Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Rules and Regulations 9299

the environment. Therefore, lessees

must contact the appropriate MMS

Regional Supervisor prior to burning

liquid hydrocarbons.

The MMS recognizes that the best

way to provide restrictions on burning

liquid hydrocarbons is by rulemaking.

Therefore, MMS is issuing a proposed

rule under a separate Federal Register

Notice that will cover the restrictions on

burning liquid hydrocarbons.

The proposed rule will also give the

public the opportunity to comment on

the restrictions on burning liquid

hydrocarbons.

Dated: December 23, 1994.

Bob Armstrong,

Assistant Secretary, Land and Minerals

Management.

[FR Doc. 95–3985 Filed 2–16–95; 8:45 am]

BILLING CODE 4310–MR–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 372

[OPPTS–400006A; FRL–4929–6]

Butyl Benzyl Phthalate; Toxic

Chemical Release Reporting;

Community Right-to-Know

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is granting a petition to

delete butyl benzyl phthalate (BBP)

from the list of toxic chemicals under

section 313 of the Emergency Planning

and Community Right-to-Know Act

(EPCRA). By promulgating this rule,

EPA is relieving facilities of their

obligation to report releases of BBP that

occurred during the 1994 calendar year

and releases that will occur in the

future. This relief applies only to

reporting requirements under section

313 of EPCRA.

EFFECTIVE DATE: This rule is effective

February 17, 1995.

FOR FURTHER INFORMATION CONTACT: For

specific information on this rule: Maria

J. Doa, Petition Coordinator, Mail Code

7408, Environmental Protection Agency,

401 M St., SW., Washington, DC 20460,

Telephone: 202–260–9592. For more

information on EPCRA section 313:

Emergency Planning and Community

Right-to-Know Hotline, Environmental

Protection Agency, Mail Code 5101, 401

M St., SW., Washington, DC 20460, Toll

free: 1–800–535–0202, In Virginia and

Alaska, 703–412–9877 or Toll free TTD:

1–800–553–7672.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Statutory Authority

This final rule is issued under section

313(d) and (e)(1) of the Emergency

Planning and Community Right-toKnow Act of 1986 (EPCRA), 42 U.S.C.

11023. EPCRA is also referred to as Title

III of the Superfund Amendments and

Reauthorization Act (SARA) of 1986

(Pub. L. 99–499).

B. Background

Section 313 of EPCRA requires certain

facilities manufacturing, processing, or

otherwise using listed toxic chemicals

to report their environmental releases of

such chemicals annually. Beginning

with the 1991 reporting year, such

facilities must also report pollution

prevention and recycling data for such

chemicals, pursuant to section 6607 of

the Pollution Prevention Act (42 U.S.C.

13106). When enacted, section 313

established an initial list of toxic

chemicals that was comprised of more

than 300 chemicals and 20 chemical

categories. Section 313(d) authorizes

EPA to add or delete chemicals from the

list, and sets forth criteria for these

actions. Under section 313(e)(1), any

person may petition EPA to add

chemicals to or delete chemicals from

the list. EPA has, from time-to-time,

added and deleted chemicals from the

original statutory list.

EPA issued a statement of petition

policy and guidance in the Federal

Register of February 4, 1987 (52 FR

3479), to provide guidance regarding the

recommended content and format for

petitions. On May 23, 1991 (56 FR

23703), EPA published guidance

regarding the recommended content of

petitions to delete individual members

of section 313 metal compound

categories. EPA has also published a

statement clarifying its interpretation of

the section 313(d)(2) criteria for adding

and deleting chemicals from the section

313 list (59 FR 61439, November 30,

1994).

II. Description of Petition and Proposed

Response

On January 12, 1987, EPA received

from the Monsanto Company a petition

to delete BBP from the list of toxic

chemicals subject to reporting under

section 313 of EPCRA. BBP was

included on the original list of toxic

chemicals when EPCRA was enacted.

