Lead and Lead Compounds; Lowering of Reporting Thresholds; Community Right-to-Know Toxic Chemical Release Reporting
Federal RegisterAug 3, 1999
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400140; FRL-6081-4]
RIN 2070-AD38
Lead and Lead Compounds; Lowering of Reporting Thresholds;
Community Right-to-Know Toxic Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to lower the reporting thresholds for lead
and lead compounds which 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
believes that lead and lead compounds are persistent, bioaccumulative
toxic (PBT) chemicals that warrant lower reporting thresholds than
those currently established under EPCRA section 313. Today's proposed
action also includes a limitation on the reporting of lead when
contained in certain alloys and proposed modifications to certain
reporting exemptions and requirements for lead and lead compounds.
DATES: Written comments, identified by the docket control number OPPTS-
400140, must be received by EPA on or before September 17, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION section of this
document.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Petitions
Coordinator, 202-260-3882, e-mail: [email protected], for
specific information on this proposed rule, or for more information on
EPCRA section 313, 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 Notice Apply to Me?
You may be potentially affected by this notice if you manufacture,
process, or otherwise use lead or lead compounds. Potentially affected
categories and entities may include, but are not limited to:
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Examples of Potentially
Category Affected Entities
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Industry Facilities that: process
copper ores, lead and zinc
ores; operate pulp mills,
petroleum refineries,
primary copper smelters,
primary and secondary
nonferrous metal smelters,
gray/ductile iron foundries,
steel foundries, blast
furnaces, steel mills,
petroleum bulk stations and
terminals, industrial
boilers that burn coal,
wood, petroleum products,
and electric utilities that
combust coal and/or oil for
distribution of electricity
in commerce; facilities that
manufacture, process, or use
inorganic pigments, small
arms ammunition, asphalt
paving mixtures and blocks,
storage batteries, motor
vehicles and motor vehicle
equipment; manufacture
electronic components and
accessories.
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Federal Government Federal facilities that:
manufacture, process, or use
lead or lead compounds; burn
coal or petroleum products.
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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 preceding ``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/homepage/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-400140. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as confidential business information (CBI). This
official record includes the 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 12 noon to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the Center is (202)
260-7099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. Be sure to identify the appropriate docket control
number (i.e., ``OPPTS-400140'') in your correspondence.
1. By mail. Submit written comments to: Document Control Office
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
DCO is: 202-260-7093.
3. Electronically. Submit your comments electronically by E-mail
to: ``[email protected].'' Please note that you should not
submit any information electronically that you consider to be CBI.
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption. Comments and data
will also be accepted on standard computer disks in WordPerfect 5.1/6.1
or ASCII file format. All comments and data in electronic form must be
identified by the docket control number OPPTS-400140. Electronic
[[Page 42223]]
comments on this proposal may also be filed online at many Federal
Depository Libraries.
D. How Should I Handle CBI Information that I Want to Submit to the
Agency?
You may claim information that you submit in response to this
document as CBI by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential will be included in the public
docket by EPA without prior notice. If you have any questions about CBI
or the procedures for claiming CBI, please consult with the technical
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
II. What is EPA's Statutory Authority for Taking These Actions?
These actions are proposed under sections 313(f)(2) and 328 of
EPCRA, 42 U.S.C. 11023(f)(2) and 11048.
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using a listed toxic chemical in amounts above
reporting threshold levels, to report their environmental releases of
each chemical annually. These reports must be filed by July 1 of each
year for the previous calendar year. Facilities also must report
pollution prevention and recycling data for such chemicals, pursuant to
section 6607 of PPA.
A. What is EPA's Statutory Authority to Lower EPCRA Reporting
Thresholds?
Section 313 contains 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).'' 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 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 has
also committed the determination of the levels at which to establish an
alternate threshold 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 ``facilities subject to the requirements''
of section 313 as the facilities currently reporting, in part because
section 313(b)(1)(A) provides that ``the requirements of [section 313]
shall apply'' to facilities that meet all the reporting criteria and
hence are required to file reports. 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 guidance for exercising this authority appears in
the statute.
While the ``substantial majority'' requirement of section 313(f)(2)
applies whether EPA is raising or lowering thresholds, EPA believes
that as a practical matter this standard can operate to constrain EPA's
action only when the Agency is raising the thresholds and thereby
reducing reporting. Under those circumstances, the releases reported
under the new threshold would be lower than those being reported under
the current threshold, and EPA would be required to determine that the
reduction in reporting would not be so great as to fail the
``substantial majority'' test. When EPA lowers thresholds, however, the
substantial majority test is met as a matter of logical necessity,
because the lower thresholds are almost always likely to result in
increased, rather than decreased, reporting. The required findings
therefore can be made without the need for quantitative support. Thus,
EPA has found that the revised reporting thresholds contained in
today's proposed action meet the ``substantial majority'' test in
section 313(f)(2).
Because Congress provided no prerequisites to the exercise of EPA's
authority to lower the thresholds, and little explicit guidance, EPA
looked to the purposes of section 313 to help guide the exercise of its
discretion. EPCRA section 313(h) indicates that the data collected
under EPCRA section 313 are intended:
. . . to inform persons about the 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. (42 U.S.C. 11023(h)).
EPA has identified several purposes of the EPCRA section 313 program,
as envisioned by Congress, including: (1) Providing a complete profile
of toxic chemical releases and other waste management activities; (2)
compiling a broad-based national data base for determining the success
of environmental regulations; and (3) ensuring that the public has easy
access to these data on releases of toxic chemicals to the environment.
(See 62 FR 23834, 23836, May 1, 1997). EPA considered these purposes in
exercising its discretion to establish lower reporting thresholds under
EPCRA section 313 for lead and lead compounds, which the Agency has
determined are persistent, bioaccumulative chemicals.
B. What is EPA's Statutory Authority for Making Modifications to Other
EPCRA Section 313 Reporting Requirements?
Congress granted EPA extremely broad 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. How Did EPA Develop this Proposal and What is the Scope of the
Comments Being Solicited?
A. Why Was Lead Not Addressed in the Recently Proposed PBT Rule?
In EPA's recent proposed rule to lower the EPCRA section 313
reporting thresholds for certain PBT chemicals (64 FR 688, January 5,
1999) (FRL-6032-3), EPA reviewed the bioaccumulation data for two lead
compounds: tetramethyl and tetraethyl lead. However, the analysis was
limited to the data for the intact compounds and did not address the
potential availability of lead from these compounds or other lead
compounds or the potential for lead to bioaccumulate. In the January 5,
1999 proposed rule for PBT chemicals, EPA made the following statements
about lead and lead compounds:
EPA is aware of additional available data that may indicate that
lead and/or lead compounds meet the bioaccumulation criteria
discussed in this proposed rule. EPA intends to review these
additional data to determine if lead and/or lead compounds should be
considered PBT chemicals and whether it would be appropriate to
establish lower reporting thresholds for these chemicals. Any such
determination will be made part of an additional rulemaking
activity. (See 64 FR 717, column 1).
Since development of the January 5, 1999 proposed rule, EPA has
received numerous comments requesting that the Agency include lead and
lead compounds as PBT chemicals under EPCRA section 313 and set lower
reporting thresholds (see the docket
[[Page 42224]]
support for the proposed rule (docket control number OPPTS-400132)).
Many of these comments were received well into the comment period on
the January 5, 1999 proposed rule. Rather than delay movement on the
January 5, 1999 proposed rule until EPA was ready to proceed with lead
and lead compounds, the Agency elected to address lower reporting
thresholds for lead and lead compounds as a separate proposal. EPA
believes that such an approach will allow both the Agency and those
commenters especially interested in lead and lead compounds to focus on
the issues specifically related to these substances. Accordingly,
today's proposed rule is the result of EPA's review of the available
information on lead and lead compounds, and is the Agency's response to
the requests for lower reporting thresholds for lead and lead compounds
based on their persistence and bioaccumulation.
B. What is the Scope of Comments Being Solicited on this Proposed Rule?
EPA recognizes that this proposal for lead and lead compounds may
raise similar issues to those raised in the January 5, 1999 proposed
rule. For the purposes of this proposal, however, EPA is only
soliciting comments on how these proposed actions would affect EPCRA
section 313 reporting on lead and lead compounds, the impacts these
proposed changes would have on the burden of section 313 reporting for
lead and lead compounds, and the benefits such reporting would provide
the public. Comments of a more generic nature were solicited in the
January 5, 1999 proposed rule, and should have been submitted during
the comment period for that proposal, which closed April 7, 1999. EPA
will respond to timely comments on these generic issues in the final
PBT chemicals rule. The Agency will limit its consideration of and
responses to comments submitted in the comment period for this proposal
to those that relate to section 313 reporting of lead and lead
compounds. To the extent that comments were submitted on the January 5,
1999 proposed rule that a commenter believes are relevant to this
proposal, the commenter must resubmit or reference those comments for
inclusion in the docket for this proposal, along with an explanation of
why the comments are relevant to lead and lead compounds.
C. What are the Issues on Which EPA is Interested in Receiving Comment?
The Agency is particularly interested in receiving comments on the
general policy issues, as they apply to lead and lead compounds, that
were discussed and raised for comment in Unit IX. of the preamble to
the PBT proposed rule (see 64 FR 688, at 717). It is important for EPA
to clarify that this proposal does not introduce any new issues beyond
those associated with lead and lead compounds (e.g., persistence data
for lead, bioaccumulation data for lead, estimated number of reports).
The Agency is therefore only seeking comments on the generic issues
that relate specifically to the proposal to lower the reporting
threshold for lead and lead compounds. The changes that EPA is
proposing to make to the reporting requirements for lead and lead
compounds are discussed in detail in Unit VI. of this preamble,
including the applicability to lead and lead compounds of the general
amendments to EPCRA section 313 reporting requirements for PBT
chemicals presented in the proposed PBT rule. Accordingly, comments on
the following issues, which were previously identified and for which
comment was sought in Unit IX. of the preamble to the proposed PBT rule
(see 64 FR 688, at 717), are only requested on this proposal insofar as
the comments relate particularly to lead and lead compounds: (1)
Whether EPA should attempt to estimate the releases that would be
reported at an ``average'' facility at each of the identified options
for a lowered threshold, the appropriate methodology for estimating
releases from all affected industry sectors, and whether EPA should
then use those estimates to select the lowered threshold that would
capture some overall percentage of releases, e.g., 75 - 80%; (2)
whether EPA should consider lowering the reporting thresholds for lead
and lead compounds based on either persistence or bioaccumulation
(rather than both); (3) whether EPA should consider other mechanisms
for further minimizing the potential impacts associated with lowering
the reporting thresholds for lead and lead compounds (i.e., it was
suggested that EPA develop a modified Form A with thresholds more
appropriate for lead and lead compounds, retain de minimis thresholds
for lead and lead compounds (perhaps at a lower level), retain whole
number reporting, the half-pound rule, and range reporting for lead and
lead compounds, establish an activity qualifier restricting the lower
reporting threshold to the manufacture of lead and lead compounds,
retaining the higher current thresholds with respect to import, process
or use activities, and that EPA modulate the frequency of reporting).
D. What Other Comments Should the Public Submit?
EPA believes that the additional information provided by lowering
the TRI reporting thresholds for PBT chemicals, including lead and lead
compounds, will be valuable to communities and will significantly
enhance their knowledge about toxic chemical releases and other waste
management activities that may be of concern to them. At the same time,
EPA recognizes that today's proposal, along with its earlier proposal
to lower reporting thresholds for various other PBT chemicals (64 FR
688), will increase the burden imposed by the TRI program on facilities
that must provide information. EPA is mindful of the importance of
minimizing reporting burden, while continuing to provide communities
with high quality right-to-know information. EPA is genuinely
interested in reducing TRI reporting burden, while assuring that the
goals and objectives of EPCRA section 313 continue to be met.
EPA has already initiated a number of burden reducing activities in
the TRI program. For example, EPA is currently reviewing the original
list of EPCRA section 313 chemicals in response to suggestions that EPA
evaluate those chemicals against the EPCRA section 313(d) criteria. EPA
is also developing reporting guidance, including guidance specifically
for small businesses, which will simplify and ease reporting burdens.
These efforts include the development of intelligent reporting software
with built-in error checking routines and calculation methodologies;
the development of a single facility identification program for
facilities that report to EPA; and the development of guidance to
facilitate more consistent use of chemical nomenclature, reporting
units, and time frames across different programs.
As a means of identifying other potential areas for reducing TRI
reporting burden, EPA initiated an intensive stakeholder process to
comprehensively evaluate current TRI reporting. An important part of
this stakeholder process was a review conducted by the Toxics Data
Reporting (TDR) Committee of the National Advisory Council on
Environmental Policy and Technology (NACEPT). EPA asked the TDR
Committee to develop recommendations to improve the right-to-know
information available to communities and to help streamline reporting
to ease the paperwork burden for facilities affected by the
requirements. Specifically, the Committee was asked to examine the
[[Page 42225]]
format of and nomenclature in the Form R, seek opportunities for burden
reduction, and evaluate EPA's presentation of the data in public
information documents. The TDR Committee met eight times between
September 1997 and October 1998, and issued its final report in May
1999. The TDR Committee report is available on the Internet at
www.epa.gov/opptintr/tri, and a copy of the report is also available in
the public version of the official record for this proposed rule.
In their final report to the Agency, after noting that the TDR
Committee did not reach final consensus on most issues, the TDR
Committee presented the various suggestions raised during the
discussions as ``ideas'' without any indication of the level of support
for them. These ideas fall under the broad categories of burden
reduction, the public data release (PDR), and the Form R. Some of the
burden reduction ideas presented by the TDR Committee include the
creation of an intelligent software program for reporters, the
integration of reporting across programs, the provision of industry
specific guidance, the expansion of the EPCRA section 313 exemptions,
and options for increasing eligibility for the alternate threshold as
certified by Form A. With regard to the Form R, most of the Committee's
suggestions involved the addition of data elements intended to further
clarify the information currently collected, particularly on the waste
management data. The Committee also offered ideas for improving the
PDR, including adding information to the PDR that would provide
additional context for the TRI data.
