[Federal Register Volume 64, Number 209 (Friday, October 29, 1999)]
[Rules and Regulations]
[Pages 58666-58753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28169]
[[Page 58665]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 372
Persistent Bioaccumulative Toxic (PBT) Chemicals; Final Rule
Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 /
Rules and Regulations
[[Page 58666]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400132C; FRL-6389-11]
RIN 2070-AD09
Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of
Reporting Thresholds for Certain PBT Chemicals; Addition of Certain PBT
Chemicals; Community Right-to-Know Toxic Chemical Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is lowering the reporting thresholds for certain
persistent bioaccumulative toxic (PBT) chemicals that are subject to
reporting under section 313 of the Emergency Planning and Community
Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution
Prevention Act of 1990 (PPA). EPA is also adding a category of dioxin
and dioxin-like compounds to the EPCRA section 313 list of toxic
chemicals and establishing a 0.1 gram reporting threshold for the
category. In addition, EPA is adding certain other PBT chemicals to the
EPCRA section 313 list of toxic chemicals and establishing lower
reporting thresholds for these chemicals. EPA is removing the fume or
dust qualifier from vanadium and adding all forms of vanadium with the
exception of vanadium when contained in alloys. EPA is also adding
vanadium compounds to the EPCRA section 313 list of toxic chemicals.
However, EPA is not lowering the reporting thresholds for either
vanadium or vanadium compounds. EPA is taking these actions pursuant to
its authority under EPCRA section 313(f)(2) to revise reporting
thresholds and pursuant to its authority to add chemicals and chemical
categories that meet the EPCRA section 313(d)(2) toxicity criteria. The
additions of these chemicals are based on their carcinogenicity or
other chronic human health effects and/or their significant adverse
effects on the environment. Today's actions also include modifications
to certain reporting exemptions and requirements for those toxic
chemicals that are subject to the lower reporting thresholds. This
document also announces the effective date of Sec. 372.27 of the Code
of Federal Regulations, which contained information collection
requirements and which was originally published in the Federal Register
on November 30, 1994.
DATES: 40 CFR 372.27 became effective on March 17, 1995, when the
Office of Management and Budget approved its information collection
requirements. This rule shall take effect on December 31, 1999. For
purposes of EPCRA section 313(d)(4), the chemical additions shall be
considered made as of November 30, 1999, and shall apply for the
reporting year beginning January 1, 2000.
FOR FURTHER INFORMATION CONTACT: For technical information on this
final rule contact: Daniel R. Bushman, Petitions Coordinator,
Environmental Protection Agency, Mail Code 7408, 401 M St., SW.,
Washington, DC 20460; telephone number 202-260-3882, e-mail address:
[email protected]. For general information on EPCRA section 313,
contact the 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 TDD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you manufacture, process, or
otherwise use aldrin, chlordane, dioxin and certain dioxin-like
compounds, heptachlor, hexachlorobenzene, isodrin, mercury, mercury
compounds, methoxychlor, octachlorostyrene, pendimethalin,
pentachlorobenzene, polychlorinated biphenyls, certain polycyclic
aromatic compounds, tetrabromobisphenol A, toxaphene, trifluralin, and
vanadium (except alloys) or vanadium compounds. See Table 1 in Unit
V.C. for a more detailed listing. Potentially affected categories and
entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of Potentially Affected
Category Entities
------------------------------------------------------------------------
Industry SIC major group codes 10 (except
1011, 1081, and 1094), 12 (except
1241), or 20 through 39; industry
codes 4911 (limited to facilities
that combust coal and/or oil for
the purpose of generating power for
distribution in commerce); 4931
(limited to facilities that combust
coal and/or oil for the purpose of
generating power for distribution
in commerce); or 4939 (limited to
facilities that combust coal and/or
oil for the purpose of generating
power for distribution in
commerce); or 4953 (limited to
facilities regulated under the
Resource Conservation and Recovery
Act, subtitle C, 42 U.S.C. section
6921 et seq.), or 5169, or 5171, or
7389 (limited to facilities
primarily engaged in solvent
recovery services on a contract or
fee basis)
------------------------------------------------------------------------
Federal Government Federal facilities
------------------------------------------------------------------------
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 could also be
affected. To determine whether your facility would be affected by this
action, you should carefully examine the applicability criteria in part
372, subpart B of Title 40 of the Code of Federal Regulations. If you
have questions regarding the applicability of this action to a
particular entity, consult the person listed in the ``FOR FURTHER
INFORMATION CONTACT'' section.
B. How Can I Get Additional Information or Copies of this Document or
Other Support Documents?
1. Electronically. You may obtain electronic copies of this
document from the EPA Internet Home Page at http://www.epa.gov/. On the
Home Page select ``Laws and Regulations'' and then look up the entry
for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-400132. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and any other information related to this action, including any
information claimed as confidential business information (CBI). This
official record includes the
[[Page 58667]]
documents that are physically located in the docket, as well as the
documents that are referenced in those documents. The public version of
the official record does not include any information claimed as CBI.
The public version of the official record, which includes printed,
paper versions of any electronic comments submitted during an
applicable comment period, is available for inspection in the TSCA
Nonconfidential Information Center, North East Mall Rm. B-607,
Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from
noon to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Center is (202) 260-7099.
II. Statutory Authority
EPA is finalizing these actions under sections 313(d)(1) and (2),
313(f)(2), 313(g), 313(h), and 328 of EPCRA, 42 U.S.C. 11023(d)(1)-(2),
11023(f)(2), 11023(g), 11023(h) and 11048; PPA section 6607, 42 U.S.C.
13106.
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using a listed toxic chemical in amounts above
reporting threshold levels, to report certain facility specific
information about such chemicals, including the annual quantity
entering each environmental medium. These reports must be filed by July
1 of each year for the previous calendar year. Such facilities also
must report pollution prevention and recycling data for these
chemicals, pursuant to section 6607 of PPA.
A. What is the Authority for the Addition of Chemicals?
Section 313 established an initial list of toxic chemicals
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. EPA has added and deleted
chemicals from the original statutory list on the basis of the criteria
in subparagraph (A), (B) and/or (C) of subsection (d)(2) of EPCRA
section 313. Under section 313(e)(1), any person may petition EPA to
add chemicals to, or delete chemicals from, the list on the grounds
that it does or does not meet the criteria at 313(d)(2)(A) or (B).
Pursuant to EPCRA section 313(e)(1), EPA must respond to petitions
within 180 days, either by initiating a rulemaking or by publishing an
explanation of why the petition is denied. EPCRA section 313(d)(2)
states that a chemical may be added to the list if any of the three
listing criteria set forth there are met. Therefore, in order to add a
chemical, EPA must find that at least one criterion is met, but does
not need to examine whether all other criteria are also met. EPA has
published a statement elaborating its interpretation of the section
313(d)(2) and (3) criteria for adding and deleting chemicals from the
section 313 list (at 59 FR 61432, November 30, 1994) (FRL-4922-2).
B. What is the Authority for the Lowering of Reporting Thresholds?
EPA is finalizing these actions pursuant to its authority under
EPCRA section 313(f)(2) to revise reporting thresholds. EPCRA section
313 establishes default reporting thresholds, which are set forth in
section 313(f)(1). Section 313(f)(2), however, provides that EPA:
may establish a threshold amount for a toxic chemical different
from the amount established by paragraph (1). Such revised threshold
shall obtain reporting on a substantial majority of total releases
of the chemical at all facilities subject to the requirements of
this section. The amounts established by EPA may, at the
Administrator's discretion, be based on classes of chemicals or
categories of facilities.
This provision provides EPA with broad, but not unlimited, authority to
establish thresholds for particular chemicals, classes of chemicals, or
categories of facilities, and commits to EPA's discretion the
determination that a different threshold is warranted. Congress also
committed the determination of the levels at which to establish any
alternate thresholds to EPA's discretion, requiring only that any
``revised threshold shall obtain reporting on a substantial majority of
total releases of the chemical at all facilities subject to the
requirements'' of section 313. 42 U.S.C. 11023(f)(2).
For purposes of determining what constitutes a ``substantial
majority of total releases,'' EPA interprets the language in section
313(f)(2), ``facilities subject to the requirements of [section 313],''
to refer to those facilities that fall within the category of
facilities described by sections 313(a) and (b), i.e., the facilities
currently reporting. Subsection (a) lays out the general requirement
that ``the owner or operator of facilities subject to the requirements
of this section shall'' file a report under EPCRA section 313.
Subsection (b) then defines the facilities subject to the requirements
of this section:
[t]he requirements of this section shall apply to owners and
operators of facilities that have 10 or more full-time employees and
that are in Standard Industrial Classification Codes 20-39, . . .
and that manufactured, processed, or otherwise used a toxic chemical
listed under subsection (c) of this section in excess of the
quantity of that toxic chemical established under subsection (f) of
this section during the calendar year for which a toxic chemical
release form is required under this section.
Thus, in revising the reporting thresholds, EPA must ensure that, under
the new thresholds, a substantial majority of releases currently being
reported will continue to be reported. No further prerequisites for
exercising this authority appears in the statute.
C. What is the Authority for Modifications to Other EPCRA Section 313
Reporting Requirements?
Today's actions also include modifications to certain reporting
exemptions and requirements for those toxic chemicals that are subject
to the lower reporting thresholds. Congress granted EPA rulemaking
authority to allow the Agency to fully implement the statute. EPCRA
section 328 provides that the ``Administrator may prescribe such
regulations as may be necessary to carry out this chapter'' (28 U.S.C.
11048).
III. Background Information
A. What is the General Background for this Action?
Under EPCRA section 313, Congress set the initial parameters of the
Toxic Release Inventory, but also gave EPA clear authority to modify
reporting in various ways, including authority to change the toxic
chemicals subject to reporting, the facilities required to report, and
the threshold quantities that trigger reporting. By providing this
authority, Congress recognized that the TRI program would need to
evolve to meet the needs of a better informed public and to refine
existing information. EPA has, therefore, undertaken a number of
actions to expand and enhance TRI. These actions include expanding the
number of reportable toxic chemicals by adding 286 toxic chemicals and
chemical categories to the EPCRA section 313 list in 1994. Further, a
new category of facilities was added to EPCRA section 313 on August 3,
1993, through Executive Order 12856, which requires Federal facilities
meeting threshold requirements to file annual EPCRA section 313
reports. In addition, in 1997 EPA expanded the number of private sector
facilities that are required to report under EPCRA section 313 by
adding seven new industrial groups to the list of covered facilities.
At the same time, EPA has sought to reduce the burden of EPCRA section
313 reporting by actions such as delisting chemicals it has determined
do not meet the statutory listing criteria and establishing
[[Page 58668]]
an alternate reporting threshold of 1 million pounds for facilities
with 500 pounds or less of production-related releases and other
wastes. Facilities meeting the requirements of this alternate threshold
may file a certification statement (Form A) instead of reporting on the
standard EPCRA section 313 form, the Form R.
In today's actions, EPA is finalizing enhanced reporting
requirements that focus on a unique group of toxic chemicals. These
toxic chemicals which persist and bioaccumulate in the environment are
commonly referred to as persistent bioaccumulative toxic chemicals or
PBT chemicals. To date, with the exception of the alternate threshold
certification on Form A, EPA has not altered the statutory reporting
threshold for any listed chemicals. However, as the TRI program has
evolved over time and as communities identify areas of special concern,
thresholds and other aspects of the EPCRA section 313 reporting
requirements may need to be modified to assure the collection and
dissemination of relevant, topical information and data. Towards that
end, EPA is increasing the utility of TRI to the public by adding a
number of chemicals to the section 313 list of toxic chemicals that
persist and bioaccumulate in the environment and by lowering the
reporting thresholds for a number of toxic chemicals that have these
properties. Toxic chemicals that persist and bioaccumulate are of
particular concern because they remain in the environment for
significant periods of time and concentrate in the organisms exposed to
them. EPA believes that the public understands that these PBT chemicals
have the potential to cause serious human health and environmental
effects resulting from low levels of release and exposure (Refs. 75 and
76). Lowering the reporting thresholds for PBT chemicals will ensure
that the public has important information on the quantities of these
chemicals released or otherwise managed as waste, that would not be
reported under the 10,000 and 25,000 pound/year thresholds that apply
to other toxic chemicals.
B. What Outreach Has EPA Conducted?
EPA has engaged in a comprehensive outreach effort. This outreach
served to inform interested parties, including industry groups affected
by the rule, state regulatory officials, environmental organizations,
labor unions, community groups, and the general public of EPA's
intention to add certain PBT chemicals to the list of toxic chemicals
under EPCRA section 313 and lower the applicable reporting thresholds
for a subset of PBT chemicals. For all interested parties, EPA held
three public meetings (in Chicago, IL (February 23, 1999); San
Francisco, CA (March 5, 1999); and Washington, DC (February 16, 1999))
during the comment period for the proposal. Participants included a
range of industry representatives, trade associations (representing
both small and large businesses), law firms representing industry
groups, environmental groups, the general public, plus other groups and
organizations. For state and tribal governments, EPA attended the
regularly-held public meetings of the Forum on State and Tribal Toxics
Action (FOSTTA) to discuss the PBT proposal. EPA also received
substantial public comment on this proposal, to which EPA is responding
in this Final Rule and the Response to Comments document (Ref. 69). In
response to the strong interest by the public, and to allow more
individuals and groups to submit their comments, EPA extended the
public comment period to April 7, 1999 (at 64 FR 9957, March 1, 1999)
(FRL-6066-1). Additional information regarding EPA's outreach may be
found in supporting documents included in the public version of the
official record.
IV. Summary of Proposal
A. What Chemicals Did EPA Propose to Add to the EPCRA Section 313 List
of Toxic Chemicals?
In an initial screening of PBT chemicals that appear on the list of
chemicals of concern in the various chemical initiatives, EPA
identified seven chemicals and one category of chemicals that persist
and bioaccumulate in the environment but that were not on the list of
EPCRA section 313 toxic chemicals. Although identification of these
chemicals for initial consideration prior to this rulemaking was based
on their status as PBT chemicals, their proposed addition in this
rulemaking was based solely on the determination that they meet the
EPCRA section 313(d)(2) listing criteria. All of the chemicals proposed
for addition were found to be reasonably anticipated to cause serious
or irreversible chronic human health effects at relatively low doses or
ecotoxicity at relatively low concentrations, and thus are considered
to have moderately high to high chronic toxicity or high ecotoxicity.
The chemicals and chemicals categories EPA proposed to add to the list
of EPCRA section 313 toxic chemicals include: Dioxin and dioxin-like
compounds category, benzo(g,h,i)perylene, benzo(j,k)fluorene
(fluoranthene), 3-methylcholanthrene, octachlorostyrene,
pentachlorobenzene, tetrabromobisphenol A (TBBPA), vanadium (except
alloys) and vanadium compounds.
B. What Persistence and Bioaccumulation Issues Did EPA Consider?
As noted above, for purposes of the proposed rule, EPA conducted
its first, limited review of chemicals for their persistence and
bioaccumulation properties under EPCRA section 313. EPA first
established criteria to be used under section 313 for determining if a
chemical persists or bioaccumulates in the environment. These criteria
were then applied to determine whether the chemicals included in the
review have the potential to persist and bioaccumulate in the
environment. The initial group of chemicals reviewed were the result of
EPA's screening assessment of two lists of persistent and
bioaccumulative chemicals: (1) The Great Lakes Binational Level 1 list
(Ref. 24); and (2) chemicals that received high scores for persistence
and bioaccumulation in the initial version of the Waste Minimization
Prioritization Tool (WMPT) developed by EPA's Office of Solid Waste
(Ref. 74). Finally, included in this initial review were the chemicals
included in the dioxin and dioxin-like compounds category that EPA had
proposed for addition to the section 313 list in 1997 (at 62 FR 24887,
May 7, 1997) (FRL-5590-1).
1. Persistence. A chemical's persistence refers to the length of
time the chemical can exist in the environment before being destroyed
(i.e., transformed) by natural processes. The proposal discussed those
aspects of persistence that are important to consider in determining a
chemical's persistence in the environment and set forth the criteria
that EPA used for determining whether a chemical is persistent for
purposes of reporting under EPCRA section 313. Numerous organizations
and internationally negotiated agreements have set numerical criteria
for environmental persistence, many of which have been developed
through consensus processes (Ref. 68). Of those reviewed, the criteria
for persistence in water, soil, and sediment tend to cluster around two
half-lifes, 1 to 2 months and 6 months while the persistence criterion
for air was either a half-life of 2 or 5 days. A half-life of 6 months
for water, soil, and sediment and half-lifes of either 2 or 5 days for
air were chosen by the international organizations as criteria for
chemicals that are being banned or
[[Page 58669]]
severely restricted. However, EPCRA section 313 is an information
collection and dissemination program. EPA believes that persistence
criteria consistent with the criteria applied to chemicals that are of
global or regional (e.g., Europe and the Great Lakes) concern and that
are targeted for ban, restriction, or phase-out are inappropriate for
such a program. Chemicals that meet the persistence criteria used in
the international agreements are the extremely persistent chemicals.
Applying these strict criteria to EPCRA section 313 would result in a
very narrow list of chemicals that would focus on only extremely
persistent chemicals. This is inconsistent with one of the fundamental
tenets of right-to-know which is to provide the public with information
on toxic chemicals that have the potential to cause adverse effects in
their community. Further, persistence criteria of half-lifes of 6
months and 5 days have not been used to establish whether a chemical is
a PBT chemical but rather whether a chemical should have restrictions
on its uses. The Agency stated in the proposal its belief that half-
life criteria of 2 months for water, sediment, and soil and 2 days for
air will include a better representative sample of chemicals that
persist in the environment. Therefore, EPA used a half-life criterion
of 2 months for water, sediment, and soil and a half-life of 2 days for
air for the purposes of determining under EPCRA section 313 whether a
toxic chemical is persistent in the environment. Under these criteria,
if a toxic chemical meets any one of the media-specific criteria, it is
considered to be persistent.
2. Bioaccumulation. Bioaccumulation is a general term that is used
to describe the process by which organisms may accumulate chemical
substances in their bodies. The term refers to both uptake of chemicals
from water (bioconcentration) and from ingested food and sediment
residues. The discussions and data on bioaccumulation in the proposed
rule dealt strictly with aquatic organisms because most of the
bioaccumulation data are from aquatic studies. The proposal also
discussed, in detail, those aspects of determining bioaccumulation that
are important to consider in assessing whether a particular chemical
will bioaccumulate in the environment.
A chemical's potential to bioaccumulate can be quantified by
measuring or predicting a chemical's bioaccumulation factor (BAF) or a
chemical's bioconcentration factor (BCF). Sources of BAF and BCF data
for the chemicals included in the proposed rule included a mixture of
both predicted and measured BAF and BCF values. The record for the
proposed rule includes a document that explains the origin of the BAF
or BCF value selected for each PBT chemical (Ref. 71). Most data were
retrieved from the U.S. EPA's AQUIRE data base (Ref. 58) and the
Japanese Chemicals Inspection and Testing Institute (CITI) data base
(Ref. 18a).
As with persistence, a number of organizations and internationally
negotiated agreements have set numerical criteria for bioaccumulation,
many of which have been developed through a consensus processes. Of
those reviewed, the criteria used for bioaccumulation was a BAF/BCF
numerical value of either 5,000 or 1,000 or, in some cases, 500. The
bioaccumulation criteria chosen by the international organizations as
criteria for chemicals that are being banned or severely restricted was
5,000. However, for the same reasons discussed in Unit IV.B.1., EPA
stated that the criteria used by the international organizations would
not be appropriate for purposes of EPCRA section 313. Therefore, EPA
used a BAF/BCF numerical criterion of 1,000 for determining if a
chemical is bioaccumulative for purposes of EPCRA section 313.
3. Persistence and bioaccumulation data. In the proposal, EPA
presented the bioaccumulation and persistence data for the PBT
chemicals being considered. More detailed discussions of the sources of
these data are provided in the support documents (Refs. 7 and 71). When
considering the bioaccumulation and persistence potential of chemical
categories, EPA reviewed the individual bioaccumulation and persistence
data for the category members and determined in which tier the entire
chemical category should be placed. For chemicals that had half-life
ranges that bracketed the persistence tiers, EPA considered the types
of studies supporting the half-life ranges and determined the most
appropriate tier for each chemical.
C. How Did EPA Propose to Address Dioxin and Dioxin-Like Compounds?
In response to a petition from Communities For A Better
Environment, EPA issued a proposed rule (at 62 FR 24887) to add a
category of dioxin and dioxin-like compounds to the EPCRA section 313
list of toxic chemicals. As part of that action, EPA proposed to move
11 co-planar polychlorinated biphenyls (PCBs) from their listing under
Chemicals Abstract Service Registry (CAS) Number 1336-36-3 to the
dioxin and dioxin-like compounds category. However, since PCBs persist
and bioaccumulate, EPA stated its belief in the proposed rule that PCBs
should be subject to lower reporting thresholds. Thus EPA believed
there was no need to move the 11 co-planar PCBs to the proposed dioxin
and dioxin-like compounds category. Therefore, EPA withdrew its
original proposal to modify the listing for PCBs and instead proposed
to lower the reporting thresholds for the current PCB listing which
covers all PCBs (at 64 FR 710). Because of this change, the proposed
dioxin and dioxin-like compounds category included only the 7
polychlorinated dibenzo-p-dioxins and the 10 polychlorinated
dibenzofurans identified in the proposed rule. In order to focus
reporting on those facilities that actually add to the environmental
loading of the dioxin and dioxin-like compounds and to reduce reporting
burden, EPA proposed to add the activity qualifier ``manufacture only''
to the category. This qualifier would have limited reporting to those
dioxin and dioxin-like compounds that are manufactured at the facility,
including those coincidentally manufactured.
D. What Proposed Changes to Reporting Requirements for PBT Chemicals
Did EPA Consider?
1. Changes to reporting thresholds. In evaluating potential lower
reporting thresholds for PBT chemicals, EPA considered not only their
persistence and bioaccumulation and the purposes of EPCRA section 313,
but also the potential burden that might be imposed on the regulated
community. Because all PBT chemicals persist and bioaccumulate in the
environment, they have the potential to pose greater exposure to humans
and the environment over a longer period of time (Refs. 75 and 76). The
nature of PBT chemicals indicates that small quantities of such
chemicals are of concern, which provides strong support for setting
lower reporting thresholds than the current section 313 thresholds of
10,000 and 25,000 pounds. For determining the levels at which reporting
thresholds should be set for these chemicals, EPA adopted a two-tiered
approach. EPA made a distinction between persistent bioaccumulative
toxic chemicals and highly persistent, highly bioaccumulative toxic
chemicals by proposing to set lower reporting thresholds based on two
levels of persistence and bioaccumulation potential. EPA proposed to
set a manufacture, process and otherwise use threshold of 100 pounds
for PBT chemicals and a threshold of 10 pounds for that subset of PBT
chemicals that are highly persistent and highly
[[Page 58670]]
bioaccumulative toxic chemicals. One exception to this is the reporting
threshold for the dioxin and dioxin-like compounds category, see the
discussion in Unit IV.D.2.
In determining the appropriate reporting thresholds to propose for
PBT chemicals, EPA started with the premise that low or very low
reporting thresholds may be appropriate for these chemicals based on
their persistence and bioaccumulation potentials only. EPA then
considered the burden that would be imposed by lower reporting
thresholds and the distribution of reporting across covered facilities.
Considering the factors described above, in addition to the purposes of
EPCRA section 313, EPA proposed to lower the manufacture, process, and
otherwise use thresholds to 100 pounds for PBT chemicals and to 10
pounds for that subset of PBT chemicals that are highly persistent and
highly bioaccumulative. EPA presented the proposed section 313
reporting thresholds for each of the PBT chemicals considered. For
purposes of section 313 reporting, threshold determinations for
chemical categories are based on the total of all toxic chemicals in
the category (see 40 CFR 372.25(d)).
2. Special reporting threshold for dioxin and dioxin-like
compounds. The category of dioxin and dioxin-like compounds are highly
persistent and highly bioaccumulative toxic chemicals. However, this
category of chemicals poses unique problems with regard to setting
section 313 reporting thresholds because these chemicals are generally
produced in extremely small amounts compared to other section 313
chemicals. In response to EPA's original proposal to add dioxin and
dioxin-like compounds, EPA received numerous comments suggesting that
the reporting threshold for this category be set at zero. EPA stated
its belief that rather than setting a zero reporting threshold it would
be better to set a very low threshold that provides facilities with a
clear indicator of when they are required to report. EPA proposed a
manufacture threshold of 0.1 gram for the category. EPA expressed its
intent to develop reporting guidance for industries that may fall
within this reporting category. In addition to the proposed lower
reporting threshold for the dioxin and dioxin-like compounds category,
EPA requested comment on an alternative way of reporting release and
other waste management data for this category. This alternative
included reporting release and other waste management data for the
dioxin and dioxin-like compounds category in terms of grams of toxicity
equivalents (TEQs).
E. What Other Reporting Issues Did EPA Consider for PBT Chemicals?
1. De minimis exemption. In 1988, EPA promulgated the de minimis
exemption because: (1) The Agency believed that facilities newly
covered by EPCRA section 313 would have limited access to information
regarding low concentrations of toxic chemicals in mixtures that are
imported, processed, otherwise used or manufactured as impurities; (2)
the Agency did not believe that these low concentrations would result
in quantities that would significantly contribute to threshold
determinations and release calculations at the facility (53 FR 4509,
February 16, 1988); and (3) the exemption was consistent with
information collected by the Occupational Safety and Health
Administration's (OSHA) Hazard Communication Standard (HCS). However,
given that: (1) Covered facilities currently have several sources of
information available to them regarding the concentration of PBT
chemicals in mixtures; (2) even minimal releases of persistent
bioaccumulative chemicals may result in significant adverse effects and
can reasonably be expected to significantly contribute to exceeding the
proposed lower thresholds; and (3) the concentration levels chosen, in
part, to be consistent with the OSHA HCS are inappropriately high for
PBT chemicals, EPA's original rationale for the de minimis exemption
does not apply to PBT chemicals. EPA therefore proposed to eliminate
the de minimis exemption for PBT chemicals. EPA did not propose,
however, to modify the applicability of the de minimis exemption to the
supplier notification requirements (40 CFR 372.45(d)(1)) because the
Agency believed there was sufficient information available.
2. Use of the alternative threshold and Form A. EPA stated its
belief that use of the existing alternate threshold and reportable
quantity for Form A would be inconsistent with the intent of expanded
PBT chemical reporting. The general information provided in the Form A
on the quantities of the chemical that the facility manages as waste is
insufficient for conducting analyses on PBT chemicals and would be
virtually useless for communities interested in assessing risk from
releases and other waste management of PBT chemicals. EPA, therefore,
proposed excluding all PBT chemicals from the alternate threshold of 1
million pounds.
3. Proposed changes to the use of range reporting. EPA stated its
belief that use of ranges could misrepresent data accuracy for PBT
chemicals because the low or the high end range numbers may not really
be that close to the estimated value, even taking into account its
inherent error (i.e., errors in measurements and developing estimates).
EPA believed this uncertainty would severely limit the applicability of
release information where the majority of releases, particularly for
PBT chemicals, are expected to be within the amounts eligible for range
reporting. Given EPA's belief that the large uncertainty that would be
part of these data would severely limit their utility, EPA proposed to
eliminate range reporting for PBT chemicals.
4. Proposed changes to the use of the half-pound rule and whole
numbers. EPA currently allows facilities to report whole numbers and to
round releases of 0.5 pound or less to zero. EPA explained its concern
that the combination of requiring the reporting of whole numbers and
allowing rounding to zero would result in a significant number of
facilities reporting their releases of some PBT chemicals as zero. EPA,
therefore, proposed that all releases or other waste management
quantities greater than \1/10\ of a pound of PBT chemicals (except
dioxins) be reported, provided that the appropriate activity threshold
has been exceeded. For the category of dioxin and dioxin-like
compounds, which have a proposed reporting threshold of 0.1 gram, EPA
proposed that facilities report all releases and other waste management
activities greater than 100 micrograms (ug) (i.e., 0.0001 gram).
5. Proposed changes to other EPCRA section 313 reporting
requirements. The alkyl lead compounds tetraethyl lead (CAS No. 78-00-
2) and tetramethyl lead (CAS No. 75-74-1) are currently reportable
under the EPCRA section 313 category listing for lead compounds.
However, these two chemicals specifically appear on the Binational
Level 1 list of chemicals that have been identified for virtual
elimination from the Great Lakes and thus are of special concern. EPA,
therefore, proposed that separate reports be filed for these two
members of the lead compounds category, which would allow better
tracking of these specific lead compounds. In addition, EPA proposed to
list ``vanadium'' and ``vanadium compounds'' and delete the EPCRA
section 313 listing for ``vanadium (fume or dust).'' Since vanadium
without the fume or dust qualifier would be a new section 313 listing,
EPA did not propose to include additional reporting on alloys
containing vanadium. In the proposal, EPA deferred making a final
decision on
[[Page 58671]]
vanadium contained in alloys until the Agency could complete a
scientific review of issues pertinent to some alloys. EPA proposed to
include the qualifier ``except when contained in an alloy'' in the
vanadium listing. EPA also requested comment on the adequacy of
existing studies for determining the bioaccumulation potential of
cobalt and cobalt compounds.
V. Summary of the Final Rule
A. Which Chemicals is EPA Adding to the List of Toxic Chemicals Under
EPCRA Section 313?
In this action, EPA is adding seven chemicals and two chemical
compound categories to the list of toxic chemicals subject to reporting
under EPCRA section 313. These chemicals include: benzo(g,h,i)perylene,
benzo(j,k)fluorene (fluoranthene), 3-methylcholanthrene,
octochlorostyrene, pentachlorobenzene, TBBPA, vanadium (except when in
an alloy), vanadium compounds, and a category consisting of 17
specified dioxin and dioxin-like compounds. EPA has determined that
each of these chemicals and chemical compound categories meets the
listing criteria under EPCRA section 313(d)(2). Two of these chemicals,
3-methylchloanthrene and benzo(j,k)fluorene (fluoranthene), are being
added as members of the polycyclic aromatic compounds (PACs) category.
Vanadium, with the qualifier ``fume or dust,'' has been on the list of
toxic chemicals since the program's inception in 1987. In today's
action, however, the Agency is removing the ``fume or dust'' qualifier
from the vanadium listing. However, EPA is not including reporting on
vanadium when contained in alloys. EPA is finalizing the proposed
qualifier ``except when contained in an alloy'' to the vanadium
listing. Therefore all elemental vanadium, unless it is in an alloy, is
now reportable under EPCRA section 313. In addition to modifying the
qualifier, EPA is also adding a new vanadium compounds category. Thus,
all chemical compounds that contain vanadium are reportable under this
listing. Further, EPA is finalizing its proposal (62 FR 24887) to add
dioxins and 16 dioxin-like compounds. However, the Agency is modifying
the qualifier that it originally included with this listing. In the PBT
proposed rule, EPA proposed to add the dioxin and dioxin-like compounds
category with the qualifier ``manufacturing only.'' However, based on
comments the Agency received, EPA is changing this qualifier to
include: Manufacturing; and the processing or otherwise use of dioxin
and dioxin-like compounds if the dioxin and dioxin-like compounds are
present as contaminants in a chemical and if they were created during
the manufacturing of that chemical.
B. Which Chemicals is EPA Including as PBT Chemicals Under EPCRA
Section 313?
EPA has made the final determination that 18 of the chemicals and
chemical categories proposed meet the EPCRA section 313 criteria for
persistence and bioaccumulation. Thus EPA is lowering the reporting
threshold for all of these toxic chemicals. These chemicals and their
final thresholds are listed in Table 1 below:
Table 1.--Reporting Thresholds for EPCRA Section 313 Listed PBT
Chemicals
------------------------------------------------------------------------
Section 313
Reporting
Chemical Name or Chemical CASRN Threshold (in
Category Name pounds unless
noted otherwise)
------------------------------------------------------------------------
Aldrin 309-00-2 100
------------------------------------------------------------------------
Benzo(g,h,i)perylene 191-24-2 10
------------------------------------------------------------------------
Chlordane 57-74-9 10
------------------------------------------------------------------------
Dioxin and dioxin-like compounds NA 0.1 grams
category (manufacturing; and
the processing or otherwise use
of dioxin and dioxin-like
compounds if the dioxin and
dioxin-like compounds are
present as contaminants in a
chemical and if they were
created during the
manufacturing of that chemical)
------------------------------------------------------------------------
Heptachlor 76-44-8 10
------------------------------------------------------------------------
Hexachlorobenzene 118-74-1 10
------------------------------------------------------------------------
Isodrin 465-73-6 10
------------------------------------------------------------------------
Methoxychlor 72-43-5 100
------------------------------------------------------------------------
Octachlorostyrene 29082-74-4 10
------------------------------------------------------------------------
Pendimethalin 40487-42-1 100
------------------------------------------------------------------------
Pentachlorobenzene 608-93-5 10
------------------------------------------------------------------------
Polycyclic aromatic compounds NA 100
category
------------------------------------------------------------------------
Polychlorinated biphenyl (PCBs) 1336-36-3 10
------------------------------------------------------------------------
Tetrabromobisphenol A 79-94-7 100
------------------------------------------------------------------------
Toxaphene 8001-35-2 10
------------------------------------------------------------------------
Trifluralin 1582-09-8 100
------------------------------------------------------------------------
Mercury 7439-97-6 10
------------------------------------------------------------------------
[[Page 58672]]
Mercury compounds NA 10
------------------------------------------------------------------------
EPA is deferring its decision for two chemicals and one chemical
category. Specifically, EPA is deferring a determination on dicofol
while the Agency continues to review the available persistence data.
EPA is also deferring its decision on cobalt and cobalt compounds
because it needs to further investigate the bioaccumulative potential
of these chemicals.
C. What Thresholds Has EPA Established for PBT chemicals?
EPA is finalizing the thresholds it proposed for PBT chemicals in
the January 5, 1999 (64 FR 688) Federal Register. Specifically, EPA is
finalizing two thresholds based on the chemicals' potential to persist
and bioaccumulate in the environment. The two levels include setting
section 313 manufacture, process, and otherwise use thresholds at 100
pounds for PBT chemicals and at 10 pounds for that subset of PBT
chemicals that are highly persistent and highly bioaccumulative. One
exception is the dioxin and dioxin-like compounds category. The dioxin
and dioxin-like compounds category threshold determination required
special consideration because these highly persistent and highly
bioaccumulative compounds are manufactured in extremely small amounts
compared to other section 313 chemicals. In order to capture release
and other waste management data, EPA is setting the threshold for the
dioxin and dioxin-like compound category at 0.1 gram.
D. What Exemptions and Other Reporting Issues is EPA Addressing?
EPA is eliminating the de minimis exemption for the PBT chemicals
included in today's final rule. However, this action will not affect
the applicability of the de minimis exemption to the supplier
notification requirements (40 CFR 372.45(d)(1)). During the inter-
agency review process, it was suggested that EPA consider constructing
an exemption for facilities in SIC code 5171, i.e., Petroleum Bulk
Plants and Terminals. Specifically, it was suggested that EPA exempt
the processing of PBT chemicals in petroleum products. Before EPA can
consider this exemption, EPA must determine that these facilities
process and release and otherwise manage as waste very small aggregate
quantities of PBT chemicals. The Agency is soliciting comments and
information on this suggestion, particularly any information that could
provide a factual basis for such an exemption. Please send your
comments to the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section within the next 60 days. EPA will evaluate this
suggestion, and provide a response within approximately 180 days.
In today's action, EPA is also excluding all PBT chemicals from
eligibility for the alternate threshold of 1 million pounds and
eliminating for PBT chemicals range reporting for on-site releases and
transfers off-site for further waste management. This will not affect
the applicability of the range reporting of the maximum amount on-site
as required by EPCRA section 313(g). EPA is addressing the alkyl lead
compounds, tetraethyl lead (CAS No. 78-00-2), and tetramethyl lead (CAS
No. 75-74-1), in a separate rulemaking for lead and lead compounds (64
FR 42222, August 3, 1999) (FRL-6081-4). Therefore, EPA is not
finalizing any action with respect to these two lead compounds in
today's action.
EPA proposed to require reporting of all releases and other waste
management quantities greater than \1/10\ of a pound of PBT chemicals
(except dioxin), provided that the accuracy in the underlying data on
which the estimate is based supports this level of precision. Also, EPA
stated that releases and other waste management quantities would
continue to be reported to two significant digits. In addition, EPA
stated that for quantities of 10 pounds or greater, only whole numbers
would be required to be reported. For the category of dioxin and
dioxin-like compounds, which have a proposed reporting threshold of 0.1
gram, EPA proposed that facilities report all releases and other waste
management activities greater than 100 g (i.e., 0.0001 gram).
After reviewing all the comments on this issue, EPA is providing
additional guidance on the level of precision at which facilities
should report their releases and other waste management quantities of
PBT chemicals. Facilities should still report releases and other waste
management quantities greater than 0.1 pound (except dioxins) provided
the accuracy and the underlying data on which the estimate is based
supports this level of precision. Rather than reporting in whole
numbers and to two significant digits, if a facility's release or other
waste management estimates support reporting an amount that is more
precise than whole numbers and two significant digits, then the
facility should report that more precise amount. The Agency believes
that, particularly for PBT chemicals, facilities may be able to
calculate their estimates of releases and other waste management
quantities to \1/10\ of a pound and believes that such guidance is
consistent with the reporting requirements of sections 313(g) and (h).
E. What is the Relationship Between This Rule and the Clean Air Act
Mercury Information Collection Request?
Throughout calendar year 1999, EPA has been using authority under
section 114 of the Clean Air Act to require all coal-fired power plants
over 25 mega watts to submit to EPA the results of analyses of the
mercury content of their coal. A representative sample of these plants,
stratified by type of plant and type of coal burned, have been required
to perform stack testing to determine the amount (and species) of
mercury emitted. The stack testing will allow EPA to develop a set of
emissions factors that can be applied to the mercury in coal analysis
to generate mercury emissions estimates for each coal-fired plant. EPA
does not intend to continue to require plants to submit either the coal
analysis or the stack testing beyond the current requirement. Therefore
for the purpose of reporting mercury releases to the TRI, EPA expects
coal-fired power plants that do not have monitoring or stack test data
for the reporting year to use the emissions factors that EPA will
develop and make available to the public in the summer of 2000.
[[Page 58673]]
VI. Summary of Public Comments and EPA Responses
A. What Comments Did EPA Receive on its Statutory Authority to Add
Chemicals and Lower the Reporting Threshold and What is EPA's Response?
Several commenters assert that EPCRA section 313(f)(2) only grants
EPA the authority to raise the statutory thresholds, but not to lower
them. They agree that the substantial majority test is met ``as a
matter of logical necessity'' when EPA lowers the reporting threshold,
and argue that this makes the ``substantial majority'' test essentially
meaningless when thresholds are lowered. They argue that this
demonstrates that Congress did not intend for EPA to lower reporting
thresholds, only to raise them.
These commenters also rely on the language of other provisions of
EPCRA section 313 to support their argument that Congress did not grant
EPA authority to lower thresholds. They rely on the fact that section
313(f)(2) does not provide that EPA can ``raise or lower'' thresholds,
unlike section 313(d), under which EPA can ``add or delete'' chemicals
from the list, and section 313(b), under which EPA can ``add or
delete'' industry sectors. In addition, the commenters argue that
section 313(f)(2) is analogous to section 313(l), where, despite the
use of the otherwise neutral term ``modify,'' Congress clearly meant
for EPA only to make the reporting requirements less frequent (i.e.,
less stringent). Based on these provisions, they also argue that, where
Congress intended EPA to have the authority to both expand and restrict
reporting, the statute explicitly provides the authority, but where
Congress only intended to authorize EPA to reduce the reporting burden,
it provided a neutral term, and then restricted it. The commenters
argue that in section 313(f)(2), Congress qualified EPA's authority
with a substantial majority restriction that only makes sense if EPA
raises the thresholds.
EPA disagrees with the commenters' interpretations. Section
313(f)(2) clearly authorizes EPA to lower thresholds, as well as to
raise them. The plain language of this provision provides that ``the
Administrator may establish a threshold different from the amount
established by paragraph (1).'' It clearly does not state that the
Administrator may only establish a higher threshold than the amount
established by paragraph (1), which appears to be the commenters'
interpretation. Moreover, in the House debate on the conference report,
Representative Edgar, one of EPCRA's sponsors, noted:
The EPA is authorized to revise these thresholds, but only if
such revised thresholds obtain reporting on a substantial majority
of total releases, especially if such revised thresholds raise the
statutory levels,. . . (A Legislative History of the Superfund
Amendments and Reauthorization Act of 1986, Committee Print, vol. 6,
5315) (emphasis added).
The clear implication of this statement is that Congress intended EPA
to have the authority to lower, as well as to raise, the statutory
thresholds.
The commenters' interpretation that EPA lacks the authority to
lower the thresholds conflicts with Congressional intent in other ways.
During debate on the Conference Report, Representative Edgar noted that
``This act is intended to provide a comprehensive view of toxic
chemical exposure and, hopefully, provide a basis for more sensible and
effective local, State, and national policies.'' Legislative History at
5316. See, also, Legislative History at 5313 and 5338. And yet without
the authority to lower the thresholds, EPA cannot ensure that this
objective is achieved. For example, Congress included PCBs on the
original list of EPCRA section 313 chemicals, thereby indicating an
intent to provide the public with a ``comprehensive view of exposure''
to PCBs; but under the original reporting requirements, EPA only
received 6 reports. Under no interpretation can six reports be
characterized as obtaining ``a comprehensive view of toxic chemical
exposure.'' Legislative History at 5315.
EPA also disagrees with the comment that the Agency's
interpretation has rendered this provision meaningless. This argument
is based on a logical fallacy; a standard need not constrain agency
action to the same degree in all circumstances to be meaningful.
Congress may impose a standard that constrains actions to varying
degrees in different circumstances. In this case, the Congressional
debate on this provision indicates that Congress was most concerned
with the loss of publicly available information that may result from
raising the thresholds. See, e.g., Legislative History at 5315-16. It
is therefore reasonable to assume that Congress chose to impose a
standard that presented a greater constraint on the Agency's ability to
raise thresholds, and therefore created a ceiling beyond which the
Agency was not authorized to modify thresholds.
Further, notwithstanding the fact that under EPA's interpretation
of section 313(f)(2), the Agency can meet the statutory standard
without the need for quantitative support when it lowers the threshold,
EPA does not believe that Congress has granted it unfettered discretion
to establish a different threshold. As discussed at length in Unit
VI.E., Congress provided significant guidance in other provisions of
the statute and the legislative history, to guide the Agency's exercise
of discretion under this provision. Moreover, as noted above, the
substantial majority requirement establishes a ceiling beyond which the
Agency is not authorized to modify thresholds.
EPA also disagrees with the commenters' interpretation of other
provisions of EPCRA section 313. In general, Congress established the
basic framework of right-to-know reporting in EPCRA section 313, and
selectively granted EPA carefully qualified authority to adjust
individual parameters as appropriate. For example, EPA is authorized to
modify the chemicals on the EPCRA section 313 list, the SIC codes and
facilities covered by section 313, the reporting frequency, and the
reporting thresholds, but each grant of authority is constrained to
varying degrees by the standards contained in each respective
provision. As the commenters have correctly noted, where Congress
intended to restrict the Agency's authority to modify the original
requirements, it did so explicitly. For example section 313(l)
specifically limits EPA's authority to modify the reporting frequency:
``. . .but the Administrator may not modify the frequency to be any
more often than annually.'' Similarly Congress included no provision
authorizing any amendments to the generally applicable employee
threshold. It is therefore reasonable to assume that had Congress
intended to only permit EPA to raise the thresholds, they would have
included such an explicit restriction in the provision. Moreover, as
noted earlier in this unit, the little legislative history that exists
on this provision indicates that Congress intended EPA to have the
discretion to both raise and lower the reporting thresholds. Further,
EPA disagrees with the commenters' interpretation that Congress relied
on different statutory construction to indicate its decision not to
grant the Agency authority to decrease reporting thresholds, rather
than relying on an explicit restriction in the plain language of the
statute. EPA is aware of no indication of such Congressional intent in
the legislative history, nor have the commenters cited to any. More to
the point, the commenters' interpretation is clearly refuted by the
inclusion in section 313(l) of an explicit restriction, demonstrating
that where Congress
[[Page 58674]]
intended to restrict EPA's authority, it did so explicitly.
One commenter argues that EPA lacks authority to lower the
thresholds based on a comparison of the language in EPCRA sections 311
and 312 authorizing EPA to revise the section 311 and section 312
thresholds, with the language of section 313(f)(2). The commenter
states that Congress could have used this same broad and simple
language in section 313, and argues that because it did not, but
instead chose to impose the ``substantial majority'' requirement, this
demonstrates that Congress did not intend EPA to have the authority to
lower the thresholds. Instead, the commenter argues, Congress was
concerned with reporting burden when it crafted section 313, and so
declined to grant EPA authority to lower the thresholds.
EPA disagrees. There is no significant difference between the
language in sections 311, 312, and 313 that supports the commenter's
interpretation. Unlike section 313, Congress did not establish
thresholds in sections 311 and 312, but granted the Administrator broad
discretion to determine whether a threshold was even appropriate; at
what level to establish the threshold; and to modify it as appropriate.
The language with which Congress conferred this authority provides that
``the Administrator may establish threshold quantities. . . .'' This is
almost identical to the language of section 313(f)(2), which simply
provides that ``the Administrator may establish a threshold amount for
a toxic chemical different from the amount established by paragraph
(1).'' The commenter's argument turns wholly on the inclusion of the
``substantial majority'' requirement, and as explained above, EPA does
not believe that this standard either precludes EPA from lowering
thresholds or demonstrates Congressional intent to do so.
Several commenters challenged EPA's finding that its alternate
thresholds would capture a substantial majority of total releases,
contending that the Agency had impermissibly relied on an increase in
the number of reports submitted. The commenters assert that EPA is
required to estimate releases at these facilities and determine, on a
percentage basis, whether a ``substantial majority'' of all releases of
each chemical, from all facilities subject to EPCRA section 313, will
be captured. One commenter noted that, even if lowering the threshold
for an EPCRA section 313 chemical results in an increase in the number
of reports on the chemical, this does not necessarily mean that the
additional reports will capture a substantial majority of the total
releases from all facilities subject to EPCRA section 313 reporting. In
order for the lower threshold to meet the statutory test, the threshold
must result in capturing at least two thirds of all releases of the
chemical at covered facilities. The commenter contended that the number
of reports is irrelevant to the percentage of releases captured by the
reports. If a certain chemical were present at only one facility in the
country subject to EPCRA section 313, the submission of one report on
the chemical accounting for at least 66% of the releases from that
facility would satisfy the ``substantial majority'' test. By contrast,
if a lower threshold generated 1,000 new reports on a EPCRA section 313
chemical, the ``substantial majority'' test would not be met if those
reports did not account for at least 66% of the total releases from all
facilities subject to EPCRA section 313. This may be the case, for
example, if a large percentage of releases of the EPCRA section 313
chemical occurred at facilities otherwise subject to EPCRA section 313
that do not meet the threshold for that particular chemical that
triggers the obligation to report the releases.
EPA disagrees with the commenter's interpretation. As noted in the
proposed rule, EPA interprets the language in 313(f)(2), ``facilities
subject to the requirements of [section 313],'' to refer to those
facilities that fall within the category of facilities described by
sections 313(a) and (b). Subsection (a) lays out the general
requirement that ``the owner or operator of facilities subject to the
requirements of this section'' file an EPCRA section 313 report.
Subsection (b) then further defines the facilities subject to the
requirements of this section:
[t]he requirements of this section shall apply to owners and
operators of facilities that have 10 or more full-time employees and
that are in Standard Industrial Classification Codes 20-39, . . .
and that manufactured, processed, or otherwise used a toxic chemical
listed under subsection (c) of this section in excess of the
quantity of that toxic chemical established under subsection (f) of
this section during the calendar year for which a toxic chemical
release form is required under this section.
Thus, to be subject to the requirements, a facility must meet all three
of the requirements laid out in subsection (b). This means that the
class of facilities subject to reporting under section 313 will vary
according to the individual chemical. Moreover, facilities that have
not exceeded a threshold for a particular chemical are not ``subject to
the requirements'' of EPCRA section 313 for that chemical.
To determine whether a particular threshold, either higher or
lower, for an individual chemical meets the substantial majority test,
one would compare the total national aggregate of releases of the
chemical by covered facilities at the existing thresholds with the
estimated total national aggregate of releases at the proposed
alternate threshold, and determine whether a substantial majority of
releases reported under the original thresholds would be reported.
Logically, the universe of facilities subject to the requirements under
a lower threshold will always be either equivalent to, or greater, than
the universe of facilities that are subject to the requirements under
the existing thresholds. Moreover, because facilities subject to the
requirements of section 313 must report ``the annual quantity of the
toxic chemical entering each environmental medium,'' EPA can meet the
substantial majority standard when lowering the thresholds, without the
need for quantitative support; i.e., facilities that report, must
report their releases and other waste management quantities. In this
instance, the number of reports serves as an adequate surrogate for
releases because essentially all releases (and other waste management
quantities) will be reported by facilities subject to the requirements
of this section.
In other words, facilities ``subject to the requirements of this
section'' are those that must file EPCRA section 313 reports. Thus, the
baseline against which the ``substantial majority of total releases''
is measured is the category of facilities that currently submit
reports. Consequently, if quantitative support for its finding were
necessary, EPA would be justified in relying on the number of reports
to make its finding.
By contrast, although it is not clear exactly how the commenters
interpret the phrase ``facilities subject to the requirements of this
section,'' it is clear that they do so without reference to all of the
requirements in subsections (a) and (b). And essentially, any
interpretation that ignores any portion of subsection (b), results in
an interpretation of EPCRA section 313(f)(2) as ``facilities otherwise
or potentially subject to the requirements of this section.'' This is
inconsistent with the plain language of section 313(f)(2). The
commenters can only support their argument that EPA has not met the
``substantial majority'' test by assuming that all facilities,
irrespective of whether they are in a covered SIC code or they exceed
the existing thresholds, are subject to EPCRA section
[[Page 58675]]
313, and that EPA must ensure that it captures a substantial majority
of releases from the universe of those facilities. If this were
correct, the addition of certain SIC codes could be a prerequisite to
lowering thresholds for certain chemicals. Such a requirement is not
currently included in section 313. The commenters have provided no
support in either the statute or legislative history for these
interpretations. Nor have the commenters provided any support for the
interpretation that ``substantial majority'' equates to a particular
percentage, such as 66%.
Finally, EPA notes, as it noted in the proposed rule, that, for
several reasons, it does not believe that it has the necessary
information to develop even reasonably accurate estimates of the
potential releases that would be reported at an average facility at
each of the identified options for a lowered threshold. Specifically,
EPA believes that: (1) Sufficient information is not currently
available for these chemicals, and (2) there is insufficient
information on the numerous processes employed by all the sectors
involved to calculate a comprehensive release estimate for each sector.
While there are some data available, comprehensive data are not
available for all sectors and chemicals. EPA further notes that none of
the commenters provided either any information or methodology to
address this issue, notwithstanding EPA's specific request.
Two commenters rely on excerpts from the debate on the Conference
Report with respect to section 313(f)(2) to argue that EPA is only
authorized to revise the thresholds if EPA presents a convincing
analysis that revisions to the threshold will capture a substantial
majority of the releases while also ensuring that it is not placing
undue burdens on facilities which contribute little to such releases.
The commenters argue that EPA has not satisfied the substantial
majority requirement, and to do so, must conduct a more thorough
assessment of the burden imposed on industry focused on the volume of
releases that will be captured, not the number of reports. Another
commenter compares the legislative history of sections 311 and 312 with
313, and concludes that Congress clearly intended EPA to factor burden
into section 313 threshold questions.
EPA disagrees. Ultimately, EPA must comply with the statutory
language, and section 313(f)(2) does not impose any requirement on the
Agency to rely on the type of analyses described by the commenter. In
addition, the commenters' reliance on the statements made during the
Conference Report debate are misplaced. The commenter only quotes part
of Representative Edgar's statement; the full quotation indicates only
that EPA must present a convincing case, ``based on verifiable,
historical data'' that the statutory thresholds warrant revision. As
discussed below in Unit VI.E., EPA believes it has presented a
convincing case that the thresholds should be lowered for PBT
chemicals. The commenter also failed to include the portion of
Representative Edgar's statement explaining that a convincing case was
particularly necessary if the effect of the modification was to raise
the thresholds. See, Legislative History at 5315.
Nonetheless, as discussed in greater detail in Unit VI.E., EPA
considered the burden that lower thresholds would impose on industry in
selecting the PBT thresholds. EPA believes that the levels it has
adopted will capture significantly more information about PBT chemicals
than current thresholds, but will not be unduly burdensome on industry.
In addition, as discussed in the Response to Comments document (Ref.
69), EPA believes that the number of reports filed is a more accurate
measure of burden than the volume of releases.
A commenter alleges that EPA's interpretation of section 313(f)(2)
contradicts its prior statements regarding threshold changes. The
commenterstates that EPA was clear in the original EPCRA section 313
rulemaking that the statute requires a substantial majority finding
supported by actual data. For example, in the June 1987 proposed rule,
EPA stated: ``The Agency is interested in data that would support the
necessary finding that a modified threshold would still generate
reporting on a substantial majority of total releases, as the statute
requires.'' And in the February 16, 1988 final rule promulgating EPCRA
section 313 requirements, EPA stated
. . .the first few years' data should be evaluated to determine
whether modifications of the threshold would meet the statutory test
of obtaining reporting on a substantial majority of the releases
(i.e., pounds released per year) of each chemical from subject
facilities. EPA may consider changing the reporting thresholds based
on several years of data collection.
The commenter also notes that in neither the proposed nor final rule
establishing EPCRA section 313 requirements did EPA specifically assert
that it had the authority to lower thresholds.
EPA disagrees that its statements in this rulemaking contradict its
prior statements in the 1988 rulemaking. As a preliminary matter, EPA
has never denied that the requirement that a revised threshold obtain
reporting on a substantial majority of total releases applies to any
action lowering the reporting thresholds. Specifically, EPA's
discussion in the 1987 proposed rule was in the context of a response
to proposals from the Small Business Administration (SBA) that the
Agency raise the thresholds to capture only larger facilities. EPA's
statements in the 1988 final rule also need to be evaluated with SBA's
proposals in mind. Moreover, while it is true that the discussion to
which the commenter cited did not distinguish between lowering and
raising the thresholds (it was intended as a response to comments on
both sides of the issue), EPA notes that the majority of the comment
summary focuses on requests to raise the thresholds. Finally, while it
is true that EPA did not specifically assert its authority to lower the
thresholds in either rule, neither did EPA deny that EPCRA section
313(f)(2) grants it this authority. However, it is worth noting that in
the final rule, EPA responded to comments from environmental and public
interest groups requesting that the Agency lower the thresholds, and
that EPA never stated or implied that it lacked the authority to lower
thresholds.
One commenter states that EPA's authority to lower reporting
thresholds is not limitless. The commenter argues that a decision to
lower the thresholds must be tied to the overall purpose of the Act,
namely, to inform the public of potential health risks posed by the
presence of toxic chemicals released to the environment in their
communities. A regulatory decision to capture more reports under EPCRA
section 313 must be based on the need to inform the public of health
risks associated with the releases captured in those reports.
Otherwise, the usefulness of the TRI data base begins to diminish. EPA
needs to demonstrate that the releases of the PBTs at such small
amounts pose a meaningful risk to the public health. Another commenter
asserts that EPA is relying on the purposes of EPCRA to support its
interpretation of section 313(f), and argues that, although section
313(h) does describe intended uses for TRI data, section 313(h) itself
does not describe the purposes or intention of section 313. The
commenter instead relies on several provisions of section 313 and
argues that the purpose and intention of Congress to make information
available to the public was balanced by concerns about the potential
burden of the TRI program. The commenter also states that the uses
[[Page 58676]]
Congress anticipated for TRI data do not outweigh the balance that
Congress intended between generating information and minimizing burden,
and do not grant EPA blanket authority to expand the reporting
requirements.
EPA agrees with the commenter that its authority to lower reporting
thresholds is not limitless, and that its decision to lower the
thresholds must be tied to EPCRA's overall purposes. However, EPA
believes that Congress granted the Agency broad, but not unfettered,
discretion to determine when it is appropriate to lower thresholds, and
to determine the specific thresholds that are appropriate. As discussed
in greater detail in Unit VI.E., EPA believes that its decision to
lower the thresholds, and the thresholds it has chosen, reflect these
principles.
However, EPA generally disagrees with the remainder of the
commenter's conclusions. As discussed in more detail in Unit VI.F., EPA
is not required to base its decisions under EPCRA section 313 on the
need to inform the public of health risks associated with reported
releases and other waste management quantities. And as discussed
elsewhere in this preamble and the Response to Comments document (Ref.
69), EPA believes that the information that will be reported as a
result of this rulemaking will provide useful information to the
public.
In large measure, the issues raised in the second comment closely
relate to the specific thresholds and EPA's rationale for choosing
them, and this issue is discussed in more detail in Unit VI.E. However,
to the extent it relates to EPA's interpretation of section 313(f)(2),
some response is also provided here.
As a preliminary matter, while it is true that EPCRA section 313
does not explicitly identify the purposes of the section, the
Conference Report makes clear that subsection (h) of section 313:
Describes the intended uses of the toxic chemical release forms
required to be submitted by this section and expresses the purposes
of this section. The information collected under this section is
intended to inform the general public and the communities
surrounding covered facilities about releases of toxic chemicals, to
assist in research, to aid in development of regulations,
guidelines, and standards, and for other similar purposes.
(Conference Report at 299).
Contrary to the commenter's assertion, the Agency never indicated
that it was relying on section 313(h) to expand its authority under
section 313(f)(2). Rather, EPA noted that it was relying on the
purposes of section 313 as an additional source of Congressional
direction to guide the Agency's exercise of discretion under this
provision. EPA relied on section 313(h), in part, because the Agency
believes that its implementation of EPCRA generally should be guided by
EPCRA section 313's purposes. In addition, section 313(h) shares
certain elements with the Congressional guidance on section 313(f)(2)
in the legislative history. As discussed in greater detail in Unit
VI.E., EPA has distilled those common elements, and relied on them to
guide its discretion in establishing the specific thresholds under
section 313(f)(2).
EPA also disagrees with the commenter's assertion that the purpose
of EPCRA is to achieve a balance between the public's right to
information about their potential exposures to toxic chemicals and the
reporting burden imposed on industry. EPCRA section 313(f)(2) does not
require EPA to consider burden in establishing revised thresholds.
Although EPA has included the reporting burdens imposed on industry as
one consideration in determining the appropriate thresholds, the Agency
is also mindful that the authors of EPCRA, while sensitive to the
burdens EPCRA section 313 reporting placed on industry, never intended
this consideration to outweigh the public's need for access to
information concerning release and waste management, and thus their
potential exposure to toxic chemicals. See, e.g., Legislative History
at 5315-16 and 5338-39. And with respect to the assertion that the
general purposes of section 313 are to balance the public's right-to-
know about toxic chemical releases and other waste management in their
communities against the reporting burdens EPCRA section 313 imposes,
EPA notes that reporting burden is not included anywhere in section
313(h). Nor does the strong policy directive underlying EPA's overall
implementation of EPCRA section 313 support such an interpretation.
Representative Edgar, one of the bill's primary architects noted:
The heart of the Federal Right-to-Know Program is its reporting
requirements, which are intended to provide a comprehensive picture
of the community's and the Nation's exposure to toxic chemicals. As
the Environmental Protection Agency, the States, and localities
implement this program, they should be guided by several general
principles.
First, Congress recognizes a compelling need for more
information about the Nation's exposure to toxic chemicals. Until
now, the success of such regulatory programs such as the Clean Air
Act, the Resource Conservation and Recovery Act, and the Clean Water
Act has been impossible to measure because no broad-based national
information has been compiled to indicate increases or decreases in
the amounts of toxic pollutants entering our environment. As a
result, the reporting provision in this legislation should be
construed expansively to require the collection of the most
information permitted under the statutory language. Any discretion
to limit the amount of information reported should be exercised only
for compelling reasons. . . . Legislative History at 5313.
Significantly, Representative Edgar did not include reporting burden as
one of the general principles that should guide the Agency's
implementation of EPCRA section 313. Rather, he stated:
This is a new Federal initiative, and I recognize the desire of
some of my colleagues to move ahead cautiously to ensure that
burdens imposed on industry are not excessive. Frankly, my concerns
rest with the families that live in the shadows of these chemical
and manufacturing plants. I have put myself in their shoes and have
fought for a program that looks after their needs. This legislation
gets us well on the path to the full disclosure they deserve. Id at
5316.
Nonetheless, EPA has considered the legislative history on section
313(f)(2), including the excerpts cited by the commenter, and
determined it would be reasonable to include some consideration of the
reporting burdens in selecting its revised thresholds. The degree to
which EPA included burden in its selection of the thresholds
established in this rulemaking is discussed at length in Unit VI.E. and
the Response to Comments document (Ref. 69).
EPA agrees that section 313(h) does not grant EPA unfettered
discretion to expand EPCRA's reporting requirements; as noted in a
previous response, Congress established the basic parameters of the
EPCRA section 313 reporting requirements, and selectively granted EPA
carefully qualified authority to modify certain of them. In this
action, for example, EPA is only affecting the activity thresholds, but
Congress established other limitations that govern whether a facility
is subject to reporting. For example, facilities with fewer than 10
employees are not subject to reporting under subsection 313(b)(1).
B. What Comments Did EPA Receive on Persistence Criteria,
Bioaccumulation Criteria, and Toxicity Criteria, and What Are EPA's
Responses?
1. Comments on EPA's general approach. Several commenters contend
that only chemicals which are globally recognized as persistent
bioaccumulative toxic chemicals should form the foundation of the EPCRA
section 313 PBT chemical list and criteria. The application of the
criteria in this manner is consistent with several existing
international agreements and
[[Page 58677]]
programs, such as the Great Lakes Binational Strategy, the North
American Commission on Environmental Cooperation (NACEC), the United
Nations Economic Commission for Europe's (UNECE) agreement to address
persistent organic pollutants (POPs), and the United Nations
Environmental Programme (UNEP). These programs have prompted widely
accepted numerical values for persistence and bioaccumulation and
defined parameters for assessing toxicity. These criteria have also
been adopted with U.S. support and leadership and the commenters
contend that it is not clear why EPA is now taking a vastly different
approach to identifying PBT criteria in the proposed rule. The
commenters suggest that EPA conform the criteria for PBT chemicals on
EPCRA section 313 with the criteria and chemicals that are part of the
programs being implemented by the NACEC, UNECE, and UNEP. By doing so,
EPA would harmonize the U.S. program with similar international
programs that focus on a narrow set of PBT chemicals.
