4500 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 372

[OPPTS–400140D; FRL–6722–4]

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: Final rule.

SUMMARY: EPA is lowering 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).

The reporting thresholds are being

lowered to 100 pounds. The lower

reporting thresholds apply to lead and

all lead compounds except for lead

contained in stainless steel, brass, and

bronze alloys. EPA is taking these

actions pursuant to its authority under

EPCRA section 313(f)(2) to revise

reporting thresholds. Today’s actions

also include modifications to certain

reporting exemptions and requirements

for lead and lead compounds.

DATES: This rule shall take effect on

February 16, 2001; with the first reports

at the lower thresholds due on or before

July 1, 2002, for the 2001 calendar year.

FOR FURTHER INFORMATION CONTACT: For

technical information on this final rule

contact: Daniel R. Bushman, Petitions

Coordinator, Environmental Protection

Agency, Mail Code 2844, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number 202-260-

3882, e-mail address:

bushman.daniel@epa.gov. For general

information on EPCRA section 313,

contact the Emergency Planning and

Community Right-to-Know Hotline,

Environmental Protection Agency, Mail

Code 5101, 1200 Pennsylvania Ave.,

NW., Washington, DC 20460, Toll free:

1-800-535-0202, in Virginia and Alaska:

703-412-9877 or Toll free TDD: 1-800-

553-7672. Information concerning this

action is also available on EPA’s Web

site at http://www.epa.gov/tri.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

You may be potentially affected by

this action if you manufacture, process,

or otherwise use lead or lead

compounds. Potentially affected

categories and entities may include, but

are not limited to:

Category Examples of Potentially Affected Entities

Industry SIC major group codes 10 (except 1011, 1081, and 1094), 12 (except 1241); or 20 through 39; or industry

codes 4911 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce); or 4931 (limited to facilities that combust coal and/or oil for the purpose of generating

power for distribution in commerce); or 4939 (limited to facilities that combust coal and/or oil for the purpose

of generating power for distribution in commerce); or 4953 (limited to facilities regulated under the Resource

Conservation and Recovery Act, subtitle C, 42 U.S.C. section 6921 et seq.); or 5169; or 5171; or 7389 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis)

Federal Government Federal facilities

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. To determine whether your

facility would be affected by this action,

you should carefully examine the

applicability criteria in part 372 subpart

B of Title 40 of the Code of Federal

Regulations. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed in the preceding of FOR FURTHER

INFORMATION CONTACT section.

B. How can I get additional information

or copies of this document or other

support documents?

1. Electronically. You may obtain

electronic copies of this document from

the EPA internet Home Page at http://

www.epa.gov/. On the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the ‘‘Federal Register’’ listings at http:/

/www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPPTS–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 noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The telephone number of the

Center is (202) 260-7099.

II. What is EPA’s Statutory Authority

for Taking These Actions?

EPA is finalizing these actions under

sections 313(f)(2), 313(g), 313(h), and

328 of EPCRA, 42 U.S.C. 11023(f)(2),

11023(g), 11023(h), and 11048; and

section 6607 of PPA, 42 U.S.C. 13106.

Section 313 of EPCRA requires certain

facilities manufacturing, processing, or

otherwise using a listed toxic chemical

in amounts above reporting threshold

levels, to report certain facility specific

information about such chemicals,

including the annual releases and other

quantities entering each environmental

medium. These reports must be filed by

July 1 of each year for the previous

calendar year. Such facilities also must

report recycling and other waste

management data and source reduction

activities for such chemicals, pursuant

to section 6607 of PPA.

A. What is EPA’s Statutory Authority To

Lower EPCRA Reporting Thresholds?

EPA is finalizing these actions

pursuant to its authority under EPCRA

section 313(f)(2) to revise reporting

thresholds. EPCRA section 313

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4501

establishes default reporting thresholds,

which are set forth in section 313(f)(1).

Section 313(f)(2), however, provides

that EPA:

may establish a threshold amount for a

toxic chemical different from the amount

established by paragraph (1). Such revised

threshold shall obtain reporting on a

substantial majority of total releases of the

chemical at all facilities subject to the

requirements of this section. The amounts

established by EPA may, at the

Administrator’s discretion, be based on

classes of chemicals or categories of facilities.

This provision provides EPA with

broad, but not unlimited, authority to

establish thresholds for particular

chemicals, classes of chemicals, or

categories of facilities, and commits to

EPA’s discretion the determination that

a different threshold is warranted.

Congress also committed the

determination of the levels at which to

establish any alternate thresholds to

EPA’s discretion, requiring only that

any ‘‘revised threshold shall obtain

reporting on a substantial majority of

total releases of the chemical at all

facilities subject to the requirements’’ of

section 313. 42 U.S.C. 11023(f)(2).

For purposes of determining what

constitutes a ‘‘substantial majority of

total releases,’’ EPA interprets the

language in section 313(f)(2), ‘‘facilities

subject to the requirements of [section

313],’’ to refer to those facilities that fall

within the category of facilities

described by sections 313 (a) and (b),

i.e., the facilities currently reporting.

Subsection (a) lays out the general

requirement that ‘‘the owner or operator

of facilities subject to the requirements

of this section shall’’ file a report under

EPCRA section 313. Subsection (b) then

defines the facilities subject to the

requirements of this section:

[t]he requirements of this section shall

apply to owners and operators of facilities

that have 10 or more full-time employees and

that are in Standard Industrial Classification

Codes 20-39, . . . and that manufactured,

processed, or otherwise used a toxic

chemical listed under subsection (c) of this

section in excess of the quantity of that toxic

chemical established under subsection (f) of

this section during the calendar year for

which a toxic chemical release form is

required under this section.