On July 20, 1987, following a review

which consisted of a toxicity evaluation

and an exposure analysis, EPA proposed

to grant the petition to delete BBP from

the section 313 list by issuing a

proposed rule in the Federal Register

(52 FR 27226).

The proposal to grant the petition was

based upon EPA’s preliminary finding

that BBP did not meet the listing criteria

found in section 313(d) of EPCRA. It

was EPA’s belief that there was not

sufficient evidence to demonstrate that

BBP causes or can reasonably be

anticipated to cause significant adverse

human health or environmental effects.

One concern which remained

following the initial review was the

apparently widespread presence of BBP

in the environment despite low

anticipated release levels. Because of

this concern, EPA stated in the

proposed rule that the delisting would

not be promulgated until the 1987 Toxic

Chemical Release Inventory (TRI)

reports submitted pursuant to section

313 could be examined to confirm that

there were no substantial releases of

BBP from covered facilities (see unit III.

of this preamble).

Only one commenter, the Monsanto

Company, responded to EPA’s proposal

to delete BBP from the section 313 list

of toxic chemicals. The Monsanto

Company concurred with EPA’s

proposed deletion but objected to the

decision to delay promulgation until the

1987 TRI reports could be reviewed.

Based upon evaluation of the petition,

available toxicity and exposure

information, the review of the 1987 -

1992 TRI reports, and the comment,

EPA affirms its determination that BBP

does not meet any of the toxicity criteria

listed in section 313(d). Therefore, EPA

is deleting BBP from the list of

chemicals subject to reporting under

section 313 of EPCRA.

BBP also appears on the Priority

Pollutant List (PPL) of section 307 of the

Clean Water Act (33 U.S.C. 1317);

however, at this time EPA believes that

insufficient data preclude the derivation

of ambient water quality criteria for BBP

by the Agency.

This petition does not request that

any action be taken under any statutory

provision other than EPCRA section

313, and today’s rule should not be

inferred as an action under any statutory

provision other than EPCRA section

313. Each statute prescribes different

standards for adding or deleting

chemicals of pollutants from their

respective list. Specifically, the deletion

of BBP from the EPCRA section 313 list

does not alter its regulatory status under

other statutory provisions. Today’s rule

is based solely on the criteria in EPCRA

section 313.

III. EPA’s Review of Butyl Benzyl

Phthalate

As discussed in the proposal, EPA

preliminarily determined that BBP has

low toxicity with respect to human
9300 Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Rules and Regulations

health, and moderate environmental

toxicity. Under these circumstances,

EPA believes that it is appropriate to

consider exposure in its listing

decisions (see position set out in

November 30, 1994 Federal Register

cited above). Therefore, EPA’s review of

BBP consisted of two main components:

a toxicity evaluation and a release and

exposure analysis. EPA has concluded

that (1) human health effects from BBP

are not expected to be significant for

purposes of section 313, and (2) BBP’s

moderate environmental toxicity,

coupled with a low concern for

persistence and bioaccumulation, does

not represent a significantly high level

of risk for the purposes of section

313(d). Details of the review can be

found in the proposed rule (52 FR

27226) and in the document entitled

‘‘Hazard Assessment of n-Butyl Benzyl

Phthalate’’ in the public docket.

A. Toxicity Evaluation

1. Human toxicity. At the time of

publication of the proposed rule, EPA

had preliminarily placed BBP in EPA’s

weight-of-evidence cancer risk

assessment Category D (i.e., available

evidence inadequate to determine

human carcinogenic potential). EPA

later placed BBP in weight-of-evidence

Category C (i.e., a possible human

carcinogen based on limited evidence in

animals).

BBP’s classification is based upon a

1982 study conducted by the National

Toxicology Program (NTP). Because of

serious flaws in this study, NTP has

undertaken a second animal study to

evaluate the carcinogenicity of BBP. It

was initially expected that results of this

study would be available by 1994. EPA

has waited for a number of years for the

results of this study; however, there is

currently no indication that the study

will be completed and results made

available in the near future. Therefore,

EPA has decided to take action on this

petition at this time using the existing

cancer study. If the results of the NTP

study indicate that BBP can reasonably

be anticipated to cause cancer, EPA will

re-evaluate the chemical and may

consider re-adding BBP to the section

313 list of toxic chemicals.