The TDR Committee report also mentions a more general approach for
burden reduction that involves establishing, either through regulation
or guidance, limitations on the level of effort and data accuracy
required for TRI reports. For example, this approach might include
greater use of default parameters and standardized estimation methods
based on best engineering practices, and/or a percentage rule in which
a facility would be required to collect information and report only
some fixed percentage of releases (e.g., 90%). This latter approach
could allow facilities to focus their reporting efforts on larger
sources of releases and ignore some smaller sources, as long as they
reported at least the specified percentage of total releases. The
absolute quantity not reported would vary from toxic chemical to toxic
chemical and from facility to facility. EPA requests comments on the
substance of this approach, including mechanisms that would allow
implementation consistent with EPCRA section 313. In particular, EPA is
interested in comments regarding the potential impacts of this approach
on the facility reporting burden and on the integrity of the TRI data
and community right-to-know.
In addition to the TDR Committee report, EPA has received other
suggestions for burden reduction in the TRI program. Although EPA has
already requested comment on the suggestion that EPA effectively modify
the frequency of reporting for PBT chemicals (see 64 FR 688, at 718),
and lead and lead compounds (see Unit III.C. of this preamble), it has
been suggested that EPA consider changing the frequency of reporting
under EPCRA section 313 in general, i.e., require biennial reporting.
EPA is requesting comment on the utility of biennial reporting and
whether that approach would provide for significant burden reduction
for affected facilities. EPA welcomes comment on the availability of
information that would allow the Agency to make the requisite findings
under EPCRA section 313(i)(3)(B), especially how consideration of
alternate reporting requirements should pertain to the facilities in
the recently added industry sectors for which first reports have just
recently been received, the lack of readily available information on
EPCRA section 313 chemicals from existing sources, and what available
information may exist to allow EPA to address the requirements of the
law.
EPA places great importance on reducing burden on the public and is
currently considering the various suggestions it has received,
including the ideas in the TDR Committee report, and others received
from industry and other agencies. EPA welcomes additional suggestions,
and specifically requests comment on the ideas presented in the TDR
Committee report, particularly those that relate to burden reduction.
IV. Explanation for Lowering Reporting Thresholds
A. What is the General Background for this Rulemaking?
In 1986, Congress passed EPCRA. This new law recognized the unique
role that communities can play in assuring environmental protection at
the local level. Just prior to the passage of EPCRA, fatal chemical
releases from a chemical manufacturing facility in Bhopal, India
highlighted the need for developing and sharing both emergency planning
information and routine release information with the public. The
identification of United States facilities, chemicals, and processes
identical to the Bhopal situation brought home the potential for
similar accidents in the United States as well as a recognition that
routine releases of toxic chemicals associated with routine facility
processes could pose significant risks to communities. These routine,
annual releases, if assessed at all, were known only to the facilities
themselves. Communities however, were unaware of the magnitude and
potential consequences of such releases.
Section 313 of EPCRA resulted in the creation of the Toxics Release
Inventory (TRI). TRI is a publicly available data base that provides
quantitative information on toxic chemical releases and other waste
management activities. With the collection of this information for the
first time in 1987, came the ability for the public, government, and
the regulated community to understand the magnitude of chemical
emissions in the United States; to compare chemical releases among
facilities and transfers of chemical wastes among States, industries,
and facilities; and perhaps most importantly, to assess the need to
reduce and where possible, eliminate these releases and other waste
management activities. TRI enables all parties interested in
environmental progress to establish credible baselines, to set
realistic goals, and to measure progress over time, in meeting those
goals. The TRI system provides a neutral yardstick by which progress
can be measured by all interested parties. TRI is an important tool in
empowering the Federal government, State governments, industry,
environmental groups, and the general public, to fully participate in
an informed dialogue about the environmental and human health impacts
of toxic chemical releases and other waste management activities.
Prior to EPCRA, the kind of information contained in the TRI
generally was nonexistent or unavailable to the Federal government,
State governments, emergency preparedness teams or the general public,
and often was not disclosed until after major impacts on human health
and the environment were evident. This ``after the fact'' disclosure of
information did little to help plan for or prevent such serious health
and environmental impacts. While permit data are generally cited as a
public source of environmental data, they are often difficult to
obtain, are not multi-media, and present only a limited perspective on
a facility's overall environmental performance. While other sources of
data are sometimes cited as substitutes for TRI data, based on its own
research, EPA is unaware of
[[Page 42226]]
any other publicly available, nationwide data base that provides multi-
media, facility-specific release and other waste management information
to the public in a readily accessible form. With TRI, and the real
gains in understanding it has produced, communities now know which
industrial facilities in their area release or otherwise manage as
waste listed toxic chemicals.
Under EPCRA section 313, Congress set the initial parameters of
TRI, but also gave EPA clear authority to modify TRI in various ways,
including 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 (59 FR 61432, November 30, 1994) (FRL-4922-2). Further, a
new category of facilities was added to EPCRA section 313 on August 3,
1993, through Executive Order 12856 (58 FR 41981, August 6, 1993),
which requires Federal facilities meeting threshold requirements to
file annual TRI 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 (62 FR 23834, May 1, 1997) (FRL-5578-3). At the same
time, EPA has sought to reduce the burden of EPCRA section 313
reporting by actions such as delisting chemicals that were determined
not to meet the statutory listing criteria and establishing 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 TRI report, the Form R.
In today's action, EPA is proposing enhanced reporting requirements
for lead and lead compounds. Lead and lead compounds are toxic
chemicals that persist and bioaccumulate in the environment. To date,
with the exception of facilities subject to the alternate threshold
exemption, EPA has not altered the statutory reporting threshold for
all 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 proposing to
increase the utility of TRI to the public by lowering the reporting
thresholds for lead and lead compounds. Lead and lead compounds, being
PBT chemicals, 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 it is important that the public
understand that these PBT chemicals can have serious human health and
environmental effects resulting from low levels of release and
exposure. Lowering the reporting thresholds for lead and lead compounds
would ensure that the public has important information on the
quantities of these PBT chemicals released or otherwise managed as
waste, that would not be reported under the current thresholds.
B. Why Should EPCRA Section 313 be Used to Focus on Chemicals that
Persist and Bioaccumulate?
As discussed in Unit VI.A. of this preamble, EPA is proposing to
lower the EPCRA section 313 reporting thresholds for lead and lead
compounds because these substances persist and bioaccumulate in the
environment. A chemical's persistence refers to the length of time the
chemical can exist in the environment before being destroyed by natural
processes. Bioaccumulation is a general term that is used to describe
the process by which organisms may accumulate certain chemicals in
their bodies. The term refers to both uptake of chemicals from water
(bioconcentration) and from ingested food and sediment residues. PBT
chemicals, such as lead and lead compounds, are therefore toxic
chemicals that partition to water, sediment, or soil and are not
removed at rates adequate to prevent their bioaccumulation in aquatic
or terrestrial species. Chemicals that persist and bioaccumulate have
been found in shellfish, birds, human adipose tissue, and other
mammals. See Unit V. of this preamble for a more detailed discussion of
and definitions for the terms persistence and bioaccumulation and the
data for lead and lead compounds.
Review of existing data leads EPA to believe that, as a general
matter, the release to the environment of toxic chemicals that persist
and bioaccumulate is of greater concern than the release of toxic
chemicals that do not persist or bioaccumulate. Since PBT chemicals can
remain in the environment for a significant amount of time and can
bioaccumulate in animal tissues, even relatively small releases of such
chemicals from individual facilities have the potential to accumulate
over time to higher levels and cause significant adverse impacts on
human health and the environment. EPA believes that the availability of
information on PBT chemicals, and specifically lead and lead compounds,
is a critical component of a community's right-to-know. Therefore, it
is particularly important to gather and disseminate to the public
relevant information on the releases and other waste management
activities of PBT chemicals.
Thus, for PBT chemicals, releases and other waste management
activities that occur at facilities that manufacture, process, or
otherwise use such chemicals even in relatively small amounts are of
concern. Under current reporting thresholds, a significant amount of
the releases and other waste management activities involving lead and
lead compounds are not being captured. The public, therefore, does not
have the information needed to determine if lead and lead compounds are
present in their communities at levels that may pose a significant
risk. By lowering the section 313 reporting thresholds for lead and
lead compounds, EPA would be providing communities across the United
States with access to data that may help them in making this
determination. This information could also be used by government
agencies and others to identify potential problems, set priorities, and
take appropriate steps to reduce any potential risks to human health
and the environment.
Several EPA offices have ongoing projects and programs that are
dealing with issues concerning PBT chemicals, such as lead and lead
compounds. EPA has established the PBT planning group which is a
coordinating body consisting of representatives from various program
offices throughout EPA that are dealing with PBT chemicals. This group
has developed a strategy to reduce pollution from PBT chemicals through
the application of regulatory and non-regulatory authorities, with a
strong emphasis on pollution prevention. Under this initiative, the
reporting of PBT chemicals at lower thresholds under EPCRA section 313
would provide data on PBT chemicals to EPA, industry, and the public.
The availability of that data can allow all parties to identify and
track releases of PBT chemicals and monitor the progress
[[Page 42227]]
of the programs designed to reduce the amount of PBT chemicals entering
the environment. The data would also allow EPA and others to design
prevention strategies that are focused and effective.
EPA is also participating in several international efforts to
reduce or eliminate pollution from PBT chemicals. These efforts
include: the Commission for Environmental Cooperation (CEC) Process for
Identifying Candidate Substances for Regional Action Under the Sound
Management of Chemicals Initiative, the United Nations Environment
Programme Persistent Organic Pollutants (POPs) Negotiations, and the
Canada-United States Strategy for the Virtual Elimination of Persistent
Toxic Substances in the Great Lakes Basin.
The program between the United States and Canada focuses on
pollution of the Great Lakes by PBT chemicals, which has been a matter
of great concern for both countries. However, the Canada-United States
Strategy for Virtual Elimination of Persistent Toxic Substances in the
Great Lakes Basin contains commitments that apply nationwide, including
those for alkyl lead. EPA has established the Great Lakes National
Program Office (GLNPO) to develop and implement programs to reduce
pollution of the Great Lakes. GLNPO works in cooperation with
counterpart organizations in Canada, most notably Environment Canada,
to carry out its mission. The ``Final Water Quality Guidance for the
Great Lakes System'' (60 FR 15366, March 23, 1995) (FRL-5173-7)
identified ``Pollutants that are Bioaccumulative Chemicals of Concern
(BCCs)'' among the ``Pollutants of Initial Focus in the Great Lakes
Water Quality Initiative.'' Working with that list, Canada and the
United States agreed on an initial list of chemicals identified as
``Substances Targeted by the Canada-United States Strategy for the
Virtual Elimination of Persistent Toxic Substances in the Great Lakes
Basin'' (Ref. 1). A subset of the targeted substances is often referred
to as the ``Binational Level 1 List,'' and includes chemicals both
countries have committed to ``virtually eliminate'' from the Great
Lakes, through meeting a series of interim reduction goals, some of
which are national in scope. Virtual elimination is to be attained by
programs implemented voluntarily by each country. The Binational Level
1 List includes alkyl lead, and the associated commitment reads: ``US
Challenge: Confirm by 1998, that there is no longer use of alkyl lead
in automotive gasoline. Support and encourage stakeholder efforts to
reduce alkyl lead releases from other sources.'' The information that
would be reported under this proposed rule regarding alkyl lead would
directly contribute to the Agency's ability to ``support and encourage
stakeholder efforts to reduce releases'' as agreed to in the Binational
Strategy.
EPA discussed the issue of reporting on PBT chemicals under section
313 in its January 12, 1994 chemical expansion proposed rule (59 FR
1788) (FRL-4645-6). In the preamble to the proposed rule, EPA
specifically requested comment on whether PBT chemicals should be added
to the section 313 list. EPA also asked for comments on what
modifications to reporting requirements, such as lowering reporting
thresholds or modifying the de minimis exemption, would need to be made
in order to ensure that release and transfer information would be
collected for such chemicals. In response to EPA's request for comments
on the reporting of PBT chemicals, 39 commenters responded, with 35 of
these commenters fully supporting such reporting under section 313. In
addition, of the over 620 comments EPA received on its 1997 proposal to
add a dioxin and dioxin-like compounds category, over 520 commenters
supported lowering the reporting thresholds for the proposed category.
Many commenters also suggested that EPA lower the reporting threshold
for all toxic chemicals that persist and bioaccumulate. EPA will
provide specific responses to these comments as part of any final rule
developed to add the dioxin and dioxin-like compounds category to the
section 313 list and lower the reporting thresholds. EPA has recently
addressed the issue of lower reporting thresholds for certain other PBT
chemicals in a proposed rule that was published on January 5, 1999 (64
FR 688) (FRL-6032-3).
V. Review of Persistence, Environmental Fate, and Bioaccumulation
Data for Lead and Lead Compounds
A. What are Persistence and Environmental Fate and What Data are
Available for Lead and Lead Compounds?
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 environmental media for which persistence is
measured or estimated include air, water, soil, and sediment; however,
water is the medium for which persistence values are most frequently
available. It is important to distinguish between persistence in a
single medium (air, water, soil, or sediment) and overall environmental
persistence. Persistence in an individual medium is controlled by
transport of the chemical to other media, as well as transformation to
other chemical species. Persistence in the environment as a whole is a
distinct concept. It is based on the observations that the environment
behaves as a set of interconnected media, and that a chemical substance
released to the environment will become distributed in these media in
accordance with the chemical's intrinsic (physical/chemical) properties
and reactivity. For overall persistence, only irreversible
transformation contributes to net loss of a chemical substance.
Although metals and metal compounds, including lead and lead
compounds, may be converted from the metal to a metal compound or from
one metal compound to another in the environment, the metal cannot be
destroyed. Thus, metals are obviously persistent in the environment in
some form. The form of the metal that exists in the environment depends
on its environmental fate. Environmental fate refers to the ultimate
result of physical, chemical, and biological processes acting upon a
metal or metal compound once released into the environment. The
environmental fate determines whether the metal or the metal from a
metal compound will be available for exposure to organisms once
released into the environment. The environmental fate of a metal or
metal compound varies depending on the environmental conditions and the
physical/chemical properties of the metal in question.
The information summarized below for the environmental fate of lead
in each environmental medium represents the key elements influencing
the transport, transformation, and bioavailability of lead in air,
soil, water and sediments. Commenters should consult the support
documents and review the studies contained and referenced therein for
further information. The information summarized below as well as a more
extensive review of the existing data on the environmental fate of lead
is contained in The Environmental Fate of Lead and Lead Compounds (Ref.