Thus, in revising the reporting

thresholds, EPA must ensure that, under

the new thresholds, a substantial

majority of releases currently being

reported will continue to be reported.

No further prerequisites for exercising

this authority appears in the statute.

B. What is EPA’s Statutory Authority for

Making Modifications to Other EPCRA

section 313 Reporting Requirements?

Today’s actions also include

modifications to certain reporting

exemptions and requirements for lead

and lead compounds. Congress granted

EPA rulemaking authority to allow the

Agency to fully implement the statute.

EPCRA section 328 provides that the

‘‘Administrator may prescribe such

regulations as may be necessary to carry

out this chapter’’ (28 U.S.C. 11048).

III. Background Information

A. What is the General Background for

this Action?

Under EPCRA section 313, Congress

set the initial parameters of the Toxics

Release Inventory (TRI), but also gave

EPA clear authority to modify reporting

in various ways, including authority to

change the toxic chemicals subject to

reporting, the facilities required to

report, and the threshold quantities that

trigger reporting. By providing this

authority, Congress recognized that the

TRI program would need to evolve to

meet the needs of a better informed

public and to refine existing

information. EPA has, therefore,

undertaken a number of actions to

expand and enhance TRI. These actions

include expanding the number of

reportable toxic chemicals by adding

286 toxic chemicals and chemical

categories to the EPCRA section 313 list

in 1994. Further, a new category of

facilities was added to EPCRA section

313 on August 3, 1993, through

Executive Order 12856, which requires

Federal facilities meeting threshold

requirements to file annual EPCRA

section 313 reports. In addition, in 1997

EPA expanded the number of private

sector facilities that are required to

report under EPCRA section 313 by

adding seven new industrial groups to

the list of covered facilities. At the same

time, EPA has sought to reduce the

burden of EPCRA section 313 reporting

by actions such as delisting chemicals it

has determined do not meet the

statutory listing criteria and establishing

an alternate reporting threshold of 1

million pounds for facilities with 500

pounds or less of production-related

releases and other wastes. Facilities

meeting the requirements of this

alternate threshold may file a

certification statement (Form A) instead

of reporting on the standard EPCRA

section 313 form, the Form R.

On October 29, 1999 (64 FR 58666),

EPA finalized enhanced reporting

requirements that focused on a unique

group of toxic chemicals that persist and

bioaccumulate in the environment.

These chemicals are commonly referred

to as persistent bioaccumulative toxic

chemicals or PBT chemicals. Until that

action, with the exception of the

alternate threshold certification on Form

A, EPA had not altered the statutory

reporting threshold for any listed

chemicals. However, as the TRI program

has evolved over time and as

communities identify areas of special

concern, thresholds and other aspects of

the EPCRA section 313 reporting

requirements may need to be modified

to assure the collection and

dissemination of relevant, topical

information and data. Toxic chemicals

that persist and bioaccumulate are of

particular concern because they remain

in the environment for significant

periods of time and concentrate in the

organisms exposed to them. The

October 29, 1999, PBT chemical final

rule set forth criteria to be used by the

EPCRA section 313 program for

evaluating whether a listed toxic

chemical persists or bioaccumulates in

the environment. EPA has evaluated

lead and lead compounds using these

criteria, and has concluded that lead

and lead compounds are PBT chemicals.

Thus, as with the PBT chemical final

rule, today’s action further increases the

utility of TRI to the public by lowering

the reporting thresholds for lead and

lead compounds. Lowering the

reporting thresholds for lead and lead

compounds will ensure that the public

has important information on the

quantities of these chemicals released or

otherwise managed as waste, that would

not be reported under the 10,000 and

25,000 pound/year thresholds that

apply to most other listed toxic

chemicals.

B. What Outreach Has EPA Conducted?

EPA has engaged in a comprehensive

outreach effort relating to this action.

This outreach served to inform

interested parties, including industries

and small businesses affected by the

rule, state regulatory officials,

environmental organizations, labor

unions, community groups, and the

general public of EPA’s intention to

lower the applicable EPCRA section 313

reporting thresholds for lead and lead

compounds. EPA held three public

meetings (in Los Angeles, CA

(November 30, 1999); Chicago, IL

(December 2, 1999); and Washington,

DC (December 14, 1999)) during the

comment period for the proposal.

Participants included a range of

industry representatives, trade

associations (representing both small

and large businesses), law firms

representing industry groups,

environmental groups, the general

public, plus other groups and

organizations. For state and tribal

governments, EPA attended the

regularly-held public meetings of the

Forum on State and Tribal Toxics

4502 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

Action (FOSTTA) to discuss the

proposed rule. EPA also received

substantial public comment on the

proposed rule, to which EPA is

responding in this Final Rule and the

Response to Comments document (Ref.

1). In response to the strong interest in

the proposed rule, and to allow more

individuals and groups to submit their

comments, EPA extended the public

comment period. The comment period

was first extended from September 17 to

November 1, 1999 (at 64 FR 51091,

September 21, 1999) (FRL–6382–9) and

then again from November 1 to

December 16, 1999 (at 64 FR 58370,

October 29, 1999) (FRL–6391–8) to

allow commenters time to supplement

or revise their comments in light of the

decisions made in the final PBT

chemical rulemaking (64 FR 58666).

Additional information regarding EPA’s

outreach may be found in supporting

documents included in the public

version of the official record.

IV. Summary of Proposal

A. What Persistence and Environmental

Fate Data were Presented 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 it is released into the environment.

The environmental fate determines the

extent to which 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 in the

proposed rule for the environmental fate

of lead in each environmental medium

represented the key elements

influencing the transport,

transformation, and bioavailability of

lead in air, soil, water and sediments.

