[Federal Register Volume 60, Number 33 (Friday, February 17, 1995)]
[Rules and Regulations]
[Pages 9299-9301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3937]



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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.

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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-to-Know 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 [[Page 9300]] 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 
[[Page 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.

Sec. 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