Health and Safety Information
EPA and OSHA Could Improve Their Processes for Preparing Communication Products Gao ID: GAO-08-265 March 31, 2008Agencies address their missions not only through regulations but also by issuing communication products--such as guidance, fact sheets, and brochures--that can provide crucial information to regulated parties and the public. Since 2000, the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency's (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) developed new versions of such products to address the potential hazards of exposure to asbestos in automotive brakes. GAO was asked to describe (1) how OSHA and OPPTS prepared their products on asbestos in automotive brakes, (2) the general processes that OSHA and OPPTS use to prepare their communication products, and (3) how these processes compare to those for rulemaking and how recent administration initiatives might affect them. GAO reviewed and analyzed available documents and interviewed officials at OSHA, OPPTS, and the Office of Management and Budget (OMB).
OSHA and OPPTS followed different paths from 2000 through 2007 to update communication products on asbestos in automotive brakes and clutches. OSHA took longer than OPPTS to produce a final product, and OPPTS' process incorporated more steps to obtain input from external parties. Twice before final posting, OSHA officials had decided to not release drafts that had been prepared, because they needed more data to understand how pervasive asbestos in brake products were and wanted to avoid raising unnecessary alarm. For a time, staff from OSHA and OPPTS considered releasing a joint product. Overall, OSHA and OPPTS took years to complete all the process steps to produce their products on asbestos in automotive brakes and clutches--approximately 5-? years for OSHA and approximately 3-? years for OPPTS. In preparing their respective communication products, both OSHA and OPPTS generally followed applicable agency policies and procedures. Both OSHA and OPPTS have standard processes that guide the initiation, development, review, and dissemination of their communication products. OSHA publicly posts all of its applicable instructions, while OPPTS publicly posts only some. Under both agencies' processes, communication products may be initiated by various sources, developed only after getting management approval, and undergo intraagency coordination and management-level clearance. But interagency (including OMB) or other external reviews are not always required. OSHA's policies for disseminating products focus on responsibilities for posting and maintaining final products on the agency's Web site. Beginning at the development phase, OPPTS policies call for the formulation of a communication plan intended to ensure that the dissemination of a particular product is tailored to reach the intended audience. The agencies' processes establish no specific time frames or benchmarks for how long the preparation of a product should take. GAO identified at least five areas where the agencies' processes for preparing communication products and those for rules have significant differences. In contrast to the agencies' processes for communication products, rulemaking imposes requirements on agencies regarding (1) justification of the rule, (2) interagency reviews of drafts, (3) transparency of the processes used, (4) opportunities for public comment, and (5) the public's ability to monitor development and review. These differences are to be expected, given the binding effect of rules, and are each rooted in legal requirements that apply to rulemaking, but not to the preparation of communication products. In January 2007, the administration imposed new requirements for agencies' significant guidance documents, for example requiring agencies to provide OMB advance notice and an opportunity to consult on significant guidance before issuance. These changes move the treatment of significant guidance closer to the requirements for rules but do not cover any other types of communication products.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-08-265, Health and Safety Information: EPA and OSHA Could Improve Their Processes for Preparing Communication Products
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
March 2008:
Health And Safety Information:
EPA and OSHA Could Improve Their Processes for Preparing Communication
Products:
GAO-08-265:
GAO Highlights:
Highlights of GAO-08-265, a report to congressional requesters.
Why GAO Did This Study:
Agencies address their missions not only through regulations but also
by issuing communication products”such as guidance, fact sheets, and
brochures”that can provide crucial information to regulated parties and
the public. Since 2000, the Occupational Safety and Health
Administration (OSHA) and the Environmental Protection Agency‘s (EPA)
Office of Prevention, Pesticides, and Toxic Substances (OPPTS)
developed new versions of such products to address the potential
hazards of exposure to asbestos in automotive brakes. GAO was asked to
describe (1) how OSHA and OPPTS prepared their products on asbestos in
automotive brakes, (2) the general processes that OSHA and OPPTS use to
prepare their communication products, and (3) how these processes
compare to those for rulemaking and how recent administration
initiatives might affect them. GAO reviewed and analyzed available
documents and interviewed officials at OSHA, OPPTS, and the Office of
Management and Budget (OMB).
What GAO Found:
OSHA and OPPTS followed different paths from 2000 through 2007 to
update communication products on asbestos in automotive brakes and
clutches. OSHA took longer than OPPTS to produce a final product, and
OPPTS‘ process incorporated more steps to obtain input from external
parties. Twice before final posting, OSHA officials had decided to not
release drafts that had been prepared, because they needed more data to
understand how pervasive asbestos in brake products were and wanted to
avoid raising unnecessary alarm. For a time, staff from OSHA and OPPTS
considered releasing a joint product. Overall, OSHA and OPPTS took
years to complete all the process steps to produce their products on
asbestos in automotive brakes and clutches”approximately 5-½ years for
OSHA and approximately 3-½ years for OPPTS. In preparing their
respective communication products, both OSHA and OPPTS generally
followed applicable agency policies and procedures.
Both OSHA and OPPTS have standard processes that guide the initiation,
development, review, and dissemination of their communication products.
OSHA publicly posts all of its applicable instructions, while OPPTS
publicly posts only some. Under both agencies‘ processes, communication
products may be initiated by various sources, developed only after
getting management approval, and undergo intraagency coordination and
management-level clearance. But interagency (including OMB) or other
external reviews are not always required. OSHA‘s policies for
disseminating products focus on responsibilities for posting and
maintaining final products on the agency‘s Web site. Beginning at the
development phase, OPPTS policies call for the formulation of a
communication plan intended to ensure that the dissemination of a
particular product is tailored to reach the intended audience. The
agencies‘ processes establish no specific time frames or benchmarks for
how long the preparation of a product should take.
GAO identified at least five areas where the agencies‘ processes for
preparing communication products and those for rules have significant
differences. In contrast to the agencies‘ processes for communication
products, rulemaking imposes requirements on agencies regarding (1)
justification of the rule, (2) interagency reviews of drafts, (3)
transparency of the processes used, (4) opportunities for public
comment, and (5) the public‘s ability to monitor development and
review. These differences are to be expected, given the binding effect
of rules, and are each rooted in legal requirements that apply to
rulemaking, but not to the preparation of communication products. In
January 2007, the administration imposed new requirements for agencies‘
significant guidance documents, for example requiring agencies to
provide OMB advance notice and an opportunity to consult on significant
guidance before issuance. These changes move the treatment of
significant guidance closer to the requirements for rules but do not
cover any other types of communication products.
What GAO Recommends:
GAO recommends that OSHA and OPPTS ensure that their key general
processes for preparing communication products are documented, made
publicly available, and include time frames or benchmarks, where
appropriate. OSHA and EPA provided technical comments on a draft of
this report. EPA also generally agreed with the recommendations. OMB
did not comment.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-265]. For more
information, contact Mathew J. Scire at (202) 512-6806 or
sciremj@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
OSHA and OPPTS Used Different Processes during Multiyear Efforts to
Complete Communication Products on Asbestos:
Multiple Policies, Procedures, and Practices May Apply to the
Preparation of Communication Products:
More Transparency and Documentation Requirements Apply to Rulemaking
Than to the Preparation of Communication Products:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Preparation of OSHA and OPPTS Communication Products on
Asbestos in Automotive Brakes:
Appendix III: Asbestos-Automotive Brake and Clutch Repair Work:
Appendix IV: Current Best Practices for Preventing Asbestos Exposure
Among Brake and Clutch Repair Workers:
Appendix V: Comments from the Environmental Protection Agency:
Appendix VI: GAO Contact and Staff Acknowledgments:
Figures:
Figure 1: Examples of OSHA and EPA Communication Products:
Figure 2: Example of Potential Exposure to Asbestos in Automotive
Brakes:
Figure 3: Timeline on Preparation of OSHA and EPA/OPPTS Products on
Asbestos in Brakes:
Figure 4: OSHA Process for Preparing Safety and Health Information
Bulletins:
Figure 5: EPA/OPPTS Process for Preparing Communication Products:
Abbreviations:
APA: Administrative Procedure Act:
CACG: Compliance Assistance Coordinating Group:
DOL: Department of Labor:
DSTM: Directorate of Science, Technology and Medicine:
EPA: Environmental Protection Agency:
GPRA: Government Performance and Results Act:
IQA: Information Quality Act:
LEP: local emphasis program:
OAS: Office of the Assistant Secretary:
OIRA: Office of Information and Regulatory Affairs:
OMB: Office of Management and Budget:
OPPTS: Office of Prevention, Pesticides, and Toxic Substances:
OSHA: Occupational Safety and Health Administration:
PRP: Product Review Process:
SHIB: Safety and Health Information Bulletin:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 31, 2008:
The Honorable Lynn Woolsey:
Chairwoman:
Subcommittee on Workforce Protections:
Committee on Education and Labor:
House of Representatives:
The Honorable Nick Lampson:
Chairman:
Subcommittee on Energy and Environment:
Committee on Science and Technology:
House of Representatives:
The Honorable David Wu:
House of Representatives:
Federal regulatory agencies address their missions not only by
promulgating and enforcing regulations, but also by issuing a wide
variety of related communication products, such as guidance documents,
fact sheets, and brochures. Although not legally binding, as are
regulations, these products can play an important role in providing
information to regulated parties and the general public. For example,
communication products may be used to alert target audiences about
potential hazards, advise them on ways to prevent or mitigate exposure
to the hazards, and provide guidance on complying with applicable
federal regulations. The Office of Management and Budget (OMB) has
noted that as the scope and complexity of regulatory programs have
grown, agencies increasingly have relied on products such as guidance
documents to inform the public and to provide direction to their
staffs. As a result, both Congress and OMB have taken an increased
interest in the issuance of these products.
You were interested in actions taken since 2000 by the Department of
Labor's (DOL) Occupational Safety and Health Administration (OSHA) and
the Environmental Protection Agency (EPA) regarding potential health
hazards posed by exposure to asbestos during automotive brake and
clutch repairs to help illustrate the uses of communication products
and the processes by which such products are prepared. Both agencies
had published materials about asbestos in brakes and clutches prior to
2000. In 1986, OSHA published asbestos standards and EPA issued a
safety brochure (known as the Gold Book) that provided information to
automobile professional and home mechanics on preventing exposure to
brake and clutch dust that may contain asbestos fibers. In 1994, OSHA
updated and made mandatory work practice standards (regulations)
regarding occupational exposure to asbestos, including automotive brake
repair in commercial shops. For example, the standards require that
employers prohibit certain practices, such as the use of compressed
air, to remove asbestos. Beginning in 2000, a series of events, news
articles, and research studies refocused attention on the issue and
prompted OSHA and EPA's Office of Prevention, Pesticides, and Toxic
Substances (OPPTS) to announce plans to disseminate updated information
to the public. As the asbestos-in-brakes issue reemerged, it also
generated controversy. Some parties raised concerns that workers and
the general public were not aware that asbestos was still present in
both old and replacement brakes and clutches and continued to pose a
health risk to persons performing repairs. Other parties cited data
published since 1986 that they believed showed no increased risk of
asbestos-related illnesses associated with brake work. Media reports
also raised concerns about the length of time taken by both OSHA and
OPPTS to release new communication products.
In response to this controversy, and to obtain insights about the intra-
and interagency processes used for developing and reviewing the
asbestos information and similar products, you asked us to address the
following questions:
1. How did OSHA and OPPTS initiate, develop, review, and disseminate
updated communication products on exposure to asbestos in automotive
brakes, how long did the processes take, and did the agencies follow
applicable policies and procedures?
2. What general policies and procedures do OSHA and OPPTS have for the
initiation, development, review, and dissemination of communication
products?[Footnote 1]
3. How do the agencies' policies and procedures for communication
products compare to those applicable to the initiation, development,
review, and dissemination of rules, and what might be the effects of
2007 administration initiatives on guidance documents?
To address the first objective, we obtained and analyzed information on
the preparation of the OSHA and OPPTS communication products on
asbestos in automotive brakes. We asked agency officials to provide a
chronology and description of events that led to the initiation,
development, review, and eventual dissemination of the products. We
also asked the officials to provide any available documentation that
would corroborate the events and processes described in their
respective chronologies. To address the second objective, we reviewed
available documents on the agencies' applicable internal policies,
procedures, and practices (collectively referred to as processes
throughout this report) that govern the preparation of communication
products.[Footnote 2] We interviewed agency officials at DOL/OSHA and
EPA/OPPTS about their respective agencies' processes for preparing
communication products, as well as officials at OMB about interagency
reviews of such products. We assessed the processes to determine how
they addressed the generic phases of product preparation. To address
the third objective, we again reviewed applicable documents and
interviewed officials at the three agencies to obtain information about
the differences between rulemaking and the processes used to prepare
communication products. We also solicited the views of agency officials
regarding effects they anticipated from implementation of amendments to
the executive order on regulatory review and planning and an OMB
bulletin on good guidance practices.
Our scope and methodology were limited to focusing on only the broad
category of communication products--not all nonrule regulatory
products--and on the applicable processes of OSHA and OPPTS, the two
agencies responsible for preparing the communication products on
asbestos in automotive brakes. To illustrate the application of the
agencies' processes for preparing such products, we relied on detailed
examinations of the asbestos communication products because we
concluded that it would not be possible to identify a representative
sample of issued products in order to do a comparative analysis that
would be meaningful and generalizable to a larger population of
products.[Footnote 3] Because the agencies keep only limited
documentation on the preparation of communication products, we also
relied heavily on testimonial evidence. We conducted our review in
Washington, D.C., from September 2006 through October 2007 in
accordance with generally accepted government auditing standards.
Detailed information on our scope and methodology appears in appendix
I.
Results in Brief:
From 2000 through 2007, OSHA and OPPTS followed different paths to
prepare their respective communication products on preventing exposure
to asbestos in automotive brakes and clutches. Among the primary
differences, the agencies initiated work on their asbestos products in
response to different triggers, OSHA took longer than OPPTS to produce
a final product, and OPPTS' process incorporated more steps to obtain
input from external parties. The primary trigger for OSHA's development
of a Safety and Health Information Bulletin (SHIB) on asbestos in
brakes was a media report about the potential hazard of asbestos
exposure during brake and clutch repair work and lack of awareness on
the part of workers and the general public. OPPTS initiated work on an
asbestos brochure in response to both a request for correction of the
1986 Gold Book under the Information Quality Act (IQA)[Footnote 4] and
the results of an EPA asbestos strategy project. OSHA began work on its
product in December 2000 and released a final product in July 2006.
Twice before final posting, OSHA officials had decided to not issue the
SHIBs that had been prepared, largely due to OSHA management concerns
about the extent to which asbestos in brake products was a problem and
to avoid unnecessary alarm. OPPTS initiated work on its asbestos
brochure in 2003, solicited public comments on a draft in August 2006,
and published a final brochure in March 2007. For a time, staff from
OSHA and OPPTS considered releasing a joint product. OSHA's review
process for the information bulletin was primarily internal; after OSHA
completed its internal reviews and clearance of the information
bulletin, it posted the SHIB to its Web site. According to OPPTS
officials, OSHA officials did not notify them of OSHA's decision to
release the SHIB prior to its posting. By contrast, before OPPTS
disseminated its brochure, it provided drafts of its brochure to OSHA,
OMB, and other agencies for interagency coordination and review and
sought comments from the general public through the Federal Register.
OPPTS also developed a communication plan to facilitate notifying
appropriate parties about the brochure and ensure that dissemination
would reach the intended audience. Overall, OSHA and OPPTS took years
to complete all of the steps of their processes from initiation through
dissemination of products on asbestos in automotive brakes--
approximately 5-½ years for OSHA and approximately 3-½ years for OPPTS.
In doing so, both OSHA and OPPTS generally followed applicable agency
policies and procedures for preparing communication products, as
described below.
Both OSHA and OPPTS have standard processes that guide the preparation
of their communication products. The agencies have documented many, but
not all, of these processes. OSHA-specific directives govern
preparation of that agency's products, but a mix of EPA-wide and OPPTS-
specific processes apply to OPPTS products. OSHA publicly posts all of
its directives, while EPA and OPPTS make publicly available only some
applicable internal procedural guidance documents. Per the general OSHA
and OPPTS processes, several sources might initiate the need to develop
a new product or to revise an existing one. During the development
phase, both agencies require management approval to proceed with
proposed products, make determinations about the appropriate product
type and applicable processes, and draft the product. The review phase
at both agencies requires coordination within the agency and management-
level review and approval. Current OSHA processes call for review and
clearance of all products by upper management, including the Assistant
Secretary of OSHA. OSHA is implementing a centralized database to track
the development and review of all proposed compliance assistance
materials. The required levels of review under OPPTS processes vary
according to factors such as the complexity and sensitivity of the
product's subject. In both agencies' processes, interagency (including
OMB) or other external reviews are not always required. OSHA officials
pointed out that their process is largely internal, but if OSHA
consults external stakeholders, the agency usually involves such
stakeholders after a draft has been prepared. OPPTS' processes prompt
outreach to external parties throughout the process. OSHA's
dissemination instructions focus on responsibilities for posting and
maintaining the final products, which are available, by product type,
on the agency's Web site. Per agency guidance, OPPTS typically develops
a communication plan intended to ensure that its announcement and
release of a particular product is tailored to reach the intended
audience. However, EPA officials noted that it would be difficult to
compile a listing of all their disseminated communication products
because of the great variety and number of products they produce and
because they increasingly post information to their Web site using a
variety of formats and links to convey the information. The agencies'
processes set no specific timeframes or benchmarks for how long the
preparation of a product, from initiation through dissemination, should
take.
