the proposed certification requirement. Some commenters argued that the
certification requirement increases the regulated community's burden,
but provides no corresponding benefit. Other comments urged EPA to
incorporate the ``reasonable inquiry'' concept from Title V compliance
certifications into the proposed certification framework. These
commenters described the ``reasonable

inquiry'' concept as requiring certification based on ``information and
belief formed after reasonable inquiry.'' The commenters argued that
this was necessary because a senior official signing a certification
could not be expected to have or obtain personal knowledge of all the
facts potentially relevant to the findings response report. Similarly,
a facility encouraged EPA to coordinate the certification statement in
this rule with the certification statement that is already required
under CAA Title V. One commenter stated that EPA's rules regarding
self-audits impose a less stringent certification requirement, and
recommended that a less stringent standard may be appropriate here,
too, if the third-party compliance audit provisions are finalized.
    In this rule, EPA is requiring a senior corporate officer, or an
official in an equivalent position, to certify in the findings response
report that:
     He or she engaged a third-party to perform or lead an
audit team to conduct a third-party audit in accordance with the
requirements of 40 CFR 68.59 or 68.80,
     The attached RMP compliance audit report was received,
reviewed, and responded to under the senior officer's direction or
supervision by qualified personnel, and
     Appropriate responses to the findings have been identified
and deficiencies were corrected, or are being corrected, consistent
with the requirements of subparts C or D of 40 CFR part 68.
    EPA believes these requirements and the associated certification
are consistent with equivalent certification requirements in many EPA
regulations, including in the CAA Title V regulations (40 CFR
70.5(d).\58\)
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    \58\ ``(d) Any application form, report, or compliance
certification submitted pursuant to these regulations shall contain
certification by a responsible official of truth, accuracy, and
completeness. This certification and any other certification
required under this part shall state that, based on information and
belief formed after reasonable inquiry, the statements and
information in the document are true, accurate, and complete.''
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    EPA agrees that senior corporate officials do not necessarily have
high levels of technical expertise; however, these officials and
entities include key managers responsible for establishing internal
corporate accountability and overseeing corporate prioritization,
budgeting, and operations. Indeed, the Security and Exchange Commission
(SEC) requires other specified documents to be provided to such
individuals, committees, and boards for similar reasons.\59\ Finally,
EPA believes that the certification will minimize corporate failures to
properly address and implement compliance audit findings and
recommendations. Adopting a less stringent standard would not be
appropriate. EPA expects that the senior corporate official
certification of the audit findings will improve facility and public
confidence that third-party audit report findings and recommendations
are promptly and properly addressed.
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    \59\ Under Section 3(a)(58) of the Exchange Act as added by
Section 205 of the Sarbanes-Oxley Act, the term audit committee is
defined as ``[a] committee (or equivalent body) established by and
amongst the board of directors of an issuer for the purpose of
overseeing the accounting and financial reporting processes of the
issuer and audits of the financial statements of the issuer'' (if no
such committee exists with respect to an issuer, the entire board of
directors of the issuer). See Securities and Exchange Commission, 17
CFR 240.10A-3--Listing standards relating to audit committees (68 FR
18818, April 16, 2003, as amended at 70 FR 1620, January 7, 2005; 73
FR 973, January 4, 2008).
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    Senior corporate officer or equivalent official. Comments were
received requesting clarification of the terms ``senior corporate
officer, or official in an equivalent position.'' Some commenters
recommended that EPA incorporate the ``responsible official''
definition from the CAA's Title V operating permit program for major
stationary sources which allows for certification by corporate
leadership or a ``duly authorized representative'' appointed by
corporate officials.
    One commenter stated that the certification requirement risks
infringing on the senior corporate official's Fifth Amendment privilege
against self-incrimination. The commenter stated that the Supreme Court
has held that the privilege protects against compulsory disclosures to
the government when those disclosures have ``the direct and
unmistakable consequences of incriminating'' the disclosing party, and
concluded that the proposed certification requirement may compel
precisely those sorts of disclosures. The commenter went on to state
that the certification necessarily admits the existence of
``deficiencies'' which can only be interpreted as violations of the CAA
and which could certainly be a significant link in a chain of evidence
tending to establish guilt in a criminal case. One commenter also
argued that the certification requirement raises First Amendment
concerns by compelling speech that does not serve a sufficient
government interest to avoid running afoul of the right to free speech
because it is unclear what government interest the certification
advances and the relevant section of the rule is not narrowly tailored
to that interest.
    EPA disagrees with this recommendation to allow delegation of the
certification to a duly authorized representative. The certification
indicates that the compliance audit report was received, reviewed, and
responded to under the senior corporate officer's direction or
supervision by qualified personnel. Similar to the requirement to
submit the findings response report to the audit committees of the
Board of Directors, a senior corporate official ensures accountability
and overseeing corporate prioritization, budgeting, and operations.
    Furthermore, the language of the certification cites the actions
that are taken by the owner or operator pursuant to these requirements,
and includes, among other things, a statement that based on personnel
knowledge and experience, or inquiry of personnel involved in
evaluating the report findings and or inquiry of personnel involved in
evaluating the report findings and determining appropriate responses to
the findings, the information submitted herein is true, accurate, and
complete. This language is equivalent to the language in certifications
that support submissions under Title V of the CAA. EPA continues to
believe that it is important for a senior corporate official, or an
official in an equivalent position, sign such a certification, ensuring
that the owner or operator is aware of the findings and responses, and
will be correcting the deficiencies, pursuant to these requirements.
For smaller entities without corporate officials, the official in an
equivalent position for purposes of this requirement may include the
owner or operator, or designated representatives of the owner or
operator, including facility manager, operations manager, or another
official at or above that level. Regarding comments concerning self-
incrimination in connection with the certification requirement, the
certification does not contain an acknowledgement of a violation. It
merely describes the actions taken by the owner or operator pursuant to
the third-party audit requirements, and states that the information
submitted is true, accurate, and complete. The certification and report
are not required to be automatically submitted to the implementing
agency.
n. Schedule Implementation
    EPA received comments supporting the proposed requirement for
owners and operators to ``promptly'' address deficiencies noted in
audit reports. A few commenters stated that there should be no specific
timeframe for addressing deficiencies identified during a third-

party audit, reasoning that there will be a wide variety of possible
site-specific actions that an owner or operator may take to address
audit findings. Another commenter believed it was appropriate to
require ``prompt'' correction of deficiencies, but encouraged EPA to
provide guidelines on what would be considered ``prompt'' action.
    Some commenters recommended specific timeframes for addressing
deficiencies. One commenter recommended that deficiencies be corrected
``promptly'' and no later than six months absent a written extension
from EPA. A few commenters recommended that facilities be required to
promptly implement corrective actions and that deficiencies be
addressed within 18 months. However, some of these commenters stated
that facilities should be given the opportunity to request an
extension, if needed, from the implementing agency. Another commenter
recommended that facilities be given 24 months to correct deficiencies
after the facility has identified an appropriate response, with the
deficiencies presenting the highest risk of injury being addressed
first.
    One commenter recommended that EPA allow stationary sources to
develop a reasonable schedule for correcting audit findings that would
be based on the types of audit findings and the resulting efforts to
implement them appropriately, rather than at a pace that may impede
sound and sustainable implementation processes. One commenter stated
that the proposal does not account for the likelihood that plans and
schedules for addressing deficiencies may need to change. To account
for needed changes, the commenter recommended that EPA should clarify
that the details of the schedule are not binding.
    EPA disagrees with commenters that suggested incorporating a
prescribed schedule for addressing findings in the final rule and we
are finalizing the schedule implementation provision of Sec. Sec.
68.59(f)(2) and 68.80(f)(2) as proposed. The owner or operator's third-
party audit findings response report must include ``a schedule for
promptly addressing deficiencies'' but does not prescribe a specific
timeframe or due dates by which the deficiencies must be addressed.
Thus, under the final rule, the owner or operator must exercise best
judgement to determine how, and when, to prioritize and address
actions, consistent with the normal definition of ``promptly'' as
meaning quickly, without delay.\60\ EPA finds that this approach best
provides the flexibility owners or operators will need to address a
potentially very wide range of deficiencies and other findings noted in
third-party audit reports. This allows the facility owner or operator
to develop a reasonable schedule for correcting audit findings that
would be based on the types of audit findings and the resulting efforts
to implement them appropriately.
---------------------------------------------------------------------------

    \60\ See definition of ``promptly,'' Cambridge English
Dictionary, at http://dictionary.cambridge.org/us/dictionary/english/promptly.
---------------------------------------------------------------------------

    EPA also disagrees with commenters' suggestions to request a
schedule extension from the implementing agency. The implementing
agency will not receive a copy of the final audit report or findings
response report and therefore it is inappropriate to request an
extension to address deficiencies identified in the findings response
report. In the event that a schedule must change due to unforeseen
circumstances, EPA recommends that the owner or operator document the
reasons for the change and update the schedule to reflect revised
dates.
o. Submitting Reports to the Board of Directors
    EPA received comments both supporting and opposing the proposed
requirement to submit the audit report to the audit committee of the
Board of Directors. Those in support reasoned that it will make the
Board of Directors aware of the deficiencies, and noted that the
requirement will allow the Board of Directors the opportunity to
properly budget for corrective actions.
    Several commenters, including facilities and industry trade
associations, opposed the proposed requirement to submit the audit
report to the Board of Directors, arguing that it is generally
unnecessary or inappropriate to do so. These commenters stated that the
requirement would unduly constrain facilities that may have other
processes to involve facility leadership in responding to findings from
third-party audits. Similarly, an industry trade association reasoned
that this requirement subverts company policy established under the
rule's management provisions and that the program would be most
effective if each company is allowed to determine the most appropriate
chain of command and reporting. The commenter also warned that such a
requirement could set a precedent for other regulatory programs, which
could result in Boards of Directors receiving a deluge of technical
information that they do not have time to address and that they are in
no position to interpret.
    One commenter recommended that EPA provide definitions for Board of
Directors and audit committee to avoid ambiguity. The commenter also
recommended that EPA specify a timeframe for this report to be
submitted to the Board's audit committee. Furthermore, the commenter
urged EPA to address how this requirement would be documented as
completed or what documentation would be required to demonstrate that
the owner or operator does not have an audit committee or comparable
committee.
    Boards of Directors and their audit committees play an important
role in establishing internal corporate accountability and overseeing
corporate prioritization, budgeting, and operations. EPA believes that
providing the audit committee of the Board of Directors with third-
party audit findings will ensure the committees and their Boards of
Directors are aware of any deficiencies and have the opportunity to
properly budget for any required corrective actions in a timely manner.
EPA expects that this approach will improve facility and public
confidence that third-party audit report findings and recommendations
are promptly and properly addressed.
    Therefore, the final rule requires the owner or operator to
immediately, upon its completion, provide to the audit committee of the
Board of Directors, or other comparable committee or individual, if
applicable a copy of the:
     Findings response report; and
     Implementation schedule to address deficiencies identified
in the audit findings response report.
    EPA does not agree that we should define ``Board of Directors'' and
``audit committee.'' Facility owners or operators should consider their
corporate structure to determine if there is, in fact, a committee or
individual that may serve to oversee auditing and compliance oversight.
The closing clause in Sec. Sec.  68.59(e)(3) and 68.80(e)(3), ``if
applicable,'' replaces the corresponding language in the proposed
rulemaking, ``if one exists.'' ``If applicable,'' in this context, is
intended to clarify that owners or operators not otherwise required by
law to have an audit committee of the Board of Directors or that have
not, otherwise, established or designated a comparable committee or
individual, are not subject to the requirements in Sec. Sec.
68.59(e)(3) and 68.80(e)(3).
    Finally, in response to concerns about demonstrating compliance
with this requirement, EPA recommends that the facility document how
the owner or