EPA believes that it would be inappropriate to merely adopt the
criteria and list of chemicals managed under the international programs
cited because the purposes of the TRI program are different than the
purposes of the cited international programs. The TRI was established
by Congress under EPCRA section 313 in response to public demand for
information on toxic chemicals being released in their communities. The
TRI program is national in scope, but a significant part of its
overriding goal is to provide information on releases to local
communities so that they can determine if the releases result in
potential risks. The entire concept of TRI, and indeed other, similar
Pollutant Release and Transfer Registries (PRTRs) since established in
several nations, is founded on the belief that the public has the right
to know about chemical use, release, and other waste management in the
areas in which they live, as well as the hazards associated with these
chemicals. This emphasis is fundamentally different from the global
focus of the UNEP negotiation and its concept of residual risk. It is
EPA's position that the domestic, community-based purposes of EPCRA
section 313 have important implications with regard to the criteria
used to identify toxic chemicals as persistent and/or bioaccumulative,
as well as the methods and models used to evaluate persistence and/or
bioaccumulation.
EPCRA section 313 charges EPA with collecting and disseminating
information on releases, among other waste management data, so that
communities can estimate local exposure and local risks. One intent of
EPCRA section 313 is to provide information to the public so that they
can take an active role in determining what risks resulting from toxic
chemical releases in their community are acceptable. This basic local
empowerment is a cornerstone of the right-to-know program.
EPCRA section 313(h) states that:
The release forms required under this section are intended to
provide information to the Federal, State, and local governments and
the public, including citizens of communities surrounding covered
facilities. The release form shall be available, consistent with
section 11044(a) of this title, to inform persons about releases of
toxic chemicals to the environment; to assist governmental agencies,
researchers, and other persons in the conduct of research and data
gathering; to aid in the development of appropriate regulations,
guidelines, and standards; and for other similar purposes.
EPCRA section 313 establishes an information collection and
dissemination program. EPA interprets EPCRA section 313(g)(2) to
require facilities to use readily available information to prepare each
chemical-specific EPCRA section 313 report. The statute does not
require that the facility conduct additional monitoring or emissions
measurements to determine these quantities. A facility must only use
readily available data or reasonable estimation methods in preparing
the quantitative information it reports.
The purpose of EPCRA section 313 is not to ban the manufacture or
use of a chemical, to restrict releases of the chemical, or to dictate
how it should be used or released. As a result, the burden and control
EPCRA section 313 imposes is significantly less than that imposed by a
statute that controls the manufacture, use, and/or release of a
chemical. The focus of EPCRA section 313 is not equivalent to the focus
of a statute or international agreements in which chemicals are to be
banned, phased-out, or restricted.
In contrast, the international agreements cited by the commenters
are intended to ban, restrict, or phase-out the manufacture, use and/or
release of a limited set of persistent organic pollutants and certain
heavy metals that are highly persistent and highly bioaccumulative.
Descriptions of the purposes of the Protocol on Persistent Organic
Pollutants (POPs); Convention on Long-Range Transboundary Air Pollution
(LRTAP), UNECE, UNEP on POPs, North American Commission for
Environmental Cooperation's Sound Management of Chemicals (NACEC SMOC),
as well as the International Council of Chemical Associations' (ICCA)
position on POPs are presented below. The following quotes clearly
illustrate that the intent of the international agreements is to
narrowly focus on that subset of toxic chemicals which are of regional
(e.g., North America and Europe) or global concern.
UNECE LRTAP
The ultimate objective is to eliminate any discharges, emissions
and losses of POPs. The Protocol bans the production and use of some
products outright (aldrin, chlordane, chlordecone, dieldrin, endrin,
hexabromobiphenyl, mirex and toxaphene). Others are scheduled for
elimination at a later stage (DDT, heptachlor, hexachlorobenzene,
PCBs). Finally, the Protocol severely restricts the use of DDT, HCH
(including lindane) and PCBs. The Protocol includes provisions for
dealing with the wastes of products that will be banned. (The 1998
Aarhus Protocol on Persistent Organic Pollutants (POPs); Convention
on Long-Range Transboundary Air Pollution, United Nations Economic
Commission for Europe (UNECE) at http://www.unece.org/env/lrtap)
(Ref. 54)
UNEP
International action to protect health and the environment
through measures which will reduce and/or eliminate emissions and
discharges of persistent organic pollutants, including the
development of an international legally binding instrument.
(Governing Council Decisions 20/24, 1999; United Nations
Environmental Programme at http://irptc.unep.ch/pops/newlayout/
negotiations.htm) (Ref. 57)
NACEC SMOC
NACEC SMOC has developed action plans for PCBs, DDT, chlordane,
and mercury. The action plans include 1) for PCBs ``work toward the
virtual elimination of PCBs in the environment, which the task force
is interpreting as no measurable release to the environment'', 2)
for DDT ``gradual reduction of DDT use for malaria control'' and
``additional reductions,'' 3) for chlordane ``phase-out of chlordane
use'', and 4) for mercury ``reduce sources of anthropogenic mercury
pollution.'' The longer-term goal of the plan is to reduce the
presence of mercury in the environment to achieve naturally
occurring levels.'' (North American Cooperation for the Sound
Management of Chemicals (June 1998); North American Commission for
Environmental Cooperation at http://www.cec.org/english/profile/
coop/Pollute_f.cfm?format=1) (Ref. 40)
ICCA
ICCA Position: ICCA member associations have demonstrated their
commitment to sound chemicals management, and to the goal of
reducing the potential human health and environmental risks that may
be associated with POPs. Many POPs are already subject to
considerable voluntary risk management by chemical companies, and
the uses of most substances identified as POPs has been discontinued
or extremely limited
[[Page 58678]]
by chemical companies within the countries represented by ICCA
member associations. (International Council of Chemical Associations
(ICCA) Briefing Note on Persistent Organic Pollutants (POPs) (April
21, 1998) at http://www.icca-chem.org/issues.htm) (Ref. 26)
In addition, as directed under EPCRA section 313(h), EPA makes the
TRI data available to various groups, including international
organizations, that, in turn, use the information to decide whether to
ban, restrict, or phase-out chemicals.
For the same reasons, EPA also disagrees that only substances
globally recognized as POPs should provide the basis of persistence
criteria for this rulemaking. POPs are organic chemicals whose
characteristics of persistence in the environment, accumulation in
biological organisms and toxicity make them priority pollutants that
cause significant environmental risks to humans and ecosystems. The
substances or substance categories being considered for implementation
of global controls through the UNEP negotiations (UNEP/GC.18/32, 1995:
aldrin, chlordane, DDT, dieldrin, endrin, heptachlor, mirex, toxaphene,
hexachlorobenzene, PCBs, polychlorinated dibenzo-p-dioxins and furans)
(Refs. 44 and 45) were selected largely because they or their
degradation products pose risks that may occur far from their sites of
initial entry into the environment. The UNEP action is the global
counterpart to similar, regional negotiations, most notably the UNECE
Convention on Long-Range Transboundary Air Pollution (LRTAP) (Ref. 54);
the North American Free Trade Agreement (NAFTA) CEC Initiative on the
Sound Management of Chemicals (Ref. 39); and the bilateral US/Canada
agreement to control discharge or release of POPs in the Great Lakes
basin (Ref. 23). A central theme of the UNEP action, consistent with
its global scope, is the notion of residual risk, meaning specifically
that to be subject to the negotiations, it is not sufficient for a
substance to pose risks within a nation or regionally, rather it must
pose risks to populations and nations distant from release sites.
2. Comments on EPA's individual criteria. The same commenters state
that EPA should use the international criteria being applied by UNEP,
UNECE LRTAP, NACEC SMOC, for persistence, bioaccumulation, and
toxicity. Some of these commenters also include the criteria developed
by CMA (CMA, PTB Policy Implementation Guidance: Product Risk
Management Guidance for PTBs (February 1996)). One commenter includes
the criteria developed by the ICCA for POPs. Another commenter states
that there is no reason to adopt criteria that are significantly more
stringent than those used in other programs. One commenter states that
EPA should consider the degree of toxicity and focus on the most toxic
chemicals. Some commenters state that EPA should couple the persistence
and bioaccumulation criteria to each other. They believe that these
criteria should not be considered independently. The numerical criteria
presented by some of the commenters are provided below:
Table 2.--Numerical Persistence and Bioaccumulation Criteria Suggested by Commenters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Environment Canada
UNEP POPs/CEG Toxic Substances
CMA PTB Policy NACEC SMOC UNECE (LRTAP) POPs FRAMEWORK Management Policy ICCA
(June 1995)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Persistence Half-life = 6 Half-life > = 2 Half-life> 2 Half-life > [2 or Half-life > = 2 Half-life = 6
months in water days air; 6 months water or 6 6] months soil/ days air; 6 months water, 1
or 1 year in soil months water/ months soils/ sediment; or months water/ year soil
soil; or 1 year sediment; or other evidence soil; 1 year sediments, or 5
sediment otherwise that substance is sediment days air
sufficiently sufficiently
persistent to be persistent to be
of concern of concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioaccumulation BAF/BCF > = 5,000 BAF/BCF >= 5,000 BAF/BCF > 5,000 or BCF/BAF > 5,000 or Half-life > 2 BCF > 5,000 or log
or estimation or Log Kow > = 5 Log Kow > 5 or Log Kow> [4 or months water or 6 Log Kow > 5 and
techniques factors such as 5]; evidence that months soils/ <7.5, MW<700 and
high toxicity substance with sediment (or substance is not
significantly otherwise metabolized
lower BCF/BAF is sufficiently
of concern, e.g., persistent to be
due to high of concern)
toxicity/
ecotoxicity; or
monitoring data
in biota
indicating
sufficient
bioaccumulation
to be of concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 58679]]
Toxicity Professional Acute and chronic Potential to Evidence that CEPA - toxic Expert judgment
judgment in (including affect human (chronic) that acute
evaluation of toxicity of health and/or the toxicity or aquatic
aquatic toxicity, breakdown environment ecotoxicity data lethality,
wildlife products, if adversely indicate a subchronic and
toxicity, oral/ appropriate) potential for chronic aquatic
dermal/inhalation damage to human toxicity, acute
toxicity (mammals health or the wildlife
and birds), environment toxicity, oral/
reproductive caused by the dermal/inhalation
toxicity, substance toxicity in
neurological resulting or mammals and
toxicity; anticipated from birds,
carcinogenicity, long-range carcinogenicity,
mutagenicity, and/ transport mutagenicity,
or teratogenicity teratogenicity,
reproductive
toxicity,
neurological
toxicity, and
immune system
effects must be
demonstrated or
expected to occur
at the
concentrations
observed in the
environment
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA is establishing criteria in this rulemaking for the TRI program
for persistence and bioaccumulation. EPCRA section 313(d)(2) already
provides toxicity criteria for the TRI program. While EPA chose in this
rulemaking to focus on chemicals that are toxic and persistent and
bioaccumulative, EPA did not state that the persistence criterion could
only be applied in conjunction with the bioaccumulation criterion and
vice versa. EPA has not tied the criteria together because there is no
scientific rationale to define persistence criteria in terms of both
bioaccumulation and persistence and to define bioaccumulation both in
terms of persistence and bioaccumulation. As illustrated by the
descriptions of persistence and bioaccumulation provided in the
proposed rule, persistence and bioaccumulation are separate chemical
and/or biological processes. They are not by definition dependent upon
the other.
A chemical's persistence refers to the length of time the
chemical can exist in the environment before being destroyed. (at 64
FR 698)
and
Bioaccumulation is a general term that is used to describe the
process by which organisms may accumulate chemical substances in
their bodies. (at 64 FR 703)
A chemical is not considered to be persistent if it is only
bioaccumulative. For example, a chemical may be extremely persistent
and yet not bioaccumulate appreciably. For example, metals cannot be
destroyed in the environment and thus are extremely persistent. Some
metals bioaccumulate appreciably while others do not. However, the
degree to which a metal can bioaccumulate does not affect the metal's
persistence in the environment. The connection suggested by the
commenters is not scientifically justified. Thus, EPA does not believe
that persistence criteria can be applied only in conjunction with the
bioaccumulation criteria. EPA reiterates that in this rulemaking the
Agency chose to focus on those toxic chemicals that meet both the
persistence and bioaccumulation criteria proposed for EPCRA section
313. In the future, the Agency may focus on toxic chemicals that are
either persistent or bioaccumulative.
A discussion of the individual criteria is presented in the
remainder of this unit.
a. Persistence. EPA proposed persistence criteria for the TRI
program of half-lifes of 2 months in water, soil, and sediment and 2
days in air. As discussed in Unit VI.B.1., EPA disagrees that it must
choose persistence criteria for EPCRA section 313, an information
collection and dissemination program, consistent with the international
criteria being applied to chemicals that are of global or regional
(e.g., Europe and the Great Lakes) concern and that are being targeted
for ban, restriction, or phase-out. Chemicals that meet the persistence
criteria used in the international agreements are extremely persistent
chemicals. Applying these criteria to EPCRA section 313 would result in
a very narrow list of chemicals that would focus on only extremely
persistent chemicals. This is inconsistent with both the purposes of
EPCRA section 313 and with EPA's technical judgment. There is no
``bright line'' that separates what is persistent from what is not
persistent. The degree of persistence is a continuum. Chemicals with a
half-life of 2 to 6 months are not non-persistent. They are less than
chemicals with a half-life of greater than 6 months. The degree of
persistence that should be used as criteria is not an absolute
scientific determination. Rather it is a combination of science and
policy. As discussed in the proposed rule and the remainder of this
section, organizations have generally used as persistence criteria
half-lifes of 2 months and/or 6 months for water, soil, and sediment.
[[Page 58680]]
The determination of which set of numerical criteria to apply will
depend on the final intent: for example, providing communities with
information on persistent chemicals that can build up in their
environment versus banning the manufacture and use and eliminating
releases of a chemical that has global impacts. For EPCRA section 313,
which provides information on toxic chemicals to communities,
researchers, and governments, the criteria should be in keeping with
both science and the intent of the statute.
Long-range transport (LRT) and residual risk are relevant
domestically, since chemical substances may be transported regionally
and transcontinentally, resulting in exposures at sites distant from
releases but still within U.S. borders. Nevertheless, as a general
rule, the closer the sources and receptor are, the more likely it is
that released material will reach that receptor. The 12 UNEP POPs or
their degradation products all meet or exceed the half-life criterion
of 6 months for soil, water, or sediment, often by large margins (Refs.
44 and 45), and the 6 months criterion thus acts to isolate these
substances for international attention aimed at limiting LRT. But a
shorter half-life criterion is necessary to protect communities from
bioaccumulative toxicants derived from sources closer to home, since,
all other things being equal, a pollutant reaches nearby populations in
less time than distant ones.
An article by Wania and Mackay (Ref. 81) is often cited in
discussions of ``global distillation'' of relatively mobile POPs such
as hexachlorobenzene and lindane, which tend to have inverted
concentration profiles such that concentrations increase with distance
from the source (i.e., from temperate to polar regions) rather than the
reverse. What may be less obvious is that the converse is also true;
namely, that less volatile substances show no significant latitudinal
dependence; that low-mobility POPs such as mirex and the more highly
chlorinated PCBs tend to undergo rapid deposition and retention close
to their sources; and that all but high or relatively high mobility
chemicals are expected to show ``normal'' concentration profiles, such
that concentrations decline with distance from warmer sources to colder
remote regions (Ref. 81). A recent study of organochlorine contaminants
in sea otters illustrates this point. Although the levels of total DDTs
observed were not considered toxicologically significant, Bacon et al.
(Ref. 8) found the highest levels in California sea otters (ca. 850
micrograms per kilogram (g/kg)) but much lower levels in
Aleutian otters (40 g/kg) and southeast Alaska otters (1
g/kg), and attributed the higher levels in the California
otters to extensive DDT use and production in this region from the
1950s to the 1970s. Even UNEP's Criteria Expert Group (CEG), which is
charged with developing criteria and procedures for addition of
substances beyond the original 12 POPs, has highlighted the importance
of ``near-field'' exposures:
In warmer climates exposures may occur closer to the source;
e.g., occupational exposure during use, or local exposure caused by
runoff from use or leaking from stockpiles. Food, such as fish, may
be a major route of intake also in warmer climates [in contrast to
Arctic and sub-Arctic regions] and POPs may accumulate in the food
chain and reach high levels in predatory species in these
conditions. (UNEP/POPS/INC/CEG/1/2: 1998) (Ref. 56)
An additional factor that argues for adopting the more protective
persistence criterion is the need for communities with vulnerable
populations to have access to data on release and other waste
management quantities. Examples of such populations include toddlers
who play in contaminated soil, local farmers who consume their own
produce, and subsistence as well as sport fishers, who often consume
large quantities of what they catch. The relative importance of any of
these pathways depends on the properties of the substance, rates and
media of release and other factors, but ingestion of bioaccumulating
substances may occur by all of these routes. The Organization for
Economic Cooperation and Development (OECD) guidance on the assessment
of indirect human exposure to chemical toxicants is consistent with EPA
policy, and states that in the case of local, site-specific emissions,
one or more of these subgroups may be particularly endangered (Ref.
53).
From a scientific perspective there is no one best persistence
criterion. However, it is simply not accurate to state that there is no
precedent or basis for using a persistence criterion of 2 months. As
outlined in the proposed rule (64 FR 701), similar values have been
proposed by several authorities, including the Ontario, Canada Ministry
of Environment and Energy (MOEE) for its Candidate Substances List for
Bans or Phaseouts (Ref. 36); the Canadian initiative for Accelerated
Reduction/Elimination of Toxics (ARET) (Refs. 1 and 2); the
International Joint Commission's (IJC) Great Lakes Water Quality
Agreement (GLWQA) (Ref. 27); and the UNECE's LRTAP Convention, which
did adopt 2 months as the persistence criterion of record for water
(Ref. 54). In each of these programs the focus was on persistent,
bioaccumulative and toxic substances, and it is noteworthy that all are
national or regional, not global, in scope. Thus, a trend exists in
which authorities with domestic or regional mandates to take action to
reduce risks from indirect exposure to PBT chemicals have recommended
half-life criteria substantially lower than 6 months.
EPA's Office of Water maintains a Listing of Fish and Wildlife
Advisories (LFWA) for the U.S. and territories, which listed 2,299
advisories in 1997 (Ref. 29). U.S. states and territories and Native
American tribes have primary responsibility for issuing advisories for
the general population, which include recommendations to limit or avoid
consumption of certain fish and wildlife from specific water bodies.
The overwhelming majority of the advisories are for well recognized PBT
chemicals (chlordane, mercury, PCBs, etc.), but many less familiar
substances are also represented. The number and content of advisories
in LFWA clearly indicate that toxicologically significant levels of
chemical contaminants, specifically PBT chemicals, are often found in
fish and wildlife that are caught noncommercially and consumed by the
U.S. population. It is generally impossible to determine the exact
source(s) of exposure for the species and locations included in any
given advisory, but it seems highly unlikely that the majority of
listed contaminants in U.S. waters could be derived from non-U.S.
(i.e., geographically distant) sources. The LFWA thus lends further
support to the contention that concern for exposure to PBT chemicals is
not limited to situations where the exposure results primarily from
LRT. It should be noted that the fact that no advisories have been
issued for a particular chemical does not mean that it does not
persist. Not all species of aquatic organisms are tested nor are all
water bodies, in addition, each state determines what it will use as
the level of concern for issuing an advisory.
A series of Toxic Substances Control Act (TSCA) section 5
Premanufacture Notifications (PMNs) submitted to EPA in 1990 also
illustrates that exposure to PBT chemicals is not limited to LRT (Refs.
37 and 38), and also demonstrates: (i) Why EPA believes that the
persistence criterion for bioaccumulating substances in soil, water, or
sediment should be set substantially lower than 6 months; and (ii) that
for purposes of EPCRA section 313, concern for potential exposures to
persistent and bioaccumulative toxics
[[Page 58681]]
must extend beyond the UNEP's 12 widely acknowledged POPs. The
substances in question were alkylated diphenyls for use as solvents,
and for which EPA expected discharge to receiving streams and rivers.
The submitter supplied data on use and disposal, aquatic toxicity, and
biodegradability. The submitted environmental fate data and EPA
estimates of biodegradability based on structural analogs suggested
that half-lifes in water would be well below 6 months, but not
necessarily lower than 2 months. As a result of concerns expressed by
EPA, use was limited to sites where resulting water concentrations
could be limited to 1 microgram per liter (g/L) or less;
concomitantly, the submitter was also informed of EPA's belief that a
potential for long-term risk existed, but that EPA could not quantify
this risk since assessments typically evaluated releases over only 1
year. In 1998, results of monitoring were announced by the State EPA
and revealed that the alkylated biphenyls had been found in fish
fillets and sediment samples from the receiving stream.
One commenter contends that the persistence criteria of half-lifes
of 2 months for water, soil, and sediment and 2 days for air may not be
sufficiently protective (i.e., the criteria may be too high).
EPA disagrees with the comment. EPA believes that it should adopt
criteria that focus on toxic chemicals that will build up in the
environment, while at the same time not limiting the list of persistent
toxic chemicals to only those that are of global concern. As discussed
earlier in this section, EPA believes that 2 months is a reasonable
half-life criterion given the purposes of EPCRA section 313. EPA
believes that application of lower criteria would include so many
substances as to be impractical. Further, given the uncertainties that
often exist regarding physical properties and environmental behavior of
chemicals, caution is especially appropriate for substances with
shorter half-lifes, since they are (all other things being equal) less
likely to build up in the environment than more persistent substances.
EPA believes that the adoption of criteria of half-lifes of 2 months in
water, soil, and sediment and a half-life of 2 days in air allows EPA
to balance the need to provide communities and other data users with
information on toxic chemicals that persist in their environment
without being overly inclusive or restrictive.
One commenter contends that a half-life criterion for air of 2 days
should be considered sufficient in and of itself for designating
substances as persistent.
EPA agrees with the comment. EPA made the following statements in
the proposed rule regarding the 2-day air half-life criterion and its
use in the determination as to whether a chemical was a PBT under EPCRA
section 313:
For the purposes of determining whether a toxic chemical is
persistent in the environment under section 313, EPA used a half-
life criterion of 2 months for water/sediment and soil and a half-
life of 2 days for air. Given the above discussions, EPA believes
that, for purposes of reporting under section 313, these values are
appropriate for determining whether a toxic chemical is persistent
in the environment and will persist long enough in the environment
to bioaccumulate or be transported to remote locations. Under these
criteria, if a toxic chemical meets any one of the media specific
criteria, then it is considered to be persistent. Thus if a toxic
chemical's half-life in water or sediment or soil is equal to or
greater than 2 months or greater than 2 days for air then the toxic
chemical is considered to be persistent for purposes of section 313.
Note that when considering persistence in connection with the
potential for a toxic chemical to bioaccumulate, meeting the air
half-life criteria alone would not be sufficient, since a chemical's
potential to bioaccumulate is usually dependent on it being
persistent in either water, sediment, or soil. In determining
whether the chemicals in this proposal were persistent, EPA did not
rely solely on the persistence in air. (at 64 FR 702)
It is clear from the discussion above that EPA agrees with the
commenter that when considering persistence alone an air half-life of 2
days would be considered sufficient to classify a chemical as
persistent under EPCRA section 313. However, for the reasons explained
above, if a chemical only meets the 2-day air half-life persistence
criteria, EPA does not believe that would be sufficient for classifying
a chemical as a PBT under EPCRA section 313.
Some commenters contend that EPA's two-tiered approach to the
persistence criteria is confusing.
EPA notes that it proposed only one set of persistence criteria for
EPCRA section 313, half-lifes of 2 months or greater in water, soil,
and sediment and 2 days in air. The Agency did not propose to use half-
lifes of 6 months or greater in water, soil, and sediment and 2 days in
air as a second set of persistence criteria for EPCRA section 313.
However, for purposes of setting reporting thresholds in this
rulemaking, the Agency did choose to focus on the subset of PBT
chemicals that have half-lifes of 6 months or greater in water, soil,
or sediment (and BCF/BAFs greater than 5,000) by proposing a 10 pound
reporting threshold.
For the reasons given above, EPA reaffirms its intention to use a
half-life of 2 months as the criterion for persistence in water, soil,
and sediment and a half-life of 2 days as the criterion for air when
characterizing a chemical as persistent for purposes of EPCRA section
313.
b. Bioaccumulation. EPA proposed as bioaccumulation criteria for
the TRI program bioaccumulation/bioconcentration factors of 1,000. As
discussed in Unit VI.B.1., EPA disagrees that it must choose for EPCRA
section 313, bioaccumulation criteria consistent with the international
criteria. Applying these strict criteria to EPCRA section 313 would
result in a very narrow list of chemicals that would focus on only
extremely bioaccumulative chemicals. This is inconsistent with the
purposes of EPCRA section 313 and with EPA's technical judgment. There
is no ``bright line'' that separates what is bioaccumulative from what
is not bioaccumulative. The degree of bioaccumulation is a continuum.
Chemicals with BCFs or BAFs of 1,000 to 5,000 are not non-
bioaccumulative. They are less bioaccumulative than chemicals with BCFs
or BAFs greater than 5,000. The degree of bioaccumulation that should
be used as a criterion is not an absolute scientific determination.
Rather it is a combination of science and policy. As discussed in the
proposed rule and below, organizations have generally used as
bioaccumulation criteria BAFs/BCFs of 1,000 and 5,000. The
determination of which numerical criterion to apply will depend on the
final intent: for example, providing communities with information on
bioaccumulative chemicals that can accumulate in organisms versus
banning the manufacture and use and eliminating releases of a chemical
that has global impacts. For EPCRA section 313 which provides
information on toxic chemicals to communities, researchers, and
governments, the criteria should be in keeping with both the Agency's
scientific judgment and the intent of the statute.
From a scientific perspective there is no one bioaccumulation
criterion. However, it is simply not accurate to state that there is no
precedent or basis for using a bioaccumulation criterion of 1,000. As
noted in the proposed rule, for a number of years EPA scientists and
programs have used a BCF of 1,000 or more to indicate a high level of
concern for bioaccumulation. In addition, this value has been used in
some Canadian projects, many dealing with the Great
[[Page 58682]]
Lakes basin. Also, Germany proposed a BAF/BCF criterion of 1,000 during
negotiation of the LRTAP Protocol. Support for a BAF criterion of 1,000
also comes from the Final Water Quality Guidance for the Great Lakes
System (FWQGGLS) (60 FR 15366, March 23, 1995) (FRL-5173-7). In this
document, EPA stated that bioaccumulation of persistent pollutants is a
serious environmental threat to the Great Lakes Basin Ecosystem and
that chemicals identified as bioaccumulative chemicals of concern
(BCCs) (i.e., with BAF values greater than 1,000) would receive
increased attention and more stringent controls. The final guidance
designated as BCCs those chemicals with human health BAFs greater than
1,000 that were derived from certain field-measured BAFs. One commenter
believed that the BAF criteria used in the FWQGGLS did not provide
support for the use of a BAF of 1,000 since a more strenuous
methodology taking more factors into account was used. However, EPA
believes that this does provide support for the criteria established
for the purposes of EPCRA section 313 because, although the underlying
technical assessments may be more stringent, the bioaccumulation level
of concern is still a BAF of 1,000. Also, as noted by some commenters,
EPA has proposed to use a BCF/BAF of 1,000 to trigger testing under
TSCA section 5(e) (63 FR 53417). Specifically, for chemicals subject to
TSCA section 5 that have a BAF of 1,000 or greater and that meet
certain toxicity and persistence criteria (similar to the EPCRA section
313 persistence criteria) testing would be ``triggered'' by specific
production limits. While the manufacturer of the chemical would be
allowed to commercialize the substance, certain controls could be
stipulated, including specific limits on exposures, releases, or uses.
EPA notes that in the same Federal Register document, the Agency has
proposed that chemicals that have a bioaccumulation factor of 5,000 and
that meet certain toxicity and persistence criteria (e.g., half-life of
6 months or greater in soil) be placed in a ``Ban Pending Testing,''
bin. Chemicals meeting these criteria could be subject to more
stringent control up to a ban on commercial production.
Not only is there precedent for the use a BCF/BAF of 1,000, but EPA
believes that the purposes of the statute argue for the use of the more
expansive criterion. Data on PBT chemicals are the type of information
that will be of particular use to specific communities such as those
that consist of subsistence fishers. Subsistence fishers (as well as
sports fishers) are more highly exposed to PBT chemicals than the
general population. Subsistence fishers consume large quantities of
what they catch. In addition, children are affected by lower doses of
certain PBTs than are adults. Children of both subsistence fishers and
sport fishers will consume larger quantities of lake food and seafood
than children in other communities. As discussed in Unit VI.B.2., EPA's
Office of Water maintains a Listing of Fish and Wildlife Advisories
(LFWA) for the U.S. and its territories, which listed 2,299 advisories
in 1997 (Ref. 29). The overwhelming majority of the advisories are for
well-recognized PBT chemicals (chlordane, mercury, PCBs, etc.), but
many less familiar substances are also represented. The number and
content of advisories in LFWA clearly indicate that toxicologically
significant levels of chemical contaminants, specifically PBTs, are
often found in fish and wildlife that are caught noncommercially and
consumed by the U.S. population. It should be noted that the fact that
no advisories have been issued for a particular chemical does not mean
that the chemical does not bioaccumulate. Not all species of aquatic
organisms are tested nor are all water bodies. In addition, each state
determines what it will use as the level of concern for issuing an
advisory. EPA believes that it would be inconsistent with the intent of
EPCRA section 313 to limit the information on bioaccumulative toxic
chemicals to only information for the most bioaccumulative.
One commenter contends that EPA did not provide scientific
justification for its choice of the bioaccumulation criterion of a BCF/
BAF of 1,000. The commenter states the EPA's discussion of the origin
of the 1,000 BCF/BAF value at a 1976 meeting sponsored by the American
Society of Testing and Materials, and its reaffirmation in 1995 in a
research article by two of the original authors, the use of the value
by scientists in EPA's Office of Research and Development's Duluth
Laboratories, by EPA's Office of Pollution Prevention and Toxics in the
review of chemicals under TSCA sections 4 and 5, by EPA's Office of
Water in the Final Water Quality Guidance for the Great Lakes System,
and the use by other authorities, such as the German government, to
identify chemicals of high concern for bioaccumulation do not provide a
technical basis for choosing a value of 1,000 as a criterion for
bioaccumulation. The commenter contends that a criterion of 5,000 is
scientifically supportable because chemicals with a BCF/BAF of 5,000
have a high potential to biomagnify.
As discussed above, there is no scientifically ``best''
bioaccumulation criterion. The degree of bioaccumulation is a
continuum. A chemical does not bioaccumulate only if it has a BCF that
is 5,000 or greater. A chemical that has a BCF of 1,000 will
bioaccumulate, specifically the chemical will be present in an organism
at a concentration that is 1,000 times greater than its concentration
in the surrounding aqueous environment. Rather the choice of a value
along the bioaccumulation spectrum is based to a large degree on how
the criterion is to be used, e.g., to track chemicals entering a
particular environment, or to restrict the use of chemicals, etc. As
such the choice of a bioaccumulation criterion is a combination of
science and policy.
The commenter did not provide support for the contention that 5,000
was scientifically the ``best'' bioaccumulation criterion.
Specifically, the commenter did not indicate why as a scientific matter
a BCF of 5,000 was preferable to a BCF of, for example 4,000 or a BCF
of 15,500. While the commenter did note that chemicals that have a BCF
of 5,000 tend to have a high potential to biomagnify, the commenter did
not indicate in what way this factored into his determination that a
BCF of 5,000 is the scientifically ``best'' bioaccumulation criterion.
In addition, EPA does not agree that a BAF or BCF of 5,000 indicates
that a chemical will be more likely to biomagnify since
biomagnification is a much more complex process. Biomagnification is
not a separate process from bioaccumulation or bioconcentration, but is
instead a specific example or subset of both. Biomagnification has been
defined as: The result of the processes of bioconcentration and
bioaccumulation by which tissue concentrations of bioaccumulated
chemicals increase as the chemical passes up through two or more
trophic levels (Ref. 43). The difference between bioaccumulation and
biomagnification is that for a chemical to biomagnify its level of
bioaccumulation must increase as it moves up the food chain. The whole
concept of biomagnification can be viewed as controversial (Ref. 9) and
biomagnification has been studied for only a few chemicals. Most
importantly, biomagnification is not required in order to have a
concern for chemicals that bioaccumulate. This is because
bioaccumulation in even one species can have a serious impact on that
species or any other species that feeds on it. For example, if a
chemical only bioaccumulates in fish then the fish will
[[Page 58683]]
be exposed to higher concentrations of the chemical as will anything
that eats the fish. Therefore, EPA believes that there is no reason to
establish biomagnification as a criterion for PBT chemicals since
bioaccumulation is of more than sufficient concern in and of itself.
None of the other commenters who believe that the bioaccumulation
criterion of 1,000 is too expansive suggested that EPA adopt another
value, other than the 5,000 value used in international agreements,
addressed in previous responses in this unit. At most, several
commenters took issue with the fact that the EPCRA section 313
bioaccumulation criterion (BCF/BAF of 1,000) is 5 fold less than the
international bioaccumulation criterion of a BCF/BAF or 5,000. Given
that for each of these programs the focus was on PBT chemicals that are
of global concern, EPA believes that as a matter of public policy, it
is more appropriate for a reporting program to use a more protective
criterion than that used in international agreements that seek to ban
or severely restrict the use and/or release of chemicals.
One commenter believes that EPA should not adopt a bioaccumulation
criterion (BCF/BAF of 1,000) for EPCRA section 313 that is more
stringent than the criterion for a Great Lakes BCCs (a human health BAF
of 1,000). EPA notes that BCCs will receive stringent controls which is
not the case for toxic chemicals identified as bioaccumulative (and
persistent) under EPCRA section 313.
Many commenters supported the proposed bioaccumulation criterion of
a BCF/BAF or 1,000. However, one of these commenters believes that
1,000 should be the criterion only if the BCF or BAF is a measured
value. If the BCF is an estimated value, then the criterion should be
500.
EPA believes that such a two-tiered approach will add confusion.
Further, estimated or predicted BCFs are often based on measured data
and equations that have been found to correlate well with measured
data. In addition, EPA believes that a BCF of 500 is overly expansive.
EPA believes that expanding the criteria to include estimated BCFs of
500 would label so many chemicals as bioaccumulative as to be
impractical. EPA believes that the adoption of the criterion of BCF/BAF
of 1,000 allows EPA to balance the need to provide communities with
information on toxic chemicals that bioaccumulate without being overly
inclusive or restrictive.
Some commenters contend that EPA's two-tiered approach to the
bioaccumulation criteria is confusing. EPA notes that it proposed only
one bioaccumulation criterion for EPCRA section 313, a BCF/BAF of
1,000. The Agency did not propose to use a BCF/BAF of greater 5,000 as
a second bioaccumulation criterion for EPCRA section 313. However, for
purposes of setting reporting thresholds in this rulemaking, the Agency
did choose to focus on the subset of PBT chemicals that have a BCF/BAF
greater than 5,000 (and half-lifes greater than 6 months) by proposing
an even lower reporting threshold.
For the reasons given above, EPA reaffirms its intention to use a
BCF/BAF of 1,000 as the criterion for characterizing a chemical as
bioaccumulative under EPCRA section 313.
c. Toxicity. A number of commenters contend that EPA should set a
separate toxicity criteria for PBT chemicals. EPA disagrees. EPCRA
section 313 provides toxicity criteria at section 313(d)(2) to be used
in adding a chemical to or deleting a chemical from the EPCRA section
313 list of toxic chemicals. These criteria are:
(A) The chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects
at concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
(B) The chemical is known to cause or can reasonably be
anticipated to cause in humans-
(i) cancer or teratogenic effects, or
(ii) serious or irreversible-
(I) reproductive dysfunctions,
(II) neurological disorders,
(III) heritable genetic mutations, or
(IV) other chronic health effects.
(C) The chemical is known to cause or can reasonably be
anticipated to cause, because of-
(i) its toxicity,
(ii) its toxicity and persistence in the environment, or
(iii) its toxicity and tendency to bioaccumulate in the
environment, a significant adverse effect on the environment of
sufficient seriousness, in the judgment of the Administrator, to
warrant reporting under this section.
Given that Congress has provided EPA with specific toxicity criteria,
and that listed chemicals are statutorily defined as ``toxic
chemicals,'' the Agency does not believe that additional ``toxicity''
criteria would be appropriate. One reason is that the Agency is
concerned that this would imply that TRI data on the toxic chemicals
that meet the statutory toxicity criteria are of less value than TRI
data that meet both the statutory toxicity criteria and some additional
toxicity criteria that would be developed by EPA. EPA believes that
bifurcating the list with an additional, non-statutory toxicity
criteria would be inconsistent with the intent of Congress. In
addition, it is worth noting that some of the toxicity criteria
presented by the commenters are fundamentally consistent with the
toxicity criteria outlined in the statute. However, EPA notes that some
of the criteria provided by the commenters are risk criteria rather
than hazard criteria. For example, see ICCA Briefing Note on POPs
(April 21, 1998) (Ref. 26). As discussed at length in the final rule
adding 286 chemicals to the EPCRA section 313 list (59 FR 61432), the
EPCRA section 313(d)(2)(B) toxicity criteria (chronic toxicity) are
hazard criteria, not risk criteria. The EPCRA section 313(d)(2)(C)
criteria are primarily hazard based with only a limited exposure
component. To impose additional toxicity criteria for purposes of
defining a PBT or a PT or BT chemical based on risk rather than hazard
would be inconsistent with EPCRA section 313. See, e.g., Legislative
History at 5186. Risk assessment may be appropriate for use under
statutes that control the manufacture, use and/or release of a
chemical. However, EPCRA section 313 is an information collection
provision that is fundamentally different from other environmental
statutes that control or restrict chemical activities. For these
reasons, EPA believes that it is inappropriate to add toxicity
criteria, beyond the criteria provided by Congress at EPCRA section
313(d)(2).
3. Persistence and bioaccumulation consideration under EPCRA
section 313(d)(2)(C)(ii) and (iii). The criteria that EPA has laid out
in this rule for determining if a chemical is a persistent and/or
bioaccumulative chemical are not the same criteria EPA uses when
conducting assessments for listing chemicals pursuant to EPCRA section
313(d)(2)(C)(ii) and (iii). These sections of EPCRA allow EPA to
consider whether a chemical meets the listing criteria based on ``its
toxicity and persistence in the environment'' or ``its toxicity and
tendency to bioaccumulate in the environment.'' Including consideration
of persistence and/or bioaccumulation modifies the way in which EPA
assesses a chemical's toxicity for purposes of listing. EPA interprets
the results of the toxicity data in light of a chemical's persistence
and/or bioaccumulation, and adjusts its concerns for the chemical's
toxicity in accordance with the degree to which a chemical persists or
bioaccumulates. For example, standard aquatic toxicity tests provide
toxicity results in time frames that range from hours to a few weeks.
For aquatic toxicity that results
[[Page 58684]]
from such short exposure times, a chemical with a persistence half-life
of even 2 weeks will result in a greater potential for exposure and
therefore increased concern for the concentration at which toxicity is
expressed. In this case, EPA would be concerned about the chemical's
persistence at levels well below a half-life of 2 months or more.
Because EPA's concern under these provisions is with the
interrelationship between two chemical properties and how that affects
whether the chemical can reasonably be anticipated to cause a
significant adverse effect on the environment, EPA believes that it
needs to be able to consider a broader range of values. By contrast,
the persistence and bioaccumulation criteria established in today's
rulemaking serve a different purpose; they are intended to operate
independent of a chemical's toxicity, to identify a fixed class of
chemicals. EPA has provided this explanation to clarify the different
purposes of the persistence and bioaccumulation criteria established in
this rule, and the use of persistence and bioaccumulation in
assessments pursuant to EPCRA section 313(d)(2)(C)(ii) and (iii).
C. Criteria as they Apply to Metals
Many commenters contend that the persistence criteria proposed by
EPA were developed for organic chemicals and cannot be applied to
metals, or if applied, are not useful in screening for hazard. The
critical parameter in determining risk is bioavailability, not
persistence. This has been recognized by international organizations of
which EPA is a member, so it is unclear why it is now necessary for EPA
to deviate from these policies. Metals are not harmful if they are not
in a bioavailable form. Moreover, metals are natural components of the
earth's crust and many are accumulated by living organisms because they
are essential nutrients. Two of the commenters state that because
persistence is defined as ``the failure of a substance to readily
biodegrade,'' this concept has no relevance for metals.
EPA disagrees. The scientific literature contains many definitions
of persistence which vary in detail, but center on a common theme:
persistence is the ability of a chemical substance to remain in a
particular environment in an unchanged form. This definition makes no
mention whatsoever of any specific processes that may impact a
substance's environmental fate, such as biodegradation. According to
this definition, specific metal compounds may or may not be persistent
depending on the form of the metal and environmental conditions, but
the elemental metal itself obviously meets the definition, and this was
acknowledged in the majority of comments received.
That elemental metals are persistent by definition is widely
accepted. While they may take different oxidation states that can be
interconverted, the elemental metal itself cannot be destroyed. For
example, chromium (VI) may convert to chromium (III). Both are simply
different forms of chromium. All elemental metals therefore meet the 2
months half-life criterion automatically. Given this, it is obviously
false to assert, as did the majority of commenters on this issue, that
EPA's proposed persistence criteria cannot be applied to metals. The
position of many commenters was that in determining whether a metal or
metal compound may actually pose a risk if released to the environment,
bioavailability is much more important than the fact that a substance
meets the formal ``definition'' of persistence. EPA agrees that
bioavailability is important in determining the potential for the metal
to be accumulated in organisms, but parent metals do have the potential
to become available from metal compounds under common environmental
conditions. Availability of the metal ion may be the result of biotic
or abiotic processes. There are a number of environmental factors which
EPA considers in determining the availability of the metal ion. These
include hydrolysis, pH effects on solubility, photolysis, aerobic and
anaerobic transformations, and in vivo transformations. As outlined in
the remainder of this section, it is realistic to expect that, in
general, metals when released into the environment can encounter
conditions in which they are available at levels sufficient to exert
toxicity and bioaccumulate.
EPA also disagrees with the commenters' claims, direct or implied,
that metals released to the environment as a result of human activity
must be of negligible concern because they:
Cannot be converted to bioavailable forms; or even if
initially bioavailable are rapidly sequestered in such a way that
subsequent exposure is impossible; or
If bioavailable, are naturally wholesome and good because
organisms need them to function.
EPA disagrees with this simplistic view. Metals can enter the
environment in bioavailable forms or can be converted in the
environment into bioavailable forms. As shown below, metals and metal
compounds may be available to bioaccumulate under many realistic and
common environmental conditions.
The commenters are correct in stating that metals released to the
environment from anthropogenic sources are affected by prevailing
environmental conditions, meaning broadly the wide variety of physical,
chemical and biological processes that act upon them, and these
collectively determine the form in which the metal ultimately exists.
According to Klein (Ref. 28), interconversion of inorganic metal
compounds can be quite rapid, especially for ionic forms, and as a
result the chemical form in which an elemental metal is released may
not be the predominant form post-release. Generally, the ionic forms of
inorganic metals are the most available. Availability is affected by
many factors and its determination is complex. For metals environmental
conditions can affect their availability. A detailed scientific
discussion of the environmental fate of lead, which is representative
of other metals, and that is illustrative of many of the more important
environmental variables that affect availability is provided in Refs.
14, 28, 30, 50, 66a, 72, and 84. See also the preamble to EPA's recent
proposal to lower the EPCRA section 313 reporting thresholds for lead
and lead compounds (64 FR 42222). The same basic chemical properties
and environmental variables will affect the degree of availability of a
metal in the environment regardless of the specific metal. There is no
metal that is unavailable under all conditions.
EPA recognizes that lead and lead compounds are the subject of an
EPA proposal under EPCRA section 313 (64 FR 42222). The inclusion of
the discussion of the environmental fate of lead and lead compounds
does not predetermine EPA's decision on the appropriate thresholds that
should be set for lead and lead compounds. That determination will be
based on a number of factors, including the bioaccumulation of lead.
Microbial transformations in soil, water, and sediment are often
important in determining the overall fate of metals and metal
compounds, and therefore the potential for formation of bioavailable
forms. Metals known to undergo microbial oxidation/reduction processes
include, antimony, arsenic, iron, mercury, selenium, and tellurium
(Ref. 11). Arsenic microbiology illustrates the importance of
environmental conditions in the interconversion of inorganic forms of
arsenic. Microbial populations in activated sludge can oxidize arsenite
to arsenate under aerobic conditions, but under anaerobic conditions
such as often predominate in sediments, arsenate can be reduced to
arsenite and
[[Page 58685]]
beyond. Both arsenites and arsenates can be available in the
environment (Ref. 11). Microorganisms can reduce mercury in the form of
mercuric chloride to elemental mercury, and are also capable of
producing elemental mercury from organomercurials such as
phenylmercuric acetate and methylmercuric chloride. Although the
reduction of Hg2+ to elemental mercury can be regarded as
decreasing availability, the elemental mercury formed is volatile and
more likely to enter the global atmospheric circulation.
Mercury is perhaps better known for its potential to be
biomethylated by bacteria in the environment (Ref. 11). Mercury has
very high stability constants with organic ligands and can form true
organometallic compounds (Ref. 6). As indicated by Stumm and Morgan
(Ref. 49), metals and metalloids that form stable alkyl compounds are
of special concern because they may be volatile; may accumulate in
cells; and are toxic to the central nervous system of higher organisms.
Methylmercury is highly bioaccumulative and is by far the best studied
example of microbial bioalkylation. However, methylation of arsenic is
also fairly well-characterized, involves the replacement of substituent
oxygen atoms by methyl groups (e.g., arsenate is biomethylated to form
dimethylarsine), and is important in the transfer of arsenic from
sediment to the atmosphere (Ref. 11). Lead, germanium, selenium,
tellurium, tin, and several other metals can also be biomethylated
(Ref. 49).
Many of the commenters noted that certain metals are indeed
micronutrients (e.g., cobalt, copper, and iron), and are accumulated
precisely because they are required for certain cellular functions. It
does not follow, however, that any amount of the same metal is
acceptable or desirable. Accumulation of essential elements is usually
governed by homeostatic mechanisms that control uptake (Ref. 28), but
excessive uptake is possible and can be toxic to an organism. For
example, selenium which is a micronutrient can cause selenosis at doses
as low as 0.023 milligrams per kilogram per day (mg/kg/day). Clinical
signs of selenosis include the characteristic ``garlic odor'' of excess
selenium excretion in the breath and urine, thickened and brittle
nails, hair and nail loss, lowered hemoglobin levels, mottled teeth,
skin lesions, and central nervous system (CNS) abnormalities
(peripheral anesthesia, acroparesthesia, and pain in the extremities)
(Ref. 61). Similarly, copper, which is an essential nutrient, at high
doses can cause vascular injury and hemolytic anemia. It should also be
noted that copper exhibits high acute and chronic toxicity to aquatic
organisms that results in the death of the organism (61 FR 54381,
October 18, 1996) (FRL-5396-9), and inhalation of hexavalent chromium
is known to cause cancer in humans (Ref. 60), even though chromium in
very small oral doses is a micronutrient (Ref. 25). Moreover, the
commenters freely cite Allen (Ref. 4), Chapman (Ref. 18) and other
authors to the effect that metals are accumulated ``deliberately''
depending on the physiological needs of the organism, but it is clear
that this applies only to metals that are essential nutrients. Metals
are generally taken into cells by nutrient metal transport systems, and
these are not sufficiently specific to completely exclude nonessential
metals, some of which may be toxic and/or bioaccumulative. In this
situation nutrient metals can be displaced from their binding sites by
undesirable, toxic metals, which then gain access to the cell interior
with concomitant exclusion of the essential metal (Ref. 49). Toxic
metal ions are then free to react with critical enzymes or otherwise
disrupt cellular functions if they reach certain levels. Often this
toxicity occurs at relatively low doses. For example, inorganic arsenic
is a known human carcinogen and causes chronic toxicity at doses as low
as 0.014 mg/kg/day (Ref. 59). Lead has no known biological function in
humans but is readily absorbed and has been shown to cause various
toxic effects. For example, children can suffer permanent damage from
lead poisoning, resulting in lowered intelligence, learning
disabilities, hearing loss, reduced attention span, and behavioral
abnormalities (Ref. 66).
EPA concludes that under many environmental conditions, metals and
metal compounds may be available to express toxicity and to
bioaccumulate, and that these effects are not necessarily limited to
metals that are not essential nutrients. It is appropriate, therefore,
to be concerned about the potential adverse effects, and one step in
this direction is to more accurately assess emissions from
anthropogenic activities. EPCRA section 313 provides that opportunity.
Precedent for this concern exists at the international level in the
form of a protocol for heavy metals under the UNECE LRTAP, which is
currently being negotiated. The draft protocol expresses concern ``. .
.that emissions of certain heavy metals are transported across national
boundaries and may cause damage to ecosystems. . .and may have harmful
effects on human health. . .,'' and specifically advocates assessing
and controlling emissions caused by human activities (Ref. 54).
Several commenters raised the issue of EPA participation in various
international organizations, claiming that any attempt to apply EPA's
proposed persistence and bioaccumulation criteria and/or assessment
approach to metals would violate the policies of these organizations,
whose positions EPA has previously endorsed. These claims are false
because the commenters either misunderstand or misstate the
aforementioned policies. The main focus of the commenter's attention is
two documents, the OECD's Harmonized Integrated Hazard Classification
System for Human Health and Environmental Effects of Chemical
Substances (Ref. 41), and the North American Agreement on Environmental
Cooperation (NAAEC)'s Process for Identifying Candidate Substances for
Regional Action under the Sound Management of Chemicals Initiative
(Ref. 39). A report from a joint Canada/European Union Technical
Workshop on metals (Ref. 17) was also cited by commenters and reached
similar conclusions.
The OECD document's pronouncements on metals are contained in
paragraphs 22 and 23 of that document. Paragraph 22 reads as follows:
For inorganic compounds and metals, the concept of degradability
as applied to organic compounds has limited or no meaning. Rather
the substance may be transformed by normal environmental processes
to either increase or decrease the bioavailability of the toxic
species. Equally, the use of bioaccumulation data should be treated
with care. Specific guidance will be [but has not yet been] provided
on how these data for such materials may be used in meeting the
requirements of the classification criteria. (Ref. 41)
By ``degradability as applied to organic compounds'' OECD means
molecular degradation, most often by microbial degradation and/or
hydrolysis or other abiotic processes, to progressively simpler organic
chemical structures, leading eventually to inorganic substances like
carbon dioxide and water. But, note, paragraph 22 does not in any way
suggest that metals are not persistent. Moreover, it does not suggest
that OECD hazard classification criteria cannot be applied, only that
``care'' (i.e., professional judgment) is required in the
interpretation of data relative to the classification criteria. In
fact, EPA agrees that bioavailability is important in determining the
potential for the metal to be accumulated in organisms.
[[Page 58686]]
The Agency has analyzed information on the environmental fate of
metals, and, as noted above, asserts its professional judgment that the
parent metals do have the potential to become available from metal
compounds under commonly encountered environmental conditions.
Therefore, the Agency's treatment of metals is consistent with the
OECD's intent.
The same holds with respect to NAAEC's pronouncements under the
SMOC (Ref. 39). The focus of NAAEC/SMOC (Ref. 39) is the development of
North American Regional Action Plans (NARAPs) for substances that pose
significant risk to human health and the environment in all three
member countries (namely, Mexico, Canada, and the United States). To
date, NARAPs have been established for DDT/chlordane, PCBs, and mercury
(note: a metal). NAAEC/SMOC (Ref. 39) acknowledges the persistence of
metals, but highlights the role of expert judgment in assessing
potential bioavailability of metals and metal compounds:
For naturally occurring substances such as metals and minerals,
the Task Force understands that the direct application of the
persistence and bioaccumulation criteria proves very
difficult.....Organometals can behave like other persistent organic
pollutants in their metallic form, and as certain compounds, metals
tend to be infinitely persistent though not necessarily in a form
that is bioavailable, and in some cases, they naturally
bioaccumulate for beneficial purposes in organisms (i.e., essential
elements). Expert judgment is essential for a meaningful evaluation
of these substances.
Further, an earlier section of the document (Ref. 39) states,
It is understood that expert scientific judgment plays a
significant role in acknowledging and addressing the difficulties
posed by quantitative criteria for persistence and bioaccumulation,
particularly in relation to naturally-occurring substances like
metals and minerals where the potential for transformation to
complexes or metallic species which are more or less bioavailable,
are emerging as important considerations.
It is difficult to read into the preceding any intention to exclude
metals and metal compounds from consideration, as many commenters
imply, and more specifically, to declare that these substances have no
potential to pose risk because they are never released in bioavailable
forms; cannot be converted to bioavailable forms under any foreseeable
circumstances, etc. On the contrary, it is clear from the preceding
language as well as the inclusion of mercury among the NARAPs developed
to date that any substance judged to be potentially bioavailable and
that otherwise meets the SMOC criteria, whether organic or inorganic,
should not be excluded as a candidate for action. As outlined above, it
is realistic to expect that, in general, released metals can encounter
conditions in which they are available at levels sufficient to exert
toxicity and bioaccumulate. Therefore, the Agency's treatment of metals
is consistent with international policy under NAAEC/SMOC (Ref. 39).
Finally, EPA reminds commenters that a mechanism already exists to
address concerns for any metal compound for which the data show that
the metal cannot become available. The issue of bioavailability was
addressed previously for EPCRA section 313 chemical assessments through
EPA's policy and guidance concerning petitions to delist individual
members of the metal compound categories listed under EPCRA section 313
(56 FR 23703, May 23, 1991). This policy states that if the metal in a
metal compound cannot become available as a result of biotic or abiotic
processes, then the metal will not be available to express its
toxicity, and by extension, to bioaccumulate. If the intact metal
compound is not toxic and the metal is not available from the metal
compound, then such a chemical is a potential candidate for delisting.
EPA has received fewer than 10 petitions to delete individual metal
compounds because the petitioner contended that the metal portion of
the metal compound would not be available under environmental
conditions or in vivo.
D. Multimedia Modeling
One commenter contends that EPA should clarify how and when
multimedia models will be used in the evaluation of PBT chemicals. EPA
should not use the EQC model or other multimedia models as the sole
determinant of potential risk. If exposure and use information is
available, a detailed technical evaluation based on these data is
preferred over modeling based on hypothetical exposure and loading
scenarios.
The purpose of this rulemaking is to lower reporting thresholds for
certain EPCRA section 313 substances that are being designated as
persistent and bioaccumulative, and to list several additional
substances that meet EPCRA section 313 listing criteria and are also
persistent and bioaccumulative. Although neither quantitative risk nor
exposure assessments have been performed, nor are they required under
EPCRA, designation as a PBT does imply the existence of potential risk.
However, contrary to the comment, EPA has not proposed that multimedia
models be used as the sole factor in determining persistence. As
clearly stated in the proposed rule, EPA intends to use such modeling
``as an additional factor, in conjunction with reaction half-lifes for
individual media, bioaccumulation/bioconcentration factors, etc., in
justifying [the] actions proposed.''
In the proposed rule EPA did explain in a general way (at 64 FR
703) how models would be used in PBT evaluation, and stated that
results of multimedia modeling may be used to override compartment
(medium)-specific degradation half-lifes, but only if all model inputs
are judged sufficiently accurate. This leaves unspecified what specific
value(s) might be used for overall environmental persistence criteria
(expressed either as an overall residence time or overall half-life).
To date no international scientific or regulatory authority has
proposed any such criterion for POPs/PBT chemicals, and the complex
relationship between compartment-specific and overall persistence
criteria is in fact a major topic of current research.
One commenter raises concerns regarding the modification EPA made
to the EQC III model that deleted advective losses and sediment burial.
EPA modified the model to exclude advective losses and sediment
burial because if these processes are included the persistence based on
destruction will be underestimated. In multimedia modeling, advection
can be viewed as the flow into or out of the evaluative environment or
``box.'' These include processes such as downstream flow in surface
waters, dispersion downwind in air, and burial in sediments. The model
considers these non-destructive processes to result in loss from the
evaluative environment in the same way that destruction does. However,
these processes simply result in the transport of a chemical to another
part of the environment downwind or downstream from where it is
released, or its deposition into sediments, but not the destruction of
the chemical.
The persistence of a chemical calculated when the model is run
considering advective losses include non-destructive transport
processes which remove the chemical from the evaluative environment.
For example, the environmental persistence of a chemical released to
water which does not significantly partition to sediments, degrade, or
volatilize will reflect the rate at which the water to which it is
released flows out of the evaluative environment. In this example, the
[[Page 58687]]
relative rate of non-destructive transport out of the evaluative
environment may be more rapid than the processes which result in the
destruction of the chemical. Thus, the persistence calculated by the
model will be less than if advective transport from the evaluative
environment was not considered.
EPA used the model to evaluate persistence based on destruction in
a multimedia environment. This is consistent with EPCRA section 313
persistence criteria in that the criteria are based on destruction, not
transport of the chemical. The Level III (non-equilibrium partitioning,
steady state mass balance) models are preferred for developing
qualitative and quantitative predictions of chemical distribution,
pathways, and relative concentrations (Ref. 16). Level III models can
also be used to assess persistence (Ref. 33). At steady state (level
III) conditions the amount of chemical is unchanging with time and the
input and output rates for a compartment are equal. The overall
residence time of the chemical is the mass of the chemical in the
compartment divided by the input or output rates. This represents the
average time the chemical will reside in the compartment. Output may be
by reactions that result in the destruction of the chemical or by
advective flow (non-destructive) usually in air or water. When the
model is modified to eliminate advective flow, the persistence of a
chemical based on the rates of reactions that result in the destruction
of the chemical can be assessed. Webster et al (Ref. 82) used this
approach in evaluating the environmental persistence of chemicals using
a multimedia fate model and noted that if advective loss is included,
the residence time is reduced and can give a misleading impression of a
short persistence. It was also noted that these advective losses ``. .
.merely relocate the chemical; they do not destroy it.'' EPA also used
a modified version of the EQC level III model as a tool to assist on
the characterization of the persistence of the chemicals subject to
this rule. In this version of the model only irreversible
transformation contributes to net loss of a chemical. In other words,
the model was modified to represent a ``closed box'' in which the
effect of processes that serve only to move the chemical from within
the evaluative environment to outside of it, primarily in air and water
(advective losses) were nullified. Sediment processes responsible for
transport of the chemical from the evaluative environment such as
sediment burial were similarly treated. The intent of this modification
was to make sure that only processes responsible for the destruction of
the chemical were considered in evaluating its persistence in a
multimedia environment. EPA supports the use of level III multimedia
models modified, as described, for their ability to simultaneously
consider reaction rates and partitioning so as to give a reasonable
assessment of the persistence of chemicals in the multimedia
environment.
However, EPA notes that its reliance on the multimedia modeling was
limited. As discussed in the proposed rule (at 64 FR 703) and in Unit
VI.B.2., EPA primarily considered media-specific data and made a case-
by-case determination about the persistence of each chemical.
E. Thresholds
The issue most frequently raised by commenters was the Agency's
choice of thresholds and the factors that EPA considered in lowering
the thresholds. Many commenters contended that EPA should not consider
burden in choosing thresholds. They believe that EPA should set a
threshold of 10 pounds for PBT chemicals and 1 pound for that subset of
PBT chemicals that are both highly persistent and highly
bioaccumulative. Some commenters believe that EPA should set a
threshold of 1 pound for all chemicals that are PBT chemicals. Numerous
commenters believe that the threshold for reporting should be zero.
Other commenters believe that burden should have been a greater
consideration in EPA's choice of reporting thresholds. Many of these
commenters believe that EPA should set thresholds based on some
percentage of releases that would be reported.
EPA disagrees with these commenters. As explained in the proposal,
the Agency considered a number of factors to determine the appropriate
thresholds that should be established for these chemicals. EPA relied
on the language of EPCRA sections 313(f)(2) and (h), and the
legislative history to elicit the following principles to guide its
exercise of discretion in lowering the thresholds, and in selecting the
specific thresholds for PBT chemicals: (1) The purposes of EPCRA
section 313; (2) the ``verifiable, historical data'' that convinces EPA
of the need to lower the thresholds; (3) the chemical properties shared
by the members of the class of toxic chemicals for which EPA is
lowering the thresholds i.e., the degree of persistence and
bioaccumulation; and (4) the reporting burden imposed by revised
thresholds to the extent that such consideration would not deny the
public significant information from a range of covered industry
sectors. Further, EPA believes that in the language of EPCRA section
313, and its legislative history, Congress provided direction on the
appropriate weight to allocate to each of these considerations in
implementing EPCRA section 313(f)(2). These considerations underlay the
entire process by which EPA determined the appropriate thresholds. But,
as noted below, the Agency's choice of revised thresholds was governed,
and ultimately constrained, by EPCRA section 313's overriding purpose,
which is to provide government agencies, researchers, and local
communities, with a comprehensive picture of toxic chemical releases
and potential exposures to humans and ecosystems.
In general, EPA's implementation of EPCRA section 313 is guided by
the statutory purposes described by EPCRA section 313(h), which
provides:
The release forms required under this section are intended to
provide information to the Federal, State, and local governments and
the public, including citizens of communities surrounding covered
facilities. The release form shall be available. . .to inform
persons about releases of toxic chemicals to the environment; to
assist governmental agencies, researchers, and other persons in the
conduct of research and data gathering; to aid in the development of
appropriate regulations, guidelines, and standards; and for other
similar purposes.
In addition to section 313(h), EPA was also guided by several
statements on the principles intended to guide EPA's implementation of
EPCRA section 313 made by Representative Edgar, one of EPCRA section
313's principal architects, during debate on the Conference Report.
See, Legislative History at 5313-16. In the course of his statement,
Representative Edgar also articulated EPCRA section 313's overriding
purpose, which is:
to provide a comprehensive view of toxic chemical exposure and,
hopefully, provide a basis for more sensible and effective local,
State, and national policies. Legislative History at 5316 (emphasis
added).
Based on the existing reporting requirements, the Agency believes
that there are still significant gaps in the picture the TRI data
provides local communities, government agencies, and researchers. One
of the most significant of these gaps is a comprehensive picture of the
releases and potential exposure of PBT chemicals to humans and the
environment. Currently, only a very limited picture of releases and
other waste management of PBT chemicals is available from the TRI data,
in part, as a result of the current thresholds. For
[[Page 58688]]
example, under the current reporting thresholds, in 1997, EPA received
only 29 reports on mercury and mercury compounds, and 6 reports on
PCBs. This does not present a ``comprehensive view of toxic chemical
exposure.'' In addition, information on the releases and other waste
management of PBT chemicals is particularly significant because these
chemicals both persist and bioaccumulate. Individually, each of these
attributes has the potential to pose increased exposures to humans and
the environment. Toxic chemicals possessing both attributes have the
potential to pose significant exposures to humans and ecosystems over a
longer period of time; even small amounts of PBT chemicals that enter
the environment can accumulate to elevated concentrations in the
environment and in organisms, and therefore have a greater potential to
result in adverse effects on human health and the environment.