This information, as well as a more

extensive review of the existing data on

the environmental fate of lead are

contained in The Environmental Fate of

Lead and Lead Compounds (Ref. 2) and

in the references contained therein.

Based on this information, EPA

concluded that processes commonly

observed in the environment can result

in the release of available (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 showed that under many

environmental conditions lead is

available to express its toxicity and to

bioaccumulate. In the EPCRA section

313 program, the issue of the

environmental availability of metals

from metal compounds is broader than

just its implications for whether a

chemical is a PBT. The issue of both the

environmental availability and

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 from

the EPCRA section 313 list of toxic

chemicals. EPA developed this petition

policy specifically to address such

circumstances.

B. What Aquatic Bioaccumulation Data

was Presented 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

term bioaccumulation refers to uptake of

chemicals by organisms both directly

from water and through their diet (Ref.

3). 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.

4). 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

certain lead compounds ( lead salts) in

aquatic plants and animals are often

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4503

above a bioconcentration/

bioaccumulation factor of 1,000 and in

some species at or greater than 5,000.

Lead is bioaccumulated by aquatic

organisms such as plants, bacteria,

invertebrates, and fish. The principle

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. 5), 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.

The bioaccumulation 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, can be found in

the bioaccumulation support document

(Ref. 6). Concentrations of lead

monitored in various organisms were

determined by comparing

concentrations in the environment

(water) with concentrations measured in

the organisms. In general,

bioconcentration values for four

freshwater invertebrate species ranged

from 499 to 1,700 (Ref. 7). 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 had 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 at or

above 5,000. The references cited for

blue mussels include a range of values,

the upper end of which is essentially

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.

C. What Human Bioaccumulation Data

was Presented for Lead and Lead

Compounds?

There is a great deal of information

available on the bioaccumulation of lead

in humans and the effects that such

accumulation can have (Refs. 8, 9, 10,

and 11). The bioaccumulation 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. 12 and 13).

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 the most recent publicly available

National Health and Nutrition

Examination Surveys (see Ref. 9),

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 (mg/ 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 indicates that nearly

900,000 children aged 1–5 have

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. 14). 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 may

appear modest, the total accumulation

rate is actually 80-fold. The increase is

80-fold because children undergo a 40-

fold increase in skeletal mass. 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. Such absorbed

and accumulated lead can cause

significant deleterious health effects,

particularly in children.

D. What Proposed Conclusions did EPA

Reach from Its Proposal Review of the

Available Data on Lead and Lead

Compounds?

EPA’s review of the available

information on lead and lead

compounds led EPA to conclude that

lead and lead compounds are highly

persistent and at the least,

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 available, the

data indicate that under many

environmental conditions lead does

become available. The conclusion that

lead is available 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, has been found to

bioaccumulate in organisms observed in

the environment, and has been found to

bioaccumulate in humans. EPA noted in

its proposal that 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 at or above 5,000.

The references cited for blue mussels

include a range of values, the upper end

of which is essentially 5,000 (i.e.,

4,985). In addition, EPA explained that

‘‘[t]he bioaccumulation and persistence

of lead in humans is well documented’’

and requested comment on how such

4504 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

data should be regarded in classifying

lead and lead compounds as highly

bioaccumulative.

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 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, provided the

basis for EPA preliminarily concluding

that lead and lead compounds are

highly persistent and highly

bioaccumulative.

E. What Changes to the Reporting

Thresholds did EPA Propose for Lead

and Lead Compounds?

In evaluating potential lower

reporting thresholds for lead and lead

compounds, EPA considered not only

their persistence and bioaccumulation

properties and the purposes of EPCRA

section 313, but also the potential

burden that might be imposed on the

regulated community. Because PBT

chemicals, including lead and lead

compounds, persist and bioaccumulate

in the environment, they have the

potential to pose greater exposure to

humans and the environment over a

longer period of time. The nature of PBT

chemicals, including 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 10,000 and 25,000 pounds. For

determining how low reporting

thresholds should be set for PBT

chemicals, including lead and lead

compounds, EPA adopted a two-tiered

approach. Thus, EPA made a distinction

between persistent bioaccumulative

toxic chemicals and that subset of PBT

chemicals that are highly persistent and

highly bioaccumulative by setting lower

reporting thresholds based on two levels

of concern. As explained in the final

PBT rule and in the proposed lead rule,

this approach identifies as PBT

chemicals those that are persistent (i.e.,

with half-lifes of at least 2 months) and

those that are bioaccumulative (i.e.,

based on aquatic studies showing BAF/

BCF values of at least 1,000 and/or

human data showing evidence of

bioaccumulation). Further, as also

explained in the PBT rule and the

proposed lead rule, highly PBT

chemicals are identified as those that

are highly persistent (i.e., with half-lifes

of 6 months or greater) and those that

are highly bioaccumulative (e.g., BAF/

BCF values of 5,000 or greater). EPA

preliminarily concluded that lead and

lead compounds to be highly persistent

and highly bioaccumulative toxic

chemicals.

In determining the appropriate

reporting thresholds to propose for lead

and lead compounds, EPA started with

the premise that low or very low

reporting thresholds may be appropriate

for these chemicals based on their

persistence and bioaccumulation

potentials only. EPA then considered

the burden that would be imposed by

lower reporting thresholds and the

distribution of reporting across covered

facilities. Using this approach and

considering the factors described above

and the purposes of EPCRA section 313,

EPA proposed to lower the manufacture,

process, and otherwise use thresholds to

10 pounds for lead and lead

compounds. For purposes of section 313

reporting, threshold determinations for

chemical categories, including lead

compounds, are based on the total of all

toxic chemicals in the category (see 40

CFR 372.25(d)).