operator complied with this requirement and maintain that documentation
with the findings response report. This may include identifying who
received a copy of the report and the date it was provided. If there is
no audit committee of the Board of Directors or a comparable committee
or individual, then the owner or operator should consider documenting
that no committee or individual exists.
p. Third-Party Audit Recordkeeping
    Some commenters supported the proposed third-party audit
recordkeeping requirements. However, some commenters opposed the
requirement to retain copies of the draft audit report. A few
commenters opposed the requirement that records be retained at the
stationary source.
    EPA agrees with commenters that opposed maintaining draft audit
reports. Therefore, EPA is not finalizing the proposed requirement in
Sec. Sec.  68.59(e)(2) and 68.80(e)(2) for owners or operators to
retain copies of all draft third-party audit reports. The final rule
requires that the owner or operator retain as records certain documents
at the stationary source, including the two most recent final third-
party audit reports, related findings response reports, documentation
of actions taken to address deficiencies, and related records. The
final audit report must include a summary of any significant revisions
between draft (if any) and final versions of the report.
    The final rule also requires the owner or operator to retain
records at the stationary source in order to ensure that records are
readily available to stationary source staff to review and utilize and
for implementing agency inspectors to access during site inspections.
These documents may be retained electronically as long as they are
immediately and easily accessible to the owner or operator and the
owner or operator retains the signed original documents, where
appropriate.
q. Other Comments
    One commenter encouraged EPA to correct what it described as a
grammatical error within Sec. Sec.  68.58(a) and 68.79(a).
Specifically, the commenter urged EPA to correct the plural reference
to the owner or operator by changing the word ``they'' to ``it'' to
make it clear that only one of the entities needs to conduct an audit.
    EPA is not making this recommended revision. Both the owner and
operator are responsible to evaluate compliance with the prevention
program requirements of the rule and we do not believe that this
language has been confusing. However, to clarify, we do agree that as
long as the audit is performed, only one of the entities needs to have
conducted the audit.

C. Safer Technology and Alternatives Analysis (STAA)

1. Summary of Proposed Rulemaking
    EPA proposed to modify the PHA provisions in Sec.  68.67 by adding
paragraph (c)(8) to require certain industry sectors to conduct a safer
technology and alternatives analysis (STAA) and to evaluate the
feasibility of any inherently safer technology (IST) identified. EPA
proposed to limit the requirement to owners or operators of facilities
with Program 3 regulated processes in North American Industrial
Classification System (NAICS) codes 322 (paper manufacturing), 324
(petroleum and coal products manufacturing), and 325 (chemical
manufacturing).
    In the proposed rulemaking, EPA specified that the STAA would
consider, in the following order of preference:
     IST or inherently safer design (ISD),
     Passive measures,
     Active measures, and
     Procedural measures.
    EPA further indicated that the owner or operator would be able to
evaluate a combination of these risk management measures to reduce risk
at the process.
    EPA also proposed to add several definitions that relate to an STAA
in Sec.  68.3. EPA proposed active measures to mean risk management
measures or engineering controls that rely on mechanical, or other
energy input to detect and respond to process deviations. Some examples
of active measures included alarms, safety instrumented systems, and
detection hardware (such as hydrocarbon sensors).
    EPA proposed feasible to mean capable of being successfully
accomplished within a reasonable time, accounting for economic,
environmental, legal, social, and technological factors. EPA further
clarified in the definition that environmental factors would include
consideration of potential transferred risks for new risk reduction
measures.
    For inherently safer technology or design, the proposed definition
meant risk management measures that:
     Minimize the use of regulated substances,
     Substitute less hazardous substances,
     Moderate the use of regulated substances, or
     Simplify covered processes in order to make accidental
releases less likely or the impacts of such releases less severe.

The proposed definition of ``passive measures'' meant risk management
measures that use design features that reduce the hazard without human,
mechanical, or other energy input. EPA provided examples of passive
measures that included pressure vessel designs, dikes, berms, and blast
walls.
    Finally, EPA proposed procedural measures to mean risk management
measures such as policies, operating procedures, training,
administrative controls, and emergency response actions to prevent or
minimize incidents. EPA sought comment on these proposed revisions.
2. Summary of Final Rule
    After review and consideration of public comments, EPA is
finalizing the STAA provision in Sec.  68.67(c)(8), and related
definitions in Sec.  68.3, as proposed, with the following
modifications:
     EPA is substituting the term ``practicability'' for
``feasibility'' in proposed Sec.  68.67(c)(8)(ii) of the PHA
requirements;
     EPA is substituting the term ``practicability'' for
``feasible'' in the definition in Sec.  68.3 and substituting the
phrase ``the capability'' for ``capable,'' while retaining the
remaining definition as proposed; and
     EPA is revising the definition of ``passive measures'' by
clarifying that these measures not only reduce a hazard but reduce the
frequency or consequence of a hazard.

Significant comments on the proposed STAA provisions and related
definitions are discussed in section IV.C.3 of this preamble.
3. Discussion of Comments and Basis for Final Rule Provisions
    Many commenters from environmental advocacy groups and some state
agencies expressed support for the proposal to require an STAA to
improve process safety. However, some believed that implementation of
feasible safer alternatives, particularly IST, should be required and
that STAA requirements should apply to a greater universe of facilities
and not just those in the chemical manufacturing, petroleum refining
and paper manufacturing industries. Many commenters, mostly from
industry, requested that EPA remove IST and design requirements from
the rule entirely for a variety of reasons, or requested significant
clarifications to applicability if the STAA provision is finalized.

    As noted previously, except for substituting the term
``practicable'' for ``feasible'' and some other definition changes, EPA
is finalizing the STAA provisions as proposed. We continue to rely on
the rationale expressed in the proposed rulemaking. In the discussion
that follows and in the Response to Comment document, we explain our
consideration of the comments and our analysis and response.\61\
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    \61\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
---------------------------------------------------------------------------

    We recognize there may be multiple, rational approaches to STAA. We
determined that it was reasonable to require STAA for sectors that have
had a high per facility incidence of reportable accidental releases and
where the complexity and variety of methods of chemical handling
demonstrate the potential for process safety revisions. We do this in
part to balance potential accidental release rate reduction and cost.
There are some sectors, such as water treatment, with known ISTs that
we do not require to evaluate or implement ISTs under this rule. In the
water treatment sector in particular, the sector's lower accidental
release rates do not demonstrate that requiring thousands of facilities
to conduct STAA would result in a significant drop in accidental
releases.\62\ In contrast, even if some of the sectors we have
identified for the STAA requirement already may have voluntarily
undertaken an STAA approach (at least at new facilities), accidental
release rates remain higher for these industries, technologies advance
over time, and ensuring a minimum level of application of the STAA
approach limits the disincentives for sector members to be leaders in
adoption of safer technologies. We do not mandate the adoption of any
IST found to be practicable in part because we recognize that a passive
measure or other approach on the STAA hierarchy may also be effective
at risk reduction; we continue to leave the adoption of particular
accident prevention approaches to owners' and operators' reasonable
judgment. We discuss other factors that have led us to select
particular industries for STAA and particular requirements in our STAA
approach in response to particular comments.
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    \62\ An intentionally-caused release through the criminal act of
a third-party would be an accidental release because the emission
would be unanticipated from the perspective of the owner or operator
of the stationary source. Where the location of a water treatment
source could expose large populations to regulated substances, we
believe it is appropriate for such sources to work with local
emergency planners and homeland security officials to reduce the
risk. Nevertheless, such isolated cases do not justify a mandate
across the industry in place of a case-specific review.
---------------------------------------------------------------------------

a. Legal Issues
    Various commenters raised potential legal issues or challenges
regarding the STAA requirements based on CAA authority, Congressional
intent, deficient analysis or substantiation, vagueness of
requirements, and jurisdiction.
    Several industry associations and individual companies commented
that EPA lacked the legal authority to require assessment of STAA in
general and IST/ISD in particular. One argued that the authority for
RMPs rests in subparagraph (B) of CAA section 112(r)(7), while the
authority for design and equipment changes rests in subparagraph (A).
Several argued that EPA did not adequately explain its change of
position from the one adopted in the 1996 final RMP rule, which did not
require the assessment or implementation of IST. In light of EPA's
position that the 1996 final RMP rule and EPA's program implementation
provided incentives to adopt IST, some argued that requiring STAA
analysis without requiring implementation of changes would offer no new
benefit to public health and safety; these commenters suggested that
IST had been informally used already for decades where it was feasible.
Another commenter said the STAA requirement could effectively ban
certain chemicals without the authority to do so. Others noted that IST
consideration would lead to increased liability issues for facilities
because, even if a source was not required to implement IST by rule,
should an accident happen, plaintiffs could cite the failure to adopt
the IST in a court case. A commenter criticized the requirement as too
amorphous to be meaningfully implemented and enforced in a non-
arbitrary manner. Other commenters said IST is more properly within the
authority of OSHA, that EPA's record did not reveal consultations and
coordination with OSHA as required by CAA section 112(r)(7)(D), and
that subsequent to the enactment of the 1990 CAA Amendments, Congress
had denied both EPA and DHS the authority to require IST when it
rejected bills requiring or authorizing IST.
    In contrast to the comments discussed previously, a coalition of
environmental, labor, community and other public groups, as well as a
mass mail campaign, commented that EPA must adopt STAA in its final
rule not only for NAICS codes we proposed but for all facilities where
STAA is feasible. In the commenters' view, the proposed amendments are
inconsistent with the statute's prevention objectives and its
preference for measures that completely eliminate potential hazards
because only certain sectors are required to undertake STAA while
others only have requirements imposed after accidental releases.
Additionally, the commenters argue that the authority to ``make
distinctions'' among classes of facilities in CAA section 112(r)(7)(A)
and to ``recognize differences'' among types of sources in CAA section
112(r)(7)(B) does not include the authority to exempt entire sectors
from STAA; even if the statute gave such authority, EPA failed to
explain how it is relying on that authority. Finally, the commenters
contended EPA's action was arbitrary and capricious by failing to
account for the significant value STAA could provide to facilities,
workers, and communities by not only removing hazards but by saving
money through removing potential liability and sometimes improving
industrial efficiency.
    EPA disagrees with the comments that the CAA does not authorize the
STAA provisions of this final rule. Both subparagraphs (A) and (B) of
CAA section 112(r)(7) authorize STAA and IST in particular. EPA cited
all of paragraph (7) as authority for ``[e]ach of the portions of the
Risk Management Program rule we propose to modify.'' 81 FR 13646, March
14, 2016.\63\ The authority section for 40 CFR part 68 references CAA
section 112(r) and is not limited to particular paragraphs and
subparagraphs. The proposed rulemaking also noted that subparagraph (A)
had been invoked in the rulemaking petition on IST. Therefore, EPA
provided sufficient notice that we contemplated action under any
authority under CAA section 112(r)(7). Nevertheless, we also view that
our authority to require STAA assessments or an IST review is
consistent with subparagraph (B). Under subparagraph (B), EPA has broad
authority to develop ``reasonable regulations . . . for the prevention
of accidental releases.''
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    \63\ We note that our more extensive discussion of authority for
the RMP rule provided in the 1993 proposal focused on CAA
112(r)(7)(B)(i) and (ii), 58 FR 54191-93 (October 20, 1993), which
the proposal for the Modernization rule referenced for additional
authority discussion.
---------------------------------------------------------------------------

    Further support for IST can be found in both the Conference Report
accompanying the 1990 CAA Amendments and the Senate Report explaining
the provisions of the Senate bill that closely mirrors enacted
provisions. In discussing the ``Hazard Assessments'' required by
section