2) and in the references contained therein.
Most lead released to air eventually settles back to ground level
by dry deposition or washout by rain. Thus, airborne lead is either
returned to soil surfaces by deposition or to surface water by
deposition or surface runoff. However, while airborne, some lead
compounds (e.g., lead halides) can
[[Page 42228]]
undergo reactions to produce lead sulfates and carbonates.
After deposition in the soil environment, lead may bind strongly by
mechanisms such as the formation of insoluble complexes with organic
material, clay minerals, phosphate, and iron-manganese oxides common in
many soils. These mechanisms can lower the levels of soluble lead in
soils. However, some of the lead in the soil environment (0.2 to 1%)
may be water soluble. The extent of sorption appears to increase with
increasing pH. Under acidic conditions, levels of lead in soil water
can increase significantly. The solubility of lead increases linearly
in the pH range of 6 to 3. At a pH of 5 to 9, heavy metals such as lead
may bind to the surface of clay minerals. Cation exchange capacity
(CEC, related to soil clay content) and pH also influence the capacity
of soil to immobilize lead. Generally, as the CEC and pH increase, the
capacity of a soil to sorb lead increases. Conversely, soils with lower
CEC and pH tend to have a lower capacity to sorb lead. Using organic
chelation as a model, the total capacity of soil to immobilize lead can
be predicted by the linear relationship developed by Zimdahl and
Skogerboe (Ref. 3). Using this equation to predict saturation capacity
from CEC and pH, it can be shown that a pH drop from 5.5 to 4.0 would
reduce estimated soil absorption capacity 1.5 times, thereby increasing
the concentration of available lead in soil water.
A number of field studies demonstrate the effect of environmental
conditions on the mobility of lead in soils. In all of these studies,
variables including pH, soil organic matter content and the chemical
species of lead present, had a significant influence on soil lead
mobility. Data indicate that when the pH and soil organic matter
content are low and conditions favor the formation of soluble forms of
lead, the mobility of lead increases. Therefore, decreasing pH can lead
to increasing concentrations of lead in soil water. Other studies
demonstrate that when pH and soil organic matter are high, lead
mobility in soils is decreased. Limited data indicate that organolead
compounds may be converted into water-soluble lead compounds in some
soil. Degradation products of tetramethyl and tetraethyl lead, the
trialkyl lead oxides, are expected to be significantly more mobile in
soils than the parent tetraalkyl lead compounds would be.
The levels of soluble lead in surface waters depend on the pH of
the water and the dissolved salt content. Equilibrium calculations show
that at a pH greater than 5.4, the total solubility of lead is
approximately 30 micrograms per liter (g/L) in hard water and
approximately 500 g/L in soft water. In soft water, sulfate
ions limit the lead concentration in solution through the formation of
lead sulfate. The lead carbonates limit lead in solution at a pH
greater than 5.4 (Ref. 4). Concentrations as high as 330 g/L
could be stable in water at a pH near 6.5 and an alkalinity of about 25
milligrams (mg) bicarbonate ion per liter. Water having these
properties is common, for example, in runoff areas of New York State
and New England. In other waters, where alkalinity and pH are higher,
the relative concentrations of soluble lead may be lower.
Lead also forms complexes with organic matter in water. The organic
matter includes humic and fulvic acids that are the primary complexing
agents in soils and widely distributed in surface waters. The presence
of fulvic acid in water has been shown to increase the rate of solution
of lead sulfide 10 to 60 times (Refs. 5 and 6). At pH levels near
neutral (i.e., about 7.0), soluble lead-fulvic acid complexes are
present in solution. As pH levels increase, the complexes are partially
decomposed, and lead hydroxide and carbonate are precipitated, and may
either remain suspended or fall to the sediment. Other studies have
shown that humic acid in freshwater and marine sediments, and in the
aqueous phases, are capable of complexing various amounts of metals. In
some circumstances, this process could potentially reduce the levels of
soluble lead present.
At neutral pH, lead generally moves from the dissolved to the
particulate form with ultimate deposition in sediments. There is
evidence that in anaerobic sediments, lead can undergo biological or
chemical methylation. This process could result in the remobilization
and reintroduction of transformed lead into the water column where it
could be available for uptake by biota, and volatilization to the
atmosphere. However, tetramethyl lead may be degraded in aerobic water
before reaching the atmosphere.
In conclusion, EPA believes that processes commonly observed in the
environment can result in the release of bioavailable (ionic) lead
where it can be bioaccumulated by organisms. These processes may occur
in soil and aquatic environments with low pH and low levels of clay and
organic matter. Under these conditions, the solubility of lead is
enhanced and if there are no sorbing surfaces and colloids, lead ion
can remain in solution for a sufficient period to be taken up by biota.
Lead sorption to soil organic matter has been shown to be pH dependent.
Decreasing pH can lead to increasing concentrations of lead in soil
water; while increasing pH can lead to decreasing concentrations of
lead in soil water.
The Agency's analysis of the environmental fate of lead and lead
compounds, therefore, shows that under many environmental conditions
lead is available to express its toxicity and to bioaccumulate. The
bioavailability of metals such as lead has been raised as an issue at
recent public meetings on EPA's January 5, 1999 proposed rule on PBT
chemicals (64 FR 688). It has been suggested that metals will not be
bioavailable from certain metal compounds that may be released into the
environment and that therefore they should not be considered PBT
chemicals. The issue of the bioavailability of metals from metal
compounds is broader than just its implications for whether a chemical
is a PBT. The issue of bioavailability has been addressed for EPCRA
section 313 chemical assessments through EPA's policy and guidance
concerning petitions to delist individual members of the metal compound
categories listed under EPCRA section 313 (May 23, 1991, 56 FR 23703).
This policy states that if the metal in a metal compound cannot become
available as a result of biotic or abiotic processes then the metal
will not be available to express its toxicity. If the intact metal
compound is not toxic and the metal is not available from the metal
compound then such a chemical is a potential candidate for delisting.
EPA developed this petition process specifically to address such
circumstances.
EPA requests comment on its discussion of the scientific
information concerning the fate, transport, and the availability of
lead in the environment, and on how this information should be
considered in classifying lead as a PBT chemical.
B. What is Bioaccumulation and What Aquatic Bioaccumulation Data are
Available for Lead and Lead Compounds?
Bioaccumulation is a general term that is used to describe the
process by which organisms may accumulate chemical substances in their
bodies. The discussions and data on bioaccumulation in this unit (i.e.,
Unit V.B.) deal strictly with aquatic organisms. This is not to imply
that bioaccumulation cannot occur in non-aqueous environments and in
fact Unit V.C. of this preamble discusses the bioaccumulation of lead
in humans,
[[Page 42229]]
including bioaccumulation from non-aqueous media. The term
bioaccumulation refers to uptake of chemicals by organisms both
directly from water and through their diet (Ref. 7). EPA has defined
bioaccumulation as the net accumulation of a substance by an organism
as a result of uptake from all environmental sources (60 FR 15366). The
nondietary accumulation of chemicals in aquatic organisms is referred
to as bioconcentration, and may be described as the process through
which a chemical is distributed between the organism and environment
based on the chemical's properties, environmental conditions, and
biological factors such as an organism's ability to metabolize the
chemical (Ref. 8). EPA has defined bioconcentration as the net
accumulation of a substance by an aquatic organism as a result of
uptake directly from the ambient water through gill membranes or other
external body surfaces (60 FR 15366). A chemical's potential to
bioaccumulate can be quantified by measuring or predicting the
chemical's bioaccumulation factor (BAF). EPA has defined the BAF as the
ratio of a substance's concentration in tissue of an aquatic organism
to its concentration in the ambient water, in situations where both the
organism and its food are exposed and the ratio does not change
substantially over time (60 FR 15366). A chemical's potential to
bioaccumulate can also be quantified by measuring or predicting the
chemical's bioconcentration factor (BCF). EPA has defined the BCF as
the ratio of a substance's concentration in tissue of an aquatic
organism to its concentration in the ambient water, in situations where
the organism is exposed through water only and the ratio does not
change substantially over time (60 FR 15366).
A review of the ecotoxicological literature indicates that
bioconcentration values of lead and lead compounds (lead salts) in
aquatic plants and animals are often above a bioconcentration/
bioaccumulation factor of 1,000. Lead is bioaccumulated by aquatic
organisms such as plants, bacteria, invertebrates, and fish. The
principal form that is believed to be accumulated is divalent lead
(i.e., lead in its plus 2 oxidation state (Pb+2)). It has
been shown that fish held in water at a pH of 6.0 accumulate three
times as much lead as fish held in water at a pH of 7.5 (Ref. 9), thus
as pH decreases the availability of divalent lead increases. Older
organisms usually have the highest body burdens, and lead accumulates
in bony tissues to the greatest extent.
Table 1 below summarizes some of the data reviewed concerning the
extent (magnitude) of lead bioaccumulation found to occur in many
aquatic plants and animals and the lead bioconcentration factors (BCF)
determined or measured from laboratory studies conducted for certain
durations using BCF test methods. Only some of the laboratory
calculated values or monitored field values near or above a
bioaccumulation factor of 1,000 are included in Table 1; additional
data can be found in the bioaccumulation support document (Ref. 10).
Concentrations of lead monitored in various organisms listed in Table 1
were determined by comparing concentrations in the environment (water)
with concentrations measured in the organisms.
[[Page 42230]]
Table 1.--Bioaccumulation/Bioconcentration Data for Lead and Lead Compounds in Aquatic Organisms.
----------------------------------------------------------------------------------------------------------------
Chemical Tested/ Field
Test Species Monitored BCF Value1 Concentration Reference
(concentration) Factor2
----------------------------------------------------------------------------------------------------------------
Freshwater Species
Snail (Lymnaea palustris) Lead nitrate (12 1,700; 3,100 (soft NA Ref. 11
g/L) tissue); 2,500
(whole animal)
----------------------------------------------------------------------------------------------------------------
Phytoplankton, 13 species Lead (0.4-2.5 NA 10,000x or Ref. 12
(Melosira italica and g/dm3 greater(3)
Asterionella formosa were
dominants)
----------------------------------------------------------------------------------------------------------------
Green alga (Selenastrum Lead nitrate (5 10,000(3) NA Ref. 13
capricornutum) g/L)
----------------------------------------------------------------------------------------------------------------
Green alga (Selenastrum Lead nitrate (50 2,900(3) NA Ref. 13
capricornutum) g/L)
----------------------------------------------------------------------------------------------------------------
Green alga (Cladophora sp.) Lead NA 390x(3); 690x(3); Ref. 14
and 1,695x(3)
----------------------------------------------------------------------------------------------------------------
Pondweed (Pontamogeton sp.) Lead NA 525x(3) and Ref. 15
1,695x(3)
----------------------------------------------------------------------------------------------------------------
Rainbow trout (Salmo gairdneri) Lead (3.5 g/L; 24 g/L) (intestinal
lipids)
----------------------------------------------------------------------------------------------------------------
Marine Species
Blue mussel (Mytius edulis) Lead nitrate; Lead 2,570 and 2,800 NA Refs. 17 and 18
(10 g/ (soft parts);
L); Lead (500 2,427(3) (kidney)
g/L) and 306(3) (soft
parts); 4,985(3)
(soft parts)
----------------------------------------------------------------------------------------------------------------
Eastern oyster (Crassostrea Lead (1, 3.3 1,320(3) and NA Ref. 19
virginica) g/L) 691(3) (soft
parts)
----------------------------------------------------------------------------------------------------------------
Brown alga (Fucus vesiculosus) Lead (1-7.5 (3) Ref. 20
m>g/L)
----------------------------------------------------------------------------------------------------------------
Algae (Ulva sp.) Lead (1-7.5 (3) Ref. 20
m>g/L)
----------------------------------------------------------------------------------------------------------------
Algae (Enteromorpha linza) Lead (1-7.5 (3) Ref. 20
m>g/L)
----------------------------------------------------------------------------------------------------------------
Algae (Blidingia minima) Lead (1-7.5 (3) Ref. 20
m>g/L)
----------------------------------------------------------------------------------------------------------------
American Lobster (Homarus Lead (50 g/L) gland)
----------------------------------------------------------------------------------------------------------------
1BCF values are calculated from laboratory studies.
2Field concentrations are estimated from water:organism sample comparisons.
3Value was converted from a dry weight value to a wet weight value using appropriate conversion factors.
Additional information concerning lead's bioaccumulation potential
is summarized in the bioaccumulation support document for this proposed
rule (Ref. 10). In general, bioconcentration values for four freshwater
invertebrate species ranged from 499 to 1,700 (Ref 22). BCFs for two
species of freshwater fish were much lower, 42 and 45. However, certain
fish tissues have much higher BCF values, e.g., the BCF value for the
intestinal lipids in rainbow trout were as high as 17,300. Freshwater
phytoplankton and both marine and freshwater algae accumulate or
concentrate lead to very high levels (e.g., greater than 10,000x). BCF
values for marine bivalve organisms were as high as 4,985 for blue
mussels. Eastern oysters also have BCF values greater than 1,000. These
data indicate that many of the BCF values and measured environmental
concentration factors for lead are above 1,000 with several species
having BCF or observed concentration factors above 5,000. The
references cited for blue mussels include a range of values, the upper
end of which is very close to 5,000 (i.e., 4,985). There are also a few
fish tissues that have BCFs greater than 10,000, though most of the
available fish data are below 5,000.
EPA requests comment on its discussion of the scientific
information concerning the bioaccumulation of lead in aquatic
organisms, and on how this information should be evaluated in assessing
the bioaccumulative potential of lead and lead compounds.
C. What Data are Available on the Human Bioaccumulation of Lead and
Lead Compounds?
There is a great deal of information available on the
bioaccumulation of lead in humans and the effects that such
[[Page 42231]]
accumulation can have. Much of this information is summarized and cited
in the following documents, The Agency for Toxic Substances and Disease
Registry Toxicological Profile on Lead (Ref. 23), EPA's Risk Analysis
to Support Standards for Lead in Paint, Dust, and Soil (Ref. 24), and
EPA's Air Quality Criteria for Lead (Ref. 25). EPA's Office of
International Affairs has also established an Internet site that
provides information on lead including lists of various EPA documents
on lead that are available as well as links to other EPA programs and
agencies that have information on lead and its hazards (Ref. 26). This
unit provides a summary of some of the information from these sources
that relates to the ability of lead to accumulate in humans.
