# 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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A99-28169

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** October 29, 1999
- **Citation:** 64 FR 58666

## Text

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/ 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 param

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A99-28169. Public record. Not legal advice.