[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:

------------------------------------------------------------------------
                                                Examples of regulated   
                 Category                             entities          
------------------------------------------------------------------------
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.             
------------------------------------------------------------------------

    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 <a href="http://
www.epa.gov/swercepp/">http://
www.epa.gov/swercepp/</a> 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]
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