F. What Other Reporting Issues Did EPA

Consider for Lead and Lead

Compounds?

1. De minimis exemption. In 1988,

EPA promulgated the de minimis

exemption because: (1) The Agency

believed that facilities newly covered by

EPCRA section 313 would have limited

access to information regarding low

concentrations of toxic chemicals in

mixtures that are imported, processed,

otherwise used or manufactured as

impurities; (2) the Agency did not

believe that these low concentrations

would result in quantities that would

significantly contribute to threshold

determinations and release calculations

at the facility (53 FR 4509, February 16,

1988); and (3) the exemption was

consistent with information required by

the Occupational Safety and Health

Administration’s (OSHA) Hazard

Communication Standard (HCS).

However, given that: (1) Covered

facilities currently have several sources

of information available to them

regarding the concentration of PBT

chemicals in mixtures; (2) even minimal

releases of persistent bioaccumulative

toxic chemicals may result in significant

adverse effects and can reasonably be

expected to significantly contribute to

exceeding the proposed lower

thresholds; and (3) the concentration

levels chosen, in part, to be consistent

with the OSHA HCS are inappropriately

high for PBT chemicals, EPA’s original

rationale for the de minimis exemption

does not apply to PBT chemicals. EPA

therefore proposed to eliminate the de

minimis exemption for lead and lead

compounds based on their status as PBT

chemicals. EPA did not propose,

however, to modify the applicability of

the de minimis exemption to the

supplier notification requirements (40

CFR 372.45(d)(1)) because the Agency

believed there was sufficient

information available.

2. Use of the Alternative threshold

and Form A. EPA stated its belief that

use of the existing alternate threshold

and reportable quantity for Form A

would be inconsistent with the intent of

expanded reporting for PBT chemicals

such as lead and lead compounds. The

general information provided in the

Form A on the quantities of the

chemical that the facility manages as

waste is insufficient for conducting

analyses on PBT chemicals and would

be virtually useless for communities

interested in assessing risk from releases

and other waste management of PBT

chemicals. EPA, therefore, proposed

excluding lead and lead compounds

from the alternate threshold of 1 million

pounds.

3. Proposed changes to the use of

range reporting. EPA stated its belief

that use of ranges could misrepresent

data accuracy for lead and lead

compounds because the low or the high

end range numbers may not really be

that close to the estimated value, even

taking into account any inherent error in

reporting (i.e., errors in measurements

and developing estimates). EPA

believed this uncertainty would

severely limit the applicability of

release information where the majority

of a facility’s releases are within the

amounts eligible for range reporting.

Given EPA’s belief that the large

uncertainty that would be part of these

data would severely limit their utility,

EPA proposed to eliminate range

reporting for lead and lead compounds.

4. Proposed changes to the use of the

half-pound rule and whole numbers.

EPA currently allows facilities to report

whole numbers and to round releases of

0.5 pound or less to zero when reporting

on EPCRA section 313 listed chemicals

not designated as PBT chemicals in the

October 29, 1999 final rule. EPA

explained its concern that the

combination of requiring the reporting

of whole numbers and allowing

rounding to zero would result in a

significant number of facilities reporting

their releases of lead and lead

compounds as zero. EPA, therefore,

proposed that all releases or other waste

management quantities greater than 1⁄10

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4505

of a pound of lead and lead compounds

be reported, provided that the

appropriate activity threshold has been

exceeded.

5. Proposed exemption for the

reporting of lead in certain alloys. In the

proposal, EPA proposed to defer making

a final decision on lower reporting

thresholds for lead contained in

stainless steel, brass, and bronze alloys

until the Agency could complete an

ongoing scientific review of issues

pertinent to the reporting of these types

of 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 these three

types of alloys. EPA, therefore, proposed

to include a qualifier to the listing for

lead in 40 CFR 372.28. This qualifier

would read ‘‘this lower threshold does

not apply to lead when contained in a

stainless steel, brass, or bronze alloy.’’

V. Summary of the Final Rule

A. What Threshold Has EPA Established

for Lead and Lead Compounds?

EPA is finalizing manufacture,

process, and otherwise use thresholds of

100 pounds for lead and lead

compounds, with the first reports at this

lower threshold due on or before July 1,

2002, for the 2001 calendar year. This

lower reporting threshold does not

apply to lead contained in stainless

steel, brass, and bronze alloys nor do

any of the other changes discussed

below in Unit V.B. However, lead

contained in stainless steel, brass, and

bronze alloys remains reportable under

the 25,000 pound manufacture and

process reporting threshold and the

10,000 pound otherwise use reporting

threshold.

B. What Exemptions and Other

Reporting Issues is EPA Addressing for

Lead and Lead Compounds?

EPA is eliminating the de minimis

exemption for lead and lead

compounds. However, this action will

not affect the applicability of the de

minimis exemption to the supplier

notification requirements (40 CFR

372.45(d)(1)). In today’s action, EPA is

also excluding lead and lead

compounds from eligibility for the

alternate threshold of 1 million pounds

and eliminating range reporting for onsite releases and transfers off-site for

further waste management for lead and

lead compounds. This will not affect the

applicability of the range reporting of

the maximum amount on-site as

required by EPCRA section 313(g). EPA

proposed to require reporting of all

releases and other waste management

quantities greater than 1⁄10 of a pound of

lead and lead compounds. Also, EPA

proposed that releases and other waste

management quantities would continue

to be reported to two significant digits.