112(r)(7)(B), the Conference Report specifies that such assessments
``shall include . . . a review of the efficacy of various release
prevention and control measures, including process changes or
substitution of materials.'' \64\ Conference Report at 340-41. The STAA
analysis is such a review.\65\ The Senate Report identifies as
``release prevention measures'' many of the techniques that are now
known as IST--substitution of less hazardous materials, reduction in
the severity of the conditions of processing and complexity of the
process, and decreasing volumes of chemicals in storage.\66\ Senate
Report at 242. That subsequent Congresses did not enact additional
legislation on IST is irrelevant to what was enacted and intended at
the time of enactment.
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    \64\ H. Rep. 101-952, Clean Air Act Amendments of 1990
Conference Report to Accompany S. 1630, 101st Cong., 2d Session,
340-41. October 26, 1990.
    \65\ EPA chose to incorporate into the prevention program
provisions several of the hazard assessment elements mentioned in
the conference report and to limit the hazard assessment portions of
40 CFR subpart B to the offsite consequence analysis and accident
history in order to better conform the RMP rule to the format of the
PSM rule. 58 FR 54194 (October 20, 1993).
    \66\ Clean Air Act Amendments of 1989, Report of the Committee
on Environment and Public Works, U.S. Senate together with
Additional and Minority Views to Accompany S. 1630. S. Report No.
101-228. 101st Congress, 1st Session, p. 242, December 20, 1989.
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    The proposed rulemaking, 81 FR 13646, March 14, 2016, provided an
extensive discussion of developments concerning IST since the 1996
final RMP rule. As we explained, EPA adopted a rule in 1996 that
provided incentives for IST without a specific mandate to either
conduct studies of IST or implement IST measures. From 1996 on, EPA has
recognized that good PHA techniques will often identify opportunities
to make new and existing processes and operation inherently safer.
However, in the 1996 rule and thereafter, we also recognized that IST
is not the only way to prevent accidents, and that sometimes IST can be
impractical, especially for existing sources.
    The STAA approach we adopt in this action places IST in a hierarchy
that allows for sources to choose non-IST approaches to accident
prevention, such as passive mitigation, active mitigation, and
administrative controls. While the EPA did not, in 1996, expressly
require facilities to analyze and implement IST specifically, this rule
places IST in a set of options to be studied. EPA relies on sources
making rational decisions once presented with STAA studies and
selecting prevention approaches that optimize the cost of the measures
taken and costs avoided (e.g., liability, operational efficiency,
image). Such an approach is similar to the approach to energy
assessments recently taken in the major source and area source boiler
rules under CAA section 112(d) and affirmed in U.S. Sugar Corp v.
EPA.\67\
---------------------------------------------------------------------------

    \67\ United States Sugar Corp. v. EPA, 830 F.3d 579 (D.C. Cir.
2016).
---------------------------------------------------------------------------

    We acknowledge that many sources have conducted STAA analyses
already. For these sources, the cost of implementing the new STAA
requirement should be lessened. The requirement we promulgate in this
rule captures those slower in considering IST in high accident
industries rather than harms leaders. There are no specific chemicals
banned by this final rule. While we recognize that companies have moved
away from certain processes, such as those that involve the storage of
large quantities of methyl isocyanate, in order to make facilities
safer, we leave process design decisions to the reasonable judgment of
owners and operators under this action.
    EPA disagrees with the comments concerning IST being more properly
within the authority of OSHA. It is plain from the history of the 1990
Amendments that both agencies were given authority to prevent
accidents, and that Congress contemplated EPA adopting some IST
measures as appropriate. Furthermore, EPA has a history of prior
coordination with OSHA to define and promote STAA when developing the
EPA and OSHA, Chemical Safety Alert: Safer Technology and Alternatives
(EPA 550-F-15-003; June 2015).\68\
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    \68\ https://www.epa.gov/sites/production/files/2015-06/documents/alert_safer_tech_alts.pdf.
---------------------------------------------------------------------------

    Not only for STAA, but also for other provisions of this final
rule, the record adequately reflects EPA's coordination and
consultation with Department of Labor (DOL)/OSHA and DOT. As an initial
matter, both DOL and DOT were part of the Working Group under Executive
Order 13650. That order and report of the Working Group reflect
consultation and direction regarding the development of the this final
rule. Second, we note that EPA's decision to not consider the
regulation of AN at this time explicitly is based on an effort to
coordinate any potential regulatory requirements for this substance
with actions contemplated by other agencies, including OSHA. Third,
while the content of interagency deliberations are not for the record
for judicial review under CAA section 307(d), multiple agencies have an
opportunity to review a draft rule under Executive Order 12866
Regulatory Planning and Review. Finally, OSHA had representatives
attend the SBAR panel which discussed the development of the proposed
rulemaking. All of this is a matter of public record in the docket for
this rulemaking.
    Consistent with the structure of the RMP rule, EPA has placed IST
among the methods a facility may choose to adopt to prevent accidents.
Commenters who argue that we have failed to require accident prevention
by not mandating the adoption of IST measures for all facilities
wherever feasible fail to acknowledge that non-IST methods for
preventing accidents may be reasonable in some circumstances. To the
extent that these regulations are imposed under subparagraph (B), these
regulations have an overriding requirement to be reasonable. While it
is true that similar quantities of chemicals under the same conditions
present similar hazards regardless of sector, various sectors present
different likelihood of release. Some sectors handle chemicals
differently under conditions that are more likely to lead to severe
releases. The record reflects that the likelihood of severe accidents
is greater in the sectors that must conduct STAA analysis under this
final rule. Thus, it is reasonable to have different requirements for
these sectors than for others. Independent of whether any new IST/ISD
is adopted, there is a cost to conducting an STAA analysis. EPA has
reasonably limited STAA analysis requirements to sectors that we view
as most likely to likely to have more frequent, severe releases that
are most likely to be benefit from STAA review. Inherent in our
approach is distinguishing among classes and types of facilities. We
expect that the adoption of STAA analysis requirements in this final
rule will advance IST not only in the sectors targeted by the rule, but
also more generally as experience is gained and opportunities for
technology transfer are developed.
b. Applicability
    Limiting applicability of STAA provisions. While some commenters
supported EPA's proposal to limit applicability of STAA provisions to
the petroleum refining, chemical manufacturing, and paper manufacturing
sectors, other commenters objected to this aspect of the proposal. Many
commenters, including a mass mail campaign joined by approximately 300
commenters, expressed concern that the proposed rulemaking arbitrarily
determined which industries have feasible and worthwhile alternatives,
and which communities and facilities would benefit from STAAs. These
commenters

asserted that limiting the requirement to certain industry sectors
would exempt other sectors that pose a significant threat to the
public. Commenters argue that focusing on accident rate to target
sectors for STAA was not a credible way to forecast and prevent rare
catastrophic events that tend to fall out of existing patterns.
    Some commenters urged EPA to apply the STAA requirement to all
sources, or all Program 3 sources. Other commenters, including another
mass mail campaign joined by approximately 17,250 commenters,
recommended that EPA require assessment and implementation of STAA for
industries where safer alternatives are feasible or well demonstrated,
such as water supply, wastewater treatment, power generation, food and
beverage manufacturing, and others. Several other commenters indicated
that EPA should apply the STAA provisions to facilities with the
largest worst case scenario populations, or to the 2,000 high-risk
facilities cited in EPA's 2017-2019 National Enforcement Initiative
(NEI). A few commenters suggested that EPA implement a pilot program
requiring IST implementation for a subset of sectors considered
extremely high risk, such as wastewater or drinking water treatment
plants, bleach plants, refineries using hydrogen fluoride and for those
facilities among the 2,000 high-risk facilities cited in the EPA's NEI
2017-2019 proposal. A few commenters believe that the proposed STAA
requirements have failed to address the disproportionate health and
safety threats in communities of color and low-income communities, and
want the STAA provisions to apply to all RMP facilities.
    In this rule, EPA is finalizing the STAA provisions as proposed,
which limits applicability of the STAA requirements to Program 3
processes in the petroleum refining, chemical manufacturing, and paper
manufacturing sectors. EPA does not believe that the final provisions
have been limited arbitrarily, or that the Agency's decision to limit
applicability of the STAA provisions to the petroleum refining,
chemical manufacturing, and paper manufacturing sectors implies that
other sectors do not have viable safer technology alternatives. In the
proposed rulemaking, EPA acknowledged that most RMP-regulated sectors
could identify safer technologies and alternatives. However, the Agency
proposed to limit the applicability of the STAA provisions to
facilities in complex manufacturing sectors with high accident rates.
EPA took this approach in order to target these provisions to the
industrial sectors with the potential to achieve the greatest safety
improvements through consideration of safer technology alternatives.
EPA explained that sources involved in complex manufacturing operations
have the greatest range of opportunities to identify and implement
safer technology, particularly in the area of inherent safety, because
these sources generally produce, transform, and consume large
quantities of regulated substances under sometimes extreme process
conditions and using a wide range of complex technologies. Therefore,
such sources can often consider the full range of inherent safety
options, including minimization, substitution, moderation, and
simplification, as well as passive, active, and procedural measures.
Further, EPA noted that RMP facilities in the three selected sectors
have been responsible for a relatively large number of accidents,
deaths, and injuries, and the most costly property damage.\69\
Facilities in these sectors also have significantly higher accidents
rates as compared to other sectors.\70\ EPA agrees that there is no way
to forecast rare catastrophic events; however, we believe it is
appropriate to target sectors that have had a large number of accidents
and have the greatest opportunity to identify safer technologies.
---------------------------------------------------------------------------

    \69\ For more information, see Chapter 6 of the Regulatory
Impact Analysis--Accidental Release Prevention Requirements: Risk
Management Programs Under the Clean Air Act, Section 112(r)(7). This
document is available in the docket for this rulemaking (Docket ID
Number EPA-HQ-OEM-2015-0725).
    \70\ For more information, see EPA, January 27, 2016. Technical
Background Document for Notice of Proposed Rulemaking: Risk
Management Programs under the Clean Air Act, Section 112(r)(7). This
document is available in the docket for this rulemaking (Docket ID
Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------

    While EPA does not believe it is necessary to require all sources,
all Program 3 sources, or all sources in industry sectors where
feasible safer technology alternatives have been identified to perform
an STAA, the Agency encourages such sources to consider performing an
STAA, and to determine practicability of IST or ISD considered, even if
they are not subject to the STAA provisions of the final rule.
    EPA does not agree that only sources with large worst-case scenario
populations, or only sources on EPA's high risk facility list should be
required to comply with the STAA provisions. EPA believes it is not
appropriate to apply the STAA provisions only to sources with specified
worst case scenario populations for several reasons. First, EPA's OCA
requirements allow regulated facilities to use any commercially or
publicly available air dispersion modeling techniques, provided the
techniques account for the modeling conditions specified in the rule
and are recognized by industry as applicable as part of current
practices. This flexibility can result in two similar facilities
obtaining significantly different endpoint distances (and vulnerable
zone populations) simply through choosing different modeling
techniques. By linking the STAA requirement to the worst case scenario,
EPA could inadvertently cause some facilities to recalculate their OCA
using a different modeling approach, simply to avoid the STAA
requirement, and without actually implementing process changes that
might reduce the facility's worst case scenario. Second, linking the
STAA requirement to large worst case scenario populations would
effectively bias the applicability of the requirement to facilities in
densely populated areas, and potentially exempt equally hazardous
facilities in or near less densely populated communities. Third, this
application of the STAA requirement would disregard the criteria that
EPA has used in the proposed rulemaking--accident history and facility
complexity, which EPA believes provide a stronger rationale for
limiting the applicability of the requirement. In addition, EPA
believes that targeting the STAA requirements to the larger and more
complex processes will benefit minority communities, who are located
closer to larger facilities with more complex chemical processes and
who bear a larger portion of risk from chemical accidents. Lastly,
distribution of worst-case scenario population information is
restricted under the CAA, and this would effectively prohibit the
public from knowing which facilities are required to perform an STAA.
    For similar reasons, EPA does not agree with commenters'
suggestions to develop a pilot program to apply to a subset of high
risk facilities or to apply the STAA requirement to facilities on EPA's
high risk facility list. This list is generated, in part, using worst
case scenario population information (chemical quantities and accident
history are also considered, although sector accident frequency is
not), and therefore the list may not be publicized by EPA.
    Apply to facilities using different incident rate methodology.
Several commenters objected to EPA's methodology for selecting
industrial sectors subject to STAA requirements using an incident rate
based on the

