[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Rules and Regulations]
[Pages 45134-45136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22512]
[[Page 45133]]
_______________________________________________________________________
Part IX
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 68
Accidental Release Prevention Requirements; Interpretations; Final Rule
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules
and Regulations
[[Page 45134]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 68
[FRL-5881-9]
Accidental Release Prevention Requirements; Interpretations
AGENCY: Environmental Protection Agency.
ACTION: Interpretations.
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SUMMARY: The Environmental Protection Agency is announcing clarifying
interpretations of the accident prevention regulations authorized by
section 112(r) of the Clean Air Act (CAA). First, the Agency is
clarifying the method for calculating whether a quantity of a regulated
substance in a listed solution exceeds its regulatory threshold under
these rules. Second, the Agency is clarifying that certain reports and
studies required by the accident prevention rules do not need to be
reported under section 8(e) of the Toxic Substances Control Act (TSCA)
or under the rules implementing TSCA section 8(d). The interpretations
announced today clarify the Agency's existing policy and should help
regulated entities understand their compliance obligations under these
regulations.
EFFECTIVE DATE: August 25, 1997.
ADDRESSES: The docket for this notice is A-97-28. This notice pertains
to previous final rules under dockets A-91-73 and A-91-74.
FOR FURTHER INFORMATION CONTACT: Regarding CAA section 112(r) and part
68, Vanessa Rodriguez, Chemical Engineer, Chemical Emergency
Preparedness and Prevention Office, Environmental Protection Agency
(5101), 401 M St., S.W., Washington, DC 20460, (202) 260-7913.
Regarding TSCA section 8(d), David R. Williams, Associate Branch Chief,
401 M St. S.W., Washington DC 20460, (202) 260-3468. Regarding TSCA
section 8(e), Richard H. Hefter, Jr., TSCA Section 8(e) Coordinator,
High Production Volume Chemicals Branch, Office of Pollution Prevention
and Toxics (7403), 401 M St. S.W., Washington, DC 20460, (202) 260-
3470.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially affected by this action are those stationary
sources that have more than a threshold quantity of a regulated
substance in a process. Regulated categories and entities include:
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Examples of regulated
Category entities
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Chemical Manufacturers.................... Industrial organics &
inorganics, paints,
pharmaceuticals, adhesives,
sealants, fibers.
Petrochemical............................. Refineries, industrial
gases, plastics & resins,
synthetic rubber.
Other Manufacturing....................... Electronics, semiconductors,
paper, fabricated metals,
industrial machinery,
furniture, textiles.
Agriculture............................... Fertilizers, pesticides.
Public Sources............................ Drinking and waste water
treatment works.
Utilities................................. Electric and Gas Utilities.
Others.................................... Food and cold storage,
propane retail, warehousing
and wholesalers.
Federal Sources........................... Military and energy
installations.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table also could be
affected. To determine whether a stationary source is affected by this
action, carefully examine the provisions of part 68 and related
notices. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding FOR FURTHER INfORMATION CONTACT section.
I. Introduction and Background
The Clean Air Act (CAA), section 112(r), contains requirements for
the prevention of accidental releases. The goal of the accidental
release provisions is to prevent accidental releases and minimize the
consequences of releases by focusing on those chemicals and operations
that pose the greatest risk. The CAA requires EPA to develop a list of
regulated substances that, in the event of an accidental release, are
known to cause or may be reasonably expected to cause death, injury, or
serious adverse effects to human health and the environment. At the
time EPA promulgates its list of regulated substances, EPA also must
establish threshold quantities for each regulated substance. Stationary
sources that have more than a threshold quantity of a regulated
substance are subject to accident prevention regulations promulgated
under CAA section 112(r)(7).
On January 31, 1994, EPA promulgated the list of regulated
substances and thresholds that identify stationary sources subject to
the accidental release prevention regulations (59 FR 4478) (the ``List
Rule''). EPA subsequently promulgated a rule requiring owners and
operators of these stationary sources to develop programs addressing
accidental releases and to make publicly available risk management
plans (``RMPs'') summarizing these programs. (61 FR 31668, June 20,
1996) (the ``RMP Rule''). On April 15, 1996, EPA proposed amendments to
the List Rule (61 FR 16598) and on June 20, 1996, stayed certain
provisions of the list and threshold regulations affected by the
proposed amendments (61 FR 31730). On May 22, 1997, EPA proposed
additional amendments to the List Rule (62 FR 27992). For further
information on these regulations, section 112(r), and related statutory
provisions, see these notices. These rules can be found in 40 CFR part
68, ``Chemical Accident Prevention Provisions,'' and collectively are
referred to as the accidental release prevention regulations.