The bioaccumulation and persistence of lead in humans is well
documented. Although lead has no known biological function in humans,
it is readily absorbed through the gut and can be absorbed by
inhalation and, to some extent by dermal contact. Absorption of lead
can occur as a result of exposure to air-borne forms of lead, as well
as ingestion or contact with contaminated soil and dust. Children and
developing fetuses are known to absorb lead more readily than adults
and to excrete it at a lower total rate. These findings are especially
significant since young children are most susceptible to the adverse
effects associated with lead exposure. Lead absorption varies from very
low levels (e.g., 5%) up to essentially 100%. Lead absorption appears
to be linked to particle size, the chemical composition, and other
factors (Refs. 27 and 28). Long-lasting impacts on intelligence, motor
control, hearing, and neurobehavioral development of children have been
documented at levels of lead that are not associated with clinical
intoxication and were once thought to be safe. An analysis of human
blood-lead level data collected from most recent National Health and
Nutrition Examination Surveys (see Ref. 24), showed that approximately
4.4% of the nation's children aged 1-5 years have blood-lead
concentrations at or above 10 micrograms per deciliter (g/dL),
which is the current action level established by the Centers for
Disease Control. While this is a significant improvement over the 88%
of children who had blood lead levels above this threshold in 1976,
before the phase-out of lead in gasoline, it is still cause for concern
because it leaves nearly 900,000 children aged 1-5 with unacceptably
high blood-lead levels.
Once lead is absorbed in the body, it is primarily distributed to
the blood, soft tissues (kidney, bone marrow, liver, and brain) and to
the mineralizing tissue (bones and teeth). In one study it was shown
that in adults, following a single dose of lead, one-half of the lead
absorbed from the original exposure remained in the blood for
approximately 25 days after exposure, in soft tissues for about 40
days, and in bone for more than 25 years (Ref. 29). Once in the bone,
lead can re-enter the blood and soft tissues. Under certain
circumstances, such as pregnancy and lactation, lead can more readily
re-enter blood and soft tissues. Thus, accumulation of lead in bone can
serve to maintain elevated blood lead levels years after exposure. The
total amount of lead in long-term bone retention can approach 200 mg
for adult males 60-70 years old (and even higher with occupational
exposure). For adults, up to 94% of the total amount of lead in the
body is contained in the bones and teeth but for children only about
73% is stored in their bones. While the increase in bone lead level
across childhood is modest, the total accumulation rate is actually 80-
fold when the 40-fold increase in skeletal mass that children undergo
is taken into account. While lead absorption rates are influenced by
several parameters, including route of exposure, chemical speciation,
the physical/chemical characteristics of the lead and the exposure
medium, as well as the age and physiological states of the exposed
individual, there is substantial documentation that a significant
amount of lead can be absorbed and accumulated in humans.
EPA requests comments on its discussion of the scientific
information concerning the bioaccumulation of lead in humans and on how
this information should be considered in classifying lead and lead
compounds as ``highly bioaccumulative.''
D. What are EPA's Conclusions from the Review of the Available Data on
Lead and Lead Compounds?
EPA's review of the available information on lead and lead
compounds has led EPA to conclude that lead and lead compounds are
highly persistent and highly bioaccumulative. The persistence of lead
in the environment is not in question since, as a metal, lead cannot be
destroyed in the environment. With respect to whether lead or lead
compounds released to the environment will result in lead that is
bioavailable, the data indicate that under many environmental
conditions lead does become available. The conclusion that lead is
bioavailable in the environment is confirmed by the data on the
bioaccumulation of lead in aquatic organisms and in humans as a result
of environmental exposures. As for lead's bioaccumulation potential,
lead has been shown to bioaccumulate in laboratory studies and has been
found to bioaccumulate in organisms observed in the environment. These
data indicate that many of the BCF values and measured environmental
concentration factors for lead are above 1,000 with several species
having BCF or observed concentration factors above 5,000. The
references cited for blue mussels include a range of values, the upper
end of which is very close to 5,000 (i.e., 4,985). There are also a few
fish tissues that have BCFs greater than 10,000, though most of the
available fish data are below 5,000.
A high concern for the bioaccumulation potential for chemicals with
BCF values above 1,000 is consistent with the discussion of BCF values
in the recent proposed rule on PBT chemicals (January 5, 1999, 64 FR
688). In addition, there is considerable information on the
accumulation of lead in humans, including children who are the most
susceptible to the toxic effects of lead. The data on lead's
persistence and availability in the environment, the observed high
bioaccumulation values in aquatic organisms, and lead's ability to
accumulate in humans, are the basis for EPA's conclusion that lead and
lead compounds are highly persistent and highly bioaccumulative.
E. Are There Particular Issues on Which EPA is Interested in Receiving
Comment?
The Agency recognizes that there are several complex technical
issues surrounding the availability and bioaccumulation of lead and
lead compounds. For example, during the inter-agency review process it
was suggested that the bioavailability of lead in the environment could
be constrained by many abiotic factors such that lead is not available
in certain environments. These abiotic factors include: Soils have a
high capacity to immobilize lead and therefore limit its availability;
high pH levels may reduce lead bioavailability; organic matter can
decrease lead bioavailability; inorganic constituents can reduce lead
availability in aqueous environments; and, increasing water hardness
can also reduce lead availability. The Agency specifically requests
comments on these issues.
[[Page 42232]]
VI. What Changes are EPA Proposing to Make to the Reporting
Requirements for Lead and Lead Compounds?
A. What Changes are EPA Proposing for the Reporting Thresholds for Lead
and Lead Compounds?
EPA is proposing to lower the reporting thresholds for lead and
lead compounds.
1. What was considered in the selection of lower reporting
thresholds? In selecting potential lower reporting thresholds for lead
and lead compounds, EPA considered not only their persistence and
bioaccumulation but also the potential burden that might be imposed on
the regulated community by lower reporting thresholds. Each of these
important considerations is discussed below.
a. How was persistence and bioaccumulation considered in threshold
selection? Because lead and lead compounds persist and bioaccumulate in
the environment, they have the potential to pose human health and
environmental risks over a longer period of time. Thus, even small
amounts that enter the environment can lead to elevated concentrations
in the environment and in organisms which can result in adverse effects
on human health and the environment. The nature of lead and lead
compounds 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 25,000 and 10,000
pounds.
For determining how low reporting thresholds should be set for PBT
chemicals, including lead and lead compounds, EPA has adopted a two-
tiered approach. Under this approach, EPA identifies PBT chemicals that
should have a lower reporting threshold as those chemicals with half-
lives of at least 2 months and BAF/BCF values of at least 1,000. This
approach also recognizes that toxic chemicals that have very high
persistence and bioaccumulation potentials (e.g., chemicals with half-
lives of 6 months or more and BAF/BCF values of 5,000 or more), like
those that have been widely recognized as PBT chemicals, are of
greatest concern and should have an even lower reporting threshold. EPA
believes that for toxic chemicals that are highly persistent and
bioaccumulative, any release of the toxic chemical can result in
elevated concentrations in the environment and organisms because of
their very high persistence and bioaccumulation potentials. As a
result, consideration of persistence and bioaccumulation alone would
lead EPA to set a reporting threshold for the subset of highly
persistent bioaccumulative chemicals that approaches zero in order to
provide the most relevant data to communities. However, EPA believes
that it is appropriate to set a low threshold for toxic chemicals that
persist and bioaccumulate and to set a lower threshold for toxic
chemicals that are highly persistent and bioaccumulative.
Because lead cannot be destroyed in the environment and because
lead is available in the environment, EPA believes that lead and lead
compounds are highly persistent. The bioaccumulation data for lead and
lead compounds includes many BCF or concentration values well above
5,000, and there is additional data that show that lead bioaccumulates
in humans. Given this data, EPA considers lead and lead compounds to be
highly bioaccumulative. Thus, EPA believes that based solely on the
degree of persistence and bioaccumulation, it would be appropriate to
set section 313 manufacture, process, and otherwise use thresholds of 1
pound for lead and lead compounds. This approach is consistent with the
general approach that EPA has taken for setting reporting thresholds
for PBT chemicals that are highly persistent and highly bioaccumulative
as discussed in the recent proposed rule on PBT chemicals (64 FR 688).
As EPA stated in the January 5, 1999 proposed rule, EPA believes
that communities have a greater right-to-know about chemicals which can
reasonably be anticipated to be present in the community at higher
levels (64 FR 688). This is particularly the case for lead which, as a
metal, cannot be destroyed in the environment. Releases of lead and
lead compounds from facilities subject to section 313 reporting
requirements, therefore, can increase the potential exposure to lead
within communities relative to a chemical that can be destroyed.
The increased exposure potential also applies to chemicals with
different BCFs. The identical amount of two different chemicals,
chemical A with a BCF of 1,000 to fish and chemical B with a fish BCF
of 5,000, will result in different exposures to fish that consume other
organisms lower in the food chain that have been exposed to these
chemicals. For example, organisms that consume the fish exposed to
chemical B will usually be exposed to greater quantities of the
chemical than organisms that consume the fish exposed to chemical A,
assuming identical feeding rates and other conditions. Due to concerns
for its higher accumulation potential, a lower threshold would be set
for Chemical B than for Chemical A.
b. Was burden considered in threshold selection and what is the
proposed threshold for lead and lead compounds? As discussed above, in
determining the appropriate reporting thresholds to propose for lead
and lead compounds, EPA started with the premise that very low
reporting thresholds may be appropriate for lead and lead compounds
based solely on their persistence and bioaccumulation potential. EPA
then considered the burden that would be imposed by four sets of
reporting thresholds. The thresholds considered were: (1) The 1 pound
threshold discussed above; (2) 10 pounds; (3) 100 pounds; and (4) 1,000
pounds. For each threshold, EPA estimated the number of additional
reports that facilities might be required to file and the costs
associated with the filing of those additional reports (see Tables 3
and 4 in Unit VII.E.4. of this preamble). Based on the potential
burdens, EPA believes it is appropriate to lower the reporting
thresholds to a level that would capture significantly more information
about lead and lead compounds than current thresholds but that would
not be unduly burdensome on industry. Therefore, EPA is proposing to
lower the manufacture, process, and otherwise use thresholds to 10
pounds for lead and lead compounds. This consideration of burden is
consistent with the approach EPA used in the January 5, 1999 proposed
rule (64 FR 688), in which the preferred thresholds were set an order
of magnitude higher than EPA would have proposed based solely on the
degree of persistence and bioaccumulation.
EPA requests comment on its consideration of industry burden in
establishing lower reporting thresholds for lead and lead compounds,
including comments on the extent to which burden should be considered
in EPA's decision. EPA requests comment on whether the Agency should
lower the reporting threshold to 1 pound for lead and lead compounds
rather than the 10 pound reporting threshold proposed in this document.
EPA requests comment on whether there are any policy reasons for
selecting the 1 pound reporting threshold rather than the 10 pound
reporting threshold. Such policy reasons could include the fact that
the 10 pound reporting threshold for lead and lead compounds, which are
highly persistent and bioaccumulative, may not capture all releases
that are of concern to local communities. Alternatively, EPA also seeks
comment on reasons for selecting reporting thresholds of 100 pounds and
1,000 pounds.
[[Page 42233]]
c. What is the relationship of the EPCRA section 313 reporting
thresholds to other statutory thresholds? For purposes of establishing
EPCRA section 313 reporting thresholds, Congress has expressed a clear
intent to obtain reporting on a substantial majority of total releases
of the chemical at all facilities subject to the requirements of the
section, and to assure that this information is reported to EPA and the
states and provided to the user community. In this action, by proposing
to lower the reporting thresholds for lead and lead compounds, EPA is
working to assure that communities are provided with data on these
toxic chemicals, which are frequently manufactured, processed, or
otherwise used in quantities well below the existing reporting
thresholds of 25,000 pounds and 10,000 pounds and consequently are not
reported to EPA and the states. In choosing the proposed EPCRA section
313 thresholds for lead and lead compounds, EPA took into consideration
a number of factors including small business impacts, overall reporting
burden, and report generation in addition to utility of the
information. It has been EPA's goal, under the EPCRA section 313
program, to maintain a balance between community right-to-know and
overall reporting burden for the affected industry.
EPCRA section 313 provides one of several authorities through which
EPA collects data. Each of these authorities has different criteria and
different purposes. Many are aimed at supporting environmental
decisionmaking and standard setting with community involvement in these
processes. The thresholds established under EPCRA section 313 are
designed to meet the statutory requirements of the Act as well as the
overarching goal of informing the public about chemical releases and
other waste management practices in their communities. Other EPA
statutes such as the Clean Water Act (CWA), the Clean Air Act (CAA),
and Resource Conservation and Recovery Act (RCRA) also have information
collection provisions, whose criteria, coverage, scope and purpose may
be different from that of EPCRA section 313. The thresholds proposed
here, for purposes of EPCRA section 313, should not be construed to
limit or expand the data collection goals or authorities of other EPA
programs.
B. What is the de minimis Exemption and What Changes is EPA Proposing
to Make to the Use of the de minimis Exemption for Lead and Lead
Compounds?
As part of the final rule implementing the reporting provisions of
EPCRA section 313 (53 FR 4500, February 16, 1988), EPA adopted a
limited de minimis exemption for listed toxic chemicals in mixtures.
The de minimis exemption allows facilities to disregard certain
concentrations of chemicals in mixtures or other trade name products
they import, process, or otherwise use in making threshold calculations
and release and other waste management determinations for section 313
reporting. This exemption does not apply to the manufacture of a toxic
chemical unless the toxic chemical is manufactured as an impurity or is
imported.
EPA adopted this exemption in response to comments requesting some
type of concentration limitation for listed toxic chemicals in mixtures
or other trade name products as a burden reducing measure. Commenters
contended that it would be extremely burdensome for suppliers,
processors, and other users of mixtures or trade name products to have
to account for quantities below a de minimis level. Most of these
commenters requested that EPA adopt a de minimis concentration
limitation consistent with the Occupational Safety and Health
Administration (OSHA) Hazard Communication Standard (HCS) requirement.