number of RMP-reportable accidents per facility in the industry sector.
These commenters expressed concern that the proposal to require STAAs
from only three NAICS codes is based on an incorrect approach to, and
interpretation of, incident rates. An industry trade association
commented that looking at the number of accidents per facility does not
allow for direct comparisons as it does not account for the relative
number of employees at a facility. This commenter argued that EPA
should recalculate this value using the number of accidents per hours
worked or the number of accidents per full time worker, and reasoned
that such a calculation would be more consistent with the incident rate
calculations conducted by the Occupational Safety and Health
Administration (OSHA) and the Bureau of Labor Statistics (BLS). Another
industry trade association remarked that EPA's methodology ignores not
only the size of the facility but also the quantity of chemicals and
the number of covered process units at a given facility. According to
this commenter, upon normalizing the petroleum refining sector's
accident rate to account for the number of process units and the
diversity of facilities being compared, the accident rate for this
sector is lower than for most other sectors. The commenter also
expressed concern that EPA's proposal to subject this sector to the
STAA requirement ignores the industry's significant recent safety
improvements that EPA itself has noted in the NPRM, and that industries
such as poultry processing have higher incident rates than petroleum
refining or chemical manufacturing, even though these industries are
not subject to the STAA requirement.
    A trade association representing the paper manufacturing industry
urged EPA to remove the STAA requirement for that sector. The industry
trade association stated that paper manufacturing should not be
considered a ``complex'' manufacturing process, and cited EPA's
Technical Background Document \71\ which, according to the commenter,
does not categorize paper manufacturing facilities as ``complex.''
Additionally, the commenter remarked that the paper manufacturing
industry has a much lower level incident risk than other sectors based
on injuries offsite, and stated that of the roughly 15,000 offsite
injuries mentioned by EPA, the paper manufacturing industry was
responsible for only two. Citing Exhibit 6-4 of EPA's Regulatory Impact
Analysis for the proposed rulemaking, the commenter asserted that the
entire U.S. paper manufacturing sector has been responsible for the
fewest offsite injuries out of any industrial sector over the ten-year
study period. This commenter concluded that implementing the
requirement for the paper industry would not enhance public safety, and
that the industry has made significant strides to increase safety
procedures in recent years.
---------------------------------------------------------------------------

    \71\ EPA. January 27, 2016. Technical Background Document for
Notice of Proposed Rulemaking: Risk Management Programs under the
Clean Air Act, Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------

    Another commenter stated that EPA's use of routine incident rates
in selecting industry sectors to conduct STAAs was faulty because
frequent smaller incidents cannot be used to reliably predict
infrequent catastrophic events.
    EPA acknowledges that there were other possible methods of
selecting industry sectors that would be subject to STAA requirements.
All of the methods offered by commenters--normalizing accident rates by
FTE, number of process units, chemical quantities, etc.--were
considered but ultimately rejected by the Agency. EPA does not believe
normalizing accident rates by FTE or chemical quantity is appropriate
because prior research has shown that the interaction between these
factors and incident rates is complex, and that none of these
variables, by itself, is a suitable proxy for the relative risk of a
catastrophic chemical release incident at a facility.\72\ Likewise,
selecting industry sectors for applicability of the rule's STAA
provisions using an approach similar to that used for OSHA personal
injury statistics (e.g., OSHA lost workday injury and illness rates)
would not identify sectors with higher chemical process risks. These
OSHA rate data generally scale directly with the number of employees
because most of the incidents measured in these metrics involve single-
person injuries (e.g., overexertion, sprains and strains, slips, trips,
falls, injuries due to contact with objects and equipment, etc.).\73\
In other words, facilities with more employees are more likely to
suffer higher amounts of these ``lost workday'' injuries, but not
necessarily higher numbers of chemical release incidents.
---------------------------------------------------------------------------

    \72\ Elliott, M.R., Kleindorfer, P.R., and Lowe, R.A., The Role
of Hazardousness and Regulatory Practice in the Accidental Release
of Chemicals at U.S. Industrial Facilities, Risk Analysis, Vol. 23,
No. 5, 2003.
    \73\ See, e.g., ``Nonfatal Occupational Injuries and Illnesses
Requiring Days Away from Work, 2014,'' U.S. Department of Labor,
Bureau of Labor Statistics, November 19, 2015. Available at http://www.bls.gov/news.release/osh2.nr0.htm.
---------------------------------------------------------------------------

    Furthermore, EPA chose not to normalize accident rates by the
number of process units for two reasons. First, regulated sources have
significant discretion in determining covered process boundaries--some
petroleum refineries and large chemical manufacturing facilities
containing numerous unit process operations have chosen to consider
their entire plant as a single covered process, while other similar
plants have divided their stationary source into dozens of different
covered processes. Therefore, normalizing accident rates by the number
of processes could result in a less accurate reflection of a sector's
historical accident propensity. More importantly, even if a higher
accident rate at a large facility is due, in part, to the facility
having more covered processes, that fact does not reduce its risk to
the surrounding community. For the community, it is the frequency of
accidents at its neighbor that matters, not the rate per process. In
fact, the relatively higher likelihood of accidental releases at such
sources further warrants their consideration, and potential
application, of safer alternative technologies.
    EPA disagrees that its approach ignores recent safety improvements
on the part of the petroleum refining sector. The Agency views the
application of safer technology alternatives as an approach to hazard
control that can be applied throughout the life-cycle of a facility. A
facility's recent implementation of a safer technology alternative does
not foreclose consideration of additional safer technologies in the
future. Facilities that have already implemented safer technology
alternatives should document their implementation in their next PHA,
determine whether there is additional information that should be
considered in their STAA, and continue to consider additional safer
alternatives during subsequent PHA re-validation cycles.
    EPA agrees that the poultry processing sector, when that sector is
considered separately from other food and beverage industry sectors,
has a slightly higher RMP facility incident rate than the petroleum
refining sector. However, EPA did not include the poultry processing
sector under the final rule STAA provision because the poultry
processing sector, by itself, does not delineate a meaningful
technological subgrouping of RMP facilities. Poultry processing
facilities are just one of many different types of food and beverage
manufacturing and processing facilities covered under the RMP
regulation. The common technology among these facilities that results
in their coverage under the RMP

regulation is ammonia refrigeration. While EPA is aware that some RMP
facilities in the poultry processing sector have had serious chemical
accidents, the Agency does not believe that these accidents are usually
related to the fact that these facilities process poultry. Rather, they
generally relate to the design, maintenance, or operation of the
ammonia refrigeration system at the facility, and are similar to the
causes of accidents involving ammonia refrigeration systems at other
types of food and beverage processing facilities. Therefore, when
considering the accident rates of RMP-covered poultry processing
facilities, EPA believes the proper approach is to combine RMP
facilities in this sector with RMP facilities in all other sectors in
the food and beverage industry, as indicated in the RIA for the final
rule.\74\ When this is done, the accident frequency for the food and
beverage manufacturing sector is significantly lower than the accident
frequency for the petroleum refining sector.
---------------------------------------------------------------------------

    \74\ Regulatory Impact Analysis--Accidental Release Prevention
Requirements: Risk Management Programs Under the Clean Air Act,
Section 112(r)(7). This document is available in the docket for this
rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------

    EPA disagrees with the commenter that argued the paper
manufacturing sector should be exempt from the STAA provision of the
final rule because the sector has had fewer accidents with offsite
injuries, or because the sector was not characterized as ``complex'' by
EPA's economic analysis. While it is true that the paper manufacturing
sector has had fewer accidents with offsite injuries than other
sectors, this is partly due to the relatively small number of RMP
facilities (70) in the paper manufacturing sector. Additionally, the
great majority of the offsite injuries reported by RMP facilities
resulted from a single accident at the Chevron Richmond refinery,
therefore it is inappropriate to compare offsite injuries from the
paper manufacturing sector to the total of all offsite injuries that
occurred during the ten-year period analyzed.\75\
---------------------------------------------------------------------------

    \75\ According to the CSB, ``approximately 15,000 people from
the surrounding communities sought medical treatment at nearby
medical facilities for ailments including breathing problems, chest
pain, shortness of breath, sore throat, and headaches. Approximately
20 of these people were admitted to local hospitals as inpatients
for treatment.'' CSB, January 2015, Final Investigation Report:
Chevron Richmond Refinery Pipe Rupture and Fire, Chevron Richmond
Refinery #4 Crude Unit, Richmond, California, August 6, 2012, Report
No. 2012-03-I-CA, http://www.csb.gov/assets/1/16/Chevron_Final_Investigation_Report_2015-01-28.pdf.
---------------------------------------------------------------------------

    More importantly, offsite injury is only one of several types of
accident consequences that require reporting under the RMP rule. Other
reportable consequences include deaths, injuries, and significant
property damage on-site, and known offsite deaths, evacuations,
sheltering-in-place, property damage and environmental damage. When all
RMP-reportable accident consequences for a sector are considered, and
normalized by the number of sources in the sector, the paper
manufacturing sector has the second highest accident rate among all
sectors regulated under the RMP rule. EPA believes this approach is a
better gauge of the historical accident propensity for a sector than
considering only accidents with offsite injuries.
    While it is also true that EPA did not characterize the paper
manufacturing sector as ``complex'' in the Technical Background
Document \76\ and for estimating the costs of most rule provisions
within the RIA, it did do so for purposes of the STAA provision, and
arguably could have done so for all rule provisions. Paper
manufacturing facilities, and particularly large integrated pulp and
paper mills, are clearly more complex than most other RMP facilities,
which only involve chemical storage (e.g., agricultural ammonia
distribution facilities) or simple chemical processes (e.g., water
treatment). The main purpose for EPA's broad characterization of
certain sectors as ``complex'' and all others as ``simple'' for certain
rule provisions within the RIA was because the Agency judged that the
cost of implementing those rule provisions would vary primarily by the
complexity of the processes involved, and that a rough two-tier
division of regulated sources (e.g., simple vs. complex) would suffice
to establish cost estimates for those rule provisions. However, EPA did
not use this two-tier division for purposes of estimating the costs of
the rule's STAA provision. For the STAA provision, EPA included paper
manufacturing as a sector that involves ``complex manufacturing
operations.'' EPA chose to apply the STAA requirement to sources
involved in complex manufacturing operations because these sources have
the greatest range of opportunities to identify and implement safer
technology, particularly in the area of inherent safety. These sources
generally produce, transform, and consume large quantities of regulated
substances under sometimes extreme process conditions and using a wide
range of complex technologies. For more information, see the preamble
discussion in the proposed rulemaking at 81 FR 13688, March 14, 2016.
---------------------------------------------------------------------------

    \76\ EPA. January 27, 2016. Technical Background Document for
Notice of Proposed Rulemaking: Risk Management Programs under the
Clean Air Act, Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------