We identified at least five areas where the agencies' processes for
preparing communication products and those for rules have significant
differences: (1) justification for the action, (2) interagency reviews
of drafts, (3) transparency of the processes, (4) opportunities for
public comment, and (5) the public's ability to monitor development and
review. These differences are to be expected, given the legal effect
and consequences of rules, and are each rooted in legal requirements
under statutes and executive orders that apply to rulemaking. For
communication products in general, there are no statutory requirements,
and the specific processes used by the two agencies we reviewed also do
not require that agency staff provide justification, submit draft
products for OMB review, document and publicly disclose the process,
solicit public comments, or disseminate information that would allow
the public to track the status of communication products before
issuance. However, Bush Administration initiatives from January 2007
imposed requirements on significant guidance documents that are similar
to those for rules--such as OMB review of draft significant guidance
and providing mechanisms for public comment--but the changes do not
cover any other types of communication products, nor do they extend the
transparency requirements applicable to OMB's reviews of draft rules to
its reviews of guidance.[Footnote 5]
Because agencies' communication products can convey critical
information to the public, the transparency, accountability, and
timeliness of the processes by which agencies prepare these products
are important. Therefore, we are recommending that the Assistant
Secretary of OSHA and the Administrator of EPA ensure that their key
general policies and procedures for preparing communication products
are documented and publicized and that, where appropriate, they
incorporate time frames or benchmarks in their processes to prompt the
timely dissemination of information that the agencies have determined
is needed by regulated parties or the public in general. In addition,
our review indicated that OSHA could benefit from employing some of the
practices used by EPA/OPPTS, and EPA/OPPTS could benefit from some of
OSHA's practices, to enhance their processes. While we recognize that
both agencies have taken some steps in each of the following areas, we
are nevertheless recommending that the Administrator of EPA consider
adopting certain practices for OPPTS (and other EPA offices as
appropriate), such as making key general policies and procedures
publicly available and augmenting mechanisms for maintaining an
inventory of the products that the agency disseminates. We are
recommending that the Assistant Secretary of OSHA augment specific
procedures in OSHA's directives, when appropriate, to prompt greater
outreach to external parties and to develop communications strategies
for dissemination of final products. In comments on a draft of this
report, EPA generally agreed with the recommendations, concurring that
a formal, well-understood process for coordination and review of
communication materials is important to ensure quality information
products. EPA also commented that a fair amount of flexibility and
discretion is necessary for the development of communication materials
and identified steps that the agency has taken that address elements of
our recommendations. EPA and OSHA also provided technical comments and
suggestions that we incorporated as appropriate. OMB did not provide
comments.
Background:
Asbestos is the name given to a number of naturally occurring fibrous
silicate minerals mined for their useful properties, such as thermal
insulation, chemical and thermal stability, and high tensile strength.
Asbestos has been used intentionally in the manufacture of products
ranging from insulation and roofing materials to floor tiles and
automotive brakes, and it may occur as a contaminant in a variety of
mineral products, including vermiculite, talc, and gravel. However,
asbestos fibers embedded in lung tissue over time may cause serious
lung diseases, including pleural abnormalities, reduced lung function,
asbestosis, lung cancer, and mesothelioma. Diseases caused by
inhalation of asbestos fibers may not appear until years after exposure
has occurred.
Multiple federal agencies, including OSHA and EPA, have roles and
responsibilities for regulating or otherwise addressing hazards
associated with exposure to asbestos. In July 1989, EPA issued a final
rule banning most asbestos-containing products.[Footnote 6] In October
1991, the United States Court of Appeals for the Fifth Circuit vacated
and remanded EPA's rule as it applied to existing asbestos-containing
products, but left intact that portion banning products that were not
being manufactured, produced, or imported when the rule was published
on July 12, 1989, which includes all new uses of asbestos as defined in
the ban.[Footnote 7] Specifically with regard to asbestos in automotive
brakes and clutches, OSHA's asbestos standard requires the use of
controls and safe work practices to protect employees of automotive
repair facilities.[Footnote 8] State and local governments with
employees who perform brake and clutch work in states without OSHA-
approved state plans must follow the identical regulations found under
the EPA Asbestos Worker Protection Rule.[Footnote 9] EPA also provides
information for home mechanics outside the automotive repair industry.
Asbestos is a hazard for which agencies use both rules and
informational communication products to protect the health of workers
and the general public. Rules and nonrule communication products affect
the public differently and serve different purposes. The Administrative
Procedure Act (APA)[Footnote 10] defines a rule, in part, as "the whole
or a part of an agency statement of general or particular applicability
and future effect designed to implement, interpret, or prescribe law or
policy or describing the organization, procedure, or practice
requirements of an agency."[Footnote 11] The APA established the most
long-standing and broadly applicable federal requirements for informal
rulemaking, also known as notice and comment rulemaking.[Footnote 12]
Among other things, the APA generally requires that agencies publish a
notice of proposed rulemaking in the Federal Register.[Footnote 13]
After giving interested persons an opportunity to comment on the
proposed rule by providing "written data, views, or arguments," and
after considering the public comments, the agency may then publish the
final rule.[Footnote 14] OSHA rulemaking is conducted pursuant to
separate--although analogous--provisions found in the Occupational
Safety and Health Act of 1970, as amended.[Footnote 15] Rules affect
regulated entities by creating binding legal obligations and are
subject to judicial review by the courts if, for example, a party
believes that an agency did not follow required rulemaking procedures.
In contrast, communication products, such as guidance documents and
other informational products for the public, are generally advisory in
nature and informational in content. In fact, under the APA, there is a
statutory exception for having to go through notice and comment
rulemaking for general statements of policy and interpretive
rules.[Footnote 16] Agencies sometimes include disclaimers in guidance
and other communication products to specifically note that the
documents have no binding effect on regulated parties or the agencies
themselves. OSHA and EPA officials noted that their offices produce
large numbers of a variety of different communication products that may
include, but are not limited to, brochures and pamphlets, compliance
guides, educational and training materials, guidance, and regulatory
fact sheets. These products have different characteristics and
purposes. For example, in most cases OSHA develops SHIBs to address a
new hazard or refocus the public's attention on a recurring hazard in
light of a recent incident, while informational fact sheets are limited
to discussing OSHA standards and technical information, and "quick
cards" are a simplified form of fact sheets that are targeted to a
specific worker audience. Figure 1 illustrates some of the different
types of products disseminated by OSHA and EPA.
Figure 1: Examples of OSHA and EPA Communication Products:
[See PDF for image]
This figure is an illustration of some of the OSHA and EPA
Communication Products. Some of the items depicted are:
"What You Need to Know About Lead Poisoning;"
OSHA Fact Sheet;
PCBs Interpretive Guide (web page);
FAQs: Information on Compact Fluorescent Light Bulbs (from
energystar.gov);
OSHA Quick Card.
Source: GAO presentation of EPA and OSGA products.
[End of figure]
Despite the general distinctions between rules and communication
products, determining whether an agency action is a rule is sometimes
difficult and has been the subject of much litigation.[Footnote 17]
Legal scholars and federal courts have at times struggled to determine
whether an agency action is a rule that should be subject to the APA's
notice and comment requirements or is simply guidance or a policy
statement, and therefore exempt from these requirements.[Footnote 18]
Even though not legally binding, communication materials and guidance
documents can have a significant impact, both because of agencies'
reliance on large volumes of such products and the fact that the
products can prompt changes in the behavior of regulated parties and
the general public.[Footnote 19] Concerns about the effects of agency
guidance documents and how to ensure that agencies do not cross the
line into rulemaking when drafting guidance are part of what prompted
OMB to issue a bulletin on good guidance practices in January 2007.
We have published prior work on both agencies' actions to address
hazards associated with asbestos and the rulemaking process in general.
Several reports and testimonies that we released in 2007 contained
findings and recommendations about opportunities to improve federal
agencies' communication of information about potential asbestos
hazards.[Footnote 20] These products showed the need to be timely in
getting out information to the public. For example, had additional or
more complete information been provided, people might have made
different decisions or taken different actions to protect themselves.
In addition, Congress has often asked us to review aspects of federal
rulemaking procedures and practices.[Footnote 21] However, with rare
exceptions, such as a report on agencies' small entity compliance
guides, we have not previously been asked to review agencies' general
processes regarding communication products.[Footnote 22] Our prior
reports and testimonies contained a variety of recommendations to
improve various aspects of rulemaking procedures and practices.
OSHA and OPPTS Used Different Processes during Multiyear Efforts to
Complete Communication Products on Asbestos:
OSHA and OPPTS followed different paths from 2000 through 2007 to
prepare their SHIB and brochure, respectively, on asbestos in
automobile brakes and clutches. Among the primary differences, the two
agencies initiated work on their asbestos products in response to
different triggers, OSHA took longer than OPPTS to produce a final
product, and OPPTS' process incorporated more steps to obtain input
from external parties. Each agency initiated the development of their
product in response to external events that agency officials decided
needed to be addressed through the publication of communication
products. In total, OSHA and OPPTS took years to complete all the steps
of their processes from initiation through dissemination of their
products on asbestos in automotive brakes--approximately 5-½ years for
OSHA and approximately 3-½ years for OPPTS. In doing so, both OSHA and
OPPTS generally followed applicable agency policies and procedures for
preparing communication products, as described below. The following is
a description of the steps that OSHA and OPPTS took to initiate,
develop, review, and disseminate the communication products on asbestos
in automobile brake and clutch repairs.
OSHA and OPPTS Initiated Development of Products on Asbestos in
Response to Different Triggers:
From 2000 through 2007, OSHA and OPPTS responded to the potential
hazards associated with exposure to asbestos in brake and clutch
repairs by developing and publishing their own communication products.
(Fig. 2 illustrates one of the potential hazards.)
Figure 2: Example of Potential Exposure to Asbestos in Automotive
Brakes:
[See PDF for image]
This figure is a photograph of potential exposure to asbestos in
automotive brakes, and contains the following information:
Using compressed air in brake and clutch repair has the potential to
cause exposure to asbestos fibers because compressed air blows brake
and clutch dust into the air.
Source: EPA.
[End of figure]
However, each agency initiated its product in response to different
triggering events. In December 2000, an OSHA regional office became
aware of a media report that discussed the potential exposure to
asbestos during brake and clutch repairs and its effect on automobile
mechanics. According to the article, there were indications that
mechanics were being exposed to asbestos levels potentially much higher
than the level recommended in the standards. The article also raised
concerns that many people were unaware that the EPA ban on asbestos
products had been partially overturned and that asbestos-related
products--including automobile brakes--were still being sold and used.
Therefore, mechanics and automobile shop owners might not have been
taking preventive measures to avoid exposure to asbestos fibers. OSHA
regional officials suggested that the agency could either issue a
hazard alert to automotive associations via the internet as a means of
disseminating information to the public, or implement a local emphasis
program (LEP) to address this issue.[Footnote 23] After being notified
by its regional office, the OSHA National Office decided that the
agency's response would be to develop a hazard information bulletin.
According to agency officials, LEPs are developed by the regional or
area office and reviewed by the Directorate of Enforcement Programs,
however, the regional office did not develop an LEP to address the
issues of exposure to asbestos in automotive brakes. Officials decided
that among the OSHA communication products available, the health
information bulletin would alert the public in the most efficient
manner. However, according to OSHA officials, the asbestos SHIB was
unique because, in most cases, a SHIB is developed to address a new
hazard or refocus the public's attention on a recurring hazard in light
of a recent incident. This was not the case for the asbestos bulletin
because there had not been any recent incidents associated with
asbestos in automobile brakes.
OPPTS began to develop its communication product in 2003 in response to
two events. The first was an EPA-initiated asbestos strategy project
that recommended in its 2003 report that the agency revise its
materials on asbestos. This project focused on how oversight, outreach,
and education could help identify priorities and promote innovative
approaches and best practices to address and manage costs and risks
associated with asbestos. The other triggering event was a request for
correction under the IQA that asked EPA to withdraw its 1986 Gold Book.
Among other things, the IQA allows "affected persons" to seek and
obtain correction of information maintained and disseminated by
agencies. In essence, the requester asserted that the Gold Book
contained statements that were based on inadequate and inappropriate
scientific information, and that the book itself was badly outdated
given the scientific studies published since 1986. Once the agency
received the request for correction, updating the Gold Book became a
higher priority. OPPTS officials acknowledged that, although the
information provided by the Gold Book was still accurate, the format
and presentation of the information could be perceived as very
technical and not "user-friendly." Therefore, officials decided to
develop a product that would provide the necessary information and meet
the needs of professional automobile mechanics and home mechanics, in a
simple and user-friendly format. They agreed that the best approach
would be a brochure. However, according to OPPTS officials the brochure
was also a unique communication product. In most cases, OPPTS develops
a communication product in response to a need that is identified by the
agency itself or is brought to the attention of agency officials.
According to agency officials, the brochure for the existing Gold Book
was under revision to provide more relevant context and illustrations
and to conform with communications practices developed in the years
since its last publication in 1986 (including practices of plain
English language and Web site addresses for additional information).
Revision of the asbestos brochure did not address a new need and did
not provide new information that was not available elsewhere on EPA's
Web site.
OSHA and OPPTS Took Years to Develop and Release Updated Communication
Products on Asbestos in Brakes:
As illustrated in figure 3, the preparation of the OSHA and OPPTS
communication products on asbestos in automobile brakes occurred over
several years, but OSHA's SHIB was in development longer than OPPTS'
brochure. From initiation to public dissemination of a final SHIB,
OSHA's process took approximately 5-½ years. OPPTS' process took
approximately 3-½ years. OSHA and OPPTS officials stated that one
reason for the delay in developing and disseminating the asbestos
communication products was that other priorities, such as responding to
Hurricane Katrina in the fall of 2005, overtook the development of
these communication products. However, officials from both agencies
pointed out that previously released information about the dangers of
exposure to asbestos, applicable protective standards, and protective
measures remained available during the products' development.
Figure 3: Timeline on Preparation of OSHA and EPA/OPPTS Products on
Asbestos in Brakes:
[See PDF for image]
This figure is an illustration of the timeline on preparation of OSHA
and EPA/OPPTS products on asbestos in brakes. The following information
is depicted:
Date: December 2000;
Event: Media reports on the continued presence of asbestos in
automobile brakes;
OSHA: Initiation of informational product.
Date: January 2001;
OSHA: Development of product begins.
Date: June 2003;
OSHA: Internal review of product begins.
Date: August 2003;
Event: EPA/OPPTS receives a request for correction regarding existing
guidance on asbestos in automobile brakes;
EPA: Initiation of informational product.
Date: September 2003;
EPA: Development of product begins.
Date: April 2004;
OSHA: Initiation of informational product; Development of product
begins.
Date: September 2004;
Event: EPA/OPPTS officials decide not to proceed with the brochure and
defer to OSHA and its SHIB;
EPA: Internal review of product begins.
Date: October 2005;
OSHA: Internal review of product begins.
Date: February 2006;
EPA: Initiation of informational product; Development of product
begins.
Date: May 2006;
Event: Newspaper article on the delays at OSHA and EPA in releasing
products on asbestos in automobile brakes.
Date: June 2006;
EPA: Internal review of product begins.
OSHA: Initiation of informational product; Development of product
begins; Internal review of product begins.
Date: July 2006;
EPA: External review and public comment of product begins;
OSHA: Product issued.
Date: March 2007;
EPA: Product issued.
Source: GAO analysis of EPA and OSHA information.
[End of figure]
OSHA began developing its SHIB in 2001, and posted the final version of
the SHIB to the agency's Web site in the summer of 2006. During these 5-
½ years, OSHA officials drafted the SHIB and reviewed it, but did not
clear it on two separate occasions (see fig 5). In 2003, agency
officials decided not to publish the SHIB because they were unsure of
the extent to which asbestos in brake products was a problem. They were
concerned about raising an unnecessary alarm about the possible
exposure to asbestos in automobile brakes because they found
information about the problem was limited and inconclusive. In 2004,
OSHA received a draft of OPPTS' brochure addressing the same issue. At
that time, OSHA was still conducting research to determine the extent
to which asbestos-containing products were still available in the
market. For example, OSHA staff reviewed data from the U.S. Geological
Survey that indicated that there were still friction products with
asbestos available in the market but it was difficult to determine the
exact amount of automobile brake and clutch products that contained
asbestos. However, officials determined that none of the sources were
able to provide information on the extent to which asbestos-containing
brakes and clutches were still available in the market. In 2005, OSHA
again decided against issuing a revised SHIB because it repeated
existing standards, and agency officials were still uncertain as to the
extent to which automobile brakes and clutches containing asbestos were
still available in the market.[Footnote 24] OSHA officials said that
the development of the SHIB was given lower priority when the agency
staff became involved with the response to Hurricane Katrina, including
the production of compliance assistance materials related to this
event. In 2006, OSHA officials received the OPPTS' draft brochure prior
to its publication in the Federal Register and also became aware of
another media report that raised concerns about the delays and the lack
of activity at OSHA on the SHIB. OSHA officials consulted with an
automobile manufacturer to determine if asbestos-containing brakes and
clutches were still being used in the manufacture of new automobiles
and the extent to which these parts were still available in the market.
While the information was still inconclusive, at the end of July 2006,
OSHA officials decided to issue the SHIB--that included a cross-
reference to the EPA asbestos Web site--and posted it to the agency's
Web site. (See app. III for a copy of the final asbestos SHIB.)
