit programs.
84.46 Quality system records retention.

Subpart E--Quality System


Sec.  84.40  Quality system, general requirements.

    The applicant shall be responsible for the establishment, 
execution, and maintenance of a quality system that ensures that 
devices produced under the applicant's certificate of approval meet the 
specifications to which they are certified under this Part and are 
reliable, safe, effective, and otherwise fit for their intended uses.
    (a) To request and to maintain an approval under this Part, the 
applicant shall establish and maintain a quality system that is 
compliant with the International Organization for Standardization (ISO) 
Q9001:2000 standard: Quality management systems--Requirements, 3rd 
edition, approved on December 15, 2000. ISO Q9001:2000 is incorporated 
by reference into this section 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. A copy is available for inspection 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. A copy is also available for inspection at NIOSH, 
National Personal Protection Technology Laboratory, Bruceton Research 
Center, 626 Cochrans Mill Road, Pittsburgh, PA 15236. To arrange for an 
inspection at NIOSH, call 412-386-6593. Copies of the standard are also 
available for purchase from the American National Standards Institute, 
25 West 43rd St., New York, NY 10036; Web page: http://www.ansi.org; 
phone 212-642-4900.
    (b) If deemed necessary by NIOSH, NIOSH shall evaluate the 
compliance of the applicant with the ISO Q9001:2000 standard on the 
basis of an audit conducted by NIOSH.
    (c) The applicant shall submit to NIOSH either of the following, as 
appropriate, to document compliance with the ISO Q9001:2000 standard:
    (1) For applicants who are registered by a qualified registrar 
under the ISO 9001:2000 standard or any update to this ISO standard, a 
copy of the most recent registration; or

[[Page 75055]]

    (2) For all other applicants, a statement self-attesting to being 
in compliance with the ISO 9001:2000 standard.


Sec.  84.41  Quality manual requirements.

    (a) The applicant shall submit a copy of the current quality manual 
to NIOSH together with the initial application for respirator 
certification under Sec.  84.11 of this part.
    (b) The applicant shall also submit to NIOSH a current copy of the 
quality manual:
    (1) Whenever it is substantially revised or, at a minimum, once 
every four (4) years; and
    (2) Upon the request of NIOSH.


Sec.  84.42  Quality control plan content.

    (a) The applicant shall develop a quality control plan that 
documents all manufacturing, assembly, inspection, testing, and 
servicing processes applicable to the respiratory device for which 
certification is sought and maintained. The quality control plan shall 
contain the following elements:
    (1) Quality control plan flowchart. The flowchart must depict all 
processes used in the production of the approved device, including 
processes comprising manufacturing, assembly, inspection, testing, and 
servicing of the device and its components. All inspection and testing 
activities conducted throughout the entire production process must be 
included. The quality control plan flowchart must be submitted with 
each application for approval of a device submitted under Sec.  84.11 
of this Part.
    (2) Design, Production, and/or Engineering Drawings and 
Specifications. Drawings and specifications must be accurate and 
sufficiently detailed to fulfill their use in procurement, 
manufacturing, assembly, inspection, and testing activities. Upon 
request by NIOSH, the applicant shall provide copies of these drawings 
or specifications to NIOSH or an authorized NIOSH representative for 
inspection and review.
    (3) Assembly, Inspection, and Testing Procedures. The applicant 
shall design, document, and validate procedures for all assembly, 
inspection, and testing activities, whether procured or performed by 
the applicant, to ensure that sufficient process description is 
available to successfully perform all necessary production activities. 
Acceptance and rejection workmanship criteria must be incorporated into 
relevant procedures to assure that the approved device meets all 
design, performance, and regulatory requirements. Upon request by 
NIOSH, the applicant shall provide copies of these procedures to NIOSH 
or an authorized NIOSH representative.
    (4) Critical to Quality Characteristics (CTQC).
    (i) The applicant shall generate, maintain, and update as 
necessary, CTQC documents for each stage in the production process for 
an approved respiratory device. A CTQC document shall list all 
Critical, Major A, Major B, and Minor characteristics for which 
inspection or testing shall be performed. Upon request by NIOSH, the 
applicant shall provide copies of CTQC documents to NIOSH or an 
authorized NIOSH representative.
    (ii) The applicant shall incorporate the criteria listed in a CTQC 
document into inspection procedures established pursuant to paragraph 
(a)(3) of this section at the appropriate stages of assembly. The 
appropriate stage of assembly for a criterion is a stage at which the 
criterion can be fully evaluated by the assembler without the 
evaluation being obstructed or otherwise limited as a result of the 
addition to the assembly of other hardware, components, or performance 
elements.
    (iii) The applicant shall classify each of the CTQC of the device 
according to the importance of the potential effect of a 
nonconformance, into the following classes:
    (A) Critical. A nonconformance 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;
    (B) Major A. A nonconformance, other than critical, that is likely 
to result in failure to the degree that the respirator does not provide 
any respiratory protection, or a nonconformance that reduces protection 
and is not detectable by the user;
    (C) Major B. A nonconformance, other than Major A or critical, that 
is likely to result in reduced respiratory protection and is detectable 
by the user; and
    (D) Minor. A nonconformance that is not likely to materially reduce 
the usability of the respirator for its intended purpose, or a 
nonconformance that is a departure from established standards and has 
little bearing on the effective use or operation of the respirator.
    (5) Incoming, In-process, and Final Inspection Sampling Plan 
Requirements. Incoming, in-process, and final inspection sampling shall 
conform to one or more of the following quality assessment sampling 
plans:
    (i) The use of zero defect sampling plans where inspection is used. 
The sampling plans in Military Standard MIL-STD-1916 provide levels for 
verifying component acceptability for each of the CTQC:
    (A) Critical characteristics shall use verification level VII;
    (B) Major A characteristics shall use verification level VI;
    (C) Major B characteristics shall use verification level III;
    (D) Minor characteristics shall use verification level II.\6\
---------------------------------------------------------------------------