    EPA disagrees that the agency used ``routine'' incident rates to
select industry sectors covered by the STAA provision. Accidents
meeting EPA reporting criteria include accidental releases from covered
processes that result in deaths, injuries, and significant property
damage on-site, and known offsite deaths, injuries, evacuations,
sheltering-in-place, property damage and environmental damage. EPA
believe that such accidents generally either resulted in, or could
reasonably have resulted in, a catastrophic release of a regulated
substance, and are therefore an appropriate criterion to consider when
identifying industrial sectors that may benefit public safety the most
by analyzing safer alternative technologies.
    Eliminate or exempt batch toll chemical manufacturers. In the
context of exempting batch toll processors from the STAA provision,
some commenters recommended that processes governed by government
agency specifications or through a contractual relationship with a
customer should not be subject to the STAA provision because in these
cases, the customer specifies the manufacturing process. According to
one commenter, the customer is subject to regulation, often from the
FDA or EPA. An industry trade association requested that EPA explicitly
state in the body of the regulation that the STAA requirement would not
apply to processes in whole or in part specified by a government agency
or through any contractual obligation.
    EPA disagrees with the suggestion to exempt batch toll
manufacturers from the STAA requirement. Safer technology alternatives
include many options beyond chemical substitution. For example, IST
could involve minimization of stored raw material chemicals, making
process changes that make it less likely to release the chemical
(moderation), or reducing complexity in the process in order to make
accidents less likely (simplification). Therefore, even where a
contractual relationship or regulation requires a regulated batch toll
manufacturing facility to use a particular regulated substance in
specified quantities, owners and operators of batch toll manufacturing
facilities should still consider other potential IST measures besides
chemical substitution. The facility must also consider potential safer
alternatives beyond IST, such as passive measures instead of or in
combination with active

measures, or active measures instead of procedural measures. Toll
manufacturers may use RMP chemicals for purposes in addition to making
a formulated product, such as for cleaning equipment, wastewater
treatment or refrigeration, for which chemical substitution may not be
prohibited by regulation or contractual relationship. Also, the final
rule does not require regulated sources to implement IST or ISD
considered, so there is no conflict between this final rule and other
regulations that may apply to RMP-regulated facilities subject to STAA
requirements. For example, an owner or operator would be in compliance
with the STAA requirement to consider potential chemical substitution
as part of the analysis if he or she determines that a chemical
substitution is not practicable because the substitution is prohibited
by another regulation The owner or operator would still need to
consider other types of IST (minimization, moderation, or
simplification), and passive, active, and procedural measures in the
analysis.
    Applicability to water treatment facilities. Some commenters,
including professionals and a mass mail campaign joined by
approximately 300 commenters, urged that water supply and wastewater
treatment facilities should be subject to the proposed STAA provision.
A number of commenters expressed concern about threats posed by water
and wastewater facilities and related operations. Several commenters
asserted that technologically and economically feasible alternatives
are available for water supply and wastewater treatment facilities, and
suggested that exploring the implementation of these alternatives would
be beneficial for the safety of workers, personnel, and communities
associated with the facilities. One commenter stated that the costs for
water facilities to convert to safer alternatives are feasible, and
remarked that it is possible to adopt IST without disrupting
operations.
    Alternatively, a few industry trade associations and government
organizations stated that STAA should not be applied to water
facilities citing that any STAA requirement would be repetitive and
counterproductive and that drinking water utilities already have to
consider a variety of public health and safety factors under the Safe
Drinking Water Act (SDWA).
    EPA disagrees with commenters who suggest subjecting water and
wastewater treatment facilities to STAA requirements. EPA's approach to
applying the STAA requirement was to identify industry sectors with the
greatest accident frequency at RMP-regulated facilities within the
sector, and with the greatest opportunity to apply STAA risk management
measures. While EPA agrees that water supply and wastewater treatment
facilities often have feasible alternatives available, according to RMP
accident history data, the sector is among the least accident-prone
sectors covered under the risk management program. Therefore, the final
rule does not apply the STAA requirement to the water and wastewater
treatment sector. EPA acknowledges that drinking water utilities
already may have considered alternative technologies for their
disinfection process while addressing safety and health considerations,
risk tradeoffs and compliance with the SDWA.
    Limit applicability to major process changes or after accidents. A
few commenters want EPA to consider having a requirement similar to
that required by Contra Costa County for facilities to conduct an STAA
whenever major process changes are proposed and in the aftermath of
accidents, when there are often significant opportunities for making
process improvements as equipment is rebuilt or repaired. One commenter
noted that the CCHS program requires an ISS analysis during the design
of new processes, for PHA recommendations, or for major changes
resulting from incident investigation recommendations, root cause
analysis or MOC review that could reasonably result in a major chemical
accident or release. This commenter noted that California's proposed
refinery regulations are following the same requirements as the CCHS
program. Other commenters recommended that instead of requiring STAA
analyses at least every five years in conjunction with the a PHA
revalidation, EPA should require the analysis only after accidents.
    Another commenter recommended modifying the wording in section
68.67(c)(8) to limit the provisions to new processes or major
modifications to existing processes. The commenter also remarked that
stationary sources' management of change (MOC) programs should be
updated to account for process changes and allow for reassessment of
the IST analysis. The commenter concluded that this will ensure that
existing IST components are not removed, replaced, or changed without
revalidating the IST feasibility criteria.
    EPA disagrees that the STAA requirement should be triggered only by
a major process change. While the Agency acknowledges that a major
process change could be an opportune time to evaluate safer technology
alternatives, the Agency is concerned that requiring STAA reviews only
after major process changes could result in some processes rarely or
never being evaluated for safer technology alternatives. This could
occur if few or no major changes occurred during the life of the
process. Also, limiting the STAA to only major process changes could
create a disincentive to upgrading processes if facilities chose not to
make improvements to avoid having to perform an STAA. EPA is also
concerned that there is no common definition or understanding of the
term ``major process change'' that could easily be applied to the wide
range of processes affected by the STAA requirement. Therefore, while
EPA agrees that integrating STAA reviews into a facility's MOC program
(and other prevention programs) may often be beneficial, the Agency
believes it is appropriate to incorporate the STAA provision into the
PHA section of Sec.  68.67, rather than the MOC section of Sec.  68.75.
Nevertheless, EPA encourages owners and operator to also consider safer
technology alternatives whenever major process changes are planned.
    EPA is revising the PHA requirements in Sec.  68.67 to require that
the PHA address findings from incident investigations as well as any
other potential failure scenarios. Other potential failure scenarios
may include those introduced from major process changes or new designs
or those discovered as a result of an accident investigation. Thus, EPA
believes that the PHA with its requirement to encompass IST review as
part of the PHA process, would cover the same process changes whether
they result from an incident investigation, MOC action or other process
change.
    Finally, EPA disagrees that the STAA requirement should be
triggered only by accidental releases. Although the Agency agrees that
accidental releases may indeed signal to the owner or operator that
safer technology alternatives should be considered, the Agency prefers
that owners and operators evaluate safer technologies before accidents
occur, with the aim of ultimately preventing such accidents. Also,
similar to the Agency's objection to requiring STAA reviews only after
major process changes, requiring an STAA only after an accident would
mean that many processes subject to this provision may never undergo an
STAA.
    Limit applicability of STAA requirements to the design phase of a
process. Several commenters, including

industry trade associations suggested that EPA should not require STAAs
for existing facilities or processes. Numerous commenters, including
facilities, industry trade associations, local agencies, and a Federal
agency, stated that an STAA is more appropriate during the design phase
of a new process or facility, or during significant modifications. Some
commenters, including a local agency, encouraged EPA to require STAAs
to consider the highest level of hazard control (referring to the
``hierarchy of controls'') that is feasible during the design phase or
whenever a facility makes a change. Another commenter stated that
adding a new regulatory requirement, particularly for existing
operations, is unnecessary to address inherently safer design, and that
safer technology reviews should not be part of a PHA.
    In contrast, other commenters urged that safer technologies
analyses are an ongoing need and should not be limited to new
facilities. A state agency and an individual urged that IST should be
performed for all new projects, processes, or stationary sources
throughout various phases of a project's life cycle. According to the
commenter, performing a separate IST analysis for the entire existing
process approximately every five years allows evaluators to see the big
picture rather than just the minute details associated with a typical
PHA process.
    EPA disagrees that STAA analyses should only be required during the
initial design phase of a facility. While the greatest potential
opportunities for using IST occur early in process design and
development, many IST options may still be practicable after the
initial design phase. Furthermore, STAA involves more than just IST.
Safer technology alternatives also include passive measures, active
measures, and procedural measures, and these measures can be modified
and improved after the initial design of a facility. EPA notes that
many RMP-regulated facilities were originally constructed decades ago,
yet major enhancements have been reported in some plants that have been
operating for many years.\77\ CCPS explains that inherently safer
strategies can be evaluated throughout the lifecycle of a process,
including operations, maintenance and modification, and EPA agrees with
this approach.
---------------------------------------------------------------------------

    \77\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley, p. 25.
---------------------------------------------------------------------------

    Lastly, EPA disagrees that the PHA is not an appropriate risk
management program element in which to integrate the STAA. EPA believes
that safer technologies can and should be evaluated during the full
life-cycle of a covered process, and the PHA is the fundamental and
recurring risk management program element concerned with overall
analysis and control of process hazards. By integrating the STAA with
the PHA, every process subject to the provision will undergo an STAA,
every five years. EPA believes that five-year revalidation will give
the owner or operator the opportunity to identify new risk reduction
strategies, as well as revisit strategies that were previously
evaluated to determine whether they are now practicable.
    Owners and operators of new construction facilities that will be
subject to the RMP rule should consider performing the STAA portion of
their initial PHA well enough in advance of facility construction so
that the full range of inherently safer designs is considered, and
include this evaluation in the initial PHA for the process.
c. Definitions
    Feasible definition. Many commenters, including a facility, several
trade associations and an environmental advocacy group, remarked that
EPA did not sufficiently explain any of the five factors (``economic,
environmental, legal, social and technological'') for facilities to
consider in the proposed definition of ``feasible,'' and asserted that
the examples provided by EPA are unhelpful and vague. The commenters
argue that the proposed rulemaking does not provide sufficient guidance
on the feasibility component of the STAA review. As such, the
commenters conclude that these factors are so expansive and vague that
they do not provide any clear guidance as to how feasibility of IST
should be determined, and therefore have no place in the RMP rule.
According to one commenter, even if the five measures are properly
defined, they do not address the full range of issues in the
operational life of a project rather than just the processing phase.
    A mass mail campaign joined by approximately 300 commenters warned
that ``accounting for'' these factors could be used as an excuse to
avoid necessary implementation measures.
    An industry trade association said that it does not want EPA to
elaborate further on the proposed STAA requirement. One commenter
stated that it would be very subjective and difficult to prescribe in
regulations what is ``feasible'' for a facility and that any ``one-size
fits all'' approach to process safety would limit employers' ability to
react to real facts on the ground. In regards to incorporating ISTs
into safety programs, the commenter asserted that only facility
operators know whether IST is appropriate given the complexities of
their unique operating environments, and no one program will work for
all facilities.
    EPA believes that the same tools and methods that facilities
currently use for their PHA can be used to identify and measure hazards
and risks of any safer alternative options. Further explanation of the
economic, environmental, legal, social and technological factors
included in the ``practicability'' definition of this final rule can be
found in NJDEP's Guidance for Toxic Catastrophe Prevention Act (TCPA)-
Inherently Safer Technology (IST) Review, Attachment 1 Feasibility
guidance.\78\
---------------------------------------------------------------------------

    \78\ http://www.nj.gov/dep/enforcement/tcpa/downloads/IST_guidance.pdf.
---------------------------------------------------------------------------

    EPA did not define the various factors, such as ``economic'' or
``social'' used in the proposed definition of ``feasible'' or in the
revised term ``practicability.'' The examples in the proposed
rulemaking preamble are taken from the guidelines provided by CCPS, and
are not exclusive of other situations. EPA believes that the definition
of ``practicability'' in the final rule provides sufficient flexibility
for the owner or operator to determine whether an IST or ISD considered
could be successfully accomplished. EPA does not believe that we should
further define ``economic or social factors'' in the rule because
further specificity of these terms would likely be too prescriptive and
would not encompass all the possible conditions and outcomes that might
be encountered when determining the practicability of an IST or ISD
considered in the STAA. EPA expects that facility owners and operators
will use their expertise and make reasonable judgements when
considering the appropriate meaning of economic or social factors so
that any decisions regarding possible implementation of IST is not
driven towards changes that would cause unintended adverse
consequences.
    Finally, EPA disagrees with commenters' assertion that accounting
for the factors in the definition of ``practicability'' could be used
as an excuse to avoid necessary implementation measures. EPA is not
requiring IST or ISD implementation in the final rule and, therefore,
further clarifying the practicability definition will not impact IST or
ISD implementation.

