[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]
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