In 2003, OPPTS officials began to develop their brochure in response to
the request for correction and its internal review of asbestos
information products. OPPTS officials reviewed existing data to
determine the prevalence of asbestos-containing automobile brakes and
clutches in the market. OPPTS staff also consulted officials at the
U.S. Geological Survey as well as with industry officials to determine
if asbestos-containing products were still available in the market.
According to their contacts, there were still products with asbestos
available in the market but it was difficult to determine the amount of
products. OPPTS officials decided that given the uncertainty about the
prevalence, there was a need to inform the public about the potential
hazard. By April 2004, after developing a draft of the brochure, OPPTS
was ready to submit its draft for comments from other federal agencies.
In July, OPPTS staff learned about the SHIB that OSHA had begun to
draft in 2001 that addressed the same hazard. At various points during
the rest of the development of the brochure, staff at OSHA and OPPTS
worked together to ensure that the OPPTS brochure incorporated language
from the OSHA SHIB and cross-referenced the OSHA SHIB and Web site. By
the fall of 2004, OPPTS officials decided to defer to OSHA. They halted
further development of the brochure. According to OSHA officials, in
early 2005, EPA officials indicated to OSHA that they were no longer
interested in pursuing a joint communications product on exposure to
asbestos in automotive brakes. In 2006, OSHA officials confirmed their
decision not to publish the information bulletin, and OPPTS officials
moved forward with the development of their brochure, because they were
responding to a request for correction, and finalized the draft by the
summer. In August 2006, OPPTS published its draft brochure, and in
March 2007 OPPTS published the final brochure. (See app. IV for a copy
of the final brochure.)
OPPTS also consulted and coordinated with officials at OMB. Because
OPPTS was responding to a request for correction, OMB, in its oversight
role under IQA, monitored the agency's response to the request.
However, there was no formal requirement for interagency coordination
between OMB and OPPTS in developing communication products. According
to OSHA officials, OMB's inquiries into the SHIB development were due
to EPA reporting to OMB that it was not developing its own response to
the request for correction because OSHA was developing a SHIB that
addressed the same hazard. However, there was no requirement for OMB to
monitor or review the development of the SHIB.
While OSHA and OPPTS developed new products that addressed the same
health hazard and varied in the amount of time needed for development
and review, agency officials stated that neither product contained any
information that was not already available to the public. OSHA's
information bulletin was based on the existing workplace asbestos
standards, and EPA's brochure was an update to the Gold Book (a 16-page
booklet). According to agency officials, these were products that were
intended not only to inform the public about the potential health
hazard, but also to provide other sources of information within each
agency in a more user-friendly format. However, the EPA brochure
differs from the previous Gold Book in several ways. The Gold Book not
only drew attention to what it considered to be very serious health
consequences that resulted from exposure to asbestos during brake and
clutch repair, but also stated that it was very difficult to make the
repair of asbestos-containing parts safe. The new brochure lists the
health consequences of exposure to asbestos, but also outlines best
practices that when followed, can reduce the potential for exposure to
asbestos so that repair work on asbestos brakes can be conducted in a
safe manner. While the brochure does not elaborate on the reasons for
the discussion on best practices, OPPTS officials stated that the
shorter brochure (a trifold pamphlet) was intended to be more user-
friendly and not a compilation of all of the available information on
the potential health consequences associated with asbestos exposure in
a single publication. (Within the brochure, officials provided the link
to the agency's Web page that has more information on the health
consequences associated with asbestos exposure.) Some of the
respondents to OPPTS' request for public comments questioned these
differences in content. For example, one organization said that the
draft failed to provide sufficient information concerning the risks of
asbestos and appropriate risk practices and recommended that the final
brochure address in more detail the issue of latency in the effects of
asbestos disease, and that language of the EPA document should mirror
the language of the OSHA SHIB, for example by stating that "Mechanics
should assume that all brakes have asbestos-type shoes." Another
respondent, while generally supportive of the changes made in the new
brochure, stated that warnings of health effects associated with
exposure to asbestos listed in the new document should be expanded and
should include information about the danger of exposing family members
by wearing work clothes home. OPPTS officials stated that the intent of
the brochure was to update the Gold Book and convey the work practice
information in a more user-friendly format, and that other information
related to asbestos could be found on the agency's Web site.
OSHA and OPPTS Included External Parties to Different Degrees in the
Review of the Asbestos Products:
Under both OSHA and OPPTS processes, reviewing a communication product
always includes internal review but also may include external review.
[Footnote 25] This external review may come from other federal
agencies, industry groups, or the general public. In developing its
brochure, OPPTS sought comments from external parties and the general
public. In comparison, OSHA's process had more limited participation
from external parties. As part if its process, OPPTS consulted with
other federal agencies in the development of the brochure.[Footnote 26]
In addition, in order to determine the extent to which asbestos was
still present in automobile brakes and clutches, OSHA and OPPTS staff
consulted officials at the U.S. Geological Survey. OSHA also consulted
with an automobile manufacturer and OPPTS consulted with some
automobile parts manufacturers and retailers to determine if asbestos-
containing products were still prevalent. According to their contacts,
there were still products with asbestos available in the market but it
was difficult to determine their prevalence. Once OPPTS officials
decided to develop their own brochure, they submitted the draft to OMB
for review and coordination of the interagency review. Once the
interagency review was completed, OPPTS published a notice of
availability in the Federal Register and asked for public comments to
the brochure. After agency officials revised the draft brochure in
response to comments, they resubmitted the brochure to OMB for final
review.
OSHA officials did not generally include external parties in the
development of OSHA's information bulletin, and its collaboration with
OPPTS staff was a result of outreach by OPPTS officials. For example,
when officials were trying to determine the extent to which asbestos-
laden brakes and clutches were still available, OSHA officials
consulted the U.S. Geological Survey as well as an automobile
manufacturer to determine if asbestos-containing brakes and clutches
were still being used in the manufacture of new automobiles and the
extent to which these parts were still available in the market.
However, there was no evidence of attempts to obtain data from other
parties, such as automobile parts distributors or retailers. OSHA also
did not seek public comments on its draft bulletin.
OSHA and OPPTS Posted Asbestos Communication Products on Their Web
Sites:
When OPPTS officials develop a communication product, they also develop
a communication plan to ensure that the agency's announcement and
publication of the product reaches the intended audience. In developing
the brochure, OPPTS also developed a communication plan that included a
projected issuance date, identified the audiences and other
stakeholders, and the method(s) for dissemination. According to the
communication plan for the asbestos brochure, OPPTS officials notified
OSHA officials about the dissemination of the brochure prior to its
publication in the Federal Register and posting onto the EPA Web site.
OPPTS officials also notified the media by announcing the brochure in
its weekly media advisory that also provided the Web link to the
agency's asbestos information page [hyperlink,
http://www.epa.gov/asbestos].[Footnote 27] After submitting the
brochure for final review by OMB, OPPTS officials published the
brochure in the Federal Register and on the agency's Web site. After
posting the brochure, EPA removed the Gold Book from its Web site.
OSHA guidance, unlike that for OPPTS, does not require the agency to
develop in advance a communications strategy to ensure that
communication products reach their intended audience. Once OSHA
officials developed and reviewed their information bulletin, they
posted it to their Web site [hyperlink,
http://www.osha.gov/dts/shib/shib072606.html][Footnote 28] and
announced its issuance in their biweekly e-news memo, Quick Takes, an
OSHA publication that is available to interested parties. This
publication has a circulation of more than 50,000 subscribers. In
addition, the release of the SHIB was listed on the opening page of the
agency's public Web site under the feature, What's New. However,
according to OPPTS officials, OSHA officials did not notify them of
OSHA's decision to release the SHIB prior to its posting on the OSHA
Web site.
Multiple Policies, Procedures, and Practices May Apply to the
Preparation of Communication Products:
Both OSHA and OPPTS have standard policies, procedures, and practices
that guide the initiation, development, review, and dissemination of
their communication products, but agency officials noted that not all
of the processes are documented. OSHA and OPPTS officials identified
for us the main processes that their agencies use. In particular, the
officials provided detailed descriptions of the processes applicable to
preparing OSHA SHIBs and OPPTS communication materials--those that
applied to the preparation of the agencies' products on asbestos in
automotive brakes and clutches. Because of the great variety of
products that the agencies produce, there may be other processes
applicable to a given communication product, but the processes
identified are those that should most often apply to communication
products. We reviewed these processes to determine how they addressed
four generic phases: (1) initiation, (2) development, (3) review, and
(4) dissemination of communication products. In the following sections,
we identify the key OSHA and EPA/OPPTS processes and summarize the
process steps the agencies said they typically follow to prepare OSHA
SHIBs and OPPTS communication materials, such as brochures.
OSHA-Specific Instructions Guide the Agency's Preparation of Compliance
Assistance Products:
OSHA primarily follows agency-specific instructions, rather than any
DOL-wide procedures, when preparing compliance assistance products,
although DOL's Office of the Solicitor is included in the review and
clearance process. Agency officials identified several specific OSHA
instructions as most helpful in understanding their review and
clearance process and aspects of OSHA's compliance assistance material
production. These include the OSHA directives on clearance of policy
issuances, nonpolicy issuances, and SHIBs.[Footnote 29] In September
2007, OSHA issued an instruction on preparing Safety and Health
Compliance Assistance Products that may now provide the most relevant
process guidance for preparing such products.[Footnote 30] Compliance
assistance products or materials covered by this instruction include,
but are not limited to, SHIBs, quick cards, fact sheets, posters, and
pamphlets. OSHA has made all of its directives publicly available on
the agency's Web site. However, agency officials said that not all
details about their processes and standard practices appear in the
written directives. Figure 4 illustrates the process that OSHA
officials said they follow to prepare SHIBs.
Figure 4: OSHA Process for Preparing Safety and Health Information
Bulletins:
[See PDF for image]
This figure is a wireframe flowchart of the OSHA Process for Preparing
Safety and Health Information Bulletins. The following process is
depicted:
Triggers:
* New, unusual, noteworthy, significant health and safety hazards;
* Inadequacies of controls in workplace;
* Industrial systems‘ vunerability;
* Accident, injury, or illness preventative measure;
* Personal protective equipment or early warning systems;
* Lessons learned from catastrophic or major incidents;
* Credible scientific/technical finding substantiating occupational
safety or health hazards;
* External stakeholders (e.g., Chemical Safety Board).
Triggers initiate the Site Development Process, as follows:
1) Does field management determine issue merits national attention?
If no, end process. If yes, proceed.
2) Does Regional/National Office Directorate determine issue merits
national attention? If no, end process. If yes, proceed.
3) Does Office of the Assistant Secretary (OAS) approve SHIB
development? If no, end process. If yes, proceed.
4) Information is forwarded to appropriate subject matter experts
(Field, stakeholders and/or National Office).
5) National Office Directorates develop SHIB based on information and
recommendations.
6) Directorate of Science, Technology and Medicine(DSTM) formats SHIB
final draft to ensure uniformity of information and prepares required
correspondences.
7) Draft SHIB is circulated to OSHA, DOL Solicitors (SOL), and external
stakeholders (if appropriate).
8) Do all offices concur? If no, proceed to step 9. If yes, proceed to
step 11.
9) SHIB is returned to appropriate office for revision.
10) Office researches and addresses issues. Return to step 6.
11) SHIB is sent to OAS for approval.
12) Does OAS approve? If no, proceed to step 13. If yes, proceed to
step 17.
13) Staff addresses concerns.
14) Is staff able to resolve minor issues? If yes, return to step 11.
If no proceed to step 15.
15) Major issues are identified.
16) Is development continued? If no, end process. If yes, return to
step 9.
17) Does DOL Executive Secretary approve and sign off? If no, return to
step 13. If yes, proceed to step 18.
18) OAS signature.
Posting and dissemination:
19) DSTM distributes SHIB to regional offices and coordinates with the
Office of Communications regarding press release.
20) SHIB is posted on OSHA Web page.
21) SHIB is announced in QuickTakes.
Source: GAO presentation of OHSA information.
[End of figure]
OSHA officials noted that the flowchart, although based on the SHIB
directive, shows additional intricacies and review loops that can occur
in the actual development and review of a SHIB (unwritten elements of
the process). In general, the officials noted that everything goes
through the clearance process, and there is little room for discretion,
although they could deviate in an emergency situation if the Assistant
Secretary of OSHA approves it.
Although the flowchart and the following narrative summary focus on the
process for SHIBs, we also include in the discussion below information
to illustrate how other key OSHA directives are similar or different
from the SHIB process, with a particular emphasis on OSHA's new
directive for preparing compliance assistance products.
Initiation:
OSHA officials noted that a variety of triggers can initiate a decision
to update or create a product, including, for example, evidence of
inadequacies of controls in the workplace or lessons learned from
catastrophic or major incidents. OSHA's directive on SHIBs specifically
identifies seven circumstances when it might be appropriate to use a
SHIB and eight types of safety and health issues that might be covered
by a SHIB (although OSHA does not limit SHIBs to only these issues).
For example, the SHIB directive states that it might be appropriate to
disseminate information to or through OSHA field offices as a SHIB when
OSHA becomes aware of new, unusual, noteworthy, previously
unrecognized, or little known but significant occupational safety and
health hazards. Officials said that most ideas for SHIBs come from the
field, and most come out of OSHA's inspections. Among the types of
safety and health issues that a SHIB might address are common
misunderstandings or misnomers involving worker safety and health
issues (such as the misunderstanding that asbestos was banned).
Development:
The development phase includes two main steps, management approval to
proceed with the development of a product and the actual drafting of
the product. Selecting the appropriate type of product is an important
element in the initial approvals, because this helps to determine which
agency policies and procedures should apply. OSHA officials said that,
in general, the specific procedures and clearances that would be
required are driven mostly by whether a product is a policy or
nonpolicy issuance.[Footnote 31] The OSHA instruction on nonpolicy
issuances includes a process flow checklist to determine whether a
proposed issuance is appropriate for release as a nonpolicy issuance.
One distinguishing feature of OSHA's instructions is that for SHIBs in
particular and compliance assistance products in general, the Assistant
Secretary of OSHA must approve the proposed product before development
of a draft can proceed.[Footnote 32] There are also earlier steps
during which field, regional, and national office officials determine
whether an issue merits national attention. These approvals serve as an
important internal control. For example, according to agency officials,
OSHA developed its instruction on compliance assistance products to (1)
implement a process that ensures that the development of guidance is
appropriately coordinated between the national office and field
operations before resources are spent to develop the products and (2)
establish a process by which guidance projects are approved by OSHA
management before the expenditure of resources.
Centralized top-management approval is a prominent feature of OSHA's
new instruction on compliance assistance products. Under that
instruction, the initiating OSHA region, directorate, or office must
obtain approval from the Assistant Secretary of OSHA before development
of any such products. To do so, OSHA will filter the proposals through
OSHA's Compliance Assistance Coordinating Group (CACG). Proposals are
to be entered into a database and, unless expedited review has been
requested, CACG will coordinate requests for presentation to the
Assistant Secretary on a quarterly basis. (OSHA's directive indicates
that the agency will use the "Compliance Assistance Products under
Development" database to track not only the initiation and approval of
proposed products, but also their development and clearance.) CACG will
submit all requests to the Assistant Secretary and note the ones that
the group recommends for development. OSHA's instructions also prompt
the initiator of the request to indicate the potential economic
significance of the compliance assistance product.
If an approved idea merits a national product, OSHA will begin
development of a SHIB by going through the appropriate subject matter
office to prepare a draft. OSHA's Directorate of Science, Technology,
and Medicine (DSTM) is responsible for developing and issuing most
SHIBs, but other directorates may forward ideas for, or contribute to,
a SHIB. During the development phase, national and field office staff
may consult with each other. However, according to agency officials,
OSHA typically does not survey or consult with outside parties for
additional information when developing a SHIB. OSHA's instructions
require that draft SHIBs and other compliance assistance products
include a disclaimer, noting, for example, that the product is not a
standard or regulation and creates no new legal obligations.
Review:
The review phase requires internal agency reviews and approvals and
might also include interagency reviews, external reviews, or both.
During the formal internal review process, a draft SHIB will go through
the Directors of OSHA's offices. Agency officials told us that,
ultimately, Directors are responsible for approving the product and are
instructed to "look at the totality of the document when signing it."
For draft SHIBs, internal reviews are to include coordination with the
Office of Communications, the Office of the Solicitor, and other OSHA
Directorates (such as the Directorate of Enforcement Programs and the
Directorate of Standards and Guidance). Other internal stakeholders who
may review a draft SHIB include officials in OSHA regional offices.
In some cases, the SHIB process may include seeking a review of the
draft SHIB by entities or individuals outside of OSHA, such as
recognized experts, state or federal agencies, and professional
organizations. The SHIB directive suggests that the Director of DSTM
refer to current OSHA Alliances to ensure inclusion of appropriate
stakeholders (for example, trade associations connected with a topic).
However, OSHA officials pointed out that their process for SHIBs and
other guidance documents is largely internal, unless there is some
reason to go outside OSHA. Officials told us that some products, such
as guidance on pandemic flu, go through interagency and OMB review. If
OSHA consults external stakeholders, agency officials said that these
stakeholders are usually involved after a draft has been prepared.
However, in some circumstances, such as if a fatality helped to trigger
development of a SHIB, OSHA could involve external stakeholders up
front.