In addition, EPA proposed that for

quantities of 10 pounds or greater, only

whole numbers would be required to be

reported. After reviewing all the

comments on this issue, EPA is

providing additional guidance on the

level of precision at which facilities

should report their releases and other

waste management quantities of lead

and lead compounds. Facilities should

still report releases and other waste

management quantities greater than 0.1

pound provided the accuracy and the

underlying data on which the estimate

is based supports this level of precision.

Rather than reporting in whole numbers

and to two significant digits, if a

facility’s release or other waste

management estimates support

reporting an amount that is more precise

than whole numbers and two significant

digits, then the facility should report

that more precise amount. The Agency

believes that, particularly for PBT

chemicals such as lead and lead

compounds, facilities may be able to

calculate their estimates of releases and

other waste management quantities to

1⁄10 of a pound and believes that such

guidance is consistent with the

reporting requirements of sections

313(g) and (h).

VI. Summary of Public Comments and

EPA Responses

A. How is EPA Responding to

Comments Relating to Generic Issues?

EPA received numerous comments

relating to the generic issues raised and

resolved in the first rulemaking on PBT

chemicals, published on October 29,

1999 (64 FR 58666); for example,

whether the Agency should select lower

thresholds based on a risk assessment.

Some commenters merely reiterate

comments raised in the previous

rulemaking. Other commenters

rephrase, in terms of lead and lead

compounds, comments that have been

previously submitted on these generic

issues, without presenting additional

information or concerns specific to lead

and lead compounds.

In its proposal to lower the thresholds

for lead and lead compounds, EPA

explicitly limited its request for

comments to issues specific to lead and

lead compounds, such as whether lead

and lead compounds meet the EPCRA

section 313 persistence and

bioaccumulation criteria articulated in

the PBT rule and proposed lead rule,

and whether lead and lead compounds

present such unique technical or policy

issues that they merit different

treatment than that established for

either the class of PBT chemicals or the

subset of highly persistent and highly

bioaccumulative toxic chemicals (see 64

FR 42224 and 58666). Notwithstanding

that EPA extended the comment period

on this rulemaking to allow for an

additional 48 days following

publication of the final PBT chemical

rule, commenters failed to present

issues or information that persuades the

Agency to revisit the decisions made

with respect to generic issues in the PBT

chemical rule, or that provides any basis

for treating lead and lead compounds

separately from how the Agency

generally approachs PBT chemicals

within the EPCRA section 313 program.

To the extent that commenters

provide comments on the generic issues

that were specific to lead and lead

compounds, these comments are

addressed in this preamble and in the

Response to Comments (RTC) document

for this final rule (Ref. 1). For responses

to those comments on the generic issues

that were not specific to lead and lead

compounds the reader is referred to the

PBT chemical final rule (64 FR 58666)

and the associated Response to

Comments document (Ref. 15). The

remainder of this Unit contains

responses to major comments on the

issues of the EPCRA section 313

reporting thresholds for lead and lead

compounds, the technical information

regarding the persistence and

bioaccumulation potential of lead and

lead compounds, and the alloys

reporting limitation for lead. Responses

to major comments on EPA’s economics

analysis (Ref. 16) and regulatory

assessment determinations are

contained in Units VII and IX

respectively. Additional responses to

comments not addressed in this

preamble are contained in the RTC

document for this final rule (Ref. 1).

B. What Comments did EPA Receive on

its Statutory Authority to Lower

Reporting Thresholds for Lead and Lead

Compounds?

Several commenters allege that under

EPA’s interpretation of EPCRA section

313(f)(2), Congress did not provide an

‘‘intelligible principle’’ for determining

whether or how much to lower a

statutory threshold, thereby rendering

this provision unconstitutional as an

improperly broad delegation of

legislative power. The commenters raise

several points in support of this

contention; several commenters cite

4506 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

EPA’s statement in the proposal that

‘‘Congress provided no prerequisites to

the exercise of EPA’s authority to lower

[EPCRA section 313] thresholds’’ to

demonstrate that EPA does not have the

authority to lower the thresholds

without violating the non-delegation

doctrine. Other commenters support

this allegation merely by reference to

the fact that EPCRA section 313(f)(2)

does not prohibit the Agency from

establishing a threshold of ‘‘0.’’ Another

commenter contends that the

unconstitutional delegation of authority

is even more striking than it was in

section 109(b)(1) of the Clean Air Act,

which at least provided the Agency with

the direction to set standards ‘‘requisite

to protect the public health’’ and ‘‘with

an adequate margin of safety.’’ EPCRA,

the commenter states, sets forth no

standard for establishing reduced

reporting thresholds. To support their

assertions, several of these commenters

specifically cite the decision in

American Trucking Association v. EPA,

175 F.3d 1027 (D.C. Circuit, 1999) cert.

granted sub nom. Browner v. American

Trucking Association, 120 S.Ct 2003

(US May 22, 2000)(No. 99–1247).

EPA disagrees. As a preliminary

matter, EPA disagrees with the

interpretation of the non-delegation

doctrine articulated in American

Trucking, and has appealed that

decision to the Supreme Court.

Nonetheless, EPA believes that Congress

has provided an ‘‘intelligible principle’’

sufficient for the delegation of authority

contained in EPCRA section 313(f)(2).

The commenters appear to have

fundamentally misunderstood EPA’s

explanation of its rationale for selecting

the specific thresholds adopted in the

final PBT chemical rule, and the

implications these actions had for the

selection of the thresholds for lead and

lead compounds. As part of the

discussion in the final PBT chemical

rule, EPA noted that for several reasons,

it was establishing ‘‘two sets of revised

thresholds based on two classes of PBT

chemicals,’’ and stated its intention that

‘‘the revised thresholds establish a set of

categories that would be generally

applicable to future designated PBT

chemicals.’’ (64 FR 58689). Thus, the

selection of the specific threshold for

lead and lead compounds is governed

by the analyses laid out in EPA’s

preamble to the final PBT chemical rule

and in the proposed lead rule. See also

EPA’s rationale for the specific

threshold chosen for lead and lead

compounds, infra at Unit VI.E. Under

this construct, taking into account the

aquatic and human data available.