As a first step in addressing the significant gap of information on
PBT chemical releases and waste management, EPA considered whether to
lower the reporting thresholds for PBT chemicals. EPA then looked to
section 313(f)(2) for further guidance on how to proceed. Since
lowering the thresholds ensures that ``all facilities subject to the
requirements of [section 313]'' will continue to report, the
requirement in section 313(f)(2) that a revised threshold obtain a
``substantial majority of total releases of each chemical at all
facilities subject to the requirements of this section'' can be met
without the need for quantitative support. Consequently, EPA looked to
other sources of Congressional direction in the statute and legislative
history to guide its exercise of discretion in establishing revised
thresholds.
Given that there is no guidance on implementing section 313(f)(2)
in the Conference Report, EPA looked to the debate on the Conference
Report. In this context, Representative Edgar, stated:
It is also important to clarify the intent of Congress in
establishing thresholds for reporting under this section. . . .These
thresholds were designed to obtain reporting on both a substantial
majority of the Nation's toxic chemical releases and to obtain
reporting from a large number of firms. These thresholds reflect
Congress' judgement that such thresholds appropriately balance the
need for information against the burden on facilities required to
provide such information. The EPA is authorized to revise these
thresholds, but only if such revised thresholds continue to obtain
reporting on a substantial majority of total releases. Any
determination by the EPA regarding the ability of revised thresholds
to obtain reporting on a substantial majority of releases,
especially if such revised thresholds raise the statutory levels,
must be based on verifiable, historical data which presents a
convincing case that the statutory levels must be revised.
Legislative History at 5313 (emphasis added).
And during the House debate, Representative Swift noted that any
revised threshold ``should be designed to improve the usefulness of the
reports. It must be structured to obtain reporting on a substantial
majority of the total nationwide releases of the toxic chemical at all
facilities covered by section 313.'' Id. at 5338 (emphasis added).
In determining how to structure its threshold revisions, and
particularly how it would improve the usefulness of the reports, EPA
also consulted EPCRA's purposes, laid out in subsection (h). In this
context, EPA also considered the statements made by Senator Stafford
during debate on the Conference Report:
This section also requires the Administrator to computerize the
data reported on the required forms and to make these data public by
various means. Successful implementation of this requirement is
vital to the basic purpose of the program. The data should be
managed in the computer in such a way as to allow a wide variety of
analyses. For example, it should be possible to retrieve data, not
only about individual facilities, but also aggregate data organized
by type of chemical, type of effect, geographic location, company
name, etc. as well as combinations of these parameters. . . .
Legislative History at 5186 (emphasis added).
Based on this Congressional guidance, EPA reached several
conclusions. First, ample ``verifiable, historical data'' exists to
support EPA's conclusions that PBT chemicals persist for long periods
of time in the environment and bioaccumulate in organisms, including
humans; that this persistence and bioaccumulation can result in higher
exposures to humans and the environment; and that to ``obtain a
substantial majority of the Nation's toxic chemical releases,'' lower
thresholds for PBT chemicals are warranted. For example, PCBs have been
found throughout the Great Lakes in sediments, water, and aquatic
organisms. Multimedia analyses indicate that the majority (80-90%) of
human exposure to chlorinated organic compounds, such as PCBs comes
from the food pathway, a lesser amount (5-10%) from air, and minute
amounts (less than 1%) from water. Most of the data available on human
exposure to PCBs in the Great Lakes come from the analyses of
contaminant levels in drinking water and sport fish. The consumption of
contaminated sport fish and wildlife can significantly increase human
exposure to the Great Lakes critical pollutants, such as PCBs. The
sport fish are exposed to PCBs by consumption of sediments and through
water (Ref. 76). See also Refs. 75 and 77.
Further, EPA strongly believes that increased reporting on PBT
chemicals will improve the usefulness of the data on these chemicals.
There are currently very few reports for some of the PBT chemicals,
such as mercury, mercury compounds and PCBs. The currently available
data provide a distorted picture of potential exposures to humans and
the environment, because at the current thresholds only a fraction of
the releases from facilities otherwise subject to EPCRA section 313 are
reported. This limited reporting results in a significant
underestimation of the releases from the industry sectors covered by
EPCRA section 313. As such, the current data are of limited use for
evaluating the potential exposures to humans and the environment of
toxic chemicals that persist and bioaccumulate. Expanding the picture
of releases, and therefore potential exposures, will increase the
utility of all the TRI data on these chemicals. See, e.g., Economic
Analysis, Chapter 6.4 (Ref. 67).
On these bases, EPA determined that revising the thresholds would
be an important first step in closing the information gap on PBT
chemicals. The Agency then began the process of determining the
appropriate levels at which to establish the revised thresholds. For a
number of technical and policy reasons, EPA chose an approach focused
on two classes of PBT chemicals: (1) Toxic chemicals that meet the
EPCRA section 313 persistence and bioaccumulation criteria discussed in
Unit VI.B., i.e., those toxic chemicals that have half-lifes of 2
months or greater in water/sediment or soil and that have
bioaccumulation or bioconcentration factors of 1,000 and (2) the subset
of PBT chemicals that are highly persistent and highly bioaccumulative,
i.e., those toxic chemicals that have half-lifes of 6 months or greater
in water/sediment or soil and that have bioaccumulation or
bioconcentration factors of 5,000 or greater.
First, for the most persistent and bioaccumulative toxic chemicals
any release will lead to elevated concentrations in the environment and
in organisms. EPA believes that such highly persistent and highly
bioaccumulative toxic chemicals are of international, as well as
national concern, because of the extent of their
[[Page 58689]]
persistence and bioaccumulation. As discussed elsewhere in this
preamble, these facts have been widely recognized; there are a number
of international agreements that ban, restrict, or phase out the
manufacture, use and/or release of highly persistent and highly
bioaccumulative toxic chemicals.
Similarly, toxic chemicals that are persistent and bioaccumulative
are of national, regional, and local concern. As discussed elsewhere in
this preamble, toxic chemicals that are persistent and bioaccumulative
present a significant concern to many local communities due to the
proximity of the communities to industrial sources. All other things
being equal, a pollutant reaches nearby populations in less time than
distant ones. Thus, toxic chemicals that persist and bioaccumulate can
pose significant exposures to communities and ecosystems that
immediately surround industrial sources as well as those communities
that are subject to regional transport.
Given the international support for the extreme limitations on the
use and release of toxic chemicals that are highly persistent and
highly bioaccumulative, and the significant exposures that persistent
and bioaccumulative toxic chemicals can pose to both local communities
and broader regions of the United States and North America, EPA
believes that it is appropriate to lower the reporting thresholds for
both (1) Persistent and bioaccumulative toxic chemicals and (2) for
highly persistent and highly bioaccumulative toxic chemicals. In
addition, EPA believes this information is important to the public,
government agencies, and researchers; for example, the information
reported by facilities under the lower thresholds will help these
groups assess the loading of the PBT chemicals in both local and
regional ecosystems, e.g., a small lake or river or a larger ecosystem
such as the Great Lakes or the Chesapeake Bay. See also, Economic
Analysis at Chapter 6, pages 32-50 for examples of other uses of TRI
data (Ref. 67).
Second, EPA considered how the revised thresholds would provide the
information on PBT chemicals needed to assist the public to obtain ``a
comprehensive view of toxic chemical exposure,'' as well as to assist
government agencies, researchers, and other persons to conduct research
and to establish appropriate regulations, guidelines and standards, in
accordance with the directives laid out in subsection (h). EPA
determined that providing greater information on two identifiable
classes of chemicals best achieved these ends. It is consistent with
the actions of a significant number of the groups that would use this
information; for example, as discussed in Unit VI.B., UNEP is in the
process of negotiating an international agreement on the class of
persistent organic pollutants with half-lifes of 6 months and BCF/BAF
values of 5,000. See also Economic Analysis at Chapter 6, pages 46-48
for examples of how TRI data will be used (Ref. 67). Moreover, EPA
determined that data on members within the same class are more easily
comparable; the members of the classes EPA established in this
rulemaking share a qualitatively comparable level of concern based on
their potential for increased exposure. The Agency believed that
creating two distinct classes of comparable chemicals would
significantly enhance the ability of researchers, government agencies,
and other similar persons, to use the reports. Establishing distinct
classes of comparable chemicals normalizes the subsequent years' data,
providing a baseline against which data users can ascertain trends over
time. Consequently researchers can more easily distinguish, and
therefore track, the releases and other waste management of highly PBT
chemicals, to evaluate the efficacy and progress of the policy
strategies intended to address the risks of PBT chemicals, such as the
Binational Great Lakes Water Quality Initiative. Finally,
administrative convenience argued for establishing a limited number of
alternate thresholds. As a practical matter, it would be burdensome for
both the Agency and the regulated community to track a variety of
individual thresholds for separate chemicals. In addition, because this
was only the Agency's initial rulemaking to lower thresholds for
certain PBT chemicals, EPA intended that the revised thresholds
establish a set of categories that would be generally applicable to
future designated PBT chemicals. All of these considerations led the
Agency to conclude that it should establish two sets of revised
thresholds based on two classes of PBT chemicals.
Thus, having concluded it was appropriate to focus the rulemaking
on two classes of chemicals, persistent and bioaccumulative toxic
chemicals and that subset of PBT chemicals that are highly persistent
and highly bioaccumulative, EPA began the process of determining the
specific thresholds that would achieve the purposes of subsections
(f)(2) and (h). The intrinsic properties of PBT chemicals argue for
very low thresholds. The subset of PBT chemicals that are highly
persistent and highly bioaccumulative warrant, in the absence of other
considerations, a threshold approaching zero. Any release of these
toxic chemicals is of global concern because they can persist for long
periods of time, can maintain their identity even after undergoing long
range transport, and can bioaccumulate to a significant degree. As
discussed above, and at length in Unit VI.B., the potential impacts
that can result from any release of toxic chemicals that are highly
persistent and highly bioaccumulative have been widely recognized.
There are a number of international agreements that ban, restrict, or
phase out the manufacture, use and/or release of the most persistent
and bioaccumulative toxic chemicals.
However, EPA believes that a zero threshold would be impractical.
Attempting to require facilities to determine if they manufacture,
process, or otherwise use any amount whatsoever of these chemicals
would be extremely burdensome and perhaps technically impossible.
Without an actual numerical threshold, many facilities might report
some amount of these chemicals in a misguided attempt to assure
compliance. This could lead to misleading and inaccurate data on the
actual sources of these chemicals. EPA believes that rather than
setting a zero reporting threshold it would be better to set a very low
threshold that provides facilities with a clear indicator of when they
are required to report. In general for purposes of EPCRA section 313, 1
pound is the practical equivalent of zero for these chemicals. EPA
explained these considerations in the proposed rule (64 FR 712) and has
received no information from commenters that convinces the Agency to
pursue a different approach.
EPA then considered the relative degree of persistence and
bioaccumulation between the two classes of chemicals. EPA wanted to
establish two sets of revised thresholds with the same approximate
relationship to each other, as the relative exposure potentials of PBT
chemicals to that subset of highly persistent and highly
bioaccumulative PBT chemicals. Simply stated, chemicals with half-lifes
of 6 months or greater and a BAF/BCF of 5,000 or greater have a higher
exposure potential than chemicals with half-lifes of 2 months or
greater and a BAF/BCF of 1,000 or greater. However, although, as
discussed below, EPA could establish a qualitative relationship, the
Agency could not reliably quantify the relative exposure potential
across the board for all of the members of both classes. Therefore, in
attempting to translate the qualitative exposure potential of PBT
[[Page 58690]]
chemicals to that subset of PBT chemicals that are highly persistent
and highly bioaccumulative into a qualitative threshold relationship,
EPA considered both the attributes of these chemicals and factors
specific to thresholds.
The manufacture, process, and otherwise use thresholds are not
equivalent to release thresholds although, in many cases, the quantity
manufactured or otherwise used will be very similar to the quantity
released. Thus, even if EPA were able to quantify the relative exposure
potential of PBT chemicals and that subset of PBT chemicals that are
highly persistent and highly bioaccumulative, based on their degrees of
persistence and bioaccumulation, and their interrelationship, the
Agency would not rely solely on this to select a quantitative threshold
relationship between these two classes of chemicals because: (1) The
manufacturing, processing, and otherwise use thresholds are not
equivalent to release thresholds, and (2) the quantity released, not
the quantity manufactured, processed or otherwise used, is a critical
factor in determining exposure.
Nonetheless, EPA believes that the relative reporting thresholds
should be based to some extent upon the qualitative differential
between the potential exposures that may result from releases of PBT
chemicals and that subset of PBT chemicals that are highly persistent
and highly bioaccumulative.
There is not a direct quantifiable relationship between the
potential exposures that can result from equivalent releases of a toxic
chemical that persists in the environment with a half-life of 6 months
and that has a bioaccumulation factor of 5,000 and releases of a toxic
chemical that persists in the environment with a half-life of 2 months
and that has a bioaccumulation factor of 1,000. The potential exposure
to humans and the environment will depend upon a number of factors,
including release patterns, environment variables such as soil type,
surface water chemistry, the types and distribution of flora and fauna,
and fish consumption patterns. However, EPA did consider the relative
differences in the potential exposures between these two classes. For
example, after 1 year, there will be more than 15 times as much of a
highly persistent chemical that remains in the environment than of a
persistent chemical, all other things being equal. Similarly, fish will
accumulate more than 5 times as much of the highly bioaccumulative
chemical than of the bioaccumulative chemical, all other things being
equal. While EPA believes that it can qualitatively describe the
relative relationship of highly persistent chemicals to persistent
chemicals and the relative relationship of highly bioaccumulative
chemicals to bioaccumulative chemicals, the Agency cannot at the
present time, define the relative relationship of persistence and
bioaccumulation between the two classes of chemicals. This is in large
part due to the many variables that must be considered in determining
the potential exposures both due to the interaction of these chemical
attributes and the large number of environmental factors that must be
considered when evaluating persistence and bioaccumulation together.
Although EPA could not develop an exact quantitative threshold
relationship between the two classes of chemicals, the Agency did
consider the factors discussed above and did rely to some extent on the
numerical relationships between the highly persistent and persistent
chemicals and the highly bioaccumulative and bioaccumulative chemicals.
Therefore, given that: (1) Highly bioaccumulative toxic chemicals will
accumulate approximately 5 times greater than bioaccumulative toxic
chemicals, (2) highly persistent toxic chemicals will remain in the
environment after 1 year, at a level about 15 times greater than
persistent toxic chemicals, (3) the fact that the EPCRA section 313
reporting thresholds are not release thresholds but that in some
instances the quantities manufactured or otherwise used will be very
similar to the quantity released, and (4) toxic chemicals that persist
in the environment with half-lifes of 2 months and bioaccumulation
factors of 1,000 or greater can be of both local and regional concern,
EPA believes that the threshold for PBT chemicals should be a factor of
10 greater than the threshold for that subset of PBT chemicals that are
highly persistent and highly bioaccumulative. EPA believes that this
ratio balances the uncertainties and factors, including numerical
factors, that the Agency considered. Therefore, based on the chemicals'
intrinsic characteristics, EPA would establish thresholds of 1 pound
for that subset of PBT chemicals that are highly persistent and highly
bioaccumulative and 10 pounds for PBT chemicals.
However, the legislative history of section 313(f)(2) indicates
that in establishing the original thresholds, Congress recognized the
burden imposed on the regulated community. Lowering thresholds
necessarily will increase that burden. Therefore, EPA determined it
would be reasonable to include some consideration of reporting burden
in selecting thresholds for PBT chemicals. But EPA accorded less weight
to burden than to the other considerations discussed above. First,
neither section 313(f)(2), section 313(h), nor any other provision of
EPCRA requires EPA to consider burden. Second, EPA was mindful of the
fact that in several places in the legislative history Congress made
clear it never intended impacts on reporting facilities to outweigh the
public's right-to-know about their potential exposures to toxic
chemicals. For example, although Representative Edgar recognized that
Congress had considered burden in establishing the statutory
thresholds, he did not include reporting burden as one of the general
principles that should guide the Agency's implementation of EPCRA
section 313 as a whole. Rather, he stated:
This is a new Federal initiative, and I recognize the desire of
some of my colleagues to move ahead cautiously to ensure that
burdens imposed on industry are not excessive. Frankly, my concern
rest with the families that live in the shadows of these chemical
and manufacturing plants. I have put myself in their shoes and have
fought for a program that looks after their needs. This legislation
gets us well on the path to the full disclosure they deserve.
Legislative History at 5316. See also, Legislative History at 5185-
86 (Senate debate on the Conference Report).
As noted in Unit VI.A, one of the major pieces of Congressional
guidance on the establishment of alternate thresholds was to obtain a
comprehensive picture of ``total nationwide releases of the toxic
chemical at all facilities covered by section 313.'' This language,
plus other Congressional directives on implementing section 313
generally, such as section 313(h), reflect an interest in obtaining
information from a broadly representative range of sources.
Consequently, EPA determined that the Agency should consider burden
only to the extent that it would not deny the public significant
information from a range of covered industry sectors.
Therefore, EPA estimated the number of reports that would be
submitted by each industry sector for four groups of thresholds, 1 and
10 pounds, 10 and 100 pounds, 100 and 1,000 pounds, and 1,000 pounds
for both classes of chemicals. These options were selected for the
following reasons. EPA needed a reasonable but finite number of options
to evaluate, and the options described above represent a reasonable
picture of the entire range of potential revised thresholds. Data
limitations on the manufacturing, processing, and otherwise use of PBT
chemicals in the numerous industries, processes, and uses covered by
EPCRA section 313
[[Page 58691]]
constrained EPA's ability to make meaningful and reliable distinctions
between threshold options that are less than an order of magnitude
apart. For example, while EPA believes it can reliably estimate the
difference in the number of reports from a 10 pound reporting threshold
and a 100 pound reporting threshold, EPA believes that the data are
insufficient to allow it to make a meaningful and reliable distinction
in estimates of options that are closer than an order of magnitude such
as 35 pounds and 50 pounds. EPA explained its data limitations in the
proposal, and commenters provided no information that would allow the
Agency to increase the resolution of its analysis. Consequently, for
the final rule, EPA analyzed options that were orders of magnitude
apart from the two thresholds identified through its technical review:
1 pound for highly persistent and highly bioaccumulative chemicals, and
10 pounds for persistent and bioaccumulative chemicals.
Based on information provided in the economic analysis for this
rulemaking, at the technical reporting thresholds EPA would obtain
information from a broad range of facilities (Ref. 67a). The analysis
showed that at a threshold of 1 pound, the public would obtain
information from all industry sectors that are currently subject to
EPCRA section 313, and that have been identified as manufacturing,
processing, or otherwise using those highly persistent highly
bioaccumulative toxic chemicals that are part of this rulemaking
(except dioxin and dioxin-like compounds which are discussed below). At
a threshold of 10 pounds, the public would obtain information from all
industry sectors that are currently subject to EPCRA section 313, and
that have been identified as manufacturing, processing, or otherwise
using those PBT chemicals that are part of this rulemaking. At the
technical reporting thresholds, the estimated costs of the additional
reports filed would have totaled $355 million in the first year, and
$193 million in subsequent years (Ref. 67). EPA considered these costs,
even though it cannot quantify the value of the information obtained or
lost at the various thresholds, and cannot quantify the relationship
between the reporting costs and the value of the information reported,
or lost, at a particular threshold.
At thresholds of 10 pounds for highly persistent and highly
bioaccumulative chemicals and 100 pounds for persistent and
bioaccumulative chemicals, EPA is still able to obtain a significant
amount of information on both classes of PBT chemicals from a wide
range of industry sectors and sources. For example, no reporting on
TBBPA would be lost from any sources or industry sectors at 100 pounds,
and some information on octachlorostyrene would be potentially lost
from only one industry sector, pesticide manufacturing facilities. At
these thresholds, EPA does, however, lose information significant to
local communities; for example, EPA loses considerable reporting on
mercury and mercury compounds at 10 pounds, but the loss of information
is localized in a limited number of industry sectors, and the public
will still obtain some reporting from all of the currently covered
industry sectors (Ref. 67a). For this threshold option, EPA estimated
the total burden at these thresholds to be $191 million for the first
year, and $105 million for subsequent years (Ref. 67).
At thresholds of 100 and 1,000 pounds and higher, EPA's analysis
indicated that the public, government agencies, and researchers would
lose information on many of the PBT chemicals from certain industry
sectors and sources. For example, at a threshold of 100 pounds for
toxic chemicals that are highly persistent and highly bioaccumulative,
the Agency would not obtain reporting on mercury and mercury compounds
generated in boilers in the manufacturing sector or information on
octachlorostyrene from the primary metal industries (Ref. 67a).
However, at these thresholds, EPA estimated the total first year costs
to be $99 million and $55 million in subsequent years (Ref. 67).
These analyses led EPA to several conclusions. First, thresholds of
10 pounds for highly persistent and highly bioaccumulative chemicals
and 100 pounds for persistent and bioaccumulative chemicals, achieve a
significant reduction in reporting burden. Second, at these thresholds
EPA obtains information from a broad distribution of industry sectors.
Although EPA also loses information significant to local communities at
these thresholds, it maintains the overall distribution of reporting
from a broad range of industry sectors nationally. EPA could have
attempted to compensate for the community-level loss of information on
individual members of the classes of PBT chemicals (i.e., by
establishing separate thresholds of 1 pound or 10 pounds for individual
chemicals), but only by failing to take reporting burden into account
for those individual chemicals. As explained previously, the
availability of the data limited EPA's ability to distinguish
meaningfully between thresholds separated by less than an order of
magnitude. In addition, establishing separate thresholds would
sacrifice many of the benefits of receiving information from comparable
facilities using comparable chemicals, discussed earlier in this unit.
Thus greater information for local communities would be achieved at the
expense of the increased utility of the reports for other purposes
established under EPCRA section 313(h)--e.g., assisting governmental
agencies, researchers, agencies and other persons in the conduct of
research and data gathering; and aiding in the development of
appropriate regulations, guidelines, and standards. EPA believes that,
to be consistent with the overriding policy directive in subsection
(h), it must achieve a balance between improving the utility of the
reports for all of the groups that rely on TRI data. Finally, as noted
earlier in this Unit, administrative convenience argues against the
establishment of individual thresholds. Among other issues, it would be
burdensome on both EPA and the regulated community to track a variety
of separate thresholds. Moreover, EPA intends the revised thresholds
established in this rulemaking for the two classes of PBT chemicals to
be generally applicable to future members of the two classes; absent a
strong technical or policy concern to the contrary, it would ultimately
be inconsistent with the purposes of EPCRA section 313 for chemicals
that share such common characteristics to have vastly different
thresholds.
Therefore, EPA believes its selection of thresholds of 100 pounds
for PBT chemicals and 10 pounds for that subset of PBT chemicals that
are highly persistent and highly bioaccumulative, balances the purposes
of EPCRA section 313 and the Agency's desire to provide a comprehensive
picture on releases and potential exposures of PBT chemicals, while
factoring in an appropriate degree of the consequent impact on the
regulated community.
Dioxin and dioxin-like compounds are highly persistent and highly
bioaccumulative toxic chemicals. As discussed above, toxic chemicals
that are highly persistent and highly bioaccumulative warrant, in the
absence of other considerations, a threshold approaching zero. But, for
the reasons discussed previously in this section, EPA does not believe
that a zero threshold would be practical. However, because the dioxin
and dioxin-like compounds are manufactured in extremely small amounts,
EPA needed to select a threshold lower than that for the other highly
persistent and highly
[[Page 58692]]
bioaccumulative chemicals in order to obtain any reporting.
In choosing reporting thresholds for these chemicals, the Agency
considered the extent of the information on dioxin and dioxin-like
compounds that would be made available to the public, government
agencies and researchers. EPA considered whether this level of
information would provide them with ``a comprehensive view of toxic
chemical exposure,'' given the attributes of dioxin and dioxin-like
compounds, and with ``broad-based national information.'' At a
threshold of 0.1 gram, the public would obtain information from all
industry sectors that are subject to EPCRA section 313 and that have
been identified in the Inventory of Sources of Dioxin in the United
States (Ref. 3). EPA does not believe that a higher threshold, i.e.,
1.0 grams, would provide the public with broad-based national
information because there would be no information on the manufacture
and release and other waste management of certain sectors. For example,
at a higher threshold, EPA anticipates that there would be no reporting
from hazardous waste incinerators, pulp mills, non high ferrous foundry
industries, and secondary lead smelters (Ref. 67a). At thresholds lower
than 0.1 gram, there is greater coverage within certain industry
sectors, with a concomitant significant increase in burden. EPA
believes its selection of a threshold of 0.1 gram for dioxin and
dioxin-like compounds balances the purposes of EPCRA section 313 and
the Agency's desire to provide a comprehensive picture on releases and
exposures of dioxin and dioxin-like compounds while factoring in an
appropriate degree of the resultant impact on the regulated community.
F. What Comments Did EPA Receive on Exposure and Risk Considerations
and What Are EPA's Responses?
One of the most significant issues raised by commenters relates to
the Agency's lack of consideration of quantitative risk in modifying
the section 313(f) reporting thresholds. Specifically, a number of
commenters believe that EPA should use quantitative risk as a criterion
in determining whether to lower the reporting thresholds and in
choosing a particular reporting threshold for each PBT chemical. The
commenters contend that EPA should conduct risk assessments and make a
formal determination that at a particular threshold releases of the PBT
chemical pose a risk before lowering the reporting threshold. While the
majority of commenters who commented on the issue believe that EPA
should make a risk determination before modifying the reporting
thresholds, the rationale for their conclusions varied. Some commenters
state that a risk determination is required by EPCRA because the intent
of EPCRA is to provide information to the public of potential risks
posed by the presence of toxic chemicals released to the environment in
their communities. Some commenters state that in addition to addressing
the substantial majority test, EPCRA section 313(f)(2) requires EPA to
use the degree of risk that releases will pose to communities as a
determinant in choosing new thresholds. Other commenters state that
consideration of risk is a required component of any action under EPCRA
section 313. In support of this position, one of the commenters cites
two D.C. Circuit Court decisions. Other commenters contend that it
would be good public policy to choose a threshold based on risks. Some
commenters contend that EPA should lower the reporting thresholds only
for those chemicals that present the highest risks to the public. One
commenter, however, believes that the Agency should not consider the
degree of risk in making a determination to lower the reporting
thresholds for PBT chemicals because the consideration of risk in past
actions taken by EPA under other environmental statutes have not
resulted in a decrease of human health or environmental risks due to
PBT chemicals. The commenter states that the increasing number of fish
advisories and the lingering and, in some cases, increasing levels of
PBT chemicals in the environment and in fish, wildlife, and human
tissue demonstrates the magnitude of the failure of the ``risk
management strategy.''
EPA disagrees with the commenters' assertion that evidence of risk
is required prior to lowering the threshold for any EPCRA section 313
chemical. Section 313(f)(2) addresses revisions to the reporting
thresholds. It does not require EPA to establish, prior to the lowering
of reporting thresholds, that releases at a particular threshold will
result in specific quantitative risks. That section expressly provides
that the Administrator may establish a threshold amount for a toxic
chemical different from the 25,000 pound threshold for manufacturing
and processing activities and the 10,000 pound threshold for otherwise
use activities. The only prerequisite for revising the reporting
threshold for a toxic chemical is that the revised threshold obtain
reporting on a substantial majority of total releases of the chemical
at all facilities subject to the requirements of EPCRA section 313. As
discussed in Units II.B. and VI.A., EPA believes that it has satisfied
the requirements of EPCRA section 313(f)(2) without the need for
quantitative support.
EPA believes that the commenters attribute a purpose to EPCRA that
is inconsistent with that clearly intended by Congress. Specifically,
Congress stated in EPCRA section 313(h) that:
The release forms required under this section are intended to
provide information to the Federal, State, and local governments and
the public, including citizens of communities surrounding covered
facilities. The release form shall be available,. . .to inform
persons about releases of toxic chemicals to the environment; to
assist government agencies, researchers, and other persons in the
conduct of research and data gathering; to aid in the development of
appropriate regulations, guidelines, and standards; and for other
similar purposes. 42 U.S.C. section 11023(h).
Neither EPCRA section 313(h) nor its legislative history directs EPA to
limit the collection of information on releases to those releases that,
from the Federal government's perspective, pose significant local human
and environmental exposure and human health and environmental risks.
See, e.g., Legislative History at 5186.
Federal and local perspectives on what may be an acceptable risk
are likely to be very different. The roles of local government and the
Federal government differ significantly in terms of ensuring
environmental quality. In passing EPCRA, Congress determined that it is
for the public to take the information reported on the use and releases
and other waste management of toxic chemicals, and to determine whether
these releases result in potential risks that the community determines
warrant further action given other factors, such as economic and
environmental conditions, or particularly vulnerable human or
ecological populations. Congress did not intend the Federal government
to consider these specific local factors prior to determining whether
certain information should be made public or prior to determining
whether a different threshold should be established for one or more
toxic chemicals.
The intent of EPCRA section 313 is to move the determination of
what risks are acceptable from EPA to the communities in which the
releases occur. This basic local empowerment is a cornerstone of the
right-to-know program. EPCRA section 313 establishes an information
collection and dissemination program. The burden it imposes is
significantly less than the
[[Page 58693]]
burden imposed by a statute which controls the manufacture, use, and/or
disposal of a chemical. EPCRA section 313 requires that a facility use
readily available data, or if such data are not available, reasonable
estimates to prepare each chemical-specific report. The statute does
not require that the facility conduct monitoring or emissions
measurements to determine these quantities. This is in contrast to
other environmental statutes that may require a facility to monitor
releases, change its manufacturing process, install a specific waste
treatment technology, or dispose of wastes in a certain manner. As
such, the Agency believes that as a matter of policy the standard that
must be met to require information pursuant to EPCRA section 313 is
less than that required to regulate a chemical under a statute such as
the Clean Air Act. See, e.g., Legislative History at 5186.
Further, contrary to assertions by some commenters, EPCRA section
313 does not require the collection of quantitative risk data nor does
the statute require that risk data be disseminated to the public.
Rather TRI data provide communities with information on releases and
other waste management quantities. TRI data cannot, in themselves,
provide information on quantitative risks to individual communities. A
determination of the potential risk that a chemical release may pose is
dependent upon a number of factors, including the toxicity of the
chemical, the physical chemical properties of the chemical, the
specific media to which the chemical is released, and site-specific
information that will determine the estimated exposures. While TRI data
are not in themselves measures of risk, they are an important input
that local communities can use along with the factors described in this
section to determine potential risks to themselves, their children,
their communities, and their environment that may result from releases
of toxic chemicals.
EPA's decision to lower the reporting threshold for PBT chemicals
is rationally related to the EPCRA section 313 goals of informing
communities, assisting research and data gathering, and aiding the
development of regulations and guidelines. Because PBT chemicals
persist in the environment for a significant period of time and
bioaccumulate in animal tissues, PBT chemicals have the potential to be
pervasive in the environment, in the food chain, and often in humans.
In short, for PBT chemicals, releases and other waste management
activities for relatively small amounts of PBT chemicals are of
concern. Accordingly, pursuant to the intended purposes of EPCRA, even
relatively small releases and other waste management activities for PBT
chemicals need to be reported in order to inform communities, assist
those engaged in research and data gathering, and to aid the
development of regulations and guidelines. Lowered reporting thresholds
for PBT chemicals are needed to obtain reporting on these relatively
small releases and other waste management activities for PBT chemicals.
Consequently, EPA believes that including consideration of the
quantitative risk in establishing the thresholds would be poor public
policy that would be inconsistent with the overall principles of EPCRA.
Finally, the reference by one of the commenters to two D.C. Circuit
Court decisions is misplaced. In support of its position that EPA must
undertake a risk assessment of any toxic chemical it is considering for
lower reporting thresholds, the commenter cites American Petroleum
Institute v. Costle, 665 F.2d 1176, 1187 (D.C. Cir. 1981), cert.
denied, 455 U.S. 1034 (1982), and Milwaukee Metropolitan Sewerage
District v. EPA, 40 F.3d 392 (D.C. Cir. 1994). Neither case cited by
the commenter addresses EPCRA. Nor do these cases establish a generally
applicable principle of law that risk assessments are required prior to
any government action. In Milwaukee Metropolitan Sewerage the court
reviewed standards adopted by EPA in a Clean Water Act regulation. In
American Petroleum Institute the court reviewed the primary and
secondary national ambient air quality standards for ozone promulgated
by EPA under the Clean Air Act. Both the Clean Air Act and the Clean
Water Act have no bearing on EPCRA section 313. Unlike the statutes at
issue in the cases cited by the commenter, consideration of risk is not
a requirement of section 313(f)(2) for modifying the reporting
thresholds for EPCRA section 313 listed chemicals, and, in fact, the
consideration of risk is generally not required for any rulemaking
under section 313. Troy Corporation v. EPA, 120 F.3d 277 (D.C. Cir.
1997).
Some commenters further state that in proposing to change EPCRA
section 313 reporting thresholds, EPA has not addressed any of the
factors the Agency mentioned when it originally promulgated EPCRA
section 313 regulations. In the February 16, 1988 final rule, EPA
stated:
EPA may consider a number of factors for threshold modification
including exposure factors such as population density, the distance
of population from covered facilities, and the types of releases.
Threshold modifications could also take into account the relative
potency of the chemical or class of chemicals and effects of
concern. (53 FR 4508).
In this statement, the commenters contend that EPA correctly mentions
factors that relate to risk (i.e., exposure and relative toxicity). The
current proposal to change reporting thresholds under EPCRA section 313
fails to address these factors.
As is clearly evident in the quote from the February 16, 1988 final
rule, EPA stated that these were things that it ``may consider'' or
that could be taken into account. These statements do not require that
the possible factors mentioned above be a basis for any change in the
reporting thresholds nor do they preclude the consideration of factors
such as the persistence and/or bioaccumulation of toxic chemicals in
modifying the reporting thresholds. This statement was not a commitment
that EPA would consider risk in any decision to modify reporting
thresholds. It merely provided examples of things that the Agency may
consider.
As explained in previous responses, EPA does not believe that it
would be good public policy to consider factors related to quantitative
risk with respect to establishing thresholds for PBT chemicals. Given
the degree of persistence and bioaccumulation that these toxic
chemicals exhibit, EPA believes that the value of this information to
the public outweighs the policy considerations presented in favor of
considering risk factors in establishing revised thresholds. Any other
decision would be inconsistent with the legislative intent underlying
EPCRA section 313.
Finally, EPA notes that this decision is consistent with the
approach adopted in modifying the thresholds to establish a 1 million
pound manufacture, process, or otherwise use threshold for facilities
that have 500 pounds or less of production-related waste (59 FR 61488,
November 30, 1994) (FRL-4920-5). Any decision to include risk
considerations in establishing modified thresholds under section
313(f)(2) would compel the Agency to re-examine the thresholds
established for facilities with less than 500 pounds of production-
related waste.
Several commenters contend that a chemical's degree of persistence
and bioaccumulation are unrelated to the chemical's exposure potential.
They disagree that persistence and bioaccumulation are necessarily
indicators of exposure or exposure potential. As an example, the
commenter states that many of the compounds EPA is targeting are highly
lipophilic, non-water soluble
[[Page 58694]]
compounds, and the greatest potential for bioaccumulative effects is
through uptake from the water column. EPA should evaluate how these
compounds partition in the environment. Those that are not bioavailable
have limited exposure potential, and therefore limited risk. Thus, the
commenter believes that EPA must consider exposure in conjunction with
persistence and bioaccumulation.
EPA disagrees with the commenters. All other things being equal,
the chemical with a higher degree of persistence and bioaccumulation
will have a greater exposure potential than the chemical with a lower
degree of persistence and bioaccumulation. For example, all other
things being equal, a chemical that has a half-life in water of 4
months will have a higher exposure potential to aquatic organisms than
a chemical with a half-life in water of 1 month. Fifty percent of the
first chemical will remain in the water after 4 months while only 12.5%
of the second chemical will remain in the water after 4 months. After 4
months, aquatic organisms will be exposed to 4 times more of the first
chemical than the second chemical. Clearly the chemical with the
greater persistence has the higher exposure potential.
EPA does not believe that the commenter's example supports their
contention that persistence and bioaccumulation are unrelated to
exposure potential. As EPA understands the commenter's example,
chemicals that have the greatest bioaccumulation potential will not be
bioavailable in water because they are highly lipophilic and non-water
soluble. Thus, because they are not bioavailable in water, they cannot
bioaccumulate in aquatic organisms. A well-studied example that clearly
contradicts the commenter's claim is the bioaccumulation of
polychorinated biphenyls (PCBs) in the Great Lakes. PCBs have BAFs as
high as 141,000,000 (Table 1, at 64 FR 707-8) and very, very low water
solubility. PCBs have been found throughout the Great Lakes in
sediments, water, and aquatic organisms. Multimedia analyses indicate
that the majority (80-90%) of human exposure to chlorinated organic
compounds, such as PCBs comes from the food pathway, a lesser amount
(5-10%) from air, and minute amounts (less than 1%) from water. Most of
the data available on human exposure to toxic substances in the Great
Lakes come from the analyses of contaminant levels in drinking water
and sport fish. The consumption of contaminated sport fish and wildlife
can significantly increase human exposure to the Great Lakes critical
pollutants. The sport fish are exposed to PCBs by consumption of
sediments and in water, from which they bioaccumulate the PCBs (Ref.
62).
Some commenters contend that EPCRA requires that EPA consider the
risks that a chemical may pose when making determinations to add a
chemical to the EPCRA section 313 list of toxic chemicals. In support
of this position, one commenter cites two D.C. Circuit Court decisions.
As discussed in detail in the final rule adding 286 chemicals to
EPCRA section 313 (59 FR 61432), EPA disagrees with commenters that the
Agency must include a risk assessment component to EPCRA section 313
determinations. While the Agency believes that there are limited
circumstances where it may be appropriate to consider risk in making
listing determinations, e.g., acute human health effects, EPA does not
believe that the intent of EPCRA, the EPCRA section 313 toxicity
criteria, or the legislative history support the contention that risk
assessment is a required component of all EPCRA section 313 listing
determinations.
The EPCRA section 313 toxicity criteria require that exposure and
risk factors be considered only when determining if the toxic chemical
should be listed on EPCRA section 313 based on its acute human health
effects, but even then in only a very limited manner. The statute
mandates that EPA consider whether ``a chemical is known to cause or
can reasonably be anticipated to cause significant adverse acute human
health effects at concentration levels that are reasonably likely to
exist beyond facility site boundaries.'' EPA has, and will continue to
look at exposures reasonably likely to exist beyond facility site
boundaries when making a listing determination pursuant to EPCRA
section 313(d)(2)(A). However, EPA notes that none of the toxic
chemicals added in today's action were added pursuant to paragraph (A)
of that section.
The statute is silent on the issue of exposure considerations for
the section 313(d)(2)(B) and (C) criteria. The language of section 313
does not prohibit EPA from considering exposure factors when making a
finding under either section 313(d)(2)(B) or section 313(d)(2)(C).
However, the language of sections 313(d)(2)(B) and (C) does not require
the type of exposure assessment and/or risk assessment argued by the
commenters. EPA believes that it has the discretion under both section
313(d)(2)(B) and section 313(d)(2)(C) to consider, where appropriate,
those exposure factors that may call into question the validity of
listing of any specific chemical on EPCRA section 313.
EPA believes that its position regarding the limited use of risk in
listing decisions is consistent with the purpose and legislative
history of EPCRA section 313, as illustrated in the following passage
from the Conference report:
The Administrator, in determining to list a chemical under any
of the above criteria, may, but is not required to, conduct new
studies or risk assessments or perform site-specific analyses to
establish actual ambient concentrations or to document adverse
effects at any particular location. (H. Rep. 99-962, 99th Cong., 2nd
Sess., p. 295 (October 3, 1986)). See also Legislative History at
5186.
This passage indicates that Congress did not intend to require EPA to
conduct new studies, such as exposure studies, or to perform risk
assessments. Therefore, Congress did not consider these activities to
be mandatory components of all section 313 decisions. EPA believes that
this statement combined with the plain language of the statutory
criteria clearly indicate that Congress intended that the decision of
whether and how to consider exposure under EPCRA section 313(d)(2)(B)
and (C) should be left to the Agency's discretion. EPA has carefully
considered when and how to use exposure to fully implement the right-
to-know provisions of EPCRA. The Agency believes that exposure should
be considered only in very limited circumstances when adding a chemical
to EPCRA section 313(d)(2)(B) or (C). The Agency's interpretation of
the section 313(d)(2) and (d)(3) criteria for modifying the section 313
list of toxic chemicals is discussed in the final rule adding 286
chemicals to EPCRA section 313 (at 59 FR 61440-2). And in fact, EPA's
interpretation was upheld by the D.C. Circuit in Troy v. EPA, 120 F.3d
277. The addition of chemicals pursuant to EPCRA section 313(d)(2)(B)
and (C) in today's rulemaking is consistent with this interpretation.
The intent of EPCRA section 313 is to move the determination of
which risks are acceptable from EPA to the communities in which the
releases occur. This basic, local empowerment is a cornerstone of the
right-to-know program. EPCRA section 313 establishes an information
collection and dissemination program. It provides the public with
information that can be used with other site-specific factors to
determine if releases into their communities result in risks that the
community determines warrant further action given other factors, such
as economic and environmental
[[Page 58695]]
conditions, or particularly vulnerable human or ecological populations.
In addition, the reference by one of the commenters to two D.C.
Circuit Court decisions is misplaced. In support of its position that
EPA must undertake a risk assessment of any toxic chemical it is
considering to add to EPCRA section 313, the commenter cites American
Petroleum Institute v. Costle, 665 F.2d 1176, 1187 (D.C. Cir, 1981),
cert. denied, 455 U.S. 1034 (1982), and Milwaukee Metropolitan Sewerage
District v. EPA, 40 F.3d 392 (D.C. Cir. 1994). As discussed in a
previous response in this unit, neither case cited by the commenter
addresses EPCRA. In addition, since both cases were decided prior to
Troy, by the same court, that decided the specific issue raised by the
commenter, nothing in the two earlier cases cited by the commenter can
overrule that decision.
G. Which Chemicals is EPA Adding to the List of EPCRA Section 313 Toxic
Chemicals?
EPA is adding the following chemicals to the EPCRA section 313 list
of toxic chemicals: dioxin and dioxin-like compounds,
benzo(g,h,i)perylene, benzo(j,k)fluorene (fluoranthene), 3-
methylcholanthrene, octachlorostyrene, pentachlorobenzene,
tetrabromobisphenol A, vanadium (except alloys) and vanadium compounds.
EPA conducted a hazard assessment on each chemical being added to the
EPCRA section 313 list of toxic chemicals today. This assessment was
separate and independent from the review conducted to determine each
chemical's persistence and bioaccumulation potential, although EPA
considered some of the same data in certain of its hazard assessments.
EPA finds that each chemical being added today meets the criteria for
chronic human toxicity and/or environmental toxicity, as set forth at
EPCRA sections 313(d)(2)(B) and (C). A summary discussion of the basis
for listing each of these chemicals as well as other related issue are
presented in the remainder of this unit. A more extensive discussion of
these issues is included in the Response to Comments document (Ref. 69)
and supporting documents.
1. Dioxin and dioxin-like compounds category. There were a number
of comments received on the addition of the dioxin and dioxin-like
compounds category and these are addressed in detail in the Response to
Comments document (Ref. 69). Most of the comments on the toxicity data
that EPA presented in support of the addition of the category concern
the dioxin-like compounds since most commenters seemed to agree that
2,3,7,8-tetrachlorodibenzo-p-dioxin (dioxin or 2,3,7,8-TCDD) meets the
criteria for listing under EPCRA section 313(d)(2)(B). A number of
commenters did not believe that there was sufficient information to add
any of the dioxin-like compounds while several commenters argue that
the data on the octa- and heptachlorodibenzo-p-dioxins in particular
were not sufficient. Commenters also argue that reliance on established
toxicity equivalence factors (TEFs) does not provide sufficient support
for determining that the dioxin-like compounds meet the EPCRA section
313(d)(2)(B) criteria.
EPA disagrees with the commenters that contend that there are not
sufficient data to add the dioxin-like compounds pursuant to EPCRA
section 313(d)(2)(B). 2,3,7,8-TCDD is generally recognized as one of
the most studied toxic compounds found in the environment. To require
the degree of documentation supporting toxicological classification of
2,3,7,8 -TCDD as a necessary criterion for determining that other
dioxin-like compounds exhibit dioxin-like toxicity or for listing under
EPCRA section 313 is an arbitrary and unrealistic criteria. As
discussed in more detail in the Response to Comments document (Ref.
69), a more scientifically supportable set of criteria for determining
if compounds exhibit dioxin-like toxicity was proposed by the World
Health Organization European Centre for Environmental Health (WHO-ECEH)
and the International Programme on Chemical Safety (IPCS) consultation
group. These criteria include: (1) A compound must show a structural
relationship to TCDD; (2) a compound must bind to the Ah receptor; (3)
a compound must elicit Ah receptor-mediated biochemical and toxic
responses; and (4) a compound must be persistent and accumulate in the
food chain. Each of the 2,3,7,8 substitute dioxins and furans included
in the dioxin TEQ approach meet these criteria (Ref. 3).
The commenters often quoted from the EPA Science Advisory Board
(SAB) review of EPA's draft dioxin reassessment, to help support the
claim that dioxin-like compounds other than 2,3,7,8-TCDD should not be
included in the toxic release inventory. The SAB report is a complex
document containing a number of contrasting observations. Care must be
taken to accurately capture the SAB's concerns. For example, in their
Executive Summary, the SAB concluded that, ``The use of the TEFs as a
basis for developing an overall index of public health risk is clearly
justified''; they caution, however, ``that practical application
depends on the reliability of the TEFs and the availability of
representative and reliable data.'' In their summary conclusions, the
SAB stated:
The document (EPA Draft Reassessment) represents a departure
from the earlier EPA risk assessment for dioxin, which dealt
primarily with 2,3,7,8-TCDD. In addressing a broad range of dioxin-
like compounds having the common property of binding to the Ah
receptor and producing related responses in cells and whole animals,
it creates opportunities for a holistic assessment of the cumulative
impacts of these broadly distributed anthropogenic pollutants. Thus,
while the environmental concentrations of each compound alone may be
too low to produce effects of concern, the combined exposure may be
producing effects that warrant concern. The use of the concept of
TEFs and the concentrations of the compounds in foods and
environmental media to produce an overall index of public health
risk is clearly justifiable.
The character and thrust of these statements made by the SAB are
significantly different from those selectively chosen by many of the
commenters opposing the addition of some or all of the dioxin-like
compounds. The apparent contradiction between these broad concluding
statements by the SAB and those cited by several commenters is due, in
part, to commenters confusing the SAB criticisms of the text of the
draft reassessment with statements about the general state of
scientific knowledge. The SAB clearly felt that EPA needed to do a more
rigorous job of discriminating between the inferences it drew about the
toxicity of 2,3,7,8-TCDD, other 2,3,7,8 substitute dioxins and furans,
and dioxin-like PCBs. Many of the comments cited were intended to help
EPA generate a more rigorous scientific discussion in its final
reassessment document rather than to represent substantive conclusions
reached by the SAB on the nature of dioxin toxicology. Fully taking
these concerns into consideration it was still the SAB's overall
judgment, as stated above, that ``the use of the TEFs as a basis for
developing an overall index of public health risk is clearly
justified.''
Some commenters argue that there are qualitative differences in the
toxicity of the different 2,3,7,8-substituted isomers of
polychlorinated dioxins (PCDDs) and furans (PCDFs). Specifically, there
are structural differences between the more toxic, lower chlorinated
isomeric PCDDs and PCDFs and the higher chlorinated cogeners to the
extent that the octa- and hepta-PCDDs and PCDFs should not be added to
the list of EPCRA section 313
[[Page 58696]]
toxic chemicals. These arguments are not valid for several reasons.
First, there are data from subchronic studies for both octa- and hepta-
PCDDS and PCDFs which demonstrate dioxin-like effects (Refs. 19, 21,
79, and 80). The new WHO TEFs are based on these subchronic studies
(Ref. 78). While short-term studies indicate limited dioxin-like
effects of these chemicals, these contrasting results are readily
explained by the structural differences between the octa- and hepta-
PCDDS and PCDFs compared to the lower chlorinated PCDDs and PCDFs. The
relative potency of the dioxin-like compounds is related to both their
ability to bind to the Ah receptor and their pharmacokinetic properties
(Ref. 20). The water solubility of PCDDs and PCDFs decrease with
increasing chlorine substitution. Hence the octa- and hepta-PCDDS and
PCDFs are significantly less soluble in aqueous solutions compared to
the lower chlorinated PCDDs and PCDFs. These solubility problems limit
the amount of chemical that can be absorbed in high dose acute toxicity
studies. The lack of effect observed in the high dose acute studies is
consistent with the limited aqueous solubility of these compounds.
However, low dose subchronic studies allow the chemicals to be better
absorbed and bioaccumulate to concentrations which produce biochemical
and toxic effects (Refs. 19, 21, 79, and 80). Once again this is
consistent with the evidence of dioxin-like effects of these chemicals
observed in the low-dose subchronic studies. Although not legally
required to determine that a chemical meets the listing criteria under
EPCRA section 313(d)(2)(B), it should be noted that human exposure to
octa- and hepta-PCDDs and PCDFs are subchronic low dose exposures,
similar to the experimental studies which demonstrate dioxin-like
effects of these chemicals (Refs. 19, 21, 79, and 80).
While there are structural differences between the octa- and hepta-
PCDDs and PCDFs compared to the lower chlorinated PCDDs and PCDFs,
these differences result in quantitative not qualitative differences in
the toxicity of these chemicals. The quantitative differences are
demonstrated by the lower potency of the octa- and hepta-congeners
compared to TCDD. In addition, the TEFs reflect these quantitative
differences by assigning lower TEF values to the octa- and hepta-PCDDS
and PCDFs. While there is limited evidence that the shape of the dose-
response curve for induction of CYP1A1 activity in vitro for
octachlorodibenzo-p-dioxin (OCDD) is different from TCDD, in vivo
evidence indicates that the dose response for CYP1A1 induction by
octachlorodibenzofuran (OCDF) in three tissues is equivalent to TCDD
(Ref. 20). However, it should be noted that these are quantitative not
qualitative differences.
Commenters also argue that octa- and hepta-PCDDs and PCDFs should
not be listed because ``there is a growing consensus in the scientific
community that the potential risks posed by dioxins are largely driven
by a limited number of dioxin and dioxin-like compounds (tetra-, penta-
, and hexa-PCDDs and PCDFs and certain coplanar PCBs).'' It is
important to remember that, as discussed in Unit VI.F., EPCRA section
313 is primarily a hazard-based rather than a risk-based statute. The
``growing consensus'' on dioxin toxicity is probably best captured by
the revised TEFs recently established by the WHO (Ref. 78). In this
review the scientific evidence for ascribing values of relative
toxicity to octa- and hepta-PCDDs and PCDFs was specifically reviewed,
as evidenced by the lowering of the TEF for OCDD and OCDF by a factor
of 10. In the course of the deliberations by the WHO panel of
internationally distinguished scientists, there was the opportunity to
remove both octa- and hepta-PCDDs and PCDFs from the TEF listings.
However, the WHO panel concluded that the best scientific
interpretation of the data available was to leave hepta-PCDDs and PCDFs
unchanged and reduce but not eliminate OCDD from TEQ calculations. Even
with this reduced toxicity, OCDD and OCDF clearly meet the listing
criteria of EPCRA section 313(d)(2)(B).
EPA disagrees with the commenters that contend that TEFs are not
adequate support for listing chemicals under EPCRA section 313. The
development of TEFs has been a rigorous scientific effort involving a
number of international panels of scientific experts and has involved
the careful review of all relevant scientific literature. EPA believes
that the development and review processes used for the generation of
the TEFs was sound and represents a reasoned and reliable judgment on
the dioxin toxicity of each of the 17 dioxin and dioxin-like compounds.
The Response to Comments document (Ref. 69) includes an extensive
discussion of the history of the development of dioxin TEFs which
demonstrates why EPA believes that the TEFs are well supported
scientifically and consequently have been openly adopted by the
international scientific and regulatory community. In addition, as EPA
has previously explained (59 FR 61432), the Agency believes that EPCRA
section 313 allows a chemical category to be added to the list, where
EPA identifies the toxic effects of concern for at least one member of
the category and then shows why those effects can reasonably be
expected to be caused by all other members of the category. Here,
individual toxicity data are not available for all members of the
category; however, there is sufficient information to conclude based on
generally accepted scientific principles, that all of these chemicals
are highly toxic based on structural and physical/chemical property
similarities to those members of the category for which data are
available.
Thus, EPA reaffirms that there is sufficient evidence for adding
dioxin and dioxin-like compounds on EPCRA section 313 pursuant to EPCRA
section 313(d)(2)(B) based on the available cancer and other serious
chronic health effects data for these compounds. Therefore, EPA is
finalizing the listing of dioxin and dioxin-like compounds on the EPCRA
section 313 list.
a. Manufacturing only qualifier for dioxins and dioxin-like
compound category. Comments were mixed with regard to EPA's proposal to
add a manufacture only qualifier to the dioxin and dioxin-like
compounds category. Some commenters agree with EPA's statements in the
proposed rule concerning the burden reduction aspects of the qualifier
and the fact that as a result, the dioxin reporting would focus on
facilities that manufacture dioxin and dioxin-like compounds rather
than those that process or otherwise use raw materials containing
dioxin and dioxin-like compounds that have accumulated in those raw
materials. Some commenters state that the qualifier would avoid
duplicative testing and administrative costs among many processing and
using industries which do not necessarily discharge dioxins or furans
into the environment. Some commenters state that all releases of dioxin
and dioxin-like compounds must be reported, not just those resulting
from the manufacture of these chemicals. Other commenters note that a
significant gap is created by the manufacture only qualifier because it
would exclude the processing and otherwise use of chemicals than
contain dioxin and dioxin-like compounds as a result of the processes
used to manufacture them. Commenters specifically cite
pentachlorophenol as an example of a chemical that is contaminated with
dioxin and dioxin-like compounds from its manufacturing process.
Commenters state that the processing and use of such chemicals
[[Page 58697]]
result in the release of dioxin and dioxin-like compounds that would go
unreported under the manufacture only qualifier. One commenter states
that if the qualifier is finalized the commenter would like to see
language that requires facilities to report if the background levels of
dioxin are modified, concentrated, or somehow added to in the
manufacturing process. Another commenter states that if the Agency
wants to exempt animal sources of dioxin, such as dioxin contained in
meat and other animal products, it should craft the rule to do so and
not cut out other significant sources of dioxin in the environment by
exempting all facilities that process material containing dioxin.
EPA believes that in order to obtain any reporting on dioxin and
dioxin-like compounds a very low threshold is required, which is
several orders of magnitude lower than the thresholds for other PBT
chemicals. At such a low reporting threshold it is estimated that
thousands of reports could potentially be filed by facilities, mainly
food processing facilities, due to the amount of dioxins in the raw
materials they process. The dioxins found in the meat and dairy
products that food processors handle have been previously released,
circulated in the environment, and bioaccumulated in animals; thus
these are not additional loadings to the environment but loadings that
have already occurred and cycled through the environment due to the
persistence and bioaccumulative properties of these compounds. The
unique combination of very low thresholds, the number of food
processors that would be required to file, and the fact that they would
be filing because of the bioaccumulation of previously released
material, led EPA to add the manufacture only qualifier to the dioxins
category. The qualifier was added in response to the unique set of
conditions that apply to the reporting of dioxin and dioxin-like
compounds. The manufacture only qualifier was added to reduce reporting
burden on facilities, mainly in the food processing industry, that
results from the unique combination of circumstances related to the
reporting for these chemicals and to focus on those activities that add
to the loading of dioxins in the environment rather than on activities
dealing with previously released and bioaccumulated chemicals.
However, EPA acknowledges that the commenters who noted that the
processing and otherwise use of chemicals contaminated with dioxin and
dioxin-like compounds as a result of their manufacturing process, are
correct that these would be newly created and thus any releases of
dioxin and dioxin-like compounds that are due to the processing and
otherwise use of such chemicals would be new loadings on the
environment. In addition, EPA agrees, and has never stated otherwise,
that the processing or use of chemicals contaminated with dioxin and
dioxin-like compounds could result in the release of these chemicals to
the environment. Given the fact that the manufacture of certain
chemicals also results in the manufacture of dioxin and dioxin-like
compounds that remain with those chemicals as impurities, EPA believes
that releases and other waste management quantities for the dioxin and
dioxin-like compounds found as impurities with those chemicals should
be reported under the dioxin and dioxin-like compounds category. Thus,
EPA's original proposal would have created an exemption that was too
broad. Consequently, EPA is modifying the qualifier to read as follows:
Dioxin and dioxin-like compounds (Manufacturing; and the
processing or otherwise use of dioxin and dioxin-like compounds if
the dioxin and dioxin-like compounds are present as contaminants in
a chemical and if they were created during the manufacturing of that
chemical)
EPA believes that narrowing its proposal in this fashion is consistent
with EPA's intention to focus on new loadings to the environment for
dioxin and dioxin-like compounds.
One commenter states that the activity qualifier for dioxin and
dioxin-like compounds is intended to minimize the burden of reporting
on naturally-occurring constituents of raw materials and that this
qualifier would be consistent with the PBT criteria set forth by
Canada's Department of the Environment in their Toxic Substances
Management Policy. The commenter states that the Canadian policy
requires a chemical to be ``predominantly anthropogenic'' to be
considered a PBT chemical. The commenter states that EPA's assumption
that these compounds are ubiquitous in raw materials may be incorrect.
The commenter further states that these compounds may be formed in
combustion processes due to the ubiquitous presence of precursor
chemicals in coal, such as natural hydrocarbons and chlorine. The
commenter argues that it is not reasonable to expect the hydrocarbon
nor the chlorine to be removed from the raw material prior to
combustion. Thus, the ``incidental manufacture'' of extremely minute
amounts of these chemicals may be unavoidable.
EPA disagrees that the sole basis for its qualifier was to minimize
the burden of reporting. The qualifier was added in response to the
unique set of conditions that apply to the reporting of dioxin and
dioxin-like compounds. As noted above, EPA was, and remains, concerned
that, because dioxin is ubiquitous in the environment, the reporting be
focused on those facilities that actually add to the environmental
loading of these chemicals. EPA did not state that dioxin and dioxin-
like compounds would be ubiquitous in all raw material and did not
intend to imply that all raw materials contain these compounds. EPA
stated that these compounds are ubiquitous in the environment and,
thus, facilities that process raw materials containing these compounds
might have to report because of the very low reporting threshold
necessary to obtain reports from any sources, including those
facilities that coincidentally manufacture them. In addition, although
the qualifier may be consistent with Canada's Toxic Substances
Management Policy, EPA has not proposed any requirement that a chemical
must be ``predominantly anthropogenic'' to be considered a PBT chemical
under EPCRA section 313. The commenter is correct that dioxin and
dioxin-like compounds may be manufactured in combustion processes due
to the ``ubiquitous presence of precursor chemicals'' and that such
``incidental manufacture'' may be unavoidable. However, the mere
presence of the dioxin precursors will not guarantee dioxin production.
There are well documented conditions that favor the formation of
dioxins during combustion, and in some cases it may be possible to
stringently control fuel composition, flow times, temperature, and
other conditions in order to substantially reduce or even eliminate the
incidental manufacture of dioxins during combustion processes.
b. Withdrawal of the proposal to include dioxin-like PCBs in the
dioxin category. Several commenters support EPA's decision to withdraw
the proposal to modify the current PCB listing and move the 11 co-
planar PCBs to the proposed dioxin and dioxin-like compounds category
and retain the co-planar PCBs as part of the current PCB listing. Two
commenters support EPA's decision to leave co-planar PCBs out of the
dioxin and dioxin-like compounds category since the structure,
metabolism, gene regulation, and toxicities of PCBs are substantially
different from those of 2,3,7,8-tetrachlorodibenzo-p-dioxin. One
commenter takes exception to the use of the term ``dioxin-like'' as a
way of describing PCBs and other chlorinated
[[Page 58698]]
compounds and agrees that the PCBs should be kept out of the ``dioxin-
like'' class. Other commenters also argue that PCBs are more
appropriately classified as PCBs, not dioxin-like compounds.
One commenter contends that since these chemicals are no longer
allowed to be distributed in commerce, maintaining a separate EPCRA
section 313 chemical category for these chemicals will streamline data
management. This approach will also enable EPCRA section 313 reporting
for this category of chemicals to be more consistent with existing data
already collected for the purposes of complying with TSCA. Further the
commenter asserts that approach is also consistent with EPA's
Reinvention Policy and will enable ``one-stop'' reporting.
Another commenter asserts that it is unclear just how many grams of
dioxin-like compounds would be excluded from this reporting since there
are conflicting Agency proposals at work: the first is a much lower
threshold for dioxins. The second includes only dioxins manufactured on
site. Since PCBs are not generally manufactured on site, these 11
dioxin-like compounds would not be reported under the proposal if they
were included as dioxins. On the other hand, if all dioxins
(manufactured, processed, and otherwise used) are included in the EPCRA
section 313 threshold determination, these 11 PCBs could make the
difference between a facility's reporting or not reporting dioxins. If
the dioxin threshold remains as proposed, then the 11 PCBs should
remain with the PCB category. Further the commenter argues that if the
threshold is expanded to include sources other than those that
manufacture dioxin on-site, then the PCBs should be part of the dioxin-
like compounds category. If EPA does not modify the dioxin threshold to
include all dioxin uses, the 11 dioxin-like PCBs should remain with the
PCB category.
While EPA agrees with the commenters that the co-planar PCBs should
remain as part of the current PCB listing, the Agency does not agree
with all of the reasons the commenters have presented. As EPA stated in
the proposed rule:
. . .EPA has determined that all PCBs persist and bioaccumulate.
Since PCBs persist and bioaccumulate, EPA believes that they should
be subject to lower reporting thresholds, and thus there is no need
to move the 11 co-planar PCBs to the proposed dioxin and dioxin-like
compounds category. Therefore, EPA has decided to withdraw its
proposal to modify the current listing for PCBs and instead proposes
to lower the reporting thresholds for the current PCB listing which
covers all PCBs. EPA believes that, since all PCBs persist and
bioaccumulate, it is appropriate to lower the reporting threshold
for this class of chemicals and that this proposal is less
burdensome than requiring separate reporting on the dioxin-like PCBs
as part of the proposed dioxin and dioxin-like compounds category
(at 64 FR 710).
