[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Proposed Rules]
[Page 75045-75057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de08-23]
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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: niocindocket@cdc.gov. 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 niocindocket@cdc.gov.
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:
niocindocket@cdc.gov. 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
[[Page 75047]]
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
[[Page 75048]]
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\
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\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.
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(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:
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\7\ Renamed American Society for Quality.
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(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\
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\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.
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(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