45134 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 68

[FRL–5881–9]

Accidental Release Prevention

Requirements; Interpretations

AGENCY: Environmental Protection

Agency.

ACTION: Interpretations.

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:

Category Examples of regulated 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 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).
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 cutoff, 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;
45136 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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 fiveyear 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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