In the preamble to the final PBT

chemical rule, and the associated

Response to Comments Document (Ref.

15) , EPA described at length the

process by which it distilled

Congressional guidance from various

sources, such as the language and

legislative history of EPCRA sections

313(f)(2) and (h), to guide its exercise of

discretion in lowering the thresholds.

See (e.g., (64 FR 58687–692).

Specifically, EPA explained:

EPA relied on the language of EPCRA

sections 313(f)(2) and (h), and the

legislative history, to elicit the following

principles to guide its exercise of

discretion in lowering the thresholds,

and in selecting the specific thresholds:

(1) The purposes of EPCRA section 313;

(2) the ‘‘verifiable, historical data’’ that

convinces EPA of the need to lower the

thresholds; (3) the chemical properties

shared by the members of the class of

toxic chemicals for which EPA is

lowering the thresholds (i.e., the degree

of persistence and bioaccumulation);

and (4) the reporting burden imposed by

revised thresholds to the extent that

such consideration would not deny the

public significant information from a

range of covered industry sectors.

Further, EPA believes that in the

language of EPCRA § 313, and its

legislative history, Congress provided

direction on the appropriate weight to

allocate to each of these considerations

in implementing EPCRA section

313(f)(2). These considerations underlay

the entire process by which EPA

determined the appropriate thresholds.

But the Agency’s choice of revised

thresholds was governed, and ultimately

constrained, by EPCRA section 313’s

overriding purpose, which is to provide

government agencies, researchers, and

local communities, with a

comprehensive picture of toxic

chemical releases and potential

exposures to humans and ecosystems.

Id. at 58687.

EPA also disagrees with the analyses

on which the commenters rely to

support their assertions that Congress

provided no intelligible principle to

guide EPA’s delegated authority under

EPCRA section 313(f)(2). Whether the

legislative guidance offered sufficiently

constrains the discretion delegated to

the Agency under EPCRA section

313(f)(2) must be evaluated against the

actual ‘‘power to roam’’ that this

provision confers on EPA. Michigan v.

EPA, 213 F.3d 663, 680-81 (D.C. Cir.

2000). As discussed in Unit II.A., as

EPA interprets the requirements in

section 313(f)(2), the standard operates

as an effective constraint when the

Agency increases the thresholds, but as

a practical matter, cannot provide the

same level of constraint when the

Agency decreases the thresholds.

However, as previously explained, EPA

relied on this standard to elicit factors

to guide its exercise of discretion. See,

64 FR 58687–692.

But the mere fact that Congress

provided neither explicit prerequisites

in section 313(f)(2) to the Agency’s

determination that a lower threshold is

warranted, nor a standard whose plain

language effectively constrains EPA’s

discretion in selecting the appropriate

lower threshold, does not necessarily

render this provision unconstitutional.

The issue is whether Congress granted

the Agency too much discretion to

modify the statutory thresholds—not

merely whether Congress provided a

standard to significantly constrain the

Agency’s discretion in lowering the

thresholds. See Michigan v. EPA, 213

F.3d at 680; International Union v.

OSHA, 37 F.3d 665 (D.C. Cir. 1994).

Examination of the former issue

demonstrates that in section 313(f)(2),

EPA’s ‘‘power to roam’’ is relatively

narrow.

In section 313(f), Congress established

thresholds as a baseline, and delegated

authority to EPA to modify them

provided that the ‘‘revised thresholds

shall obtain reporting on a substantial

majority of total releases of the chemical

at all facilities subject to the

requirements of this subsection.’’ As

previously explained, EPA interprets

this to require that any revised

threshold obtain reporting on a

substantial majority of the total releases

reported by facilities reporting under

the existing, baseline thresholds. See,

Unit II.A. supra, and 64 FR 58673–676.

This standard effectively constrains

EPA’s ability to increase the thresholds,

and thereby deprive government

agencies, researchers, and local

communities of information that would

provide them with a comprehensive

picture of toxic chemical releases and

potential exposures to humans and

ecosystems, contrary to EPCRA section

313’s overriding purpose. The discretion

exercised in this rule is EPA’s discretion

to establish thresholds between 0 and

10,000 pounds or 25,000 pounds; this

can hardly be characterized as an

‘‘immense power to roam.’’

Moreover, the impact of any revised

threshold is distinctly limited, which

courts have recognized as a relevant

factor in evaluating the degree of

authority that Congress delegates to an

Agency. See, e.g., Michigan, 2000 WL

180,650 (‘‘a mass of cases in courts had

upheld delegations of effectively

standardless discretion, and

distinguished them precisely on the

ground of the narrower scope within

which the agencies could deploy that

discretion’’); American Trucking, 175

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4507

F.3d at 1037 (‘‘The standards in

question affect the whole economy,

requiring a more precise delegation than

would otherwise be the case’’ (citations

omitted)). Here, that means within the

context of all of the other prerequisites

Congress established for TRI reporting,

and of the other relevant statutory

provisions constraining the Agency’s

ability to modify those requirements.

Irrespective of the modified threshold, a

facility must still employ more than ten

full-time employees; its primary SIC

code must fall within one of the listed

SIC codes; and it must be

manufacturing, processing, or otherwise

using one (or more) of the currently

listed chemicals. 42 U.S.C. § 11023 (b).