EPA did not base its decision on a determination that co-planar PCBs
were not ``dioxin-like'' and keeping them under the current PCB listing
should not be interpreted as such a determination. Also, since EPA is
not expanding the qualifier for the dioxin and dioxin-like compounds
category to include all processing and otherwise use activities, the
amounts of co-planar PCBs that might be reportable under the category
would not be expected to contribute significantly to threshold
determinations for the category at most facilities.
Four commenters specifically do not support EPA's decision to
withdraw the proposal to modify the current PCB listing. Commenters
assert that the aggregation of dioxin-like PCBs together with other
PCBs will fail to provide reporting of useful information on dioxin-
like PCBs. The commenters either contend that the PCBs should be
included in the dioxin-like compounds category or the PCBs and all
dioxin-like compounds should be reported separately. One commenter
argues that the aggregate reporting of dioxin-like PCBs and other PCBs
fails to provide any information on the release of dioxin-like PCBs to
meet the research, regulatory, or public information goals of EPA's
proposal. This commenter raises several points. The commenter contends
that specifically, even if some facilities releasing dioxin-like PCBs
reported these releases as a portion of their total PCBs production of
10 pounds annually or greater, information on dioxin-like PCBs releases
would still be unobtainable. The commenter asserts that aside from the
food chain, where some dioxin-like PCBs tend to concentrate
disproportionately, available measurements indicate that these dioxin
compounds are only a small portion of the mass of all PCB compounds.
The commenter further argues that some of these dioxin compounds such
as PCB-126 are far more toxic than other dioxin-like and non dioxin-
like PCBs. Thus, the commenter asserts that in addition to all of the
problems of dioxin-like chemical aggregate reporting, one would not
know what, if any, portion of the total PCBs reported were dioxin-like.
The commenter contends that the dioxin-like co-planar PCBs also should
be reported individually so that a TEQ for all 28 dioxin and dioxin-
like compounds can be calculated. Another commenter argues that based
on information about current body burdens of co-planar PCBs, they
compose as much or an even greater percentage of one's overall exposure
than the 17 dioxin and dioxin-like compounds. This commenter cites an
EPA document that stated that: ``[e]stimates of exposure to dioxin-like
CDDs and CDFs based on dietary intake are in the range of 1-3 pg TEQ/
kg/day. Estimates based on the contribution of dioxin-like PCBs to
toxicity equivalents raise the total to 3-6 pg TEQ/kg/day.'' Some
commenters contend that reporting the co-planar PCBs differently from
the 17 dioxin and dioxin-like compounds would make any assessment of
the overall release and potential health impact of these types of
compounds difficult. One commenter argues that PCBs are currently
contaminating sediments and industrial sites nationally and have ruined
fish as a natural resource for human consumption across the nation and
that the distinction between dioxin-like PCBs and dioxin-like compounds
made under this rule is a distinction without a difference. This
commenter urges EPA to include all dioxin-like compounds, including
PCBs, in the dioxin-like compounds category and to require strict
accounting from all sources which release these compounds and which
manufacture them, incidentally or by design.
One commenter contends that the failure to report dioxin-like PCBs
as a distinct entity separate from other PBT chemicals may hold back
information on a significant portion of the total dioxin-like hazard
from releases by facilities that report under EPCRA section 313, even
if all dioxin and furan releases were reported. The commenter argues
that environmental exposure measurements, such as those from fish in
San Francisco Bay and from human tissues nationally, indicate that
dioxin-like PCBs contribute a very significant portion of the total
toxicity hazard from exposure to all dioxin-like chemicals. The
commenter also asserts that PCB releases might in some cases represent
an inadequately measured yet significant portion of the ongoing dioxin
release hazard. If, for example, PCB-126 comprises even \1/10\ of the
PCBs release measured from San Francisco Bay Area sources, it would
contribute substantially to total dioxin-like toxicity emission from
some of these facilities. The commenter contends that the failure to
provide release information on dioxin-like PCBs under EPA's proposal
[[Page 58699]]
may result in failure to inform the public about a significant portion
of the total dioxin toxicity that is still released.
EPA agrees that PCBs are toxic chemicals of concern that have
caused significant contamination of the environment and that co-planar
PCBs may have dioxin-like health effects. However, this does not, in
itself, create a requirement that the co-planar PCBs must be moved from
their current PCB listing to the dioxin and dioxin-like compounds
category. EPA does not believe that the co-planar PCBs must be reported
separately from the non co-planar PCBs because they may be more toxic
than other PCBs. In general, chemical categories consist of chemicals
that vary in their level of toxicity but this variability alone does
not mean that release information must be reported separately for each
chemical in the category. EPA believes that all PCBs are of concern and
that leaving the co-planar PCBs under the current PCB listing will
still provide the public with useful and important information. In
deciding not to move the co-planar PCBs to the dioxin category, EPA
also considered any potential additional burden associated with
splitting the reporting for PCBs into two different listings, as well
as the fact that facilities are not likely to be able to determine
quantities of the specific co-planar PCBs in question. Specifically,
EPA considered the lack of readily available estimation techniques for
determining quantities of co-planar PCBs, as opposed to other PBT
chemicals and the PCB listing as a whole (co-planar PCBs will be
included in the estimation of PCBs). EPA determined that since all PCBs
are of concern and since the reporting threshold for all of the PCBs
under the PCB listing would be lowered substantially, that requiring
separate reporting on the co-planar PCBs was not warranted.
One commenter contends that the failure to report dioxin-like PCBs
would fail to provide information on that subgroup of dioxin-like
compounds for which there is the greatest need for additional
information. The commenter argues that EPA's evaluation of the emission
of dioxin-like chemicals nationwide shows that there is less
information on releases of dioxin-like PCBs than there is for other
dioxin compounds. The commenter asserts that similarly, their survey of
source information in the San Francisco Bay Area shows that, despite
many measurements of dioxin and furan releases, and despite a handful
of source measurements confirming PCBs, there are few or no source
measurements for dioxin-like PCBs. The commenter argues that the
information on releases from facilities is even less available for the
dioxin-like PCBs than it is for the other dioxin-like chemicals and
that EPA's analysis in the proposed rule fails to consider adequately
this extreme need for source release information.
EPA agrees that there is far less information available on co-
planar PCBs than for dioxin and other dioxin-like compounds. Much less
testing and analysis has been conducted for these chemicals. This would
pose an additional problem for reporting on the co-planar PCBs
separately from the other PCBs. EPA considered the ability to estimate
quantities of specific co-planar PCBs and determined that there is a
lack of readily available estimation techniques for co-planar PCBs. In
fact, at this time, the Agency would not be able to provide guidance
for making a reasonable estimate of quantities of co-planar PCBs that
may be manufactured in certain processes. In addition, EPCRA section
313 does not require any additional monitoring beyond that required by
other provisions of law so listing the co-planar PCBs separately would
not mean that additional source measurements would be developed. Thus,
listing under EPCRA section 313 will not require the development of
additional monitoring data that could be used to make reasonable
estimations of thresholds or releases and other waste management
quantities. Given the lack of information available for estimating
quantities of co-planar PCBs and the potential additional burden
associated with splitting the reporting for PCBs into two different
listings, EPA decided to leave the co-planar PCBs under the current PCB
listing.
One commenter asserts that the burden on industrial producers of
dioxin-like PCBs is not an appropriate reason for excluding dioxin-like
PCBs from the dioxin and dioxin-like compounds category because this
will not meet EPCRA's right-to-know goal for dioxin-like PCBs. The
commenter contends that EPA's cost analysis does not address dioxin-
like PCBs specifically and thus, EPA's rationale in Unit VI. of the
preamble of the proposed rule (64 FR 688) that ``this proposal is less
burdensome than requiring separate reporting on the dioxin-like PCBs''
is not based on any cost analysis in EPA's proposal. The commenter
argues further that in any case, aggregate reporting of dioxin-like
PCBs with a 10 pound threshold will fail to obtain the required
reporting on a substantial majority of dioxin-like PCBs or to provide
needed information about dioxin-like PCB releases and therefore, EPA's
perceptions regarding reporting burden cannot properly outweigh the
public's need for the information which is denied under EPA's new
proposal. The commenter refers to the proposal to retain dioxin-like
PCBs under the PCB listing as the ``less than 10 pounds exemption.''
The commenter asserts that existing evidence demonstrates that many
dioxin producing processes such as waste incinerators, oil-fired
boilers, and other processes also produce potentially significant
amounts of PCBs which are released to the environment from these
facilities. The commenter argues that this evidence suggests that at
least some facilities reporting under EPCRA section 313 are likely to
be releasing dioxin-like PCBs as a portion of these PCB releases. The
commenter contends that the evidence also suggests that most or all
releases of dioxin-like PCBs at these facilities may be associated with
total annual PCB production of less than 10 pounds per facility and
thus, EPA may not meet the requirement that a substantial majority of
dioxin-like PCBs be reported under this exemption.
Reporting burden was not the sole or even most important factor in
EPA's decision not to move the co-planar PCBs to the dioxin and dioxin-
like compounds category. In reaching its final decision, EPA considered
the fact that additional information would be collected on all PCBs by
lowering the threshold for the PCB listing and that the additional
information that would be collected was sufficient for EPCRA section
313 purposes, as well as less burdensome. Even in its proposal EPA did
not conclude that reporting burden alone outweighed the public's right-
to-know about chemical releases. As stated in other responses to this
issue, EPA is also concerned about the ability to estimate quantities
of specific co-planar PCBs since there is a lack of readily available
estimation techniques for co-planar PCBs. It is correct that EPA did
not attempt to quantify the reduction in burden that would result from
not including the co-planar PCBs in the dioxin and dioxin-like
compounds category. However, EPA believes that it would be inherently
less burdensome since facilities would not have to attempt to determine
if they can estimate co-planar PCBs separately and filing one form
would obviously be easier and less confusing than attempting to track
and adjust the amounts that must be applied to two different listings
and filing two reports. With regard to the issue of obtaining reporting
on a substantial majority of ``dioxin-like PCB'' releases, as stated in
EPCRA section 313(f)(2), the
[[Page 58700]]
determination of whether a revised threshold meets the ``substantial
majority'' standard is measured against the ``total releases of the
chemical at all facilities subject to the requirements of this
section.'' As EPA stated in the proposed rule:
For purposes of determining what constitutes a ``substantial
majority of total releases'', EPA interprets ``facilities subject to
the requirements'' of section 313 as the facilities currently
reporting, ... (at 64 FR 689).
Currently, facilities required to report on PCBs must report on all
PCBs, not just the co-planar PCBs or any other individual PCBs. The
current listing includes all PCBs. Consequently EPA does not believe
that the requirements of section 313(f)(2) function as an impediment to
its decision to withdraw its proposal to include the co-planar PCBs in
the dioxin and dioxin-like compounds category. As discussed in Units
II.B. and VI.A., EPA believes that it has satisfied the requirements of
EPCRA section 313(f)(2), without the need for quantitative support.
c. Listing dioxin and dioxin-like compounds as a category versus
individual listing of each chemical. Some commenters contend that
reporting dioxin and dioxin-like compounds as one category would not
provide useful information and asked that the individual compounds be
reported. One commenter recommends that reporting on individual
chemical species should be required when the information is available.
One commenter who supports the individual reporting of all of the
dioxin and dioxin-like compounds, states that the amounts of individual
dioxin compounds released from facilities is part of the important
public information needed to assist research and policy development.
The commenter claims that reporting as a category will not provide the
public with the information to assess the relative hazards of releases
since one dioxin-like compound can have a relative hazard several
orders of magnitude less than 2,3,7,8-tetrachlorodibenzo-p-dioxin. This
commenter also states that different sources often emit a different mix
of dioxin compounds and that this information is widely used to trace
dioxin contamination to specific root causes. The commenter states that
the relative amounts of the many different dioxin-like chemicals in a
sample are compared to create a ``profile'' which might match the
profile created by emission from a particular source. The commenter did
not support the reporting of the category based on toxic equivalents
(TEQs) but thought it important for the users of the data to be able to
determine TEQs. Some other commenters make the same general argument
that individual isomer reporting is needed to facilitate risk
characterization including transport and fate of the different isomers.
Some commenters contend that certain dioxin-like compounds such as
octachlorodibenzo-p-dioxin and octachlorodibenzofuran should not be
reported since they are ubiquitous in the environment and are the least
toxic under the toxic equivalent factors (TEFs). One commenter states
that EPA should require reporting only for the most toxic congeners:
the tetra-, penta-, and hexa-congeners and not the hepta- and octa-
congeners which are less toxic and less relevant from a risk
standpoint. Other commenters state that only 2,3,7,8-
tetrachlorodibenzo-p-dioxin should be reported. Some commenters contend
that reporting for these compounds should not be required at the same
reporting threshold as the other dioxin and dioxin-like compounds. Most
commenters who would like to exclude certain dioxin-like compounds did
not indicate that they wanted individual reporting of the remaining
compounds. Some commenters support the reporting of dioxin and dioxin-
like compounds as a category, as EPA proposed. One commenter states
that if reporting is not limited to just 2,3,7,8-tetrachlorodibenzo-p-
dioxin, then the commeter supports EPA's proposal to limit the category
to only the 7 dioxins and 10 furans listed in the proposed rule.
After consideration of all of the comments on this issue, EPA has
decided that the best way to report on dioxin and dioxin-like compounds
is to report them as a category. This is consistent with the way EPA
has addressed other groups of chemicals that share the same toxic
effect and in this case are also generated as complex mixtures. As
discussed in Units VI.G.1.d. and e., reporting as a category and based
on TEQs would not provide users of the data with information on which
compounds contribute the most to the TEQ total. In addition, requiring
facilities to report each compound individually would impose an
additional burden on the industries that will be required to report.
However, EPA agrees that being able to determine the amounts of the
individual dioxin and dioxin-like compounds would make the data more
useful. Therefore EPA will add a section to the Form R that will
require the reporting facility to provide the distribution of dioxin
and each dioxin-like compound for the total quantity that the facility
is reporting. If a facility has information on the distribution of the
dioxin and dioxin-like compounds, the facility must report either the
distribution that best represents the distribution of the total
quantity of dioxin and dioxin-like compounds released to all media from
the facility; or its one best media-specific distribution. This
information is only required if it is available from the data used to
calculate thresholds, releases, and other waste management quantities,
no additional analysis is required. As with all other reporting under
EPCRA section 313, this information will only be required if the
facility has information that can be used to make a reasonable estimate
of the distribution from the available data. With the distribution of
congeners reported on each Form R, the user of the data can determine
the grams of dioxin and each individual dioxin-like compound that makes
up the total quantity reported on the Form R. Under this reporting
mechanism, all of the information that the commenters have stated is
important to determining the significance of quantities reported under
this category will be provided to the public but the reporting
facilities will still only have to file one report. Any of the other
possible options, such as reporting in terms of TEQs or reporting each
individual compound separately, either do not provide all of the
information the commenters would like to have, or impose too great an
additional reporting burden without providing the public with
significant additional information.
d. Using mass versus TEQs for reporting releases and other waste
management quantities. Most of the commenters on this issue suggest
that EPA should require that release and other waste management data
for the dioxin and dioxin-like compounds category be reported in terms
of TEQs rather than in terms of absolute grams. The following list is a
summary of the various reasons provided by the commenters in support of
reporting dioxin and dioxin-like compounds in terms of TEQs: (1) All
dioxin data reported under other EPA programs as well as other Federal
and state regulatory programs are reported in terms of toxicity
equivalents; (2) the public is familiar with dioxin data reported in
terms of TEQs and reporting in other units would cause confusion and be
misleading; (3) TEQs provide more meaningful information than total
weights since they take into account the relative toxicities of the
various dioxin-
[[Page 58701]]
like compounds; (4) facilities that report under other regulatory
programs are likely to rely upon TEQ data that they already have; (5)
use of absolute mass may cause misleading comparisons between grams and
grams TEQ; (6) releases reported in absolute mass make it difficult to
assess the impacts these compounds may have on the environment due to
the differences in their toxicities; and (7) reports based on TEQs
would provide far more useful information about potential community
risks than reports based on the total mass of compounds in the category
since more risk information would be provided.
One commenter argues that EPA's justification for adding the
category is based on assumptions about the toxicity of the other
dioxin-like compounds relative to dioxin itself and that given these
assumptions the reporting of TEQs makes sense. The commenter states
that under current TEQ schemes, these dioxin-like compounds are all
less toxic than dioxin, as much as 1,000 times less, and that
facilities should not simply sum emissions on the Form R for compounds
with such drastically different toxicities. One commenter suggests that
EPA require the reporting of both grams and TEQs and if not both, then
just grams. This commenter asserts that if only grams are reported, the
data will be somewhat difficult to interpret without any further
information, but if only TEQs are required to be reported, then there
are uncertainties about what and how much is discharged.
Another commenter states that if EPA is going to require dioxin
reporting as a group and not by specific chemicals, TEQ reporting is an
unnecessary complication. The commenter states that the TEFs used to
formulate the TEQs are constantly reviewed and changed, which would
necessitate EPA review and possible reissuance of new TEFs each year.
The commenter argues that this would make previous years' TRI data
impossible to compare once the changes were made.
While EPA recognizes that TEQs are a common way of expressing
quantities of dioxin-like compounds, EPA does not believe that
reporting in these units would be the best or most appropriate way to
report for the dioxin and dioxin-like compounds category under EPCRA
section 313. Although some commenters believe that TEQ reporting should
be used since not all of the dioxin-like compounds are as toxic as
dioxin itself, EPA has determined that all of the dioxin-like compounds
meet the listing criteria of EPCRA section 313. Since all of these
compounds meet the listing criteria, the actual mass of each member of
the category should be reported. To do otherwise would deny the public
information on the actual quantities of toxic chemicals entering the
environment. It would also be inconsistent with all other reporting of
EPCRA section 313 toxic chemicals since none of them are reported based
on relative toxicities. In addition, this would be inconsistent with
EPCRA section 313(g)(1)(C)(iv) which requires that ``the annual
quantity of the toxic chemical entering each environmental medium'' be
reported.
Some of the commenters state that TEQs should be used because they
provide more risk information to the public than just reporting mass.
While TEQs do provide information on relative toxicity, EPA does not
believe that increasing the amount of risk information is a basis for
changing the EPCRA section 313 method for reporting from mass-based to
relative toxicity-based. As discussed in Unit VI.F., EPCRA section 313
is not a risk-based program, and reporting is not intended to
communicate information about relative risks. Rather it provides local
communities with data on release and other waste management quantities
on listed toxic chemicals, so that they may use the data in conjunction
with information on chemical properties (e.g., persistence and
bioaccumulation) and site-specific information to determine if releases
present a potential risk. It is also not clear, as some commenters
state, that the public is more familiar with dioxin data reported in
terms of TEQs or that they will understand TEQs any better than grams.
EPA does not believe that the fact that other programs require
reporting in TEQs and that facilities will already have TEQ information
is a significant reason to require TEQ reporting under EPCRA section
313. Since the first piece of information that is required to determine
TEQs is the grams of dioxin and each dioxin-like compound, these
facilities should already have the gram-based information they would
need. In addition, as stated above, EPCRA section 313 reporting serves
the purposes of EPCRA section 313; other programs, e.g., the CWA, are
risk-based command and control programs.
Several commenters also disagree with the concerns that EPA raised
in the proposed rule, which were:
. . .there are three significant disadvantages to reporting in
TEQs. First, revisions in TEF factors for individual dioxin-like
compounds in future years would require changes to the calculations
in the reported release and other waste management quantities, thus
making year to year comparisons more difficult, unless the
particular dioxin-like compounds are identified. Second, some
facilities may not be able to report in TEQs, since, although they
may be able to estimate a mass quantity for the category as a whole,
they may not have enough information to estimate the relative
distribution of all category members. Third, TEQ reporting would be
different from all other TRI reporting, which is mass-based, and may
cause additional confusion. (at 64 FR 712-713)
Some commenters contend that EPA's first concern is not valid since the
EPCRA section 313 reporting requirements have been changed several
times in the past in spite of difficulties in comparing future reports
to past performance. Two commenters state that this same logic could be
applied to the use of AP-42 factors which EPA acknowledges have been
revised and refined over the years, and that this also diminishes the
value of year-to-year reporting comparisons. One commenter suggests
that EPA could minimize any confusion that might be caused by a
subsequent change in one or more TEFs by each year specifically
publishing or cross referencing the TEFs that must be used for that
reporting period.
One commenter contends that EPA's second and third concerns
appeared weak in light of the much greater risk information provided by
a TEQ approach. Some commenters contend that EPA's third concern is not
valid since the reporting requirement being proposed for dioxin and
dioxin-like compounds is different whether TEQs are used or not. One
commenter states that the third concern is clearly dwarfed by the
confusion that would ensue if all dioxin-like compounds were reported
as equivalent, when the hazards vary by a factor of 500. One commenter
states that reporting dioxin on a TEQ basis will cause more rather than
less confusion if the public mistakenly compares data in grams with
data presented in grams TEQ. Some commenters agreed with the concerns
EPA expressed in the preamble. One commenter states that it agreed with
these concerns but that the concern about year-to-year comparisons
being more difficult also applies to the reporting of a single mass
value for the entire category. The commenter contends that since the
amounts of the individual dioxin-like compounds would not be known, if
TEFs change, one cannot adjust previously reported values to reflect
the changes in TEFs. This commenter suggests that in order to make the
information reported of greatest use, the mass of dioxin and each of
the dioxin-like compounds should be reported once a TEQ threshold is
exceeded.
One commenter argues that while TEQs are a valid and scientifically
[[Page 58702]]
sound metric for reporting the likely health hazard of a compound, that
was not the intended purpose of the EPCRA section 313 reporting
requirement. The commenter claims that reporting dioxin and dioxin-like
compounds in TEQs will cause confusion, since all other reporting under
EPCRA is done in terms of mass and does not take toxicity into account.
EPA believes, as do some of the commenters, that the concerns that
were expressed in the proposed rule for reporting dioxin and dioxin-
like compounds in terms of TEQs under EPCRA section 313 are valid. EPA
disagrees with those commenters who claim that since other changes in
reporting have occurred, such as revisions to AP-42 emission factors,
there should be no concern for the changes that might occur in TEFs and
the resulting TEQs. The fact that certain changes have occurred in
reporting requirements or methods of estimation and that those changes
may make certain year-to-year comparisons more difficult does not
reduce the concern for knowingly selecting reporting units, based on
relative toxicity as opposed to emission factors, that have changed in
the past and may well change in the future. Also, EPA would be required
to choose a particular set of TEFs (i.e., as of 1999) and would need to
amend them by rulemaking each time the TEFs were revised. Changes in
TEFs and the resulting TEQs would be unlike any of the past changes in
EPCRA section 313 reporting since none of these reporting changes were
related to the relative toxicity of chemicals that meet the listing
criteria of EPCRA section 313. The cross referencing or publishing of
the TEFs that must be used for each reporting period would still not
allow year-to-year comparisons since without knowing a facility's
distribution of each of the category members the TEQ cannot be
recalculated. EPA's concerns that some facilities may not be able to
report in terms of TEQs are also valid. Although most facilities that
will be able to make reasonable estimations for the dioxin and dioxin-
like compounds category should be able to report in terms of TEQs,
there may be some that can only report in actual mass units and they
should not be exempt from reporting. EPA is also still concerned that
TEQs would be different than other EPCRA section 313 reporting units,
since they are not based on absolute mass, and that this could cause
confusion. EPA does not agree with the commenters that state that this
does not matter since the reporting for the dioxin and dioxin-like
compounds category is going to be different anyway. The only real
reporting difference for the dioxin and dioxin-like compounds category
is that the reporting units are in grams rather than pounds. To
determine the amounts in pounds all that one would have to do is
multiply the grams by 0.002204. However, TEQ reporting would be much
different since in order to understand the reported value one would
need to understand the basis for TEFs, what they are, how they relate
to dioxin, and how TEQs are calculated from the individual TEFs. This
obviously requires more knowledge on the part of the data user than
simply understanding different units of mass and does have the
potential to cause some confusion.
One commenter contends that neither total mass nor TEQ reporting
provides sufficient information on reduction in potential exposure and
risk. The commenter asserts that it is possible that a facility could
reduce its dioxin TEQ while releasing a greater mass of dioxin-like
compounds, but neither total mass nor TEQ reporting would really
provide a good picture of what a facility was doing. The commenter
suggests that if EPA wants to provide TEQ information to the public, it
should also require facilities to report dioxins by individual
chemical, rather than as a group.
Another commenter that favors the reporting of dioxin and dioxin-
like compounds as individual chemicals claims that reporting as a
category but in TEQs would still fail to reveal the amounts of
individual dioxin compounds released. The commenter argues that this
alternative would provide no information on individual compounds for
use in tracing dioxin source profiles. The commenter contends that
reporting in TEQs would provide better information on the relative
toxicity hazard based upon today's toxicity information but that
information on the relative toxicity of the many dioxin-like chemicals
is improving and thus toxicity factors for some of these compounds will
change in the future. The commenter claims that in future years the
Inventory would have to choose between keeping the old toxicity
calculation (and becoming irrelevant in comparison with other research
data), or changing the toxicity calculation (and becoming irrelevant
for tracking changes in dioxin release rates over time). The commenter
contends that the need to aid research and policy development based on
current science and the need to track release rates over time are
fundamental to the Inventory's purpose and that this alternative must
be rejected as just another ill-advised aggregate reporting scheme. The
commenter recommends that EPA require the reporting of dioxin and
dioxin-like compounds in the way these compounds are measured and
analyzed by scientists and government agencies, as individual
chemicals, and consider an additional service by EPA to calculate and
report dioxin toxicity as TEQ for the year-to-year data using the most
recent toxicity information which becomes available.
Several commenters make the point that for dioxin and dioxin-like
compounds neither reporting total mass nor reporting in terms of TEQs
provides sufficient information on potential exposures and risks, and
that neither would allow for the tracing of dioxin source profiles. EPA
agrees that neither approach would provide all of the data that the
commenters would like to have reported and that being able to determine
TEQs would provide additional useful information. A common solution to
the TEQ issue that the commenters suggest, was to report dioxin and
each individual dioxin-like compound separately rather than as a
category. However, EPA believes that this approach would be overly
burdensome and unnecessary to get the kind of data that would be the
most useful. As discussed in the previous section of this unit, many
other commenters requested that dioxin and dioxin-like compounds be
reported separately rather than as a category. After consideration of
all of the comments on this issue, EPA has determined that the best way
to report for the dioxin and dioxin-like compounds category is to
report in terms of absolute grams for the entire category. This is
consistent with all other reporting under EPCRA section 313 and will
provide the most consistent information from year-to-year. However, EPA
agrees with most of the commenters that being able to determine TEQs
from the reported data and being able to determine which individual
chemicals are include in a facilities report would make the data more
useful to the public. Therefore, as discussed in the previous section
of this unit, EPA will add a section to the Form R that will require
the reporting facility to provide the distribution of dioxin and each
dioxin-like compound for the total quantity that the facility is
reporting. If a facility has information on the distribution of the
dioxin and dioxin-like compounds, the facility must report either the
distribution that best represents the distribution of the total
quantity of dioxin and dioxin-like compounds released to all media from
the facility; or its one best media-
[[Page 58703]]
specific distribution. This information is only required if it is
available from the data used to calculate thresholds, releases, and
other waste management quantities, no additional analysis is required.
As with all other reporting under EPCRA section 313, this information
will only be required if the facility has information that can be used
to make a reasonable estimate of the distribution from the available
data. With the distribution of the individual members of the category
reported on each Form R, the user of the data can determine the grams
TEQ that correspond to the absolute grams reported and can adjust the
grams TEQ as TEF values change over time. Under this reporting
mechanism, all of the information that the commenters state is
important to determining the significance of quantities reported for
this category will be provided to the public on one Form R. This way
all parties can express the data in whichever format they believe is
best, and since the first thing that must be determined under any
reporting method is the mass of each member of the category, there
should be little, if any, additional burden associated with including
the distribution.
e. Using TEQs as the basis for reporting thresholds. All of the
commenters on this issue requested that the reporting threshold for the
dioxin and dioxin-like compounds be set in terms of TEQs. Most of the
commenters indicate that the reasons they support a TEQ-based threshold
were the same as the reasons they support reporting release and other
waste management quantities in terms of TEQs (see the first paragraph
of the preceding section of this unit). Two commenters argue that since
EPA proposed to use TEQs for reporting release and other waste
management quantities, that not basing the reporting threshold on TEQs
would be inconsistent. The commenters contend that a facility may
trigger reporting by having emissions that exceed the threshold (in
terms of absolute weight) but have no significant reporting quantity
(in terms of TEQ equivalent weight) and, therefore, no significant
health risk. The commenters recommend the use of a consistent approach
where TEQs are used for both threshold determinations and release and
other waste management quantities. The commenters state that such an
approach would be consistent with the health risk rationale for EPCRA
reporting, yet not rely on site-specific risk approaches that may
evolve over time. Another commenter had similar concerns suggesting
that it would be extremely burdensome and unnecessarily complex to have
thresholds based on absolute grams and release and other waste
management quantities reported in TEQs and recommends that EPA should
use TEQs for both.
One commenter claims that it may ease the reporting burden somewhat
to base the EPCRA section 313 reporting threshold on a TEQ basis rather
than attempting to develop mass-based estimates. Another commenter
contends that in order to determine the sum of the mass of the 17
dioxin and dioxin-like compounds, one already will have determined the
mass of each compound individually and that with data reported by
compound, a TEQ can easily be calculated. The commenter also suggests
that there are short-term screening bioassays for determining the TEQ
of a sample that are less expensive, more sensitive, and can be done
more rapidly than traditional analytical chemistry methods. The
commenter states that rather than facilities trying to guess what their
releases may be, in an attempt to avoid spending money on expensive
analytical chemistry methods, if the reporting threshold were based on
TEQs, a facility can readily and more inexpensively screen its
releases. The commenter argues that having a reporting threshold based
on TEQ is more representative of potential health risks and recommends
that EPA consider using some amount of TEQs as the reporting threshold.
Another commenter suggests that one option would be to report releases
of each dioxin-like compound if the total, in TEQ, exceeds some chosen
threshold.
One commenter that suggests that TEQs should be used for
thresholds, notes that reporting dioxin on a mass basis is quite
different from reporting on a TEQ basis. The commenter asserts that
since some of the dioxin-like compounds have TEFs of 0.001 then the 0.1
gram threshold could require facilities that produce 0.0001 gram TEQ of
dioxin to report. The commenter claims that when compared to the
estimate that there are 2,973 grams TEQ of U.S. dioxin emissions such
amounts are insignificant and meaningless. The commenter maintains that
using TEQs instead of the mass of each compound for determining whether
an EPCRA reporting threshold for dioxin and dioxin-like compounds is
exceeded would not deprive EPA or the public of information regarding
meaningful releases of dioxin. The commenter also recommends that
whatever units EPA decides to use should be the same for thresholds and
for release and other waste management quantities.
One commenter suggests that EPA should require sources to use
toxicity factors in calculating the manufacturing threshold for dioxin
and dioxin-like compounds to avoid triggering the threshold based
solely on non-detection. The commenter states that the 17 dioxin-like
compounds to which the 0.1 gram proposed reporting threshold would
apply vary in toxicity by a factor of 1,000 but that EPA does not take
this variation in toxicity into consideration for the purpose of
determining the manufacturing threshold.
EPA did not propose to use TEQs as the units of measurement for the
EPCRA section 313 reporting threshold for dioxin and dioxin-like
compounds. EPA has the same concerns for using TEQs for EPCRA section
313 thresholds as it does for reporting releases and other waste
management quantities in terms of TEQs, and most of the issues raised
here have been addressed in the preceding section of this unit. Most
importantly, since EPA has determined that each of the dioxin-like
compounds meets the listing criteria of EPCRA section 313, the actual
mass of each member of the category should be included in threshold
determinations. Also, the fact that the TEFs and thus the TEQs can
change over time, is even more important for thresholds since TEF
changes would in effect change the threshold, because for example, the
same mass quantity that would have exceeded the threshold before the
change may not exceed the threshold after the change.
As one of the commenters pointed out, using TEQs as the units for
the reporting threshold is much different than using actual mass. The
commenter showed how a 0.1 gram threshold for a dioxin-like compound
with a TEF of 0.001 would be equivalent to a 0.0001 gram TEQ threshold.
The opposite of this is that if the 0.1 gram threshold were in units of
TEQ, then for dioxin-like compounds with a 0.001 TEF, it would take 100
grams to reach the reporting threshold. Using TEQs as the units for the
reporting threshold would thus be equivalent to establishing separate
thresholds for each member of the dioxin and dioxin-like compounds
category based on their relative toxicity. EPA does not believe that
any of the reporting requirements of EPCRA section 313 should be based
on relative toxicities since, as discussed in Unit VI.F., EPCRA section
313 is not a risk-based program and reporting is not intended to
communicate information about the Federal government's risk
determinations for individual chemicals. Rather it provides local
communities with data on release and
[[Page 58704]]
other waste management quantities on listed toxic chemicals, so that
they may use the data in conjunction with information on chemical
properties (e.g. persistence and bioaccumulation) and site-specific
information to determine if releases present a potential risk.
Several commenters express concern about consistency between the
units of measurement for the threshold for the dioxin and dioxin-like
compounds category and the units of measurement used to report releases
and other waste management quantities. While EPA is not adopting the
use of TEQ as some commenters requested, EPA is being consistent since
absolute gram quantities will be used for both thresholds and the
reporting of releases and other waste management quantities.
EPA does not agree with those commenters who state that the
information collected under a 0.1 gram threshold would, in some cases,
represent such a small portion of the estimated national amount of
dioxin TEQs that the data would not be useful. On a facility-by-
facility basis, the amounts reported may be a small percentage of the
national total, but that does not mean that it will not be useful or
meaningful to the public. One of the purposes of EPCRA section 313 is
to provide information to communities about releases into their
community. A small percentage of national releases may pose potential
risks to local communities. Further, even information that shows little
or no releases helps communities to understand what risks may be or may
not be present in their communities and helps government agencies to
target resources. In addition, since not all of the sources of dioxin
and dioxin-like compounds will be reporting under EPCRA section 313,
the amount reported will be a larger portion of the total amount
reported under EPCRA section 313 than it will be on a national basis.
The issue of how many sources of dioxin and dioxin-like compounds are
captured by EPCRA section 313 are addressed in the Response to Comments
document (Ref. 69) for this rulemaking.
EPA does not agree that reporting in terms of TEQs would
necessarily be less burdensome. As one commenter states, in order to
determine the sum of the mass of the 17 dioxin and dioxin-like
compounds, one already will have determined the mass of each compounds
individually and that with data reported by compound, a TEQ can easily
be calculated. Since the TEQs are calculated from the relative amounts
of dioxin and each dioxin-like compound that is present, it is an
additional step to present the data in terms of TEQs and therefore it
should not be less burdensome.
f. Reporting guidance for dioxin and dioxin-like compounds. A
number of commenters requested that EPA develop reporting guidance for
the dioxin and dioxin-like compounds category.
EPA agrees that guidance should be provided to assist facilities in
determining threshold and release quantities for the dioxin and dioxin-
like compounds category. As EPA stated in the proposed rule:
EPA intends to develop reporting guidance for industries that
may fall within this reporting category. The guidance developed will
be consistent with the methods and procedures that EPA has developed
for determining if dioxin and dioxin-like compounds are present in
various industrial processes, including Method 23 (Ref. 77)
developed for electric utilities. In developing the reporting
guidance for the dioxin and dioxin-like compounds category EPA will
work with interested parties to provide the best possible guidance
for reporting facilities (at 64 FR 712).
EPA will provide a guidance document to assist certain facilities in
making thresholds and release determinations for the dioxin and dioxin-
like compounds category. The guidance document will be consistent with
EPA established methods of measuring or estimating quantities of dioxin
and dioxin-like compounds, including Method 23.
2. Benzo(g,h,i)perylene (CAS No. 191-24-2) (Ref. 70). EPA proposed
to add benzo(g,h,i)perylene to EPCRA section 313 pursuant to EPCRA
section 313 (d)(2)(C). One commenter states that EPA should not add
benzo(g,h,i)perylene to the EPCRA section 313 list of toxic chemicals
because there are insufficient data to support the EPCRA section
313(d)(2)(C) determination. The commenter states that EPA used
predicted aquatic toxicity values based on quantitative structure
activity relationship (QSAR) analysis but did not provide any toxicity
data. The commenter contends that EPA did not provide any evidence to
support the statement that aquatic QSAR equations show a high
correlation between predicted and measured toxicity values, and did not
provide any other information to support use of QSAR for this type of
chemical.
EPA disagrees with the commenter's statements. EPA provided the
following discussion in the proposed rule:
Three of the chemicals being proposed for listing
(benzo(g,h,i)perylene, 3-methylcholanthene, and octachlorostyrene)
have been found to meet the EPCRA section 313(d)(2)(C) criteria for
ecotoxicity based on predicted aquatic toxicity values generated
from quantitative structure activity relationship (QSAR) equations
and other predictive techniques. As previously stated (58 FR 63500,
December 1, 1993), EPA believes that, where no or insufficient
actual measured aquatic toxicity data exist upon which to base a
decision, toxicity predictions generated by QSARs and other
predictive techniques may constitute sufficient evidence that a
chemical meets the section 313 listing criteria. EPA's authority to
use such predictive techniques derives from section 313(d)(2) of the
statute, which states that EPA shall base its listing determinations
on, inter alia, ``generally accepted scientific principles.'' EPA
believes that the aquatic QSAR equations that are in widespread use
and show a high correlation between predicted and measured aquatic
toxicity values can be considered to be ''generally accepted
scientific principles'' and can appropriately form the basis of a
listing determination (Ref. 70). (at 64 FR 693)
EPA believes that QSAR data is valid predicted aquatic toxicity data
and the fact that no actual toxicity studies were provided does not
mean that the available data were insufficient to determine that
benzo(g,h,i)perylene met the listing criteria of EPCRA section
313(d)(2)(C). In addition, EPA did provide support for the statement
that aquatic QSAR equations are in widespread use and show a high
correlation between predicted and measured aquatic toxicity values. The
docket for the proposed rule contained a document titled ``SAR/QSAR in
the Office of Pollution Prevention and Toxics'' In: Environmental
Toxicology and Risk Assessment: 2nd Volume, STP 1216. One of the
articles in this reference was titled Validation of Structure Activity
Relationships Used By the USEPA's Office of Pollution Prevention and
Toxics for the Environmental Hazard Assessment of Industrial Chemical.
This includes the methods of SAR for the class of neutral organic
chemicals which, as discussed in the support document, was used for
benzo(g,h,i)perylene since it is a neutral organic chemical. Thus, EPA
did provide support for its conclusions about QSAR analysis and for the
use of QSAR for benzo(g,h,i)perylene.
This commenter also states that EPA uses an estimated Log
Kow in its aquatic toxicity prediction and argues that Log
Kow is an inaccurate predictor for many chemicals
particularly if it is estimated rather than measured. The commenter
contends that EPA's basis for the listing of benzo(g,h,i)perylene is a
prediction based upon a prediction, with no actual data and that this
is not a sufficient basis for listing under EPCRA section 313 and it
does not meet the statutory requirements for listing that a chemical is
``known to cause or can reasonably be
[[Page 58705]]
anticipated to cause'' a significant adverse effect.
EPA disagrees with the commenter's conclusions. The majority of the
SAR calculations in the ECOSAR Class Program are based upon the
octanol/water partition coefficient (Kow or Log P) since
there is a correlation between Log P and toxicity. Using the measured
aquatic toxicity values and estimated Log P values, regression
equations can be developed for a class of chemicals. Toxicity values
for a chemical within that class may then be calculated by inserting
the estimated Kow into the class regression equation and
correcting the resultant value for the molecular weight of the
compound. The ecological assessment guidelines for predicting the
toxicity of chemicals with limited measured aquatic toxicity data have
been used for over a decade (Ref. 35). The commenter has not provided
the Agency with any concrete information or data indicating that this
approach either is not a generally accepted scientific approach or is
unreliable, and the Agency finds no reasonable basis to change these
techniques at this time. In addition, the commenter did not provide any
data to indicate that the predicted Log Kow for
benzo(g,h,i)perylene was inaccurate.
This commenter also contends that EPA's failure to consider
exposure in this proposed rule is particularly important for
benzo(g,h,i)perylene. The commenter argues that given the properties of
benzo(g,h,i)perylene, any release into water will result in the vast
majority (more than 99%) of the compound being partitioned to sediment
or adsorbed onto suspended particulates and organics in the water
column and thus the potential for this chemical to be in a toxic form
and pose risk in natural systems is low.
EPA disagrees with the commenters' contention that EPA should
consider exposure in its determination that benzo(g,h,i)perylene meets
the EPCRA section 313(d)(2)(C) listing criteria. As discussed in Unit
VI.F., EPA is only required to consider exposure under a limited set of
circumstances. In the final chemical expansion rule (59 FR 61432), EPA
further explained its policy on the use of exposure considerations
under EPCRA section 313(d)(2)(C) and the fact that the Agency does not
consider exposure for chemicals that are highly ecotoxic. As EPA
explained in the final rule:
The Agency believes that exposure considerations are not
appropriate in making determinations (1) under section 313(d)(2)(B)
for chemicals that exhibit moderately high to high human toxicity
(These terms, which do not directly correlate to the numerical
screening values reflected in the Draft Hazard Assessment
Guidelines, are defined in unit II.) based on a hazard assessment,
and (2) under section 313(d)(2)(C) for chemicals that are highly
ecotoxic or induce well-established adverse environmental effects
(at 59 FR 61441).
Although EPA does not believe that it would be appropriate to consider
exposure, EPA also disagrees with the commenter's characterization of
the fate of benzo(g,h,i) perylene. Environmental fate models show that
the chemical will only partition about 60% to the sediment. Also, the
Agency cannot rely on the environment to serve as a sink for this
chemical. Other environmental conditions such as turbidity, biological
activity, or the chemical activity in water could cause redistribution
of the chemical into the water column again.
Based upon QSAR equations and other predictive techniques, EPA has
concluded that benzo(g,h,i)perylene is toxic. It has the potential to
kill fish, daphnia, and algae, among other adverse effects, based on
chemical and/or biological interactions. Benzo(g,h,i)perylene can cause
these toxic effects at relatively low concentrations. The predicted
aquatic toxicity values for benzo(g,h,i)perylene, based upon QSAR
analysis using the equation for neutral organics and an estimated Log
Kow of 6.7, included calculated values of 0.030 milligrams
per liter (mg/L) for the fish 96-hour LC50 (i.e., the
concentration that is lethal to 50% of test organisms) and 0.0002 mg/L
for fish chronic toxicity; 0.012 mg/L for daphnia 48-hour
LC50 and 0.027 mg/L for the daphnid 16-day chronic
LC50; and 0.03 mg/L for the algae 96-hour EC50
(i.e., the concentration that is effective in producing a sublethal
response in 50% of tests organisms) with an algal chronic toxicity of
0.012 mg/L.
Benzo(g,h,i)perylene can cause its toxic effects at relatively low
concentrations, therefore EPA considers it to be highly toxic. Since
benzo(g,h,i) perylene is toxic at relatively low concentrations EPA
believes that it causes or can reasonably be anticipated to cause a
significant adverse effect on the environment. In addition, because of
the nature of the potential significant adverse effects, e.g., fish,
daphnia, and algae kills, and the impacts such effects can have on
ecological communities and ecosystems, EPA has determined that they are
of sufficient seriousness to warrant reporting.
EPA reaffirms that there is sufficient evidence for listing
benzo(g,h,i)perylene on the EPCRA section 313 list of toxic chemicals
pursuant to EPCRA section 313(d)(2)(C)(i) based on the available
ecotoxicity information for this chemical. Therefore, EPA is finalizing
the addition of benzo(g,h,i)perylene on the EPCRA section 313 list.
3. Benzo(j,k)fluorene (fluoranthene) (CAS No. 206-44-0) (Ref 70).
EPA proposed to add fluoranthene to EPCRA section 313 pursuant to EPCRA
sections 313 (d)(2)(B) and (C). EPA received no comments specific to
the carcinogenicity data that EPA presented in the proposed rule in
support of the addition of fluoranthene to the EPCRA section 313 list
of toxic chemicals. Thus, EPA reaffirms that there is sufficient
evidence for adding fluoranthene to this list of EPCRA section 313
toxic chemicals pursuant to EPCRA section 313(d)(2)(B) based on the
available carcinogenicity data for this chemical.
One commenter argues that EPA should refrain from listing
fluoranthene pending additional assessment of the data. The commenter
contends that EPA's reported toxicity values for fluoranthene span a
range of about two orders of magnitude and that for such a wide range,
it is necessary to evaluate potential exposure to determine which
scenarios, and therefore which types of data, are most relevant to this
compound following a release. The commenter argues that fluoranthene is
a highly lipophilic compound that will bind primarily to sediment and
suspended organics, so it is not clear whether the reported toxicity
values on which EPA relies for the listing are applicable to this
compound in the environment. EPA assumes the commenter was referring to
data used to support EPA's proposal to list fluoranthene pursuant to
EPCRA section 313(d)(2)(C).
As discussed in Unit VI.F., EPA does not believe that it is
appropriate to consider exposure for chemicals that are highly ecotoxic
as the data for fluoranthene clearly shows it is. However, even if EPA
were to consider exposure, the commenter provided no data to support
the assumption that fluoranthene will bind primarily to sediments and
suspended organics, and EPA believes that fluoranthene will partition
to water as well as sediment. While the ecotoxicity data for
fluoranthene does range over about two orders of magnitude that does
not, in itself, form a basis for conducting an exposure assessment.
There are data that clearly show that fluoranthene is highly ecotoxic.
Thus, an exposure assessment is not required. While it does not impact
EPA's assessment, EPA notes that of the ecotoxicity values presented in
the proposed rule, 9 were within the same order of magnitude, 4
[[Page 58706]]
were one order of magnitude higher, and 2 were two orders of magnitude
higher. Thus, 60% are within the same order of magnitude and 87% are
within one order of magnitude. EPA does not believe that this
represents a very wide distribution as the commenter implies.
Based on the available toxicity data, EPA has concluded that
fluoranthene is toxic. It has the potential to kill mysid shrimp, a
variety of freshwater benthic species and various saltwater species and
it can also cause other adverse effects on fish and mysids, based on
chemical and/or biological interactions. Fluoranthene can cause these
toxic effects at relatively low concentrations. Ecotoxicity values for
fluoranthene include a calculated 96-hour LC50 of 0.04 mg/L
for mysid shrimp. Using standard acute toxicity tests, fluoranthene has
been tested in 12 freshwater species from 11 genera. For freshwater
benthic species, the acute 96-hour LC50 calculated values
are 0.032 mg/L for an amphipod (Gammarus minus), 0.070 mg/L for a hydra
(Hydra americana), 0.17 mg/L for an annelid (Lumbriculus variegatus),
and 0.17 mg/L for a snail (Physella virgata). For saltwater species,
the 96-hour LC50 values are 0.051 mg/L for a mysid
(Mysidopsis bahia), 0.066 mg/L for an amphipod (Ampelisca abdita), 0.14
mg/L for a grass shrimp (Palaemonetes pugio), and 0.50 mg/L for an
annelid (Neanthes arenaceodentata). Fathead minnows exposed to
fluoranthene at a concentration of 0.0217 mg/L for 28 days in a chronic
early life-stage test showed a reduction of 67% in survival and a 50.2%
reduction in growth relative to the controls. In a 28-day chronic
study, mysids exposed to 0.021 mg/L of fluoranthene showed a 26.7%
reduction in survival and a 91.7% reduction in reproduction; at 0.043
mg/L all mysids died. In a 31-day study, mysids showed a reduction of
30% in survival, 12% in growth, and 100% in reproduction relative to
controls at a concentration of 0.018 mg/L of fluoranthene.
Fluoranthene can cause its toxic effects at these relatively low
concentrations, therefore EPA considers it to be highly toxic. Since
fluoranthene is toxic at relatively low concentrations, EPA believes
that it causes or can reasonably be anticipated to cause a significant
adverse effect on the environment. In addition, because of the nature
of the potential significant adverse effects, e.g., kills of mysid
shrimp, a variety of freshwater benthic species, and various saltwater
species, and the impacts such effects can have on ecological
communities and ecosystems, EPA has determined that they are of
sufficient seriousness to warrant reporting.
Thus, EPA reaffirms that there is sufficient evidence for adding
fluoranthene on the EPCRA section 313 list of toxic chemicals pursuant
to EPCRA section 313(d)(2)(C)(i) based on the available ecotoxicity
information for this chemical.
Therefore, EPA is finalizing the listing of fluoranthene on the
EPCRA section 313 list.
4. 3-Methylcholanthrene (CAS No. 56-49-5) (Ref. 70). EPA proposed
to add 3-methylcholanthrene to EPCRA section 313 pursuant to EPCRA
sections 313(d)(2)(B) and (C). EPA received no comments on the
carcinogenicity data that EPA presented in the proposed rule in support
of the addition of 3-methylcholanthrene to the EPCRA section 313 list
of toxic chemicals. Thus, EPA reaffirms that there is sufficient
evidence for adding 3-methylcholanthrene to the list of EPCRA section
313 toxic chemicals pursuant to EPCRA section 313(d)(2)(B) based on the
available carcinogenicity data for this chemical.
No comments were received concerning the ecotoxicity data that EPA
presented for 3-methylcholanthrene in the proposed rule. Based upon
quantitative structure activity relationship (QSAR) equations and other
predictive techniques, EPA has concluded that 3-methylcholanthrene is
toxic. It has the potential to kill fish and daphnia as well as cause
other adverse effects on fish, daphnia, and algae based on chemical
and/or biological interactions. 3-Methylcholanthrene can cause these
toxic effects at relatively low concentrations. The predicted aquatic
toxicity values for 3-methylcholanthrene, based on QSAR analysis using
the equation for neutral organics and an estimated Log Kow
of 7.05, include a calculated fish 96-hour LC50 of 0.009 mg/
L and a chronic fish toxicity value of 0.003 mg/L, a daphnia 48-hour
LC50 of 0.005 mg/L and a 16-day chronic LC50 of
0.015 mg/L, and an algae 96-hour EC50 of 0.0105 mg/L with a
calculated chronic toxicity value of 0.014 mg/L.
3-Methylcholanthrene can cause its toxic effects at these
relatively low concentrations; therefore, EPA considers it to be highly
toxic. Since 3-methylcholanthrene is toxic at relatively low
concentrations, EPA believes that it causes or can reasonably be
anticipated to cause a significant adverse effect on the environment.
In addition, because of the nature of the potential significant adverse
effects, e.g., fish and daphnia kills, and the impacts such effects can
have on ecological communities and ecosystems, EPA has determined that
they are of sufficient seriousness to warrant reporting.
Thus, EPA reaffirms that there is sufficient evidence for listing
3-methylcholanthrene on the EPCRA section 313 list of toxic chemicals
pursuant to EPCRA section 313(d)(2)(C)(i) based on the available
ecotoxicity information for this chemical.
Therefore, EPA is finalizing the listing of 3-methylcholanthrene on
the EPCRA section 313 list.
5. Octachlorostyrene (CAS No. 29082-74-4) (Ref. 70). EPA proposed
to add octachlorostyrene to EPCRA section 313 pursuant to EPCRA
sections 313(d)(2)(B) and (C). One commenter argues that
octachlorostyrene (OCS) should not be included in the EPCRA section 313
PBT chemicals list. The commenter contends that OCS was included as a
PBT chemical simply because it appears on several lists of persistent
and bioaccumulative chemicals and not based on a thorough evaluation of
its toxicity. The commenter argues that there is limited toxicity data
for OCS and cited two statements that were in EPA's support document
for the addition of OCS and the other chemicals being added in this
rulemaking. The two statements the commenter cited were:
The health hazard data which support TRI listing are very
limited. Human health data were not located. (Ref. 70 p. 48)
EPA disagrees with the commenters' conclusions. The commenter did
not comment on the actual toxicity data that EPA provided as the basis
for listing OCS pursuant to EPCRA section 313(d)(2)(B). Rather the
commenter takes two statements that were contained in the support
document out of context to support their apparent contention that there
are insufficient data to list OCS under EPCRA section 313(d)(2)(B). The
fact that the commenter has taken these statements out of context is
demonstrated by the content of the rest of the paragraph that contained
the statements the commenter cited:
Laboratory studies on rats suggest OCS may have acute and
chronic effects on the liver, kidneys, and thyroid. In a long-term
study (one year) of rats a LOAEL of 0.31 mg/kg/day was determined
based on significant histological effects on these organs. (Ref. 70)
The statements the commenter cited only acknowledged that there was not
a vast amount of toxicity data for OCS and specifically, that there
were no human studies; they do not support the commenters' conclusion
that OCS does not meet listing criteria of EPCRA
[[Page 58707]]
section 313(d)(2)(B). In addition, these statements were from the
summary section of the discussion on OCS, more detailed discussion of
the toxicity data for OCS was contained in the other sections on OCS
toxicity but the commenter provided no comments on this information.
EPA reaffirms that there is sufficient evidence for adding OCS to
the EPCRA section 313 list of toxic chemicals pursuant to EPCRA section
313(d)(2)(B) based on the available hepatic, nephric, and thyroid
toxicity data for this chemical.
The same commenter also claims that the toxicity comparisons to
hexachlorobenzene are not supported and that no references or rationale
are provided to support basing the aquatic toxicity of OCS on that of
hexachlorobenzene. As with the human health data, the commenter argues
that there are limited environmental toxicity data for OCS and cited
some statements that were in EPA's support document. The statements the
commenter cited were:
So far as is known, after a search of former EEB chemical files,
the ecological hazard of OCS has never been formally reviewed under
TSCA section 4 or in the OPPT Risk Management (RM) process. OCS was
briefly reviewed for aquatic toxicity in August 1986, as part of an
OTS (now OPPT) chemical scoring project. Thus, available information
on OCS is very limited. (Ref. 70, p. 52)
EPA disagrees with the commenter's conclusions. The commenter has
not commented on the actual toxicity data but rather states that the
data are limited and that hexachlorobenzene is not an appropriate
analogue for predicting the aquatic toxicity data for OCS. The
statements the commenter cited only acknowledged that there was not a
vast amount of toxicity data for OCS, they do not support the
commenter's conclusion that OCS does not meet the listing criteria of
EPCRA section 313(d)(2)(C). Contrary to the commenter's statement, EPA
did provide a reference to the use of hexachlorobenzene as an
appropriate analogue for OCS. As EPA stated in the same section of the
support document the commenter cited:
OCS is one of 7 compounds in this chemical class (chlorinated
styrenes) with the generic formula
C8H8-xClx, where x equals 8 for
OCS. This class is analogous to the chlorinated benzenes; for
example hexachlorobenzene (HCB), is considered to be an appropriate
analogue chemical for OCS (2). (Ref. 70, page 52).
The reference EPA cited is a previous EPA analysis of this class of
chemicals that also used hexachlorobenzene as an appropriate analogue
for OCS. EPA believes that since OCS and hexachlorobenzene are both
highly chlorinated derivatives of benzene they can reasonably be
anticipated to have similar toxicities. However, in addition to aquatic
toxicity data on hexachlorobenzene, EPA provided the results of a QSAR
analysis of OCS, using a measured Log Kow of 7.7, that gave
a predicted 14-day LC50 value of 6 g/L for guppies.
Based upon QSAR equations and analogue data, EPA has concluded that
OCS is toxic. It has the potential to kill fish and inhibit
photosynthesis in algae, among other adverse effects, based on chemical
and/or biological interactions. OCS can cause these toxic effects at
relatively low concentrations. The predicted aquatic toxicity value for
OCS, based upon QSAR analysis using a measured Log Kow of
7.7, is an estimated 14-day LC50 of 6 g/L for
guppies. Based on the chemical analogue hexachlorobenzene, OCS can
reasonably be anticipated to inhibit photosynthesis in algae at a
concentration of 30 g/L and have a calculated subchronic
EC50 value of 16 g/L for daphnids.
OCS can cause its toxic effects at these relatively low
concentrations; therefore, EPA considers it to be highly toxic. Since
OCS is toxic at relatively low concentrations, EPA believes that it
causes or can reasonably be anticipated to cause a significant adverse
effect on the environment. In addition, because of the nature of the
potential significant adverse effects, e.g., fish kills, and inhibition
of photosynthesis in algae and the impacts such effects can have on
ecological communities and ecosystems, EPA has determined that they are
of sufficient seriousness to warrant reporting.
EPA reaffirms that there is sufficient evidence for listing OCS on
the EPCRA section 313 list of toxic chemicals pursuant to EPCRA section
313(d)(2)(C)(i) based on the available ecotoxicity information for this
chemical.
Therefore, EPA is finalizing the addition of OCS on the EPCRA
section 313 list.
6. Pentachlorobenzene (CAS No. 609-93-5) (Ref. 70). EPA proposed to
add pentachlorobenzene to EPCRA section 313 pursuant to EPCRA sections
313(d)(2)(B) and (C). No comments were received concerning the human
health toxicity data that EPA presented in the proposed rule. Thus, EPA
reaffirms that there is sufficient evidence for adding
pentachlorobenzene on EPCRA section 313 pursuant to EPCRA section
313(d)(2)(B) based on the available hepatic, nephric, hematological,
and developmental toxicity data for this chemical.
No comments were received concerning the ecotoxicity data that EPA
presented for pentachlorobenzene in the proposed rule. Based on the
available toxicity data, EPA has concluded that pentachlorobenzene is
toxic. It has the potential to kill fish and mysid shrimp as well as
cause other adverse effects on algae and daphnia, based on chemical
and/or biological interactions. Pentachlorobenzene can cause these
toxic effects at relatively low concentrations. Aquatic acute toxicity
calculated values for pentachlorobenzene include a sheepshead minnow
96-hour LC50 of 0.83 mg/L, bluegill sunfish 96-hour
LC50s of 0.25 mg/L and 0.3 mg/L, a guppy 96-hour
LC50 of 0.54 mg/L, and a mysid shrimp 96-hour
LC50 of 0.16 mg/L. Because pentachlorobenzene can cause
these toxic effects at these relatively low concentrations, EPA
considers it to be highly toxic. Additional acute toxicity calculated
values include algae 96-hour EC50s of 1.98 mg/L and 6.78 mg/
L, and daphnia 48-hour EC50s of 1.3 mg/L and 5.28 mg/L.
Considering pentachlorobenzene's persistence and bioaccumulation
potential pentachlorobenzene is considered highly toxic to aquatic
organism at these higher concentrations.
As discussed above, pentachlorobenzene is highly toxic. Because
pentachlorobenzene is highly toxic at relatively low concentrations,
EPA believes that it causes or can reasonably be anticipated to cause a
significant adverse effect on the environment. In addition, because of
the nature of the potential significant adverse effects, e.g., fish and
mysid shrimp kills as well as other adverse effects on algae and
daphnia, and the impacts such effects can have on ecological
communities and ecosystems, EPA has determined that they are of
sufficient seriousness to warrant reporting.
Thus, EPA reaffirms that there is sufficient evidence for adding
pentachlorobenzene on the EPCRA section 313 list of toxic chemicals
pursuant to EPCRA section 313(d)(2)(C)(i), (ii), and (iii) based on the
available ecotoxicity information for this chemical.
Therefore, EPA is finalizing the listing of pentachlorobenzene on
the EPCRA section 313 list.
7. Tetrabromobisphenol A (CAS No. 79-94-7) (Ref. 70). EPA proposed
to add TBBPA to EPCRA section 313 pursuant to EPCRA sections
313(d)(2)(B) and (C). One commenter claims that the study cited by EPA
in support of its
[[Page 58708]]
conclusion that TBBPA meets the EPCRA section 313(d)(2)(B) criteria for
listing based on developmental toxicity was not a study on TBBPA. The
study in question was submitted to EPA by ICI Americas Inc. with a
cover letter identifying Saytex 111, the product tested, as being
TBBPA. The product was identified as TBBPA by both name and CAS number.
EPA has determined that the product tested was not TBBPA as claimed
by the submitter but has been unable to determine why it was
misidentified by the submitter. ICI Americas is now Zeneca at the
Delaware location that submitted the study. A Zeneca staff member
researched the submission and found that the report was originally from
Ethyl Corporation and that no other report on TBBPA was submitted to
EPA on that date. Without the misidentified developmental study, no
adequate toxicology studies or other data were located by EPA that
support the addition of TBBPA pursuant to EPCRA section 313(d)(2)(B).
Thus, EPA is not adding TBBPA based on concerns for developmental
toxicity or any other human health effects.
The same commenter provides comments on the persistence and
bioaccumulation of TBBPA and contends that there are insufficient data
to conclude that TBBPA meets the listing criteria of EPCRA section
313(d)(2)(C)(ii) and 313(d)(2)(C)(iii). These two sections deal with
EPA's authority to add a chemical based on its ``toxicity and
persistence in the environment'' and its ``toxicity and tendency to
bioaccumulate in the environment'' respectively. However, the commenter
does not contend that TBBPA does not meet the listing criteria of EPCRA
section 313(d)(2)(C)(i) which addresses EPA's authority to add a
chemical based on its ``toxicity'' without consideration of persistence
and bioaccumulation. EPA believes that TBBPA is persistent and
bioaccumulative as discussed in Unit VI.H. However, EPA did not propose
to add TBBPA to the EPCRA section 313 list of toxic chemicals based on
its persistence or bioaccumulation data, and neither of these
properties were mentioned in the toxicity discussion of TBBPA in the
proposed rule. Rather, EPA based its listing decision on the
ecotoxicity data alone which indicated that TBBPA was highly toxic even
without consideration of persistence or bioaccumulation.
Based the available toxicity data, EPA has concluded that TBBPA is
toxic. It has the potential to kill fish, daphnid, and mysid shrimp,
among other adverse effects, based on chemical and/or biological
interactions. TBBPA can cause these toxic effects at relatively low
concentrations. Aquatic acute toxicity calculated values for TBBPA
include a fathead minnow 96-hour LC50 of 0.54 mg/L, a
rainbow trout 96-hour LC50 of 0.40 mg/L, a bluegill sunfish
96-hour LC50 of 0.51 mg/L, and a daphnid 48-hour
LC50 of 0.96 mg/L; mysid shrimp 96-hour LC50
values ranged from 0.86 to 1.2 mg/L depending on the age of the shrimp.
Aquatic chronic toxicity calculated values from a daphnia 21-day study
resulted in a Maximum Acceptable Toxicant Concentration (MATC) that was
between 0.30 and 0.98 mg/L (geometric mean 0.54 mg/L) based on a
significant reduction in reproduction rates; a fathead minnow 35-day
study resulted in a MATC that was calculated to be between 0.16 and
0.31 mg/L (geometric mean 0.22 mg/L) based on adverse effects on embryo
and larval survival.