Since issuing the SHIB on asbestos in brakes, OSHA revised its review
process that draft SHIBs be referred to the DOL Executive Secretariat,
on a case-by-case basis, for concurrence before the Assistant Secretary
of OSHA signs and disseminates the completed product. For SHIBs
prepared by DSTM, part of the review package includes a table that
contains all comments made during the review process and their
disposition. The officials noted that there can be an iterative "loop"
to this process, not reflected in the written SHIB directive.
Specifically, if major issues surface during reviews, but the agency
still wishes to proceed with a SHIB, officials would revise the
document to address the concerns, and the draft would have to go
through appropriate review steps again.
Under the September 2007 OSHA instructions on compliance assistance
products, the review and clearance processes are very similar to those
outlined in the SHIB directive. However, unlike the SHIB directive, the
instructions on compliance assistance products include some specific
time frames for reviews. For example, offices generally are required to
allow at least 20 working days for review of compliance assistance
products. After incorporating appropriate changes, OSHA management
determines whether a second review is needed.[Footnote 33] The
instructions also note, however, that when a product is submitted for
approval by the Assistant Secretary, clearances or concurrences from
reviewers may not be more than 120 days old; otherwise, another review
is needed.
Dissemination:
The directives on SHIBs and compliance assistance products encourage
staff to coordinate with the Office of Communications regarding design
and issuance of the product, including appropriate public notification.
The directives identified by OSHA officials include provisions
specifying responsibilities for posting, distributing, and maintaining
the final products. The final products are posted on OSHA's Web site,
by product type.
OSHA officials told us that OSHA does have processes to allow public
comments on SHIBs or to provide public notification before the SHIBs
are posted in final form, however, there is no requirement for either
of these actions except in the case of significant guidance as defined
by OMB. OSHA officials said that when approval is received per the
review process, they simply post the signed SHIB. Sometimes there is a
press release, but not always. The officials said there have been a few
exceptions--not involving SHIBs--where the agency asked for comments on
the Web before drafting guidance documents.
OSHA's directives establish no specific time frames or benchmarks for
how long the entire process for producing a final product should take
from initiation through development, review and dissemination, although
the compliance assistance directive identifies time frames for a few
review steps. There is not likely to be one single standard that would
be appropriate for all products and in all circumstances, but the
absence of time frames or benchmarks leaves OSHA's processes with no
mechanisms to prompt the timely release of communication products. In
fact, some aspects of OSHA's processes, such as the possibility of
repeating development and review steps (as shown in the asbestos SHIB
example) may contribute to delays. Timeliness is only one of a range of
performance indicators that agencies should use to measure whether they
are achieving their goals--others include the quantity, quality, cost,
and outcome of agencies' program activities--and this range is
important because managers must balance competing goals.[Footnote 34]
Nevertheless, it is an indicator that merits attention, especially once
an agency has determined that there is a need to communicate
information about how people can protect themselves from health and
safety hazards. The very nature of such communication products
indicates that timeliness is a necessary element for their
effectiveness.
OPPTS Uses a Mix of EPA-Wide and Its Own Processes to Prepare
Communication Products:
OPPTS officials identified both OPPTS-specific and a number of EPA-wide
internal processes that they use to prepare communication products. In
general, agency officials told us that they do not follow the same
procedures or conduct the same level of review for all products,
although there may be a standard procedure and level of review for some
categories of products. The detailed steps of the internal procedures
may vary according to multiple factors, such as the specific type of
product; the offices involved in the process; the significance of the
document and the type of information it contains--for example, whether
the information to be provided is new or an update; and the complexity
and sensitivity of the subject. Agency officials noted that not all of
their processes are documented in written guidance.
EPA and OPPTS have different processes that apply to different types of
nonrule products. At EPA, nonrule products include, among others,
communication materials, scientific documents, analyses, reports,
guidance, and compliance assistance materials. Among the main EPA-wide
procedures or guidelines that may affect the procedural steps followed
to prepare communication products are (1) EPA's Action Development
Process: Guidance for EPA Staff on Developing Quality Actions, (2)
Policy and Implementation Guide for Communications Product Development
and Approval (guidelines from EPA's Office of Public Affairs, also
referred to as the agency's Product Review Process), (3) the agency's
procedures for notices to be published in the Federal Register, and (4)
EPA's information quality guidelines. The Product Review Process and
the information quality guidelines are publicly available on EPA's Web
site, but the other guidelines are not.[Footnote 35] Other policies,
procedures, and guidelines also might apply depending on the type of
document that is being created. In addition, each EPA office and
region, including OPPTS, has its own internal procedures and guidelines
for the development and dissemination of the various products.
OPPTS therefore follows applicable EPA-wide processes, as well as its
own processes, when preparing its products. In particular, OPPTS
officials identified a general five-phase process for preparing
communication products based on the EPA Product Review Process: (1)
initiation, (2) development, (3) review within EPA, (4) interagency/
external review, and (5) dissemination. According to the officials,
regardless of whether written procedures are developed for a particular
category of products, the process that OPPTS follows is built around
these core phases. Figure 5 illustrates the OPPTS process for preparing
communication products. OPPTS officials characterized this process as
one that they typically follow to prepare products, such as the
brochure on preventing asbestos exposure among brake and clutch repair
workers.[Footnote 36] However, it is not necessary for each
communication product to follow each of these steps.
Figure 5: EPA/OPPTS Process for Preparing Communication Products:
[See PDF for image]
This figure is a wireframe flowchart of the EPA/OPPTS Process for
Preparing Communication Products. The following process is depicted:
Initiation:
1) The need for the Information Document is Identified (OPPTS
Activity).
2) OPPTS may consult with partner Agencies and/or stakeholders on the
need for the Information Document, as appropriate (Partner Agencies;
Shareholder/public).
3) OPPTS management reviews and approves the need for the Information
Document pursuant to EPA‘s Product Review Process (PRP) (OPPTS
Activity).
Development:
4) Is there a process specific to the document type? If no, go to step
5. If yes, go to step 6.
5) OPPTS prepares a workplan & schedule, then develops the document,
working with other EPA offices/regions, partner Agencies and
stakeholders, as appropriate. Go to step 7.
6) Implement process to develop document, see examples.
7) OPPTS Management Sign-off? If no, go to step 8. If yes, go to step
9.
8) Address issues as appropriate. Return to step 7.
Review within EPA:
9) Circulate within EPA for broader review, including PRP review, if
applicable. Go to step 10 or 11 as appropriate.
10) Circulate a draft to partner agencies for review, if appropriate.
Go to step 12 or 13 as appropriate.
Interagency review:
11) Revise document as needed to address comments.
12) Submit a draft to OMB for interagency review, if appropriate. Go to
step 13.
12) Publish a draft for public review and comment, if appropriate. Go
to step 11.
Dissemination:
14) Final OPPTS Management sign-off and EPA issuance.
15) OPPTS disseminates the final document. Based on Communications
Plan, OPPTS contacts interested parties through listserv notifications
and other announcements.
Source: GAO presentation of OPPTS information.
[End of figure]
Initiation:
During the initiation phase, OPPTS officials generally will identify
the need for the product, identify the type of product to consider
developing (for example, Web page, fact sheet, brochure, or Q&A
document), consult with stakeholders (if officials determine there is a
need for consultation), and obtain approval for the concept from the
appropriate officials. Agency officials told us that the need to
develop a new communication product, or to revise or update an existing
product, might arise from several sources, including a legal mandate,
identification by their staff responding to inquiries or implementing a
program, or OPPTS management. In some cases, OPPTS may consult with
another agency or affected stakeholders to identify the need for
creating or revising a communication product. In the case of a product
developed as a result of a regulatory program, the stakeholders may be
representatives of the regulated community or other interested members
of the public. Pursuant to EPA's Product Review Process for
Communications Materials, an important step in initiation is that OPPTS
management agrees that the product needs to be developed or revised,
and EPA's Office of Public Affairs also reviews and approves the
concept.
Development:
Once a concept for a product is approved, the program officials consult
with stakeholders (as appropriate), develop a time frame for product
completion and a plan for disseminating the product (a communications
plan), and determine whether a specific process applies to the
development of a particular product. Once a development process is
either identified or developed, the process must be approved by OPPTS
management prior to developing the product. OPPTS officials told us
that development time frames may vary for different product types
depending on the specific needs identified and circumstances related to
that product, and also depending on whether a process has been
developed or needs to be developed. Unless specifically mandated by
statute, or driven by other legal deadlines or an identified critical
need, the time frame for developing the product is flexible and subject
to change based on competing demands for the staff's attention and
other resources. The agency's processes set no specific time frames for
how long development of a product should take. In addition, OPPTS may
decide to engage partner agencies, stakeholders, or both at different
points during the development of the product, based primarily on the
circumstances specific to the particular product. According to OPPTS
officials, because the nature of communication products and the
circumstances surrounding their development vary significantly, the
process provides sufficient flexibility to ensure the development of a
quality product. (EPA's Action Development Process, the detailed
guidance that the agency as a whole follows when developing its most
significant actions--such as regulations, policy statements, risk
assessments, and guidance documents--is similarly flexible. The
required process steps for development vary according to the agency's
determinations about the priority of the action, from those that
require the attention of the EPA Administrator to those that are
delegated to one of EPA's offices.)
Review:
All OPPTS communication products must undergo internal review pursuant
to the agency's Product Review Process. Specifically, agency processes
require that a communication product be approved by OPPTS management
both at initiation and again at the final draft stage. Any issues or
comments that might arise during the OPPTS management review must be
addressed before the product undergoes broader EPA review. OPPTS also
circulates draft communication products to those EPA offices that work
on similar issues (including regional offices, depending on the issue)
and central offices, such as EPA's Office of General Counsel and Office
of Public Affairs.
Although not required, depending on the nature of the particular
communication product, OPPTS may seek reviews by other agencies (such
as those interested in programs or topics related to the product) and
OMB before finalizing the product. In some cases, this may involve more
than one agency. OPPTS has on occasion provided advance copies of
certain high-profile products to OMB for an informal review. This
usually has been in response to a request from OMB but also on occasion
when OPPTS wanted OMB's input.[Footnote 37]
OPPTS might also seek comments from nonfederal parties. In general,
communication products developed by OPPTS do not all undergo a formal
notice and comment stage. OPPTS considers whether such a step is
necessary as part of the planning process based on the nature and
circumstances surrounding the particular product. Even when not
required to do so, OPPTS may still seek public comments on the product
in circumstances involving new types of communication products,
stakeholder interest, external commitments for comment opportunities,
potentially controversial issues, or for other reasons. OPPTS officials
told us that when the agency uses notice and comment for a particular
product, it opens a public docket. Public comments are submitted to
that docket, and the public can access the product, other relevant
information (if any), and any comments received.
Dissemination:
Once the product has undergone internal review, interagency/external
review (if necessary), and final OPPTS management approval and
signature, OPPTS disseminates the product to the general public. To
obtain management approval for public release, OPPTS staff will prepare
a final version of the product, along with any related materials, using
EPA's Product Review Process for all communications products. OPPTS
typically develops a Communication Plan to ensure that its announcement
and release of a particular product is tailored to reach the intended
audience. EPA's written guide on communication products includes
guidance to agency staff about communications planning. In cases where
the product is related to a well-established program area, OPPTS might
maintain a list of interested parties who wish to be notified whenever
OPPTS releases anything related to that established program area. EPA's
Product Review Process includes a mechanism for OPPTS to coordinate the
development and review of the Communication Plan for the particular
product with communication specialists across the agency. OPPTS also
consults with EPA's Office of Public Affairs on all releases.
EPA officials told us that it would be difficult to compile a list of
all disseminated communication products because of the great variety
and number of products they produce.[Footnote 38] However, the agency
maintains several lists of some of the available products for the
public; for example, officials noted that the National Service Center
for Environmental Publications is a central repository for EPA
documents available for distribution, but this is not all-inclusive. An
EPA official also pointed out that almost all communication products--
whether from OPPTS or other EPA program offices--ultimately are
reviewed by EPA's Office of Public Affairs, which maintains an
inventory of all public communication products that it has reviewed. As
OPPTS officials said, it may also be less meaningful to attempt to
catalog communication materials as the agency increasingly posts
information to its Web site for quicker dissemination and wider
accessibility and uses a variety of simpler, more focused formats to
convey that information. They said that the differences between EPA's
1986 Gold Book and the agency's 2007 asbestos brochure illustrate this
change. While the agency's goal for the Gold Book was to compile all of
the available information into a single publication, OPPTS now provides
links to source documents, rather than repeating all the details. OPPTS
officials noted that using a link or reference ensures that the public
has up-to-date information and minimizes the need to correct or revise
the brochure when the source information changes. Nevertheless, the
ability to track and monitor the communication products that the agency
is disseminating is important for internal control purposes--
specifically to ensure that relevant, reliable, and timely information
is available for management decision making and for external reporting
purposes.
As was the case with OSHA's procedures, the EPA/OPPTS procedures
establish no specific time frames or benchmarks for how long the entire
process of producing communication products should take. Although OPPTS
prepares schedules for individual products during the development
phase, agency officials indicated that the time frames for the agency's
products are flexible and subject to change based upon competing
demands for the staff's attention and other resources, unless
specifically mandated by statute, or driven by other legal deadlines or
an identified critical need. While we recognize, as previously stated,
that there is not likely to be a single standard appropriate for all
products and in all circumstances, without some suggested time frames
or benchmarks--such as limits on the length of intra-or interagency
reviews--the EPA/OPPTS processes may not prompt the timely release of
communication products.
More Transparency and Documentation Requirements Apply to Rulemaking
Than to the Preparation of Communication Products:
There are significant differences in the requirements that apply to
rulemaking compared to the preparation of communication products,
because rulemaking must comply with legal requirements that are not
applicable to the preparation of communication products. Overall, there
is less need for transparency and documentation regarding the
preparation of communication products, which are not legally binding,
compared to rules, which are. This is reflected in the requirements
that apply to each. In January 2007, the administration amended the
executive order on OMB's oversight of draft rules and issued an OMB
bulletin on good guidance practices. Among other provisions, these
initiatives expanded coverage of some requirements for OMB review of
significant draft rules to also include significant guidance documents
and also required agencies to disclose more information about
significant guidance. These changes bring the treatment of significant
guidance closer to that for rules. However, the initiatives do not
cover any other types of communication products, nor will they extend
the transparency and documentation requirements applicable to OMB's
reviews of draft rules to its reviews of significant guidance.
Processes for Preparing Rules and Communication Products Have
Significant Differences:
Although OSHA and OPPTS follow the same basic procedural steps--
initiation, development, review, and dissemination--for producing
communication products and rules, we identified at least five general
areas in which the procedures governing rules and communication
products can differ significantly. These differences are to be
expected, given the legal effect and consequences of rules. The
differences in each of these areas are rooted in legal requirements
that apply to rulemaking. For communication products in general, there
are no statutory requirements, and the specific processes used by the
two agencies we reviewed also do not impose requirements in the five
areas outlined below.[Footnote 39]
Providing a justification - Under the APA, agencies are required to
reference the legal authority under which a rule is proposed in a
Federal Register notice and either the terms and substance of the
proposed rule or a description of the subjects and issues
involved.[Footnote 40] Under other statutes and executive orders--such
as the Paperwork Reduction Act,[Footnote 41] Regulatory Flexibility
Act,[Footnote 42] Unfunded Mandates Reform Act,[Footnote 43]
Congressional Review Act,[Footnote 44] and Executive Order 12866 on
regulatory planning and review[Footnote 45]--agencies may also be
required to complete and publish analyses supporting the rule and the
options selected by the agency. In some cases, statutes impose
additional requirements on specific kinds of rules, such as
requirements for public hearings. There are no such general statutory
requirements for agencies to provide justification for their
communication products, although, as discussed above, OSHA and OPPTS
procedures typically involve a step where agency officials determine
that there is a need for a proposed communication product.[Footnote 46]
Interagency reviews - Under Executive Order 12866, OMB's Office of
Information and Regulatory Affairs (OIRA) reviews significant draft
rules (for example, rules expected to have an annual effect of $100
million or more on the economy or that raise other coordination,
budgetary, or policy issues) before they are published as proposed or
final rules.[Footnote 47] The executive order generally requires OIRA
to complete its reviews of significant rules within 90 days after an
agency formally submits a draft regulation. In contrast, officials from
OMB, OSHA, and EPA all noted that there generally are no formal
procedures and requirements governing interagency and OMB reviews of
communication products--with the exception of a recently implemented
requirement for OMB reviews of significant guidance documents
(discussed below). Agency officials confirmed that such reviews do take
place informally for some communication products (although they are not
necessarily required).