This reclassification resulted from

further review of the existing evidence;

no new evidence has been found

beyond that considered in EPA’s initial

review of this petition to delete BBP

from the section 313 list. Therefore, EPA

continues to believe that, while the

limited animal evidence available for

BBP suggests a possible carcinogenic

effect, the study providing this evidence

is flawed. Because of the flawed nature

of the study, EPA has concluded that

BBP exhibits low toxicity for purposes

of EPCRA 313(d)(2)(B) listing decisions.

Accordingly, exposure consideration

will be factored in. EPA has no evidence

to indicate other potential human

toxicity.

2. Environmental toxicity. As

discussed in the proposal, EPA has

concluded that BBP is moderately but

not highly ecotoxic. There is low

concern for potential bioconcentration,

and the half-life for primary

biodegradation of BBP is approximately

2 days, which indicates that the

substance should have low persistence

in the environment.

B. Release and Exposure Analysis

EPA has received and entered into the

section 313 TRI data base more than 100

reports per year for BBP for reporting

years 1987 to 1992. EPA examined these

reports primarily for water releases,

both directly to surface waters and

through Publicly Owned Treatment

Works (POTWs). For these years, from

18 to 53 companies reported water

releases to POTWs and from 1 to 15

reported releases directly to surface

water. For the releases to POTWs, EPA

assumed (based on the physical and

chemical characteristics of BBP) that

BBP releases are 90 percent removed in

wastewater treatment at the POTW

before the final release to surface water.

EPA analyzed the 1987 reported

release data to estimate the surface

water concentrations based upon mean

and low receiving stream flow data,

where available. Where stream flow data

were unavailable, the POTW mean

effluent flow was used as a worst-case

estimate. Where BBP releases were

reported as a range (e.g., 1 to 499 lb/yr),

the upper end of the release range was

used as a conservative estimate for

purposes of this section 313 analysis.

No firms were identified with a

potential surface water concentration at

or above the Lowest Effect

Concentration (LEC) for BBP of 110 ppb

(chronic aquatic ecotoxicity) under

mean flow conditions. Under low flow

conditions, two firms had a predicted

concentration of this magnitude (200

ppb for one firm, and an unquantifiable,

high concentration for the other site).

The other 17 firms all had estimated

surface water concentrations under low

flow conditions of 30 ppb or less.

The release patterns from subsequent

years were similar, and thus the

analyses using 1987 data were

considered representative of subsequent

years. To confirm this assumption, an

additional exposure review was

conducted using 1992 release data (the

most current data available). Estimates

of concentrations downstream from TRI

facilities were made using recent stream

flow data. Surface water concentrations

for the five highest releasers of BBP

ranged from 0.03 ppb to 1.0 ppb during

mean flow conditions, and from 0.2 ppb

to 18.8 ppb during low flow conditions.

Only the 18.8 ppb value exceeds the

Maximum Acceptable Toxicant

Concentrations (MATCs) for several

algal species. However, because the low

flow conditions are only expected to

occur during one 7–day event in 10

years, EPA does not believe that this

will result in adverse effects to the

environment. Efforts were made to

check as many sites as feasible in

addition to the five highest releasers,

because moderate releases may lead to

higher concentrations for streams with

less dilution. The surface water

concentrations for the stream found to

have potentially higher concentrations

were estimated to be less than 2 ppb

during mean flow conditions, and less

than 13 ppb for low flow conditions.

Again, although the low flow

concentrations may exceed the MATC

for certain algal species, the duration of

exceedence is not expected to be

sufficient to result in significant adverse

effects.