TBBPA can cause its toxic effects at these relatively low
concentrations; therefore, EPA considers it to be highly toxic. Since
TBBPA is toxic at relatively low concentrations, EPA believes that it
causes or can reasonably be anticipated to cause a significant adverse
effect on the environment. In addition, because of the nature of the
potential significant adverse effects, e.g., fish, daphnid, and mysid
shrimp kills, and the impacts such effects can have on ecological
communities and ecosystems, EPA has determined that they are of
sufficient seriousness to warrant reporting.
EPA reaffirms that there is sufficient evidence for listing TBBPA
on the EPCRA section 313 list of toxic chemicals pursuant to EPCRA
section 313(d)(2)(C)(i) based on the available ecotoxicity information
for this chemical. Therefore, EPA is finalizing the addition of TBBPA
on the EPCRA section 313 list.
8. Vanadium and vanadium compounds. EPA proposed to add vanadium
and vanadium compounds to EPCRA section 313 pursuant to EPCRA sections
313(d)(2)(C). One commenter cited the following statement from the
proposed rule, ``However, very few toxicity tests have been conducted
with invertebrates.'' The commenter argues that, beyond vanadium
pentoxide, the Agency appears to have very little toxicity data on
vanadium compounds. The commenter contends that the paucity of toxicity
data on many different forms of vanadium compounds in the proposal, as
well as in the literature, does not appear to support the Agency's
belief that ``the evidence is sufficient to list vanadium and vanadium
compounds on EPCRA section 313 pursuant to EPCRA section 313(d)(2)(C)
based on the available ecotoxicity information on vanadium and vanadium
compounds'' (at 64 FR 698).
EPA disagrees with the commenters' conclusions. Although there is
limited information on vanadium's toxicity on invertebrates, data that
were available for invertebrates shows that vanadium is toxic to these
species. Furthermore, EPA's assessment of vanadium's toxicity included
algae and vertebrates, and showed that the chemical is highly toxic to
aquatic organisms. The data on vanadium are not limited to vanadium
pentoxide, the ecological data provided in the proposed rule for
vanadium evaluates vanadium toxicity based on data for other vanadium
compounds including: sodium metavanadate, sodium orthovanadate, vanadyl
sulfate, and ammonium vanadate. In assessing the ecological toxicity of
vanadium and vanadium compounds, EPA evaluated the parent metal
(vanadium) and determined that it is highly toxic to some aquatic
species and anticipated to cause a significant adverse effect on the
environment of sufficient seriousness to warrant reporting. Thus,
vanadium, the parent metal in vanadium compounds, is the concern, not
the other components of each vanadium compound. Many metals are tested
in the salt form because these forms are readily soluble in aqueous
solutions. The toxicity data for vanadium shows that the metal is
highly toxic (aquatic toxicity < 1 mg/L) to the most sensitive species.
This evaluation of vanadium's toxicity is acceptable according to
traditional guidelines for the assessment of toxic substances as
conducted by the Agency for over 2 decades. In addition, when
consideration is given to vanadium's persistence it is also considered
highly toxic at higher concentrations.
Three commenters contend that since most vanadium compounds are
practically insoluble, they consequently have very low bioavailability,
and thus it is likely that they could qualify for delisting. The
commenters argue that the delisting process is extremely cumbersome,
time-consuming and costly. One of these commenters contends that it is
inappropriate to list all of vanadium compounds based on aquatic
toxicity of the few compounds cited in the proposed rule. The
bioavailability of metals such as vanadium was also raised as an issue
at the public meetings held for this rulemaking. It was suggested that
the parent metal will not be bioavailable from certain metal compounds
that may be released into the environment and that therefore the
compounds cannot be
[[Page 58709]]
properly characterized as a PBT chemicals.
EPA disagrees with these comments. First, it should be noted that
EPA has not addressed whether vanadium and vanadium compounds can
properly be classified as PBT chemicals in this rulemaking. The sole
issue, therefore, is whether vanadium and vanadium compounds meet the
EPCRA section 313(d)(2)(C) listing criteria. EPA's analysis of the
environmental fate of vanadium and vanadium compounds shows that under
many environmental conditions vanadium will be available and thus is
able to express its toxicity. The commenters have not provided EPA with
any data or acceptable scientific studies indicating that vanadium in
any particular compound will not become available in the environment.
In fact, at least one commenter appears to indicate that these vanadium
compounds may merely have low solubility. In these compounds, the
parent metal vanadium can become available. While water soluble
vanadium compounds would obviously provide vanadium in an immediately
bioavailable form, solubility is not the only factor to consider in
determining the bioavailability of vanadium from a vanadium compound.
In addition to solubility, processes such as: hydrolysis at various
pHs; solubilization in the environment at various pHs; photolysis;
aerobic transformations (both abiotic and biotic); anaerobic
transformation (both abiotic and biotic); and bioavailability when the
compounds are ingested (solubilization in and/or absorption from the
gastrointestinal tract and solubilization in various organs) need to be
considered. In Unit VI.C., EPA discusses in detail the persistence and
bioavailability of metals in general.
The issue of bioavailability has been addressed for EPCRA section
313 chemical assessments through EPA's policy and guidance concerning
petitions to delist individual members of the metal compound categories
on the EPCRA section 313 toxic chemical list (56 FR 23703). This policy
states that if the metal in a metal compound cannot become available as
a result of biotic or abiotic processes then the metal will not be
available to express its toxicity. If the intact metal compound is not
toxic and the metal is not available from the metal compound then such
a chemical is a potential candidate for delisting.
One commenter argued that the lowest toxicity value cited by EPA
for a marine algal species was for Dunaliella marina with a 9-day
LC50 of 0.5 mg/L but that EPA omitted a study which tested
the same species and reported no significant adverse effects at a
concentration of 50 mg/L.
EPA believes that the study that reported the 9-day LC50
of 0.5 parts per million (ppm) on Dunaliella marina, is accurate and
was acceptably conducted within the guidelines for ecological
assessments of hazardous chemicals. This study shows the most sensitive
species' response to the chemical. There are differences in the two
studies that could explain the range of toxicity between the two. They
are: (1) Differences in the exposure times, (2) the species used in the
experiments, and (3) the form of vanadium that was exposed to the
organisms. The exposure time in the study EPA cited reported a 9-day
LC50 of 0.5 mg/L. However, the study the commenter cites did
not report an LC50 duration. Also, the species for the study
EPA cited reported the test species to be Dunaliella marina (salina),
but the study the commenter cited only reported the genus name for this
organism. Furthermore, the study EPA cited reported the form of
vanadium as sodium vanadate, but the study the commenter cites only
reported using the vanadium compound without reporting the specific
salt form. It is clear that any one of the three factors mentioned, or
some combination of these factors, likely accounts for the variation in
toxicity between the two studies.
One commenter argues that a study, omitted in EPA's review of
vanadium toxicity, on nine algal species showed no significant
reduction in productivity (as measured by chlorophyll synthesis) at
vanadium concentrations in excess of 10 mg/L. The commenter also
contends that the authors of the study also demonstrated that phosphate
concentrations were critical in the toxicity of vanadium to algae.
The Agency has not neglected to review the study cited by the
commenter. However, EPA interprets the study cited by the commenter as
describing the competition uptake between vanadium and phosphorus in an
algal medium containing two different kinds of phosphorus
concentrations (i.e., phosphorus deficient and phosphorus sufficient).
Also, this study was performed only on freshwater algae and one form of
vanadium (orthovanadate) which only exists in a pH range of 3 to 6.
This study did report a moderately high toxicity value for Scenedesmus
acutus between 5 and 177 M, which continues to support EPA's findings
that vanadium is toxic to algae. Furthermore, EPA is aware that there
are studies that were not included in the assessment that showed that
the chemical was more toxic than the values reported in EPA's
assessment. However, each study was carefully reviewed based on EPA's
extensive evaluation process which reviews studies for conformance with
generally accepted scientific standards and tests. The studies that
were reported in EPA's assessment used generally accepted, validated
scientific methods for evaluating aquatic toxicity. The toxicity values
that were reported in the ecological assessment of vanadium toxicity
were from well-conducted studies.
One commenter argues that it appears from a review of the data that
the contention that vanadium is highly toxic to algae has no basis. The
commenter contends that with the exception of one study on a single
species, Ceratium hirundinella, none of the studies on freshwater algae
showed significant toxicity at concentrations below 10 mg/L. The
commenter states that the lowest level of toxicity reported for a
marine species (Dunaliella marina) was an LC50 of 0.5 mg/L,
but that there is conflicting evidence that the threshold of toxicity
for this species may be higher than 50 mg/L. The commenter concludes
that there appears to be little evidence that vanadium is a highly
toxic agent to algae. The commenter also argues that evaluating the
toxicity of a compound based on the response of individual algal
species can be misleading. The commenter contends that algae never
exist within either marine or freshwater environments as monocultures,
but rather as dynamic mixed populations. The commenter concludes that
unless a compound can be shown to have a broad effect over an entire
assemblage or over numerous species of either freshwater or marine
species, it is not likely to have a significant effect within the
natural environment.
EPA's assessment on algae toxicity shows that vanadium is highly
toxic based on the most sensitive species' response to the chemical.
There is no conflict in the threshold of toxicity of Dunaliella marina.
As stated above, there are three factors that most probably account for
the differences between the study EPA cited and the study the commenter
cites. After careful review of the available data, it is EPA's
professional judgment that the study EPA cited provides accurate and
valid data.
Algae studies have been included in ecological risk assessments for
over 2 decades. Several guidelines on different species have been
written to show that these genera are important in the environment and
show sensitivity in how chemicals affect the biota. EPA
[[Page 58710]]
agrees that algae usually do not exist in monocultures in the marine or
freshwater environment. However, testing monocultures species is the
most accurate method to determine whether a chemical is directly
harmful to that species. Therefore, if a compound is highly toxic to a
particular species of algae or any species, its effects can be
extrapolated to represent other species exposed to that chemical. This
evaluation process has been used by the Agency and accepted by OECD for
over two decades, and used on thousands of chemicals. Vanadium's
toxicity ranges from highly toxic to moderately toxic for algae in
EPA's assessment. It is reasonable from the evidence in EPA's
assessment of vanadium that the species that is the most sensitive to
the chemical can represent the toxicity for all other species based on
this narrow range. EPA's final evaluation of any chemical's toxicity is
based on the most sensitive species' response.
One commenter contends that the study EPA cited that reported the
144-hour LC50 of 0.4 and 0.5 mg/L for vanadyl sulfate
(VOSO4) and ammonium metavanadate
(NH4VO3), respectively, were actually values for
VOSO4 and sodium metavanadate (NaVO3)
respectively. The commenter contends that the 144-hour LC50
for NH4VO3 was l.5 mg/L. The commenter also
argues that EPA neglected to report from the same study a 144-hour
LC50 of 1.1 mg/L for vanadate pentoxide
(V2O5) for this species. The commenter also
contends that the findings of 144-hour LC50s of 2.5 to 8.1
mg/L in goldfish (Carassius auratus) for the same four vanadium species
were also omitted.
The comment concerning the vanadium compounds for the 144-hour
LC50s of 0.4 and 0.5 mg/L is correct. EPA inadvertently
cited to the incorrect compound in the study. The correct vanadium
compounds will be reflected in an update to the support document.
However, sodium metavanadate, is still a vanadium compound and the
study therefore continues to support EPA's findings that vanadium is
highly toxic to fish. The other values of 2.5 and 8.1 mg/L merely
provide further support for EPA's finding that the vanadium is
moderately toxic to fish. However, considering vanadium's persistence
in the environment, EPA believes that it is highly toxic at
concentrations between 1 and 10 mg/L. Thus the goldfish values provide
further support to EPA's finding that vanadium is highly toxic to some
aquatic organisms.
One commenter contends that in assessing the toxicity of vanadium
to fish, EPA neglected to review the following studies: (1) Hamilton
and Buhl (1997), who reported a 96-hour LC50 for the
flannelmouth sucker (Catostomus latipinnis) of 11.7 mg/L; (2) Taylor et
al. (1985), who reported a 96-hour LC50 for English sole
(Limanda limanda) of 26.8 mg/L; (3) Ernst and Garside (1987), who
reported a 96-hour LC50 for the brook trout (Salvelinus
fontinaliis) alevins of 24 mg/L and for yearlings of 7-15 mg/L (the
authors also reported that the method by which stock solutions are
formulated could have a dramatic effect on the toxicity of vanadium
through its effects on the polymeric form of the metal in the test
study); and (4) Hamilton and Buhl (1990), who reported a 96-hour
LC50 for chinook salmon (Oncorhynchus tshawytscha) fry of
16.5 mg/L.
EPA undertook an exhaustive review of vanadium toxicity. The
studies the commenter has listed show that vanadium compounds are
moderately toxic to fish, which further support EPA's findings on the
toxicity of vanadium. EPA's review of the studies cited in the proposed
rule are not contradicted or undermined by the studies provided by the
commenter, and continue to support the Agency's conclusion that
vanadium and vanadium compounds are highly toxic to some aquatic
species.
One commenter states that the background document to support EPA's
proposal to list vanadium and vanadium compounds indicates that the
proposed listing is based on data for five vanadium compounds: vanadium
pentoxide, sodium metavanadate, sodium orthovanadate, vanadyl sulfate,
and ammonium vanadate. The commenter contends that EPA may consider
listing under EPCRA section 313 for the individual compounds for which
the Agency has data, but EPA is not justified in listing a broad
``vanadium and vanadium compounds'' category based on data for only
five compounds. The commenter suggests that EPA consider individual
listings for these compounds, or a category consisting only of the
compounds for which the Agency has data.
EPA disagrees with the commenter's characterization of the Agency's
assessment of vanadium and vanadium compounds. In assessing the
ecological toxicity of vanadium and vanadium compounds, EPA evaluated
the parent metal (vanadium) and determined that it is highly toxic to
some aquatic organisms and can reasonably be anticipated to cause a
significant adverse effect on the environment of sufficient seriousness
to warrant reporting pursuant to EPCRA section 313(d)(2)(C). Thus,
vanadium, the parent metal in vanadium compounds, is the concern, not
the other components of each compound. Many metals are tested in the
salt form because they are readily soluble in aqueous solutions. The
toxicity data for vanadium shows that the metal is highly toxic
(aquatic toxicity < 1 mg/L) to the most sensitive species. In addition,
because vanadium is persistent, EPA considers any toxicity values
between 1 and 10 mg/L as indicating high ecotoxicity. This evaluation
of vanadium's toxicity is acceptable according to traditional
guidelines for the assessment of toxic substances conducted by the
Agency for over two decades.
EPA has also provided sufficient basis for the inclusion of all
vanadium compounds in the category. As EPA stated in the 1994 chemical
expansion final rule:
The Agency believes it satisfies the statutory criteria to add a
category to the list by identifying the toxic effect of concern for
at least one member of the category and then showing why that effect
may reasonably be expected to be caused by all other members of the
category. (at 59 FR 61442) See also, Troy, supra at 277.
EPA developed a hazard assessment for vanadium which reviewed the
toxicity data for several vanadium compounds. The assessment indicated
that the vanadium from these compounds is highly toxic to aquatic
organisms. Since it is the vanadium from these compounds that is highly
toxic rather than the intact chemical compound, EPA believes that all
chemicals that are a source of vanadium meet the EPCRA section
313(d)(2)(C) listing criteria. Thus, EPA has established the toxic
effect of concern, the chemical species that causes the effect, and the
basis for why it may reasonably be expected that all members of the
vanadium compounds category can cause the effects of concern.
Based on the available toxicity data, EPA has concluded that
vanadium and vanadium compounds are toxic. They have the potential to
kill fish, algae, and invertebrates as well as causing a range of other
adverse effects on fish, algae, and invertebrates, based on chemical
and/or biological interactions. Vanadium and vanadium compounds can
cause these toxic effects at relatively low concentrations. Toxicity
data for vanadium and vanadium compounds include for algae, a 9-day
LC50 of 0.5 mg/L, a 15-day LC50 of 0.5 mg/L,
inhibition of growth at 0.1 ppm, adverse effects on cell division at 3
ppb, 20 ppb, and 0.5 ppm; and for fish, a 96-hour LC50 of
0.62 ppm, and growth and survival depression of larvae at 0.17 ppm.
Because vanadium and vanadium
[[Page 58711]]
compounds can cause these toxic effects at these relatively low
concentrations, EPA considers these chemicals to be highly toxic.
Additional toxicity values include for algae, 9-day LC50s of
2 and 3 ppm, and a 15-day LC50 of 2 mg/L; for invertebrates,
a 9-day LC50 of 10 ppm; and for fish, 96-hour
LC50s of 6.4 ppm, 10 ppm, and 7 mg/L, an LC50 of
5.6 mg/L, an 11-day LC50 of 1.99 mg/L, 14-day
LC50s from 1.95 to 4.34 mg/L, and 7-day LC50s
from 1.9 to 6.0 ppm. Considering vanadium's persistence, vanadium and
vanadium compounds are considered highly toxic to aquatic organism at
these higher concentrations.
As discussed above, vanadium and vanadium compounds are highly
toxic. Because vanadium and vanadium compounds are toxic at relatively
low concentrations, EPA believes that they cause or can reasonably be
anticipated to cause a significant adverse effect on the environment.
In addition, because of the nature of the potential significant adverse
effects, e.g., fish, algae, and invertebrate kills as well as a range
of other adverse effects on fish, algae, and invertebrates, and the
impacts such effects can have on ecological communities and ecosystems,
EPA has determined that they are of sufficient seriousness to warrant
reporting.
Thus, EPA reaffirms that there is sufficient evidence for adding
vanadium and vanadium compounds on the EPCRA section 313 list of toxic
chemicals pursuant to EPCRA section 313(d)(2)(C)(i) and (ii), based on
the available ecotoxicity information for vanadium and vanadium
compounds.
Therefore, EPA is finalizing the listing of vanadium and vanadium
compounds on the EPCRA section 313 list.
a. Reporting limitation of alloys. A number of commenters support
EPA's proposed determination to defer the reporting of vanadium when
contained in alloys (64 FR 717). Many commenters also suggest that the
Agency adopt a reporting limitation for the other metals such as
chromium, copper, manganese, and nickel which are commonly found in
alloys. The commenters assert that alloys have significantly different
bioavailability, bioaccumulation, and toxicity characteristics than
other forms of metals, and thus should be treated separately. The
commenters argue that alloys are inherently more stable than unalloyed
materials, do not enter the environment as readily as unalloyed
materials and hence do not interact as greatly with organisms, and
should be considered safer from an environmental and human health
perspective. The commenters suggested that alloys should be treated
separately not only for threshold changes, but also for EPCRA section
313 listings in general and recommend excluding alloys from general
EPCRA section 313 listings for metals.
One commenter states in regard to the reporting of metals in alloys
that it makes little or no sense to require the reporting of such
``useless'' information, since the information does not serve the
purpose of informing the community. The commenter contends that not
adding vanadium when contained in alloys would help to achieve EPCRA
section 313's underlying purpose, i.e., to provide the public with
meaningful information, while at the same time reducing the burden on
reporting facilities. Another commenter argues that the proposed alloys
exemption correctly recognizes that metals in alloys are not generally
available for exposure or for toxic effects. The commenter argues that
expansion of the exemption would improve the TRI data base by reporting
only releases that may pose risks to human health and the environment,
thereby providing the public with more meaningful data.
Two commenters state that the definition of vanadium alloys should
include ``fused alloy slag'' in the qualifier as well. The commenters
contend that the state of the vanadium in a ferroalloy form is one of
intimate chemical combination on the atomic level, not a simple mixture
of individual components and it is inherently stable and cannot be
dissociated by ordinary means. The commenters argue that likewise, the
fused alloy slag formed represents an intimate chemical combination of
materials as a result of the smelting operation. The commenters assert
that these elemental materials may include various components such as
gangue or ore, ash of fuel, refractory lining, or other stable oxides
with the ultimate characterization resting upon the chemical stability
of the resultant fused alloy bearing slag. Thus, the commenters argue,
vanadium contained in either alloy or alloy slag form is fused in a
stable compound and therefore, no releases of vanadium into the
environment would occur from either substance. The commenters state
that the true environmental issue to consider in the formulation of an
activity qualifier is the leachability of the material in that state,
and since in both of the aforementioned cases the vanadium is in a
stable compound, leaching would not be expected. The commenters assert
that without allowing an exemption for fused alloy slag, large volumes
of steelmaking and ferroalloy slag will unnecessarily fall under this
reporting requirement. The commenters request that EPA reconsider its
position and expand the definition of alloy to include both vanadium
alloys and vanadium alloy slags.
EPA agrees with those commenters that support EPA's belief that it
would be inappropriate, at this time, to change the status quo
regarding reporting vanadium when contained in an alloy. As EPA stated
in the proposed rule, the Agency is reviewing the issue of whether
there should be any changes to the reporting requirements for metals
contained in alloys.
In the proposed rule, EPA did not state, and did not intend to
imply, that EPA considers alloys to be ``safe,'' or as some commenters
suggested, that EPA had ``correctly'' recognized that metals in alloys
are not generally available for exposure or to express their toxic
effects. EPA has not completed its review of the alloys issue and has
made no conclusions regarding whether there should or should not be any
type of limitation or exemption for any metals contained in alloys.
EPA's proposal merely recognized that while this issue was under
review, it would not be appropriate to add alloy forms of vanadium.
The commenters contend that alloys have significantly different
bioavailability, bioaccumulation, toxicity characteristics than other
forms of metals and are inherently more stable than unalloyed materials
and do not enter the environment as readily as unalloyed materials. EPA
believes that the issue with alloys is primarily bioavailability, i.e.,
do the metals contained in alloys become available. This issue is the
focus of EPA's current review. At this point in time, while EPA is in
the process of a scientific review of the issues pertinent to alloys,
the Agency is not prepared to make a final determination on whether
vanadium in vanadium alloys meet the EPCRA section 313(d)(2) toxicity
criteria.
The commenters did not provide any data to support their
contention. The Agency does not believe that a metal compound in a slag
necessarily will be environmentally unavailable; rather, the Agency's
experience with a previous EPCRA section 313(d) review of manganese
slags, indicates that at least in some cases the metal will be
available (60 FR 44000, August 24, 1995) (FRL-4954-6).
Some commenters suggested that EPA create an alloys reporting
limitation for all metals contained in alloys. However, as EPA has
stated, the review of whether any kind of exemption or reporting
limitation should be granted for certain metals in alloys is still
under review and until the Agency has thoroughly reviewed the available
data, EPA is not
[[Page 58712]]
prepared to extend the reporting limitation to any other metals. For
example, EPA is not lowering the reporting threshold for cobalt and
cobalt compounds, and therefore the Agency is taking no action with
respect to a reporting limitation for cobalt when contained in alloys.
One commenter asserts that for reasons of consistency--which helps
ensure data quality--with existing EPCRA section 313 metal compound
categories, they oppose adding the qualifier ``except when contained in
an alloy'' in any new listing for vanadium.
EPA has not completed its review of the alloys issue and has made
no conclusions regarding whether there should be any type of general
limitation or exemption for any metals contained in alloys. EPA merely
recognized that while this issue was under review it would not be
appropriate to increase the reporting requirements for those facilities
that would otherwise submit reports for vanadium contained in alloys.
Therefore, as discussed earlier in this section, EPA has expanded the
EPCRA section 313 listing for vanadium by removing the ``fume or dust''
qualifier for vanadium, but has not added the alloy forms of vanadium.
Until EPA has the opportunity to fully evaluate the available data, the
Agency is not prepared to make a final determination whether vanadium
contained in alloys meets the EPCRA section 313(d)(2) listing criteria
and should therefore be added. EPA believes that consistency, in this
context, does not provide a sufficient basis to require reporting of
vanadium contained in alloys.
H. Persistence and Bioaccumulation
The persistence and bioaccumulation data for the PBT chemicals
covered by this final rule are listed in Table 3. A discussion of these
data follows Table 3.
Table 3.--Persistence and Bioaccumulation Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water Half-
Chemical Category/Chemical Name CASRN BCF BAF Air Half-life life Soil Half-life
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dioxin/Dioxin-Like Compounds
Polychlorinated dibenzo-p-
dioxins
1,2,3,4,6,7,8-heptachlorodibenzo- 35822-46-9 1,466 12.2-4.2 hrs 20 yrs
p-dioxin
1,2,3,4,7,8-hexachlorodibenzo-p- 39227-28-6 5,176 12.4-2.7 hrs 20 yrs
dioxin
1,2,3,6,7,8-hexachlorodibenzo-p- 57653-85-7 3,981 12.4-2.7 hrs 20 yrs
dioxin
1,2,3,7,8,9-hexachlorodibenzo-p- 19408-74-3 1,426 12.4-2.7 hrs 20 yrs
dioxin
1,2,3,4,6,7,8,9- 3268-87-9 2,239 20.4-4.8 hrs 20 yrs
octachlorodibenzo-p-dioxin
1,2,3,7,8-pentachlorodibenzo-p- 40321-76-4 10,890 14.8-2.0 hrs 20 yrs
dioxin
2,3,7,8-tetrachlorodibenzo-p- 1746-01-6 5,755 9.6-1.2 hrs 20-1.5 yrs
dioxin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Polychlorinated dibenzofurans
1,2,3,4,6,7,8- 67562-39-4 3,545 25.0-4.3 hrs 20 yrs
heptachlorodibenzofuran
1,2,3,4,7,8,9- 55673-89-7 3,545 25.0-4.3 hrs 20 yrs
heptachlorodibenzofuran
1,2,3,4,7,8- 70648-26-9 3,586 13.3-3 hrs 20 yrs
hexachlorodibenzofuran
1,2,3,6,7,8- 57117-44-9 3,586 13.3-3 hrs 20 yrs
hexachlorodibenzofuran
1,2,3,7,8,9- 72918-21-9 10,300 13.3-3 hrs 20 yrs
hexachlorodibenzofuran
2,3,4,6,7,8- 60851-34-5 3,586 13.3-3 hrs 20 yrs
hexachlorodibenzofuran
1,2,3,4,6,7,8,9- 39001-02-0 1,259 29.4-13.7 hrs 20 yrs
octachlorodibenzofuran
1,2,3,7,8- 57117-41-6 33,750 11.6-1.2 hrs 20 yrs
pentachlorodibenzofuran
2,3,4,7,8- 57117-31-4 42,500 11.6-1.2 hrs 20 yrs
pentachlorodibenzofuran
2,3,7,8-tetrachlorodibenzofuran 51207-31-9 2,042 11.5-2.1 hrs 20 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticides
Aldrin 309-00-2 3,715 10 hrs-1 hr 24 days1 9 yrs-291 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlordane 57-74-9 11,050 >6,000,0002 5 days-12 hrs 239 days 8-0.4 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Heptachlor 76-44-8 19,953 10.5 hrs-1 hr 129.4-23.1 hrs 4 yrs-8 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Isodrin 465-73-6 20,180 10 hrs-1 hr 5 yrs-180 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methoxychlor 72-43-5 8,128 12 hrs-1 hr 15.2-5 days 136-81 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pendimethalin 40487-42-1 1,944 21-2 hrs 1300-54 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Toxaphene 8001-35-2 34,050 16 days-19 hrs 5 yrs-1 yr 11-1 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trifluralin 1582-09-8 5,674 3.2-0.42 hrs 36.5-4.5 days1 394-99 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Polycyclic Aromatic Compounds
[[Page 58713]]
Benzo(a)pyrene 50-32-8 912 2.4 hrs 17.3-5.4 yrs 14.6 yrs-151 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(b)fluoranthene 205-99-2 5,631 1.4 days-3.4 hrs 100 14.2 yrs-87 days
days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(r,s,t)pentaphene 189-55-9 26,280 13 hrs-1 hr 371-232 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(a)anthracene 56-55-3 800 13 hrs-1 hr 3-1.2 yrs 2.0 yrs-240 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
7,12-Dimethylbenz(a)anthracene 57-97-6 5,834 4-0.4 hrs 6 yrs-1 yr 28-20 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenzo(a,h)anthracene 53-70-3 31,440 13 hrs-1 hr 100 2 yrs-240 days
days
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-Methylcholanthrene 56-49-5 17,510 3-0.3 hrs 3.8-1.7 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
7H-Dibenzo(c,g)carbazole 194-59-2 16,900 23-2 hrs >160 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(k)fluoranthene 207-08-9 10,090 12 hrs-1 hr 11 yrs-139 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(j)fluoranthene 205-82-3 10,090 12 hrs-1 hr 10.5 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenzo(a,e)pyrene 192-65-4 6,875 13 hrs-1 hr 371-232 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenzo(a,h)pyrene 189-64-4 26,280 13 hrs-1 hr 371-232 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indeno(1,2,3-cd)pyrene 193-39-5 28,620 7.6-0.34 hrs 730-58 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenz(a,h)acridine 226-36-8 3,500 13 hrs-1 hr >160 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenz(a,j)acridine 224-42-0 18,470 23-2 hrs >160 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(g,h,i)perylene 191-24-2 25,420 10.0-0.31 hrs 100 1.8 yrs-173 days
days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenzo(a,e)fluoranthene 5385-75-1 26,280 10 hrs-1 hr 371-232 days3
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-Methylchrysene 3697-24-3 9,388 5-0.5 hrs 3.8 yrs-79 days4 2.7 yrs-255 days4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dibenzo(a,l)pyrene 191-30-0 6,875 13 hrs-1 hr 371-232 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(a)phenanthrene 218-01-9 800 13 hrs-1 hr 3.8 yrs-79 days 2.7 yrs-255 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-Nitropyrene 5522-43-0 908 4 days-10 hrs 44 yrs-16 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzo(j,k)fluorene 206-44-0 5,100 20-2 hrs 13 yrs-110 days
(fluoranthene)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metals/Metal Compounds
Mercury5 and Mercury compounds 7439-97-6 7,000-36,000 see footnote 5 see footnote 5 see footnote 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Polychlorinated Biphenyl 1336-36-3 >200,0002,6
(PCBs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,3,4,4,5,5- 39635-31-9 4,922 191-19 days >56 days >5-3.92 yrs
heptachlorobiphenyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,3,4,4,5-hexachlorobiphenyl 38380-08-4 37,590 127-13 days >56 days >5-3.42 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,3,4,4,5-hexachlorobiphenyl 69782-90-7 37,590 114-11 days >56 days >5-3.42 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 58714]]
2,3,4,4,5,5-hexachlorobiphenyl 52663-72-6 37,590 114-11 days >56 days >5-3.42 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,3,4,4,5,5-hexachlorobiphenyl 32774-16-6 73,840 88-9 days >56 days >5-3.42 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,3,4,4-pentachlorobiphenyl 32598-14-4 196,900 >134,000,0002 80-8 days >56 days 7.25-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,4,4,5-pentachlorobiphenyl 74472-37-0 196,900 67-7 days >56 days 7.25-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,4,4,5-pentachlorobiphenyl 31508-00-6 184,300 >141,000,0002 80-8 days >56 days 7.25-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,3,4,4,5-pentachlorobiphenyl 65510-44-3 196,900 50-5 days >56 days 7.25-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,3,4,4,5-pentachlorobiphenyl 57465-28-8 196,900 57-6 days >56 days 7.25-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,3,4,4-tetrachlorobiphenyl 32598-13-3 105,900 37-4 days >98 days 4.83-0.91 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Chemicals
Hexachlorobenzene 118-74-1 29,600-66,000 >2,500,0002 1,582-158 days 5.7-2.7 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Octachlorostyrene 29082-74-4 33,113 >117,000,0002 10 hrs-1 hr 5.7-2.7 yrs7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pentachlorobenzene 608-93-5 8,318 >640,0002 460-46 days 194 days->22 yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tetrabromobisphenol A 79-94-7 780; 1,200; 3,200 9 days-1 day 84-48 days 44-179 days
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The reported half-life data for water are suspected to include significant removal from the medium by processes other than degradation (e.g.,
volatilization).
2Values are for Piscivorous Fish.
3Since data could not be found for this chemical, the data for the dibenzopyrenes (192-65-4; 189-64-0; 191-30-0), which are structural analogues, was
used.
4Since data could not be found for this chemical, the data for benzo(a)phenanthrene (218-01-9), a structural analogue was used.
5The bioaccumulation potential for the parent metals is assumed to be equivalent to the associated metal compounds since in the environment the parent
metals may be converted to a metal compound. Since metals are not destroyed in the environment they persist longer than 6 months.
6Lowest value reported for a dichlorinated PCB.
7Since no data could be found for this chemical, the data for the structural analogues hexachlorobenzene (118-74-1) and pentachlorobenzene (608-93-5)
was used.
1. Persistence--a. Dioxin and dioxin-like compounds. In the
proposal, EPA preliminarily determined that dioxin and dioxin-like
compounds have persistence half-life values in soil that ranged from
1.5 years to more than 20 with all but one chemical having a soil half-
life of more than 20 years. EPA has reviewed information and all
comments received on dioxin and dioxin-like compounds' persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that dioxin and dioxin-like compounds persist in the
environment with half-lives of 2 months or greater and therefore meet
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical category can be found in
EPA's Response to Comments document for this rulemaking (Ref. 69) and/
or in EPA's support documents for this rulemaking (Ref. 7). In
addition, dioxin and dioxin-like compounds persist in the environment
with a half-life of greater than 6 months making it highly persistent.
This, plus other factors, supports EPA's decision to lower the
threshold to 0.1 gram.
b. Aldrin. In the proposal, EPA preliminarily determined that
aldrin has persistence half-life values in soil of 291 days to 9 years
and a persistence half-life value in water of 24 days. EPA has reviewed
information and all comments received on aldrin's persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that aldrin persists in the environment with a half-
life of 2 months or greater and therefore meets the persistence
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69) and/or in EPA's support
documents for this rulemaking (Ref. 7).
c. Chlordane. In the proposal, EPA preliminarily determined that
chlordane has persistence half-life values in soil of 0.4-8 years and a
persistence half-life value in water of 239 days. EPA has reviewed
information and all comments received on chlordane's persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that chlordane persists in the environment with a
half-life of 2 months or greater and therefore meets the persistence
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69)
[[Page 58715]]
and/or in EPA's support documents for this rulemaking (Ref. 7). In
addition, chlordane persists in the environment with a half-life of
greater than 6 months which supports EPA's decision to lower the
threshold to 10 pounds.
d. Heptachlor. In the proposal, EPA preliminarily determined that
heptachlor has persistence half-life values in soil of 8 days to 4
years and a persistence half-life value in water of 23.1-129.4 hours.
EPA has reviewed information and all comments received on heptachlor's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that heptachlor persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 7). In addition,
heptachlor persists in the environment with a half-life of greater than
6 months which supports EPA's decision to lower the threshold to 10
pounds.
e. Isodrin. In the proposal, EPA preliminarily determined that
isodrin has persistence half-life values in soil of 180 days to 5
years. EPA has reviewed information and all comments received on
isodrin's persistence characteristics. Taking into account this
information, as indicated in Table 3, EPA finds that isodrin persists
in the environment with a half-life of 2 months or greater and
therefore meets the persistence criterion established in this
rulemaking. A complete discussion of EPA's findings on this chemical
can be found in EPA's Response to Comments document for this rulemaking
(Ref. 69) and/or in EPA's support documents for this rulemaking (Ref.
7). In addition, isodrin persists in the environment with a half-life
of greater than 6 months which supports EPA's decision to lower the
threshold to 10 pounds.
f. Methoxychlor. In the proposal, EPA preliminarily determined that
methoxychlor has persistence half-life values in soil of 81 to 136 days
and a persistence half-life value in water of 5 to 15.2 days. EPA has
reviewed information and all comments received on methoxychlor's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that methoxychlor persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 7).
g. Pendimethalin. In the proposal, EPA preliminarily determined
that pendimethalin has a persistence half-life value in soil of 54 to
1,300 days. EPA received several significant comments addressing
pendimethalin's persistence potential which are addressed below. EPA
has reviewed information and all comments received on pendimethalin's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that pendimethalin persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 7).
One commenter contends that EPA has miscategorized pendimethalin as
a PBT chemical based on limited screening data which conflicts with
conclusions reached by EPA in its risk assessment under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The commenter
believes that the characterization of pendimethalin is inaccurate and
will lead to misplaced effort and misplaced focus on listed chemicals,
and that there will be no benefit to the public or the environment in
lowering the reporting threshold for pendimethalin.
EPA disagrees with the commenter. EPA did not base its
determination that pendimethalin meets the EPCRA section 313
persistence criteria, nor that pendimethalin is highly persistent on
``screening'' data. EPA's conclusion that pendimethalin persists with a
half-life greater than 6 months is based on a well-conducted study in
which pendimethalin degrades in soil with a half-life of 1,322 days.
Further, even if these data were discounted, there are numerous data
submitted in support of reregistration of pendimethalin under FIFRA
that provide strong evidence that pendimethalin meets the EPCRA section
313 persistence criteria, i.e., a half-life greater than 2 months. A
more detailed discussion of these data is presented in the following
responses. Contrary to the assertion by the commenter, the
categorization of pendimethalin as a PBT chemical as described in the
proposed rule is not in conflict with the conclusions reached by EPA
during the FIFRA assessment. In addition, EPA disagrees that there will
be no benefits to the public or the environment from lowering the
thresholds for pendimethalin. EPA believes that pendimethalin, like all
PBT chemicals, is of special concern because it has the potential to
cause adverse effects even when released to the environment in small
quantities because it can bioaccumulate in organisms to levels much
greater than those present in the environment. EPA believes that
lowering the reporting threshold for pendimethalin will provide
information to the public that will increase their awareness of low
levels of releases to the environment which have the potential to
concentrate in organisms and cause adverse effects, which is fully
consistent with the purposes of EPCRA section 313.
The commenter states that EPA has ignored bioavailability in
designating pendimethalin as a PBT chemical and argues that the true
bioaccumulation potential for pendimethalin is greatly overestimated
based on the results of the standard laboratory fish bioconcentration
study. The commenter asserts that when data on bioavailability,
degradation, and depuration are all considered, the ``real world''
bioconcentration potential for pendimethalin is low and, therefore
pendimethalin should not be mischaracterized as a PBT chemical.
The bioavailability data the commenter refers to was not
specifically identified. Bioavailability of a chemical will vary from
environment to environment and soil type to soil type. Caution must be
taken, however, not to draw the erroneous conclusion that because a
chemical has been shown to have a high affinity to sorb to sediments in
aquatic environments that it will not be available for uptake by
aquatic organisms. Examples like the PCBs (see Unit VI.F. for a further
discussion on this issue) indicate that although some of these
compounds have sorption coefficients much greater than pendimethalin,
they are still widely found in the tissues of aquatic organisms in
contaminated waters. Further, it would be erroneous to state that
pendimethalin is not bioavailable because if it were not bioavailable
it could not function as an herbicide.
The commenter claims that using EPA's own criteria (half-lifes
longer than 2 months in water, sediment, or soil, or a half-life longer
than 2 days in air) pendimethalin cannot be classified as persistent.
Rather the commenter contends that pendimethalin has ``low'' or ``low
to moderate'' persistence.
The commenter is incorrect. The Agency has set persistence criteria
of half-lifes for soil, sediment, and water
[[Page 58716]]
greater than 2 months and a half-life in air of greater than 2 days.
Chemicals meeting these criteria are considered persistent for purposes
of EPCRA section 313. There are, in fact, no qualifiers such as
``low,'' ``moderate,'' or ``high'' associated with the persistence
criteria. The commenter's characterization of the persistence of
pendimethalin as ``low'' or ``low to moderate'' is thus not
particularly relevant. It appears, based on the comments, that the
commenter defines low to moderate persistence as a half-life of greater
than 2 days in air and greater than 2 months in soil, sediment, or
water. If this is the case, then the commenter in fact concurs with
EPA's assessment of pendimethalin as persistent (half-life greater than
2 months in soil or water and greater than 2 days in air).
If the commenter, instead, meant that pendimethalin has half-lifes
of less than 2 months in soil or water, and 2 days in air, EPA notes
that the commenter has failed to provide data to support that
assertion, and that EPA's review of the data support the Agency's
conclusion.
A commenter cites numerous laboratory and field dissipation studies
in support of the claim that pendimethalin does not meet the
persistence criteria.
EPA disagrees that the degree of persistence of pendimethalin can
be characterized by the field dissipation studies cited by the
commenter. Field dissipation studies are not equivalent to the studies
which measure the half-life for destruction of a chemical in a specific
medium (i.e., soil, water, or air). Field dissipation studies are
designed to measure the rate or extent of chemical loss from the medium
after application of the chemical. The processes by which the chemical
is lost may include not only those that result in destruction of the
chemical, but those which only transport the chemical from one medium
to another such as volatilization. The studies cited by the commenter
measure the dissipation of pendimethalin from soil. For a relatively
volatile chemical such as pendimethalin, field dissipation studies are
of limited use in assessing persistence because an unknown amount of
pendimethalin will be transported from soil to air, resulting in a
measured loss from that medium, but not destruction. Thus, the field
dissipation studies cited by the commenter will underestimate the
persistence of pendimethalin in soil.
The commenter cites several laboratory experiments on the
degradation of pendimethalin in soil to support the argument that
pendimethalin does not meet the persistence criteria. For example, they
state that laboratory aerobic soil degradation studies have been
conducted in which pendimethalin was applied to soil grab samples and
incubated under controlled conditions. Pendimethalin degraded in
laboratory soil studies with half-lifes ranging from 31 to 1,322 days.
In the Reregistration Eligibility Decision (RED) for Pendimethalin (Ref
63) document, EPA explained that 172 days was used instead of 1,322
days because:
The half-lifes for aerobic soil metabolism ranged from 42-563
days in the literature studies referenced below with a guideline
study reporting a half-life of 1,322 days for a total of 27 total
observations. Because of the range of half-life values, statistical
analyses of the available data were performed. The mean, median, and
modal half-lifes are 126, 122, and 122 days, respectively, with a
standard deviation of 66 days (n=24). The half-life values of 409,
563, and 1,322 days were not included in the final statistical
analyses because they were greater than three standard deviations
from the mean. Based on soils and crops that are normally treated
with pendimethalin, the reviewer assumed that temperatures would
likely range from 20-30 deg.C and soil moisture contents from 50-
75% Field Capacity (FC). The range of observed half-lifes in the
above experimental conditions was 72-172 days.
The commenter contends that the 1,322-day half-life value is assumed to
be an outlier (Ref. 5), the range was 31 to 172 days. Thus, it is
claimed that laboratory studies also indicate that pendimethalin has a
low to moderate persistence according to the EPCRA section 313
persistence criteria.
EPA believes that the guideline study that reported a half-life of
1,322 days represents an accurate and representative value for the
assessment of the persistence of pendimethalin in the environment. In
situations where multiple values for half-lifes are submitted under
FIFRA to EPA's Office of Pesticide Program (OPP), statistical analysis
may be conducted to determine mean values and standard deviations. The
analysis permits the use of a value for exposure assessment modeling
that takes into account the variability in data, and allows the
exclusion of values more than three standard deviations outside the
mean as ``outliers.'' The designation as an outlier does not invalidate
the study, and in fact, EPA maintains that even a study designated as
an ``outlier,'' if valid, gives useful half-life information.
In their assessment of the persistence of chemicals in soils, OPP
focuses on studies using soil types, soil moisture contents, and
temperatures consistent with the field application of the chemical in
its intended use. In the OPP review of the studies, the reviewer
assumed that in the field application of the chemical, temperatures
would likely range from 20-30 deg.C and that soil moisture would range
from 50 to 75% field capacity. The consideration of data from studies
conducted under these conditions resulted in a half-life range of 72 to
172 days for pendimethalin. It should be noted that even after the
elimination of outliers and consideration of studies relevant to normal
field application, the entire half-life range is above 2 months,
clearly meeting the criteria for persistence in soil, i.e., a half-life
of 2 months.
The releases of pendimethalin subject to EPCRA section 313
reporting, in many cases, will not be to agricultural soils under
typical application scenarios. EPA, therefore, contends that even
though some soil half-life values were not considered by OPP, either
because they were derived using studies that did not represent the
desired field conditions, or because they were labeled as statistical
outliers, the study conditions still represent realistic scenarios for
releases reported under EPCRA section 313 and are valid for use in the
determination of persistence.
The commenter cites studies conducted using flooded soils to
support the argument that pendimethalin does not meet the persistence
criteria. The commenter asserts that the studies involved the use of
pendimethalin spiked into soil grab samples covered with a shallow
layer of water and incubated in the laboratory under controlled
conditions. In laboratory flooded soil studies, pendimethalin
degradation half-lifes ranged from seven to 104 days with the majority
of studies giving half-lifes of less than 2 months. Degradation of
pendimethalin was more rapid in flooded soils than in nonflooded soils
in most instances. The commenter asserts that these results demonstrate
that pendimethalin has a low to moderate persistence in flooded soils
according to the EPCRA section 313 persistence criteria.
EPA agrees that the reported degradation half-lifes in laboratory
flooded soils studies range from 7 to 104 days. The studies were
reviewed for quality and preferred methodologies. Of the studies that
are of acceptable quality, EPA chose the highest value (most
protective) of the range to determine if the chemical meets the EPCRA
section 313 persistence criteria. In this case, the value of 104 days
would be used to characterize pendimethalin as persistent in flooded
soils. However,
[[Page 58717]]
there is not a separate persistence criterion for flooded soils, nor
are data on flooded soils preferable to other soil data. EPA notes that
other soil studies, as discussed above in this section, indicate a
half-life of 1,322 days in soils.
The commenter states that while pendimethalin is stable to
hydrolysis, it will degrade in natural water and water/sediment systems
under laboratory conditions with degradation half-lifes ranging from 4
to 22 days. Photodegradation is also rapid with half-lifes of
approximately 3.5 days. The commenter concludes that these results
indicate that pendimethalin has a low persistence in both water and its
underlying sediment according to the EPCRA section 313 persistence
criteria.
Two of the aerobic aquatic degradation studies cited by the
commenter were not provided to the Agency or are not publicly
available, (i.e., they are internal American Cyanamid studies). It is
unclear from the summary provided whether the cited studies measured
destruction of pendimethalin or its loss from the medium by non-
destructive water to air transport processes. If the latter is the
case, the ``dissipation half-lifes'' cited cannot be used to
characterize persistence. EPA agrees that if the half-lifes reported
for aerobic aquatic degradation represent half-lifes for destruction of
the chemical, they do not meet the criteria for persistence in water.
However, as noted, the full studies were not available for review and
as such, EPA cannot assume that the studies followed destruction of
pendimethalin, or that the studies meet the quality criteria outlined
in this rule.
The commenter cites a half-life range of 6 to 22 days derived from
an anaerobic aquatic degradation study to support the argument that
pendimethalin has a low persistence in both water and its underlying
sediment according to the EPCRA section 313 persistence criteria. EPA
agrees that the persistence half-life values cited by the commenter do
not meet the EPCRA section 313 persistence criteria, but points out
that additional data submitted in support of the reregistration of
pendimethalin indicated that half-lifes in aquatic environments could
be longer. OPP used flooded soil degradation studies to assess the
persistence of pendimethalin under anaerobic aquatic conditions. Half-
lifes in these studies ranged from 6 to 105 days. In its discussion of
the potential impact of pendimethalin on water resources, OPP in the
RED notes that pendimethalin has an anaerobic aquatic metabolism half-
life of 60 days. EPA believes that after review of the available data
on its persistence in water pendimethalin meets the EPCRA section 313
persistence criteria.
EPA agrees that rapid aqueous photodegradation under laboratory
studies has been reported for pendimethalin. However, the photolysis
screening tests used are designed to allow the determination of rates
of photolysis at shallow depths in pure water as a function of
lattitude and season. EPA believes that the environmental relevence of
these tests should be considered in their use to determine persistence,
and that the results are most applicable to shallow, clear waters. EPA
believes that the application of the results beyond these environments
is tenuous due to the attenuation of light by suspended matter and
increasing depth in the aquatic environment. EPA believes that
pendimethalin's tendency to sorb to soil and sediments may result,
under some circumstances, in its deposition in benthic environments
beyond the effects of aqueous photolysis. Therefore, EPA does not
believe that the half-life for pendimethalin in water should be based
on aqueous photolysis.
The commenter claims pendimethalin will not persist in air
according to the EPCRA section 313 persistence criteria for air since
it has a half-life of less than 2 days. The commenter discusses the
estimation of pendimethalin's atmospheric half-life and a study on its
photodegradation in air. The commenter cites the results of a
calculation according to the method of Atkinson performed to determine
the rate constant for reaction of pendimethalin with OH radicals in the
gas phase (Ref 42). A tropospheric half-life of 3.4 hours was
calculated using the method. The photolysis of pendimethalin was
investigated by Bossan, et al., 1995 (Ref. 15), who reported on the
photoreactivity of pendimethalin on airborne fly ash and kaolin using
simulated sunlight. Approximately 70% of applied pendimethalin degraded
within 30 minutes when adsorbed to fly ash but little degradation was
observed after 100 minutes when pendimethalin was bound to kaolin.
EPA agrees that pendimethalin does not meet the persistence half-
life criteria for air of greater than 2 days, but because it meets the
persistence criteria for soil and water, this does not affect EPA's
conclusion. As noted in the proposed final rule (at 64 FR 702), a
chemical need only meet one of the media-specific criteria to be
considered persistent.
The commenter cites EPA's pendimethalin RED document and cites its
conclusion in support of the argument that pendimethalin does not meet
the persistence criteria. The commenter describes the RED conclusions
as follows:
Pendimethalin dissipates in the environment by binding to soil,
microbially-mediated metabolism and volatilization. It is
essentially immobile in soil.
Based on laboratory studies and limited field study information,
pendimethalin is slightly to moderately persistent in aerobic soil
environments. Persistence decreases with increased temperature,
increased moisture and decreased soil organic carbon.
EPA disagrees with the commenters' suggestion that the OPP RED for
pendimethalin concludes that it does not meet the EPCRA 313 persistence
criteria. As stated in an earlier response, ``moderate'' persistence
has no relevance in the context of the proposed rule. A chemical is
considered persistent if it has half-lifes of 2 days in air or 2 months
in soil, sediment, or water, respectively.
The commenter implies that OPP has concluded that pendimethalin
does not meet the persistence criteria by selectively citing the OPP
RED while failing to acknowledge other information OPP discussed in the
document confirming the persistence of pendimethalin. OPP did not make
any formal summary conclusions regarding the overall environmental
persistence of pendimethalin. The commenter has selectively cited from
the RED by taking a few comments out of context while ignoring
additional findings which demonstrate that pendimethalin meets the
persistence criteria.
The first statement cited by the commenter addresses dissipation in
the environment. Two of the three processes (soil binding and
volatilization) responsible for dissipation do not result in the
destruction of the chemical and cannot be directly related to
persistence. Volatilization results in the relocation of the chemical
to the atmosphere. Binding to soil does not destroy pendimethalin and
under some soil conditions has been shown to increase persistence.
While microbial metabolism of pendimethalin can result in its
destruction, it has been shown to be a slow process under many
environmental conditions.
The commenter cites OPP's qualitative description of the
persistence of pendimethalin in aerobic soil environments as slight to
moderate. This does not serve as, nor did OPP intend for this statement
to represent, a quantitative description of pendimethalin's persistence
in soil. OPP does not attempt to relate this characterization to a
numeric range of persistence values in the RED, and the
[[Page 58718]]
commenter does not provide a rationale for concluding that OPP's
language indicates that pendimethalin does not meet the EPCRA section
313 persistence criteria.
The final sentence of the citation points out factors that decrease
persistence, but a more detailed reading of the RED on the subject of
pendimethalin persistence in aerobic soils reveals that its persistence
increases as temperature and soil moisture decrease, and soil organic
carbon increase.
The commenter performed a Level III EQC Multimedia Modeling
assessment for pendimethalin assuming ``best case, reasonable case, and
worst case'' scenarios. The calculated overall environmental
persistence was determined for pendimethalin to be 5 days, 58 days, and
142 days under the ``best, reasonable, and worst case'' scenarios,
respectively. The results of the multimedia model indicated that
pendimethalin will have a persistence in the environment of less than 2
months, assuming a reasonable case scenario. The commenter claims that
multimedia modeling results indicate that pendimethalin will not be
persistent according to the EPCRA section 313 persistence criteria.
The commenter notes that the values it calculated using the EQC
model are much lower than the 30 days and 487 days calculated for EPA
(Ref. 51) assuming best case and worst case scenarios. The commenter
alleges that EPA assumed that half-lifes in soil, sediment and water
were identical, 54 days and 1,322 days, respectively (Ref. 7). The data
presented above, however, indicate that these were erroneous
assumptions. The half-lifes for pendimethalin dissipation in water,
soil, and sediment are not identical, and the 1,322 day half-life is an
outlier.
The commenter concludes that pendimethalin will have a low to
moderate persistence whether found in the air, water, soil, or sediment
compartments of the environment. The commenter asserts that this is
supported by field and laboratory degradation studies, multimedia
modeling, and EPA's FIFRA registration environmental assessment of
pendimethalin. Therefore, pendimethalin should not be classified as
persistent for purposes of inclusion on the EPCRA section 313 list of
PBT chemicals.
EPA disagrees that pendimethalin will have low persistence in the
environment whether laboratory and field studies or multimedia modeling
are considered. Multimedia mass balance models offer the most
convenient means to estimate overall environmental persistence from
information on sources and loadings, chemical properties and
transformation processes, and intermedia partitioning. For the
chemicals included in the proposed rule, EPA used a modified version of
the EQC model (Ref. 33) to estimate overall environmental persistence.
Overall persistence estimated in this way is used as an additional
factor, in conjunction with reaction half-lifes for individual media,
bioaccumulation/bioconcentration factors, in justifying the
determination made by EPA in this rule.
The EQC model is based on the fugacity approach first delineated by
Mackay (Ref. 31) and subsequently applied to numerous environmental
processes (Ref. 32). It uses an ``evaluative environment'' in which
environmental parameters such as bulk compartment dimensions and
volumes (e.g., total area, volume of soil and sediment, etc.) are
standardized, so that overall persistence for chemicals with different
properties and rates of transformation may be compared on an equal
basis (Ref. 15). EPA used a version of the EQC level III model (Ref.
33) which was modified to focus on net losses by deleting model terms
for advective losses (movement out of the evaluative environment of air
and water potentially containing a chemical) and sediment burial (Ref.
82). In this version of the model only irreversible transformation
contributes to net loss of a chemical.
The overall persistence obtained from this model is calculated as
the total amount in the evaluative environment when steady state is
achieved, divided by the total loss rate. The results thus obtained are
neither an overall environmental half-life nor a compartment (or
transformation)-specific half-life; rather they are equivalent to an
environmental residence time. When only irreversible transformation
contributes to net loss--i.e., under the conditions of this version of
the EQC model--overall environmental persistence times can be converted
to half-lifes by multiplying the former by ln 2 (i.e., 0.693). The
overall half-life calculated in this way is for dissipation in the
environment as a whole and cannot be related directly to any individual
compartment.
The commenter selected media-specific environmental half-lifes for
use as input to the EQC model. The values were characterized as
``best,'' ``reasonable'' and ``worst'' case. No justification was given
for this classification. It appeared that the shortest half-lives were
categorized as ``best case.'' Based on the information provided by the
commenter, it was not always possible to determine whether the half-
lifes for soil or water selected by the commenter for use as input to
the EQC model were for destruction of chemical, or its dissipation from
the medium. As noted previously, dissipation half-lifes do not
necessarily represent destruction of the chemical since non-destructive
transport processes such as volatilization can be responsible for loss
from the medium. Their use in multimedia modeling could potentially
underestimate overall environmental persistence. This is particularly
important since the modified EQC model predicted that greater than 90%
of the pendimethalin would partition to soil at steady state. If a soil
half-life based on loss from soil by nondestructive processes was used
rather than one based on the destruction of pendimethalin, its
persistence would have been underestimated.
In its modeling of the overall environmental persistence of
pendimethalin EPA used the highest, lowest and mean values for the
ranges of media-specific half-lifes from valid studies as inputs to the
modified EQC model, not the highest and lowest as stated by the
commenter. These included a half-life for pendimethalin in soil of
1,322 days. EPA determined that the study was properly conducted and
chose the half-life value of 1,322 days for soil because it represented
the most environmentally protective half-life derived from a valid
study. The calculated overall environmental persistence half-lifes were
1 month, 8 months, and 16 months based on the highest, mean, and lowest
half-lifes, respectively. For chemicals in this rulemaking, EPA
considered the multi-media modeling EQC results in characterizing
persistence in the overall environment. EPA only intended to use
multimedia modeling results to override the medium-specific persistence
data in limited circumstances, e.g., only if all model inputs are
judged to be accurate (and, as noted above, the commenter's inputs
cannot be determined to be accurate). But even if EPA were to use the
EQC model to assess persistence, pendimethalin would be considered
persistent because, with the EPA inputs described above, EQC overall
environmental persistence half-lifes were calculated to be greater than
6 months using the mean and maximum air, soil, and water half-lifes
calculated.
In response to this comment (even though it was unclear whether the
commenter was basing its assertion on degradation data or dissipation
data), EPA conducted a new EQC assessment for pendimethalin using the
same half-
[[Page 58719]]
life inputs selected by the commenter. The calculated overall
environmental persistence half-life was greater than 2 months using the
longest half-lifes provided by the commenter for air, soil, water, and
sediment. These results support EPA's assertion that the persistence of
pendimethalin in the environment meets the EPCRA section 313
persistence criteria.
The commenter argues that the scientifically-based risk assessments
conducted on pendimethalin as a part of the pesticide registration
process should not be ignored, and that EPA should review pesticide PBT
chemical classifications with EPA registration information to ensure an
accurate analysis has been performed.
The commenter notes that EPA has determined through the review of a
complete set of studies that this material used at an approximate rate
of 1.0 to 2.0 pounds of active ingredient per acre does not present an
unreasonable risk to human health or the environment, that low levels
of pendimethalin in manufacturing wastewater releases do not pose an
unacceptable risk to the environment, and that reported EPCRA section
313 air releases do not pose a significant risk to human health or the
environment.
The commenter concludes that based on the weight of evidence it is
clear that releases of pendimethalin from manufacturing do not pose a
significant threat to human health and the environment and that
pendimethalin should not be branded as having a high potential for harm
as indicated by the proposed listing as a PBT chemical and lowering of
the reporting threshold.
EPA disagrees that the risk assessments cited by the commenter are
relevant to the characterization of pendimethalin as a PBT chemical.
The characterization of chemicals as PBT chemicals for the purpose of
this rule are based on intrinsic physical-chemical properties. Risk is
not an intrinsic property of a substance, but rather the result of the
combination of intrinsic hazard (toxicity) a substance possesses and
the exposure to a target organism under a defined set of circumstances.
It is possible for a substance to present a risk under one set of
exposure conditions, but not another. In contrast, a substance
characterized as a PBT chemical will remain a PBT chemical, regardless
of the exposure to it or its levels in the environment. (See Unit
VI.C.)
Toxic chemicals that persist and bioaccumulate are of particular
concern because they remain in the environment for significant periods
of time and concentrate in the organisms exposed to them. Furthermore,
these PBT chemicals can have serious human health and environmental
effects resulting from low levels of release and exposure.
EPA believes that the substances subject to this rule have been
characterized as PBT chemicals using scientifically sound indicators
based on the intrinsic properties of the substances. The PBT
characterization is independent of the risk the substance may pose
under a given set of circumstances. These substances have been
characterized as persistent, bioaccumulative and toxic and, therefore,
meet the criteria for lowered reporting thresholds.
Further, FIFRA requires the Agency to determine that pesticidal
uses of a chemical do not cause ``unreasonable adverse effects on the
environment,'' which is defined in FIFRA section 2(bb) as ``any
unreasonable risk to man or the environment taking into account the
economic, social, and environmental costs and benefits of the use of
pesticides'' (7 U.S.C. section 136(bb)). FIFRA is a regulatory statute,
and the impacts of regulation can be immediate and direct (e.g.,
banning of a chemical), and as such EPA examines not only the hazards
presented by the chemical, but also the specific exposure scenarios,
and weighs the risks against the benefits of the chemical. The
``unreasonable adverse effects'' determination under FIFRA is specific
to the intentional use of the chemical as a pesticide and does not
address other uses or releases of the chemical that may result from
manufacture, processing, or other use. Furthermore, a determination
under FIFRA that the use of a chemical will not result in an
``unreasonable adverse effect'' is not a determination that the
chemical is not hazardous or persistent or that the use of the chemical
is without risk, but merely that the benefits of agricultural use as a
pesticide outweigh its risks as an agricultural pesticide or that the
pesticide chemical residues on food or feed meet the standards of
section 408 of the Federal Food, Drug, and Cosmetic Act. EPCRA section
313 was not enacted to serve the same purpose as FIFRA. Listing on
EPCRA section 313 provides communities with some of the information
required to determine what risks may result from the manufacture,
processing, and use of a chemical, and to allow local communities to
determine for themselves whether such risks are acceptable, information
not provided under FIFRA.
h. Toxaphene. In the proposal, EPA preliminarily determined that
toxaphene has persistence half-life values in soil of 1 to 11 years and
a persistence half-life value in water of 1 to 5 years. EPA has
reviewed information and all comments received on toxaphene's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that toxaphene persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking. (Ref. 7). In addition,
toxaphene persists in the environment with a half-life of greater than
6 months which supports EPA's decision to lower the threshold to 10
pounds.
i. Trifluralin. In the proposal, EPA preliminarily determined that
trifluralin has persistence half-life values in soil of 99 to 394 days
and a persistence half-life value in water of 5 to 37 days. EPA has
reviewed information and all comments received on trifluralin's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that trifluralin persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 7).
j. Polycyclic aromatic compounds. In the proposal, EPA
preliminarily determined that PACs have persistence half-life values in
soil that ranged from 20 days to 13 years. All but a few had half-lifes
well in excess of 6 months. These chemicals had persistence half-life
values in water that ranged from 79 days to 44 years. EPA received one
significant comment addressing the persistence potential of PACs, which
is discussed below. EPA has reviewed information and all comments
received on PACs' persistence characteristics. Taking into account this
information, as indicated in Table 3, EPA finds that PACs persist in
the environment with half-lives of 2 months or greater and therefore
meet the persistence criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical category can be
found in EPA's Response to Comments document for this rulemaking (Ref.
69) and/or in EPA's support documents for this rulemaking (Ref. 7).
One commenter contends that EPA has incorrectly ignored
biotreatment
[[Page 58720]]
studies in evaluating persistence for PACs. EPA has also ignored a
large body of recent research on sequestration and other phenomena that
collectively act to reduce the bioavailability of soil contaminants,
such as PACs.