II. Interpretations
In conducting outreach to affected stakeholders concerning the
implementation of the accidental release prevention regulations, EPA
has attempted to clarify informally various interpretive issues
concerning both the List Rule and the RMP Rule. Furthermore,
interpretive issues have been raised by various litigants that have
petitioned for judicial review of the List Rule and the RMP Rule. EPA
has used a number of mechanisms to communicate interpretations to all
stakeholders, such as having staff participate in conferences and
seminars sponsored by stakeholders and maintaining both files of
questions and answers on its website and a hotline for addressing
public inquiries. Question and answer files can be found at http://
www.epa.gov/swercepp/ under Publications; the hotline can be reached at
(800) 424-9346. Publication in the Federal Register allows EPA to give
wider notice to the public of interpretations of the accidental release
prevention regulations that have national application or nationwide
scope and effect. Also, publication of these interpretations was part
of the settlement agreement of General Electric Company's petition for
review of the List Rule; notice of this settlement was published in the
Federal Register on May 22, 1997 (62 FR 27992).
The interpretations discussed below clarify how to determine
whether a threshold quantity for a regulated substance contained in a
listed solution has been exceeded and discuss the relationship between
offsite consequence analyses required by the RMP Rule and certain
provisions of the Toxic Substances Control Act (TSCA).
[[Page 45135]]
These interpretations are clarifications of existing regulations and
statutory provisions rather than revisions to the accidental release
prevention regulations and are consistent with the working
interpretations EPA has been using in its outreach efforts.
A. Threshold Quantities for Listed Solutions
In the regulations addressing the procedures for determining
whether a threshold quantity of a regulated toxic substance has been
exceeded, EPA set out rules for how to calculate the quantity of a
regulated substance contained in a mixture (40 CFR 68.115). In general,
the rule requires the owner or operator of a stationary source (the
``source'') to count towards a threshold the quantity of a regulated
substance contained in a mixture if the regulated substance exceeds one
percent (1%) of the weight of the mixture. However, if the partial
pressure of the regulated substance in a mixture is less than 10
millimeters of mercury (mm Hg), then the source does not need to count
the regulated substance in that mixture towards the threshold quantity
(40 CFR 68.115(b)(1)). For example, if chemical A, a regulated
substance, is present in a mixture at 5% by weight, but the partial
pressure of that substance in the mixture is 7 millimeters of mercury
(mm Hg), then the source does not need to count the regulated substance
in that mixture towards the threshold quantity.
For certain chemicals commonly handled in solution with water, EPA
established minimum concentrations for mixtures with water (40 CFR
68.130, Tables 1 and 2). These chemicals and their minimum
concentrations are ammonia (20% or greater), hydrogen chloride /
hydrochloric acid (37% or greater), hydrogen fluoride / hydrofluoric
acid (50% or greater), and nitric acid (80% or greater). EPA also
included separate listings for anhydrous forms of ammonia and hydrogen
chloride.
Some confusion has arisen over whether the one percent default
mixture rule would apply to mixtures containing aqueous solutions of
ammonia, hydrochloric acid, hydrofluoric acid, or nitric acid. When EPA
included minimum concentrations for these chemicals on the tables
listing regulated substances, EPA intended to supersede the 1% general
default rule for mixtures containing regulated toxic substances and to
provide a simpler method for threshold determination than the partial
pressure method. As EPA stated in the preamble to the List Rule,
``[t]hese chemicals, in mixtures or solutions with concentrations below
the specified cut-off, will not have to be considered in determining
whether a threshold quantity is present'' (59 FR 4478, 4488, January
31, 1994). Therefore, EPA wishes to clarify that the one percent
mixture rule established in 40 CFR 68.115(b)(1) does not apply to
aqueous solutions or mixtures containing ammonia, hydrochloric acid,
hydrofluoric acid or nitric acid for purposes of determining whether
more than a threshold quantity is present at a stationary source. For
such mixtures, the quantity of regulated substance in the mixture must
be considered only if the concentration of the regulated substance in
the total mixture equals or exceeds the specified minimum concentration
in the list rule.