Transparency of the process - In prior work, we identified transparency
as a regulatory best practice, noted that transparency requirements
help to make agencies' processes more open (and promote participation),
and quoted an Administrator of OIRA who pointed out that openness can
help transform the public debate about regulation to one of substance
rather than process.[Footnote 48] However, the transparency of the
processes used to prepare communication products is much more limited
than for rulemaking. During rulemaking, agencies typically maintain a
rulemaking record, in the form of a public docket.[Footnote 49]
Moreover, Executive Order 12866 requires OIRA and the agencies to
document and disclose certain information about OIRA's reviews of draft
rules, including the substantive changes made to rules during OIRA's
review and at OIRA's suggestion or recommendation, as well as any
documents exchanged between the agencies and OIRA. OIRA is also
required to disclosure its substantive communications (including
telephone calls, meetings, and incoming correspondence) with outside
parties (persons not employed by the executive branch) regarding rules
under review. However, as discussed in our 2003 report on this process,
such requirements do not necessarily ensure transparency.[Footnote 50]
OMB and agencies may engage in informal reviews that are not subject to
any of the documentation and disclosure requirements that apply when a
draft rule is undergoing formal review.[Footnote 51] Agencies'
preparation of communication products is not subject to the same
requirements as rulemaking for documentation and disclosure of the
processes and steps taken. Further, information related solely to the
internal practices of an agency is exempt from public disclosure under
the Freedom of Information Act.[Footnote 52] Therefore, while OSHA and
OPPTS officials confirmed that they document the internal review
processes followed to prepare communication products, such
documentation is not subject to public disclosure. Also, as we noted
earlier, the basic processes that the agencies use are not always
documented in writing or made publicly available.
Public comment - In rulemaking, agencies are required to give
interested persons an opportunity to comment on proposed rules by
providing "written data, views, or arguments," and also to consider the
public comments before issuing a final rule. There generally are no
such requirements for the agencies to provide the public an opportunity
to comment on draft communication products.[Footnote 53] However, OSHA
and OPPTS officials noted that they still may choose to seek public
comments on certain products. For example, OPPTS officials said that
they may provide external stakeholders an opportunity to comment on a
communication product in circumstances involving new products,
stakeholder interest, external commitments for comment opportunities,
potentially controversial issues, or for other reasons. OSHA officials
told us that they sometimes provide opportunities for public comment on
communication products, although they have not done so for SHIBs.
Monitoring development and review - The public is better able to track
the status of the development and review of significant rulemaking. In
response to provisions of Executive Order 12866, as amended, agencies
make general information on rulemaking in process publicly available
through mechanisms such as the Unified Agenda of Federal Regulatory and
Deregulatory Actions, the Regulatory Plan, and OMB's database on the
status of draft rules submitted for review under the executive
order.[Footnote 54] No similar mechanisms are available for publicly
tracking communication products. OSHA and OPPTS have, or are creating,
databases on the status of their communication products, but these are
for internal management purposes, and are not available to the public.
Per OSHA's September 2007 directive on compliance assistance products,
the agency will compile information on all proposed concepts in a
centralized database, including information tracking the initiation,
development, and reviews of those products. An OPPTS official told us
that her agency uses several different databases to track the
development and review of various products.[Footnote 55] She also noted
that EPA has a publications catalog that is a master inventory of all
numbered publications, but this is not all-inclusive.
Administration Initiatives Imposed New Requirements for Significant
Guidance Documents:
In January 2007, the President issued Executive Order 13422 to amend
Executive Order 12866, and OMB released a related Final Bulletin for
Agency Good Guidance Practices. The principal change made by the
executive order amendments was to establish a process regarding
interagency coordination and review of significant guidance documents
prior to their issuance. The OMB bulletin established policies and
procedures for the development, issuance, and use of significant
guidance documents by agencies.[Footnote 56] In April 2007, the
Administrator of OIRA issued a memorandum providing more specific
instructions on the implementation of the OMB bulletin and Executive
Order 13422.
According to the OMB Director, the primary focus of Executive Order
13422 and the OMB bulletin is on improving the way the federal
government does business with respect to guidance documents by
increasing their quality, transparency, accountability, and
coordination. OMB noted that well-designed guidance documents can serve
many important or even critical functions in regulatory programs and,
among other things, can channel the discretion of agency employees,
increase efficiency, and enhance fairness. OMB cited various reasons
for issuing the bulletin, noting, for example, that as the impact of
guidance documents on the public has grown, so too has the need for
good guidance practices. OMB also stated that guidance documents may
not receive the benefit of careful consideration accorded under the
procedures for development and review of rules, and OMB raised the
concern that because it is procedurally easier to issue guidance
documents, there may be an incentive for regulators to issue guidance
documents in lieu of rules. OMB also cited potential benefits from
enhancing the quality and transparency of agency guidance practices--
including, when practical, using opportunities for public input to
increase the quality of products and provide for greater public
confidence in and acceptance of agency judgments.
Among other things, the executive order, bulletin, and implementation
memorandum require agencies to (1) develop clearance procedures for
significant guidance documents; (2) provide OMB advance notice and an
opportunity for consultation on significant guidance; (3) create and
maintain a current list of all significant guidance on their Web sites
and establish a means for the public to submit comments electronically
on significant guidance, as well as requests for issuance,
reconsideration, modification, or rescission of significant guidance
documents; and (4) provide public notice and seek public comments on
any economically significant guidance.[Footnote 57] These changes move
the treatment of significant guidance closer to the requirements for
rules. However, the changes only apply to significant guidance
documents, not to any other types of communication products.
The OMB bulletin outlines basic standards expected for significant
guidance, including both approval procedures and standard elements of
each significant guidance document. OSHA officials said that although
their directive on compliance assistance products was not developed
specifically to implement OMB's bulletin and the revised executive
order, its procedures appropriately reflect those requirements. EPA
also revised its processes to reflect the new requirements for guidance
documents. As required by the bulletin, both OSHA and EPA have listed
the significant guidance documents subject to Executive Order 12866, as
amended, and OMB's bulletin on their Web sites.
Under Executive Order 12866, as amended, and OIRA's implementation
memorandum, the requirements regarding notification to OIRA of a
significant guidance document are similar, but not identical, to those
applicable to OIRA's reviews of significant rules. Agencies are
required to provide advance notification to OIRA of a significant
guidance document--as a general rule, no less than 10 days prior to
intended dissemination. If the Administrator of OIRA determines that
additional consultation is warranted, OIRA will review the guidance and
coordinate review among appropriate executive branch departments and
agencies. The Executive Order does not specify a time period for review
of significant guidance documents, but according to the implementing
memorandum, OIRA will complete its consultation on the guidance
document within 30 days or, at that time, will advise the agency when
consultation will be complete. However, the executive order amendments,
OMB bulletin, and OIRA memorandum did not extend the transparency and
documentation requirements applicable to OIRA's review of draft rules
(such as disclosing changes made at OIRA's suggestion or documenting
contacts with external parties) to its reviews of draft guidance.
Conclusions:
OSHA and OPPTS initiated work on their asbestos communication products
for different reasons, but in both cases the agencies' processes took
years to complete. OSHA initiated work in 2000 in response to news
reports that workers were not aware that asbestos had not been banned
from automotive products and might still pose a potential hazard. OPPTS
initiated work in 2003 in response to a request that the agency correct
information in its Gold Book. From initiation to dissemination of final
products, OSHA took approximately 5-½ years to publish its asbestos
SHIB, while OPPTS took approximately 3-½ years to publish its final
asbestos brochure. OSHA's iterative review process contributed to
delays in producing its SHIB, as OSHA officials cited the need to
address uncertainties regarding the prevalence of asbestos in brake
products. OPPTS officials also cited a number of explanations for the
time required to produce their final brochure, including their external
coordination and review activities and competing demands on resources.
Officials from both agencies pointed out that, during the time that
they worked on their asbestos products, information about the potential
hazard and protective measures that could be taken remained available
on the agencies' Web sites. Ultimately, both OSHA and OPPTS determined
that new asbestos communication products were needed, and the products
were publicly released.
Communication products are an important tool that OSHA and OPPTS (as
well as other agencies) use to support and augment their regulatory
activities. Communication products provide crucial information to
regulated parties and the general public. Therefore, it is important
that communication products be issued in a timely manner. Timeliness is
but one of a range of performance indicators that agencies may use to
measure whether they are achieving their goals, as managers balance
competing priorities. But timeliness seems especially relevant once an
agency has determined that there is a need to communicate information
about how people can protect themselves from health and safety hazards
to which they might be exposed. Having such information might lead
people to make different decisions or take different actions to protect
themselves than they would in the absence of such information. As the
various OSHA and OPPTS processes for preparing communication products
are currently designed, they contain few, if any, performance time
frames or benchmarks to help ensure that the processes can produce
final products in a timely fashion. Although there can be no single
standard for how long the entire process should take, OSHA's and OPPTS'
processes could benefit from general time frames or benchmarks to
provide some impetus for moving products the agencies identified as
needed through to dissemination. It should also be remembered that one
of the reasons why agencies use alternatives to rulemaking--such as
guidance or general communication products--is because these
alternatives have the advantage of being less time consuming than
rulemaking.
It is also important that the processes the agencies use to prepare
communication products be documented, transparent, and understood.
Differences between the processes for preparing communication products
and rules are to be expected, given the legal effect and consequences
of rules. Preparation of communication products should not require the
same level of justification, documentation, disclosure, and public
comment as rulemaking. However, communication products are also
important and can affect the actions of regulated parties and the
public, so enhancing the general transparency and accountability of
agencies' processes could be beneficial. Knowing the many steps that
agencies take when preparing communication products could not only help
external parties contribute, when appropriate, to the preparation of
the agencies' products, but could also help those parties to understand
why the process is sometimes lengthy.
There are opportunities for both OSHA and OPPTS to enhance the
transparency and accountability of the processes they use to prepare
communication products. Those processes are not always easy to identify
and understand, in part because of the great variety of the agencies'
products and processes, but also because not all key elements of the
processes the agencies may follow are documented. For example, with the
exception of required OMB reviews of significant guidance documents,
OMB, OSHA, and OPPTS officials noted that they have no formal written
procedures governing interagency and/or OMB reviews of communication
products. Nevertheless, agency officials confirmed that such reviews do
occur (although they are not necessarily required). As another example,
OSHA's process includes a potential review "loop" that OSHA officials
said would not be apparent from reading their directive on SHIBs but
can result in staff having to revise the product and repeat the review
process.
The transparency and accountability of the agencies' processes can also
be limited if they are not publicly disclosed. For both OSHA and OPPTS,
this would include disclosing the unwritten elements of their key
processes mentioned above, once documented. In addition, EPA/OPPTS
could do more to publicize existing written guidelines about key
processes for preparing communication products. In contrast to OSHA,
which has posted its key written process instructions, this is not
always the case for EPA/OPPTS. In particular, EPA's Action Development
Process is not publicly available but applies to the agency's most
significant actions, including rules. Although the agency's process
guidelines focus primarily on internal policies and procedures, the
final products generated by the agency may be of interest to and affect
a variety of external parties, from Congress and other federal agencies
to regulated parties and the general public. Greater disclosure about
OSHA's and OPPTS' processes could be limited to providing more
information about their general processes and would not require the
agencies to reveal the actual details of internal policy deliberations
for individual communication products.
We also observed that EPA/OPPTS identified difficulties in identifying
communication products that have been disseminated, even when we
limited our request to a subset of product types. OPPTS officials told
us that their agency increasingly relies on disseminating information
through a variety of formats and links on its Web site. They believe
this is a more effective approach to disseminating information to the
public, but it may also make it more difficult for the agency to
catalog what has been disseminated. We think that it is important, as a
matter of basic internal controls, for an agency to maintain an
inventory of the products it produces. We recognize that EPA and OPPTS
already have a number of separate databases to track various types of
communication products, but we remain concerned that some of the
products and information disseminated might not be captured by existing
databases. Adopting a mechanism such as the centralized database that
OSHA is implementing might enhance OPPTS' ability to track, identify,
and manage the inventory of its disseminated products.
OSHA also could enhance its existing processes for preparing
communication products. For example, the OPPTS processes, both in
general and as illustrated during preparation of the asbestos brochure,
prompt more and earlier consultation with external parties than seems
to be the case with OSHA's SHIB process. Although OSHA may seek
external reviews in some cases, agency officials said that their
processes for preparing SHIBs and other guidance documents are largely
internal. We recognize that this, in part, reflects the different
purposes and context for OSHA communication products, and that outreach
to external parties comes at a cost to the agency in terms of both time
and resources. However, consultation, outreach, and coordination also
can provide important benefits, as OMB cited when explaining the need
for agency good guidance practices. Just as the OMB guidance was
intended to increase the quality and transparency of agency guidance
practices--including, when practical, using opportunities for public
input to increase the quality of products and provide for greater
public confidence in and acceptance of agency judgments--so too may the
preparation of other communication products benefit from appropriate
outreach efforts.
Similarly, OSHA might wish to enhance its existing process instructions
regarding dissemination of communication products by considering
elements of the EPA/OPPTS process. While OSHA's directives prompt
agency officials to post final products to the agency's Web site and
encourage OSHA staff to consult with the agency's Office of
Communications about whether an announcement should be made, the
directives provide more guidance on distribution of the final products
within OSHA than on distribution to regulated workplaces and the
public. The EPA/OPPTS processes prompt early and ongoing attention to
effective notification about and dissemination of communication
products, through tools such as a communications plan, and also provide
more guidance to agency staff about communications planning.
Recommendations for Executive Action:
While we recognize that OSHA and EPA/OPPTS have taken some steps in
each of the following areas, more could be done to improve the
transparency, accountability, and timeliness of their processes for the
initiation, development, review, and dissemination of communication
products. Therefore, we are making the following six recommendations:
1. The Assistant Secretary for OSHA and the Administrator of EPA should
ensure that their key general policies and procedures for preparing
communication products include, as appropriate, time frames or
benchmarks to help ensure that products that the agencies have
determined are needed are developed, reviewed, and disseminated in a
timely manner.
2. The Assistant Secretary for OSHA and the Administrator of EPA should
take steps to ensure that their key general policies and procedures for
preparing communication products are fully documented. To the extent
feasible, this should include identifying the applicable policies and
procedures governing OMB/interagency coordination and reviews of such
products, as well as any other key processes that the agencies believe
are important to understanding how they prepare their products.
3. The Assistant Secretary for OSHA and the Administrator of EPA should
ensure that their agencies make public the key general policies and
procedures for preparing communication products, including any updated
in response to the previous objective.
4. The Administrator of EPA should consider adopting for OPPTS--and
other EPA offices, as appropriate--a centralized database or databases
to more completely account for the inventory of communication materials
disseminated by the agency.
5. The Assistant Secretary for OSHA should augment existing OSHA
directives on the preparation of SHIBs and other communication products
to prompt OSHA staff to identify opportunities to solicit input from
external parties, as practical, during the preparation of communication
products.
6. The Assistant Secretary for OSHA should augment existing OSHA
directives on the preparation of SHIBs and other communication products
to provide more guidance to OSHA staff on developing a communications
strategy during the product development process (for example, to
identify who the agency needs to inform of the product, how
notification and dissemination will be done, and who will be
responsible for specific notification and dissemination tasks).
Agency Comments and Our Evaluation:
We provided a draft of this report to the Secretary of Labor, the
Administrator of EPA, and the Director of OMB for their review and
comment. In comments on the report, EPA generally agreed with the
recommendations and concurred that a formal, well-understood process
for coordination and review of communication materials is important to
ensure quality information products (see app. V). With regard to the
first recommendation, EPA also commented that a fair amount of
flexibility and discretion is necessary for the development of
communication materials. We agree and had already stated in our
conclusions that there can be no single standard for how long the
process should take and in our recommendation that agencies should
incorporate time frames and benchmarks "as appropriate." EPA also noted
that the time frame associated with its development of the brakes
brochure was an anomaly and may not be a useful standard to compare to
other cases. However, we based our recommendations on our review of
EPA's (and OSHA's) general policies and procedures, not on our review
of the specific products on asbestos in brakes. With regard to the
second, third, and fourth recommendations, EPA identified steps that it
already has taken, such as more fully documenting the agency's process
guidance, making guidance available to the public on the agency's Web
site, and having a centralized approach and database on the development
of communication materials. We recognized in our conclusions and
recommendations that EPA (and OSHA) were already taking steps that
addressed some elements of our recommendations. However, as discussed
in our conclusions, we believe that more could be done to enhance the
transparency and accountability of the agencies' processes. EPA and
OSHA also provided technical comments and suggestions that we
incorporated as appropriate. OMB did not provide comments.
As we agreed with your offices, unless you publicly announce the
contents of this report earlier, we plan no further distribution of it
until 30 days from the date of this letter. We will then send copies of
this report to the Secretary of Labor, the Administrator of EPA, the
Director of OMB, and appropriate congressional committees. We will also
provide copies to others upon request. In addition, the report will be
available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staff members have any questions about this report,
please contact me at (202) 512-6806 or sciremj@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix VI.
Signed by:
Mathew J. Scire:
Director:
Strategic Issues:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
Our objectives for this report were to:
* describe the processes that the Department of Labor's (DOL)
Occupational Safety and Health Administration (OSHA) and the
Environmental Protection Agency's (EPA) Office of Prevention,
Pesticides, and Toxic Substances (OPPTS) used to initiate, develop,
review, and disseminate updated communication products on exposure to
asbestos in automotive brakes and clutches, identify how long the
processes took, and assess the extent to which the agencies followed
applicable policies and procedures;
* describe the general policies and procedures that OSHA and OPPTS have
for the initiation, development, review, and dissemination of
communication products; and:
* compare the agencies' policies and procedures for communication
products with those applicable to the initiation, development, review,
and dissemination of rules, and describe what might be the effects of
2007 administration initiatives regarding guidance documents.