Biotreatment studies include activated sludge or other wastewater
treatment studies. As EPA stated in the proposed rule (at 64 FR 700),
the reason for excluding such studies is that wastewater treatment in
general and activated sludge in particular represent conditions that
are far removed from ambient (surface) waters, soils, and sediments.
Data on environmental fate and persistence of substances in wastewater
and activated sludge normally cannot be extrapolated to the other
conditions. The commenter seems most concerned about land biotreatment
(bioremediation) studies, but in fact goes well beyond the concept of
treatability, appearing to infer that EPA has ignored all
biodegradation studies of PACs. However, this is incorrect because all
mixed-culture biodegradation studies other than activated sludge tests-
-i.e., field tests as well as lab studies that used authentic soil,
water and/or sediment grab samples--were considered in determining
persistence for all of the listed substances.
The commenter also discusses recent research indicating that
bioavailability of a substance may decline with time of incubation in
soil, and suggests that EPA should include ``reasonable bioavailability
factors'' in its determination of persistence. As an example of why
this is relevant, there has been a concern that Superfund site
remediation actions may be mistargeted if they are based on residues
released from the soils by vigorous extraction procedures, since
chemical substances in soil may become nonbioavailable yet still be
extractable for analytical purposes. Additionally, bioremediation may
fail to destroy all of a substance that such analysis shows is present,
if some portion is sequestered in a non-bioavailable state. Further,
the commenter contends that chemicals (including many PACs) are not
bioavailable if the bioavailability is considerably less than 100%. The
commenter does further specify a numerical bioavailability criteria.
The commenter over-generalizes from the research findings, using
selective citation and quotation from the literature to give the
impression that all is now known and any substance released to soil is
as good as gone toxicologically speaking. Other reports can be quoted
to the effect that the many factors determining bioavailability,
sequestration, etc. are far from completely resolved, and deserve much
further research. Moreover, sequestration does not necessarily imply
non-bioavailability. For example, in a study of PAC sequestration and
bioremediation, Tang et al. (Ref. 51a) state that:
The results of the present study suggest that extensive
biodegradation by microorganisms does not necessarily remove all of
the fraction of an aged compound that is bioavailable since some
uptake by worms occurred even after the laboratory-scale
bioremediation. . . .it is also possible that a portion of a
compound that is sequestered is available to different degrees to
dissimilar organisms. . . .It may be that the mass of material that
becomes sequestered should be considered as existing in two forms.
One form may be unavailable to all organisms because it is
physically remote and thus inaccessible. The second form may be
differentially available, and its assimilation, toxicity, and/or
biodegradation may depend on the properties of the species and its
ability to mobilize the molecules from this non-remote location.
[There is] danger if it is assumed that the disappearance of
lethality denotes the absence of bioavailability....The point is
reinforced by the case of DDT, which is sequestered in soil (13) and
whose lethality to insects totally disappears as a result of such
sequestration (5), yet a portion of that insecticide was still
assimilated by earthworms introduced into soil that was treated in
the field with DDT more than 40 years before the bioassay was
performed. . . .(emphasis added)
And in a similar paper on DDT and dieldrin, Robertson and Alexander
(Ref. 43a) state that:
The significance of soil properties in controlling sequestration
is evident in the early observation that the degree of sequestration
of lindane after 22 months was greatest in a muck, intermediate in
extent in a loam, and least in a sandy loam (11). Thus, soil
properties must be considered in attempting to predict the
bioavailability of persistent compounds. It is also evident from the
data presented herein that the bioavailability of a sequestered
toxicant varies with the exposed species. Thus, the declines in
toxicity of aged DDT and dieldrin to the three test insects were
quite different; whereas the lethality of the sequestered compound
to one species had almost disappeared, it still was effective
against a second. (emphasis added)
The conclusion is manifest: it is that although chemical substances
released to soil may become sequestered over time, it cannot be assumed
that this process necessarily leads to nonbioavailability even when the
time horizon is years. Site- and species-specific factors, as well as
substance properties, are important in determining bioavailability.
Therefore, it is appropriate to be concerned about the bioavailability
in soil and sediment of PACs and other substances that meet the PBT
criteria established for this rulemaking.
Further, there is no scientific reason why a chemical can only be
considered bioavailable if its bioavailability approaches 100%. The
degree of bioavailability will vary depending upon the environmental
conditions. In addition, as noted above the degree of bioavailability
will also be species dependent. Therefore, EPA believes that the
commenter's approach is overly simplistic.
k. Benzo(g,h,i)perylene. In the proposal, EPA preliminarily
determined that benzo(g,h,i)perylene has persistence half-life values
in soil of 173 days to 1.8 years and persistence half-life values in
water of greater than 100 days. EPA has reviewed information and all
comments received on benzo(g,h,i)perylene's persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that benzo(g,h,i)perylene persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking. (Ref. 7). In addition,
benzo(g,h,i)perylene persists in the environment with a half-life of
greater than 6 months which supports EPA's decision to lower the
threshold to 10 pounds.
1. Mercury and mercury compounds. Because metals may convert to
different oxidation states but can never be destroyed, all metals meet
the 6 months half-life criterion automatically. EPA received a few
significant comments addressing mercury and mercury compounds'
persistence. These are discussed below. EPA has reviewed information
and all comments received on mercury and mercury compounds' persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that mercury and mercury compounds persist in the
environment with half-lives of 2 months or greater and therefore meet
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical category can be found in
EPA's Response to Comments document for this rulemaking (Ref. 69) and
in EPA's support documents for this rulemaking (Ref. 7). In addition,
mercury and mercury compounds persist in the environment with a half-
life of greater
[[Page 58721]]
than 6 months which supports EPA's decision to lower the threshold to
10 pounds.
One commenter asserts that EPA should not classify all forms of
mercury as persistent. The commenter agrees that Hg (0) is properly
characterized as persistent. However, the commenter contends that EPA
is incorrect in characterizing Hg (II) as persistent because it is
removed rapidly from the atmosphere via wet and dry deposition.
EPA believes that the commenter confuses residence time with half-
life; these terms do not represent equivalent processes. There is a
distinction between atmospheric ``half-life,'' which is the amount of
time necessary for half of the chemical present to be destroyed in the
medium, and atmospheric ``residence time'' which is the length of time
a chemical resides in a particular environmental medium. For the
purposes of this rule ``half-life'' includes only irreversible chemical
transformations resulting in the destruction of chemical whereas
``residence time'' includes factors such as transport of the substance
to another medium, for example, wet and dry deposition, sorption,
complexation or sequestration; and reversible changes in speciation
(i.e., oxidation reduction reactions). EPA agrees that Hg (0) has an
average ``residence time'' in the atmosphere of about 1 year and that
Hg (II) may be deposited relatively quickly by wet and dry deposition
processes, leading to a ``residence time'' of hours to months (Ref.
42a). But the shorter residence times noted for Hg (II) are due to
physical transport from the medium, rather than irreversible
transformations resulting in the destruction of chemical. Hg (0)
released to the atmosphere is rapidly converted to Hg (II) through
ozone-mediated oxidation. However, this is not an irreversible
reaction, nor does it result in the destruction of the substance since
the Hg (II) produced from oxidation of Hg (0) by ozone can be reduced
back to Hg (0) by sulfite (Ref. 28a). The persistence of mercury will
not be mitigated simply by redox reactions of Hg (0) to and from Hg
(II). Whether as Hg (0) or as Hg (II), mercury persists in the
environment. Environmental processes may cause it to change oxidation
states or to be transported from one environmental medium to another;
however, these processes will not destroy it.
EPA agrees that the report cited provides reasonable estimates of
the fraction of mercury emissions from each source category that is
likely to be in the form of Hg (II) versus the fraction as Hg (0).
However, this information is not relevant to the assessment of the
persistence of mercury and mercury compounds because persistence
considers destruction only.
m. Polychlorinated biphenyls. In the proposal, EPA preliminarily
determined that polychlorinated biphenyls (PCBs) have persistence half-
life values in soil that ranged from 1 to 7 years and persistence half-
life values in water that ranged from 56 to 98 days. EPA has reviewed
information and all comments received on PCBs' persistence
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that PCBs persist in the environment with half-lifes
of 2 months or greater and therefore meet the persistence criterion
established in this rulemaking. A complete discussion of EPA's findings
on this chemical listing can be found in EPA's Response to Comments
document for this rulemaking (Ref. 69) and/or in EPA's support
documents for this rulemaking (Ref. 7). In addition, all of the PCBs
persist in the environment with a half-life of greater than 6 months
which supports EPA's decision to lower the threshold to 10 pounds.
n. Hexachlorobenzene. In the proposal, EPA preliminarily determined
that hexachlorobenzene has persistence half-life values in soil of 3 to
6 years. EPA has reviewed information and all comments received on
hexachlorobenzene's persistence characteristics. Taking into account
this information, as indicated in Table 3, EPA finds that
hexachlorobenzene persists in the environment with a half-life of 2
months or greater and therefore meets the persistence criterion
established in this rulemaking. A complete discussion of EPA's findings
on this chemical can be found in EPA's Response to Comments document
for this rulemaking (Ref. 69) and in EPA's support documents for this
rulemaking (Ref. 7). In addition, hexachlorobenzene persists in the
environment with a half-life of greater than 6 months which supports
EPA's decision to lower the threshold to 10 pounds.
o. Octachlorostyrene. In the proposal, EPA preliminarily determined
that OCS has persistence half-life values in soil of 3 to 6 years. EPA
received one significant comment addressing OCS's persistence potential
which is discussed below. EPA has reviewed information and all comments
received on OCS's persistence characteristics. Taking into account this
information, as indicated in Table 3, EPA finds that OCS persists in
the environment with a half-life of 2 months or greater and therefore
meets the persistence criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical can be found in
EPA's Response to Comments document for this rulemaking (Ref. 69) and/
or in EPA's support documents for this rulemaking (Ref. 7). In
addition, OCS persists in the environment with a half-life of greater
than 6 months which supports EPA's decision to lower the threshold to
10 pounds.
One commenter believes that OCS should not be considered to be a
PBT chemical. The commenter admits that OCS has the potential to
bioaccumulate and may theoretically persist in the environment, but
cites falling environmental levels of OCS and the lack of evidence of
human and environmental toxicity as justification for why OCS should
not be considered to be a persistent, bioaccumulative and toxic
chemical. The commenters contend that pentachlorobenzene and
hexachlorobenzene are not good analogs for OCS.
EPA disagrees. As discussed in Unit VI.G., EPA believes that OCS
meets the EPCRA section 313 toxicity criteria. Further, EPA believes
that OCS is highly persistent. No measured half-life data for soil or
water that met the standards for data acceptability could be located
for octachlorostyrene (CAS No. 29082-74-4). Therefore, EPA used half-
lifes for the structural analogs pentachlorobenzene (CAS No. 608-93-5)
and hexachlorobenzene (CAS No. 118-74-1) for estimating half-lifes for
OCS. EPA believes that pentachlorobenzene and hexachlorobenzene are
good analogs for OCS because they, like OCS, are highly chlorinated
benzene derivatives, which are structurally very similar. By analogy,
OCS is expected to have a half-life in soil of greater than 6 months
and greater than 2 days in air (Ref. 7). These half-lifes are
sufficient to designate OCS as persistent using the criteria described
in the proposed rule. EPA believes that its use of analog data is
scientifically supportable because like OCS both analogs are highly
chlorinated monocyclic aromatics.
EPA believes that the degree of toxicity as well as the degree of
persistence and bioaccumulation are inherent to a chemical. The
absolute level of a chemical in the environment does not affect its
degree of persistence, bioaccumulation, or whether or not it has been
shown to cause adverse effects to aquatic organisms. The absolute level
in the environment is a factor of both how much is entering the
environment and the persistence of the chemical in the environment. The
degree to which a chemical is present in aquatic organisms is not only
a measure of the BAF, but also inputs into the environment and
[[Page 58722]]
persistence. The assertions made by the commenter do not support their
contentions concerning the toxicity, persistence, or bioaccumulation of
OCS.
p. Pentachlorobenzene. In the proposal, EPA preliminarily
determined that pentachlorobenzene has persistence half-life values in
soil of 194 days to more than 22 years. EPA received no significant
comments addressing pentachlorobenzene's persistence potential. EPA has
reviewed information and all comments on pentachlorobenzene's
persistence characteristics. Taking into account this information, as
indicated in Table 3, EPA finds that pentachlorobenzene persists in the
environment with a half-life of 2 months or greater and therefore meets
the persistence criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 7). In addition,
pentachlorobenzene persist in the environment with a half-life of
greater than 6 months which supports EPA's decision to lower the
threshold to 10 pounds.
q. Tetrabromobisphenol A. In the proposal, EPA preliminarily
determined that TBBPA has persistence half-life values in soil of 44 to
179 days and persistence half-life values in water of 48 to 84 days.
EPA received several significant comments addressing TBBPA's
persistence and discusses them below. EPA has reviewed information and
all comments received on TBBPA's persistence characteristics. Taking
into account this information, as indicated in Table 3, EPA finds that
TBBPA persists in the environment with a half-life of 2 months or
greater and therefore meets the persistence criterion established in
this rulemaking. A complete discussion of EPA's findings on this
chemical can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 7).
One commenter states that EPA's determination that TBBPA is
persistent in the environment appears to be based upon a model which
uses default data, that it is difficult to interpret EPA's methodology
for applying its EQC Model Output for Toxics Release Inventory PBT Rule
Chemicals, and it therefore is not clear how EPA arrived at the
conclusion that TBBPA is persistent.
EPA disagrees that it is unclear how the EQC model was used in the
assessment of chemical persistence and that EPA used only default data.
EPA provided discussion on the conduct of the multimedia modeling in
the document titled EQC Model Output for Toxics Release Inventory PBT
Rule Chemicals (Ref. 33). EPA used chemical-specific input data (i.e.,
half-lifes in air, soil, water, and sediment and chemical properties)
where available in all multimedia modeling runs. No default data were
used in lieu of chemical-specific inputs. All chemical-specific inputs
for each chemical were listed in this document. Further, EPA explained
its use of the modified EQC model not only in the support document
identified earlier, but also in the preamble to the proposed rule. In
its description of the modeling EPA stated:
Multimedia mass balance models offer the most convenient means
to estimate overall environmental persistence from information on
sources and loadings, chemical properties and transformation
processes, and intermedia partitioning. For the chemicals included
in this proposed rule EPA used the [modified] EQC model. . .to
estimate overall environmental persistence. Overall persistence
estimated in this way is used as an additional factor, in
conjunction with reaction half-lifes for individual media,
bioaccumulation/ bioconcentration factors, etc., in justifying
actions proposed in this rule.
The EQC model is based on the fugacity approach first delineated by
Mackay (Ref. 31) and subsequently applied to numerous environmental
processes (Ref. 32). It uses an ``evaluative environment'' in which
environmental parameters such as bulk compartment dimensions and
volumes (e.g., total area, volume of soil and sediment) are
standardized, so that overall persistence for chemicals with different
properties and rates of transformation may be compared on an equal
basis (Ref. 15). EPA used a version of the EQC level III model (Ref.
33) which was modified to focus on net losses by deleting model terms
for advective losses (movement out of the evaluative environment of air
and water potentially containing a chemical) and sediment burial (Ref.
82). In this version of the model only irreversible transformation
contributes to net loss of a chemical.
The overall persistence obtained from this model is calculated as
the total amount in the evaluative environment when steady state is
achieved, divided by the total loss rate. The results thus obtained are
neither an overall environmental half-life nor a compartment (or
transformation)-specific half-life; rather they are equivalent to an
environmental residence time. When only irreversible transformation
contributes to net loss--i.e., under the conditions of this version of
the EQC model--overall environmental persistence times can be converted
to half-lifes by multiplying the former by ln 2 (i.e., 0.693). The
overall half-life calculated in this way is for dissipation in the
environment as a whole and cannot be related directly to any individual
compartment.
In the analysis EPA used the highest, lowest and mean values for
the ranges of half-lifes for soil, air, and water as inputs to the
model. These half-lifes were collected from the literature from
scientifically sound studies and were subject to data quality
standards. The overall environmental persistence half-life for TBBPA
calculated based on the EQC model was greater than 2 months but less
than 6 months using the longest half-lifes for air, soil, water, and
sediment. These results support EPA's assertion that the persistence of
TBBPA in the environment will meet the EPCRA section 313 persistence
criteria.
The commenter believes that TBBPA does not meet the persistence
criteria for air. To support this contention the commenter refers to a
study cited in a World Health Organization (WHO) document (Ref. 83).
Specifically the commenter cites photodegradation studies that
demonstrated that the half-life of TBBPA absorbed onto silica gel
exposed to ultraviolet (UV) radiation was 0.12 day in air. In addition,
the commenter contends that studies of the photolysis of TBBPA in the
presence of UV light and hydroxyl radicals show that TBBPA was totally
degraded within 5 to 6 days with an estimated 33-hour half-life. The
commenter did not provide these studies or provide references to the
original studies.
Further, the same commenter cites WHO EHC 172 (Ref. 83) for data on
photodegradation to support the claim that TBBPA does not meet the
persistence criteria for air. A review of the citation provided by the
commenter reveals that it is a secondary reference taken from
unpublished data from Bayer (Ref. 10). EPA was unable to review the
full unpublished study to determine the quality of the data, only the
summary found in the WHO document was available. In the WHO summary of
the Bayer study TBBPA adsorbed onto silica gel and was exposed to
ultraviolet irradiation at the 254 nanometer (nm) wavelength. Eight
metabolites were detected and a half-life value of 0.12 days obtained.
WHO noted that ``[i]t is difficult to derive environmental conclusions
from the results of these experiments.''
EPA believes that the environmental relevance of the test results
is doubtful.
[[Page 58723]]
While the experiment may demonstrate the potential for TBBPA to undergo
photodegradation under laboratory conditions, the experimental
conditions, to the extent they could be determined from the short
summary provided, were not environmentally relevant.
In order for a molecule to undergo photochemical change it must
absorb light. It is well known that only the transitions corresponding
to ultraviolet/visible light absorption are inherently energetic enough
to lead to chemical reactions. The wavelengths of importance for
photochemical transformations is thus ultraviolet/visible light with a
wavelength of 110 - 750 nm. When environmental photochemistry at or
near the earth's surface is considered, the wavelengths of light of
importance are further narrowed because the stratospheric ozone layer
effectively prevents UV irradiation of less than 290 nm from reaching
the earth's surface. Thus, only the light of the 290-750 nm wavelength
absorbed by a molecule can potentially lead to photochemical changes of
that molecule in the environment near the earth's surface. EPA believes
that because the subject study utilized UV irradiation at the 254 nm
wavelength, a wavelength that does not reach the earth's surface due to
mitigation by stratospheric ozone, the half-life derived is not
relevant and, therefore, cannot be used to determine the persistence of
TBBPA in air.
The commenter also refers to studies of the photolysis of TBBPA in
the presence of UV light and hydroxyl radicals in which TBBPA was shown
to totally degrade within 5 to 6 days with an estimated 33-hour half-
life. No additional information or references were provided to enable
EPA to evaluate these findings for use in the characterization of the
atmospheric half-life TBBPA.
The commenter contends that TBBPA's molecular structure makes it
inherently biodegradable. The hydroxyl moiety on the TBBPA molecule can
be readily transformed by organisms in the environment. The parent
TBBPA molecule is no longer present once this biotransformation takes
place. Therefore, based on TBBPA's structure alone, the Agency should
consider TBBPA as unlikely to be environmentally persistent.
EPA disagrees with the statement that based on structure alone, the
Agency should consider TBBPA as unlikely to be environmentally
persistent. While EPA generally believes that measured values from well
conducted studies are preferable to structure activity relationships
(SAR) as an indicator of persistence, the Agency believes that it is
possible to make some general statements about the biodegradability of
TBBPA based on its structure.
Current knowledge of structure biodegradability relationships
suggests that the presence of multiple bromines on an aromatic molecule
adversely effects biodegradation. In fact, when the biodegradability of
TBBPA is assessed with EPA structure activity relationship tools for
predicting biodegradation from structure (Refs. 46 and 47), the
presence of multiple aromatic bromines, a carbon with four single
bonds, and the molecular weight of TBBPA are all structural features
that reduce biodegradability. Therefore, even if EPA were to base its
assessment of the persistence of TBBPA on its molecular structure, the
Agency would conclude that it is not readily biodegradable.
The commenter contends that TBBPA will not meet the persistence
criteria for water, soil, and sediment because TBBPA will biodegrade in
these media. The commenter cites the results of several biodegradation
studies as demonstrating that TBBPA is not persistent in these media.
The commenter states that even though degradation studies have shown
that TBBPA is not ``readily biodegradable'' (i.e., TBBPA is not
mineralized to a significant extent by sewage sludge within 28 days)
there are studies that indicate it is not persistent. Specifically, in
studies submitted to EPA in 1989, TBBPA has been shown to be subject to
biodegradation both in soil and sediment under aerobic or anaerobic
conditions; TBBPA's estimated half-life derived from these studies is
50 days. In studies submitted by the Brominated Flame Retardants
Industry Panel to EPA, TBBPA also was shown to undergo degradation in a
sediment/water system with an estimated half-life of 48 to 84 days.
(These data were reported under the Agency's TSCA Section 4 test rule.)
The commenter argues that these data demonstrate that TBBPA does not
meet most widely (and internationally) accepted criteria for
persistence in soil or sediments (See Unit VI.B.) Therefore, TBBPA
should not be considered to be persistent for purposes of EPCRA Section
313.
The commenter cites additional research conducted on the
biodegradation of TBBPA under aerobic and anaerobic conditions in soil
(Refs. 47) and asserts that the data indicate that ``TBBPA does not
meet the most widely and internationally accepted criteria.'' EPA
discusses its assessment of the Springborn soil biodegradation studies
elsewhere in the Response to Comments document (Ref. 69). As explained
earlier, the international persistence criteria are not relevant to the
classification of persistence under the criteria adopted by the Agency,
and EPA disagrees that TBBPA should not be considered persistent
because it does not meet the ``most widely (and internationally)
accepted'' criteria. (See Unit VI.B.)
The commenter makes the argument that TBBPA has been shown to be
subject to biodegradation in soil and sediment under aerobic and
anaerobic conditions with ``estimated'' half-lifes of 50 days. Although
the commenter derived a biodegradation half-life, the method used to do
so and the validity of the value could not be determined because no
supporting information was provided. EPA questions the validity of the
50-day half-lifes estimated by the commenter on those grounds.
The commenter refers to two soil grab sample studies and a
sediment/water microbial system study. These studies investigated the
biodegradation of TBBPA in three different soil types in the presence
(aerobic) and absence (anaerobic) of oxygen, and the biodegradation of
TBBPA in a system containing sediment and river water in the presence
of oxygen. In the aerobic soil studies less than 6% ultimate
biodegradation (complete biodegradation to CO2) was observed
over the 64-day test period. The major portion of TBBPA remained in the
soil. Analysis showed after 64 days 74 to 82% TBBPA remained in a
Massachusetts sandy loam soil, 36 to 40% remained in an Arkansas silt
loam, and 41 to 43% remained in a California clay loam soil. Over the
course of the experiments, TBBPA either remained in soil undegraded,
underwent minor structural changes (primary biodegradation), or to a
very small extent (<6%), underwent complete biodegradation to
CO2. Individual values for evolved CO2 in each
soil type over time were not reported and biodegradation half-life
values were not calculated. If it is assumed in the absence of values
for CO2 evolution at sampling times spaced evenly over the
test period reported data, that TBBPA underwent a steady rate of
degradation over the duration of the experiments, approximate half-
lifes of 44 to 179 days can be estimated (Ref. 7).
Biodegradation half-lifes from the aerobic soil biodegradation
experiments can be approximated. The half-life is defined as the amount
of time necessary for the destruction of half of the chemical present
in the medium. Given that the duration of the soil biodegradation test
is 64 days (equivalent to greater than 2 months), a
[[Page 58724]]
chemical that undergoes less than 50% biodegradation by the end of the
test period would have a half-life of greater than 2 months and meet
the EPCRA 313 persistence criteria for soil. In one of the soils in
which TBBPA was tested (a Massachusetts sandy loam soil) 74 to 82% of
the original TBBPA applied remained in the soil unchanged at the end of
the 64-day test period. Thus, in this study, TBBPA was shown to have a
half-life in soil of greater than 2 months since less than 50%
degradation of TBBPA occurred in 64 days.
The biodegradation of TBBPA in the same three soils as above under
anaerobic conditions in a 64-day test has also been studied. The
results showed that 44 to 57% of the TBBPA applied to soil remained
undegraded in the Massachusetts sandy loam soil after a 64-day test
period, 53-65% in an Arkansas silt loam soil, and 90% in a California
clay loam soil. Less than 50% destruction of the test chemical occurred
over a 64-day (> 2 month) test period in all soils tested. Thus, in
this study, TBBPA was shown to have a half-life in soil of greater than
2 months since less than 50% degradation of TBBPA occurred in 64 days.
Aerobic sediment water microbial test systems containing natural
sediments and river water were used to measure degradation half-lifes
for TBBPA in 56-day experiments. Half-lifes calculated for the
biodegradation of TBBPA ranged from 48 to 84 days. Researchers found an
apparent correlation between half-lifes and TBBPA concentration, and
half-lifes and microbial concentrations. Thus, in this study, TBBPA was
shown to have a half-life in sediment water systems of greater than 2
months when either the larger value or the mean of the two values is
considered.
Further, the commenter claims that abiotic degradation of TBBPA in
water also is expected. The calculated half-life of decomposition of
TBBPA by UV radiation in water was 10.2 days in spring, 6.6 in summer,
25.9 in autumn, and 80.7 days in winter. Therefore, TBBPA is not
expected to be persistent in water. No other information was provided.
The commenter cites WHO EHC 172 (Ref. 83) for data on
photodegradation to support the claim that TBBPA does not meet the
persistence criteria for water. In its review of the literature to
evaluate the persistence of TBBPA, EPA found no information on its
photodegradation in water. A review of the citation provided by the
commenter reveals that it is a secondary reference taken from an
unpublished study from Bayer (Ref. 10). EPA was unable to review the
full unpublished study to determine the quality of the data. Only the
summary found in the WHO document was available. The Bayer study on
photodegradation in water yielded calculated half-lifes ranging from
6.6 days to 80.7 days with the longest half-life calculated during the
winter, when solar irradiation is least intense and the shortest half-
life occurring in the summer, when the solar irradiation is most
intense. The commenter did not include the fact that the effect of
cloud cover lengthened the calculated half-life by a factor of 2. Water
depth was also found to influence the direct photodegradation of TBBPA.
At the surface of a water body, solar irradiation is fairly uniform;
however, as depth increases, both the water itself and materials in it
can attenuate the transmission of solar energy through the water
column. Irradiance has been shown to decrease by greater than 90% for
both ultraviolet and visible light at a depth of 5 meters in a
eutrophic lake (Ref. 52). EPA disagrees with the commenter's conclusion
that TBBPA photodegradation in water will be sufficiently rapid that it
will not meet the persistence criteria. Based on the study cited by the
commenter which includes an 80-day ( > 2 month) half-life for
photodegradation of TBBPA in winter, and the mitigating effects of
water depth and cloud cover on rates of photodegradation, EPA believes
that a half-life of greater than 2 months in water is supported. EPA,
therefore asserts that based on these findings, TBBPA meets the EPCRA
section 313 persistence criteria of greater than 2 months in soil and
water.
2. Bioaccumulation--a. Dioxin and dioxin-like compounds. In the
proposal, EPA preliminarily determined that dioxin and dioxin-like
compounds have BCF values that range from 1,259-42,500 with 6 chemicals
over 5,000 and 6 chemicals between 3,500 and 5,000. EPA has reviewed
information and all comments received on dioxin and dioxin-like
compounds' bioaccumulation characteristics. As indicated in Table 3,
EPA finds that dioxin and dioxin-like compounds bioaccumulate in the
environment with BAF/BCF values greater than 1,000 and therefore meet
the bioaccumulation criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical category can be
found in EPA's Response to Comments document for this rulemaking (Ref.
69) and/or in EPA's support documents for this rulemaking (Ref. 71). In
addition, most of the members of the dioxin and dioxin-like compounds
category bioaccumulate in the environment with a value close to, or
well above, 5,000, which supports EPA's decision to lower the threshold
to 0.1 gram.
b. Aldrin. In the proposal, EPA preliminarily determined that
aldrin has a BCF value of 3,715. EPA has reviewed information and all
comments received on aldrin's bioaccumulation characteristics. Taking
into account this information, as indicated in Table 3, EPA finds that
aldrin bioaccumulates in the environment with a BAF/BCF value greater
than 1,000 and therefore meets the bioaccumulation criterion
established in this rulemaking. A complete discussion of EPA's findings
on this chemical can be found in EPA's Response to Comments document
for this rulemaking (Ref. 69) and/or in EPA's support documents for
this rulemaking (Ref. 71).
c. Chlordane. In the proposal, EPA preliminarily determined that
chlordane has a BCF value of 11,050. EPA has reviewed information and
all comments received on chlordane's bioaccumulation characteristics.
Taking into account this information, as indicated in Table 3, EPA
finds that chlordane bioaccumulates in the environment with a BAF/BCF
value greater than 1,000 and therefore meets the bioaccumulation
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69) and/or in EPA's support
documents for this rulemaking (Ref. 71). In addition, chlordane
bioaccumulates in the environment with a BCF value greater than 5,000
which supports EPA's decision to lower the threshold to 10 pounds.
d. Heptachlor. In the proposal, EPA preliminarily determined that
heptachlor has a BCF value of 19,953. EPA has reviewed information and
all comments received on heptachlor's bioaccumulation characteristics.
Taking into account this information, as indicated in Table 3, EPA
finds that heptachlor bioaccumulates in the environment with a BAF/BCF
value greater than 1,000 and therefore meets the bioaccumulation
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69) and in EPA's support
documents for this rulemaking (Ref. 71). In addition, heptachlor
bioaccumulates in the environment with a BAF/BCF value greater than
5,000 which supports EPA's decision to lower the threshold to 10
pounds.
[[Page 58725]]
e. Isodrin. In the proposal, EPA preliminarily determined that
isodrin has a BCF value of 20,180. EPA has reviewed information and all
comments received on isodrin's bioaccumulation characteristics. Taking
into account this information, as indicated in Table 3, EPA finds that
isodrin bioaccumulates in the environment with a BAF/BCF value greater
than1,000 and therefore meets the bioaccumulation criterion established
in this rulemaking. A complete discussion of EPA's findings on this
chemical can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 71). In addition, isodrin bioaccumulates in the
environment with a BAF/BCF value greater than 5,000 which supports
EPA's decision to lower the threshold to 10 pounds.
f. Methoxychlor. In the proposal, EPA preliminarily determined that
methoxychlor has a BCF value of 8,128. EPA has reviewed information and
all comments received on methoxychlor's bioaccumulation
characteristics. Taking into account this information, as indicated in
Table 3, EPA finds that methoxychlor bioaccumulates in the environment
with a BAF/BCF value greater than 1,000 and therefore meets the
bioaccumulation criterion established in this rulemaking. A complete
discussion of EPA's findings on this chemical can be found in EPA's
Response to Comments document for this rulemaking (Ref. 69) and/or in
EPA's support documents for this rulemaking (Ref. 71).
g. Pendimethalin. In the proposal, EPA preliminarily determined
that pendimethalin has a BCF value of 1,944. EPA has reviewed
information and all comments received on pendimethalin's
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that pendimethalin bioaccumulates in
the environment with a BAF/BCF value greater than 1,000 and therefore
meets the bioaccumulation criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical can be found in
EPA's Response to Comments document for this rulemaking (Ref. 69) and/
or in EPA's support documents for this rulemaking (Ref. 71).
h. Toxaphene. In the proposal, EPA preliminarily determined that
toxaphene has a BCF value of 34,050. EPA has reviewed information and
all comments received on toxaphene's bioaccumulation characteristics.
Taking into account this information, as indicated in Table 3, EPA
finds that toxaphene bioaccumulates in the environment with a BAF/BCF
value greater than 1,000 and therefore meets the bioaccumulation
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69) and/or in EPA's support
documents for this rulemaking (Ref. 71). In addition, toxaphene
bioaccumulates in the environment with a BAF/BCF value greater than
5,000 which supports EPA's decision to lower the threshold to 10
pounds.
i. Trifluralin. In the proposal, EPA preliminarily determined that
trifluralin has a BCF value of 5,674. EPA has reviewed information and
all comments received on trifluralin's bioaccumulation characteristics.
Taking into account this information, as indicated in Table 3, EPA
finds that trifluralin bioaccumulates in the environment with a BAF/BCF
value greater than 1,000 and therefore meets the bioaccumulation
criterion. A complete discussion of EPA's findings on this chemical can
be found in EPA's Response to Comments document for this rulemaking
(Ref. 69) and/or in EPA's support documents for this rulemaking (Ref.
71).
j. Polycyclic aromatic compounds. In the proposal, EPA
preliminarily determined that PACs have BCF values that ranged from 800
to 31,440 with 16 of the 21 members of the category having BCF values
greater than 5,000. EPA received several comments concerning the PACs
category listing and the bioaccumulation data which are addressed
below. EPA has reviewed information and all comments received on PACs'
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that PACs bioaccumulate in the
environment with BAF/BCF values greater than 1,000 and therefore meet
the bioaccumulation criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical category can be
found in EPA's Response to Comments document for this rulemaking (Ref.
69) and/or in EPA's support documents for this rulemaking (Ref. 71).
Three of the commenters support the retention of a single PACs
category while one commenter believes that splitting the category into
two categories would be the most appropriate option. Additional
specific comments were as follows. One commenter stated that PACs are
typically found as mixtures in incoming natural organic raw materials,
such as coal and that it would be difficult to separate information
into two reporting categories. Another commenter stated that reporting
as one category is also more consistent with the Great Lakes Binational
Toxics Strategy Level 2 listing for these chemicals. A commenter stated
that the alternate proposal to create two PAC categories would be
unnecessarily burdensome for the regulated community since reporting
facilities would be required to speciate their PAC releases, and, if
chemicals from both categories exceeded reporting thresholds, file two
Form R reports, instead of one. One commenter stated that use of a
single PACs category will simplify the reporting requirements; thus, it
will reduce reporting burden. Several commenters stated that according
to the proposed rule, 16 of the 21 members of the category had BCF
values greater than 5,000 and that one proposal would regard the entire
PACs category to be highly persistent and bioaccumulative, regardless
of each individual PAC's actual persistence and bioaccumulative
properties. Several commenters stated that they believed that splitting
the category into two categories would be the most appropriate course.
Another commenter stated that no chemical should be added to the highly
persistent/bioaccumulative category when it does not fit the criteria
and that in order to gain the most accurate information, two separate
categories would be the superior solution. The commenter stated that
lowering the reporting threshold for the PACs category to 10 pounds is
unjustified considering that, according to EPA data, many of the
individual PACs within the category do not meet the PBT criteria.
EPA considered splitting the PACs category into two or three
categories or listings, but EPA believes, as do most of the commenters,
that the most appropriate option is to retain a single PACs category.
The PACs category was created because the members of the category are
chemically and structurally very similar, share the same toxicological
effect (carcinogenicity), and typically are produced, released, and
otherwise managed as waste as complex mixtures rather than individual
chemicals. As such it would be more difficult to estimate releases if
the category were split into two or three categories based on the
currently available bioaccumulation data. These reasons support
retaining a single PACs category. EPA agrees with those commenters that
stated that the retention of a single PACs category would be the
simpler and less burdensome option. EPA also
[[Page 58726]]
recognizes that, based on currently available information, not all
members of the PACs category meet the highly persistence and highly
bioaccumulative criteria. Of the 21 chemicals in the PACs category
proposed for a lower threshold, 5 have BCF values that nominally do not
meet the highly bioaccumulative criteria, while the rest exceed the
highly bioaccumulative criteria. Given the structural similarities of
the members of this category and the higher bioaccumulation values for
16 of the 21 PACs, the 5 BCF values below 5,000 may underestimate, to
some extent, the bioaccumulation potential of these compounds. For
purposes of this rulemaking, EPA is classifying the PACs category as
persistent and bioaccumulative rather than highly persistent and highly
bioaccumulative. Thus, the PACs category will have a reporting
threshold of 100 pounds. However, the Agency will continue to assess
the bioaccumulation potential of this category and specifically whether
the lower bioaccumulation values for 5 members of the category are
appropriate.
k. Benzo(g,h,i)perylene. In the proposal, EPA preliminarily
determined that benzo(g,h,i)perylene has a BCF value of 25,420. EPA has
reviewed information and all comments received on
benzo(g,h,i)perylene's bioaccumulation characteristics. Taking into
account this information, as indicated in Table 3, EPA finds that
benzo(g,h,i)perylene bioaccumulates in the environment with a BAF/BCF
value greater than 1,000 and therefore meets the bioaccumulation
criterion established in this rulemaking. A complete discussion of
EPA's findings on this chemical can be found in EPA's Response to
Comments document for this rulemaking (Ref. 69) and/or in EPA's support
documents for this rulemaking (Ref. 71). In addition,
benzo(g,h,i)perylene bioaccumulates in the environment with a BCF value
greater than 5,000 which supports EPA's decision to lower the threshold
to 10 pounds.
l. Mercury and mercury compounds. In the proposal, EPA
preliminarily determined that mercury and mercury compounds have BCF
values that ranged from 7,000 to 36,000. EPA has reviewed information
and all comments received on mercury and mercury compounds'
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that mercury and mercury compounds
bioaccumulate in the environment with BAF/BCF values greater than 1,000
and therefore meet the bioaccumulation criterion established in this
rulemaking. A complete discussion of EPA's findings on this chemical
category can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 71). In addition, mercury and mercury compounds
bioaccumulate in the environment with a value above 5,000, which
supports EPA's decision to lower the threshold to 10 pounds.
m. Polychlorinated biphenyls. In the proposal, EPA preliminarily
determined that PCBs have BCF values that ranged from 4,922 to 196,900.
All of the PCBs, except one, had BCF values far exceeding 5,000. The
one exception, 2,3,3',4,4',5,5' heptachlorobiphenyl, had a BCF value of
4,922. EPA has reviewed information and all comments received on PCBs'
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that PCBs bioaccumulate in the
environment with BAF/BCF values greater than 1,000 and therefore meet
the bioaccumulation criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical listing can be
found in EPA's Response to Comments document for this rulemaking (Ref.
69) and/or in EPA's support documents for this rulemaking (Ref. 71). In
addition, with one exception, all of the PCBs listed bioaccumulate in
the environment with a value far exceeding 5,000, which supports EPA's
decision to lower the threshold to 10 pounds.
n. Hexachlorobenzene. In the proposal, EPA preliminarily determined
that hexachlorobenzene has a BCF value of 29,600 to 66,000. EPA has
reviewed information and all comments received on hexachlorobenzene's
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that hexachlorobenzene
bioaccumulates in the environment with a BAF/BCF value greater than
1,000 and therefore meets the bioaccumulation criterion established in
this rulemaking. A complete discussion of EPA's findings on this
chemical can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 71). In addition, hexachlorobenzene bioaccumulates in
the environment with a BAF/BCF value greater than 5,000 which supports
EPA's decision to lower the threshold to 10 pounds.
o. Octochlorostyrene. In the proposal, EPA preliminarily determined
that OCS has a BCF value of 33,113. EPA received one significant
comment addressing OCS's bioaccumulation potential which is discussed
below. EPA has reviewed this comment and information on OCS's
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that OCS bioaccumulates in the
environment with a BAF/BCF value greater than 1,000 and therefore meets
the bioaccumulation criterion established in this rulemaking. A
complete discussion of EPA's findings on this chemical can be found in
EPA's Response to Comments document for this rulemaking (Ref. 69) and/
or in EPA's support documents for this rulemaking. (Ref. 71). In
addition, OCS bioaccumulates in the environment with a BAF/BCF value
greater than 5,000 which supports EPA's decision to lower the threshold
to 10 pounds.
One commenter argued that OCS should not be included in the EPCRA
section 313 PBT chemicals list. The commenter contends that OCS was
included as a PBT chemical simply because it appears on several lists
of persistent and bioaccumulative chemicals and not based on a thorough
evaluation of its bioaccumulation. The commenter states that OCS has
the potential to bioaccumulate, but nonetheless, OCS levels in fish and
aquatic species in the Great Lakes continue to decline. The commenter
provides a report on the Great Lakes region and argues that OCS should
not be considered a PBT chemical since environmental concentration data
show OCS levels in the environment are decreasing at a rate of 8% to
30% per year.
EPA disagrees with the commenter's conclusions. The commenter does
not dispute the bioaccumulation values EPA presented in the proposed
rule. Rather the commenter agrees that OCS has the potential to
bioaccumulate but contends that since environmental concentrations are
declining in the Great Lakes region OCS should not be considered a PBT
chemical. The fact that OCS levels in the Great Lakes region may be
declining is not a basis for concluding that OCS is not a PBT chemical
or that it cannot bioaccumulate. There are a number of reasons that
could explain a decrease in environmental concentrations of OCS but
they do not change the fact that OCS has been shown to be highly
bioaccumulative. OCS was included as a PBT chemical because it meets
the EPCRA section 313 criterion for bioaccumulation laid out in the
proposed rule, not simply because it has appeared on several other
lists of PBT chemicals.
p. Pentachlorobenzene. In the proposal, EPA preliminarily
determined
[[Page 58727]]
that pentachlorobenzene has a BCF value of 8,318. EPA has reviewed
information and all comments received on pentachlorobenzene's
bioaccumulation characteristics. Taking into account this information,
as indicated in Table 3, EPA finds that pentachlorobenzene
bioaccumulates in the environment with a BAF/BCF value greater than
1,000 and therefore meets the bioaccumulation criterion established in
this rulemaking. A complete discussion of EPA's findings on this
chemical can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 71). In addition, pentachlorobenzene bioaccumulates in
the environment with a BAF/BCF value greater than 5,000 which supports
EPA's decision to lower the threshold to 10 pounds.
q. Tetrabromobisphenol A. In the proposal, EPA preliminarily
determined that TBBPA was found to have BCF values of 780; 1,200; and
3,200. EPA received one significant comment addressing TBBPA's
bioaccumulation which is discussed below. EPA has reviewed the comments
and information on TBBPA's bioaccumulation characteristics. Taking into
account this information, as indicated in Table 3, EPA finds that TBBPA
bioaccumulates in the environment with a BAF/BCF value greater than
1,000 and therefore meets the bioaccumulation criterion established in
this rulemaking. A complete discussion of EPA's findings on this
chemical can be found in EPA's Response to Comments document for this
rulemaking (Ref. 69) and/or in EPA's support documents for this
rulemaking (Ref. 71).
One commenter contends that the available data on TBBPA do not
support its classification as a PBT chemical. The commenter argues that
the oyster BCF value of 780 does not support the proposed criterion of
1,000. The commenter also notes that EPA fails to consider that TBBPA
is not retained in the body once dosing stops in a BCF test and that
TBBPA is rapidly eliminated. The commenter states that rapid
elimination limits any potential for biomagnification. The commenter
notes that only the highest chironomid BCF value (3,200) was cited by
EPA and not the fact that this is from a range of 650-3,200.
EPA believes that the available data do support classification of
TBBPA as a PBT chemical. Measured BCF values of 780, 1,200, and 3,200
were obtained from TSCA section 4 tests with oysters, fish and
chironomids, respectively. The measured BCF values of 1,200 and 3,200
for fish and chironomids respectively, clearly satisfy the EPCRA
section 313 bioaccumulatioin criterion of 1,000. EPA is aware that
TBBPA will be eliminated from the body eventually once exposure to the
chemical is halted; however, continuous or intermittent exposures of
TBBPA to organisms may result in significant tissue residues depending
on the exposure or release scenarios. The issue of biomagnification of
TBBPA is not relevant to determining if TBBPA is a PBT chemical. As
discussed in Unit VI.B.3., biomagnification is not required in order to
have a concern for chemicals that bioaccumulate. The highest chironomid
BCF value was listed because it is considered as a worst case
indication of bioaccumulation in sediment-dwelling invertebrates.
I. Exemptions and Other Reporting Requirements
1. De minimis exemption. Many of the commenters assert that the
initial reasons for adopting the de minimis exemption are still valid
and that this exemption should be maintained for PBT chemicals.
Specifically, several commenters contend that the de minimis exemption
was initially adopted to alleviate undue burden on reporting facilities
and that the elimination of this exemption for PBT chemicals will
significantly increase the reporting burden for this rulemaking.
EPA disagrees with the commenters' contention that the initial
reasons for adopting the de minimis exemption are valid for PBT
chemicals. As originally explained in the 1988 final rule implementing
the reporting provisions of EPCRA section 313, reiterated in the 1997
final rule adding seven new industry sectors, and discussed in the
proposal to this final rule, EPA promulgated the de minimis exemption
for several reasons, of which burden was only one. In addition to
burden reduction, EPA promulgated the de minimis exemption because: (1)
The Agency believed that facilities newly covered by EPCRA section 313
would have limited access to information regarding low concentrations
of toxic chemicals in mixtures that are imported, processed, otherwise
used or manufactured as impurities; (2) the Agency did not believe that
these low concentrations would result in quantities that would
significantly contribute to threshold determinations and release
calculations at the facility (53 FR 4509); and (3) the exemption was
consistent with information collected under the Occupational Safety and
Health Administration's (OSHA) Hazard Communication Standard (HCS). If
EPA had adopted the exemption only to reduce burden, the exemption
would have covered all uses of de minimis quantities of the toxic
chemical in mixtures. The exemption, however, includes only limited
uses of the toxic chemical in mixtures (i.e., importing, processing,
otherwise use, and manufacturing impurities) that were roughly tailored
to whether EPA expected that facilities were reasonably likely to have
information that would allow them to determine thresholds and make
release calculations.
The purpose of the PBT rulemaking, however, is different from past
rulemakings in that it is intended to capture information on
significantly smaller quantities of releases and other waste management
associated with these chemicals. Most of the PBT chemicals addressed in
this rule have been shown to cause adverse effects at concentrations
far less than the de minimis levels. For example, dioxins have been
shown to cause adverse effects at levels in the parts per trillion. In
addition, after 10 years of experience with the program, the Agency
believes there are many sources of information in addition to material
safety data sheets (MSDSs), readily available to reporters to use in
making EPCRA section 313 determinations. Some of these sources of
information include EPA guidance documents (e.g., EPCRA Section 313
Industry Guidance: Electricity Generating Facilities (EPA 745-B-99-
003)) and trade association guidance documents (e.g., National Council
of the Paper Industry for Air and Stream Improvement (NCASI) Technical
Bulletins and NCASI's Handbook of Chemical Specific Information for
SARA Title III Section 313 Form R Reporting). In addition, relevant
information has become much more accessible to covered facilities over
the past 10 years. For example, although the United States Geological
Survey's U.S. Coal Quality Database has been in existence since the mid
1970s, only more recently has it been made available on the Internet.
(http://energy.er.usgs.gov/products/databases/UScoal/index.htm).
Further, the Agency believes that it underestimated how much
information covered facilities had available to them in 1988 regarding
small concentrations of toxic chemicals in mixtures. Therefore, given
that: (1) Covered facilities have several sources of information
available to them regarding the concentration of PBT chemicals in
mixtures; (2) even minimal releases of persistent bioaccumulative
chemicals may result in significant adverse effects and these small
[[Page 58728]]
quantities can reasonably be expected to significantly contribute to
the lower thresholds; and (3) the concentration levels originally
chosen, in part, to be consistent with the OSHA HCS are inappropriately
high for PBT chemicals, EPA believes that the reasons for the de
minimis exemption that the Agency held for previous rulemakings do not
apply to PBT chemicals.
A few commenters assert that reviewing each MSDS, when a facility
may have many MSDSs for mixtures used on-site, to see if it includes
trace quantities of PBT chemicals will be very time consuming. They
contend that they do not have the manpower to track products on an
individual basis looking for trace quantities of PBT chemicals and that
these activities will be very burdensome.
EPA disagrees that eliminating the de minimis exemption for PBT
chemicals will greatly increase burden under EPCRA section 313. Covered
facilities are not required to report on toxic chemicals in mixtures
and trade name products for which they have no concentration
information or such information that is not reasonably known. However,
if facilities do have information concerning the concentration of PBT
chemicals in mixtures, such as on MSDSs, EPA does not believe it is
more burdensome for facilities to identify and evaluate process streams
containing relatively small quantities of PBT chemicals than for larger
quantities of chemicals. Although some burden is associated with the
identification and evaluation of process streams, EPA disagrees that
the elimination of the de minimis exemption would vastly increase the
extent of this required effort. Covered facilities will need to
identify and evaluate process streams when considering a PBT chemical
in concentrations below the de minimis level in the same manner they
already do for toxic chemicals found in process streams in
concentrations above the de minimis level. The additional burden can be
attributed to resources spent considering and reporting on information
they currently are allowed to disregard. Further, as explained above,
EPA adopted the de minimis exemption for several reasons, of which
burden reduction was only one, and EPA does not believe that these
original reasons apply to this PBT rulemaking.
Some commenters assert that it is unrealistic for EPA to assume
that industry will report only on what they know without making an
effort to fill the data gaps and that enforcement actions could arise
from reports based on only what is known to a facility.
EPA disagrees, however, because covered facilities are expected to
have reasonable knowledge of the toxic chemicals present at their site
and need only document their considerations concerning threshold
determinations and release and other waste management calculations. As
stated in EPCRA section 313(g)(2):
[i]n order to provide the information required under this
section, the owner or operator of a facility may use readily
available data (including monitoring data) collected pursuant to
other provisions of law, or, where such data are not readily
available, reasonable estimates of the amounts involved. Nothing in
this section requires the monitoring or measurement of the
quantities, concentration, or frequency of any toxic chemical
released into the environment beyond that monitoring and measurement
required under other provisions of law or regulation. . . .
(emphasis added)
Further, as stated previously, covered facilities are not required to
report on toxic chemicals in mixtures and trade name products for which
they have no concentration information, or for which such information
is not readily available. Therefore, it is unlikely that facilities
will have additional enforcement concerns.
Several commenters argue that the need to be consistent with the
OSHA HCS that EPA cited in the 1988 final rule continues to be relevant
with regards to collecting information on very small quantities.
EPA disagrees that the need to be consistent with OSHA to reduce
burden is sufficient to justify retaining the de minimis exemption for
PBT chemicals. EPA is not required to be consistent with the OSHA HCS.
In 1988, EPA chose to be consistent with the OSHA HCS as part of its
rationale for the exemption, because the Agency expected facilities to
be familiar with these levels and thought that covered facilities might
only have access to MSDSs for information on the content and percentage
composition of toxic chemicals in mixtures. (See 53 FR 4509) However,
EPA has never instructed facilities to stop looking if information
concerning a toxic chemical is not on an MSDS. Rather, EPA has
consistently instructed facilities to use their best readily available
data in determining compliance with EPCRA section 313. As EPA explained
earlier, given 10 years of experience with the program, the Agency
believes that facilities may have other sources of information, in
addition to MSDSs, available to them. Therefore, if a facility has
better information regarding the concentration of a toxic chemical in a
mixture, for example, that the chemical is above the de minimis level,
the facility should be using that information to comply with EPCRA
section 313. Further, EPA is consistent in some respects because under
the OSHA HCS, if an employer has reason to believe that a permissible
exposure limit for a component may be exceeded under the mixture's
normal circumstances of use, the HCS also requires employers to list
chemicals that are below the 1.0% and 0.1% thresholds. Therefore, OSHA
adopted exceptions to the 1.0% and 0.1% limits under the HCS.
Similarly, PBT chemicals are different from other toxic chemicals in
that they may pose a more significant concern to the environment in
much smaller quantities than other toxic chemicals. Furthermore, as
explained in other responses in this unit, EPA believes the remainder
of its rationale for the de minimis exemption is not applicable to PBT
chemicals. For example, contrary to the commenter's statement, the
small concentrations subject to the de minimis exemption are not
necessarily small quantities and may contribute significantly to
exceeding the lowered reporting thresholds.
Some commenters argue that the Agency has not justified why the
exemption will result in increased health risk to the public or the
environment. One commenter specifically argues that given the extremely
low levels of these PBT chemicals in coal, the risk to the general
public from these releases, which they believe is the original purpose
of the legislation, is not apparent. Another commenter asserts that EPA
must demonstrate that the removal of the exemption for specific PBT
chemicals will have a public health or environmental benefit. Yet
another commenter argues that the concentration of toxic chemicals
contained in mixtures is irrelevant to public health concerns when the
compounds of concern remain chemically bound within benign compounds.
EPA strongly disagrees with those commenters who indicated that EPA
must consider risk to the general public when determining whether to
eliminate the de minimis exemption. A primary purpose of the TRI
program is to provide data on the releases (and other waste management
activities) of listed toxic chemicals to communities so that they may
use these data in conjunction with toxicity information for the
chemical and site-specific information to determine if releases present
a potential risk. They can also use TRI data in other ways. For
example, an individual can use TRI data as a factor
[[Page 58729]]
in choosing a neighborhood in which to live. The purpose of TRI,
however, is not to make a national determination of risk, nor did EPA
consider risk in its original adoption of the de minimis exemption
under EPCRA section 313.
Moreover, as previously explained, EPA originally promulgated the
de minimis exemption based on several considerations that are
inapplicable to PBT chemicals. Where, as here, the rationale and
factual bases underlying an exemption no longer exist with respect to a
particular class, the Agency believes it cannot justify retaining the
exemption for that class. Further, the Agency has received no
information from any commenters that contradicts the Agency's factual
and legal conclusions, or that would otherwise present a basis for
retention of the de minimis exemption.
EPA also disagrees with the comment that because there are very low
levels of PBT chemicals (e.g., mercury) in coal that the risk to the
general public is not apparent. EPA believes that the commenter
misunderstands the concept of risk. Because a chemical is in a low
concentration in coal does not in itself control the level of risk that
can result when coal is combusted. For example, mercury compounds are
found in very low concentrations in coal. When coal is combusted,
mercury compounds are either converted into mercury chloride or reduced
to elemental mercury. Some of the mercury/mercury chloride is released
to air and some remains in the bottom ash. The concentration of the
mercury/mercury chloride in the air wastestream will not be the same as
the concentration originally present in the coal. Once the mercury/
mercury chloride is released, it will be carried varying distances
before it is deposited. Mercury can be transported over large
distances, while mercury chloride may be deposited relatively rapidly
by wet and dry deposition processes. The amount of mercury in a
community or ecosystem will depend upon sources both local and distant.
Once mercury has been deposited, it will bioaccumulate in organisms and
will also persist in the environment as a sink for exposure and
bioaccumulation. The amount of mercury that a human, animal, or plant
will be exposed to is related more closely to exposure pathways and the
quantity that is present in an ecosystem rather than the concentration
in the coal that is combusted. Thus, EPA believes that the commenter is
incorrect.
One commenter asserts that the elimination of the de minimis
thresholds would not yield meaningful additional information. The
commenter argues that the proposed rule vastly overstates the
significance of TRI data and therefore incorrectly concludes that the
de minimis thresholds would ``deprive communities of important
information on PBT chemicals'' (at 64 FR 714). Instead, the commenter
contends, TRI data only provide a snapshot view of releases from the
chemical industry and the few other industry sectors subject to TRI
reporting and that many potential release sources are not subject to
TRI reporting. The commenter argues that these sources overwhelm the
limited additional information that will be reported by eliminating the
de minimis exemption.
EPA disagrees that the proposed rule vastly overstates the
significance of the TRI data. The public, all levels of government, and
the regulated community have come to rely on TRI data in improving
decision-making, measuring pollution prevention, and understanding the
environmental and health consequences of toxic chemical releases and
other waste management activities. Although the Toxics Release
Inventory does not contain a complete inventory of every release, EPA
believes it does provide one of the most comprehensive and accessible
sources of release and other waste management information available.
EPA also disagrees with the commenter's assertion that the data base
only contains information from the chemical industry and a few others.
In fact, all 20 manufacturing industry groups as well as an additional
7 other industries including metal and coal mining facilities and
hazardous waste management facilities are subject to EPCRA section 313.
Further, with the addition of these 7 newly covered industries, EPA
expects over 27,500 facilities to submit over 110,000 reports on more
than 630 toxic chemicals to the TRI for the 1998 reporting year.
Currently no other sources of information can provide releases and
information on other waste management quantities and qualitative source
reduction data with the scope, level of detail, and chemical coverage
as data currently included in TRI.
Further, as EPA has previously explained, PBT chemicals can remain
in the environment for a significant amount of time and can
bioaccumulate in animal tissues. Even relatively small releases of such
chemicals have the potential to accumulate over time and cause
significant adverse impacts on human health and the environment.
Therefore, EPA believes it is particularly important to gather and
disseminate to the public relevant information on even relatively small
amounts of releases and other waste management of PBT chemicals. Under
the 10,000 and 25,000 pound/year reporting thresholds, a significant
amount of the releases and other waste management activities involving
PBT chemicals are not being captured and thus the public does not have
the information needed to determine if these chemicals are present in
their communities at levels that may pose a significant risk.
Several commenters argue that the de minimis exemption already does
not apply to the manufacture of a toxic chemical unless the toxic
chemical is manufactured as an impurity or is imported. Therefore, any
incidental manufacturing of a PBT chemical as a by-product would not be
eligible for the de minimis exemption and would be subject to
reporting. Thus, they argue, the elimination of the exemption will
provide little additional information and will not provide added value.
The commenters are correct in stating that there are instances
where PBT chemicals are manufactured as by-products and would,
therefore, not be affected by the elimination of the de minimis
exemption. However, as EPA explained in the PBT proposal, there are
also many instances where a PBT chemical may exist in a mixture or
trade name product at a concentration below the 1% or 0.1% de minimis
limit but where the processing or otherwise use of the PBT chemical in
that mixture would otherwise contribute significantly to or in itself
exceed the reporting thresholds (at 64 FR 714). For example, mercury
can be found at very low concentrations in steel. A resmelting facility
could process and release more than 100 pounds of mercury a year from
its resmelting activities. However, although this total quantity is
greater than the 10 pound proposed threshold for mercury, if the
concentration of mercury in the steel is less than the de minimis
limit, none of the mercury would be reportable if the de minimis level
is retained for PBT chemicals. Releases and other waste management
associated with these exempt activities would be absent from the TRI
data base. Because even minimal releases of PBT chemicals may result in
elevated concentrations in the environment or in an organism and can
have the potential to cause an adverse effect, EPA believes that all
releases of these chemicals are of concern and that such information is
significant and of value to the public.
a. Readily available data. Some commenters assert that the
elimination of the de minimis exemption will conflict with the
condition that reporters obtain data from readily
[[Page 58730]]
available sources. They argue that because concentrations below 1% (and
0.1% for carcinogens) are not required on MSDSs, reporters will no
longer be able to use MSDSs to screen for products containing PBT
chemicals below these concentrations. They further contend that AP-42
guidance, Air CHIEF CD-ROM, TANKS, CHEMDAT8 and WATER8 would provide
additional assistance in estimating the amount of a PBT coincidentally
manufactured in wastestreams or released; however, these tools will not
help quantify the amount of chemical in materials which are distributed
in commerce or used as feedstock. They assert that there are no other
consistent sources of information on whether a product contains a PBT
chemical below de minimis levels. They also assert that the elimination
of the de minimis exemption will cause additional burden for the
regulated community because covered facilities will struggle with how
to comply in the absence of information.
The Agency believes that since reporting first began in 1988, new
sources of information have become available to covered facilities to
use to determine concentrations of toxic chemicals in mixtures. In
addition to the data bases and information sources cited by the
commenter, EPA believes there are other sources of data that can and
should be used in making threshold determinations and release and other
waste management calculations for PBT chemicals. Examples of these
sources of information include EPA guidance documents (e.g., EPCRA
Section 313 Industry Guidance: Electricity Generating Facilities (EPA
745-B-99-003)) and trade association guidance documents (e.g., National
Council of the Paper Industry for Air and Stream Improvement (NCASI)
Technical Bulletins and NCASI's Handbook of Chemical Specific
Information for SARA Title III Section 313 Form R Reporting). In
addition, relevant information has become much more accessible to
covered facilities over the past 10 years. For example, the United
States Geological Survey's U.S. Coal Quality Database has been in
existence since the mid 1970s, but only more recently has it been made
available on the Internet. (http://energy.er.usgs.gov/products/
databases/UScoal/index.htm) EPA believes that these tools, in addition
to the ones cited by the commenter, will help covered facilities
quantify the amount of chemical in materials which are distributed in
commerce or used as feedstock and will allow covered facilities to make
reasonable calculations to comply with EPCRA section 313. Further, the
Agency believes that it underestimated how much information covered
facilities had available to them in 1988 regarding small concentrations
of toxic chemicals in mixtures. Therefore, EPA believes that facilities
have sufficient information to make threshold determinations and
release and other waste management calculations for PBT chemicals below
de minimis concentrations. However, as EPA explained above, if a
covered facility has no information, including no reasonable estimates
or other reasonably known information, on the concentration of the
toxic chemical in the mixture, they need not consider the chemical in
that mixture for threshold determinations and release and other waste
management calculations (at 53 FR 4511). Therefore if the only source
of information on a toxic chemical in a mixture is from an MSDS, and
the MSDS does not indicate if the chemical is contained in the mixture,
the facility is not required to consider the toxic chemical towards
threshold determinations or release and other waste management
calculations.
Because some facilities covered under EPCRA section 313 have more
extensive information available to them than they did in 1988, or EPA
underestimated how much information they had available in 1988, and
because these facilities are not required to report if they have no
information on the concentration of the toxic chemical, the Agency
believes that in these cases retention of the de minimis exemption
would allow facilities to avoid reporting when information is available
to them that would otherwise permit them to report.
Some commenters assert that facilities will have to begin
monitoring for trace quantities of chemicals in mixtures if the de
minimis exemption is eliminated for PBT chemicals. One commenter argues
that the only way facilities would be able to estimate the levels of
dioxin in combustion products and wastewater treatment ``would be to
undertake the costly burden of monitoring what comes off at a series of
concentrations and temperatures.'' Another commenter asserts that if
the de minimis level is eliminated, industry would be subject to
increased enforcement action because exhaustive testing may be
insufficient to detect the chemicals.
EPA disagrees with the commenters because, as stated previously,
EPCRA section 313(g)(2) limits monitoring requirements under EPCRA
section 313. Under this section, facilities are not required to perform
any additional monitoring or analysis of production, process or use
other than that already collected under other requirements. However, if
a facility is required to monitor toxic chemicals under another
statute, this data must be considered in determining thresholds and
release and other waste management calculations under EPCRA section
313. EPCRA section 313(g)(2) requires that facilities use readily
available data, or in absence of such data, facilities are required to
use reasonable estimates. If no monitoring data are available, the
facility should use other readily available information in making
threshold determinations and release and other waste management
calculations. Further, if the facility believes that it has other, more
representative data than its monitoring data, the facility should use
that information instead.