Another question that has been asked about how to calculate the
quantity of a regulated substance for a listed solution concerns
whether the source must include the entire weight of the solution
towards the threshold. For example, some have asked whether a 50,000
pound solution that is 28 percent (28%) ammonia (14,000 pounds of
ammonia contained in solution) would exceed the threshold for aqueous
ammonia, which is 20,000 pounds. Some have read the specific listing of
these solutions to mean that the entire solution is the regulated
substance, thus requiring threshold calculations to be based on the
entire solution.
In providing concentration cutoffs for specific chemicals, EPA did
not intend to treat the entire listed solution as a regulated
substance. Rather, EPA intended simply to establish an alternative
method for calculating minimum concentrations for substances that
themselves are listed. The Agency's intent can be inferred from the
location of the discussion of the concentration cut-offs in the
``threshold determination'' section of the List Rule preamble rather
than in the discussion of the listing for toxic chemicals (compare 59
FR 4481-85 with 59 FR 4488). Furthermore, the citation in Tables 1 and
2 to the Chemical Abstract Service (CAS) number refers to the regulated
substance contained in the solution rather than the entire solution.
However, the Agency has not been consistent in expressing this
interpretation since promulgation of the List Rule. For example, in the
``Risk Management Plan Rule: Summary and Response to Comments'' (``RMP/
RTC'') EPA stated, ``[i]f the regulated substance is listed as a
solution * * *, then the entire weight of the solution is used'' (page
28-104). This incorrect expression of EPA's interpretation appears to
be isolated and was not in the context of the development of the List
Rule. The action announced today reaffirms the Agency's position taken
in the List Rule context: the threshold quantities for solutions at and
above the concentrations stated in the List Rule apply only to the
quantity of the regulated toxic substance (listed in Tables 1 and 2 of
40 CFR 68.130) in the solution and do not include the water content of
the solution. Thus, in the ammonia solution example discussed above,
the threshold for aqueous ammonia would not be exceeded because the
ammonia content of the 50,000 pound solution would be 14,000 pounds
(28% of 50,000), while the relevant threshold would be 20,000 pounds of
ammonia.
B. Relationship to Certain TSCA Reporting Requirements
Among the comments received on both the List Rule and the RMP Rule
were questions that asked about whether either TSCA section 8(e) or the
rules implementing TSCA section 8(d) require reporting under TSCA of
either the RMP or the hazard assessment required by the RMP Rule. When
EPA promulgated the RMP Rule, EPA replied in the RMP/RTC that it did
not interpret the TSCA provisions to require submission of copies or
listing of either RMPs or the hazard assessments required by the RMP
Rule (RMP/RTC, page 33-56). EPA believes that an expanded discussion of
the relationship between the RMP Rule and the TSCA requirements is
appropriate and that wider dissemination of this interpretation by this
notice is useful to regulated entities.
Under TSCA section 8(d), current and prospective producers,
importers, and processors are required to submit a broad range of
unpublished health and safety studies conducted on the chemical
substances and mixtures listed at 40 CFR 716.120. Chemicals are
periodically added to section 716.120 by rulemaking. The requirements
become effective on the date specified in the final rule and
prospective reporting obligations terminate no later than 10 years
after the effective date or upon removal of the chemical substance or
mixture from section 716.120. Such health and safety studies include
but are not limited to: epidemiological or clinical studies; studies of
occupational exposure; in vivo and in vitro toxicological studies; and
studies of environmental effects. Copies of such studies possessed at
the time a person becomes subject to the reporting requirements must be
submitted, and the following kinds of studies must be listed: studies
ongoing as of the date a person becomes subject to the rule;
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studies initiated after the date a person becomes subject to the rule;
studies that are known to, but are not possessed by, a person as of the
date that person becomes subject to the rule; and studies previously
submitted to U.S. Government Agencies without confidentiality claims.
It should be noted that EPA is in the process of substantially revising
the TSCA section 8(d) reporting requirements at 40 CFR part 716 and
plans to issue a Federal Register notice detailing these revisions in
the near future. The revisions are not expected to affect the
interpretations included in this notice.