    \6\ Refer to Department of Defense Handbook MIL-HDBK-1916, 
Companion Document to Mil-Std-1916, Notice 1, 20 April 2004, Section 
8, pp. 37-42 for relevant guidance and details on the sampling 
plans.
---------------------------------------------------------------------------

    (ii) The use of sampling plans based on consumer risk. The sampling 
plans in ANSI/American Society for Quality Control \7\ Standard Q3-1988 
provide levels of component acceptability for each product 
characteristic:
---------------------------------------------------------------------------

    \7\ Renamed American Society for Quality.
---------------------------------------------------------------------------

    (A) Critical characteristics shall use a Limiting Quality (LQ) of 
0.50;
    (B) Major A characteristics shall use a Limiting Quality (LQ) of 
0.80;
    (C) Major B characteristics shall use a Limiting Quality (LQ) of 
2.00;
    (D) Minor characteristics shall use a Limiting Quality (LQ) of 
3.15.
    (iii) The use of statistical process control to determine product 
quality. Process capability indices (Cpk) and statistical control 
processes must meet or exceed the following process characteristics:
    (A) Critical characteristics shall have a Cpk > 2.00;
    (B) Major A characteristics shall have a Cpk > 1.33;
    (C) Major B characteristics shall have a Cpk > 1.33;
    (D) Minor characteristics shall have a Cpk > 1.00.


Under this paragraph, upon approval of the quality assessment plan by 
NIOSH, the applicant may reduce or eliminate inspection sampling when 
the plan criteria are met or exceeded.\8\
---------------------------------------------------------------------------

    \8\ Refer to Department of Defense Handbook MIL-HDBK-1916, 
Companion Document to Mil-Std-1916, Notice 1, 20 April 2004, Section 
5, pp. 11-30, for definitions of Cpk and for guidance on statistical 
process control.
---------------------------------------------------------------------------

    (iv) The applicant also may use a sampling plan not specified under 
this section if NIOSH finds the proposed plan to be statistically 
equivalent to the plans described in paragraphs (a)(5)(i) through (iii) 
of this section.
    (6) Sampling plan grandfather period. The following provisions 
apply to any sampling plan in effect at the time this rule becomes 
effective:
    (i) Applicants may continue to use the Acceptable Quality Level 
(AQL) inspection plan under which a device was approved by NIOSH prior 
to the

[[Page 75056]]

effective date of this provision for up to three years from the 
effective date of this revision. After such time, applicants shall 
employ only the quality assessment sampling plans approved under 
paragraphs (a)(5)(i) through (iv) of this section in the manufacture of 
devices approved under this Part.
    (ii) For any AQL inspection plan in use, the levels of component 
acceptability are as follows:
    (A) Critical characteristics shall be inspected 100 percent;
    (B) Major A characteristics shall have an acceptable quality level 
of 0.65 percent;
    (C) Major B characteristics shall have an acceptable quality level 
of 2.50 percent;
    (D) Minor characteristics shall have an acceptable quality level of 
4.00 percent.
    (7) Destructive inspection or test sampling. The applicant may also 
use a sampling plan not specified under paragraphs (a)(5)(i) through 
(iv) of this section for destructive inspection or test sampling. Such 
sampling plans must be approved by NIOSH.
    (8) If attribute sampling plans are used and characteristics are 
recorded as pass/fail, when failures occur, the applicant shall record 
the failed characteristic's actual value.
    (9) All necessary sampling plan documents shall be available for 
use at the location of the assembly, inspection, or testing activities.
    (b) NIOSH reserves the right to request additional documentation as 
necessary.
    (c) The applicant's document control system required by section 
4.2.3 of the ISO Q9001:2000 standard shall include the control of all 
drawings, plans, and other documents required in this section.


Sec.  84.43  Proposed quality control plans; approval by NIOSH.