As to specifically tracking PBT chemicals in wastewater, the
commenter does not specify whether the toxic chemicals discussed in the
comment are manufactured as by-products, are processed, or otherwise
used. As discussed above, the de minimis exemption does not apply to
toxic chemicals manufactured as by-products. Therefore, if PBT
chemicals are coincidentally manufactured during on-site wastewater
treatment, covered facilities would be required to consider those PBT
toxic chemicals for threshold determinations and release and other
waste management calculations even if the de minimis exemption were
retained for PBT chemicals. Similarly, PBT chemicals manufactured as a
result of burning fuel would not be exempt even if the de minimis
exemption were retained because manufactured by-products are not
eligible for this exemption. PBT chemicals in below de minimis
concentrations in mixtures that are imported, processed, or otherwise
used will be affected by the elimination of the de minimis exemption.
Covered facilities will need to consider these quantities towards
threshold determinations and release and other waste management
calculations. These calculations would include the amounts contained in
combustion by-products and wastewater treatment units. Additional
monitoring of these quantities, however, would not be required under
EPCRA section 313. Finally, EPA has limited the dioxin listing with the
qualifier ``manufacturing; and the processing or otherwise use of
dioxin and dioxin-like compounds if the dioxin and dioxin-like
compounds are present as contaminants in a chemical and if they were
created
[[Page 58731]]
during the manufacturing of that chemical.'' Therefore, not all
processing or otherwise use activities of the dioxin and dioxin-like
compounds category must be considered towards a facility's threshold
determinations.
Some commenters assert that EPA should maintain the de minimis
exemption for PBT chemicals present as impurities. They argue that
information on PBT chemicals present as impurities is not readily
available and that obtaining the relevant data, conducting the initial
reviews to determine what information is available, and identifying
data gaps would impose a huge burden on industry. They argue that even
developing estimates with any accuracy entails a significant amount of
time. In the instance of impurities, they assert that the absence of
data and the difficulty in developing estimates will result in a heavy
burden with little information of value being reported. These
commenters believe that the elimination of the de minimis level is a
requirement to provide new data when utilizing the de minimis
exemption.
EPA disagrees with these commenters. Although there are burdens
associated with obtaining relevant data, determining available
information and identifying data gaps, EPA disagrees that the
elimination of the de minimis exemption for PBT chemicals present as
impurities would vastly increase the extent of this required effort.
From the comment, it is unclear why requiring facilities to identify
and evaluate process streams containing small quantities of PBT
chemicals as impurities is more burdensome than for larger quantities
of these chemicals manufactured, processed, or otherwise used at a
covered facility in excess of the activity thresholds. For example, a
facility monitors for chemical A at a concentration of greater than
0.001% and monitors for chemical B at a concentration of greater than
1.5%. The monitoring is done for the same wastestream and the same
frequency. There is no differential in effort or burden. Currently, the
only difference is that facilities can ignore available data when
utilizing the de minimis exemption.
One commenter asserts that the de minimis exemption should be
retained for PBT chemicals present at mining facilities. The commenter
argues that the burden upon the mining industry is even greater in the
context of the low thresholds proposed for PBT chemicals. Further, the
commenter asserts that although EPCRA does not require covered
facilities to conduct tests concerning the amount of listed chemicals
processed, most reporters rely upon their knowledge of their
manufacturing processes and raw materials to produce meaningful data
for EPCRA section 313 reporting purposes. The commenter contends that
this is not true of the mining industry. Due to the volume of materials
moved in the extraction process and the heterogeneous nature of the
materials mined, process knowledge often is inadequate to produce a
meaningful picture of the minute levels of PBT chemicals that may be
present in mining operations. The commenter asserts that inadequate
process knowledge combined with the enormous expense of constantly
testing the processed materials makes the elimination of the de minimis
exemption for PBT chemicals unworkable as applied to mining operations.
EPA disagrees with the commenter. As the commenter points out,
under EPCRA section 313(g)(2), facilities are not required to perform
any additional monitoring or analysis of production, process, or use
other than that already collected under other statutory or regulatory
requirements. Therefore, there should be no added cost due to testing
to comply with EPCRA section 313. However, EPA believes that in many
cases mining facilities have the information needed to make reasonable
estimates regarding small concentrations of PBT chemicals in the ores
mined. In addition, as EPA explained in the 1988 final rule, if a
covered facility has no information on the concentration of the toxic
chemical in the mixture, including no reasonable estimates, the
facility need not consider the chemical in that mixture for threshold
determinations and release and other waste management calculations. If
a mining facility does have information regarding the concentration of
a toxic chemical in a mixture or trade name product, the facility must
consider all non-exempted sources of the chemical for threshold
determinations. If an activity threshold is exceeded for the chemical,
the facility must then calculate release and other waste management
quantities. Covered mining facilities will need to identify and
evaluate process streams when considering a PBT chemical in
concentrations below the de minimis level just as they already do for
toxic chemicals found in process streams in concentrations above the de
minimis level. Therefore, given that covered facilities: (1) Are not
required to perform additional monitoring; (2) are not required to
consider concentrations of toxic chemicals for which they have no
information; and (3) need only consider readily available data, EPA
disagrees that identifying and evaluating mining activities involving
mixtures containing less than 1.0% or 0.1% concentrations of PBT
chemicals will be more burdensome than for larger quantities of these
chemicals manufactured, processed, or otherwise used at a mining
facility in excess of the activity thresholds.
b. Alternate de minimis level. Several commenters argue that in
lieu of eliminating the de minimis exemption for PBT chemicals, it
would make more sense to change the level for the de minimis exemption
for these chemicals. Some commenters argue that a more appropriate
approach would be to compare the current thresholds and the current de
minimis levels and use the same ratio to create a new de minimis level
for the lowered PBT chemical thresholds. Therefore, they argue, the
existing level is 1% for a threshold of 10,000 pounds, so an analogous
reduction of the de minimis level would be 0.01% for the new proposed
threshold of 100 pounds and 0.001% for the new proposed threshold of 10
pounds per year and 1 ppb for dioxins. One commenter argues that the
current de minimis level of 0.1% for known or suspected carcinogens is
not appropriate for dioxins. They suggest that EPA lower the de minimis
exemption for dioxins proportionally to the lower reporting threshold
EPA sets in the final rule. They assert that a reporting threshold for
dioxins of 0.002 pound TEQ (not the threshold in the PBT proposal nor
the one that EPA is finalizing today), is approximately seven orders of
magnitude less than the current 10,000 pound threshold. Therefore, they
argue, the 0.1% de minimis exemption should be lowered proportionally
to 1 x 10-8%. This translates to a concentration of 100
parts per trillion.
EPA disagrees with these commenters. As explained previously, EPA
adopted the de minimis exemption for several reasons including the
desire to be consistent with information mandated by the OSHA HCS. This
OSHA standard requires the listing of hazardous chemicals on MSDSs but
allows chemical suppliers to omit from the MSDSs hazardous chemicals
that are below certain concentrations: Specifically, levels of 0.1% for
OSHA carcinogens and 1.0% for other hazardous chemicals. However, the
rationale for the OSHA HCS de minimis exemption is not relevant to PBT
chemicals and therefore, is insufficient by itself to support an
alternative de minimis exemption for PBT chemicals.
[[Page 58732]]
As explained in the 1983 final rule, OSHA chose the 1.0% concentration
limit based on comments that this level seemed to be sufficiently
protective of workers and was considered to be reasonable by a number
of commenters (48 FR 53280, at 53290, November 25, 1983). OSHA was also
persuaded by comments that in some instances the 1.0% cut-off levels
may not be protective enough with respect to certain health hazards and
adopted the 0.1% level for carcinogens (at 48 FR 53292). Specifically,
PBT chemicals are of concern because they persist and bioaccumulate in
the environment. Persistence and bioaccumulation were not considered as
a part of the OSHA rulemaking. In addition, as explained in other
responses in this unit, EPA's original rationale for this exemption is
inapplicable to PBT chemials, and the commenters have provided no
alternate rationale to support an exemption based on extrapolating new
de minimis levels from the proposed thresholds. Therefore, given the
different intents between the OSHA HCS and EPCRA section 313, EPA does
not believe that creating alternative de minimis levels for PBT
chemicals based on a ratio between the lowered threshold and the OSHA
HCS levels is appropriate.
Several commenters support EPA's elimination of the de minimis
exemption for PBT chemicals. They assert that retention of the de
minimis exemption would undermine the changes to the reporting
threshold and would allow an unnecessary loophole from reporting. They
assert that the rule does not require any additional testing for
impurities and that the only additional reporting would be for those
facilities that use sufficient quantities of mixtures or trade name
products containing PBT chemicals as impurities. One commenter asserts
that one of the original reasons for the de minimis exemption levels,
that it was based on OSHA HCS thresholds of 1.0% for hazardous
chemicals in mixtures and 0.1% for carcinogens in mixtures, does not
apply to raw materials that are not manufactured chemicals, such as
crude oil, coal, and mining inputs.
EPA agrees with these commenters and is eliminating the de minimis
exemption for PBT chemicals addressed in today's rule. As discussed
above, the reasons EPA indicated for originally adopting the de minimis
exemption are not applicable to PBT chemicals. In addition, EPA has
received no compelling arguments from commenters to extend the de
minimis exemption to PBT chemicals. Because the purpose of today's
rulemaking is different from past rulemakings in that it is intended to
capture information on significantly smaller quantities of releases and
other waste management associated with these chemicals, the de minimis
exemption could significantly limit the amount of reporting on PBT
chemicals. Therefore, given that: (1) Covered facilities have several
sources of information available to them regarding the concentration of
PBT chemicals in mixtures; (2) even minimal releases of persistent
bioaccumulative chemicals may result in significant adverse effects and
can reasonably be expected to significantly contribute to the proposed
lower thresholds; and (3) the concentration levels chosen, in part, to
be consistent with the OSHA HCS are inappropriately high for PBT
chemicals, EPA believes that the reasons for the de minimis exemption
that the Agency held for previous rulemakings do not apply to PBT
chemicals. EPA is therefore eliminating the de minimis exemption for
PBT chemicals.
c. Supplier notification. Several commenters were confused by EPA's
failure to modify the de minimis exemption for PBT chemicals under the
supplier notification requirements. As explained in the PBT proposal,
the Agency believes that covered facilities have sufficient information
available to them on PBT chemicals. The requirement of additional
information under the supplier notification requirements would result
in redundancies. Commenters that correctly understood EPA's inaction on
this topic support the retention of the de minimis exemption for
purposes of Subpart C Supplier Notification Requirements under 40 CFR
372.45(d)(1). EPA agrees with these commenters and has therefore taken
no action on the supplier notification requirements for PBT chemicals.
2. Other exemptions. Although the Agency received several comments
regarding the existing exemptions, EPA is not modifying any of these
exemptions in this rule. Any changes to these exemptions would require
additional rulemaking, and any comments submitted to EPA during this
rulemaking will be considered as part of EPA's evaluation of these
exemptions.
3. Use of alternate threshold and Form A. One issue that commenters
raise relates to EPA's proposal to exclude all PBT chemicals from the
alternate threshold of 1 million pounds for PBT chemicals. Several
commenters argue that EPA should retain the alternate threshold of 1
million pounds for PBT chemicals. EPA disagrees. As stated in detail in
the proposal, EPA believes that use of the existing alternate threshold
and reportable quantity for Form A would be inconsistent with the
intent of expanded PBT chemical reporting. The general information
provided on the Form A, on the quantities of the chemical that the
facility manages as waste is insufficient for conducting meaningful
analyses on PBT chemicals.
A commenter states that because PACs in fuel are destroyed during
combustion, EPA should retain the alternate threshold or provide a new
alternate threshold. First, the commenter did not provide any
information to support the contention that PACs in fuel are destroyed
during combustion. And, to the contrary, EPA believes that, even if
some or all of the PACs in fuel are destroyed during combustion,
additional PACs may be created during the combustion process.
Consequently, absent any information to support the basis for such an
option, or the need for an alternate threshold, EPA does not believe it
would be appropriate at this time to provide a new alternate Form A
threshold. Although EPA solicited comments on this issue in the
proposal, at this time, the Agency believes that it is appropriate to
collect and analyze several years worth of data at the lowered
thresholds before EPA considers developing a new alternate threshold
and reportable quantity appropriate for PBT chemicals.
In addition, the commenter also appears to be raising a broader
issue than just the destruction of PACs during combustion. The
commenter implies that when a facility estimates its releases to be
zero, the facility should be eligible to use the Form A. However, the
commenter appears to misunderstand how to calculate the amounts
required to determine eligibility for the Form A. Facilities may use
the Form A provided that they do not exceed 500 pounds for the total
annual reportable amount for a chemical, and that their amounts
manufactured or processed or otherwise used do not exceed 1 million
pounds. The annual reportable amount is equal to the combined total
quantities released at the facility, treated at the facility, recovered
at the facility as a result of recycle operations, combusted for the
purpose of energy recovery at the facility, and amounts transferred
from the facility to off-site locations for the purpose of recycle,
energy recovery, treatment, and/or disposal. The commenter only appears
to consider their releases as reportable amounts and does not appear to
consider quantities generated from their other waste management
activities as reportable amounts. This additional waste management
information on PBT chemicals is very important to
[[Page 58733]]
communities because it helps them understand the quantities of EPCRA
section 313 chemicals that are being transported through their
communities, the destination of these EPCRA section 313 chemicals, as
well as the reported waste management activity at the receiving
facility. In conclusion, EPA has not proposed to disregard this waste
management information in calculating the annual reportable amount,
therefore the commenter's approach is not consistent with current
reporting under Form A or appropriate as an approach for reporting on
PBT chemicals.
The commenter also states that the alternate threshold should be
retained in order to ensure that only meaningful amounts of substances
are reported under EPCRA section 313. EPA disagrees that retention of
the alternate threshold would ensure that only meaningful information
is reported under EPCRA section 313. The 500 pound waste eligibility
could be interpreted by some data users, as a worst case, to mean that
greater than 500 pounds of the chemical has been released into the
environment (i.e., 500 pounds of production-related waste as release
and some quantity of catastrophic release). Other data users may assume
that the facility had no catastrophic releases and all of the toxic
chemical in waste was managed in a manner other than as a release,
e.g., the toxic chemical in waste was recycled. For PBT chemicals where
any release is a concern, an uncertainty level of 500 pounds may result
in data that is virtually unusable. As a result, EPA does not agree
with the commenter that the alternate threshold will ensure that only
meaningful amounts of substances will be reported under EPCRA section
313.
In addition, the commenter argues elimination of the alternate
threshold for PBT chemicals will cause reporting burdens to increase
while failing to provide for the collection of substantial additional
release information. EPA's economic analysis used reporting costs for
the Form R to estimate the costs to those facilities that would not be
able to use the alternate threshold. The economic analysis also
evaluated the benefits of the collection of additional release and
other waste management of PBT chemicals (Ref. 67). The commenter does
not dispute those estimates. As a result, EPA sees no compelling
argument to revise its decision to exclude all PBT chemicals from the
alternate threshold of 1 million pounds.
A number of commenters argue that EPA should eliminate the
alternate threshold of 1 million pounds for all PBT chemicals on the
EPCRA section 313 list. One commenter asserts that in light of the
relatively small quantities of concern for PBT chemicals, particularly
those with no deliberate commercial manufacture, it makes little sense
to retain the Form A. The commenter further states that it believes
that a modified Form A would be inappropriate due to the concern over
releases of these chemicals at low levels. Another commenter adds that
the Form A is clearly inappropriate for chemicals that will now have
thresholds significantly lower than the 500 pound waste generation
level. The commenter further contends that it is not appropriate for
EPA to set a new Form A threshold for PBT chemicals, given the need to
collect more information on these substances.
EPA agrees with the commenters that all PBT chemicals should be
excluded from the alternate threshold of 1 million pounds. As stated in
detail in the proposal, EPA believes that use of the existing alternate
threshold and reportable quantity for Form A would be inconsistent with
the intent of expanded PBT chemical reporting (at 64 FR 715-716). The
general information provided in the Form A on the quantities of the
chemical that the facility manages as waste is insufficient for
conducting meaningful analyses on PBT chemicals.
EPA also agrees that a new alternate threshold for PBT chemicals
would be inappropriate due to the concern over releases and other waste
management of these chemicals at low levels. As stated in the proposal,
even small quantities of persistent bioaccumulative chemicals may cause
elevated concentrations in the environment and organisms that may cause
significant adverse effects. Given the persistent and bioaccumulative
nature of these chemicals and the need for the public to have
information about smaller amounts of these PBT chemicals, EPA believes
it would be inappropriate at this time to allow an option that would
exclude significant information on some releases and other waste
management of these chemicals.
In response to EPA's proposal to exclude all PBT chemicals from the
alternate threshold of 1 million pounds, one commenter argues that EPA
should consider establishing a new alternate reporting threshold for
these chemicals. The commenter states that, at a minimum, an alternate
reporting threshold of 10 to 100 pounds would be consistent with the
throughput-reporting threshold proposed for all PBT chemicals except
dioxins. The commenter further states that the SBA's analysis suggests
significant reductions in burden associated with alternate reporting
thresholds of 50 pounds for PBT chemicals. The commenter states that,
based on an SBA study commissioned of petroleum bulk plants, which it
estimates will be the largest group of reporters under this proposal,
it finds that most of the reports avoided by this alternate threshold
would reflect zero releases.
EPA disagrees with the comment suggesting that a new alternate
threshold be established for PBT chemicals. As stated in the proposal,
even small quantities of persistent bioaccumulative chemicals may cause
elevated concentrations in the environment and organisms that may cause
significant adverse effects. Given the persistent and bioaccumulative
nature of these chemicals and the need for the public to have
information about smaller amounts of these PBT chemicals, EPA believes
it would be inappropriate at this time to allow an option that would
exclude significant information on some releases and other waste
management of these chemicals. The general information provided in the
Form A on the quantities of the chemical that the facility manages as
waste is insufficient for conducting meaningful analyses on PBT
chemicals. Therefore, EPA does not agree that a new alternate threshold
for PBT chemicals should be established.
The commenter also suggests that reporting burdens will increase
while failing to provide for the collection of substantial additional
release information. EPA's economic analysis used reporting costs for
the Form R to estimate the costs to those facilities that would not be
able to use the alternate threshold. The economic analysis also
evaluated the benefits of the collection of additional release and
other waste management of PBT chemicals (Ref. 67). The commenter does
not dispute those estimates. As a result, EPA sees no compelling
argument to revise its decision to exclude all PBT chemicals from the
alternate threshold of 1 million pounds.
4. Data precision issues--a. Use of significant digits, half pound
and whole numbers. EPA proposed to require reporting of all releases
and other waste management quantities of PBT chemicals (except dioxin)
that are greater than \1/10\ of a pound, provided that the accuracy in
the underlying data on which the estimate is based supports this level
of precision. EPA further stated that releases and other waste
management quantities would continue to be reported to two significant
digits. In addition, EPA stated that for quantities of 10 pounds or
greater, only
[[Page 58734]]
whole numbers would be required to be reported. For the category of
dioxin and dioxin-like compounds, which have a proposed reporting
threshold of 0.1 gram, EPA proposed that facilities report all releases
and other waste management activities greater than 100 g
(i.e., 0.0001 gram).
After reviewing all comments on this issue, EPA is providing the
following guidance on the level of precision covered facilities should
use to report their releases and other waste management quantities of
PBT chemicals. Facilities should continue to report releases and other
waste management amounts greater than \1/10\ of a pound (except
dioxin), at a level of precision supported by the accuracy of the
underlying data and the estimation techniques on which the estimate is
based.
This approach is consistent with the statutory reporting
requirements when estimating reportable amounts. The statute requires
facilities to, among other things, report ``[t]he annual quantity of
the toxic chemical entering each environmental medium.'' (42 U.S.C.
11023(g)(1)(C)(iv)). To determine this ``annual quantity,'' the statute
directs facilities to use readily available data (including monitoring
data). When such data are not readily available, the statute directs
facilities to use reasonable estimates. (42 U.S.C. 11023(g)(2)).
However, while the statute allows for some level of imprecision
regarding reportable amounts, it does not create an exemption or
exception that would allow facilities to report less precisely than
provided for by their data or estimation techniques. Therefore,
facilities should report PBT chemicals as precisely as their estimation
techniques or readily available data allow. If a facility's release or
other management calculations support reporting an amount that is more
precise than two significant digits, then the facility should report
that more precise amount.
b. Use of range reporting. In the preamble to the proposed rule,
EPA requested comments on its proposal to eliminate the use of range
reporting in Form Rs for PBT chemicals. Commenters disagree with the
proposal for a number of reasons outlined below.
Commenters argue that applying different reporting conventions for
PBT chemicals would complicate EPCRA section 313 reporting, cause
compliance difficulty, and introduce data inconsistencies (i.e., ranges
for some chemicals but not for others). Commenters also argue that
eliminating the use of range reporting for PBT chemicals has the
potential to mislead the public and divert attention from actual risks.
EPA disagrees that the elimination of the use of range reporting
for PBT chemicals will cause insurmountable obstacles to EPCRA section
313 reporting and cause compliance difficulties and data
inconsistencies. There are already many different industries that
report to EPA for 643 chemicals. EPA provides numerous guidance
documents and training opportunities to reporting industries. With the
finalization of the PBT rule, EPA will provide updated guidance
documents, will prepare and provide, in those cases where it is
appropriate, chemical-specific guidance documents, and will continue to
offer training in order to assist facilities in reporting under EPCRA
section 313. EPA also believes that the Agency will be able to
adequately explain to the public the different reporting requirements
for PBT chemicals so that they are put in context of other TRI data.
EPA currently does this for other types of chemicals on the EPCRA
section 313 list such as metals and pesticides.
Additionally, EPA believes that the elimination of range reporting
is a critical part of this rulemaking, of which the ultimate intent is
to provide useful information on PBT chemicals to assist communities in
determining if PBT chemicals are present in their communities at levels
that may pose an unacceptable risk. This information on PBT chemicals
can also be used by government agencies and others to identify
problems, set priorities, and take appropriate steps to reduce any
potential risks to human health and the environment. Consequently, the
information collected about these PBT chemicals will inform the public
rather than mislead the public and will actually assist the public in
determining the risk of PBT chemicals in their communities.
Commenters also argue that reporting numerical values for PBT
chemicals assumes a level of accuracy that generally does not exist in
the measurement of releases. In addition, commenters state that
estimating numerical values would require the use of material balances,
which are difficult to apply and essentially inaccurate for chemicals
used in low concentrations. Commenters contend that, especially where
reports are estimates, ranges may in fact provide more information than
point estimates. Commenters argue that, for these reasons, elimination
of range reporting will result in inaccurate estimates. Commenters also
state that eliminating the use of range reporting for PBT chemicals
would give the false impression of precise data, where uncertainty
inherently exists.
As stated in the proposal, EPA believes that the use of ranges
could misrepresent data accuracy because the low or the high end range
numbers may not really be that close to the estimated value, even
taking into account its inherent error (i.e., error in measurements and
developing estimates) (at 64 FR 716). The user of the data must make a
determination on whether to use the low end of the range, the mid-
point, or the upper end. For example, a release of 501 pounds could be
misinterpreted as 999 pounds if reported as a range of 500-999. This
represents nearly a 100% error. This uncertainty severely limits the
applicability of release information where the majority of releases,
particularly for PBT chemicals, are expected to be within the amounts
eligible for range reporting. The utility of these data would be
severely limited given the uncertainty associated with data reported
using ranges. Therefore, due to this uncertainty, EPA believes that
facilities should report numerical values, not ranges, for PBT
chemicals.
In addition, EPA believes that the information available to the
typical EPCRA section 313 reporter is generally greater and/or more
accessible than it was 10 years ago. Because of this improved
information availability, EPA believes that many facilities will be
able to accurately estimate releases and off-site transfers for further
waste management of PBT chemicals in quantities of less than 1,000
pounds without the use of range codes. Although it may be true that
some facilities will be better able to make those estimates than
others, EPA does not believe this justifies not collecting the more
specific and useful information from those facilities that can provide
it.
Further, the Form R and Instructions and annual TRI data release
provide information on the methods used to generate information
reported and characterize many of the limitations that may apply to the
data. This aids the data user in understanding the overall nature of
the information available under EPCRA section 313. Facilities are
required, for each release or transfer amount, to indicate on the the
principal method used to determine the amount of release reported.
There are codes which allow the facility to indicate whether the
estimate is based on monitoring data, mass balance calculations,
published emission factors, or other approaches such as engineering
calculations or best engineering judgment. By looking at the
[[Page 58735]]
information provided through the use of these codes, users of the data
can gain an understanding of the degree of accuracy or uncertainty in
any particular number reported by a facility. Thus, EPA believes that
false impressions will not be communicated to the data user about the
accuracy of the information filed.
Finally, EPCRA permits facilities to use reasonable estimates in
the absence of readily available data to calculate reportable amounts.
Compliance with EPCRA section 313 does not require that additional
monitoring or sampling be done. Thus, the statute contemplates some
level of imprecision in the data that may be filed, yet, by authorizing
reporting based on reasonable estimates, affirms the community right-
to-know purposes relative to information based on such reasonable
estimates. Reporting releases of low volumes of PBT chemicals based on
such reasonable estimates is no different than reporting on other toxic
chemicals based on the same kind of information. The TRI data that has
been reported since 1987 is a blend of estimates based on monitoring
data, mass balance calculations, published emissions factors, and
engineering calculations or engineering judgment.
The commenters contend that eliminating the use of range reporting
for PBT chemicals would be extremely burdensome to facilities. EPA
explained in the proposal that the original intent of providing the
range reporting option was primarily as a burden reducing measure
focused on small businesses. In past expansion activities, EPA has
tried to retain burden reducing options wherever feasible. However, EPA
does not expect the elimination of range reporting to significantly
affect the unit cost of reporting because many facilities that could
use range reporting are not choosing to do so. An analysis of the 1997
data reported under EPCRA section 313 reveals that the number of
instances in which a range code was used for reporting quantities in
sections 5 and 6 of the Form R was 37,168. These 37,168 instances
included 7,605,305 pounds of releases and transfers using the median of
the range code reported. However, there were 66,842 instances in which
range reporting could have been used (i.e., the amounts reported where
below 1,000 pounds), but the reporting facility chose instead to report
a number rather than a range. These 66,842 instances included
13,662,758 pounds of releases and transfers. Thus, in 64% of the
instances where range reporting could have been used facilities
reported a number instead. The fact that in a majority of the instances
in which range reporting could have been used facilities opted to
report specific numbers would appear to indicate that the elimination
of range reporting for PBT chemicals is unlikely to impose any
significant additional burden on facilities. Therefore, EPA does not
expect the elimination of range reporting to have any significant
effect on unit reporting costs.
Commenters also argue that the elimination of the use of range
reporting for PBT chemicals could result in an increase in the threat
to confidential information and a possible increase in trade secret
claims. Commenters maintain that Congress considered the need to
protect trade secret information in the discussion of reporting
chemical use and presence in ranges for EPCRA section 313:
The conference substitute provides for reporting categories of
use and ranges of chemicals present because the exact use of an
identified chemical at a facility or the exact amount present may
disclose secret processes. In some circumstances, this information
may need to be reported in terms of broad 43 categories of use or
amount ranges. . . . (H.R. Report No. 99-962, 298)
However, EPA believes that the conference report language cited by the
commenter clearly refers only to the use of range reporting for the
data element entitled ``maximum amount of the toxic chemical on-site at
any time during the calendar year.'' EPA is not precluding range
reporting for maximum amounts on-site. Contrary to the notion expressed
by the commenter, Congress did not expressly direct EPA to allow range
reporting for the reporting of releases and transfers off-site for
further waste management. Additionally, in the statute, Congress
provided the only means and mechanism for facilities to protect
confidential business information (CBI) through the statute's trade
secret provisions. If the commenter believes that any report filed
might reveal confidential information as to the identity of the
chemical, the commenter may choose to file a CBI claim by following the
procedures as outlined in 40 CFR part 350. In addition, the statute is
clear that trade secret claims may only be made for the identity of the
chemical. Therefore, EPA believes that Congress adequately provided
procedures for the protection of CBI and that a possible increase in
CBI claims does not outweigh the need for increased information on
releases and other waste management of PBT chemicals. See, Legislative
History at 5185.
Commenters also argue that eliminating the use of range reporting
for PBT chemicals will not result in the collection of substantial
additional release information. EPA disagrees. The issue of range
reporting is closely tied to the lowering of the reporting thresholds
for PBT chemicals. As EPA noted in the proposal,
Since PBT chemicals can remain in the environment for a
significant amount of time and can bioaccumulate in animal tissues,
even relatively small releases of such chemicals from individual
facilities have the potential to accumulate over time to higher
levels and cause significant adverse impacts on human health and the
environment.
EPA also noted in the proposal that,
Under current reporting thresholds, a significant amount of the
releases and other waste management activities involving PBT
chemicals are not being captured and thus the public does not have
the information needed to determine if PBT chemicals are present in
their communities and at levels that may pose a significant risk.
Therefore, by the lowering of reporting thresholds, EPA will receive
important information on the quantities of PBT chemicals being released
or otherwise managed as waste. Given the lowering of the reporting
thresholds, continued use of ranges could misrepresent data accuracy
because the low or the high end range numbers may not really be that
close to the estimated value, even taking into account any inherent
error (i.e., errors in measurements and developing estimates). The user
of the data must make a determination on whether to use the low end of
the range, the mid-point, or the upper end. For example, a release of
501 pounds could be misinterpreted as 999 pounds if reported as a range
of 500-999. This represents a nearly 100% error. This uncertainty
severely limits the applicability of release information where the
majority of releases, particularly for PBT chemicals, are expected to
be within the amounts eligible for range reporting. Given that the
large uncertainty would be part of these data and would severely limit
their utility, EPA has concluded that facilities must report numerical
values, not ranges, for PBT chemicals.
In addition to the above comments, several commenters recommend the
use of multiple ranges rather than total elimination of ranges just for
PBT chemicals. One commenter generally agrees with EPA's position that
reporting ranges ``B'' (11 to 499 pounds) and ``C'' (500 to 999
pounds), as they currently exist, may be too broad to provide
meaningful information for PBT chemicals. Because the proposal does not
impose any new obligation to measure or test beyond what is currently
required, however, the commenter believes it is still
[[Page 58736]]
appropriate to retain the ``A'' reporting range of 1 to 10 pounds for
PBT chemicals. The commenter contends that the use of a specific number
conveys a sense of precision that may not actually exist. The commenter
argues that the retention of the ``A'' reporting range in its current
form, coupled with the new reporting range of ``greater than zero, but
less than 1 pound,'' will provide meaningful and valuable information
to the public on PBT chemical transfers or releases.
Another commenter agrees with the purpose underlying the EPA's
proposal to prohibit the use of range reporting for PBT chemicals and
believes the ranges authorized under the current rules are too broad to
be useful for PBT chemicals. However, the commenter believes that EPA
should recognize that reporting in ranges is often necessary because
uncertainty makes the selection of a single number arbitrary.
Another commenter argues that EPA should retain range reporting for
PBT chemicals, even if the ranges are lower than those allowed for non-
PBT chemicals. The commenter further contends that they believe that
range reporting helps to correct some of the error introduced to EPCRA
section 313 reporting through the use of estimates.
EPA disagrees that the Agency should retain the ``A'' reporting
range of 1 to 10 pounds for PBT chemicals or that the Agency should
retain some form of range reporting for PBT chemicals. As stated in the
proposal, EPA believes that the use of ranges could misrepresent data
accuracy because the low or the high end range numbers may not really
be that close to the estimated value, even taking into account its
inherent error (i.e., error in measurements and developing estimates).
The user of the data must make a determination on whether to use the
low end of the range, the mid-point, or the upper end. For example, a
release of 501 pounds could be misinterpreted as 999 pounds if reported
as a range of 500-999. This represents a nearly 100% error. Even with a
lower range such as 1 to 10 pounds, the uncertainty associated with
range reporting could severely limit the applicability of release
information for PBT chemicals. Numerical values are particularly
important since PBT chemicals can remain in the environment for a
significant amount of time and can bioaccumulate in animal tissues.
This means that even relatively small releases of such chemicals from
individual facilities have the potential to accumulate over time to
higher levels and cause adverse impacts on the environment and
organisms. The utility of these data would be limited given the
uncertainty associated with data reported using ranges. Therefore, due
to this uncertainty, EPA is requiring that facilities report numerical
values, not ranges, for PBT chemicals.
In addition, EPA believes that the information available to the
typical EPCRA section 313 reporter is generally greater and more
accessible than it was 10 years ago. Because of this improved
information availability, EPA believes that facilities will be able to
accurately estimate releases and off-site transfers for further waste
management of PBT chemicals in quantities of less than 1,000 pounds
without the use of range codes. Although it may be true that some
facilities will be better able to make those estimates than others, EPA
does not believe this justifies not collecting the more specific and
useful information from those facilities that can provide it. Further,
in the Form R, facilities are required, for each release or transfer
amount, to indicate the principal method used to determine the amount
of release reported. There are codes which allow the facility to
indicate whether the estimate is based on monitoring data, mass balance
calculations, published emission factors, or other approaches such as
engineering calculations or best engineering judgment. By looking at
the information provided through the use of these codes, users of the
data can gain an understanding of the degree of accuracy or uncertainty
in any particular number reported by a facility. Thus, EPA does not
believe that false impressions will be communicated to the data user
about the accuracy of the information filed.
Finally, as noted earlier EPCRA permits facilities to use
reasonable estimates in the absence of readily available data to
calculate reportable amounts. EPCRA does not require that additional
monitoring or sampling be done in order to report. Thus, the statute
contemplates some level of imprecision in the data that may be filed,
yet, by authorizing reporting based on reasonable estimates, affirms
the community right-to-know purposes relative to information based on
such reasonable estimates.
A number of commenters agreed with EPA's proposal that range
reporting be eliminated for all PBT chemicals on the EPCRA section 313
list. The commenters agreed with EPA's belief that the use of ranges
could misrepresent data accuracy and significantly impact the
usefulness of the data.
J. Other Issues
1. Placing reported data into context. Several commenters make the
same general comment that EPCRA section 313 does not capture all
sources of PBT chemical releases and therefore will not provide a
complete or accurate picture of the releases of these chemicals.
Commenters criticize the proposal for not putting the PBT releases from
EPCRA section 313 covered facilities into context, in terms of either
risk or the amount of PBT releases expected from non-covered facilities
or sources. EPA disagrees with the implication by several commenters
that simply because EPCRA section 313 may not capture all the sources
of releases of PBT chemicals EPA should not attempt to capture more
information from the facilities that do report under EPCRA section 313.
This comment has been voiced in every major rulemaking under EPCRA
section 313 but, as EPA has stated in the past, this is not an argument
that EPA believes should restrict any efforts to collect additional
data under EPCRA section 313. The mere fact that for some chemicals
significant release sources are not captured does not in any way
diminish the importance of the information that can be provided by
those facilities that are required to report under EPCRA section 313.
There is currently no one single reporting requirement that captures
all of the releases of PBT chemicals and makes that information
available to the public. For those chemicals that do have large release
sources not captured under EPCRA section 313, EPA will use all
available data to aid its actions and those of other international and
national organizations and the public in efforts to address concerns on
PBT chemicals. For example, all data will be considered to aid EPA's
PBT strategy or other EPA PBT related programs; EPA will not rely
solely on the data collected under EPCRA section 313. In addition, if
there are significant sources of PBT chemicals that are not reported
under EPCRA section 313, EPA will attempt to let the public know that
some sources are not captured. In fact, in the most recent TRI data
release documents, EPA has been providing information to the pubic on
other sources of releases for certain EPCRA section 313 chemicals. In
addition, EPA will continue to improve and augment public information
materials so that users of the data will have information available to
put in context the releases and other waste management of PBT chemicals
by industries reporting under EPCRA section 313 versus those industries
that do not report under EPCRA section 313.
[[Page 58737]]
In fact, rather than an argument against lowering the reporting
thresholds for PBT chemicals, EPA believes that the argument the
commenters are making is one that supports expanding the types of
facilities that should be required to report under EPCRA section 313
and not an argument that supports denying the public the right-to-know
about PBT chemical releases from EPCRA section 313 covered facilities.
Some commenters stated that since EPA did not use exposure or risk
considerations, the data on PBT chemical releases will be misleading to
the public by indicating risks where none exist. EPCRA section 313 is
not a risk-based reporting system, and, as discussed in Unit VI.F., EPA
believes that a risk-based approach to EPCRA section 313 reporting is
at odds with the overriding policy of EPCRA section 313, which is to
get information about the use, disposition, and management of toxic
chemicals into the public domain, enabling the users of this
information to evaluate the information and draw their own conclusions
about risk. The intent of EPCRA section 313 is to move the
determination of which risks are acceptable from EPA to the communities
in which the releases occur. This basic, local empowerment is a
cornerstone of the right-to-know program. In addition, EPA will
continue to improve its annual public data release as well as its
outreach and education efforts to assist users in understanding the
data. Consequently, EPA disagrees with the commenters that the
information reported on releases and other waste management of PBT
chemicals will be misleading to the public.
Another commenter states that the quantities of PBT chemicals
reported in the TRI will be far smaller than the quantities of other
chemicals which pose far less significant health risks. The commenter
is concerned that the small quantities could lead members of the public
to overlook the data on PBT chemicals. Therefore, the commenter argues
that EPA should present PBT data in a way that draws the public's
attention to it. The commenter states that it sees a danger that
without sufficient education and guidance, the public may either
overestimate or underestimate the health risks from PBT chemicals. The
commenter believes that EPA should make a commitment to ensuring that
the public is given the necessary education and guidance. EPA
understands that the quantities of PBT chemicals may be reported in
smaller quantities than other chemicals under EPCRA section 313 and
that these quantities have the potential to be overlooked. EPA is also
sensitive to the issue that data on PBT chemicals must be presented
clearly to assist data users in understanding how the information on
PBT chemicals is different from that reported on other chemicals under
EPCRA section 313. EPA will continue to improve its annual public data
release as well as its outreach and education efforts to assist users
in understanding the data. Despite the concerns voiced by the
commenters, EPA still believes that it is important to collect and
disseminate this information so that communities can use the
information with other site-specific factors to determine if releases
into their communities result in risks that the community determines
warrant further action given other factors, such as economic and
environmental conditions, or particularly vulnerable human or
ecological populations.
Another commenter expresses concern that release numbers for PBT
chemical will not be comparable to those for other chemicals with
higher reporting thresholds or to releases of the PBT chemical in
previous years. The commenter adds that the lower thresholds may
mislead the public into thinking that releases are rising or that a new
chemical has been introduced at a facility. EPA understands the
commenter's concern but does not believe this is a justification for
not collecting additional information about PBT chemicals. EPA believes
that it will be able to adequately explain to the public the different
reporting requirements for PBT chemicals so that they are put in
context of other TRI data. EPA will make clear which PBT chemicals were
reportable prior to the finalization of this rule and what the
reporting threshold was for these chemicals. Finally, EPA will continue
to improve its annual public data release as well as its outreach and
education efforts to assist users in understanding the data.
2. Manufacture only qualifier for chemicals other than dioxin. Many
commenters request that EPA add a ``manufacture only'' qualifier to all
PBT chemicals, not just the dioxin and dioxin-like compounds category.
The commenters assert that the addition of the manufacture only
qualifier to all PBT chemicals would greatly reduce the burden of the
rule. Some commenters suggest that at a minimum the manufacture only
qualifier should apply to polychlorinated biphenyls (PCBs), since EPA's
rationale for applying the qualifier to dioxin and dioxin-like
compounds is equally applicable to PCBs. One commenter contends that
EPA's statement that the manufacture qualifier is appropriate for
chemicals that are ``ubiquitous in the environment'' because otherwise
many facilities would be required to report simply due to background
levels in raw materials applies to PCBs as well. Some commenters
suggest that unintentionally manufactured by-products such as
hexachlorobenzene and octachlorostyrene should also have the
manufacture only qualifier. Some commenters argue that the burden of
the rule could be significantly reduced if EPA focused the reporting
effort on the manufacturing sector, which should help concentrate EPA's
pollution prevention efforts on the sector most likely to be able to
make reductions. Some commenters contend that the primary source for
PBT chemicals within the EPCRA section 313 reporting sectors is from
manufacturing, and these are the sources that should be focused on for
tracking PBT chemicals. Some commenters assert that EPA has
acknowledged that many chemicals identified as persistent and
bioaccumulative are not imported, processed, or otherwise used, but are
manufactured as by-products (at 64 FR 715). Some commenters assert that
they agree that manufacturing is the primary source for environmental
loading of PBT chemicals from EPCRA section 313 facilities, and thus
the effort for reporting should be concentrated on the sources where
PBT chemicals are generated and data can be gathered. Some commenters
argue that concentration on the manufacturing of PBT chemicals provides
an efficient focus for meaningful pollution prevention efforts. Some
commenters assert that they are concerned that data from importing,
processing, or otherwise use of PBT chemicals will be inaccurate and
misleading since processors and users may not have the resources to
conduct the analyses required to provide accurate estimates. One
commenter contends that the fear of enforcement might motivate those
importing, processing, or otherwise using PBT chemicals to report
``some amount'' and that such information is likely to be inaccurate,
and will not accurately reflect the true level of concern. Some
commenters assert that instead of requiring reports from the many
sources where effective emissions reductions may not be possible, that
the addition of a manufacture only activity qualifier for all PBT
chemicals will provide the public with the most accurate information on
PBT chemical emissions and the best opportunity to monitor EPCRA
section 313-related
[[Page 58738]]
environmental loading of these chemicals.
EPA believes that in order to obtain any reporting on dioxin and
dioxin-like compounds a very low threshold is required, which is
several orders of magnitude lower than the thresholds for other PBT
chemicals. At such a low reporting threshold it is estimated that
thousands of reports could potentially be filed by facilities, mainly
food processing facilities, due to the amount of dioxins in the raw
materials they process. The dioxins found in the meat and dairy
products that food processors handle have been previously released,
circulated in the environment, and bioaccumulated in animals, thus
these are not additional loadings to the environment but loadings that
have already occurred and cycled through the environment due to the
persistence and bioaccumulative properties of these compounds. The
unique combination of very low thresholds, the number of food
processors that would be required to file, and the fact that they would
be filing because of the bioaccumulation of previously released
material led EPA to propose to add only dioxin and dioxin-like
compounds that are manufactured. EPA is finalizing the addition of
dioxin with a revised qualifier in response to the unique set of
conditions that apply to the reporting of dioxin and dioxin-like
compounds. EPA proposed and is finalizing the addition of dioxin with a
qualifier to reduce reporting burden on facilities, mainly in the food
processing industry, that results from the unique combination of
circumstances related to the reporting for these chemicals and to focus
on those activities that add to the loading of dioxins in the
environment rather than on activities dealing with previously released
and bioaccumulated chemicals.
EPA did not conclude and does not believe that the manufacturing
activity is the only important source of PBT chemical releases to the
environment and believes that other activities such as processing or
use can result in significant releases of PBT chemicals, including
chemicals released to the environment for the first time. As discussed
in Unit VI.G., EPA has modified the dioxin qualifier to reflect this.
The unique combination of circumstances that exists for dioxin and
dioxin-like compounds does not exists for any of the other PBT
chemicals being added by this rule. EPA did not conclude that the
manufacture qualifier is generally appropriate for other chemicals that
are being added and that are ``ubiquitous in the environment.'' The
full statement in the proposal was ``These dioxin and dioxin-like
compounds are ubiquitous in the environment and thus under the very low
reporting thresholds necessary to get reports from any sources (see
discussion in Unit VII.A.2.), facilities that process raw materials
would be required to report simply because the raw material contains
background levels of these chemicals'' (at 64 FR 710). Clearly EPA made
this statement in the context of the ``very low reporting thresholds
necessary to get reports [for the dioxin and dioxin-like compounds
category] from any sources.'' This statement is consistent with the
unique combination of circumstances that exists for dioxin and dioxin-
like compounds and was not intended to apply to all PBT chemicals.
Neither did EPA conclude that the manufacturing activity is the
activity for which facilities would be most likely to be able to make
reductions or that EPA's pollution prevention efforts should focus
solely on the manufacturing of PBT chemicals. Commenters provided no
basis for such a conclusion and EPA believes that processors and users
of PBT chemicals also have the opportunity to make effective emissions
reductions by using less of a PBT chemical, by not using materials that
contain PBT chemicals as contaminants, etc. In addition, the purposes
of reporting under EPCRA section 313 are not limited to the collection
of information from sources where effective reductions in release and
other waste management quantities are possible. Data collected under
EPCRA section 313 can serve a variety of information purposes that do
not depend on how easy it is for the source to achieve reduction in
releases and other waste management. The commenter statement that EPA
has acknowledged that many chemicals identified as persistent and
bioaccumulative are not imported, processed, or otherwise used, but are
manufactured as by-products, is incorrect. The actual statement was:
``[m]any of the chemicals identified as persistent and bioaccumulative
in today's action are not imported, processed, or otherwise used but
are manufactured as by-products'' (at 64 FR 715). As the words
``today's action'' clearly demonstrate, this statement was not a broad
statement about all PBT chemicals but simply an acknowledgment that
many of the PBT chemicals in the proposed rule were by-products. In
addition, this statement was made in the context of the discussion on
the de minimis exemption about how removing the exemption for PBT
chemicals would affect the chemicals in the proposed rule; it was not a
statement made in connection with the discussion on the manufacture
only qualifier. EPA also did not state that manufacturing is the
primary source for environmental loading of PBT chemicals from
facilities covered under EPCRA section 313. The discussion on the
loading of chemicals in the environment from manufacturing was in
relation to the reporting of dioxin which, as discussed above, presents
a unique combination of circumstances that EPA considered to determine
how to focus its listing decision and does not apply to all PBT
chemicals. EPA disagrees with the statements that data from facilities
that import, process, or otherwise use PBT chemicals will be inaccurate
and misleading or that such facilities will report some quantity out of
fear of enforcement and that such information is likely to be
inaccurate, and will not accurately reflect the true level of concern.
EPA believes that facilities that import, process, or otherwise use PBT
chemicals will be just as able to report as facilities that manufacture
PBT chemicals. It is no more difficult to do calculations regarding
small numbers than it is to do calculations on larger numbers, so if a
facility that imports, processes, or otherwise uses PBT chemicals has
information that allows them to make a reasonable estimation of
quantities then they should be just as able to report as any
manufacturing facility would be able to report on small quantities
manufactured as by-products. If facilities that import, process, or
otherwise use PBT chemicals do not have data available that allows them
to make a reasonable estimation of quantities then they are not
required to report. As for fear of enforcement, EPA can take
enforcement actions both for under reporting and over reporting so
facilities should not report an amount of a PBT chemical in order to
avoid an enforcement action.
EPA does not believe that the unique combination of circumstances
that exists for dioxin and dioxin-like compounds exists for any of the
other PBT chemicals being added by this rule nor does EPA believe that
reduced burden or any of the other reasons suggested by the commenters
provide a sufficient reason to focus on manufacturing activity only for
the other PBT chemicals in this rule. Therefore, EPA does not believe
that it is appropriate to add a manufacture only qualifier to any of
the other PBT chemicals in this rule.
3. Waste management issues. Some commenters contend that because
activities such as recycling, approved
[[Page 58739]]
waste disposal, and treatment are incorporated into reported volumes,
the EPCRA section 313 reported releases will be substantial
overestimates of the actual quantities released to the ambient
environment. They further argue that although this information may be
useful to source reduction efforts, merging of reporting requirements
under section 313 of EPCRA and section 6607 of PPA has resulted in
information which is misleading to the public's desire to know the
actual exposures that are occurring. Another commenter asserts that by
requiring electricity generating facilities to report transfers off-
site for treatment and disposal of PCBs from transformers, EPA has
established a disincentive to properly dispose of PCB transformers and
remove them from use because most PCB wastes transferred to off-site
facilities are destroyed in regulated units which destroy at least
99.9999% of the PCBs. They are concerned that because the casual reader
may conclude additional releases of PCBs to the environment have
occurred, companies would have a disincentive to voluntarily remove
PCBs.
The commenters are incorrect in stating that EPCRA section 313
release quantities include recycling and treatment amounts. Under EPCRA
section 313, if a chemical activity threshold is met for the chemical,
covered facilities are required to report the quantity of the toxic
chemical entering each environmental medium; this includes
``releases.'' The definition of release pursuant to EPCRA section
329(8) means:
any spilling, leaking, pumping, pouring, emitting, emptying,
discharging, injecting, escaping, leaching, dumping, or disposing
into the environment (including the abandonment or discarding of
barrels, containers, and other closed receptacles) of any hazardous
chemical, extremely hazardous substance, or toxic chemical.
There is no language in this definition, any other provision of EPCRA,
or in the regulations promulgated pursuant to EPCRA section 313, that
limit this definition to ambient releases to the environment which may
result in public exposure. In fact the definition specifically includes
disposing of toxic chemicals as well as the abandonment of closed
receptacles. In addition, neither the statute nor the regulations limit
this definition to on-site releases. Therefore, the statutory
definition of release under EPCRA section 313 is significantly broader
than the commenter seems to believe.
In addition to release reporting, under section 6607(b)(1) of the
PPA, if a covered facility meets the reporting thresholds under EPCRA
section 313, the facility is required to report the ``quantity of the
chemical entering any wastestream (or otherwise released to the
environment). . . .'' This quantity includes amounts of the toxic
chemical released, treated, and recycled. However, this quantity does
not include:
[t]he amount of any toxic chemical released into the environment
which resulted from a catastrophic event, remedial action, or other one
time event, and is not associated with production processes during the
reporting year. (PPA 6607 (b)(7)) (emphasis added)
Therefore, the quantity of the toxic chemical entering the wastestream
as collected under section 6607(b)(1) of the PPA, is the amount of the
toxic chemical in production related waste. Covered facilities
currently report the amount of the toxic chemical in production related
waste as quantities of the toxic chemical released, treated, combusted
for energy recovery and recycled. These quantities are collected as
separate data elements in section 8 of the Form R. Further, facilities
report the ultimate disposition of toxic chemicals in waste such that
these quantities (i.e., amounts released, treated, combusted for energy
recovery, and recycled) are mutually exclusive. Collectively, then,
these quantities are the amount entering the waste stream or the
quantity of the toxic chemical in production related waste. For
example, a covered facility transfers 1,000,000 pounds of PCBs to an
incinerator for treatment. The covered facility knows that 999,999
pounds are destroyed in the incinerator and the remaining 1 pound is
disposed in a landfill. The facility reports 999,999 pounds as
transferred off-site for treatment and 1 pound as transferred off-site
for disposal. These two quantities are reported as separate data
elements on the Form R. The quantity reported as disposed off-site is
considered released because, as explained previously, disposal is a
type of release. The entire quantity (1,000,000 pounds) is the amount
of production related waste.
Once collected, EPA presents the TRI data to the public in a number
of formats. In its annual data release documents, EPA highlights
different aspects of the quantities of toxic chemicals released and
otherwise managed as waste. For example, EPA presents total on-site
releases and, as subsets, presents the quantities released to air,
surface water, underground injection and on-site land releases. (See
1997 Toxics Release Inventory (EPA 745-R-99-003) Figure 2-3 ``TRI On-
site Releases'') EPA also presents the quantity of total releases in
the public data release. As discussed earlier, under EPCRA section 313,
release quantities are not limited to quantities released to the
ambient environment. Therefore, total releases, as presented in the
public data release include both on and off-site releases as well as a
variety of disposal methods. For example, in Table 2-20A of the 1997
public data release, EPA presents TRI on-site and off-site releases by
chemical and type of release (e.g., air emissions, underground
injection, etc.) (1997 Toxics Release Inventory; EPA 745-R-99-003).
In addition to TRI release data, EPA presents production related
waste quantities in the public data release. Because production related
waste includes releases, EPA includes release quantities with other
waste management quantities. However, in this document, the Agency
generally distinguishes quantities of the toxic chemical released from
other types of waste management. EPA does not count the quantities of
toxic chemicals treated, combusted for energy recovery or recycled as
quantities released. (See, for example, 1997 Toxics Release Inventory
(EPA 745-R-99-003) Table 2-20A ``TRI On-site and Off-site Releases, by
Chemical, 1997'' and Table 2-20B ``TRI Chemicals in Waste, by Chemical,
1997'')
Further, EPA does not believe that the TRI program provides a
disincentive for the proper and safe handling of PCBs in transformers
managed as waste. As explained earlier, covered facilities are required
under EPCRA section 313 and section 6607 of the PPA to report
quantities of toxic chemicals released or otherwise managed as waste if
they meet a chemical activity threshold. Quantities of toxic chemicals
sent off-site for treatment are described as such. These transfers are
not included as releases. In addition, EPA disagrees that quantities of
PCBs sent off-site for treatment will be misunderstood by the public
because these quantities are accurately represented in the TRI data
base and in the public data release as a separate type of waste
management.
Another commenter asserts that the proposed rule will not encourage
waste minimization because facilities will not be able to modify
process designs to accomodate such minimization simply on the basis of
data generated from guidance documents or reasonable estimates. The
commenter asserts that although industry has made substantial
minimization gains, the technology is not available to treat or remove
chemicals of concern from manufactured products or waste (prior to
generation) at such low
[[Page 58740]]
concentrations and that any future improvements will be enormously
expensive due to the low concentrations that would likely be involved.
EPA disagrees with the commenter. In the preamble to the proposed
rule, EPA did not assert that covered facilities will begin performing
waste minimization activities as a direct result of this rulemaking.
Rather, the Agency stated that the PBT chemical rulemaking will provide
data on PBT chemicals to EPA, industry, and the public. For example,
several EPA offices have ongoing projects and programs that deal with
issues concerning PBT chemicals. EPA has established the PBT planning
group which is a coordinating body consisting of representatives from
various program offices throughout EPA that are dealing with PBT
chemicals. This group has developed a strategy to reduce pollution from
PBT chemicals through the application of regulatory and nonregulatory
authorities, with a strong emphasis on pollution prevention. The
availability of that data, in turn, can allow all parties to identify
and track releases of PBT chemicals and monitor the progress of the
programs designed to reduce the amount of PBT chemicals entering the
environment. The data will also allow EPA and others to design
prevention strategies that are focused and effective.
In addition, EPA disagrees with the commenter's last assertion
concerning the available technology and its costs. Although there are
some processes that might not, at present, be amenable to source
reduction in terms of PBT chemicals, some processes may be. For
example, it may be possible to stringently control fuel composition,
flow times, temperature, and other conditions in order to substantially
reduce or even eliminate the incidental manufacture of dioxins during
combustion processes. Therefore, EPA continues to believe that in some
cases, opportunities for pollution prevention will present themselves
resulting from information reported under EPCRA section 313 and section
6607 of the PPA.
4. Modulated reporting thresholds. The majority of commenters
contend that modulating thresholds for reporting so that lower
reporting thresholds are used every other year (with current thresholds
used in alternate years) would introduce confusion for the regulated
community and data users and would not significantly reduce burden.
Further it could discourage facilities from establishing common
standard procedures for data collection. Modulation will also result in
data gaps, undermining data consistency and tracking. Many commenters
believe that annual reporting is a fundamental attribute of TRI.
EPA agrees that modulating the reporting thresholds would introduce
confusion for both the regulated community and data users. For data
users, EPA believes that modulating the reporting thresholds would
limit the usefulness of the TRI data because there would be poor data
consistency and poorer data quality. For the regulated community, EPA
believes that the burden reduction would not be significant and would
possibly be offset by the confusion that would be introduced by
different thresholds in alternate years.
VII. What Were the Results of EPA's Economic Analysis?
EPA has prepared an economic analysis of the impact of this action,
which is contained in a document entitled Economic Analysis of the
Final Rule to Modify Reporting of Persistent Bioaccumulative Toxic
Chemicals under EPCRA Section 313 (Ref. 67). This document is available
in the public docket for this rulemaking. The analysis assesses the
costs, benefits, and associated impacts of the rule, including
potential effects on small entities. The major findings of the analysis
are briefly summarized here.
A. What is the Need for the Rule?
Federal regulations exist, in part, to address significant market
failures. Markets fail to achieve socially efficient outcomes when
differences exist between market values and social values. Two causes
of market failure are externalities and information asymmetries. In the
case of negative externalities, the actions of one economic entity
impose costs on parties that are ``external'' to any market
transaction. For example, a facility may release toxic chemicals
without accounting for the consequences to other parties, such as the
surrounding community, and the prices of that facility's goods or
services thus will fail to reflect those costs. The market may also
fail to efficiently allocate resources in cases where consumers lack
information. For example, where information is insufficient regarding
toxic releases, individuals' choices regarding where to live and work
may not be the same as if they had more complete information. Since
firms ordinarily have little or no incentive to provide information on
their releases and other waste management activities involving toxic
chemicals, the market fails to allocate society's resources in the most
efficient manner.
This rule is intended to address the market failures arising from
private choices about PBT chemicals that have societal costs, and the
market failures created by the limited information available to the
public about the release and other waste management activities
involving PBT chemicals. Through the collection and distribution of
facility-specific data on toxic chemicals, TRI overcomes firms' lack of
incentive to provide certain information, and thereby serves to inform
the public of releases and other waste management of PBT chemicals.
This information enables individuals to make choices that enhance their
overall well-being. Choices made by a more informed public, including
consumers, corporate lenders, and communities, may lead firms to
internalize into their business decisions at least some of the costs to
society relating to their releases and other waste management
activities involving PBT chemicals. In addition, by helping to identify
areas of concern, set priorities and monitor trends, TRI data can also
be used to make more informed decisions regarding the design of more
efficient regulations and voluntary programs, which also moves society
towards an optimal allocation of resources.
If EPA were not to take this action adding certain PBT chemicals to
EPCRA section 313 and lowering reporting thresholds, the market failure
(and the associated social costs) resulting from the limited
information on the release and other waste management of PBT chemicals
would continue. EPA believes that today's action will improve the scope
of multi-media data on the release and other waste management of PBT
chemicals. This, in turn, will provide information to the public,
empower communities to play a meaningful role in environmental
decision-making, and improve the quality of environmental decision-
making by government officials. In addition, this action will serve to
generate information that reporting facilities themselves may find
useful in such areas as highlighting opportunities to reduce chemical
use or release or other waste management and thereby lower costs of
production and/or waste management. EPA believes that these are sound
rationales for adding chemicals to the EPCRA section 313 list of toxic
chemicals and lowering reporting thresholds for PBT chemicals.
B. What Are the Costs Associated With This Rule?
This action will result in the expenditure of resources that, in
the absence of the regulation, could be used
[[Page 58741]]
for other purposes. The cost of the rule is the value of these
resources in their best alternative use. Most of the costs of the rule
result from requirements on industry. Approximately 11,300 facilities
are expected to submit approximately 20,000 additional Form R reports
annually. The estimated composition of this reporting, by chemical, is
shown in Table 4.
Table 4.--Summary of Chemical Reporting as Estimated for Proposed and
Final Rules
------------------------------------------------------------------------
Estimated Number of Reports (Annual)
Chemical or Chemical Category ---------------------------------------
Proposed Rule Final Rule
------------------------------------------------------------------------
Alkyl lead (tetraethyl lead and 134 N/A
tetramethyl lead)
------------------------------------------------------------------------
Benzo(g,h,i)perylene 353 909
------------------------------------------------------------------------
Dioxin and dioxin-like compounds 1,863 1,475
category
------------------------------------------------------------------------
Hexachlorobenzene 778 778
------------------------------------------------------------------------
Mercury; mercury compounds 5,230 5,346
category
------------------------------------------------------------------------
Octachlorostyrene 230 230
------------------------------------------------------------------------
Pentachlorobenzene 707 707
------------------------------------------------------------------------
Pesticides (aldrin, chlordane, 264 264
heptachlor, isodrin,
methoxychlor, pendimethalin,
toxaphene, trifluralin)
------------------------------------------------------------------------
Polycyclic aromatic compounds 4,699 7,166
(PACs) category
------------------------------------------------------------------------
Polychlorinated biphenyls (PCBs) 2,267 2,310
------------------------------------------------------------------------
Tetrabromobisphenol A 150 150
------------------------------------------------------------------------
Vanadium; vanadium compounds 654 655
category
------------------------------------------------------------------------
Total 17,329 19,990
------------------------------------------------------------------------
Table 5 displays the industry costs for this action based on the
estimated number of facilities affected and the estimated number of
additional reports. Aggregate industry costs in the first year for the
rule are estimated to be $145 million; in subsequent years they are
estimated to be $80 million per year. Industry costs are lower after
the first year because facilities will be familiar with the reporting
requirements, and many will be able to update or modify information
from the previous year's report. EPA is expected to expend $2.0 million
in the first year, and $1.6 million in subsequent years as a result of
the rule.
Table 5.--Summary of Reporting and Associated Costs as Estimated for
Proposed and Final Rules
------------------------------------------------------------------------
Proposed Rule Final Rule
------------------------------------------------------------------------
Number of new facilities 2,600 3,114
------------------------------------------------------------------------
Total number of facilities 9,515 11,257
------------------------------------------------------------------------
Number of Form Rs submitted 17,329 19,990
------------------------------------------------------------------------
First year industry costs $126 million $145 million
------------------------------------------------------------------------
Subsequent year industry costs $70 million $80 million
------------------------------------------------------------------------
EPA costs $1.4 million $1.6 million
------------------------------------------------------------------------
The estimated cost of the final rule differs from the estimated
cost of the proposed rule as shown in Table 5. There are six major
reasons for this change. First, EPA received new data during the
comment period on the concentrations of PACs and benzo(g,h,i)perylene
in distillate fuel oil. Since approximately 18,000 manufacturing
facilities subject to EPCRA 313 reporting use distillate fuel oil, this
change had a significant positive effect on the estimated number of
reports for PACs and benzo(g,h,i)perylene as shown in Table 4. Second,
the methodology for estimating reporting from facilities in SIC 5171
(Bulk Petroleum Stations and Terminals) was revised to account for the
mix of products containing PBT chemicals that are processed at these
facilities. This revision also had a positive effect on the estimated
number of reports. Third, because facility-level dioxin emission
factors for coal- and oil-burning manufacturing facilities have not
been developed, the estimated number of reporting facilities was
reduced. Fourth, the reporting qualifier for dioxin was changed from
[[Page 58742]]
``manufacture only'' to ``manufacturing; and the processing or
otherwise use of dioxin and dioxin-like compounds if the dioxin and
dioxin-like compounds are present as contaminants in a chemical and if
they were created during the manufacturing of that chemical'' in the
final rule. This resulted in additional expected reporting from
facilities that process or otherwise use chemicals with dioxin
impurities. Fifth, the Agency is not lowering EPCRA section 313
reporting thresholds for alkyl leads as part of this rulemaking.