And far from granting EPA unfettered

discretion to expand these

requirements, Congress selectively

granted EPA carefully qualified

authority to adjust individual

parameters. For example, section 313(l)

explicitly limits the Agency’s authority

to modify the reporting frequency, ‘‘...

but the Administrator may not modify

the frequency to be any more often than

annually.’’ Similarly, Congress included

no authority to amend the generally

applicable employee threshold; thus

facilities with fewer than ten employees

are not subject to reporting under

subsection 313(b)(1). In section

313(g)(2), Congress also specifically

restricted the Agency’s ability to require

industry to collect data to report under

TRI: ‘‘Nothing in [EPCRA section 313]

requires the monitoring or measurement

of the quantities, concentration, or

frequency of any toxic chemical

released into the environment . . .’’

Accordingly, the scope within which

EPA may deploy its discretion under

EPCRA section 313(f)(2) is fairly narrow,

and its impact limited.

In light of the above, EPA does not

believe that the mere fact that the

Agency is authorized to potentially

select a threshold of ‘‘0,’’ necessarily

renders section 313(f)(2)

unconstitutional. The issue underlying

the non-delegation doctrine, as the DC

Circuit has explained is ‘‘to make sure

that the regulatory principles as applied

have their origin in a judgement of the

legislature,’’ not whether Congress

authorized the Agency to establish

extremely low thresholds. International

Union v. OSHA, 37 F.3d at 669

(citations omitted). Nor does the fact

that Congress did not require the

Agency to make specific findings to

determine it was appropriate to increase

or decrease section 313 reporting

thresholds, necessarily demonstrate that

Congress failed to provide the Agency

with adequate guidance in delegating its

authority under section 313(f)(2).

One commenter further alleged that

the Agency has failed to identify an

intelligible principle ‘‘to channel its

application of these factors,’’ quoting,

American Trucking Association v. EPA.

Another commenter asserts that EPA’s

reliance on the general purposes of

EPCRA is insufficient, stating that

‘‘general purposes or factors cannot

substitute for the constitutionally

required ‘‘intelligible principle’’ by

which to identify a stopping point’’

when setting levels or thresholds.

As noted above, the Supreme Court

has granted EPA’s request to review

American Trucking. Nonetheless, EPA

disagrees that EPCRA section 313(f)(2)

falls afoul of the non-delegation

doctrine, even as interpreted and

applied in that case. As summarized

above, in the preamble to the final PBT

chemical rule, EPA identified and

explained its application of the

‘‘intelligible principle’’ that Congress

provided along with the delegation of

authority in EPCRA section 313(f)(2).

See, 64 FR 58687–692.

EPA also disagrees that its reliance on

EPCRA section 313’s general purposes

to discern EPCRA section 313’s

overriding purpose, and thereby its

intelligible principle, is insufficient.

The DC Circuit upheld a broad

delegation of legislative authority to

OSHA based on the Agency’s

demonstration of legislative guidance

found in the Act’s ‘‘overriding

purposes.’’ There, the Court noted

Were the six itemized criteria the full

statement of OSHA’s interpretation of its

statutory mandate, we might have to vacate

the rule, because the agency might still have

too much freedom to ‘‘roam between the rigor

of section 6(b)(5) standards and the laxity of

unidentified alternatives. International Union

I, 938 F.2d at 1317. But OSHA has gone on

to infer from various sections—that the Act’s

‘‘overriding purpose’’ is ‘‘to provide a high

degree of employee protection.’’ 58 FR 16,

614/3–15/1. Thus the Agency reads the Act

to require it, once it has identified a

‘‘significant’’ safety risk to enact a safety

standard that provides ‘‘a high degree of

worker protection.’’Id. at 16, 615/1. It is not

permitted to ‘‘do nothing at all’’, as we had

earlier suggested. Id. (quoting International

Union I, 938 F.2d at 1317). Rather, OSHA

reads the Act to permit it to deviate only

modestly from the stringency required by

section 6(b)(5) for health standards.

Accordingly, as construed by OSHA, the Act

guides its choice of safety standards enough

to satisfy the demands of the nondelegation

doctrine. (citations omitted). International

Union v. OSHA, 37 F.3d at 669 (emphasis

added).

The Court also explained that the

underlying purpose of non-delegation

doctrine is ‘‘to make sure that the

regulatory principles as applied have

their origin in a judgement of the

legislature.’’ Id. (citations omitted). EPA

believes that its application of EPCRA

section 313(f)(2) in this rule, as well as

in the PBT rule, similarly satisfy the

demands of the nondelegation doctrine.

C. What Science Issues Were Raised by

Commenters on the Persistence and

Bioaccumulation Criteria?

Several commenters contend that the

criteria articulated in the PBT chemical

rule to characterize the persistence and

bioaccumulation of toxic chemicals

should not be applied to metals because

the development of the persistence and

bioaccumulation criteria (as discussed

in the PBT chemical rulemaking, see 64

FR 688–729) was based largely on data

pertaining to organic substances. Thus

they contend it is inappropriate to use

these criteria to determine whether

inorganic substances, including

inorganic metal compounds, should be

classified as PBT chemicals.