The HCS provides that a supplier does not have to list a ``hazardous
chemical'' component in a mixture if that chemical comprises less than
1.0% of the mixture or 0.1% where the chemical is a carcinogen as
defined in 29 CFR 1910.1200(d)(4). OSHA chose the 1% and 0.1% limits
because the agency believed that they generally appeared to be
protective of workers and were considered reasonable by a number of
commenters (48 FR 53280, November 25, 1983).
EPA adopted the de minimis exemption primarily as a means of
reducing burden associated with the new (at the time) EPCRA section 313
reporting requirements. The Agency chose the HCS levels because: (1)
They were consistent with the existing OSHA requirements for developing
Material Safety Data Sheet (MSDS) information and with other
requirements under EPCRA sections 311 and 312; (2) suppliers of
products were familiar with these levels; (3) for the first 2 years of
reporting, users of these mixtures were only likely to be able to rely
on the product MSDS for information about the content and percentage
composition of covered toxic chemicals in these products; and (4) EPA
did not expect that the processing and otherwise use of toxic chemicals
at less than the de minimis concentration in mixtures would, in most
instances, contribute significantly to the threshold determinations or
releases of listed toxic chemicals from any given facility.
When determining whether the de minimis exemption applies to a
listed toxic chemical, the facility must consider only the
concentration of the toxic chemical in mixtures and trade name products
in process streams in which the toxic chemical is involved in a
reportable activity. If the toxic chemical in a process stream is
manufactured as an impurity, imported, processed, or otherwise used and
is below the appropriate de minimis concentration level, then the
quantity of the toxic chemical in that process stream does not have to
be applied to threshold determinations nor included in release or other
waste management determinations. If a toxic chemical in a process
stream is below the appropriate de minimis level, all releases and
other waste management activities associated with the toxic chemical in
that stream are exempt from EPCRA section 313 reporting. It is possible
to meet an activity (e.g., processing) threshold for a toxic chemical
on a facility-wide basis, but not be required to calculate releases or
other waste management quantities associated with a particular process
because that process involves only mixtures or trade name products
containing the toxic chemical below the de minimis level.
As stated above, the intent of the de minimis exemption was
primarily burden reduction. The de minimis exemption was not intended
to be a general small quantity exemption, but rather an exemption based
on the limited information likely to be readily available to facilities
newly affected by EPCRA section 313. EPA did not expect in 1988 that
``the processing and [otherwise] use of mixtures containing less than
the de minimis concentration would, in most instances, contribute
significantly to the threshold determinations or releases of listed
toxic chemicals from any given facility'' (53 FR 4509). However, given
10 years of experience with the program, EPA believes that there are
many instances where a PBT chemical, including lead or a lead compound,
may exist in a mixture at a concentration below the 1% (or 0.1% for
OSHA carcinogens) de minimis level, but where the manufacture, process,
or otherwise use
[[Page 42234]]
of the PBT chemical in that mixture would otherwise contribute
significantly to, or exceed, the lower reporting threshold proposed in
this document.
For example, a raw material is processed that contains less than
the de minimis level of lead. The quantity of raw material processed
results in significantly more than the threshold quantity of lead being
processed. Also, during the processing of lead, its concentration in
the process stream remains below the de minimis level. However, the
concentration of lead in the wastestream that results from that
processing activity is above the de minimis concentration level for
lead and the wastestream containing lead is released to the land. In
this example, because the concentration of lead in the process stream
is below the de minimis concentration, the de minimis exemption can be
taken. As a result, (1) The quantities processed do not have to be
applied to the processing threshold for lead at the facility, and (2)
quantities of lead that are released or otherwise managed as waste as a
result of this specific processing activity are exempt from release and
other waste management determinations. The exemption applies even
though lead is concentrated above the de minimis level in the
wastestream. This information would not be included in that facility's
Form R.
In addition, EPA believes that the information available to the
typical EPCRA section 313 reporter is generally greater than it was 10
years ago. Since 1987, the Air Pollution Emission Factors (AP-42)
guidance document has been repeatedly updated and expanded. For
example, several new sections were added in 1996, including a section
specific to electroplating. In the early 1990s, the Factor Information
Retrieval data base (FIRE) was developed. EPA has developed several
additional guidance documents and software programs, including Air
CHIEF CD-ROM, to aid facilities in estimating releases. Facilities also
have access to guidance from trade associations.
EPA believes that there may be significant releases of lead and
lead compounds in mixtures when these chemicals exist below the de
minimis limit and that even minimal releases of persistent
bioaccumulative chemicals may result in elevated concentrations in the
environment or in an organism that reasonably can be anticipated to
result in significant adverse effects. Therefore, EPA believes that
allowing facilities to continue to take the de minimis exemption for
lead and lead compounds, would deprive communities of important
information. While these chemicals may exist in mixtures below the de
minimis levels they will concentrate in the environment and in
organisms. Further, lead and lead compounds have been shown to cause
adverse effects at concentrations far less than the de minimis levels.
For example, EPA has stated that it appears that some of the health
effects of lead, particularly changes in the levels of certain blood
enzymes and in aspects of children's neurobehavioral development, may
occur at blood lead levels so low as to be essentially without a
threshold (Ref. 30). Thus, because lead and lead compounds can cause
adverse effects at concentrations well below de minimis levels, EPA
believes that the de minimis principle may no longer apply. See
Environmental Defense Fund v. EPA, 82 F.3d 451, 466 (D.C. Cir. 1996);
Alabama Power Co. v. Costle, 636 F. 2d 323, 360 (D.C. Cir 1979). In
addition, for the reasons articulated above, EPA is concerned about
whether other similar regulatory exemptions continue to be supportable
for lead and lead compounds. See e.g., 40 CFR 372.38(c).
Further, EPA believes that lowering the reporting thresholds for
lead and lead compounds, while leaving the de minimis exemption in
place may result in very limited reporting and undermine the very
purpose of this action. Without a concomitant change in the de minimis
exemption, lowering the reporting thresholds would not increase
reporting for lead and lead compounds from some industry sectors due to
the low concentrations in mixtures or other trade name products that
are processed or otherwise used. A facility may exceed the reporting
threshold based on some processes that involve lead or lead compounds
in a mixture where the lead or lead compound is above the de minimis
level or on activities for which the de minimis exemption is not
applicable. However, EPA expects there will be significant numbers of
activities that occur for which the de minimis exemption could
otherwise be taken. All releases and other waste management activities
associated with these activities would therefore be exempt.
Given that use of the de minimis exemption could significantly
limit the amount of reporting on lead and lead compounds under the
lower reporting threshold being proposed in today's action, EPA is
proposing to eliminate the de minimis exemption for lead and lead
compounds.
Therefore, EPA is proposing to modify 40 CFR 372.38(a) to add the
following sentence to the end thereof:
This exemption does not apply to toxic chemicals listed in
Sec. 372.28 (i.e., the chemicals for which thresholds have been
lowered), except for purposes of Sec. 372.45(d)(1).
As indicated in the proposed regulatory text, EPA is proposing to list
lead and lead compounds in Sec. 372.28.
EPA is not proposing to extend this modification to 40 CFR
372.45(d)(1) because the Agency believes that there is sufficient
information available on lead and lead compounds. Requirement of
additional information in this case would result in redundancies.
In past expansion actions, EPA has tried to retain burden reducing
options wherever feasible. However, as the TRI program evolves to meet
emerging community needs, EPA will need to reassess these exemptions
and modify them as appropriate. EPA notes that the increase in burden
resulting from eliminating the de minimis exemption for lead and lead
compounds would be limited to facilities that import, process,
otherwise use or manufacture as impurities lead and lead compounds.
Many facilities may engage in activities that result in the
manufacturing of lead and lead compounds as byproducts. In the preamble
to the 1988 final rule implementing the reporting provisions of EPCRA
section 313 (53 FR 4500), EPA explained, that the ``de minimis
limitation does not apply to the byproducts produced coincidentally as
a result of manufacturing, processing, use, waste treatment, or
disposal'' (see 53 FR 4501, column 1). EPA further explains on page
4504, column 3, its decision about the application of the de minimis
exemption to impurities and byproducts:
EPA has distinguished between toxic chemicals which are
impurities that remain with another chemical that is processed,
distributed, or used, from toxic chemicals that are byproducts
either sent to disposal or processed, distributed, or used in their
own right. EPA also considers that it would be reasonable to apply a
de minimis concentration limitation to toxic chemicals that are
impurities in another chemical or mixture. . . .Because the covered
toxic chemical as an impurity ends up in a product, most producers
of the product will frequently know whether the chemical is present
in concentrations that exceed the de minimis level, and, thus may be
listed on the Material Safety Data Sheet (MSDS) for that product
under the OSHA HCS.
This final rule does not adopt a de minimis concentration
limitation in connection with the production of a byproduct. EPA
believes that the facility should be able to quantify the annual
aggregate pounds of production of a byproduct which is not an
impurity because the substance is separated from the production
stream and used, sold, or
[[Page 42235]]
disposed of, unlike an impurity which remains in the product. (53 FR
4500).
Because many facilities may engage in activities that manufacture
lead or lead compounds as byproducts and since the de minimis exemption
does not apply to such activities, eliminating it would have no effect
on the reporting of lead and lead compounds from those facilities.
For lead and lead compounds in mixtures that are imported,
processed, or otherwise used, the increase in burden resulting from the
elimination of the de minimis exemption would be limited because EPCRA
does not require additional monitoring or sampling in order to comply
with the reporting requirements under EPCRA section 313. EPCRA section
313(g)(2) states:
In order to provide the information required under this section,
the owner or operator of a facility may use readily available data
(including monitoring data) collected pursuant to other provisions
of law, or, where such data are not readily available, reasonable
estimates of the amounts involved. Nothing in this section requires
the monitoring or measurement of the quantities, concentration, or
frequency of any toxic chemical released in the environment beyond
the monitoring and measurement required under other provisions of
law or regulation.
Information used should be based on production records, monitoring,
or analytical data, guidance documents provided by EPA and trade
associations, and reasonable judgement on the part of the facility's
management. No further monitoring or analysis of production, process,
or use is required.
EPA requests comment on its proposed modification of the de minimis
exemption for lead and lead compounds. EPA also requests comments on
whether the Agency should modify the exemptions at 40 CFR 372.38(c)
(e.g., the otherwise use exemptions, including the structural component
exemption, the routine janitorial or facility grounds maintenance
exemption; the personal use exemption, the motor vehicle maintenance
exemption, and the intake air and water exemption) such that they will
not apply to lead or lead compounds. The legal authority for these
exemptions is also the de minimis principle, and as noted above, EPA is
concerned that this doctrine may not be applicable to PBT chemicals,
such as lead and lead compounds.
C. What is the Alternative Threshold and Form A, and is EPA Proposing
Any Changes to the Use of the Alternate Threshold and Form A?
On November 30, 1994, EPA published a final rule (59 FR 61488) that
provides that facilities that have 500 pounds or less of production-
related waste (the sum of sections 8.1 through 8.7 of Form R) may apply
an alternate manufacture, process, and otherwise use reporting
threshold of 1 million pounds. Facilities that have less than 500
pounds of production-related waste of a listed toxic chemical and that
do not manufacture, process, or otherwise use more than 1 million
pounds of that listed toxic chemical may file a Form A certification
statement certifying that they do not exceed either of these quantities
for the toxic chemical. This certification statement includes facility
identification information and chemical identification information. EPA
adopted the alternate threshold and the Form A as a means of reducing
the burden associated with EPCRA section 313.
EPA believes that use of the existing alternate threshold and
reportable quantity for Form A would be inconsistent with the intent of
expanded reporting for PBT chemicals such as proposed for lead and lead
compounds in this proposed rule. While the Form A does provide some
general information on the quantities of the chemical that the facility
manages as waste, this information is insufficient for conducting
analyses on PBT chemicals, such as lead and lead compounds and would be
virtually useless for communities interested in assessing risk from
releases of lead and lead compounds. First, the threshold category for
amounts managed as waste does not include quantities released to the
environment as a result of remedial actions or catastrophic events not
associated with production processes (section 8.8 of Form R). Thus, the
waste threshold category will not include all releases. Given that even
small quantities of lead or lead compounds may result in elevated
concentrations in the environment or in an organism, that reasonably
can be anticipated to result in significant adverse effects, EPA
believes it would be inappropriate to allow an option that would
exclude information on some releases. Second, the 500 pound waste
threshold category could be interpreted by some users, as a worst-case,
to mean that greater than 500 pounds of the lead and lead compounds has
been released into the environment (i.e., 500 pounds of production-
related waste as release and some quantity of catastrophic release).
Other users may assume that the facility had no catastrophic releases
and all of the lead or lead compounds in waste was managed in a manner
other than as release, e.g., the lead and lead compounds in waste were
recycled. For those chemicals, such as lead and lead compounds, where
any release is a concern, an uncertainty level of 500 pounds will
result in data that are virtually unusable. As a result, EPA is
proposing to exclude lead and lead compounds from the alternate
threshold of 1 million pounds. Therefore, EPA proposes to modify 40 CFR
372.27 to add a new paragraph (e) to read as follows:
(e) The provisions of this section do not apply to any toxic
chemicals listed in Sec. 372.28. As indicated above, EPA is
proposing to list lead and lead compounds in Sec. 372.28.
EPA requests comment on this limitation to the use of the Form A
certification statement.
D. What is Range Reporting and What Changes is EPA Proposing to Make to
the Use of Range Reporting?
For releases and off-site transfers for further waste management of
less than 1,000 pounds of the toxic chemical, EPA allows facilities to
report the amount either as a whole number or by using range codes. The
reporting ranges are: 1-10 pounds; 11-499 pounds; and 500-999 pounds.
For larger releases and off-site transfers for further waste management
of the toxic chemical, the facility may report only the whole number.