TSCA section 8(e) states that ``any person who manufactures
[including imports], processes, or distributes in commerce a chemical
substance or mixture and who obtains information which reasonably
supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment shall
immediately inform the [EPA] Administrator of such information unless
such person has actual knowledge that the Administrator has been
adequately informed of such information.'' The type of information
required to be submitted under section 8(e) covers a broad range of
health and environmental effects studies, exposure studies, and certain
emergency release events not otherwise covered by other EPA reporting
requirements. The majority of the information submitted concerns
controlled laboratory studies of the effects of chemicals on human
health and the environment, such as animal bioassays and a wide range
of other in vivo and in vitro studies. Incidents of environmental
contamination or exposure studies based on actual releases may also be
required to be submitted based on the toxicity of the chemicals and the
likelihood that humans or the environment will be impacted. However,
modeling studies including those based on theoretical exposure data
(e.g., ``worst-case'' scenarios), are not considered reportable under
section 8(e), nor are hazard or risk assessments based on reviews of
existing data. However, data or studies underlying the assessments may
have been reportable at the time they were obtained by the companies
performing the assessments if the information was not otherwise known
to EPA.
Hazard assessments required by the RMP Rule consist of an offsite
consequence analysis component and a five-year accident history (40 CFR
68.20 through 68.42). For most sources affected by the RMP Rule, the
offsite consequence analysis requires development of two types of
release dispersion analyses, ``worst-case release scenario'' analyses
under 40 CFR 68.25 and ``alternative release scenario'' analyses under
40 CFR 68.28. Under the worst-case release scenario, the RMP Rule
provides most of the modeling parameters, while under the alternative
release scenario, a source has more flexibility in selecting modeling
parameters. The worst-case release scenario analysis does not require a
probability estimate of the specified worst-case conditions actually
occurring, although the rule provides some flexibility if the specified
conditions have not occurred in a recent period. The alternative
release scenario is supposed to represent a scenario that is more
likely to occur than the worst case scenario and that will have offsite
consequences, unless no alternative scenario would have offsite
consequences.
The two types of scenarios required to be analyzed under the hazard
assessment provisions of the RMP Rule are not unlike ``vulnerability
analyses'' that some sources have conducted for Local Emergency
Planning Committees under the Emergency Planning and Community Right-
to-Know Act (EPCRA) in that these scenarios concern theoretical upset
plant conditions rather than actual or likely exposure scenarios. The
Agency has previously expressed the view that vulnerability analyses
are not reportable under TSCA section 8(d).
The five-year accident history component of the hazard assessment
is a compilation of data on historical accidents, which would include
information on release conditions, impacts, and changes that may have
resulted from investigation of the release (40 CFR 68.42). As a
compilation of historical incidents, the five-year accident history
does not supersede requirements for notification of accidental releases
under various statutes and is distinct from the RMP Rule's requirements
for accident investigations under 40 CFR 68.60 and 68.81. In
particular, TSCA section 8(e), EPCRA section 304, and section 103 of
the Comprehensive Emergency Response, Compensation and Liability Act
(CERCLA) may require a release to be reported and follow-up
notification submitted.
Having reviewed the requirements of the RMP Rule in light of the
requirements of TSCA section 8(d) rules and TSCA section 8(e), it is
apparent that a hazard assessment mandated by the RMP Rule (i.e., worst
case and alternative case scenario analyses and five-year accident
history) is not subject to the copy and list submission requirements of
the Health and Safety Data Reporting Rule codified at 40 CFR part 716,
which implements TSCA section 8(d), and it is apparent that a hazard
assessment mandated by the RMP Rule is not subject to the reporting
requirements of TSCA section 8(e). However, the foregoing does not
affect the applicability of either TSCA section 8(e) or TSCA section
8(d) and regulations promulgated thereunder to any information or
studies used to develop such hazard assessment. For example, it has
been a longstanding EPA interpretation of TSCA section 8(e) that it
requires some releases to be reported to EPA; while such a release may
need to be compiled in the five-year accident history, the release
would remain subject to TSCA section 8(e) reporting. Similarly, a study
initiated by a source on its own as an outgrowth of the five-year
accident history, such as a follow up study on known animal impacts
from a specific accidental release, may be subject to the listing and/
or submission requirements of the TSCA section 8(d) and the rules
thereunder. Nevertheless, it should be clear that the preparation,
compiling, and reporting of hazard assessments as mandated by the RMP
Rule do not trigger the copy and list submission requirements of the
part 716 implementing regulation for TSCA section 8(d) nor do they
require reporting under TSCA section 8(e).
Dated: August 19, 1997.
Carol M. Browner,
Administrator.
[FR Doc. 97-22512 Filed 8-22-97; 8:45 am]
BILLING CODE 6560-50-U