To address the first objective, we obtained and analyzed information on
the preparation of the OSHA and OPPTS products on asbestos in
automotive brakes and clutches. We asked agency officials to provide a
chronology and description of events that led to the initiation,
development, review/clearance, and eventual dissemination of the
products. We also asked the officials to provide any documentation, to
the extent available, that would corroborate the events and processes
as described in their respective chronologies. We compared the policies
and procedures to identify the steps for (1) initiating the development
of the asbestos communication products, (2) developing, or drafting,
the asbestos communication products, (3) reviewing--internally,
externally, or both--the asbestos communication products, and (4)
disseminating the asbestos communication products. For some of the
steps, the processes are informal, and therefore, difficult to
document. Therefore, because the information was based, in large part,
on testimonial evidence, we prepared statements of facts on our review
at each agency and provided these statements to the agencies for
vetting and confirmation of the information. The agency officials
verified the information, and provided comments and technical
corrections that we incorporated, as appropriate.
To address the second objective, we reviewed the agencies' applicable
internal policies, procedures, and guidance documents governing the
preparation of communication products.[Footnote 58] We reviewed
relevant and available primary documents, such as the agencies'
Information Quality guidelines, EPA-specific guidance on the
development and review of communication products, and OSHA directives
governing the development and review of guidance documents, in
particular, Safety and Health Information Bulletins (SHIB). Further, we
interviewed agency officials at DOL/OSHA and EPA/OPPTS who are involved
in the development and review of their respective agencies'
communication products, as well as officials at the Office of
Management and Budget (OMB) to obtain information on interagency
reviews of communication products. We compared the policies and
procedures to identify the steps for (1) initiating, (2) developing or
drafting, (3) reviewing (internally and externally), and (4)
disseminating a communication product. For some of the steps, the
processes are informal and not documented. Therefore, because some of
the key information to address our findings was based on testimonial
evidence, we prepared statements of facts on our review at each agency
and provided these statements to the agencies for vetting and
confirmation of the information. The agency officials verified the
information, and provided comments and technical corrections that we
incorporated, as appropriate.
To address the third objective, we again reviewed applicable documents
and interviewed officials at the three agencies to identify information
on the similarities and differences between rulemaking and the
processes used to develop and review communication products. We also
solicited the views of agency officials regarding effects they
anticipated from implementation of the amended executive order on
regulatory review and planning and the OMB good guidance bulletin--both
of which were promulgated in final form during the course of our
review.
Our review was limited to applicable processes of OSHA and OPPTS, the
two agencies responsible for preparing communication products on
asbestos in automotive brakes, although some of the applicable
processes were DOL-or EPA-wide. Our scope and methodology for the first
two objectives focused on the broad category of communication products
at these two agencies, but did not encompass all nonrule regulatory or
technical products that they produced. To illustrate the application of
the agencies' processes for preparing such products, we performed a
detailed examination of their asbestos communication products. While we
initially had expected to compare the processes used in developing the
two asbestos products with the processes used to prepare a sample of
like products, we concluded that it would not be possible to identify a
representative sample of issued products in order to do a comparative
analysis that would be meaningful and generalizable to a larger
population of products. Agency officials told us the timeline and
process undertaken for one product could be quite different from the
timelines for other products of that type.[Footnote 59] Although our
observations on the implementation of these processes are limited to
OSHA and OPPTS and not generalizable to other parts of DOL and EPA, our
review did encompass examination of DOL-and EPA-wide policies and
procedures for communication products.
We conducted our review in Washington, D.C., from September 2006
through October 2007 in accordance with generally accepted government
auditing standards.
[End of section]
Appendix II: Preparation of OSHA and OPPTS Communication Products on
Asbestos in Automotive Brakes:
The descriptions of the events in this appendix on the preparation of
the OSHA and OPPTS communication products on asbestos in automotive
brakes were provided by officials at OSHA and OPPTS. For some of these
events, the agency officials were able to provide documentary evidence
for corroboration. However, because agencies are not required to
document their processes, much of this chronology is based on
testimonial evidence obtained from agency officials during the course
of our review.
Table:
Year: 2000;
Month: December;
Event: The OSHA Seattle Regional Office reported on a media report
revealing that a large number of employees and employers in the
automotive industry mistakenly believed that the 1989 ban on asbestos
in automotive products was still in effect. While the regional office
suggested two options for informing the public--a local emphasis
program (LEP) or an e-mail alert to industry groups--the OSHA national
office decide to develop a Hazard Information Bulletin on asbestos in
automotive products. National office decided that the LEP, e-mail
alert, or both would inform only a select segment of the populations,
and they wanted to inform the general public about this hazard.
Year: 2001;
Month:
January; Event: OSHA's national office decided to develop the bulletin.
Year: 2003;
Month: May;
Event: The Global Environment and Technology Foundation issued its
Asbestos Strategy Report commissioned by EPA to develop approaches for
asbestos oversight, outreach, and education approaches. Among the
foundation's recommendations was the update of certain existing
asbestos guidance--specifically on asbestos in buildings.
Year: 2003; Month: June;
Event: Internal discussion took place within OSHA on the advisability
of publishing the bulletin. OSHA officials decided that there were
still unanswered questions about the prevalence of asbestos-containing
automotive brakes and clutches that needed to be addressed before
disseminating the bulletin.
Year: 2003; Month: August;
Event: EPA received a challenge under the Information Quality Act to
its Guidance for Preventing Asbestos Disease Among Auto Mechanics,
commonly referred to as the Gold Book.
Year: 2003; Month: October;
Event: As a result of the recommendations from the Global Environmental
and Technology Foundation and the request for correction, EPA officials
developed a "top 6 high priority" list of documents to update. The
first document listed was the EPA Gold Book.
Year: 2004;
Month: April;
Event: OPPTS officials developed initial drafts of a brochure and
shared this information at the staff level with other agencies,
including OSHA.
Year: 2004; Month: May;
Event: OSHA's Salt Lake City Technical Center received OPPTS' draft
brochure for review. On a parallel track, OSHA officials recirculated
the draft SHIB for further agency review.
Year: 2004;
Month: June;
Event: Review of OPPTS' document alerted OSHA officials to the lack of
information/evidence concerning the extent of use of asbestos in brakes
in the United States. OSHA and OPPTS officials agreed that this needed
to be addressed and supported the issuance of a joint product.
Year: 2004;
Month: July;
Event: OPPTS and OSHA staff began collaboration to develop a joint
product after OPPTS officials became aware that OSHA was also
considering development of new materials regarding asbestos in brakes.
OSHA suggested a number of technical corrections to OPPTS' version of
the brochure with the understanding that those corrections needed to be
made before OSHA could cosponsor the brochure.
Year: 2004;
Month: September;
Event: OPPTS placed a hold on the development of the asbestos brochure
when the agency learned that OSHA was developing a bulletin that would
address the same concerns.
Year: 2005;
Month: February;
Event: OPPTS informed OSHA that they no longer wanted to be part of a
joint OSHA/OPPTS information bulletin.
Year: 2005;
Month: April;
Event: Based on concerns about the use and prevalence of asbestos in
brake friction products, OSHA contacted the U.S. Geological Survey to
determine the exact amount of asbestos imported for use in the United
States.[A]
Year: 2005;
Month: May/June;
Event: OSHA obtained a study that supported the dissemination of the
information bulletin on asbestos exposure in brake and clutch
repairs.[B] OSHA also obtained a study that cast doubt on the ability
of asbestos brake dust to cause cancer.[C] This study was referred to
OSHA's Salt Lake City Technical Center for its assessment on whether
the bulletin should be published.
Year: 2005;
Month: July;
Event: OMB contacted OSHA inquiring about the status of the information
bulletin on asbestos exposure in automotive brake and clutch repairs.
OSHA's understanding was that OMB was following up on discussions with
OPPTS on the need to revise the Gold Book on asbestos exposure in brake
and clutch repair, since OPPTS was responding to a request for
correction and OMB monitors agencies' responses to these requests. OMB
officials were concerned since OPPTS officials had indicated that they
would not be revising the Gold Book because OSHA was publishing an
information bulletin.
Year: 2005;
Month: July;
Event: OSHA staff participated in a conference call with OMB staff. OMB
was interested in the status of the information bulletin and its
relationship to OPPTS' Gold Book revision. OSHA staff explained to OMB
the background on the original OPPTS/OSHA informal agreement to issue a
joint document and OPPTS' subsequent decision not to proceed. OPPTS
officials had indicated that although their Gold Book was the subject
of a request for correction, they would rather wait for OSHA to issue
its bulletin that would include a statement about potential exposure to
home mechanics. OSHA officials explained that the bulletin was
primarily a reiteration of the OSHA asbestos standards and that there
were still issues under review. The agency had not yet decided whether
to issue the bulletin.
Year: 2005;
Month: October;
Event: OSHA officials decided there was no need to issue the bulletin
since the document, in essence, reiterated the mandatory requirements
found in Appendix F of the asbestos standards. Subsequent to this
decision, OSHA's Salt Lake City Technical Center recommended to the
agency that the bulletin should be issued. According to agency
officials, the decision not to issue the SHIB was not reexamined in
response to this recommendation because of the higher-priority demands
related to the agency's response to Hurricane Katrina.
Year: 2006;
Month: February;
Event: OPPTS officials learned that OSHA officials decided not to
proceed with the dissemination of the information bulletin. However,
because OPPTS was committed to issuing an update of the Gold Book in
response to the request for correction, it proceeded with the
development and review of its brochure.
Year: 2006;
Month: May;
Event: A newspaper article raised concerns about the length of time and
the lack of activity by OSHA and EPA in disseminating their
communication products on asbestos exposure in automotive brake and
clutch repairs.
Year: 2006;
Month: June;
Event: Once reviewed and approved within OPPTS, the draft brochure was
also reviewed by management in other EPA offices and by other agencies
with primary roles in the area of asbestos--OSHA, the National
Institute for Occupational Safety and Health, and the Agency for Toxic
Substances and Disease Registry. Additionally, although not formally
required, OMB participated in a review of the draft brochure. OMB
coordinated the interagency review and provided OPPTS officials with
comments on their draft brochure from other federal agencies.
Year: 2006;
Month: June;
Event: OSHA officials reconsidered their prior decision not to publish
the SHIB and began to recirculate their draft bulletin for review and
final preparations for dissemination.
Year: 2006;
Month: July;
Event: OSHA's Assistant Secretary approved the dissemination of the
asbestos SHIB on the agency's Web site.
Year: 2006;
Month: August;
Event: OMB officials informed OPPTS that it had completed its review of
the revised draft brochure and that all the agencies were satisfied
with the revisions. OPPTS proceeded to publish the draft brochure in
the Federal Register for public comment.
Year: 2006;
Month: August through September;
Event: After posting the bulletin on its Web site, a former OSHA
Assistant Secretary contacted the agency and suggested that the agency
might want to reconsider publication of the SHIB based on whether brake
dust is a "substantial source for exposure" to asbestos. The agency
reviewed the existing data and found that there was a need to warn
workers in the brake and clutch repair industry about the potential
risk to exposure, albeit at much lower levels. Agency staff drafted a
revision to the SHIB to reflect this finding and to acknowledge the
fact that there is a scientific debate on the relationship between
brake dust and mesothelioma. However, OSHA officials decided against
revision of the SHIB.
Year: 2007;
Month: February;
Event: OPPTS submitted its final draft of the brochure to OMB (because
the brochure was a response to a 2003 request for correction).
Year: 2007;
Month: March;
Event: Year: OPPTS published the final brochure.
Year: 2007;
Month: April;
Event: OPPTS released the final brochure in the Federal Register, and
posted the document on the agency's Web site.
Source: GAO.
[A] The U.S. Geological Survey responded that of the 7,000 metric tons
of asbestos imported into the United States in 2002, 18 percent was
used for the manufacture of friction products that include automobile
brakes and clutches.
[B] Kelly J. Butnor, Thomas A. Sport, and Victor Roggli, "Exposure to
Brake Dust and Malignant Mesothelioma: A Study of 10 Cases with Mineral
Fiber Analyses," Annals of Occupational Hygiene, vol. 47, no. 4,
(2003).
[C] Dennis J. Pasternach et al., "Environmental and Occupational Health
Hazards Associated With the Presence of Asbestos in Brake Linings and
Pads (1900 to Present): A State-of-the-Art Review," Journal of
Toxicology and Environmental Health, Part B: Critical Reviews, vol. 7,
no. 1 (2004).
[End of table]
[End of section]
Appendix III: Asbestos-Automotive Brake and Clutch Repair Work:
U.S. Department of Labor:
Occupational Safety and Health Administration:
Directorate of Science, TEchnology & Medicine:
Office of Science Technology Assessment:
Asbestos-Automotive Brake and Clutch Repair Work:
Safety and Health Information Bulletin:
SHIB 07-26-06:
Purpose:
This Safety and Health Information Bulletin is not a standard or
regulation, and it creates no new legal obligations. The Bulletin is
advisory in nature, informational in content, and is intended to assist
employers in providing a safe and healthful workplace. Pursuant to the
Occupational Safety and Health Act, employers must comply with hazard-
specific safety and health standards promulgated by OSHA or by a state
with an OSHA-approved state plan. In addition, pursuant to Section
5(a)(1), the General Duty Clause of the Act, employers must provide
their employees with a workplace free from recognized hazards likely to
cause death or serious physical harm. Employers can be cited for
violating the General Duty Clause if there is a recognized hazard and
they do not take reasonable steps to prevent or abate the hazard.
However, failure to implement any recommendations in this Safety and
Health Information Bulletin is not, in itself, a violation of the
General Duty Clause. Citations can only be based on standards,
regulations, and the General Duty Clause.
Purpose:
OSHA is issuing this Safety and Health Information Bulletin to inform
employees and employers in the automotive brake repair industry of the
precautions that must be taken when working with automotive brakes and
clutches containing asbestos. In the case of do-it-yourselfers,
[Footnote 60] OSHA does not have jurisdiction, and OSHA does not
require theses practices to be followed. To reduce the potential
exposure to asbestos, EPA strongly recommends that all automotive brake
and clutch repair work be done by professional auto mechanics. Although
the use of asbestos in friction products is declining annually, it
remains a substantial source of potential exposure. In addition, there
is still potential exposure to asbestos contained in automotive brakes
and clutches on older vehicles in need of service. Exposure to
asbestos, if not properly controlled can cause mesothelioma, lung
cancer, and asbestosis. Symptoms may not appear for years, even
decades, after contact with asbestos fibers. [Footnote 61]
Background:
Many brakes and clutches used in new and recent model automobiles do
not contain asbestos. However, it has not been totally eliminated. Some
reports have indicated that many mechanics and employees in the
automotive repair shops as well as do-it-yourselfers are unaware that
asbestos may be present in both old and replacement brakes and
clutches.
OSHA's asbestos standard requires the use of controls and safe work
practices when employees work with brake shoes and clutches that
contain asbestos. These requirements are detailed in 29 CFR 1910.1001
and specifically 1910.1001(f)(3) and Appendix F of the standard - Work
Practices and Engineering Controls. for Automotive Brake and Clutch
Inspection. Disassembly, Repair and Assembly [hyperlink,
http://www.osha.gov/slte/asbestos/index.html]. The requirements also
are discussed in the Federal Register at 59 FR 40964, 40985-87 (August
10, 1994) and 60 FR 33983 (June 29, 1995), as well as in OSHA Directive
CPL 2-2.63 (revised).
OSHA Work Practices and Engineering Controls/OSHA Methods:
All automotive brake and clutch repair facilities in the United States
must comply with the OSHA asbestos standard. The proper use of
engineering controls and work practices by properly trained employees
working on automotive brakes and clutches will reduce their asbestos
exposure below the permissible exposure level of 0.1 fiber per cubic
centimeter of air, expressed as an 8-hour time-weighted average.
Respiratory protection is not required during brake and clutch jobs
where the control methods described below are used.
The two preferred OSHA methods to control asbestos dust during brake
and clutch repair and service are: (1) a negative pressure enclosure/
HEPA (high-efficiency particulate air) vacuum system, and (2) the low
pressure/wet cleaning method. The employer may use other methods (in
conjunction with written procedures), to reduce exposure to levels
equivalent to the negative pressure enclosure/HEPA vacuum system. For
facilities that inspect, disassemble, reassemble and/or repair five or
fewer brake or clutch jobs per week, the wet method (described in
paragraph D of Appendix F) can be used. The spray can/solvent system
method can be used as an alternative preferred method since it meets
the equivalency criterion of the negative pressure enclosure/HEPA
vacuum system method. Proper training is essential to ensure that
employees use the methods in an effective manner.
Negative pressure enclosure/HEPA vacuum system method:
The negative pressure enclosure/HEPA vacuum system method includes the
following steps:
1. Enclose the brake or clutch assembly to prevent release of asbestos
fibers into the employee's breathing zone during brake or clutch
inspection, disassembly, repair, and reassembly operations. Use a
transparent enclosure with impermeable sleeves.
2. Seal the enclosure tightly and thoroughly, inspect for leaks before
beginning work.
3. The enclosure must be transparent so that the employee can clearly
see the operation during brake or clutch inspection, disassembly,
repair, and reassembly. The enclosure must also have impermeable
sleeves to allow the employee to handle the brake and clutch assembly
without penetrating the enclosure. The integrity of the sleeves and
ports must be inspected before work begins.
4. Use a HEPA-filtered vacuum to keep the enclosure under negative
pressure throughout the operation. Compressed air may be used to remove
asbestos fibers or particles from the enclosure.
5. Use the HEPA-filtered vacuum first to loosen asbestos residue from
the brake and clutch parts, then evacuate the loosened material from
the enclosure into a vacuum filter.