Human exposure potential to BBP was

also examined. The aquatic

concentrations at drinking water

utilities under mean flow conditions are

expected to be below 1 ppb (i.e., less

than 1 microgram per liter). The two

largest release facilities are both on the

Delaware River, and their combined

result (after accounting for treatment) is

less than 0.7 ppb under mean flow

conditions. These concentrations are not

expected to result in significant adverse

effects in humans.

IV. Conclusion of EPA’s Review

The hazard review conducted in 1987

concluded that BBP has low toxicity

with respect to human health and

moderate environmental toxicity. There

is no new data available which would

cause EPA to change this assessment.

EPA’s review of the 1987 and 1992 TRI

reports for BBP uncovered no

potentially significant releases at mean

flow conditions and only two

potentially significant releases at low

flow conditions. EPA’s conclusion is

that these releases do not raise sufficient

concern about potential human or

environmental exposures to warrant

retention of BBP on the section 313 list.

After reviewing available data and the

comment on the proposed rule, EPA

continues to believe that BBP does not

cause, nor can it reasonably be

anticipated to cause, the adverse human

health or environmental effects set forth

in section 313(d). Accordingly, it is
Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Rules and Regulations 9301

appropriate to delete BBP from the list

of toxic chemicals in EPCRA section

313.

V. Effective Date

This action becomes effective upon

publication. Thus the last year in which

facilities had to file a TRI report for BBP

was 1994, covering releases and other

activities that occurred in 1993. Section

313(d)(4) provides that ‘‘[a]ny revision’’

to the section 313 list of toxic chemicals

shall take effect on a delayed basis. EPA

interprets this delayed effective date

provision to apply only to actions that

add chemicals to the section 313 list.

For deletions, EPA may, in its

discretion, make such actions

immediately effective. An immediate

effective date is authorized, in these

circumstances, under 5 U.S.C. section

553(d)(1) because a deletion from the

section 313 list relieves a regulatory

restriction.

EPA believes that where the Agency

has determined, as it has with BBP, that

a chemical does not satisfy any of the

criteria of section 313(d)(2)(A)–(C), no

purpose is served by requiring facilities

to collect data or file TRI reports for that

chemical, or, therefore, by leaving that

chemical on the section 313 list for any

additional period of time. This

construction of section 313(d)(4) is

consistent with previous rules deleting

chemicals from the section 313 list. For

further discussion of the rationale for

immediate effective dates for EPCRA

section 313 delistings (see 59 FR 33205,

June 28, 1994).

VI. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action likely to

lead to a rule (1) Having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities (also referred to as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlements, grants, user

fees, or loan programs; or (4) raising

novel legal or policy issues arising out

of legal mandates, the President’s

priorities, or the principles set forth in

this Executive Order. Pursuant to the

terms of this Executive Order, EPA has

determined that this rule is not

‘‘significant’’ and therefore not subject

to OMB review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act

of 1980, EPA must conduct a small

business analysis to determine whether

a substantial number of small entities

will be significantly affected. Because

the rule will result in cost savings to

facilities, EPA certifies that small

entities will not be significantly affected

by this rule.

C. Paperwork Reduction Act

This rule relieves facilities from

having to collect information on the use

and releases of BBP. Therefore, there

were no information collection

requirements for OMB to review under

the provisions of the Paperwork

Reduction Act of 1980, 44 U.S.C. 3501

et seq.

List of Subjects in 40 CFR Part 372

Environmental protection,

Community right-to-know, Reporting

and recordkeeping requirements, Toxic

chemicals.

Dated: February 10, 1995.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides and Toxic Substances.

Therefore, 40 CFR part 372 is

amended as follows:

1. The authority citation for part 372

continues to read as follows:

Authority: 42 U.S.C. 11013 and 11028.

§ 372.65 [Amended]

2. Section 372.65(a) and (b) are

amended by removing the entire entry

for butyl benzyl phthalate under

paragraph (a) and removing the entire

CAS No. entry for 85–68–7 under

paragraph (b).

[FR Doc. 95–3937 Filed 2–16–95; 8:45 am]

BILLING CODE 6560–50–F