While EPA provided range reporting primarily as a burden reducing
measure focused on small businesses, the Agency notes a number of
drawbacks. Use of ranges could misrepresent data accuracy because the
low or the high end range numbers may not really be that close to the
estimated value, even taking into account its inherent error (i.e.,
errors in measurements and developing estimates). The user of the data
must make a determination on whether to use the low end of the range,
the mid-point, or the upper end. For example, a release of 501 pounds
could be misinterpreted as 999 pounds if reported as a range of 500 to
999. This represents a 100% error. This uncertainty severely limits the
utility of release information where the majority of a facility's
releases are within the amounts eligible for range reporting. Given
that the large uncertainty that would be part of these data would
severely limit their utility, EPA believes that facilities should
report numerical values, not ranges, for lead and lead compounds. EPA,
therefore, proposes to modify 40 CFR 372.85(b)(16)(i) to read as
follows:
An estimate of the total releases in pounds per year (releases
of toxic chemicals of less than 1,000 pounds per year may be
indicated in ranges, except for toxic chemicals set forth in
Sec. 372.28) from the facility plus an indication of the basis of
estimate:
[[Page 42236]]
EPA also proposes to modify 40 CFR 372.85(b)(16)(ii)(B) to read as
follows:
An estimate of the amount of the chemical in waste transferred
in pounds per year (transfers of toxic chemicals of less than 1,000
pounds per year may be indicated in ranges, except for toxic
chemicals set forth in Sec. 372.28) to each off-site location, and
an indication of the basis for the estimate and an indication of the
type of treatment or disposal used.
EPA requests comment on its proposal to discontinue the use of
range reporting in Form Rs for lead and lead compounds.
E. What is the Half-Pound Rule and Whole Numbers and What Change is EPA
Proposing to Make to the Use of the Half-Pound Rule and Whole Numbers?
EPA requires that facilities report numerical quantities in
sections 5, 6, and 8 of Form R as whole numbers and does not require
more than two significant digits (except where the Agency allows range
reporting; see Unit VI.D. of this preamble). EPA currently allows
facilities to round releases of 0.5 pounds or less to zero (see Toxic
Chemical Release Inventory Reporting Forms and Instructions: Revised
1997 Version (EPA 745-K-98-001), p. 27). 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 lead and lead compounds as zero. EPA, therefore, is proposing that
all releases or other waste management quantities greater than a tenth
of a pound of lead or lead compounds be reported, provided that the
appropriate activity threshold has been exceeded. Releases and other
waste management activities would continue to be reported to two
significant digits. For quantities of 10 pounds or greater, only whole
numbers would be required to be reported. For quantities less than 10
pounds, fractional quantities, e.g., 6.2 pounds, rather than whole
numbers would be required. Remember, EPCRA only requires reporting to
be based on the best readily available information or reasonable
estimates.
EPA requests comment on the proposed requirement that all non-zero
releases of lead and lead compounds greater than one tenth of a pound
be reported. EPA also requests comment on using fractional quantities
for reports under 10 pounds.
F. What Limitation is EPA Proposing for the Reporting of Lead in
Certain Alloys?
Lead can be found in various types of alloys and is subject to
reporting under section 313 when contained in these alloys. In response
to several petitions that EPA has received, the Agency has been
reviewing the issue of how metals contained in alloys, specifically
stainless steel, brass, and bronze alloys, should be reported under
section 313. Because this issue is currently being reviewed and no
final decisions concerning the reporting of lead or other metals in
alloys have been made, EPA does not believe that, at this time, it
would be appropriate to increase reporting for those facilities that
must submit reports for lead when contained in these alloys. Thus, EPA
is not proposing to make any changes, including lowering thresholds, to
the current reporting requirements for lead when contained in stainless
steel, brass, and bronze alloys. EPA is therefore proposing to exclude
lead contained in stainless steel, brass, and bronze alloys from the
lower reporting threshold and retain the current reporting thresholds
for lead when contained in stainless steel, brass, and bronze alloys.
This would result in no changes to the reporting requirements for lead
contained in stainless steel, brass, and bronze alloys until EPA makes
a final determination on whether there should be any changes to the
reporting requirements for lead and other metals contained in stainless
steel, brass, and bronze alloys. Lead contained in stainless steel,
brass, and bronze alloys would still be reportable, but only under the
current reporting thresholds. EPA would make this distinction at 40 CFR
372.28, which is the new section of the CFR that will set forth the
lower section 313 reporting threshold being proposed in this action.
This section would indicate that only lead not contained in a stainless
steel, brass, or bronze alloy would be subject to the lower reporting
threshold. EPA would also make this distinction clear in the section
313 Form R and Form A reporting instructions and other documents.
Under this proposed limitation for lead in stainless steel, brass,
and bronze alloys, reporting facilities that use lead to make stainless
steel, brass, and bronze alloys would report for lead under the lower
reporting threshold since lead is being used to manufacture an alloy.
However, once incorporated into the stainless steel, brass, and bronze
alloy, lead would not be subject to the lower reporting threshold. For
purposes of section 313 reporting, EPA considers metal compounds that
are used to make alloys to exist as the parent metal in the alloys.
Thus, the limitation on stainless steel, brass, and bronze alloy
reporting for lead would apply to lead compounds once they are
incorporated into an alloy. The cutting, grinding, shaving, etc. of a
stainless steel, brass, or bronze alloy does not negate the reporting
limitations for stainless steel, brass, and bronze alloys containing
lead.
VII. What are the results of EPA's Economic Analysis?
EPA has prepared an economic analysis of the impact of this
proposed action, which is contained in a document entitled Economic
Analysis of the Proposed Rule to Modify Reporting of Lead and Lead
Compounds under EPCRA Section 313 (Ref. 31). This document is available
in the public docket for this rulemaking. The analysis assesses the
costs, benefits, and associated impacts of the proposed rule, including
potential effects on small entities. The major findings of the analysis
are briefly summarized here.
A. What is the Need for the Rule?
This proposed rule is intended to address the market failures
arising from private choices about lead and lead compounds that have
societal costs, and the market failures created by the limited
information available to the public about the release and other waste
management activities involving lead and lead compounds. Through the
collection and distribution of facility-specific data on toxic
chemicals, TRI overcomes firms' lack of incentive to provide certain
information, and thereby serves to inform the public of releases and
other waste management of lead and lead compounds. This information
enables individuals to make choices that enhance their overall well-
being. Choices made by a more informed public, including consumers,
corporate lenders, and communities, may lead firms to internalize into
their business decisions at least some of the costs to society relating
to their releases and other waste management activities involving lead
and lead compounds. In addition, by helping to identify areas of
concern, set priorities and monitor trends, TRI data can also be used
to make more informed decisions regarding the design of more efficient
regulations and voluntary programs, which also moves society towards an
optimal allocation of resources.
Certain facilities currently report TRI data on lead and lead
compounds under the existing 10,000 and 25,000 pound reporting
thresholds. In 1996, EPA received TRI data on the release and other
waste management of over a billion pounds of lead and lead compounds
from approximately 1,600 facilities. The industry groups reporting the
largest amounts of release or other
[[Page 42237]]
waste management of lead and lead compounds in 1996 were: Electronic
and Other Electrical Equipment and Components (SIC 36); Primary Metal
Industries (SIC 33); Rubber and Miscellaneous Plastics Products (SIC
30); Stone, Clay, Glass, and Concrete Products (SIC 32); and Fabricated
Metal Products (SIC 34) (Ref. 31). EPA believes that there are
additional facilities in these and other industry groups that do not
currently report lead and lead compounds to TRI because they do not
exceed current reporting thresholds for lead and lead compounds, and/or
because the lead-containing materials they handle are currently covered
by the de minimis exemption. EPA is not able to quantify the total
multi-media releases or other waste management from these additional
facilities without TRI reporting. Since even small releases of lead and
lead compounds are of concern, EPA believes that there is a need for
reporting from these additional facilities.
If EPA were not to take this proposed action to lower the reporting
thresholds, the market failure (and the associated social costs)
resulting from the limited information on the release and disposition
of lead and lead compounds would continue. EPA believes that today's
action will improve the scope of multi-media data on releases and other
waste management of lead and lead compounds. This, in turn, will
provide information to the public, empower communities to play a
meaningful role in environmental decision-making, and improve the
quality of environmental decision-making by government officials. In
addition, this action will serve to generate information that reporting
facilities themselves may find useful in such areas as highlighting
opportunities to reduce chemical use or release and thereby lower costs
of production and/or waste management. EPA believes that these are
sound rationales for lowering reporting thresholds for lead and lead
compounds.
B. What Regulatory Options Were Considered?
EPA evaluated four regulatory options for lower reporting
thresholds in the development of this proposed rule. The options were
created by varying the reporting thresholds for lead and lead compounds
from their current levels of 25,000 pounds for manufacture and
processing, and 10,000 pounds for otherwise use of EPCRA section 313
chemicals. The options in Table 2 below summarize the scope of EPA's
analysis.
Table 2.--Summary of Options Considered
------------------------------------------------------------------------
Description of Reporting
Regulatory Option Threshold for Lead and Lead
Compounds
------------------------------------------------------------------------
Option 1 1 pound manufactured,
processed, or otherwise used
------------------------------------------------------------------------
Option 2 10 pounds manufactured,
processed, or otherwise used
------------------------------------------------------------------------
Option 3 100 pounds manufactured,
processed, or otherwise used
------------------------------------------------------------------------
Option 4 1,000 pounds manufactured,
processed, or otherwise used
------------------------------------------------------------------------
Reporting under all four options is affected by other proposed
changes in reporting requirements for lead and lead compounds. These
proposed changes include the elimination of the de minimis exemption
for lead and lead compounds, and a requirement for all facilities to
report on lead and lead compounds using the Form R. The effect of these
other proposed changes on reporting is addressed in the economic
analysis of the proposed rule (Ref. 31).
Table 3 following section E.4. of this unit displays, for each
option, the estimated number of additional reports for lead and lead
compounds expected from various industry groups under EPCRA section
313. This table is not exhaustive. While EPA believes that it has
addressed the industry groups most likely to submit additional reports
in economic analysis of the proposed rule (Ref. 31), other industry
groups may also file additional reports on lead and lead compounds. EPA
requests that commenters provide any available information on other
categories of facilities that may be affected by this proposal, as well
as any data on the number of facilities in the category that would be
affected, and the quantity of lead and lead compounds manufactured,
processed, or otherwise used by facilities in the category.
In proposing this rule, EPA has sought to balance the public's
right to know about toxic chemical releases and other waste management
practices in their neighborhoods and the benefits provided by this
expanded knowledge with the costs the rule will likely impose on
industry, including the impact on small entities.
C. What are the Potential Costs of this Proposal?
The proposed rule would result in the expenditure of resources
that, in the absence of the regulation, could be used for other
purposes. The cost of the proposed rule is the value of these resources
in their best alternative use. Most of the costs of the proposed rule
would result from requirements on industry. Table 4 following section
E.4. of this unit displays the industry costs for each option based on
the estimated number of facilities affected by this proposal. Under the
option presented in the regulatory text (Option 2), approximately
15,000 facilities would submit additional Form R reports annually. As
shown, aggregate industry costs in the first year for the proposed
alternative are estimated to be $116 million; in subsequent years they
are estimated to be $60 million per year. Industry costs are lower
after the first year because facilities will be familiar with the
reporting requirements, and many will be able to update or modify
information from the previous year's report.
Some of the facilities potentially affected by this proposed rule
may also be affected by the proposed PBT rule (64 FR 688). If these
rules are finalized as proposed, certain facilities may file additional
reports on lead or lead compounds, as well as on one or more of the PBT
chemicals from the earlier proposal. The ultimate outcome of these
separate proposals is, however, uncertain at present. Therefore,
certain facility-specific reporting costs have been included in the
economic analysis for this proposal and in the economic analysis of the
PBT proposal even though these costs would be incurred only once per
facility. Upon finalization, the aggregate cost of the two proposals
may be less than the sum of the industry costs shown in the economic
analyses of these proposals due to this potential double-counting of
reporting costs. Under the preferred options presented in the
regulatory text of this and the previous proposal, the potential
double-counting of industry costs amounts to approximately $4 million
in the first year of reporting. EPA plans to estimate the cost of the
final rules for these proposals using the regulatory framework that
exists at the time of finalization as a baseline. Further information
on the extent of potential double-counting of costs in the analyses of
the two proposals is presented in the economic analysis of this
proposal (Ref. 31).
EPA is expected to expend $1.6 million in the first year, and $1.2
million in subsequent years for programmatic, compliance assistance,
and enforcement activities as a result of the proposed rule.
[[Page 42238]]
D. What are the Potential Benefits of this Proposal?
In enacting EPCRA and PPA, Congress recognized the significant
benefits of providing the public with information on toxic chemical
releases and other waste management practices. TRI has empowered the
Federal government, State governments, industry, environmental groups
and the general public to participate in a fully informed dialogue
about the environmental impacts of toxic chemicals in the United
States. TRI's publicly available data base provides quantitative
information on toxic chemical releases and other waste management
practices. Since TRI's inception in 1987, the public, government, and
the regulated community have had the ability to understand the
magnitude of chemical releases in the United States and to assess the
need to reduce the uses and releases of toxic chemicals. TRI enables
all interested parties to establish credible baselines, to set
realistic goals for environmental progress over time, and to measure
progress in meeting these goals over time. The TRI system is a neutral
yardstick by which progress can be measured by all stakeholders.
The information reported to TRI increases knowledge of the amount
of toxic chemicals released to the environment and the potential
pathways of exposure, improving scientific understanding of the health
and environmental risks of toxic chemicals; allows the public to make
informed decisions on where to work and live; enhances the ability of
corporate leaders and purchasers to more accurately gauge a facility's
potential environmental liabilities; provides reporting facilities with
information that can be used to save money as well as reduce emissions;
and assists Federal, State, and local authorities in making better
decisions on acceptable levels of toxic chemicals in the environment.
There are two types of benefits associated with TRI reporting:
those resulting from the actions required by the rule (such as
reporting and recordkeeping), and those derived from follow-on
activities that are not required by the rule. Benefits of activities
required by the rule include the value of improved knowledge about the
release and waste management of toxic chemicals, which leads to
improvements in understanding, awareness and decision-making. It is
expected that this rulemaking will generate such benefits by providing
readily accessible information that otherwise would not be available to
the public. The proposed rule will benefit ongoing research efforts to
understand the risks posed by lead and lead compounds and to evaluate
policy strategies that address the risks.
The second type of benefits derive from changes in behavior that
may result from the information reported to EPCRA section 313. These
changes in behavior, including reductions in releases of and changes in
the waste management practices for toxic chemicals may yield health and
environmental benefits. These changes in behavior come at some cost,
and the net benefits of the follow-on activities are the difference
between the benefits of decreased chemical releases and transfers and
the costs of the actions needed to achieve the decreases.