    Consistency of feasible definition with other programs. A commenter
encouraged EPA to incorporate the definition of ``feasibility''
provided in the Contra Costa County Safety Program Guidance Document.
Another commenter stated that the proposed definition of
``feasibility'' is consistent with California's proposed California
Accidental Release Prevention (CalARP) regulations and the Contra Costa
County and the City of Richmond's Industrial Safety Ordinances.
However, a state agency, commented that there is an inconsistency with
CalARP's definition of ``feasible'' in that the proposed EPA definition
omits the terms ``health'' and ``safety,'' and the commenter encouraged
EPA to add these terms to the list of factors to consider in a
determination of feasibility.
    EPA based the feasible definition on the CCHS definition of
``feasible'' but modified the definition to add language acknowledging
that environmental factors include a consideration of the potential to
transfer risks or introduce new risks to a process or source. The
practicability definition in the final rule maintains this language.
    EPA disagrees with the suggestion to add the terms ``health'' and
``safety'' to the definition. The primary reason for EPA to consider
ISTs in a STAA is to reduce risks to health and safety of the public by
mitigating the frequency and severity of accidental releases. EPA
believes this is adequately addressed in the definition of ``inherently
safer technology or design'' of this final rule and including these
factors in the definition of ``practicability'' would be redundant.
    Suggested revisions to feasible definition. One commenter argued
that the term ``within a reasonable time'' in the definition of
``feasible'' could allow facilities to avoid implementation, and urged
EPA to exclude a time based factor from the final definition. This
commenter also argued that EPA should not make any level of cost, no
matter how minimal, an excuse to not implement any IST measures, but
rather should recognize that IST measures should be implemented unless
doing so would cause an extremely serious adverse economic effect, such
as a facility shutdown. A facility noted that the proposed feasibility
analysis does not allow sufficient time to complete the necessary work
and recommended that the timeframe be determined on a case by case
basis. A state agency commented that the feasibility of an IST must
consider factors such as timeliness of implementation and costs. This
commenter expressed concern that the definition of ``feasible'' would
allow for the implementation of IST options that may not be
economically justifiable compared to other equally protective options.
    Some commenters recommended deleting the explanation of
environmental factors in the feasible definition. These commenters
warned that this language is too specific in comparison with the
general terms included in the definition. One commenter expressed
concern that the language shows an industry bias and suggested using
the following alternative definition: ``Feasible means capable of being
successfully accomplished within a reasonable time, accounting for
economic, environmental, legal, social, and technological factors
weighed against the immediate and long-term benefits to safety and
health. A claim of infeasibility shall not be based solely on evidence
of reduced profits.''
    EPA disagrees with the commenters. Cost is a consideration when
determining whether a risk management measure can be successfully
accomplished and because EPA is not requiring implementation of any
IST, we see no reason to exclude this factor from a practicability
determination. EPA also disagrees with the suggestion to limit
consideration of reduced profits when assessing a risk management
measure because the Agency believes that cost is a valid consideration
for practicability. Identifying an amount of an allowable cost for an
IST is not something that can be prescribed in the regulation because
cost decisions are highly dependent on the economics involving a
particular process, facility and industry.
    EPA also disagrees that incorporating consideration of a reasonable
timeframe will allow facilities to avoid implementation. EPA is not
requiring IST implementation and we acknowledge that there may exist
practical limits on whether some projects or process designs can be
done to enhance safety. If a risk management measure cannot be
accomplished within a reasonable time, then the facility should ensure
that other safeguards are in place to prevent accidents instead of
relying on the uncertainty of completing a long-term project that is
dependent on future conditions such as process design, operating
budgets, etc.
    Finally, as other commenters have noted, some ISTs involving
chemical substitution or significant process redesign can result in new
hazards or risks being introduced, and these should be considered when
deciding the practicability of an IST. Thus, EPA is retaining the
explanation of environmental factors in the practicability definition
in this final rule.
    Definition should be stronger than OSHA definition of ``feasible.''
One commenter urged EPA to adopt a definition that is stronger than or
at least as protective of health and safety as the OSHA definition of
``feasible'' to provide an appropriate minimum level of protection
under CAA--42 U.S.C. 7412(r)(7) that EPA should not go below. The
commenter states that under the OSHA standard, a protective measure is
technologically feasible if, using existing technology or technology
that is reasonably expected to be developed, a typical facility could
achieve the standard in most operations most of the time. Additionally,
the protective measure is economically feasible if its costs do not
threaten the existence or competitive structure of an industry. The
commenter contends that OSHA's definition has been interpreted by
courts to mean that the mere expense of a measure, alone, cannot trump
the implementation of safety measures that are ``capable of being
done.'' The commenter believes that EPA should not set a weaker
definition that would make it less likely that IST or other prevention
measures would be implemented under Sec.  7412(r) than under OSHA's
definition. Doing so would be both inconsistent with the objectives of
Sec.  7412(r) to protect the public and with the existing framework
facilities follow under OSHA requirements, could lead to confusion for
facilities and in the courts, and result in an overall reduction in
safety measures.
    EPA disagrees with the commenter and believes the approach in the
final rule to consider the practicability of IST or ISD considered is
consistent with the intent of CAA and will not lead to an overall
reduction in safety measures. The current rule already requires the PHA
to consider active, passive and procedural risk management measures in
Sec.  68.67; however, the requirements do not prescribe exactly which
type or exactly what engineering and administrative controls must be
implemented. The regulations allow facilities to use their specific
knowledge and expertise of the process to meet the PHA requirement to
``identify, evaluate and control the hazard'' [emphasis added]. EPA is
finalizing a requirement for certain sectors to conduct a STAA that
also considers IST in the hierarchy of controls. However, requiring
facilities to implement IST instead of using passive, active or
procedural safeguards can involve extensive and very expensive changes
to a facility's

process, depending on the IST, especially if it involves substitution
of alternative chemicals and/or major process redesign. EPA believes
that a practicability consideration should address whether an IST or
ISD can be accomplished technologically, is economically possible, does
not result in an increase in hazards or other risks that cannot be
controlled, or cannot be successfully accomplished because of other
considerations. Therefore, EPA disagrees that the practicability
definition should be stronger than (or even similar to) OSHA's
interpretation of feasible.
    Harmonize feasible definition with OSHA. A facility noted that the
proposed definition of ``feasible'' in Sec.  68.3 could cause the
potential for confusion because the proposed rulemaking preamble states
that OSHA has indicated that it would be unable to adopt the term
feasible, as defined in this notice, under its PSM standard if OSHA
considers similar revisions involving IST. This is an illustration of
the need to harmonize the requirements of EPA RMP requirements with
that of OSHA PSM.
    A few commenters, including facilities and industry associations,
urged harmonization with OSHA's definition of ``feasibility'' and
requirements. A facility and an industry trade association warned of
the confusion that could ensue if ``feasibility'' is defined
inconsistently between EPA and OSHA, and encouraged EPA to use the term
``practicability'' instead. Similarly, an industry trade association
urged EPA to use the term ``practical'' in place of ``feasible.'' The
industry trade association argued that what is deemed feasible is often
not practical for a number of reasons, and asserted that any decision
to alter a technology involves a complex variety of factors such as
operating costs, associated risk, energy consumption and greenhouse gas
emissions. The commenter concluded that only facility owners should
ultimately be able to define what is feasible or practical for their
facility. In contrast, a state agency encouraged use of the term
``feasible'' rather than ``practical.'' An industry trade association
asserted that neither term should be the basis for the analysis.
    EPA agrees with commenters and is revising the rule to replace the
term ``feasible'' with ``practicability.'' EPA proposed to use the term
``feasibility'' as part of the STAA analysis as it is already widely
used in the technical literature discussing IST. However, because OSHA
is considering similar revisions to its PSM standard involving IST and
in order to eliminate the potential for confusion of different meanings
of the term ``feasible,'' \79\ EPA has decided to use the term
``practicability'' while retaining the same definition and meaning used
for ``feasible'' in the proposed rulemaking.
---------------------------------------------------------------------------

    \79\ 81 FR 13667, March 14, 2016.
---------------------------------------------------------------------------

    Hierarchy of controls. A commenter noted that California's proposed
regulations for refineries and EPA's proposed regulations would require
that the facility look for inherently safer means to reduce the
hazards, but if there is not a means to reduce the hazard, the facility
would go through a hierarchy of prevention methods and select the
highest level of prevention. This commenter and another requested that
EPA use the term ``Hierarchy of Control,'' which is a term that is
already understood, instead of adding a brand new term.
    EPA does not use the term hierarchy of control (nor substitutes a
new term for it) but instead explicitly explains the concept in the
regulation by stating that the owner or operator shall consider risk
management measures in the following order of preference:
     Inherently safer technology or design,
     Passive measures,
     Active measures, and
     Procedural measures.
    EPA believes this is consistent with proposed CalARP regulations
\80\ for Hierarchy for Hazard Control Analysis, which require
refineries to eliminate hazards using first order inherent safety
measures; to reduce any remaining hazards using second order inherent
safety measures; and to address any remaining risks in the following
sequence and priority by using passive safeguards, active safeguards,
and procedural safeguards.
---------------------------------------------------------------------------

    \80\ Draft California Accidental Release Prevention Program
(ARP) Regulations, California Governor's Office of Emergency
Services. July 5, 2016, p. 83 http://www.caloes.ca.gov/FireRescueSite/Documents/CalARP%20Proposed%20Regs%202016.pdf.
---------------------------------------------------------------------------

    Passive measures. A commenter recommended revising the definition
of ``passive measures'' to ``mean risk reduction measures designed to
reduce the probability or the consequences of an accidental regulated
chemical release without human intervention'' to better reflect that
EPA probably meant ``reducing the hazard'' as an aspect of risk
management. The commenter views ``hazard'' as the inherent capacity of
a substance to cause an adverse effect, while ``risk'' is the
probability that an adverse effect will occur, if one uses OSHA's
definition of the terms. In addition, the commenter said that the
definition of ``other energy inputs'' needs revision, and suggested
replacing the phrase ``energy inputs'' with ``human intervention'' to
meet the intent of the definition. This commenter expressed concern
that the word ``other'' in the phrase ``other energy input''
mischaracterizes pressure vessel designs, dikes, etc. as energy inputs.
This commenter also suggested that passive ``design features'' could
include mechanical or energy intervention measures and the commenter
cited examples such as automatic fire suppression systems and automatic
vapor ignition.
    EPA agrees with the commenter's suggestion to revise the definition
of ``passive measures'' to address the frequency and consequence of the
hazard. EPA based the proposed definition of ``passive measures'' on
the definition used by CCPS, which defined ``passive'' as ``minimizing
the hazard through process and equipment design features that reduce
either the frequency or consequence of the hazard without the active
functioning of any device, i.e., providing a dike wall around a storage
tank of flammable liquids.'' \81\ Thus the intent of the CCPS
definition appears to be on aspects of both hazard and risk reduction.
EPA is modifying the ``passive measures'' definition in the final rule
to clarify that passive measures reduce the frequency or consequence of
the hazard.
---------------------------------------------------------------------------

    \81\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed., p. 10. https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0253.
---------------------------------------------------------------------------

    EPA disagrees that the word ``other'' in ``other energy inputs''
characterizes pressure vessel designs and dikes as energy inputs and
also disagrees that passive design features would include automatic
fire suppression systems or automatic vapor ignition (in which a flare
is ignited). These types of measures would most likely be considered to
be active measures. CCPS, in their Guidelines for Hazard Evaluation
Procedures,\82\ cites a fire protection system as an active safeguard
because a fusible link or other engineered device must function to
successfully trip the system.
---------------------------------------------------------------------------