6. When the vacuum filter is full, spray it with a fine mist of water
before removing it. Immediately place it in a labeled, impermeable
container and dispose of it as asbestos waste in accordance with
federal, state, and local regulations and in compliance with
1910.1001(k)(6). The label must include the following information:
"Danger, Contains Asbestos Fibers, Avoid Creating Dust, Cancer And Lung
Disease Hazard."
7. Immediately clean spills or releases of asbestos containing waste
material from inside the enclosure or vacuum hose or filter. Properly
dispose of waste as asbestos waste.
Vacuum enclosure units should be large enough to fully enclose and
remove the brake drum with enough room for hammering if the drums are
difficult to remove because of wear, rust, or other reasons. Enclosure
systems should have good interior lighting to illuminate the work area.
The enclosure should completely enclose the brake drum, and form a
tight seal behind the backing plate. Air guns should never be aimed
towards the seal as this may reduce or eliminate its protective
ability.
After cleaning with compressed air, the inside surfaces of the
enclosure should be HEPA vacuumed to keep the inside clean and maintain
visibility. Each brake component should be vacuumed as it is removed
and the backing plate should be vacuumed after all the components have
been removed. Rags used to wipe or clean used brake parts, should not
be used to wipe hands. Mechanics should wear an appropriate NIOSH-
approved respirator for asbestos when changing vacuum unit filters.
Low pressure/wet cleaning method:
The low pressure/wet cleaning method involves the following steps:
1. Position a catch basin under the brake assembly to avoid splashes
and spills.
2. Gently flood the brake assembly with water containing an organic
solvent or wetting agent to prevent asbestos-containing brake dust from
becoming airborne.
3. For drum brakes, ensure that the water solution flows between the
brake drum and the brake support before removing the brake drum.
4. After removing the brake drum, thoroughly wet the wheel hub and back
of the brake assembly with the water solution to suppress dust.
5. Thoroughly wash the brake support plate, brake shoes, and other
parts before removing the old brake shoes.
6. If your system uses a filter, wet the filter when it becomes full
and before removal, with a fine mist of water, and place immediately in
an impermeable container. Label the container and dispose of it as
asbestos waste.
7. Immediately clean spills of asbestos-containing liquid or asbestos-
containing waste material using a HEPA-filtered vacuum and/or wet
methods. Properly dispose of waste as asbestos waste.
8. Dry brushing is prohibited.
9. The brake washer solution should be changed regularly for maximum
efficiency of the unit.
Wet method:
For shops that perform infrequent brake work and clutch repair work,
OSHA allows the use of a wet method as a "preferred" method. Therefore,
in facilities in which five (5) or fewer brake jobs" (five brake jobs"
are equivalent to five vehicles) or 5 clutches, or some combination
totaling 5, are inspected, disassembled, reassembled and/or repaired
per week, the mechanic/technician may control potential asbestos
exposure through the use of a spray bottle, hose nozzle, or any
implement capable of delivering a fine mist of water or amended water
at low pressure to wet down the drum or clutch housing before removing
it and to control asbestos fiber release during subsequent activities.
However, any wastewater generated must be captured and properly
disposed of without allowing it to dry on any surfaces. OSHA
anticipates that using a spray bottle will adequately control dust
without generating a large volume of wastewater.
The wet method requires the following steps:
1. Brake and clutch parts must be wetted with water or amended water
before taking any other action.
2. Wipe the brake and clutch parts clean with a cloth.
3. Place contaminated cloth into an impermeable, properly labeled
container, and then dispose of it as asbestos waste. Alternatively, the
cloth can be laundered to prevent the release of asbestos fibers in
excess of 0.1 fiber per cubic centimeter of air, expressed as an 8-hour
time-weighted average.
4. Any spilled water or amended water or asbestos-containing waste
material must be cleaned immediately with a cloth or HEPA-filtered
vacuum and not allowed to dry.
5. Do not dry brush.
The simplicity of the wet control does not eliminate the need for
correct work practices. For example, holding the spray nozzle too close
to the brake surface may cause asbestos fibers to become airborne.
Brake components should be sprayed to saturate the parts as they are
removed from the assembly.
Equivalent methods:
Like the preferred methods, an equivalent method must include a
detailed description of the practices that must be followed when the
method is used. An employer who uses such a method must have a written
description of the method that contains sufficient detail that the
method can be reproduced. The employer must provide information
demonstrating that the exposures resulting from an equivalent method
are equal to or less than exposures from the negative pressure
enclosure/HEPA vacuum system method. For purposes of equivalency,
employee exposures must not exceed 0.016 f/cc, as measured by the OSHA
reference method and averaged over at least 18 personal samples.
The following method, spray can/solvent system, maybe used as an
"equivalent" method. The spray can/solvent system may be used when
proper work practices are followed. At a minimum, the spray can/
solvent system method must follow detailed written procedures including
the following:
l. Wet the brake and clutch parts with the spray can/solvent before
taking any other action.
2. Wipe the brake and clutch parts clean with a cloth.
3. Place contaminated cloth into an impermeable, properly labeled
container, and then dispose of it as asbestos waste. Alternatively, the
cloth can be laundered to prevent the release of asbestos fibers in
excess of 0.1 fiber per cubic centimeter of air, expressed as an 8-hour
time-weighted average.
4. Immediately clean any spilled solvent or dispersed asbestos with a
cloth or HEPA vacuum.
5. Dry brushing during spray can/solvent system operations is
prohibited.
The solvents typically used in brake and clutch work are hazardous
chemicals, which requires the employer to comply with the Hazard
Communication standard. If the solvents are flammable, appropriate
precautions against fire and explosion must be taken.
Best Practices:
Mechanics should assume that all brakes have asbestos-type shoes. Worn
nonasbestos-type brake shoes cannot be readily distinguished from
asbestos-type shoes. If a mechanic assumes incorrectly that a shoe is a
nonasbestos-type and fails to utilize brake dust control procedures,
increased asbestos exposure may result.
Mechanics must be trained in the correct and most effective way to use
the control system selected by the facility manager or owner. The
danger of increased exposure to asbestos as the result of improper work
practices should be explained. Examples of improper work practice
include: directing an air nozzle at an enclosure seal, placing the
nozzle of a spray mist too close to the work surface, not placing the
vacuum nozzle close enough to the contaminated surface, turning on the
vacuum pumps before positioning the vacuum enclosure over the wheel and
leaving them on when removing the enclosure, and splashing or spilling
contaminated solutions on the floor. A control system must always be
used and consistent work procedures are essential.
Use pre-ground, ready-to-install parts when possible. If asbestos-
containing friction materials must be drilled, grooved, cut, beveled,
or lathe-turned, low speeds should always be used to keep down the
amount of dust created. All machinery should have an adequate, HEPA
equipped local exhaust dust collection system to prevent asbestos
exposures and shop contamination. Immediately clean spills of brake
dust or contaminated solutions by H EPA vacuuming or wet mopping.
A regular maintenance program for the system used to control brake dust
is essential. Maintenance should include checking and replacing seals,
nozzles, other hardware, contaminated filters and solutions. Any
deficiencies such as ineffective seals, or air nozzles should be
repaired. Disposal of asbestos contaminated material, whether it is
filters or solutions, must be in accordance with federal and state
regulations and in compliance with 1910.1001(k)(6). Periodic cleaning
will help reduce the possibility of asbestos contamination of
workbenches, floors, etc. Mechanics should perform brake and clutch
work in an area isolated from other work areas. Signs should be posted
informing employees not to eat, drink, or smoke in the brake and clutch
work area. Asbestos and other potentially toxic materials can be
ingested or inhaled during these activities.
Personal hygiene, such as frequent hand washing with soap or detergent,
should be stressed. Changing from soiled work clothes into clean
clothes before leaving work provides additional protection against
bringing asbestos into the home environment. A laundry service with
facilities for cleaning asbestos contaminated clothing must be provided
for any asbestos-contaminated work clothes.
Conclusion:
Engineering controls and good work practices must be implemented
throughout the process of performing brake and clutch inspection,
disassembly, repair, and assembly. The four types of control systems or
methods described here can effectively reduce employees' asbestos
exposure below the OSHA permissible exposure level.
Information about job hazards must be disseminated through a training
program that describes how to do properly perform a task, how each work
practice reduces potential exposure, and how employees can benefit from
these practices. No matter, which control system, is used, employees
must be trained in how to properly use it. Employees (and do-it-
yourselfers who choose not to have brake and clutch work conducted by
professional mechanics) who can recognize and control hazards are
better equipped to protect themselves from asbestos exposure. Training
and work practices should be frequently reinforced.
Business owners who are concerned about the cost of professional help
can contact the OSHA Consultation Project Office in their state for
free consultation service. Priority is given to businesses with fewer
than 250 employees at a worksite, with further consideration given to
the severity of the worksite problem. The Consultation Program can help
the employer evaluate and prevent hazardous conditions in the workplace
that can cause injuries and illness.
Source: OSHA.
[End of section]
Appendix IV: Current Best Practices for Preventing Asbestos Exposure
Among Brake and Clutch Repair Workers:
United States Environmental Protection Agency:
Current Best Practices for Preventing Asbestos Exposure Among Brake and
Clutch Repair Workers:
Figure:
[See PDF for image]
Photograph of brake assembly.
[End of figure]
This information can help professional automotive technicians and home
mechanics who repair and replace brakes and clutches. By law, most
professional automotive shops must follow the Occupational Safety and
Health Administration's (OSHA) regulations at 29 CFR 1910.1001,
specifically paragraph (f)(3) and Appendix F. These are mandatory
measures that employers must implement for automotive brake and clutch
inspection, disassembly, repair, and assembly operations. State and
local governments with employees who perform brake and clutch work in
states without OSHA-approved state plans must follow the identical
regulations found under the EPA Asbestos Worker Protection Rule
(Subpart G of 40 CFR 763).
While home mechanics are not required to follow the OSHA work practices
(or the identical requirements under the EPA Asbestos Worker Protection
Rule), by using these practices home mechanics can minimize potential
exposure to asbestos if it is present and thereby reduce their
potential risk of developing any asbestos-related diseases.
What is asbestos and how can it cause health problems?
Asbestos, a naturally occurring mineral fiber that is highly heat
resistant, can cause serious health problems when inhaled into the
lungs. If products containing asbestos are disturbed, thin, lightweight
asbestos fibers can be released into the air. Persons breathing the air
may then inhale asbestos fibers. Continued exposure can increase the
amount of fibers deposited in the lung. Fibers embedded in the lung
tissue over time may result in lung diseases such as asbestosis, lung
cancer, or mesothelioma. It can take from 10 to 40 years or more for
symptoms of an asbestos-related condition to appear. Smoking increases
the risk of developing illness from asbestos exposure.
For more information on the health effects of asbestos exposure, visit
the Agency for Toxic Substances and Disease Registry (ATSDR) at
[hyperlink, http://www.atsdr.cdc.gov/asbestos/index.html].
Why should mechanics be concerned about asbestos exposure?
Because some, but not all, automotive brakes and clutches available or
in use today may contain asbestos, professional automotive technicians
and home mechanics who repair and replace brakes and clutches may be
exposed to asbestos dust. Brake and clutch dust can be seen when a
brake disk, drum, clutch cover, or the wheel is removed from a car,
truck, or other equipment. There are also many small dust particles
that cannot be seen with the eye. If the brakes contain asbestos, the
dust may contain asbestos fibers, which could be inhaled.
Do not blow dust from brakes and clutches!
Figure:
[See PDF for image]
Photograph of brake assembly, with the following description:
Using compressed air, a brush (wet or dry), or a dry rag to clean brake
assemblages has the potential to expose you to asbestos fibers.
[End of figure]
How do I know if I have asbestos brake or clutch components?
You cannot tell whether brake or clutch components contain asbestos
simply by looking at them. For newer vehicles and parts, auto
manufacturers, auto parts retailers and packaging information, such as
labels or Material Safety Data Sheets, may be able to tell you whether
or not your brake or clutch components contain asbestos. For older
vehicles, or vehicles that have had brakes replaced, you may not be
able to easily find out if the brake or clutch components contain
asbestos.
As a best practice, OSHA states that mechanics should assume that all
brakes have asbestos-type shoes. Worn non-asbestos-type brake shoes
cannot be readily distinguished from asbestos-type shoes. If a mechanic
assumes incorrectly that a shoe is a non-asbestos type and fails to
utilize brake dust control procedures, increased asbestos exposure may
result.
As a professional automotive technician, what work practices must I
follow to reduce potential exposures to asbestos?
If you work in a commercial automotive shop that performs work on more
than five brake or clutch jobs per week, OSHA regulations require the
use of one of the following work practices or an equivalent method such
as the spray can/solvent system.
Negative-Pressure Enclosure/HEPA Vacuum System Method: This type of
enclosure and vacuum system has a special box with clear plastic walls
or windows, which fits tightly around a brake or clutch assembly to
prevent asbestos exposure.
Low Pressure/Wet Cleaning Method: This specially designed low-pressure
spray equipment wets down the brake assembly and catches the runoff in
a special basin to prevent airborne brake dust from spreading in the
work area.
If you work in a commercial automotive shop that performs work on no
more than five brake or clutch jobs per week, OSHA regulations allow
the following method instead:
Wet Wipe Method: This method involves using a spray bottle or other
device capable of delivering a fine mist of water, or amended water
(water with a detergent), at low pressure to wet all brake and clutch
parts. The brakes can then be wiped clean with a cloth.
As a home mechanic, what can I do to protect myself from asbestos
exposure?
If you are not able to determine whether your brakes or clutch contain
asbestos, you may want to consider having your brakes or clutch
serviced at a commercial automotive shop. OSHA requires special work
practices for professional automotive technicians. If, however, this is
not possible and you do not have access to the equipment professional
automotive shops use to comply with the OSHA work practices, you may
want to consider using the wet wipe method described in this brochure
[hyperlink, http://www.osha.gov/SLTC/asbestos/standards.html]. This
method has been deemed acceptable by OSHA for shops that service no
more than five brake or clutch jobs per week.
Work Practice Don'ts for Home Mechanics:
It is recommended that you:
* Do not use compressed air for cleaning. Compressed air blows dust
into the air.
* Do not clean brakes or clutches with a dry rag, brush (wet or dry),
or garden hose.
* Do not use an ordinary wet/dry vac without a high-efficiency
particulate air (HEPA) filter to vacuum dust. Invisible particles of
brake or clutch dust can stay in the air and on your clothes long after
a job is complete.
* Avoid taking work clothing inside the home or tracking dust through
the house after performing brake and clutch work to prevent exposing
your family to dust particles that may contain asbestos.
Work Practice Do's for Home Mechanics:
It is recommended that you:
* Use pre-ground, ready-to-install parts.
* If a brake or clutch lining must be drilled, grooved, cut, bevelled,
or lathe-turned, use low speeds to keep down the amount of dust
created.
* Use machinery with a local exhaust dust collection system equipped
with HEPA filtration to prevent dust exposures and work area
contamination.
* Change into clean clothes before going inside the home and wash
soiled clothes separately.
* Minimize exposure to others by keeping bystanders, as well as food
and drinks, away from the work area.
How do I dispose of waste that contains asbestos?
Employers of professional automotive technicians must ensure that they
or their waste haulers dispose of waste that contains brake or clutch
dust, including wet rags used to wipe this dust, in accordance with
Federal and local regulations, including the OSHA asbestos waste
disposal regulations. OSHA regulations (29 CFR 1910.1001(k)(6) and 29
CFR 1910.10010)(4)) require that, before waste containers with brake
and clutch dust and other asbestos waste in them are collected, they
must be sealed. The containers also must be impermeable and must be
appropriately labeled. These regulations do not apply to home
mechanics. For home mechanics, EPA recommends that asbestos waste be
double-bagged and disposed of following appropriate local
regulations to minimize exposure. You may contact your state asbestos
representative for more disposal and other information. [hyperlink,
http://www.epa.gov/asbestos/pubs/statecontact.pdf].
Where can I get additional information?
OSHA has issued a Safety and Health Information Bulletin on brake and
clutch repair that is available at [hyperlink,
http://www.osha.gov/dts/shib/shib072606.html].
EPA's Asbestos Worker Protection Rule regulations apply to certain
state and local government employees (40 CFR Part 763, Subpart G). For
more information on EPA 's Asbestos Program visit: [hyperlink,
http://www.epa.gov/asbestos] or call 202-554-1404.
Source: EPA.
[End of section]
Appendix V: Comments from the Environmental Protection Agency:
United States Environmental Protection Agency:
Office Of Prevention, Pesticides And Toxic Substances:
[hyperlink, http://ww.epa.gov]:
Washington, D.C. 20460
March 19, 2008:
Mathew Scire, Director:
Strategic Issues:
Government Accountability Office (GAO):
Dear Mr. Scire:
Thank you for providing us with an opportunity to review the final
draft report entitled: "Health and Safety Information; EPA and OSHA
Could Improve Their Processes for Preparing Communication Products."
The report emphasizes that public communication is a valuable tool to
use in fulfilling the mission of EPA and other agencies, such as the
Occupational Safety and Health Administration (OSHA). EPA agrees with
and endorses that view. Equally important and valid is the point by GAO
that a formal, well-understood process for coordination and review of
communication materials is important to ensure quality information
products. We appreciate the opportunity to work with your staff in
recent months to explain EPA's product development and review process,
and we acknowledge the recommendations you have made to EPA. We
sincerely appreciate the opportunity to allow our suggestions of
technical clarity to inform your final report.