Because the state of knowledge of the economics of information is
not highly developed, EPA has not attempted to quantify the benefits of
changing reporting thresholds for lead and lead compounds. Furthermore,
because of the inherent uncertainty in the subsequent chain of events,
EPA has also not attempted to predict the changes in behavior that
result from the information, or the resultant net benefits, (i.e., the
difference between benefits and costs of follow-on activities). EPA
does not believe that there are adequate methodologies to make
reasonable monetary estimates of either the benefits of the activities
required by the proposed rule, or the follow-on activities. The
economic analysis of the proposed rule, however, provides illustrative
examples of how the proposed rule will improve the availability of
information on the release and other waste management of lead and lead
compounds (Ref. 31).
E. What are the Potential Impacts on Small Entities of this Proposal?
In accordance with the Regulatory Flexibility Act (RFA) and the
Agency's longstanding policy of always considering whether there may be
a potential for adverse impacts on small entities, the Agency has also
evaluated the potential impacts of this proposed rule on small
entities. The Agency's analysis of potentially adverse economic impacts
is included in the economic analysis for this proposed rule (Ref. 31).
The following is a brief overview of EPA's findings.
1. What was the overall methodology for assessing potential small
entity impacts? This proposed rule may affect both small businesses and
small governments. For the purpose of its analysis for the proposed
rule, EPA defined a small business using the small business size
standards established by the Small Business Administration (SBA). For
example, the SBA size standard is 500 employees for approximately 75%
of the manufacturing industries, and either 750, 1,000 or 1,500 for the
remaining manufacturing industries, which would mean that more than
98.5% of all manufacturing firms are classified as small businesses
(Ref. 32 ). EPA defined small governments using the RFA definition of
jurisdictions with a population of less than 50,000. No small
organizations are expected to be affected by the proposed rule.
Potential small entity impacts were calculated for both the first
year of reporting and subsequent years under Option 2 (the option
presented in the proposed regulatory text). Only those small entities
that are expected to submit at least one report are considered to be
``affected'' for the purpose of the small entity analysis, although EPA
recognizes that other small entities will conduct compliance
determinations under lower thresholds. The number of affected entities
will be smaller than the number of affected facilities, because many
entities operate more than one facility. First year costs are typically
higher than continuing costs because firms must familiarize themselves
with the requirements. Once firms have become familiar with how the
reporting requirements apply to their operations, costs fall. EPA
believes that subsequent year impacts are the best measure of the
impact on small entities because these continuing costs are more
representative of the costs firms face to comply with the proposed
rule.
EPA analyzed the potential cost impact of the proposed rule on
small businesses and governments for the manufacturing sector and in
each of the recently added industry sectors separately in order to
obtain the most accurate assessment for each. EPA then aggregated the
analyses for the purpose of determining whether it could certify that
the proposed rule will not, if promulgated, have a ``significant
economic impact on a substantial number of small entities.'' RFA
section 605(b) provides an exemption from the requirement to prepare a
regulatory flexibility analysis for a rule where an agency makes and
supports the certification statement quoted above. EPA believes that
the statutory test for certifying a rule and the statutory consequences
of not certifying a rule all indicate that certification determinations
may be based on an aggregated analysis of the rule's impact on all of
the small entities subject to it.
2. What are the potential impacts on small businesses? EPA used
annual compliance costs as a percentage of
[[Page 42239]]
annual company sales to assess the potential impacts on small
businesses of this proposed rule. EPA believes that this is a good
measure of a firm's ability to afford the costs attributable to a
regulatory requirement, because comparing compliance costs to revenues
provides a reasonable indication of the magnitude of the regulatory
burden relative to a commonly available measure of a company's business
volume. Where regulatory costs represent a small fraction of a typical
firm's revenue (for example, less than 1%, or not greater than 3%), EPA
believes that the financial impacts of the regulation may be considered
not significant.
Based on its estimates for Option 2 of the proposed rule, the
Agency estimates that approximately 8,100 businesses will be affected
by the proposed rule, and that approximately 5,600 of these businesses
are classified as small based on the applicable SBA size standards. EPA
estimates that no small businesses will bear costs greater than 1% of
revenues in the first or subsequent reporting years.
3. What are the potential impacts on small governments? To assess
the potential impacts on small governments, EPA used annual compliance
costs as a percentage of annual government revenues to measure
potential impacts. Similar to the methodology for small businesses,
this measure was used because EPA believes it provides a reasonable
indication of the magnitude of the regulatory burden relative to a
government's ability to pay for the costs, and is based on readily
available data.
EPA estimates that 36 publicly owned electric utility facilities,
operated by a total of 34 municipalities, may be affected under Option
2 of the proposed rule. Of these, an estimated 18 are operated by small
governments (i.e., those with populations under 50,000). It is
estimated that none of these small governments will bear annual costs
greater than 1% of annual government revenues in the first or
subsequent reporting years.
4. What are the potential impacts for all small entities? As
discussed above, no small businesses are expected to bear annual costs
over 1% of annual revenues. None of the affected small governments are
estimated to bear annual costs greater than 1% of annual revenues. No
small organizations are expected to be affected by the proposed rule.
Thus, the total number of small entities with impacts above 1% of
revenues does not change when the results are aggregated for all small
entities (i.e., small businesses, small governments, and small
organizations).
Table 3.--Summary of Reporting Under Regulatory Options
----------------------------------------------------------------------------------------------------------------
Estimated Number of Additional Reports (Annual)
SIC Code - Industry Group ---------------------------------------------------
Option 1 Option 2 Option 3 Option 4
----------------------------------------------------------------------------------------------------------------
12 - Coal mining 321 321 321 321
----------------------------------------------------------------------------------------------------------------
29 - Petroleum refining and related industries 1,033 117 91 90
----------------------------------------------------------------------------------------------------------------
3241 - Cement, hydraulic 123 123 123 123
----------------------------------------------------------------------------------------------------------------
33 - Primary metal industries 1,130 1,130 1,109 842
----------------------------------------------------------------------------------------------------------------
367 - Electronic components and accessories 4,033 4,033 3,109 405
----------------------------------------------------------------------------------------------------------------
371 - Motor vehicles and motor vehicle equipment 2,862 2,862 1,485 201
----------------------------------------------------------------------------------------------------------------
4911/4931/4939 - Electric services 414 378 319 248
----------------------------------------------------------------------------------------------------------------
4953 - Refuse systems (RCRA subtitle C only) 80 74 64 36
----------------------------------------------------------------------------------------------------------------
5171 - Petroleum bulk stations and terminals 2,459 980 621 55
----------------------------------------------------------------------------------------------------------------
7389 - Solvent recovery services 26 24 22 14
----------------------------------------------------------------------------------------------------------------
20-39 - Other manufacturing; industrial combustion 10,142 5,001 1,498 570
----------------------------------------------------------------------------------------------------------------
Total 22,623 15,043 8,762 2,905
----------------------------------------------------------------------------------------------------------------
Table 4.--Summary of Reporting and Industry Cost of Regulatory Options
----------------------------------------------------------------------------------------------------------------
Estimated Industry Costs ($ million
Annual Number of per year)
Regulatory Options for Lead and Lead Compounds Reports -------------------------------------
First Year Subsequent Years
----------------------------------------------------------------------------------------------------------------
Opion 1--Reporting threshold of 1 lb 22,623 $174 $91
----------------------------------------------------------------------------------------------------------------
Option 2--Reporting threshold of 10 lb 15,043 $116 $60
----------------------------------------------------------------------------------------------------------------
Option 3--Reporting threshold of 100 lb 8,762 $67 $35
----------------------------------------------------------------------------------------------------------------
Option 4--Reporting threshold of 1,000 lb 2,905 $22 $12
----------------------------------------------------------------------------------------------------------------
[[Page 42240]]
VIII. What are the References Cited in this Proposed Rule?
1. The Great Lakes Binational Toxics Strategy, Canada -- United
States Strategy for the Virtual Elimination of Persistent Toxic
Substances in the Great Lakes, signed by Carol Browner, Administrator
U.S. Environmental Protection Agency and Sergio Marchi, Minister of the
Environment Government of Canada. 1997.
2. Syracuse Research Corporation. The Environmental Fate of Lead
and Lead Compounds. Prepared for David G. Lynch, U.S. Environmental
Protection Agency, under contract number SRC 68-D5-0012, March 1999.
3. Zimdahl, R.L., Skogerboe, R.K. 1977. Behavior of Lead in Soil.
Environ. Sci Technol. 11:1202-1207.
4. USEPA/ORD. Air Quality Criteria for Lead. Research Triangle
Park, NC. EPA, Office of Research and Development, Office of Health and
Environmental Assessment. 1986. EPA600/8-83-028bF
5. Bondarenko, G.P. 1968. An experimental study of the solubility
of galena in the presence of fulvic acids. Geochem. Int. 5: 525-531.
6. Lovering, T.G. ed. 1976. Lead in the Environment. Washington,
DC: US Department of the Interior, Geological Survey; Geological Survey
professional paper no. 957. S/N 024-001-02911-1
7. Rand, G.M., Fundamentals of Aquatic Toxicology, 2nd. Ed. Taylor
Francis, Washington, DC, (1995), 1125 pp.
8. Meylan, W.M., Howard, P.H., and Boethling, R.S. 1999. ``Improved
Method for Estimating Bioconcentration Factor from Octanol/Water
Partition Coefficient.'' Environ. Toxicol. Chem. 18:664-672.
9. Merlini, M. and A. Pozzi. 1977. Lead and freshwater fishes. Part
1. Lead accumulation and water pH. Environ. Pollut. 12:167-172.
10. USEPA/OPPT. Bioaccumulation/Bioconcentration Assessment For
Lead and Lead Compounds. Jerry Smrchek, Ph.D., Biologist, Existing
Chemicals Assessment Branch, Risk Assessment Division, March 31, 1999.
11. Borgmann, U., Kramer, O. and C. Loveridge. 1978. Rates of
mortality, growth, and biomass production of Lymnaea palustris during
chronic exposure to lead. J. Fish. Res. Board Canada. 35:1109-1115.
12. Denny, P. and R.P. Welsh. 1979. Lead accumulation in plankton
blooms from Ullswater, the English Lake District. Environ. Pollut.
18:1-9.
13. Vighi, M. 1981. Lead uptake and release in a experimental
trophic chain. Ecotoxicol. Environ. Safety. 5:177-193.
14. Eisler, R. 1988. Lead hazards to fish, wildlife, and
invertebrates: a synoptic review. Biological Report 85(1.14),
Contaminant Hazard Reviews Report No. 14, U.S. Fish and Wildlife
Service, U.S. Department of the Interior, Laurel, MD, 134 pp.
15. USEPA. Jenkins, D.W. 1980. Biological monitoring of trace
metals. Vol. 2. Toxic trace metals in plants and animals of the world.
Part II. EPA 600/3-80-091, U.S. Environmental Protection Agency,
Washington, DC, pp. 619-778.
16. Wong, P.T.S., Chau, Y.K., Kramer, O. and G.A. Bengert. 1981.
Accumulation and depuration of tetramethyllead by rainbow trout. Water
Res. 15:621-625.
17. Schulz-Baldes, M. 1972. Toxicity and accumulation of lead in
the common mussel Mytilus edulis in laboratory experiment. Mar. Biol.
16:226-229.
18. Schulz-Baldes, M. 1974. Lead uptake from sea water and food,
and lead loss in the common mussel, Mytilus edulis. Mar. Biol. 25:177-
193.
19. Zaroogian, G.E., Morrison, G. and J.F. Heltshe. 1979.
Crassostrea virginica as an indicator of lead pollution. Mar. Biol.
52:189-196.
20. Seeliger, U. and P. Edwards. 1977. Correlation coefficients and
concentration factors of copper and lead in seawater and benthic algae.
Mar. Pollut. Bull. 8:16-19.
21. Gould, E. And R.A. Greig. 1983. Short-term low-salinity
response in lead-exposed lobsters, Homarus americanus (Milne Edwards).
J. Exp. Mar. Biol. Ecol. 69:283-295.
22. USEPA. Ambient Water Quality Criteria for Lead. 1984. EPA 440/
5-84-027, Office of Water, U.S. Environmental Protection Agency,
Washington, DC, 1985, 81 pp.
23. ATSDR. Draft Toxicological Profile for Lead. U.S. Department of
Health and Human Services, Public Health Service, Agency for Toxic
Substances and Disease Registry. August 1997.
24. USEPA/OPPT. Risk Analysis to Support Standards for Lead in
Paint, Dust, and Soil - Volume 1. U.S. Environmental Protection Agency,
Office of Pollution Prevention and Toxics, Washington DC, EPA 747-R-97-
006, June 1998.
25. USEPA/ECAO. Air Quality Criteria for Lead - Volume 1 of IV.
U.S. Environmental Protection Agency, Environmental Criteria and
Assessment Office, Research Triangle Park, NC, EPA-600/8-83/028aF, June
1986.
26. USEPA/OIA. Technical Information Package for Lead. Internet
site: http://www.epa.gov/oiamount/tips/lead2.htm. Maintained by the
U.S. Environmental Protection Agency, Office of International Affairs.
Downloaded March 1999.
27. Davis A., Ruby M., and Bergstrom P. Factors controlling lead
bioavailability in the Butte mining district, Montana, USA
Environmental Geochemistry and Health 1994; 16(3/4):147-157
28. Davis A., Drexler J., Ruby M., and Nicholson A. Micromineralogy
of Mine Wastes in Relation to Lead Bioavailability, Butte, Montana
Environ Sci Technology 1993 Mar 16; 27(7):1415-1425
29. Rabinowitz, M.B., et. al., Kinetic Analysis of Lead Metabolism
in Healthy Humans. Journal of Clinical Investigation. 1976. 58:260-270.
30. IRIS 1999. U.S. Environmental Protection Agency's Integrated
Risk Information System Profile pertaining to lead and lead compounds.
31. USEPA, OPPT. Economic Analysis of the Proposed Rule to Modify
the Reporting Requirements for Lead and Lead Compounds under EPCRA
Section 313, (1999).
32. USSBA. Office of Advocacy - Statistics - Major Industry, Firms,
Establishment, Employment, Payroll and Receipts, 1995. Information from
the Small Business Administration on the Internet. http://www.sba.gov/
advo/stats/us_ind95.html. Downloaded on December 10, 1998.