    \82\ CCPS. 2008, Guidelines for Hazard Evaluation Procedures.
3rd ed., p. 234. http://www.aiche.org/ccps/publications/books/guidelines-hazard-evaluation-procedures-3rd-edition.
---------------------------------------------------------------------------

    IST/ISD. A number of commenters, requested clarification on the
definition of IST, ISD or Inherently Safer Measures. A few wanted
clarification as to what would qualify as ``safer'' in this context.
One labor union expressed general support for the proposed definition
of IST. One commenter asked

EPA to ensure that there is a distinction between IST and less
effective controls and management methods. This commenter argued that
chemical substitution and process changes are the most effective
methods to protect workers and the public from incidents and that these
``inherently'' safer options should be distinguished from less
effective controls and management methods. The commenter cited lesser
effective controls from the NJDEP IST compliance, such as safer
extremely hazardous substance risk location, protection of storage
vessels from weather conditions, changes in truck traffic patterns,
addition of EHS leak detectors, use of closed circuit television
systems, labeling of valves and equipment, revising procedures,
installing a simulation training station, and adding light towers for
EHS leak alarms. The commenter requested that EPA develop a precise
definition for IST and Inherently Safer Design (ISD).
    EPA disagrees with the commenters' suggestions to provide a
distinction between IST and other controls and management methods. EPA
believes that determining effective risk management strategies for a
facility is a site-specific determination and EPA encourages any
improvement that will could lead to inherently safer conditions.
Therefore, EPA is finalizing the definition of IST/ISD as proposed.
    EPA based its definition of inherently safer technologies (IST) or
design (ISD) on the four inherently safer strategies as explained in
the Inherently Safer Chemical Processes: A Life Cycle Approach by
CCPS.\83\ These four types of strategies have been widely recognized by
the industry and best encompass the concepts and principles of applying
inherent safety, which focuses on eliminating or reducing the hazards
associated with a set of conditions.
---------------------------------------------------------------------------

    \83\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed., https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0253.
---------------------------------------------------------------------------

    As the 2010 CCPS Final Report: Definition for Inherently Safer
Technology (IST) in Production, Transportation, Storage and Use \84\
states:
---------------------------------------------------------------------------

    \84\ CCPS. July 2010. Final Report: Definition for Inherently
Safer Technology in Production, Transportation, Storage, and Use,
https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0274.

    IST (Inherently Safer Technology), also known as Inherently
Safer Design (ISD), permanently eliminates or reduces hazards to
avoid or reduce the consequences of incidents. IST is a philosophy,
applied to the design and operation life cycle, including
manufacture, transport, storage, use, and disposal. IST is an
iterative process that considers such options, including eliminating
a hazard, reducing a hazard, substituting a less hazardous material,
using less hazardous process conditions, and designing a process to
reduce the potential for, or consequences of, human error, equipment
---------------------------------------------------------------------------
failure, or intentional harm. [emphasis added]

    The CCPS guidance is organized by these four strategies and
provides many examples of each type of strategy. NJDEP also uses
descriptions of the four strategies to identify available IST
alternatives in their inherently safer technology review
requirements.\85\ Although some NJ facilities may have reported some
controls that others might not strictly view as IST, EPA does not
believe that IST should be limited only to chemical substitution and
process changes. Some changes such as better labeling of equipment are
cited as examples of process simplification in CCPS' IST Checklist.
Changes involving transportation of chemicals and storage location are
also cited in the checklist because inherent safety can involve
reduction of hazard, and does not require complete elimination of a
hazard.
---------------------------------------------------------------------------

    \85\ NJDEP TCPA. March 29, 2012. NJ Title 7, Chapter 31 TCPA
Program Consolidated Rule Document, http://www.nj.gov/dep/rules/rules/njac7_31.pdf.
---------------------------------------------------------------------------

d. General Comments on STAA Requirements
    Suggestions for minimal elements for STAA methodology. An
environmental advocacy group noted that in the proposed rulemaking, EPA
states that owners and operators may use ``any available methodology or
guidance'' to conduct their STAA, but urged EPA to define the minimum
basic elements that owners or operators must include in their STAA. The
commenter believed the STAA should include an analysis of the
technical, economic, legal/regulatory, social, and hazards implications
of each major technology option, and noted that the sample
methodologies and guidance listed in the proposed rulemaking may not
include all of these elements. The commenter urged EPA to require the
economic analysis to include potential liabilities, costs, avoided
costs, and savings associated with each major STAA option evaluated.
    EPA does not believe it should specify factors other than those
already present in the PHA and STAA requirements, including the
definition of ``practicability.'' EPA believes that various resources
and guidance exist (as well as existing PHA methodologies, such as
HAZOP, What-If? Method, or checklists or a combination of these as
discussed in Chapter 8 of CCPS' book, Inherently Safer Chemical
Processes: A Life Cycle Approach \86\) that can assist facilities in
understanding how IST can reduce hazards and risk and in determining
practicability of IST or ISD considered in the STAA. Facilities can
follow, for example, guidance for IS Review Documentation found in
CCPS's Inherently Safer Chemical Processes, which suggests documenting
the summary of the approach used for the IS review (i.e., methodology,
checklist, etc.), names and qualifications of the review team, IS
alternatives considered, as well as those already implemented or
included in the design, results of each consideration including those
not considered and why, documentation of feasibility and rationale for
rejection of IS opportunities.
---------------------------------------------------------------------------

    \86\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley.
---------------------------------------------------------------------------

    While some facilities may choose to conduct an economic analysis of
potential liabilities, costs, avoided costs, and savings associated
with each major STAA option evaluated, EPA is only requiring facilities
to determine whether IST is practicable and document this
determination. It may not be always be possible to estimate avoided
costs and savings for a particular IST.
    STAA is not a suitable replacement for other prevention program
measures. An association of governments expressed concern that analyses
will not prevent accidents because human factors such as operational
bias towards production rather than safety, failures to manage changes,
failures to provide adequate training for employees and failures to
follow standards cannot be eliminated by a safer technology analysis.
The association warned that the analysis could be used as a substitute
for appropriate emergency preparedness and accident prevention
programs. The commenter also believed that adoption of safer technology
without a holistic review of risk transfers might be dangerous.
    EPA does not believe or intend that a safer technology analysis as
part of the exiting PHA would negate the need or requirements for
facilities to follow other RMP rule provisions, such as training,
managing change, and following RAGAGEP. Rather this analysis is
designed to supplement or enhance the ways that hazards or risks of an
accidental release can be eliminated or reduced by possibly more
rigorous risk reduction measures.

Facilities can evaluate the feasibility of potential safer technologies
and this evaluation can and should take into account any known
transfers of risk, as well as other considerations. For this reason,
EPA is not prescribing that facilities adopt any particular safer
alternative and is allowing any decision on implementation of IST to be
made based upon a facility's judgement using accepted hazard analysis
and their knowledge of their processes, hazards, risks and methods to
control hazards. EPA does not believe the analysis could be used as a
substitute for appropriate emergency preparedness and accident
prevention programs--existing requirements in these areas are still in
place and this final rule also provides more emphasis on emergency
coordination and response (for more information see section V of this
preamble).
    STAA guidance, regulatory incentives and voluntary partnership
programs. An industry trade association suggested the establishment of
a working group to develop decision framework and guidance materials
for STAAs. The commenter remarked that creation of a working group
would be more effective than mandating RMP facilities to conduct STAAs
with insufficient guidance. A commenter recommended that the working
group should consider existing voluntary programs that include a safer
alternatives assessment, and should consider the possibility of
establishing a public-private partnership. The commenter further
explained that the working group should explore how EPA could leverage
these programs by providing regulatory incentives to those who
participate in and fulfill the requirements of the voluntary programs.
The commenter also suggested that a partnership could be created based
on the core principles adopted by industry (i.e., stewardship) programs
and the lessons learned from existing and past voluntary partnership
programs. The commenter stated that such a program could provide
technical assistance and tools to help create awareness and instill a
quality culture of safety and security. The commenter provided a white
paper with more detailed discussion on the potential purposes,
components, incentives and requirements for a voluntary partnership
program to improve chemical safety and security.
    EPA appreciates the commenters' suggestions for developing
guidance, regulatory incentives and partnership programs for STAAs. EPA
is finalizing a regulatory provision requiring Program 3 industry
sectors in NAICS codes 322, 324, and 325 to conduct an STAA as part of
the PHA and determine the practicability of IST or ISD considered. EPA
disagrees that STAA should be limited to a voluntary partnership
program; however, EPA will further consider the merits of a potential
voluntary partnership program with industry to engage in improved
process safety practices.
    EPA believes the STAA requirements are flexible and allow the use
of industry expertise to best decide which safer technologies and
alternatives to consider, and to determine the practicability of IST or
ISD considered in the STAA. EPA will develop guidance for complying
with RMP PHA and STAA requirements before sources must comply with the
STAA provision required in this action. A draft of this guidance will
be available for public comment.
    Making STAA information available to LEPCs. A facility is concerned
that the proposed requirement to share information pertaining to
inherently safer technology or design with the local LEPC would require
specific detailed information that the LEPC may not consider relevant.
While the facility expressed willingness to share appropriate
information with the LEPC, the facility does not believe the LEPC would
be interested in the minute details of the changes in process units. An
industry trade association stated that not requiring implementation
while requiring facilities to provide LEPCs the date of implementation
or planned implementation could cause confusion.
    EPA agrees that providing LEPCs with detailed information regarding
process changes involving IST or ISD may not always be relevant or
necessary to community emergency preparedness or can be confusing. The
final rule eliminates the proposed requirements under Sec.  68.205 to
provide information to the LEPC, upon request (including IST
information). For more information about how the final rule addresses
sharing information with LEPCs or emergency response officials, see
section VI.A. of this preamble.
e. Including STAA as a PHA Requirement
    Appropriateness of PHA techniques or process for STAA. A few local
agencies expressed support for STAA measures being used as a method of
addressing PHA recommendations. Commenters, including a local agency,
encouraged the review of the STAA at least every five years.
    However, several commenters opposed including STAA in the PHA. Two
trade associations commented that requiring PHA teams to evaluate the
feasibility of IST has the potential to undermine the effectiveness of
the PHA process. The commenters argued that regulating IST is
infeasible because there is no simple answer when it comes to managing
risk. The same two trade associations and one facility asserted that a
PHA review of an existing process considers the adequacy of the
existing controls for that process while an IST review is entirely
different. The commenters believe an IST review involves a comparison
to a different technology and an operation-specific and site-specific
evaluation based on engineering judgment, in which many variables are
considered that include hazards, the location of the facility,
surrounding populations, exposures, technical feasibility and economic
feasibility. A state agency and an industry trade association warned
that requiring STAA during the PHA would be inappropriate because the
structure of a PHA does not facilitate such an analysis.
    A facility expressed concern that none of the PHA methodologies
described in the NPRM require this type of comparison, arguing that
IST/ISD methodologies are similar, but not identical, to PHA analysis
techniques. The facility stated that it would be wrong to assume that
STAA can be directly incorporated into existing PHA methodologies. A
trade association commented that in order to have PHA team members
perform a comparative analysis on alternatives, the PHA team would be
required to compile relevant process safety information for the
alternatives in order to perform the IST analysis.
    One commenter believes that IST needs to be evaluated outside of
the PHA process because the node-to-node hazard and operability study
(HAZOP) approach is minutely focused, does not look at the bigger
picture and reduces the impact of IST to localized risk reduction
measures rather than making the whole process inherently safer. The
commenter stated that a separate IST analysis for the entire existing
process is needed and could be performed every five years but
separately from the PHA since different team participants (such as
technical experts) are usually needed.
    One trade association and a facility believed that IST analyses are
not practical to conduct as part of a PHA for a defined process with
defined chemicals. The commenters claimed that to consider a
substitute, a facility operator would need to design the new process
before being able to conduct the analysis. Some facility commenters
reasoned that design and hazard reviews for new facilities can take
place years

before any PHA. An industry trade agency suggested that EPA should
include appropriate lead-time and grandfathering provisions so as not
to disrupt projects already in the design or construction phase.
Finally, an industry trade association asserted that IST decisions are
very complex and should not be determined by any government agency, and
recommended that EPA delete the proposed STAA provisions.
    EPA believes that IST analysis can be incorporated in the existing
RMP PHAs by using PHA techniques such as HAZOP, What-If? Method, or
checklists or a combination of these as discussed in Chapter 8 of CCPS'
book, Inherently Safer Chemical Processes: A Life Cycle Approach.\87\
These techniques themselves are not requirements, but tools available
to help the facility owner or operator to identify, evaluate and
control the hazards involved in the process.
---------------------------------------------------------------------------