Therefore, no additional EPCRA section 313 reporting on alkyl leads is
expected at this time. Sixth, the threshold for the PACs category was
changed from 10 pounds in the proposed rule to 100 pounds in the final
rule.
C. What Are the Benefits of This Rule?
In enacting EPCRA and PPA, Congress recognized the significant
benefits of providing the public with information on toxic chemical
releases and other waste management practices. EPCRA section 313 has
empowered the Federal government, State governments, industry,
environmental groups, and the general public to fully participate in an
informed dialogue about the environmental impacts of toxic chemicals in
the United States. EPCRA section 313's publicly available data base
provides quantitative information on toxic chemical releases and other
waste management practices. Since the TRI program's inception in 1987,
the public, government, and the regulated community have had the
ability to understand the magnitude of chemical releases in the United
States, and to assess the need to reduce the uses, releases and other
waste management of toxic chemicals. TRI enables all interested parties
to establish credible baselines, to set realistic goals for
environmental progress over time, and to measure progress in meeting
these goals over time. The TRI program is a neutral yardstick by which
progress can be measured by all stakeholders.
The information reported under EPCRA section 313 increases
knowledge of the amount of toxic chemicals released and waste
management practices, and thus aids in the evaluation of the potential
pathways of exposure, improves scientific understanding of the health
and environmental risks of toxic chemicals; allows the public to make
informed decisions on where to work and live; enhances the ability of
corporate leaders and purchasers to more accurately gauge a facility's
potential environmental liabilities; provides reporting facilities with
information that can be used to save money as well as reduce emissions;
and assists Federal, State, and local authorities in making better
decisions on acceptable levels of toxic chemicals in the environment.
There are two types of benefits associated with EPCRA section 313
reporting, those resulting from the actions required by the rule (such
as reporting and recordkeeping), and those derived from follow-on
activities that are not required by the rule. Benefits of activities
required by the rule include the value of improved knowledge about the
release and waste management of toxic chemicals, which leads to
improvements in understanding, awareness, and decision-making. It is
expected that this rule will generate such benefits by providing
readily accessible information that otherwise would not be available to
the public. The rule will benefit ongoing research efforts to
understand the risks posed by PBT chemicals and to evaluate policy
strategies that address the risks.
The second type of benefits derive from changes in behavior that
may result from the information reported under EPCRA section 313. These
changes in behavior, including reductions in releases of and changes in
the waste management practices for toxic chemicals may yield health and
environmental benefits. These changes in behavior come at some cost,
and the net benefits of the follow-on activities are the difference
between the benefits of decreased chemical releases and transfers and
the costs of the actions needed to achieve the decreases.
Because the state of knowledge about the economics of information
is not highly developed, EPA has not attempted to quantify the benefits
of adding chemicals to EPCRA section 313 or changing reporting
thresholds. Furthermore, because of the inherent uncertainty in the
subsequent chain of events, EPA has also not attempted to predict the
changes in behavior that result from the information, or the resultant
net benefits (i.e., the difference between benefits and costs). EPA
does not believe that there are adequate methodologies to make
reasonable monetary estimates of either the benefits of the activities
required by the rule, or the follow-on activities. The economic
analysis of the rule, however, does provide illustrative examples of
how the rule will improve the availability of information on PBT
chemicals (Ref. 67).
A number of commenters asserted that information on the magnitude
of PBT chemical releases that would be reported as a result of this
rule is required for EPA and commenters to evaluate the benefit of
EPA's proposed alternatives. EPA disagrees with these commenters for
the following reasons.
Existing data do not support estimates of releases to multiple
environmental media from the full range of facilities that may be
affected by the rule because most of the data required for the analysis
would only be available after the rule is in place. For most PBT
chemicals and industry sectors, up-to-date multi-media release and
other waste management estimates for affected facilities do not exist.
Even where release estimates are available for an industry sector, most
are derived from national activity levels rather than from facility-
level information. To the extent that release estimates are available,
they tend to cover only a single medium such as air. EPA does not
believe that there is sufficient information to make reasonable
predictions of the multi-media releases and other waste management
information that will be reported as a result of EPCRA section 313
rulemakings.
Some commenters note that EPA has estimated releases of certain PBT
chemicals in recent reports such as the Mercury Study Report to
Congress (Ref. 65) and the Inventory of Source of Dioxin in the United
States (Ref. 73). In fact, EPA reported the results of these reports in
its economic analysis for this proposal. These studies do not provide
community- or facility-level release estimates. The estimates in these
studies are derived using a ``top-down'' methodology in which emission
factors are applied to activity levels for entire industries. While
having an estimate of multi-media PBT releases for a specific industry
sector is a first step, other information would also be required to
estimate the releases that would be reported as a result of each
proposed alternative. Assuming that multi-media release estimates were
available for an entire industry sector, these releases would still
have to be divided among individual facilities according to some
currently unknown distribution. In addition, there is the complication
that EPCRA section 313 reporting thresholds are based on chemical
throughput (manufacture, process, or use) rather than chemical release.
The relationship between a chemical throughput that triggers the
submission of a report, and the releases reported will vary in some
currently unknown manner among industries, as well as among facilities
within an industry.
Therefore, EPA does not believe that there is sufficient
information to make reliable release estimates for this rule, when
considering all the affected chemicals and industries. The
[[Page 58743]]
uncertainties in the estimated values that go into such a calculation
make predictions of facility level reporting extremely imprecise.
Historical attempts to estimate the releases expected to be reported
under EPCRA section 313 would have been imprecise to the point of being
misleading, particularly in respect to estimates of releases per report
or per facility (which some commenters have suggested that EPA should
make). Further information on the feasibility of ex ante release
estimates is available in the Response to Comments document (Ref. 69).
Aside from the general issue of uncertainty in the estimates of
aggregate releases, predictions of releases per facility or per report
(or dollars of reporting cost per pound of releases reported) are
likely to be misleading due to the biases built into the estimates. The
predicted number of reports (and thus costs) is generally an
overestimate, since EPA's economic analyses use conservative estimates
to avoid underestimating true costs. On the other hand, predictions of
releases will tend to underestimate emissions, because while there may
be information available on releases of some chemicals from some
sectors, such estimates will not include other sources where releases
are not identified until more detailed data (such as TRI data) are
collected. Combining the two sets of estimates compounds the problem.
Since estimated pounds of releases are underestimated and reports are
overestimated, pounds per report would be biased significantly
downward. Likewise, estimates of dollars of reporting cost per pound of
releases (which varies as the inverse of pounds per report) would be
biased significantly upward.
EPA notes that there were various reports and studies about air
emissions of toxic chemicals prior to EPCRA section 313, but the
collection of facility-level data provided significant new information
on releases as well as other waste management. EPA cannot predict, at
this stage, the quantity of releases and other waste management that
will be reported as the result of this action any more accurately than
it could have predicted when it proposed the original EPCRA section 313
rule.
Aside from the issue of whether EPA can predict releases and other
waste management quantities prior to TRI reporting, EPA notes that
pounds of releases (even if known) are not a reasonable proxy for the
benefits of the information being provided. This is because the
benefits of an informational regulation are not a linear function of
the magnitude of the information being reported. EPA disagrees with the
implicit assumption by commenters that the benefits of information from
different facilities is strictly and systematically related to the
quantity reported as being released. Calculations such as the
commenters have suggested presume that the benefit to the public of
knowing about a release of 20,000 pounds is twice as large as the
benefit of knowing about a release of 10,000 pounds; and that the
benefit of knowing about a 40,000 pound release is twice the benefit of
knowing about a 20,000 pound release and four times the benefit of
knowing about a 10,000 pound release. EPA does not believe this
characterization to be accurate.
One of the central purposes of TRI data is to inform the public
about releases and other waste management of EPCRA section 313 listed
toxic chemicals in their community so that the public can form its own
conclusions about risks. The amount of releases and waste management
quantities that a community may find relevant or useful will vary
depending on numerous factors specific to that community, such as the
toxicity of the various chemicals, potential exposure to these toxic
chemicals, and the number of other facilities in the area that release
EPCRA section 313 listed toxic chemicals. Section 313(h) of EPCRA
states that the data are ``to inform persons about releases of toxic
chemicals to the environment; to assist governmental agencies,
researchers, and other persons in the conduct of research and data
gathering; to aid in the development of appropriate regulations,
guidelines, and standards; and for other similar purposes'' (See Unit
VI.E. for a more detailed discussion on the purposes of EPCRA section
313). Pounds of releases reported does not measure how the data perform
these functions, and thus is not a measure of benefits.
Finally, EPA notes that commenters on this rule did not provide
information on approaches or methodologies for estimating releases and/
or throughput, or on estimating releases from throughput data, for the
spectrum of industries, chemicals, and facilities covered by the rule.
Instead, some commenters submitted data from EPA studies (that EPA had
already reviewed in the context of this rule and used as references for
the economic analysis of the proposed rule) for very narrow slices of
the regulated universe (for example, estimated mercury releases from
electric utilities or estimated dioxin releases from the vinyl
industry). EPA considered these data and determined that they are not
sufficient to predict the releases and/or throughput that will be
reported as a result of this rule. Other commenters simply stated that
EPA should consider releases without referencing any data. None of the
commenters suggested new methodologies or approaches, or provided
information from any sources that EPA had not already reviewed and
considered. As a result, EPA continues to conclude that while there are
data available to estimate national releases for some chemicals for
some sectors, comprehensive, reliable data for all sectors and
chemicals are unavailable, resulting in an incomplete data set.
Furthermore, as stated previously, the quantity of releases reported
are not a measure of the benefits of the rule. EPA does not believe
that inaccurate or incomplete estimates of releases would aid the
decision-making process for the rule. Therefore, EPA has not estimated
the releases that would be reported as a result of the rule.
D. What are the Potential Impacts on Small Entities?
In accordance with the Regulatory Flexibility Act (RFA) and the
Agency's longstanding policy of always considering whether there may be
a potential for adverse impacts on small entities, the Agency has
evaluated the potential impacts of this rule on small entities. The
Agency's analysis of potentially adverse economic impacts is included
in the Economic Analysis for this rule (Ref. 67). The following is a
brief overview of EPA's findings.
1. Overall methodology. This rule may affect both small businesses
and small governments. For the purpose of its analysis for the rule,
EPA defined a small business using the small business size standards
established by the Small Business Administration (SBA) at 13 CFR part
121. EPA defined small governments using the RFA definition of
jurisdictions with a population of less than 50,000. No small
organizations are expected to be affected by the rule.
Only those small entities that are expected to submit at least one
report are considered to be affected for the purpose of the small
entity analysis, although EPA recognizes that other small entities will
conduct compliance determinations under lower thresholds. The number of
affected entities will be smaller than the number of affected
facilities, because many entities operate more than one facility.
Impacts were calculated for both the first year of reporting and
subsequent years. First year costs are typically higher than continuing
costs because firms must familiarize themselves with the requirements.
Once firms have become familiar with how the reporting
[[Page 58744]]
requirements apply to their operations, costs fall. EPA believes that
subsequent year impacts present the best measure to judge the impact on
small entities because these continuing costs are more representative
of the costs firms face to comply with the rule.
EPA analyzed the potential cost impact of the rule on small
businesses and governments for the manufacturing sector and in each of
the recently added industry sectors separately in order to obtain the
most accurate assessment for each. EPA then aggregated the analyses for
the purpose of determining whether it could certify that the rule will
not, if promulgated, have a ``significant economic impact on a
substantial number of small entities.'' RFA section 605(b) provides an
exemption from the requirement to prepare a regulatory flexibility
analysis for a rule where an agency makes and supports the
certification statement quoted above. EPA believes that the statutory
test for certifying a rule and the statutory consequences of not
certifying a rule all indicate that certification determinations may be
based on an aggregated analysis of the rule's impact on all of the
small entities subject to it.
2. Small businesses. EPA used annual compliance costs as a
percentage of annual company sales to assess the potential impacts on
small businesses of this rule. EPA believes that this is a good measure
of a firm's ability to afford the costs attributable to a regulatory
requirement, because comparing compliance costs to revenues provides a
reasonable indication of the magnitude of the regulatory burden
relative to a commonly available measure of a company's business
volume. Where regulatory costs represent a small fraction of a typical
firm's revenue (for example, less than 1%, but not greater than 3%),
EPA believes that the financial impacts of the regulation may be
considered not significant. As discussed above, EPA also believes that
it is appropriate to apply this measure to subsequent year impacts.
Based on its estimates of additional reporting as a result of the
rule, the Agency estimates that approximately 6,300 businesses will be
affected by the rule, and that approximately 4,400 of these businesses
are classified as small based on the applicable SBA size standards. For
the first reporting year, EPA estimates that approximately 17 small
businesses may bear compliance costs between 1% and 3% of revenues, and
that no small businesses will bear costs greater than 3%. In subsequent
years, EPA estimates that approximately 5 small businesses may bear
compliance costs between 1% and 3% of revenues, and that no small
businesses will bear costs greater than 3%. As stated above, EPA
believes that subsequent-year impacts are the appropriate measure of
small business impacts.
3. Small governments. To assess the potential impacts on small
governments, EPA used annual compliance costs as a percentage of annual
government revenues to measure potential impacts. Similar to the
methodology for small businesses, this measure was used because EPA
believes it provides a reasonable indication of the magnitude of the
regulatory burden relative to a government's ability to pay for the
costs, and is based on readily available data.
EPA estimates that 39 municipalities operate 49 publicly owned
electric utility facilities. Of these facilities, 44 are expected to
file additional reports as a result of this action. Of these affected
facilities, 15 are operated by 15 small governments (i.e., those with
populations under 50,000). It is estimated that none of these small
governments will bear annual costs greater than 1% of annual government
revenues.
4. All small entities. As discussed above, approximately 5 small
businesses are expected to bear annual costs between 1% and 3% of
annual revenues after the first year of reporting. None of the affected
small governments are estimated to bear annual costs greater than 1% of
annual revenues. No small organizations are expected to be affected by
the rule. Thus, the total number of small entities with impacts above
1% of revenues does not change when the results are aggregated for all
small entities (i.e., small businesses, small governments, and small
organizations).
VIII. What are the References for this Action?
1. Accelerated Reduction/Elimination of Toxics (ARET) Secretariat.
January 1994. The ARET Substance Selection Process And Guidelines.
2. Accelerated Reduction/Elimination of Toxics (ARET) Secretariat.
March 1995. Environment Leaders 1. Voluntary Commitments to Action on
Toxics through ARET.
3. Ahlborg, U.G., Becking, G.C., Birnbaum, L.S., Brouwer, A., Derks
HJGM, Feeley, M., Golor, G., Hanberg, A., Larsen, J.C., Liem, A.K.D.,
Safe, S.H., Schlatter, C., W rn F., Younes, M., Yrjanheikki, E. 1994.
Toxic Equivalency Factors for Dioxin-like PCBs; report on a WHO-ECEH
and IPCS Consultation, December 1993. Chemosphere 28: 1049-1067.
3a. Alexander, M. 1995. How Toxic are Toxic Chemicals in Soil?
Environ. Sci. Technol. 29:2713-2717.
4. Allen, H.E. February 11, 1999. Persistent, Bioaccumulative and
Toxic (PBT) Chemicals: Considerations for RCRA Waste Minimization of
Metals (EPA RCRA Docket #F-98 MMLP-FFFFF).
5. American Society for Testing and Materials (ASTM). 1989.
``Standard Practice for Dealing with Outlying Observations.'' Annual
Book of ASTM Standards, E178-80.
6. Andreae, M.O. 1986. Chemical Species in Seawater and Marine
Particulates. In Bernhard M, FE Brinkman and PJ Sadler (Eds.), The
Importance of Chemical ``Speciation'' in Environmental Processes.
Dahlem Konferenzen, Berlin: Springer-Verlag, pp 301-335.
7. Aronson, D. et.al., 1998. Chemical Fate Half-Lives and
Persistence Evaluation for Toxics Release Inventory PBT Rule Chemicals.
Prepared by Syracuse Research Corp. for Robert S. Boethling, USEPA
Office of Pollution Prevention and Toxics, Washington, DC. Contract
Number 68D50012 Task 451 .
8. Bacon, C.E., W.M. Jarman, J.A. Estes, M Simon and R.J. Norstrom.
1999. Comparison of Organochlorine Contaminants among Sea Otter
(Enhydra Lutris) Populations in California and Alaska. Environ.
Toxicol. Chem. 18: 452-458.
9. Barron, M.G. 1995. Bioaccumulation and bioconcentration in
aquatic organisms, pp. 652-666. In, Hoffman, D.J., Rattner, B.A.,
Burton, G.A., Jr., and Cairns, J., Jr., Handbook of Ecotoxicology,
Lewis Publishers, CRC Press, Boca Raton, FL.
10. Bayer. 1990. Unpublished data as cited in the World Health
Organization 1995 document entitled: Environmental Health Criteria
(EHC)172, Tetrabromobisphenol A and Derivatives.
11. Bodek, I., Lyman, W.J., Reehl, W.F., and Rosenblatt, D.H., Eds.
1988. Environmental Inorganic Chemistry. Properties, Processes and
Estimation Methods. New York: Pergamon.
12. Boethling, R.S., Howard, P.H., Meyland, W., Stiteler, W.,
Beauman, J., and Tirado, N. 1994. Group Contribution Method for
Predicting Probability and Rate of Aerobic Biodegradation. Environ Sci.
Technol. 28(3) 459-465.
13. Boethling, R.S., Howard, P.H., Beauman, J.A., and Larosche,
M.E., ``Factors for Intermedia Extrapolation in Biodegradability
Assessment.'' Chemosphere v. 30, (1995), pp. 741-752.
14. Bondarenko, G.P. 1968. An Experimental Study of the Solubility
of Galena in the Presence of Fulvic Acids. Geochem. Int. 5: 525-531.
[[Page 58745]]
15. Bossan, D., Wortham, H., Masclet, P., 1995. Atmospheric
Transport of Pesticides Adsorbed on Aerosols. I. Photodegradation in
Simulated Atmosphere Chemosphere 30:21-29. (PBT Docket #B1-237)
16. C.E. Cowan et al. 1995. The Multi-Media Fate Model: A Vital
Tool for Predicting the Fate of Chemicals. SETAC Press. Pensacola, FL.
17. Canada/European Union Metals and Minerals Working Group. 1996.
Report of the Technical Workshop on Biodegradation/Persistence and
Bioaccumulation/Biomagnification of Metals and Metal Compounds, 11-13
Dec 95, Brussels, Belgium (report dated April 96).
18. Chapman, P.M. 1996. Hazard Identification, Hazard
Classification and Risk Assessment for Metals and Metal Compounds in
the Aquatic Environment. ICME: International Council on Metals and the
Environment.
18a. CITI. October 1992. Biodegradation and Bioaccumulation: Data
of Existing Chemicals Based on the CSCL Japan. Edited by Chemicals
Inspection Testing Institute, Japan Chemical Industry Ecology-
Toxicology Information Center, Tokyo, Japan. ISBN 4-89074-101-1.
19. Couture, L.A., Elwell, M.R., Birnbaum, L.S. March 1988. Dioxin-
like Effects Observed in Male Rats Following Exposure to
Octachlorodibenzo-p-dioxin (OCDD) During a 13-week Study. Toxicol.
Appl. Pharmacol. 30;93(1):31-46.
20. DeVito, M.J., Birnbaum, L.S. January 1995. The Importance of
Pharmacokinetics in Determining the Relative Potency of 2,3,7,8-
tetrachlorodibenzo-p-dioxin and 2,3,7,8 tetrachlorodibenzofuran.
Fundam. Appl. Toxicol. 24(1):145-8
21. DeVito, M.J., Diliberto, J.J., Ross, D.G., Menache, M.G.,
Birnbaum, L.S. December 1997. Dose-response relationships for
polyhalogenated dioxins and dibenzofurans following subchronic
treatment in mice. I. CYP1A1 and CYP1A2 enzyme activity in liver, lung,
and skin. Toxicol. Appl. Pharmacol. ;147(2):267-80
22. Federle, T.W., Gasior, S.D., and Nuck, B.A. 1997.
``Extrapolating Mineralization Rates from the Ready CO2
Screening Test to Activated Sludge, River Water and Soil.'' Environ.
Toxicol. Chem. v. 16, pp. 127-134.
23. The Great Lakes Binational Toxics Strategy, Canada United
States Strategy for the Virtual Elimination of Persistent Toxic
Substances in the Great Lakes, signed by Carol Browner, Administrator
U.S. Environmental Protection Agency and Sergio Marchi, 1Minister of
the Environment Government of Canada. 1997.
24. The Great Lakes Binational Toxics Strategy, Canada United
States Strategy for the Virtual Elimination of Persistent Toxic
Substances in the Great Lakes basin. Level I and Level II targeted
persistent toxic substances. Great Lakes National Program Office
(GLNPO), Chicago, IL. April 7, 1997.
25. Hayes, A.W. ed. 1994. Principles and Methods of Toxicology,
3rd. ed., New York: Raven Press, pp. 423-4.
26. International Council of Chemical Associations (ICCA), Briefing
Note on Persistent Organic Pollutants (POPs). June 2, 1998. Document
Describing ICCA's Position on POPs and International Action to Address
POPs.
27. International Joint Commission (IJC). 1993. A strategy for the
Virtual Elimination of Persistent Toxic Substances. Vol. 1, Report of
the Virtual Elimination Task Force to the IJC. Windsor, Ontario,
Canada, 72 pp.
28. Klein, W. 1997. Persistence, Bioaccumulation and Ecological
Relevance of Metals in the Environment. ICME (International Council on
Metals and the Environment) Newsletter 5: 1-2.
28a. Lindqvist, O., Johansson, K., Aastrup, M., Andersson, A.,
Bringmark, L., Hovsenius, G., Hakanson, L., Iverfeldt, A., Meili, M.,
and Timm, B. 1991. Mercury in the Swedish Environment - Recent Research
on Causes, Consequences and Corrective Methods. Water, Air and Soil
Poll. 55:(all chapters)
29. Listing of Fish and Wildlife Advisories (LFWA). 1997. Database,
USEPA Office of Water. Available online at http://www.epa.gov/OST. Fact
Sheet on LFWA Also available online and in hard copy (EPA-823-F-98-009,
March 98).
30. Lovering, T.G. ed. 1976. Lead in the Environment. Washington,
DC: US Department of the Interior, Geological Survey, professional
paper no. 957. S/N 024-001-02911-1.
31. Mackay, D. 1979. Finding Fugacity Feasible. Environ. Sci.
Technol. v. 13, pp. 1218-1223.
32. Mackay, D. 1991. Multimedia Environmental Models: The Fugacity
Approach. Lewis: Chelsea, MI.
33. Mackay, D., DiGuardo, A., Paterson, S., and Cowan, C.E. 1996.
Evaluating the Environmental Fate of a Variety of Types of Chemicals
Using the EQC Model. Environ. Toxicol. Chem. v. 15, pp. 1627-1637.
34. Mackay, D., Paterson, S., and Shiu, W.Y. 1992. ``Generic Models
for Evaluating the Regional Fate of Chemicals.'' Chemosphere v. 24, pp.
695-717.
35. Meylan, W.M. and Howard, P.H. November 1998. ``User's Guide for
the ECOSAR Class Program'' Syracuse Research Corporation. Preparded for
Nabholz, J.V. and Cash, G., Risk Assessment Division, U.S.
Environmental Protection Agency.
36. Ministry of Environment and Energy for Ontario (MOEE). 1992.
Candidate Substances List for Bans or Phase-outs. Report Prepared by
the Hazardous Contaminants Branch and the Water Resources Branch, MOEE.
Ontario, Canada, ISBN 0-7729-9764-0.
37. Moss, K.T. and R.S. Boethling. March 1999. USEPA New Chemicals
Program Pbt Chemical Category. Presented at the National Meeting of the
American Chemical Society (ACS), Anaheim, CA.
38. Nabholz, J.V., M. Zeeman and D. Rodier. 1998. Case study #1:
Assessing the Ecological Risks of a New Chemical in Chapter 5. Case
studies illustrating the current state-of-the practice, pp. 205-225 in
Warren-Hicks, W.J. and Moore, D.R.J. (eds.). Uncertainty Analysis in
Ecological Risk Assessment. SETAC Special Publications Series.
Proceedings of the Pellston Workshop on Uncertainty Analysis in
Ecological Risk Assessment, 23-28 August 1995, Pellston, Michigan.
Pensacola, Fl: Society of Environmental Toxicology and Chemistry.
39. North American Agreement for Environmental Cooperation-
Commission for Environmental Cooperation (NAAEC-CEC). 1997. Draft
Process for Identifying Candidate Substances for Regional Action under
the Sound Management of Chemicals Initiative. Report to the North
American Working Group on the Sound Management of Chemicals by the Task
Force on Criteria, under the North American Agreement on Environmental
Cooperation (NAAEC). Internet site: http://www.cec.org.
40. North American Agreement for Environmental Cooperation-
Commission for Environmental Cooperation (NAAEC-CEC). 1997. Process for
Identifying Candidate Substance for Regional Action under the Sound
Management of Chemicals Initiative.
Report to the North American Working Group on the Sound Management
of Chemicals by the Task Force on Criteria. CEC, Montreal, Quebec,
Canada. Draft, July 1997.
41. OECD Environment Directorate. 1998. Harmonized Integrated
Hazard Classification System for Human Health and Environmental Effects
of Chemical Substances. As endorsed by the 28th Joint Meeting of the
Chemicals Committee and the Working Party on
[[Page 58746]]
Chemicals in November 1998. Paris: Organization for Economic
Cooperation and Development. Internet site: http://www.oecd.org.
42. Palm, W.U., and Zetch, C. 1992. ``Estimated Rate Constant for
the Reaction of Pendimethalin with OH Radicals at Room Temperature in
the Gas Phase According to the Method of Atkinson.'' Fraunhofer
Institut unpublished report ITA 42.
42a. Porcella, D. B., P. Chu, and M. A. Allan. 1996. Inventory of
North American Hg Emissions to the Atmosphere: Relationship to the
Global Mercury Cycle. Pp. 179-190 in Baeyens, W., R. Ebinghaus, and O.
Vasiliev, eds., Global and Regional Mercury Cycles: Sources, Fluxes and
Mass Balances.
43. Rand, G.M. 1995. Fundamentals of Aquatic Toxicology, 2nd. ed.
Taylor Francis, Washington, DC 1125 pp.
43a. Robertson, B. K. and Alexander, M. 1998. ``Sequestration of
DDT and Dieldrin in Soil: Disappearance of Acute Toxicity but not
Compounds.'' Environ. Toxicol. Chem. 17: 1034-1038.
44. Rodan, B. and N. Eckley. 1997. Science-policy Assessment of
POPs Screening Criteria: Report to the USEPA International Toxics
Coordinating Committee. Draft, 21 August 1997.
45. Rodan, B., D.W. Pennington, N. Eckley and R.S. Boethling. 1999.
Screening for Persistent Organic Pollutants: Techniques to Provide a
Scientific Basis for POPs Criteria in International Negotiations.
Environ. Sci. Technol., in press.
46. Springborn Laboratories, Inc. 1989. Determination of the
Biodegradability of Tetrabromobisphenol A in a Soil under Aerobic
Conditions. SLI Report: 88-11-2848. Submitted on behalf of the
Brominated Flame Retardants Industry Panel. EPA Docket #40-8998097.
47. Springborn Laboratories, Inc. 1989. Determination of the
Biodegradability of Tetrabromobisphenol A in a Soil under Anaerobic
Conditions. SLI Report: 88-11-2849. Submitted on behalf of the
Brominated Flame Retardants Industry Panel. EPA Docket #40-8998097.
48. Springborn Laboratories, Inc. 1989. Tetrabromobisphenol A
Determination of the Biodegradability in a Sediment/Soil Microbial
System. SLI Report: 89-8-3070. Submitted on Behalf of the Brominated
Flame Retardants Industry Panel. EPA Docket #40-89000034.
49. Stumm, W. and J.J. Morgan. 1996. Aquatic Chemistry, 3rd ed. New
York: Wiley.
50. Syracuse Research Corporation. March 1999. The Environmental
Fate of Lead and Lead Compounds. Prepared for David G. Lynch, U.S.
Environmental Protection Agency, under Contract Number SRC 68-D5-0012.
51. Syracuse Research Corporation, 1998. ``EQC Model Output for
Toxics Release Inventory PBT Rule Chemicals'' (PBT Docket #B1-042)
51a. Tang, J., Carroquino, M.J., Robertson, B.K., and Alexander, M.
1998. ``Combined Effect of Sequestration and Bioremediation in Reducing
the Bioavailability of Polycyclic Aromatic Hydrocarbons.'' Soil.
Environ. Sci. Technol. 32: 3586-3590.
52. Tyler, J.E. 1976. Transmission of Sunlight in Natural Water
Bodies Symposium on Nonbiological Transport and Transformation of
Pollutants on Land and Water: Processes and Critical Data Required for
Predictive Description, National Bureau of Standards.
53. Toet, C. and S. Arai. Indirect Exposure of Human Beings to
Organic Compounds. Discussion Document 4, Working Group III: Models for
Indirect Exposure by Food and Drinking Water. Distributed at the OECD
Workshop on the Application of Simple Models for Environmental Exposure
Assessment, Berlin, Germany, 11-13 December 1991.
54. United Nations Economic Commission for Europe (UNECE) Long-
Range Transboundary Air Pollution (LRTAP). March 31, 1998. Draft
Composite Negotiating Text for a Protocol on Persistent Organic
Pollutants. UNECE, EB.AIR/1998/2.
55. United Nations Economic Commission for Europe (UNECE) Long
Range-Transboundary Air Pollution (LRTAP). 1998. Protocol to the 1979
Convention on Long-Range Transboundary Air Pollution (LRTAP) on Heavy
Metals (Draft), to Be Submitted to the Ministerial Conference
``Environment for Europe'' (Arhus, Denmark, June 23-25, 1998). Website:
http://www.unece.org/env/protocol/98hm.htm.
56. United Nations Environment Programme (UNEP) Criteria Expert
Group (CEG) for Persistent Organic Pollutants (POPs). September 17,
1998. The Development of Science-based Criteria and a Procedure for
Identifying Additional Persistent Organic Pollutants as Candidates for
Future International Action. UNEP/POPS/INC/CEG/1/2.
57. United Nations Environment Programme (UNEP) Governing Council
Decisions 20/24. 1999. Declaration in Support of International Effort
to Protect Human Health and the Environment Through Measures to Reduce
and/or Eliminate Emission and Discharges of POPs.
58. USEPA. AQUIRE, the Aquatic Toxicity Information Retrieval
Database. September 22, 1995. http://www.epa.gov/medatwrk/databases/
aquire.html.
59. USEPA. Integrated Risk Information System (IRIS). ``Arsenic,
Inorganic,'' at http://www.epa.gov/iris/subst/0278.htm. Downloaded July
1999.
60. USEPA. Integrated Risk Information System (IRIS). ``Chromium
(VI),'' Internet site: http://www.epa.gov/iris/subst/0144.htm.
Downloaded July 1999.
61. USEPA. Integrated Risk Information System (IRIS). ``Selenium
and Compounds.'' Internet site: http://www.epa.gov/iris/subst/0472.htm.
July 19, 1999.
62. USEPA. 1995. Great Lakes Water Quality Initiative Technical
Support Document for the Procedure to Determine Bioaccumulation
Factors. EPA-820-B-95-005. USEPA, Office of Water: Washington, DC.
63. USEPA. 1997. Reregistration Eligibility Decision (RED)
Pendimethalin. Office of Prevention, Pesticides and Toxic Substances.
EPA 738-R-97-007.
64. USEPA, ATSDR. The Effects of Great Lakes Contaminants on Human
Health: Report to Congress (1986) Internet at: www.epa.gov/glnpo/
health/atsdr.htm.
65. USEPA, OAQPS/ORD. 1997. Mercury Study Report to Congress.
66. USEPA, OIA. Technical Information Package for Lead. Internet
site: http://www.epa.gov/oiamount/tips/lead2.htm. Downloaded March
1999.
66a. USEPA, OPPT. 1999. Bioavailability of Metals. Memorandum from
David Lynch, Exposure Assessment Branch to Maria Doa, Toxic Release
Inventory Branch, October 1999.
67. USEPA, OPPT. 1999. Economic Analysis of the Final Rule to
Modify Reporting of Persistent Bioaccumulative Toxic Chemicals under
EPCRA Section 313.
67a. USEPA, OPPT. 1999. Economic Analysis: Supplemental Information
on the Distribution of Additional Reporting from SIC Codes at Various
Lower Reporting Thresholds.
68. USEPA, OPPT. Persistent, Bioaccumulative Substances on the
Toxics Release Inventory (TRI): Report on Persistence Screening
Criteria. Boethling, R.S., U.S. Environmental Protection Agency.
September 4, 1997.
69. USEPA, OPPT. 1999. Response to Comments Received on the January
5, 1999 Proposed Rule (64 FR 688) to Lower the EPCRA Section 313
Reporting Thresholds for Persistent, Bioaccumulative Toxic (PBT)
Chemicals and to Add Certain PBT Chemicals to the EPCRA Section 313
List of Toxic Chemicals and Response to Comments
[[Page 58747]]
Received on the May 7, 1997 Proposed Rule (62 FR 24887) to Add a
Category of Dioxin and Dioxin-like Compounds to the EPCRA Section 313
List of Toxic Chemicals. Office of Pollution Prevention and Toxics,
U.S. Environmental Protection Agency, Washington, DC.
70. USEPA, OPPT. 1999. Support Document for the Addition of Certain
Chemicals to Section 313 of the Emergency Planning and Community Right-
to-Know Act. U.S. Environmental Protection Agency, Washington DC.
71. USEPA, OPPT. September 1998. Technical Support Document for
Determination of Bioaccumulation (BAF) and Bioconcentration (BCF)
Values for Persistent Bioaccumulative Toxic (PBT) Chemicals and for
Identification of PBT Chemicals. Jerry Smrchek, Ph.D., Biologist,
Existing Chemicals Assessment Branch, Risk Assessment Division.
71a. USEPA, OPPT. 1999. Unfunded Mandates Reform Act Statement.
Final Rule.
72. USEPA, ORD. 1986. Air Quality Criteria for Lead. Research
Triangle Park, NC. EPA, Office of Research and Development, Office of
Health and Environmental Assessment. EPA600/8-83-028bF.
73. USEPA, ORD. 1998. The Inventory of Sources of Dioxin in the
United States. Review Draft. EPA 600-P-98-002Aa.
74. USEPA, OSWER. June 1997. Waste Minimization Prioritization Tool
Beta Test Version 1.0 User's Guide and System Documentation (Draft).
Appendix D Draft Prioritized Chemical List. U.S. Environmental
Protection Agency, Washington DC, EPA530-R-97-019.
75. USEPA, OW. Mercury Update: Impact on Fish Advisories. EPA-823-
F-99-016.
76. USEPA, OW. Polychlorinated Biphenyls (PCBs) Update: Impact on
Fish Advisories. EPA-823-F-99-019.
77. USEPA, OW. Toxaphene Update: Impact on Fish Advisories. EPA-
823-F-99-018.
78. Van den Berg M, Birnbaum L, Bosveld A T.C., Brunstrom B, Cook
P, Feeley M, Giesy J, Hanberg A, Hasegawa R , Kennedy S, Kubiak T ,
Larsen J.C.,. Rolaf van Leeuwen, A.K. Djien Liem, Nolt C, Peterson R,
Poellinger L, Safe S, Schrenk D, Til D. Toxic Equivalency Factors
(TEFs) for PCBs, PCDDs, PCDFs for Humans and Wildlife. Environmental
Health Perspectives vol 106 December 1998.
79. Viluksela, M., Stahl, B.U., Birnbaum, L.S., Rozman, K.K.
October 1997. Subchronic/chronic toxicity of 1,2,3,4,6,7,8-
heptachlorodibenzo-p-dioxin (HpCDD) in rats. Part II. Biochemical
effects. Toxicol. Appl. Pharmacol. 146(2):217-26.
80. Viluksela, M., Stahl, B.U., Birnbaum, L.S., Schramm, K.W.,
Kettrup, A., Rozman, K.K. October 1997. Subchronic/chronic toxicity of
1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin (HpCDD) in rats. Part I.
Design, general observations, hematology, and liver concentrations.
Toxicol. Appl. Pharmacol. 146(2):207-16.
81. Wania, F. and D. Mackay. 1996. Tracking the Distribution of
Persistent Organic Pollutants. Environ. Sci. Technol. 30: 390A-396A.
82. Webster E, Mackay D, Wania F. 1998. Evaluating Environmental
Persistence. Environ. Toxicol. Chem. 17:2148-2158.
83. World Health Organization, 1995. Environmental Health Criteria
(EHC)172, Tetrabromobisphenol A and Derivatives.
84. Zimdahl, R.L. and R.K. Skogerboe. 1977. Behavior of Lead in
Soil. Environ. Sci. Technol. 11:1202-1207.
IX. Which Regulatory Assessment Requirements Apply to This Action?
A. What is the Determination under Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this is an economically
``significant regulatory action'' because it is likely to have an
annual effect of $100 million or more. This action was submitted to the
Office of Management and Budget (OMB) for review, and any substantive
comments or changes made during that review have been documented in the
public version of the official record.
EPA has prepared an economic analysis of the impact of this action,
which is contained in a document entitled Economic Analysis of the
Final Rule to Modify Reporting of Persistent Bioaccumulative Toxic
Chemicals under EPCRA Section 313 (Ref. 67). This document is available
as a part of the public version of the official record for this action
(instructions for accessing this document are contained in Unit I.B.)
and is discussed in Unit VII.
B. What is the Determination under the Regulatory Flexibility Act?
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the EPA Administrator hereby certifies that
this final rule will not have a significant economic impact on a
substantial number of small entities. The factual basis for this
determination is presented in the small entity impact analysis prepared
as part of the Economic Analysis for this final rule (Ref. 67), which
is also discussed in detail in Unit VII. and contained in the public
version of the official record for this rule. The following is a brief
summary of the Agency's factual basis for this certification.
For the purpose of analyzing potential impacts on small entities,
EPA used the RFA definition of small entities in section 601(6) of the
RFA. Under this section, small entities include small governments,
small non-profit organizations, and small businesses. No small
organizations are expected to be affected by this final rule. EPA
defined small governments using the RFA definition of jurisdictions
with a population of less than 50,000, and defined a small business
using the small business size standards established by the Small
Business Administration (SBA), which are generally based on the number
of employees or annual sales/revenue a business in a particular
industrial sector has.
Based on EPA's economic analysis, approximately 11,300 facilities
are expected to submit approximately 20,000 additional Form R reports
annually. Of these facilities, approximately 3,100 are expected to file
TRI reports for the first time as a result of today's action. EPA
estimates that the cost for collecting this information averages $5,079
per Form R in the first reporting year, and $3,557 in subsequent years.
EPA estimates that there are 15 small governments that may be affected
by the rule (i.e., EPA analysis estimates that these entities may have
to file one or more reports under the final rule). EPA estimates that
none of these small governments will bear annual costs greater than 1%
of annual government revenues. EPA estimates that 5 small businesses of
the approximately 4,400 small businesses potentially affected by the
rule will experience annual compliance costs between 1% and 3% of
annual sales after the first year of reporting. Given the relatively
small estimated impacts on small entities, EPA believes that the rule
will not have a significant economic impact on a substantial number of
small entities. This determination is for the entire population of
small entities potentially affected by this rule, since the test for
certification is whether the rule as a whole has a significant economic
impact on a substantial number of small entities.
Notwithstanding the Agency's certification of this rule under
section 605(b) of the RFA, EPA remains committed to minimizing real
impacts
[[Page 58748]]
on small entities where this does not unacceptably compromise the
informational benefits of the rule. Although not required, EPA intends
to prepare guidance for reporting on dioxin that will assist facilities
in determining their compliance needs and in properly completing the
form, which will help ensure that small entities receive assistance to
ease their burden of compliance. EPA has prepared such documents for
current reporters and has received positive feedback on their utility
from the targeted facilities. In addition, the Agency is always
interested in any comments regarding the economic impacts that this
regulatory action would impose on small entities, particularly
suggestions for minimizing that impact. Such comments may be submitted
to the Agency at any time, to the address listed in Unit I.B.
Information relating to this determination has been provided to the
Chief Counsel for Advocacy of the Small Business Administration, and is
included in the public version of the official record for this
rulemaking.
C. What is the Determination under the Paperwork Reduction Act?
The information collection requirements contained in this final
rule have been submitted to OMB under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., and in accordance with the procedures at
5 CFR 1320.11. OMB has approved the existing reporting and
recordkeeping requirements EPA Toxic Chemical Release Inventory Form R
(EPA Form No. 9350-1), supplier notification, and petitions under OMB
Control No. 2070-0093 (EPA ICR No. 1363). An Information Collection
Request (ICR) document has been prepared by EPA (EPA ICR No. 1363.10)
to amend the existing ICR to include the burden associated with the
lower reporting thresholds, and a copy may be obtained from Sandy
Farmer, Office of Information Collections (OIC); U.S. Environmental
Protection Agency (2137), 401 M St., SW., Washington, DC 20460, by
calling (202) 260-2740, or electronically by sending an e-mail message
to ``[email protected].'' An electronic copy has also been posted
with this Federal Register document on EPA's Homepage with other
information related to this action as described in Unit I.B., and may
also be downloaded from the Internet at http://www.epa.gov.icr/.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information subject to OMB approval under
the PRA unless it displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations, after initial publication in
the Federal Register, are maintained in a list at 40 CFR part 9. The
information requirements contained in this final rule are not effective
until OMB approves them.
EPCRA section 313 requires owners or operators of certain
facilities manufacturing, processing, or otherwise using any of over
600 listed toxic chemicals and chemical categories in excess of the
applicable threshold quantities, and meeting certain requirements
(i.e., at least 10 Full Time Employees or the equivalent), to report
environmental on-site releases and transfers off-site for release and
treatment. Under section 6607 of the PPA, facilities must also provide
information on the quantities of the toxic chemicals in certain waste
streams, and the efforts made to manage those waste quantities. The
regulations codifying the EPCRA section 313 reporting requirements
appear at 40 CFR part 372. Respondents may designate the specific
chemical identity of a substance as a trade secret, pursuant to EPCRA
section 322 (42 U.S.C. 11042). Regulations codifying the trade secret
provisions can be found at 40 CFR part 350. Under the final rule, all
facilities reporting under EPCRA section 313 on PBT chemicals would
have to use the Form R (EPA Form No. 9350-1), which is currently
approved by OMB.
For Form R, EPA estimates the industry reporting burden for
collecting this information (including recordkeeping) to average 74
hours per report in the first year, at an estimated cost of $5,079 per
Form R. In subsequent years, the burden is estimated to average 52.1
hours per report, at an estimated cost of $3,557 per Form R. These
estimates include the time needed to review instructions; search
existing data sources; gather and maintain the data needed; complete
and review the collection of information; and transmit or otherwise
disclose the information. The actual burden on any specific facility
may be different from this estimate depending on the complexity of the
facility's operations and the profile of the releases at the facility.
This final rule is estimated to result in reports from 11,300
respondents. Of these, 3,100 facilities are estimated to be reporting
under EPCRA section 313 for the first time as a result of the rule,
while 8,200 are currently reporting facilities that will be submitting
additional reports. These facilities will submit an estimated
additional 20,000 Form Rs. This rule therefore results in an estimated
total burden of 2.1 million hours in the first year, and 1.2 million
hours in subsequent years, at a total estimated industry cost of $145
million in the first year and $80 million in subsequent years. The
existing ICR will be amended to include an additional annual burden of
1.5 million hours (annual average burden for the first 3 years of ICR
approval).
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes, where applicable, the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information. EPA's burden estimates for the rule take into
account all of the above elements, considering that under section 313,
no additional measurement or monitoring may be imposed for purposes of
reporting.
D. What are the Determinations under the Unfunded Mandates Reform Act
and Executive Orders 12875 and 13084?
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4), EPA has determined that this action contains
a Federal mandate that may result in expenditures of $100 million or
more for the private sector in any 1 year, but that it will not result
in such expenditures for State, local, and tribal governments, in the
aggregate. Accordingly, EPA has prepared a written statement for this
rule pursuant to section 202 of UMRA, and that statement is available
in the public version of the official record for this rulemaking (Ref.
71a). The costs associated with this action are estimated in the
economic analysis prepared for this rule (Ref. 67), which is also
included in the public version of the official record and summarized in
Unit VII. The following is a brief summary of the UMRA statement for
the rule.
This rule is being promulgated pursuant to sections 313(d)(1) and
(2), 313(f)(2), 313(g), 313(h), and 328 of EPCRA, 42 U.S.C.
11023(d)(1)-(2), 11023(f)(2), 11023(g), 11023(h) and
[[Page 58749]]
11048; PPA section 6607, 42 U.S.C. 13106. The economic analysis
contains an analysis of the benefits and costs of this rule, which
estimates that the total industry costs of the rule will be $145
million in the first year and $80 million per year thereafter, and
concludes that the benefits will be significant but cannot be assigned
a dollar value due to the lack of adequate methodologies. EPA believes
that the benefits provided by the information to be reported under this
rule will significantly outweigh the costs imposed by today's action.
The benefits of the information will in turn have positive effects on
health, safety, and the natural environment through the behavioral
changes that may result from that information.
EPA has not identified any Federal financial resources that are
available to cover the costs of this rule. As set forth in the economic
analysis, EPA has estimated the future industry compliance costs (after
the first year) of this rule to be $80 million annually. Of those
entities affected by today's action, EPA has not identified any
disproportionate budgetary impact on any particular region, government,
or community, or on any segment of the private sector. Based on the
economic analysis, EPA has concluded that it is highly unlikely that
this rule will have an appreciable effect on the national economy.
EPA has determined that it is not required to develop a small
government agency plan as specified by section 203 of UMRA or to
conduct prior consultation with State, local, or tribal governments
under section 204 of UMRA, because the rule will not significantly or
uniquely affect small governments and does not contain a significant
Federal intergovernmental mandate.
Finally, EPA believes this rule complies with section 205(a) of
UMRA. The objective of this rule is to expand the public benefits of
the TRI program by exercising EPA's discretionary authority to add
chemicals to the program and to lower reporting thresholds, thereby
increasing the amount of information available to the public regarding
the use, management, and disposition of PBT chemicals and enabling a
more comprehensive view of PBT chemical exposures. In making additional
information available through TRI, the Agency increases the utility of
TRI data as an effective tool for empowering local communities, the
public sector, industry, other agencies, and State and local
governments to better evaluate risks to public health and the
environment.
As described in Unit IV.D., EPA considered burden in the threshold
selection. Existing burden-reducing measures (e.g., the laboratory
exemption and the otherwise use exemptions, which include the routine
janitorial or facility grounds maintenance exemption, motor vehicle
maintenance exemption, structural component exemption, intake air and
water exemption and the personal use exemption) will continue to apply
to the facilities that file new reports as a result of this rule. EPA
also will be assisting small entities subject to the rule, by such
means as providing meetings, training, and compliance guides in the
future, which also will ease the burdens of compliance. Many steps have
been and will be taken to further reduce the burden associated with
this rule, and to EPA's knowledge there is no available alternative to
the rule that would obtain the equivalent information in a less
burdensome manner. For all of these reasons, EPA believes the rule
complies with UMRA section 205(a).
In addition, today's rule does not create an unfunded Federal
mandate on State, local or tribal governments, nor does it
significantly or uniquely affect the communities of Indian tribal
governments. Accordingly, the requirements of section 1(a) of Executive
Order 12875, entitled Enhancing the Intergovernmental Partnership (58
FR 58093, October 28, 1993), and section 3(b) of Executive Order 13084,
entitled Consultation and Coordination with Indian Tribal Governments
(63 FR 27655, May 19, 1998), do not apply to this proposed rule.
E. What are the Determinations under Executive Orders 12898 and 13045?
Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency must consider
environmental justice related issues with regard to the potential
impacts of this action on environmental and health conditions in low-
income populations and minority populations. Pursuant to Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997), if an action is
economically significant under Executive Order 12866, the Agency must,
to the extent permitted by law and consistent with the Agency's
mission, identify and assess the environmental health risks and safety
risks that may disproportionately affect children.
By lowering the section 313 reporting thresholds for PBT chemicals,
EPA will provide communities across the United States (including low-
income populations and minority populations) with access to data that
may assist them in lowering exposures and consequently reducing
chemical risks for themselves and their children. This information can
also be used by government agencies and others to identify potential
problems, set priorities, and take appropriate steps to reduce any
potential risks to human health and the environment. Therefore, the
informational benefits of the rule will have a positive impact on the
human health and environmental impacts of minority populations, low-
income populations, and children.
F. What are the Determinations under Executive Orders 13132 and 12612?
On August 4, 1999, President Clinton issued a new executive order
on federalism, Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), which will take effect on November 2, 1999. In the
interim, the current Executive Order 12612, entitled Federalism (52 FR
41685, October 30, 1987) still applies. This action is expected to have
a limited impact on municipal governments which operate electric
utilities. EPA estimates that 39 municipalities operate 49 publicly
owned electric utility facilities. Of these facilities, 44 are expected
to file additional reports as a result of this action. Therefore EPA
concludes that this rule will not have a substantial direct effect on
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 12612.
G. What are the Determinations under the National Technology Transfer
and Advancement Act?
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless doing so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, etc.) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
[[Page 58750]]
available and applicable voluntary consensus standards.
This action does not involve technical standards, nor did EPA
consider the use of any voluntary consensus standards. In general,
EPCRA does not prescribe technical standards to be used for threshold
determinations or completion of EPCRA section 313 reports. EPCRA
section 313(g)(2) states that ``In order to provide the information
required under this section, the owner or operator of a facility may
use readily available data (including monitoring data) collected
pursuant to other provisions of law, or, where such data are not
readily available, reasonable estimates of the amounts involved.
Nothing in this section requires the monitoring or measurement of the
quantities, concentration, or frequency of any toxic chemical released
into the environment beyond that monitoring and measurement required
under other provisions of law or regulation.''
H. What are the Determinations under the Congressional Review Act?
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 31, 1999.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Hazardous
substances, Intergovernmental relations, Reporting and recordkeeping
requirements, Superfund.
Dated: October 25, 1999.
Carol M. Browner,
Administrator.
Therefore, 40 CFR part 372 is amended as follows:
PART 372--[AMENDED]
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.22 [Amended]
2. In Sec. 372.22(c), remove the phrase ``Sec. 372.25 or
Sec. 372.27.'' and add in its place ``Sec. 372.25, Sec. 372.27, or
Sec. 372.28.''.
Sec. 372.25 [Amended]
3. Section 372.25 is amended as follows:
i. In the introductory text of Sec. 372.25, remove the first clause
``Except as provided in Sec. 372.27,'' and add in its place ``Except as
provided in Secs. 372.27 and 372.28,''.
ii. In paragraphs (f), (g), and (h), remove the reference
``Sec. 372.25'' and add in its place ``Sec. 372.25, Sec. 372.27, or
Sec. 372.28''.
4. In Sec. 372.27, add a new paragraph (e) to read as follows:
Sec. 372.27 Alternate threshold and certification.
* * * * *
(e) The provisions of this section do not apply to any chemicals
listed in Sec. 372.28.
5. Add a new Sec. 372.28 to subpart B to read as follows:
Sec. 372.28 Lower thresholds for chemicals of special concern.
(a) Notwithstanding Sec. 372.25 or Sec. 372.27, for the toxic
chemicals set forth in this section, the threshold amounts for
manufacturing (including importing), processing, and otherwise using
such toxic chemicals are as set forth in this section.
(1) Chemical listing in alphabetic order.
------------------------------------------------------------------------
Reporting
Chemical name CAS No. threshold
------------------------------------------------------------------------
Aldrin.......................... 00309-00-2 100
Benzo(g,h,i)perylene............ 00191-24-2 10
Chlordane....................... 00057-74-9 10
Heptachlor...................... 00076-44-8 10
Hexachlorobenzene............... 00118-74-1 10
Isodrin......................... 00465-73-6 10
Mercury......................... 07439-97-6 10
Methoxychlor.................... 00072-43-5 100
Octachlorostyrene............... 29082-74-4 10
Pendimethalin................... 40487-42-1 100
Pentachlorobenzene.............. 00608-93-5 10
Polychlorinated biphenyl (PCBs). 01336-36-3 10
Tetrabromobisphenol A........... 00079-94-7 100
Toxaphene....................... 08001-35-2 10
Trifluralin..................... 01582-09-8 100
------------------------------------------------------------------------
(2) Chemical categories in alphabetic order.
------------------------------------------------------------------------
Category name Reporting threshold
------------------------------------------------------------------------
Dioxin and dioxin-like compounds 0.1 grams
(Manufacturing; and the processing or
otherwise use of dioxin and dioxin-like
compounds if the dioxin and dioxin-like
compounds are present as contaminants in
a chemical and if they were created
during the manufacturing of that
chemical) (This category includes only
those chemicals listed below).
67562-39-4 1,2,3,4,6,7,8-
Heptachlorodibenzofuran
[[Page 58751]]
55673-89-7 1,2,3,4,7,8,9-
Heptachlorodibenzofuran
70648-26-9 1,2,3,4,7,8-
Hexachlorodibenzofuran
57117-44-9 1,2,3,6,7,8-
Hexachlorodibenzofuran
72918-21-9 1,2,3,7,8,9-
Hexachlorodibenzofuran
60851-34-5 2,3,4,6,7,8-
Hexachlorodibenzofuran
39227-28-6 1,2,3,4,7,8-
Hexachlorodibenzo-p-dioxin
57653-85-7 1,2,3,6,7,8-
Hexachlorodibenzo-p-dioxin
19408-74-3 1,2,3,7,8,9-
Hexachlorodibenzo-p-dioxin
35822-46-9 1,2,3,4,6,7,8-
Heptachlorodibenzo-p-dioxin
39001-02-0 1,2,3,4,6,7,8,9-
Octachlorodibenzofuran
03268-87-9 1,2,3,4,6,7,8,9-
Octachlorodibenzo-p-dioxin
57117-41-6 1,2,3,7,8-
Pentachlorodibenzofuran
57117-31-4 2,3,4,7,8-
Pentachlorodibenzofuran
40321-76-4 1,2,3,7,8-
Pentachlorodibenzo-p-dioxin
51207-31-9 2,3,7,8-
Tetrachlorodibenzofuran
01746-01-6 2,3,7,8 Tetrachlorodibenzo-
p-dioxin
Mercury compounds 10
Polycyclic aromatic compounds (PACs) (This 100
category includes only those chemicals
listed below).
00056-55-3 Benz(a)anthracene
00205-99-2 Benzo(b)fluoranthene
00205-82-3 Benzo(j)fluoranthene
00207-08-9 Benzo(k)fluoranthene
00206-44-0 Benzo(j,k)fluorene
00189-55-9 Benzo(r,s,t)pentaphene
00218-01-9 Benzo(a)phenanthrene
00050-32-8 Benzo(a)pyrene
00226-36-8 Dibenz(a,h)acridine
00224-42-0 Dibenz(a,j)acridine
00053-70-3 Dibenzo(a,h)anthracene
00194-59-2 7H-Dibenzo(c,g)carbazole
05385-75-1 Dibenzo(a,e)fluoranthene
00192-65-4 Dibenzo(a,e)pyrene
00189-64-0 Dibenzo(a,h)pyrene
00191-30-0 Dibenzo(a,l)pyrene
00057-97-6 7,12-
Dimethylbenz(a)anthracene
00193-39-5 Indeno[1,2,3-cd]pyrene
00056-49-5 3-Methylcholanthrene
03697-24-3 5-Methylchrysene
05522-43-0 1-Nitropyrene
------------------------------------------------------------------------
(b) The threshold determination provisions under Sec. 372.25(c)
through (h) and the exemptions under Sec. 372.38(b) through (h) are
applicable to the toxic chemicals listed in paragraph (a) of this
section.
Sec. 372.30 [Amended]
6. Section 372.30 is amended as follows:
i. In paragraph (a), remove the phrase ``in Sec. 372.25 at'' and
add in its place ``in Sec. 372.25, Sec. 372.27, or Sec. 372.28 at''.
ii. In paragraphs (b)(1), the introductory text of (b)(3),
(b)(3)(i), and (b)(3)(iv), remove the reference ``Sec. 372.25'' and add
in its place ``Sec. 372.25, Sec. 372.27, or Sec. 372.28''.
Sec. 372.38 [Amended]
7. Section 372.38 is amended as follows:
i. In paragraph (a), add the following sentence at the end of the
paragraph to read as follows: ``This exemption does not apply to toxic
chemicals listed in Sec. 372.28, except for purposes of
Sec. 372.45(d)(1).''.
ii. In paragraphs (b), (c) introductory text, (d) introductory
text, and (f), remove the reference ``Sec. 372.25'' and add in its
place ``Sec. 372.25, Sec. 372.27, or Sec. 372.28''.
iii. In paragraphs (g) and (h), remove the phrase ``Sec. 372.25 or
Sec. 372.27'' and add in its place ``Sec. 372.25, Sec. 372.27, or
Sec. 372.28''.
8. Section 372.65 is amended as follows:
i. In the table in paragraph (a), revise the entry for ``Vanadium''
and alphabetically add four chemicals.
ii. In the table in paragraph (b), revise the CAS no. entry ``7440-
62-2'' and add four chemicals in numerical CAS no. sequence.
iii. In the table in paragraph (c), alphabetically add two
categories, ``dioxin and dioxin-like compounds'' and ``vanadium'', and
alphabetically add two chemicals, ``benzo(j,k)fluorene'' and ``3-
methylcholanthrene'', under the polycyclic aromatic compounds (PACs)
category.
The revisions and additions read as follows:
Sec. 372.65 Chemicals and chemical categories to which the part
applies.
* * * * *
(a) * * *
[[Page 58752]]
------------------------------------------------------------------------
Chemical name CAS No. Effective date
------------------------------------------------------------------------
* * * * * * *
Benzo(g,h,i)perylene 00191-24-2 1/00
* * * * * * *
Octachlorostyrene 29082-74-4 1/00
* * * * * * *
Pentachlorobenzene 00608-93-5 1/00
* * * * * * *
Tetrabromobisphenol A 00079-94-7 1/00
* * * * * * *
Vanadium (except when contained 7440-62-2 1/00
in an alloy)
* * * * * * *
------------------------------------------------------------------------
(b) * * *
------------------------------------------------------------------------
CAS No. Chemical name Effective date
------------------------------------------------------------------------
* * * * * * *
7440-62-2 Vanadium (except when 1/00
contained in an
alloy)
* * * * * * *
00079-94-7 Tetrabromobisphenol A 1/00
00191-24-2 Benzo(g,h,i)perylene 1/00
00608-93-5 Pentachlorobenzene 1/00
* * * * * * *
29082-74-4 Octachlorostyrene 1/00
* * * * * * *
------------------------------------------------------------------------
(c) * * *
------------------------------------------------------------------------
Category name Effective date
------------------------------------------------------------------------
* * * * * * *
Dioxin and dioxin-like compounds
(Manufacturing; and the processing or
otherwise use of dioxin and dioxin-like
compounds if the dioxin and dioxin-like
compounds are present as contaminants in a
chemical and if they were created during
the manufacturing of that chemical)
(This category includes only those 1/00
chemicals listed below)
67562-39-4 1,2,3,4,6,7,8-
Heptachlorodibenzofuran
55673-89-7 1,2,3,4,7,8,9-
Heptachlorodibenzofuran
70648-26-9 1,2,3,4,7,8-
Hexachlorodibenzofuran
57117-44-9 1,2,3,6,7,8-
Hexachlorodibenzofuran
72918-21-9 1,2,3,7,8,9-
Hexachlorodibenzofuran
60851-34-5 2,3,4,6,7,8-
Hexachlorodibenzofuran
39227-28-6 1,2,3,4,7,8-
Hexachlorodibenzo-p-dioxin
57653-85-7 1,2,3,6,7,8-
Hexachlorodibenzo-p-dioxin
19408-74-3 1,2,3,7,8,9-
Hexachlorodibenzo-p-dioxin
35822-46-9 1,2,3,4,6,7,8-
Heptachlorodibenzo-p-dioxin
39001-02-0 1,2,3,4,6,7,8,9-
Octachlorodibenzofuran
03268-87-9 1,2,3,4,6,7,8,9-
Octachlorodibenzo-p-dioxin
57117-41-6 1,2,3,7,8-
Pentachlorodibenzofuran
57117-31-4 2,3,4,7,8-
Pentachlorodibenzofuran
40321-76-4 1,2,3,7,8-
Pentachlorodibenzo-p-dioxin
51207-31-9 2,3,7,8-
Tetrachlorodibenzofuran
01746-01-6 2,3,7,8-
Tetrachlorodibenzo-p-dioxin
[[Page 58753]]
* * * * * * *
Polycyclic aromatic compounds (PACs): This
category includes only those chemicals
listed below).
* * * * * * *
00206-44-0 Benzo(j,k)fluorene 1/00
* * * * * * *
00056-49-5 3-Methylcholanthrene 1/00
* * * * * * *
Vanadium compounds 1/00
------------------------------------------------------------------------
9. In Sec. 372.85, revise the introductory text of paragraph
(b)(15)(i), add a new paragraph (b)(15)(ii), and revise paragraphs
(b)(16)(i)(B) and (b)(16)(ii)(B) to read as follows:
Sec. 372.85 Toxic chemical release reporting form and instructions.
* * * * *
(b) * * *
(15) * * *
(i) An estimate of total releases in pounds (except for dioxin and
dioxin-like compounds, which shall be reported in grams) per year
(releases of less than 1,000 pounds per year may be indicated in
ranges, except for chemicals set forth in Sec. 372.28) from the
facility plus an indication of the basis of estimate for the following:
* * * * *
(ii) Report a distribution of the chemicals included in the dioxin
and dioxin-like compounds category. Such distribution shall either
represent the distribution of the total quantity of dioxin and dioxin-
like compounds released to all media from the facility; or its one best
media-specific distribution.
(16) * * *
(i) * * *
(B) An estimate of the amount of the chemical transferred in pounds
(except for dioxin and dioxin-like compounds, which shall be reported
in grams) per year (transfers of less than 1,000 pounds per year may be
indicated as a range, except for chemicals set forth in Sec. 372.28)
and an indication of the basis of the estimate.
* * * * *
(ii) * * *
(B) An estimate of the amount of the chemical in waste transferred
in pounds (except for dioxin and dioxin-like compounds, which shall be
reported in grams) per year (transfers of less than 1,000 pounds may be
indicated in ranges, except for chemicals set forth in Sec. 372.28) to
each off-site location, and an indication of the basis for the estimate
and an indication of the type of treatment or disposal used.
* * * * *
[FR Doc. 99-28169 Filed 10-28-99; 8:45 am]
BILLING CODE 6560-50-F