    (a) Each proposed quality control plan submitted in accordance with 
this subpart shall be reviewed by NIOSH to determine its adequacy for 
ensuring the quality of respiratory protection provided by the 
respirator for which an approval is sought.
    (b) If NIOSH determines that the proposed quality control plan 
submitted by the applicant will not ensure adequate quality control, 
NIOSH shall require the applicant to modify the procedures and/or 
testing requirements of the plan prior to acceptance of the plan and 
issuance of any certificate of approval.
    (c) NIOSH shall incorporate approved quality control plans of the 
applicant into each certificate of approval issued to the applicant. 
The applicant shall comply with such plans. NIOSH may deem 
noncompliance with such plans as cause to revoke any and all relevant 
certificates of approval of the applicant, as provided under Sec.  
84.34 of this part.
    (d) Applicants may submit to NIOSH revisions to approved quality 
control plans as necessary. NIOSH shall review, consider the approval, 
and incorporate such plans into an applicant's relevant certificates of 
approval as provided under paragraphs (a) through (c) of this section.


Sec.  84.44  Respiratory device complaints.

    (a) Each applicant shall establish and maintain procedures for 
receiving, reviewing, evaluating, and resolving complaints related to 
the safety, quality, or performance of an approved device. Such 
procedures shall require that:
    (1) Complaints, whether written or oral, are documented, reviewed, 
evaluated, investigated as necessary, and resolved.
    (2) When a complaint is not investigated, the applicant shall 
maintain a record that specifies the reason that the complaint was not 
investigated and the name of the individual or individuals responsible 
for the decision.
    (3)(A) The applicant shall immediately evaluate and investigate any 
complaint that:
    (i) Arises from an incident involving a death, injury, near-miss, 
or other hazardous circumstance involving the health or safety of the 
user; or
    (ii) Indicates a Critical, Major A, or Major B nonconformance, as 
classified by the applicant under Sec.  84.42(a)(4)(iii) of this 
subpart.
    (B) The applicant shall notify NIOSH in writing within three work 
days of any such complaint. The notification shall include a summary of 
the complaint, the current results of the investigation, and the 
current plans for any additional investigation and/or remedial 
activities. Notification shall be submitted to NIOSH by e-mail, 
facsimile, or in hardcopy by overnight delivery, to the addresses 
provided on the NIOSH Web page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.


Sec.  84.45  Audit programs.

    (a) NIOSH audits.
    (1) Authorized NIOSH representatives shall conduct onsite 
compliance audits at manufacturing facilities involved in the 
production of respiratory devices approved or submitted for approval 
under this part.
    (i) During onsite compliance audits, the applicant shall make 
available to the NIOSH representative(s) upon request any documents or 
records germane to the provisions of this section (Sec.  84.45).
    (ii) The frequency and extent of onsite compliance audits shall be 
determined by NIOSH. NIOSH shall not conduct such audits of a 
particular manufacturing facility more than once per calendar year per 
approved device or more than once within a six-month period, except for 
cause.
    (2) NIOSH shall conduct product audits of the safety, quality, and 
performance of approved respiratory devices that have been produced.
    (i) Applicants shall provide, upon request, sufficient samples of 
approved devices, or components thereof, as NIOSH determines necessary 
to conduct the audit. For onsite compliance audits, applicants shall 
provide such samples within 30 days of the request by NIOSH. For 
product audits, applicants shall provide such samples within 90 days of 
the request by NIOSH, or as otherwise provided under this part.
    (ii) The applicant must choose audit samples randomly from the 
manufacturing process or the inventory of completed devices.
    (iii) The applicant must provide documentation describing the 
procedure by which the audit samples were selected.
    (3) NIOSH shall provide a final report of the audit process and 
results to the management representative of the applicant.
    (4) NIOSH audit results that demonstrate a failure to comply with 
requirements of this Part may be deemed cause for revocation of a 
certificate of approval as provided under Sec.  84.34 of this part.
    (5) Failure to supply audit samples shall be deemed cause for 
revocation of a certificate of approval under Sec.  84.34 of this part.
    (b) Applicant audit program.
    (1) Applicants shall conduct an annual audit on each respirator or 
respirator family for which the respirator or respirator family is not 
tested as a complete device during the manufacturing process. During 
such audit, the applicant shall notify NIOSH within three work days of 
finding any nonconformance of a critical or major characteristic, as 
classified by the applicant under Sec.  84.42(a)(4)(iii) of this 
subpart. Reports of these audits shall be made available upon request 
to NIOSH and retained by the applicant for a period of three (3) years.

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


[[Page 75057]]




Sec.  84.46  Quality system records retention.

    The applicant shall establish a retention period for the records 
required by section 4.2.4 of the ISO Q9001:2000 standard that is at 
least as long as the expected service life of the respirator's major 
components; in no case shall the retention period be less than 24 
months.

    Dated: July 23, 2008.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
[FR Doc. E8-29236 Filed 12-9-08; 8:45 am]
BILLING CODE 4163-18-P