    \87\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley.
---------------------------------------------------------------------------

    While developing the original RMP rule, EPA noted some commenters
strongly opposed any requirement for safer technology analyses because
PHA teams regularly suggest viable, effective (and inherently safer)
alternatives for risk reduction. In the preamble to the original RMP
rule, EPA agreed with these commenters, indicating that ``application
of good PHA techniques often reveals opportunities for continuous
improvement of existing processes and operations without a separate
analysis of alternatives.'' \88\ While these comments in 1996 led us to
not require STAA in the original rule, further developments in STAA,
and EPA's own experience with implementation of the rule, now indicate
that a specific mandate to conduct STAA reviews as part of the PHA will
encourage facilities who were performing PHAs that were of lower
quality but legally compliant with the old rule, to perform better
PHAs.
---------------------------------------------------------------------------

    \88\ See 61 FR 31699, June 20, 1996.
---------------------------------------------------------------------------

    Therefore, EPA disagrees with commenters that argue it is not
appropriate to include an STAA in the PHA. In fact, the RMP PHA
requirements include other aspects of an analysis that is typically
associated with process design. For example, the PHA must also address
stationary source siting issues which involve the location and
proximity of the source to local population and their numbers.
    Nevertheless, EPA agrees that for situations where an IST would
involve a new process that is entirely different from the current
process, the process design would have to exist or be developed, and
process safety information be compiled, to conduct a PHA for this new
process. EPA does not expect facility owners or operators to research
and create new process designs or conduct research into all
possibilities for the use of new chemicals. Instead, the STAA should
focus on the known and existing substitute processes and chemicals that
have been demonstrated to be in use commercially.
    If a facility is considering a chemical substitution or process
change that involves a significant redesign of their process, such
efforts involved with redesign and its evaluation may need to be
undertaken as part of a practicability study.\89\ The definition of
``practicability'' allows for consideration of technological factors,
which could include whether the potential safer alternative can be
designed and operated to meet the process functions needed. However,
not all IST involves substituting a chemical or an entirely new process
and there are other types of other IST measures (minimization,
moderation or simplification) that can be considered to address various
points within the current process where hazards and risks exist.
Furthermore, the final rule does not require the facility to implement
IST measures.
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    \89\ EPA modified the final rule to replace the term
``feasible'' defined in Sec.  68.3 with ``practicability.'' When
evaluating the practicability of an IST, the facility owner or
operator would determine whether the IST is capable of being
successfully accomplished within a reasonable time, accounting for
economic, environmental (including consideration of potential
transferred risks for new risk reduction measures), legal, social,
and technological factors.
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    Facilities may, if desired, conduct a separate IST analysis of each
covered process, outside of the PHA, if desired, as long as it is done
in same timeframe as the PHA and the results are documented. If a
facility does not have staff capable to identify and evaluate
alternatives, the facility owner or operator may require outside
assistance from engineering firms or consultants.
    The RMP PHA requirements require the facility owner or operator to
identify risk management measures that eliminate or reduce the risks
from the process hazards. If the facility has already performed such
IST analysis in the past, then the owner or operator should consider
these analyses when updating or revalidating their PHAs and determine
whether there is new information that should be considered as part of
conducting the current STAA.
    Involvement and training of employees and team members. An industry
trade association expressed concern about the potential experience
limitations of the PHA team. The commenter stated that team members may
lack the expertise required to assess all alternative technologies, and
said that in the case of inadequate experience the STAA should be
considered within the management of change element of the RMP and the
facility's ongoing risk assessment analysis. Two trade associations
commented that a PHA and an IST analysis serve two entirely different
engineering functions and the teams that conduct these reviews are
staffed differently. The two associations further commented that small
facilities do not have staff design engineers to conduct an IST review,
which means the facility would be required to absorb the cost of
retaining them even though there is no requirement that their findings
be implemented.
    One Federal agency commented that throughout the SBAR panel
process, SERs noted that this analysis would require additional
staffing such as design engineers, in addition to the chemical and
mechanical engineers already staffed for PHA analyses. The SERs added
that most small facilities do not have design engineers on staff and as
a result, would need to incur additional expenses to retain them.
    Another commenter stated that conducting a full IST/ISD review
based on yet-unproven technologies typically is an extremely complex
endeavor (particularly for a chemical production process), and would
require very different PHA teams that could adequately assess IST/ISD
(e.g., to adequately study how the hypothetical use of new IST/ISD
might create additional, unanticipated hazards throughout a process).
    Another commenter suggested that the PHA/hazard review team should
be properly educated in inherent safety analysis. A professional
organization encouraged the participation of workers in the STAA
process, but urged that these employees must have proper training and
education to participate. Some commenters recommended engaging workers
in the alternatives and feasibility assessment process and making sure
they have the ability to report anonymously and hold whistleblower
authority. One commenter urged EPA to explicitly state that union
representatives and workers can participate fully in the STAA.
    EPA believes that limiting the applicability of the STAA
requirement to only those facilities in Program 3 in the petroleum and
coal products manufacturing (NAICS code 324), chemical manufacturing
(NAICS code

325) and paper manufacturing (NAICS codes 322) minimizes the burden of
the requirement for many small businesses. Of those approximately 1,557
facilities that are subject to the STAA requirements, approximately 40%
of them are owned by small entities, however, about 86% of these small
entity-owned facilities have 20 or more full-time equivalent
employees.\90\ EPA agrees that team members conducting an STAA should
be properly trained and knowledgeable on how to conduct the analysis.
The facility owner or operator is responsible for ensuring that
facility personnel have the proper training to conduct STAAs or hire
consultants with the appropriate qualifications. EPA expects that some
facilities in NAICS codes 322, 324, and 325 will have staff qualified
to conduct the analysis. If the facility owner or operator determines
that two different teams should conduct the PHA and STAA, then they may
choose to conduct a separate STAA of each entire process, outside of
the PHA as long as it is done in same timeframe as the PHA and the
results are documented.
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    \90\ Regulatory Impact Analysis, Accidental Release Prevention
Requirements: Risk Management Programs Under the Clean Air Act,
Section 112(r)(7), using data from Exhibit 7-3 and 7-5.
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    As discussed in the RIA, the technical practicability assessment
considers the extent of process redesign, its engineering implications,
and possible costs. EPA estimates that most facilities except the large
facilities in NAICS codes 322, 324, and 325 will seek help from
consultants (i.e., engineering firms) to conduct STAA and determine the
practicability of IST/ISD considered. However, EPA does not expect
facilities to spend resources evaluating hypothetical untested
alternatives that they believe are not proven within their industry.
    Finally, the final rule provides facility owners or operators the
flexibility to use facility personnel with expertise and experience
with facility processes and their industry to conduct STAAs and
determine the practicability of IST/ISD considered. However, EPA does
not believe the RMP rule is the appropriate mechanism to address worker
rights or whistleblower protections.
    Overlap or conflict with PHA analysis. A few industry trade
associations and a facility expressed concern that an IST analysis
would detract from the goal and focus of the PHA process to identify
hazards to be addressed and to identify opportunities for continuous
improvement of operations. For example, one commenter was concerned
that in an effort to ensure compliance with new safer alternative
technology analysis regulations, PHA teams may be distracted from
identifying and addressing the hazards of existing processes by
spending too much time assessing potential alternative technologies
with which they have no experience. Two commenters elaborated, stating
that requiring IST or ISD ``consideration'' based on a laundry-list of
``factors'' would substantially increase the already extensive time
that is required to complete a PHA, and favor subjective reviews over
objective reviews of actual safety problems and the most direct and
timely techniques required to resolve them.
    EPA disagrees with the commenters. The RMP PHA requirements are not
only to identify hazards but also to incorporate measures to reduce or
mitigate those hazards. Under Sec.  68.67(a), the rule requires the
owner or operator to identify, evaluate and control the hazards
involved in the process. Several commenters acknowledge that some
companies already evaluate ``safer alternatives'' during their PHAs
when it is efficient to consider fundamental process changes. EPA
disagrees that consideration of additional inherently safer measures
necessarily precludes addressing hazards and applying other risk
reduction measures in the hierarchy of controls. If facility owners or
operators are concerned that an IST assessment could preclude other
aspects of the PHA, they may choose to conduct the STAA separately from
the PHA, as long as it is performed on the same timeframe and
documented.
    IST already incorporated as part of PHA or otherwise considered.
Another industry trade association remarked that STAA requirements are
already a component of the PHA and concluded that costs of the new
requirement would be redundant, but that these costs are incommensurate
with the much lower risks faced by facilities in their industry. One
trade association disagrees with requiring STAA as part of the PHA
because currently approved PHA methodologies already provide for
successful risk mitigation (reducing risks to personnel and the
environment to `acceptable' levels), including the consideration of
inherently safer design technologies by the PHA team where appropriate.
A commenter noted that some companies already evaluate ``safer
alternatives'' during their PHAs when it is efficient to consider
fundamental process changes. However, they consider available, proven
technologies, not ``potentially'' safer technology that may be noted in
literature, but not yet in use anywhere within their industry. Another
industry trade association remarked on the importance of process safety
information for alternatives and its availability to the PHA team. A
process safety organization commented that they believe the existing
provisions to conduct a PHA automatically includes the team to consider
safer alternatives as appropriate and applicable. An industry trade
association said that many of the activities being reported as IST in
NJDEP's IST Implementation Summary, were activities that already occur
as a matter of course in most facilities.
    A facility and multiple industry trade associations remarked that
other programs such as the Department of Homeland Security's Chemical
Facility Anti-Terrorism Standards (CFATS) already provide incentives
for facilities to promote safe practices, and implement safer
alternatives and designs. Several commenters urged EPA to avoid
burdensome requirements that overlap with the CFATS program at
additional cost without added benefit. An industry trade association
noted that CFATS allows facilities to move to a lower risk tier or out
of the program if risk profiles are reduced and vulnerabilities are
minimized, resulting in roughly 3,000 facilities that have changed
processes or inventories in ways that have enabled them to be excluded
from the program. This commenter notes that DHS's risk performance-
based approach does not mandate solutions, recognizes the unique
situation of each facility, and embraces a public-private sector effort
for implementation of safer measures. The commenter further indicated
that mandating the adoption of government-selected ISTs would be unduly
burdensome, particularly for smaller chemical facilities, and could
hinder their overall efforts at improving security.
    While EPA recognizes that some facilities may already consider ISTs
as part of a PHA, whether as part of a voluntary program or through
other incentives, EPA believes that all facilities in NAICS 322, 324,
and 325 industry sectors should consider IST to ensure that they are
considering all the options to operate their facility safer. EPA
expects that these regulatory requirements will raise industry
awareness of IST possibilities and will reduce risk. EPA is not
mandating implementation or adoption of any particular IST and will
rely on facility expertise to reduce the hazard and mitigate risk
without causing undesirable consequences such as reducing product
quality or transferring risk to some other point in the supply chain.

    Furthermore, EPA disagrees with commenters that asserted that the
STAA requirements will overlap with other regulatory requirements and
result in an increased burden with no corresponding benefit. In its
2007 Interim Rule for CFATS,\91\ DHS stated that Section 550 of the