Generally speaking, communications products represent a broad category
of materials and a fair amount of flexibility and discretion is
necessary for their development to ensure the product meets the
program's needs. There is no one template that can be used for every
product, particularly during development at the programmatic level. In
addition, the Agency has a longstanding process to ensure that products
that go out to the public are clear and consistent. This process is
managed by EPA's Office of Public Affairs (OPA). OPPTS diligently
adheres to the OPA process. The brochure, "Current Best Practices for
Preventing Asbestos Exposure Among Brake and Clutch Repair Workers,"
which is the focus of your report, followed the longstanding OPA
process.
GAO's first recommendation suggests that "...the Administrator of EPA
should ensure that their key general process guidance for preparing
communication products include, as appropriate, timeframes or
benchmarks to help ensure that products that the agencies have
determined are needed are developed, reviewed, and disseminated in a
timely manner."
The Agency agrees that developing timely communication materials is
important. However, there are times when the Agency should be allowed
the flexibility to divert resources and adjust schedules, when
necessary, from lower-priority projects to higher-priority projects
while we also endeavor to meet internally established timeframes. We
both note that the process for development and publication of the
brakes brochure was lengthy. But equally important is that the
necessary health and safety information relating to potential asbestos
hazards associated with brake and clutch repair was at all times
publicly available. The timeframe associated with developing the brakes
brochure was an anomaly, and may not be a useful standard to compare in
other cases. In addition, we urge caution in comparing the processes
and products of a single program office within EPA to the processes and
products of an entire Agency such as OSHA.
GAO's second recommendation suggests that "...the Administrator of EPA
should take steps to ensure that their general policies and procedures
for preparing communication products are fully documented. To the
extent feasible, this should include identifying the applicable
policies and procedures governing OMB/interagency coordination and
reviews of such products, as well as any other key processes that the
agencies believe are important to understanding how they prepare their
products.
We agree with this recommendation and, in fact, have been taking steps
to document more fully Agency actions as a result of the Office of
Management and Budget "Final Bulletin for Agency Good Guidance
Practices." As the Agency has been implementing "Good Guidance," we
discover that increased clarity of procedures and standardization of
product development can increase efficiencies and accountability within
EPA programs and in OPPTS in particular. OPPTS has initiated
development of guidance on products developed within our office to help
foster "Good Guidance" compliance and increased standardization and
accountability for products even if they are non regulatory or do not
need to comply with the Bulletin. Importantly, the overall Agency
product review process managed by OPA is the Agency's principal means
to ensure that all aspects of materials produced for the public are
reviewed for communications value and effectiveness, policy
coordination and conformity with various EPA requirements.
Additionally, OPA maintains an inventory of public communication
products that are under development or has reviewed. Information on
this process is published on the EPA Website and is publicly available
at: [hyperlink, http://www.epa.gov/productreview/faqs.html].
GAO's third recommendation suggests that "the Administrator of EPA
should ensure that their agencies make public the key general process
guidance for preparing communication products, including any updated in
response to the previous objective."
As stated above, OPA's process for preparation and clearance of
communication products is published on the EPA Web-site both on its
intranet and Internet pages. It is rather detailed and well-known to
the communications staffs in Program and Regional Offices, and is
available to the general public via the aforementioned web-site.
GAO's fourth recommendation suggests that "the Administrator of EPA
should consider adopting for OPPTS-and other EPA offices, as
appropriate-a centralized database or databases to more completely
account for the inventory of communication materials disseminated by
the agency."
We agree with your fourth suggestion and in fact, in OPPTS we have
existing management strategies to ensure communication materials have a
documented process to ensure timeliness, appropriate management
oversight, effectiveness and adherence to Executive Orders and other
Agency requirements. Also, the Agency does have a centralized approach
to developing communication materials, as well as a database of
communication materials planned for dissemination by the Agency. This
system is called the Product Review Tracking System (PROTRAC).
Individual Program Offices enter planned communications projects into
the database and manage them through the clearance process, which
overseen by OPA.
Again, we appreciate the opportunity to review the final draft of this
report. Should you have any further questions, please contact Beverly
Fletcher, our GAO Liaison for this report, at 202-564-5717.
Sincerely,
Signed by:
Jim Jones:
Deputy Assistant Administrator:
[End of section]
Appendix VI: GAO Contact and Staff Acknowledgments:
GAO Contact:
Mathew J. Scire, (202) 512-6806 or sciremj@gao.gov:
Acknowledgments:
In addition to the contact named above, key contributors to this report
were Tim Bober, Assistant Director; Andrea Levine; Shawn Mongin; Joseph
Santiago; John Sauter; and Crystal Williams. In addition, Tom Beall,
Robert Cramer, Donna Miller, Michael Volpe, and Greg Wilmoth provided
key assistance.
[End of section]
Footnotes:
[1] There is no single term or definition used by the agencies to refer
to these general informational products. EPA tends to use the term
communication products, and OSHA tends to refer to them as compliance
assistance products or compliance assistance materials. For consistency
in this report, we generally use the term communication products,
unless specifically referring to a particular agency, category of
products, or both. We also use the term preparation when referring
collectively to the phases of initiation, development, review, and
dissemination of communication products.
[2] More technical and analytical products--such as risk assessments,
scientific models and research, and economic benefit-cost analyses--
were not within the scope of this review, but prior GAO reports have
discussed some of the policies and procedures applicable to such
products. See, for example, GAO, Federal Research: Policies Guiding the
Dissemination of Scientific Research from Selected Agencies Should Be
Clarified and Better Communicated, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-07-653] (Washington, D.C.: May 17, 2007), and Chemical
Risk Assessment: Selected Federal Agencies' Procedures, Assumptions,
and Policies, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-01-810]
(Washington, D.C.: Aug. 6, 2001).
[3] Although OSHA and OPPTS officials said that their asbestos products
were not typical examples of communication products, the agencies
nonetheless used applicable agency procedures to prepare those
products.
[4] IQA (also referred to as the Data Quality Act) required OMB to
issue guidelines to federal agencies to ensure the "quality,
objectivity, utility, and integrity" of information disseminated to the
public. IQA also directed OMB to include in its guidelines a
requirement that federal agencies (1) develop their own quality
guidelines and (2) establish an administrative mechanism for affected
persons to seek correction of information that does not comply with OMB
guidelines (referred to as requests for correction). 44 U.S.C. § 3516
note.
[5] OMB Bulletin on "Agency Good Guidance Practices," 72 Fed. Reg. 3432
(Jan. 25, 2007). A significant guidance document is defined in this
bulletin, in part, as a guidance document disseminated to regulated
entities or the general public that may reasonably be anticipated to
lead to an annual effect of $100 million or more or adversely affect in
a material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or state,
local, or tribal governments or communities.
[6] 54 Fed. Reg. 29,460 (July 12, 1989).
[7] Corrosion Proof Fittings v. EPA, 947 F. 2d 1201, 1229 (5th Cir.
1991).
[8] See 29 C.F.R. § 1910.1001, specifically paragraph (f)(3) and
Appendix F.
[9] 40 C.F.R. § 763, Subpart G.
[10] Pub. L. No. 404, 60 Stat. 237 (1946), codified in 1966 in
scattered sections of title 5, United States Code.
[11] 5 U.S.C. § 551(4).
[12] 5 U.S.C. § 553.
[13] The APA includes exceptions to notice and comment procedures for
categories of rules such as those dealing with military or foreign
affairs and also agency management and personnel. 5 U.S.C. §§ 553(a)
and (b).
[14] 5 U.S.C. § 553(c).
[15] 29 U.S.C. § 655.
[16] 5 U.S.C. § 553(b)(A).
[17] See Jeffrey S. Lubbers, A Guide to Federal Agency Rulemaking,
Fourth Edition (Chicago, American Bar Association: 2006), 51-58.
[18] See General Elec. Co. v. EPA, 290 F.3d 377, 385 (D.C. Cir. 2002)
(striking down polychlorinated biphenyls (PCB) risk assessment guidance
as a legislative rule requiring notice and comment); Appalachian Power
Co. v. EPA, 208 F.3d 1015, 1023-24 (D.C. Cir. 2000) (overturning
emissions monitoring guidance as a legislative rule requiring notice
and comment); and Chamber of Commerce v. United States Dep't of Labor,
174 F.3d 206, 212-213 (D.C. Cir. 1999) (declaring an OSHA directive a
legislative rule requiring notice and comment).
[19] See Nina A. Mendelson, "Regulatory Beneficiaries and Informal
Agency Policymaking," 92 Cornell L. Rev. 397 (March 2007).
[20] See, for example, GAO, Hazardous Materials: EPA May Need to
Reassess Sites Receiving Asbestos-Contaminated Ore from Libby, Montana,
and Should Improve Its Public Notification Process, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-08-71] (Washington, D.C.: Oct.
12, 2007); World Trade Center: EPA's Most Recent Test and Clean Program
Raises Concerns That Need to Be Addressed to Better Prepare for Indoor
Contamination Following Disasters, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-07-1091] (Washington, D.C.: Sept. 5, 2007); and
Hurricane Katrina: EPA's Current and Future Environmental Protection
Efforts Could Be Enhanced by Addressing Issues and Challenges Faced on
the Gulf Coast, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-
651] (Washington, D.C.: June 25, 2007).
[21] See GAO, Federal Rulemaking: Past Reviews and Emerging Trends
Suggest Issues That Merit Congressional Attention, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-06-228T] (Washington, D.C.: Nov.
1, 2005); Rulemaking: OMB's Role in Reviews of Agencies' Draft Rules
and the Transparency of Those Reviews, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-03-929] (Washington, D.C.: Sept.
22, 2003); and Federal Rulemaking: Procedural and Analytical
Requirements at OSHA and Other Agencies, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-01-852T] (Washington, D.C.: June
14, 2001).
[22] GAO, Regulatory Reform: Compliance Guide Requirement Has Had
Little Effect on Agency Practices, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-02-172] (Washington, D.C.: Dec. 28, 2001).
[23] An LEP is intended to address hazards or industries that pose a
particular risk to workers in an office's jurisdiction. The LEP may
include outreach intended to make employers in the area aware of the
program as well as the hazard(s) the program is designed to reduce or
eliminate.
[24] 29 C.F.R. § 1910.1001, Appendix F.
[25] The general OSHA and OPPTS processes are described in more detail
later in this report.
[26] OPPTS officials shared the draft of the brochure with staff within
OSHA, the National Institute for Occupational Safety and Health, the
Mining Safety and Health Administration, the Consumer Product Safety
Commission, and the Centers for Disease Control and Prevention.
[27] Last accessed by GAO on March 25, 2008.
[28] Last accessed by GAO on March 25, 2008.
[29] The OSHA instructions on policy issuances are found in Directive
Number ADM 03-00-002 [ADM 8-0.2] (Dec. 11, 2000), for nonpolicy
issuances in Directive Number ADM-03-00-004 [ADM 8-0.4] (Dec. 11,
2000), and for SHIBs in Directive Number CPL 02-00-065 [CPL 2.65A]
(Aug. 27, 2003).
[30] Directive Number IPC 01-00-006 (Sept. 25, 2007).
[31] Policy issuances are official statements of OSHA published in the
Code of Federal Regulations, Federal Register, the OSHA Directives
System, or a combination of these. Such statements include OSHA rules,
regulations, and compliance assistance policies and procedures, and
also statements of policy and procedure relating to areas such as
partnerships, outreach, and educational programs. Nonpolicy issuances
include such supplementary guidance materials as OSHA's Letters of
Interpretation, agency announcements, or informational releases, such
as publications intended for the general public, news releases, routine
correspondence, or other nonpolicy statements.
[32] OSHA officials pointed out that this step, and a similar step
added under the review process to refer the SHIB to the DOL Executive
Secretariat before final signature, were not part of the SHIB
procedures at the time that OSHA updated the SHIB on asbestos in
automobile brake and clutch repair work.
[33] If the compliance assistance product contains influential
information under the agency's IQA guidelines or is a significant
guidance document under the good guidance practices memorandum
(discussed in more detail in following sections), the final product
also must be forwarded to OSHA's Directorate of Standards and Guidance
after all reviews are complete.
[34] See the Government Performance and Results Act (GPRA) of 1993,
Pub. L. No. 103-62 (Aug. 3, 1993) and the accompanying report of the
Committee on Governmental Affairs, United States Senate. GPRA was
enacted to help resolve long-standing management problems that
undermined the federal government's efficiency and effectiveness and
provide greater accountability for results.
[35] An OPPTS official said that the agency publicly posts its policies
and procedures that are pertinent to public participation, but, in
circumstances where the policies and procedures are internal and do not
include public participation, the agency opts not to make them
available on its Web site.
[36] OPPTS officials noted, however, that, unlike the OSHA process for
compliance assistance products described above, OPPTS' process for
communication products is not used for the preparation of guidance
documents. Different processes, such as the Action Development Process,
apply to EPA guidance.
[37] OPPTS officials noted that OMB and OPPTS also have an informal
agreement whereby OPPTS will offer OMB an opportunity to review its
Pesticide Registration Notices.
[38] For example, when we asked the agency to compile a list of a
subset of communication products issued since October 2002, EPA program
offices estimated that this could take from 3 to 6 months. We limited
our request to 4 of 20 product categories previously identified by EPA-
-general guidance, guidance on how to comply with a regulation,
educational and training materials, and brochures and pamphlets.
[39] In the FDA Modernization Act of 1997, Congress clarified that
FDA's guidance documents were advisory rather than legally binding, but
required public participation in some instances. 21 U.S.C. § 371(h)(1).
[40] 5 U.S.C. § 553(b).
[41] 44 U.S.C. §§ 3501-3520.
[42] 5 U.S.C. §§ 601-612.
[43] Pub. L. No. 104-4, 109 Stat. 48 (1995), codified as amended in
scattered sections of title 2, United States Code.
[44] 5 U.S.C. §§ 801-808.
[45] Exec. Order No. 12866, 58 Fed. Reg. 51,735 (Sept. 30, 1993), as
amended by Exec. Order No. 13422, 72 Fed. Reg. 2763 (Jan. 23, 2007).
[46] Per OMB's January 2007 bulletin on good guidance practices, there
is now a specific requirement that significant guidance documents
include the citation to the statutory provision or regulation that the
guidance applies to or interprets.
[47] See [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-03-929] for
a detailed description of this process.
[48] See, for example, GAO, Regulatory Reform: Prior Reviews of Federal
Regulatory Process Initiatives Reveal Opportunities for Improvements,
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-939T] (Washington,
D.C.: July 27, 2005).
[49] In his guide to federal agency rulemaking, Jeffrey Lubbers
identified three important functions of the rulemaking record: (1)
aiding public participation in the rulemaking; (2) providing the basis
for the agency's decision whether to adopt a rule and, if so, what
provisions the rule should include; and (3) assisting judicial review
of the final rulemaking decision. Lubbers, A Guide to Federal
Rulemaking, p. 320.
[50] [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-03-929].
[51] We recommended that OMB take actions to improve the transparency
of reviews of draft rules whenever they occur, not just during formal
reviews, but OMB disagreed with the recommendations.
[52] 5 U.S.C. § 552(b)(2).
[53] OPPTS officials identified an exception, under section 406 of the
Toxic Substances Control Act, which directs EPA and other agencies to
publish--and "from time to time" revise or update--an information
pamphlet about residential lead-based paint hazards. According to the
statute, both the initial issuance and any revisions of the pamphlet
must occur after notice and an opportunity for public comment. 15
U.S.C. § 2686.
[54] Information on agencies' current and past regulatory agendas and
plans and OMB's regulatory reviews is available electronically through
[hyperlink, http://www.RegInfo.gov]. The annual regulatory plans
identify agencies' regulatory priorities and contain additional details
about the most significant regulatory actions agencies expect to take
in the coming year.
[55] These include the SCOUT system that the agency uses to track
communication products that it is about to release to the public and
the PROTRACK system that tracks the review process for communication
products.
[56] The bulletin defines a "guidance document" as an agency statement
of general applicability and future effect, other than a regulatory
action (as defined in Executive Order 12866, as amended), that sets
forth a policy on a statutory, regulatory, or technical issue or an
interpretation of a statutory or regulatory issue.
[57] The bulletin defines an economically significant guidance document
as a "significant guidance document that may reasonably be anticipated
to lead to an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy or a sector of the
economy, except that economically significant guidance documents do not
include guidance documents on Federal expenditures and receipts."
[58] We found that there is no single term or definition used by the
agencies to refer to general regulatory communication products. EPA
tends to use the term communication products, and OSHA tends to refer
to them as compliance assistance products or compliance assistance
material. For consistency in this report, we generally use the term
communication products, unless specifically referring to a particular
agency, category of products, or both. Also, for purposes of
consistency, we generally use the term processes to encompass the
policies, procedures, and practices used by each agency to initiate,
develop, review, and disseminate communication products.
[59] Further, EPA/OPPTS officials indicated that it would take up to 6
months to identify or develop a population of products classified by
type from which a sample could be drawn.
[60] Non-employees outside the automotive repair industry who typically
repair or replace their own brakes at home. These individuals are not
subject to the OSHA requirements in this Safety and Health Information
Bulletin. For more information about EPA's asbestos program, do-it-
yourselfers may visit EPA's website at [hyperlink,
http://www:epa.gov/asbestos] or you may call the asbestos ombudsman's
hotline/clearing house at 1-800-368-5888.
[61] Asbestos in Brakes Exposure and Risk of Disease. Richard A. Lemen,
PhD. MSPH, American Journal of Industrial Medicine 45: 229-237 (2004).
[End of section]
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