33. USEPA, OPPT. Unfunded Mandates Reform Act (UMRA) Statement for
the Proposed Rule to Modify the Reporting Requirements for Lead and
Lead Compounds under EPCRA Section 313, April 1999.
IX. Regulatory Assessment Requirements
A. What is the Determination Under Executive Order 12866?
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
is an economically ``significant regulatory action'' subject to review
by the Office of Management and Budget (OMB) because it is likely to
have an annual effect on the economy of $100 million or more. This
action was therefore submitted to OMB for review, and any substantive
comments or changes made during that review have been documented in the
public record.
In addition, EPA has prepared an economic analysis of the impact of
this action, which is contained in a document entitled Economic
Analysis of the Proposed Rule to Modify Reporting of Lead and Lead
Compounds under EPCRA Section 313 (Ref. 31). This
[[Page 42241]]
document is available as part of the public record for this action, and
is briefly summarized in Unit VII. of this preamble.
B. What is the Determination Under the Regulatory Flexibility Act?
For the reasons explained in Unit VII. of this preamble, pursuant
to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency hereby certifies that this proposed rule will not
have a significant economic impact on a substantial number of small
entities. In brief, the factual basis of this determination is as
follows: none of the approximately 5,600 small businesses potentially
affected by the proposed rule will experience annual compliance costs
above 1% of annual sales. In addition, EPA estimates that there are 18
small governments that may be affected by the proposed rule (i.e., will
have to file reports under the proposed rule), none of which will bear
annual costs greater than 1% of annual government revenues. Given these
relatively small estimated impacts, for purposes of the RFA, EPA
believes that the proposed rule will not have a significant economic
impact on a substantial number of small entities. EPA's estimates are
based on the economic analysis (Ref. 31), and are also discussed in
Unit VII. of this preamble. This determination is for the entire
population of small entities potentially affected by this proposed
rule, since the test for certification is whether the rule as a whole
has a significant economic impact on a substantial number of small
entities.
Notwithstanding the Agency's certification of this proposed rule
under section 605(b) of the RFA, EPA remains committed to minimizing
real impacts on small entities where this does not unacceptably
compromise the informational benefits of the rule. The Agency is always
interested in any comments regarding the economic impacts that this
regulatory action would impose on small entities, particularly
suggestions for minimizing that impact. Such comments may be submitted
to the Agency at any time, to the address listed in Unit I.C. of this
preamble. To ensure consideration during the development of the final
rule, comments must be received by the date indicated in the ``DATES''
section.
Information relating to this determination has been provided to the
Chief Counsel for Advocacy of the Small Business Administration, and is
included in the docket for this rulemaking.
C. What is the Determination Under the Paperwork Reduction Act?
The information collection requirements contained in this proposed
rule have been submitted to OMB under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., and in accordance with the procedures at
5 CFR 1320.11. An amended Information Collection Request (ICR) document
has been prepared by EPA (EPA ICR No. 1363) and a copy may be obtained
from Sandy Farmer, OP Regulatory Information Division; U.S.
Environmental Protection Agency (2137); 401 M St., SW.; Washington, DC
20460, by calling (202) 260-2740, or electronically by sending an e-
mail message to ``[email protected].'' The information requirements
contained in this proposal are not effective until OMB approves them.
An Agency may not conduct or sponsor, and a person is not required to
respond to a collection of information subject to OMB approval under
the PRA unless it displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations, after initial publication in
the Federal Register, are maintained in a list at 40 CFR part 9.
Provision of this information is mandatory, upon promulgation of a
final rule, pursuant to EPCRA section 313 (42 U.S.C. 11023) and PPA
section 6607 (42 U.S.C. 13106). EPCRA section 313 requires owners or
operators of certain facilities manufacturing, processing, or otherwise
using any of over 600 listed toxic chemicals and chemical categories
(hereinafter toxic chemicals) in excess of the applicable threshold
quantities, and meeting certain requirements (i.e., at least 10 FTEs or
the equivalent), to report environmental releases and transfers of and
waste management activities for such chemicals annually. Under section
6607 of the PPA, facilities must also provide information on the
quantities of the toxic chemicals in waste streams and the efforts made
to manage those waste quantities. The regulations codifying the EPCRA
section 313 reporting requirements appear at 40 CFR part 372.
Respondents may designate the specific chemical identity of a substance
as a trade secret, pursuant to EPCRA section 322 (42 U.S.C. 11042).
Regulations codifying the trade secret provisions can be found at 40
CFR part 350.
Under the proposed rule, all facilities reporting to TRI on lead
and lead compounds would have to use the EPA Toxic Chemical Release
Inventory Form R (EPA Form No. 9350-1). OMB has approved the existing
reporting and recordkeeping requirements related to Form R, supplier
notification, and petitions under OMB Control No. 2070-0093 (EPA ICR
No. 1363).
For Form R, EPA estimates the industry reporting burden for
collecting this information (including recordkeeping) to average 74
hours per report in the first year, at an estimated cost of $5,079 per
Form R. In subsequent years, the burden is estimated to average 52.1
hours per report, at an estimated cost of $3,557 per Form R. These
estimates include the time needed to review instructions; search
existing data sources; gather and maintain the data needed; complete
and review the collection of information; and transmit or otherwise
disclose the information. The actual burden on any specific facility
may be different from this estimate depending on the complexity of the
facility's operations and the profile of the releases at the facility.
This proposed rule is estimated to result in additional reports
from approximately 15,000 respondents. Of these, approximately 5,100
facilities are estimated to be reporting to TRI for the first time as a
result of the rule, while approximately 9,900 are currently reporting
facilities that will be submitting additional reports. These 15,000
facilities will submit an estimated additional 15,000 Form Rs. This
proposed rule therefore results in an estimated total burden of 1.7
million hours in the first year, and 0.9 million hours in subsequent
years, at a total estimated industry cost of $116 million in the first
year and $60 million in subsequent years.
Under PRA, ``burden'' means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes, where applicable, the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information. EPA's burden estimates for the rule take into
account all of the above elements, considering that under section 313,
no additional measurement or monitoring may be imposed for purposes of
reporting.
[[Page 42242]]
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to EPA at the
address provided above, with a copy to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th St., NW.,
Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
Please remember to include the ICR number in any correspondence. The
final rule will respond to any comments on the information collection
requirements contained in this proposal.
D. What are the Determinations Under the Unfunded Mandates Reform Act
and Executive Orders 12875 and 13084?
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4), EPA has determined that this action contains a
``Federal mandate'' that may result in expenditures of $100 million or
more for the private sector in any 1 year, but that it will not result
in such expenditures for State, local, and tribal governments in the
aggregate. Accordingly, EPA has prepared a written statement for this
proposed rule as required by section 202 of UMRA, and that statement is
available in the public docket for this rulemaking (Ref. 33). The costs
associated with this action are estimated in the economic analysis
prepared for this proposed rule (Ref. 31), which is included in the
public docket and summarized in Unit VII. of this preamble. The
following is a brief summary of the UMRA statement for the proposed
rule.
This proposed rule is being promulgated pursuant to sections
313(f)(2) of EPCRA, 42 U.S.C. section 11023(f)(2), and section 6607 of
the Pollution Prevention Act, 42 U.S.C. section 13106. The economic
analysis estimates that the total industry costs of the proposed rule
will be $116 million in the first year and $60 million per year
thereafter, and concludes that the benefits will be significant but
cannot be assigned a dollar value due to the lack of adequate
methodologies. This information is also summarized above in Unit VII.
of this preamble. EPA believes that the benefits provided by the
information to be reported under this proposed rule will outweigh the
costs imposed by today's action. The benefits of the information will
in turn have positive effects on health, safety, and the natural
environment through the behavioral changes that may result from that
information.
EPA has not identified any Federal financial resources that are
available to cover the costs of this proposed rule. As set forth in the
economic analysis, EPA has estimated the future industry compliance
costs (after the first year) of this proposed rule to be $60 million
annually. Of those entities affected by today's action, EPA has not
identified any disproportionate budgetary impact on any particular
region, government, or community, or on any segment of the private
sector. Based on the economic analysis, EPA has concluded that it is
highly unlikely that this proposed rule will have an appreciable effect
on the national economy.
EPA has determined that the proposed rule will not significantly or
uniquely affect small governments and does not contain a significant
Federal intergovernmental mandate, so no action is needed under section
203 or 204 of UMRA.
Finally, EPA believes this proposed rule complies with section
205(a) of UMRA. The objective of this proposed rule is to expand the
public benefits of the TRI program by exercising EPA's discretionary
authority to add chemicals to the program and to lower reporting
thresholds, thereby increasing the amount of information available to
the public regarding the use, management, and disposition of listed
toxic chemicals. In making additional information available through
TRI, the Agency increases the utility of TRI data as an effective tool
for empowering local communities, the public sector, industry, other
agencies, and State and local governments to better evaluate risks to
public health and the environment, particularly at the local level.
As described in Unit VI. of this preamble, EPA considered burden in
the threshold selection. The proposed rule also contains reporting
requirements that will limit burden (e.g., reporting limitations for
lead and lead compounds in certain alloys). In addition, existing
burden-reducing measures (e.g., the laboratory exemption, and the
otherwise use exemptions, which include the routine janitorial or
facility grounds maintenance exemption, motor vehicle maintenance
exemption, structural component exemption, intake air and water
exemption and the personal use exemption) will apply to the facilities
that file new reports as a result of this proposed rule. EPA also will
be assisting small entities subject to the proposed rule, by such means
as providing meetings, training, and compliance guides in the future,
which also will ease the burdens of compliance.
Many steps have been and will be taken to further reduce the burden
associated with this proposed rule, and to EPA's knowledge there is no
available alternative to the proposed rule that would obtain the
equivalent information in a less burdensome manner. For all of these
reasons, EPA believes the rule complies with UMRA section 205(a).
In addition, today's rule does not create a mandate on State, local
or tribal governments, nor does it significantly or uniquely affect the
communities of Indian tribal governments. Accordingly, the requirements
of section 1(a) of Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), and
section 3(b) of Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998), do not apply to this proposed rule.
E. What are the Determinations Under Executive Orders 12898 and 13045
Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency has considered
environmental justice related issues with regard to the potential
impacts of this action on environmental and health conditions in low-
income populations and minority populations. Since this is an
economically significant action (i.e., it is expected to have an annual
adverse impact of $100 million or more), additional OMB review is
required under Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). The Agency has, to the extent permitted by law and
consistent with the agency's mission, identified and assessed the
environmental health risks and safety risks that may disproportionately
affect children.
By lowering the section 313 reporting thresholds for lead and lead
compounds, EPA is providing communities across the United States
(including low-income populations and minority populations) with access
to data that may assist them in lowering exposures and consequently
reducing chemical risks for themselves and their children. This
information can also be used by government agencies and others to
identify potential problems, set priorities, and take appropriate steps
to reduce any potential risks to human health and the environment.
Therefore,
[[Page 42243]]
the informational benefits of the proposed rule will have a positive
impact on the human health and environmental impacts of minority
populations, low-income populations, and children.
List of Subjects in 40 CFR Part 372
Environmental protection, Chemicals, Community right-to-know,
Hazardous substances, Intergovernmental relations, Reporting and
recordkeeping requirements, Superfund.
Dated: July 23, 1999.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 CFR part 372 be amended as
follows:
PART 372--[AMENDED]
1. The authority citation for part 372 would continue to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.22 [Amended]
2. In Sec. 372.22(c), by removing the phrase ``Sec. 372.25 or
Sec. 372.27'' and adding in its place ``Sec. 372.25, Sec. 372.27, or
Sec. 372.28''.
Sec. 372.25 [Amended]
3. In the introductory text of Sec. 372.25, by removing the first
clause ``Except as provided in Sec. 372.27,'' and adding in its place
``Except as provided in Secs. 372.27 and 372.28,''.
4. In Sec. 372.27, by adding a new paragraph (e) to read as
follows:
Sec. 372.27 Alternate threshold and certification.
* * * * *
(e) The provisions of this section do not apply to any chemicals
listed in Sec. 372.28.
5. By adding a new Sec. 372.28 to subpart B to read as follows:
Sec. 372.28 Lower thresholds for chemicals of special concern.
(a) Notwithstanding Sec. 372.25 or Sec. 372.27, for the toxic
chemicals set forth in this section, the threshold amounts for
manufacturing (including importing), processing, and otherwise using
such toxic chemicals are as set forth in this section.
(1) Chemical listing in alphabetic order:
------------------------------------------------------------------------
Reporting
Chemical name CAS no. threshold
------------------------------------------------------------------------
Lead (this lower threshold does 7439-92-1 10
not apply to lead when
contained in a stainless steel,
brass or bronze alloy)
------------------------------------------------------------------------
(2) Chemical categories in alphabetic order:
------------------------------------------------------------------------
Category name Reporting threshold
------------------------------------------------------------------------
Lead Compounds 10
------------------------------------------------------------------------
(b) The threshold determination provisions at Sec. 372.25(c)
through (h) and the exemptions at Sec. 372.38(b) through (h) are
applicable to the toxic chemicals listed in paragraph (a) of this
section.
Sec. 372.30 [Amended]
6. In Sec. 372.30(a), by removing the phrase ``in Sec. 372.25 at''
and adding in its place ``in Sec. 372.25, Sec. 372.27, or Sec. 372.28
at''.
7. In Sec. 372.38(a), by adding the following sentence at the end
of the paragraph to read as follows:
Sec. 372.38 Exemptions.
(a) * * * This exemption does not apply to toxic chemicals listed
in Sec. 372.28, except for purposes of Sec. 372.45(d)(1).
* * * * *
Sec. 372.85 [Amended]
8. Amend Sec. 372.85 as follows:
i. By removing in paragraphs (b)(15)(i) introductory text and
(b)(16)(ii)(B) the phrase ``may be indicated in ranges'' and adding in
its place ``may be indicated in ranges, except for chemicals set forth
in Sec. 372.28''.
ii. By removing in paragraph (b)(16)(i)(B) the phrase ``may be
indicated as a range'' and adding in its place ``may be indicated as a
range, except for chemicals set forth in Sec. 372.28''.
[FR Doc. 99-19729 Filed 8-2-99; 8:45 am]
BILLING CODE 6560-50-F
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