The Agency disagrees with the

commenters’ statement that the PBT

rule framework developed by EPA to

assess the persistence and

bioaccumulation of EPCRA section 313

listed toxic chemicals was designed

only for organic substances and is being

incorrectly applied to metals. The

development of EPA’s framework to

assess persistence and bioaccumulation

is described in detail in the PBT

chemical rulemaking (see 64 FR 688–

729) and in the proposed lead rule. This

framework was not developed to assess

only whether organic chemicals are

persistent and/or bioaccumulative, but

to assess whether any chemical

substance is persistent and/or

bioaccumulative, including metals and

metal compounds. EPA notes that the

public had the opportunity to comment

on the applicability of the PBT rule

criteria to metals in the PBT chemical

rulemaking. Furthermore, in the PBT

chemical rulemaking, the Agency

applied these criteria to mercury and

mercury compounds—a metal and metal

compounds category. EPA also provided

notice in the proposed PBT chemical

rulemaking that it was continuing to

evaluate the bioaccumulation data for

lead and lead compounds, and for

cobalt and cobalt compounds—also

metals (64 FR 717). EPA made clear the

PBT rule criteria were developed to

apply to metals and metal compounds,

as well as organic compounds and, in

fact, has applied the criteria to metals

and metal compounds in a previous

notice and comment rulemaking. With

respect to the half-life and BCF/BAF

criteria, scientifically these criteria are

quite applicable to metals. Finally in the

4508 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

lead proposed rule, EPA identified an

additional factor for use in determining

whether a chemical is, at the least,

bioaccumlative. EPA explained that

there is clear and convincing evidence

that lead is bioaccumulative in humans.

However, EPA requested comment on

how such human data should be

considered in determining whether a

chemical should be classified in that

subset of PBT chemicals that are highly

bioaccumulative. Commenters argue

that the human data should not be used

to classify lead as bioaccumulative

because the quantities of lead that might

be reported, they believe, would not

reduce human exposures to lead that are

of concern. As explained elsewhere,

EPA does not believe that human data

showing the bioaccumulation nature of

lead in humans should be ignored in

any assessment of lead’s

bioaccumulation potential simply on

the theory that the level of lead to which

humans are exposed and the levels

observed in humans may not correlate

to the additional information on land

release collected under this rule.

Persistence, bioaccumulation, and

toxicity are three distinct, independent

characteristics. Although in the PBT

chemical rulemaking the experimental

evidence used to derive the

environmental half-life, BAF and BCF

criteria were obtained largely from

studies that involved organic

substances, this does not preclude the

application of these criteria to inorganic

substances such as metals and metal

compounds (including lead and lead

compounds). The basis for the concern

and reason for lowering thresholds is

based on the ability of the chemical,

whether it is an organic chemical or a

metal compound, to persist and

bioaccumulate. The Agency believes

that these criteria should and must be

applicable to all chemical substances,

including metals and metal compounds.

EPA provided a detailed response to the

issue of metals as PBT chemicals in the

PBT chemical rulemaking. Persistence

and bioaccumulation are not dependent

upon whether a substance contains

carbon (i.e., is organic). Substances that

are inorganic can persist and

bioaccumulate. The underlying

molecular properties that determine

whether a substance can persist and

bioaccumulate are fundamentally the

same for organic chemicals as they are

for inorganic chemicals, including

metals and metal compounds. These

properties, as with most chemical and

biological properties of a substance, are

more dependent on the electronic and

steric characteristics of the atoms

comprising a substance, the specific

arrangement of the atoms within the

substance’s molecular structure and,

with regard to bioaccumulation, the

pharmacokinetics of the substance

within the exposed organism and the

sensitivity of the organism to the

substance.

In addition, it is scientifically valid to

establish generic criteria that are

applicable to all substances provided

that the endpoint or purpose for which

the criteria are being established

provides a common thread that is not

dependent upon the unique elements

comprising any given substance. For

example, it would be legitimate to

establish a category based on a type of

arsenic toxicity and include within that

category any substance that contains

arsenic and exhibits that toxicity

regardless of whether individual

substances are organic or inorganic. In

fact, it is common practice for scientific

organizations and regulatory agencies to

use generic criteria of this type. One

example is the criteria established by

the National Toxicology Program (NTP)

for characterizing chemical carcinogens.

The NTP is required by law to establish

a list of all substances which either are

known to cause cancer in humans, or

may reasonably be anticipated to cause

cancer in humans. A criterion used by

the NTP to characterize chemicals as

known or possible human carcinogens

include, among others, tumor

incidences in humans or experimental

animals. While the vast majority of

substances reviewed and tested by the

NTP for carcinogenicity are organic

substances, and the criterion established

by NTP was based largely from

toxicological observations pertaining to

organic substances, the criterion used by

the NTP is the same for inorganic

substances as it is for organic

substances. The NTP does not use

different criteria when evaluating

inorganic substances. This is because

the ability of a substance to cause cancer

is not dependent upon whether the

substance is organic. In fact, NTP’s

current list of substances that are known

to be human carcinogens contains both

inorganic (including metallic) and

organic substances. The carcinogenicity

of all of these substances were

characterized by the same generic

criterion. A detailed discussion of the

criteria used by the NTP is available

(Ref. 17).

1.What comments did EPA receive on

the persistence of metals and metal

compounds? EPA defines a chemical’s

persistence as the length of time the

chemical can exist in the environment

before being destroyed by natural

processes. Numerous commenters

suggested that EPA adopt a different

definition of persistence for metals and

metal compounds. They assert that the

definition of persistence as applied to

metals and metal compounds should

include the transformation of individual

metal compounds in the environment.

As discussed in detail in the following

response to comments on this issue,

EPA believes that these factors are

irrelevant to the persistence of metals

and metal compounds in the

environment. The factors that the

commenters contend should be

considered are those which address the

conversion of one metal compound to

another, which is irrelevant in

determining whether metal compounds

are persistent. While these are factors

which control the transformation of one

metal compound to another compound

of the same metal, they are not factors

which result in the destruction of the

metal. There are no environmental

factors which can or will result in the

destruction of the metal.

Some commenters disagree with

EPA’s definition of persistence. They

contend that the definition of

persistence should be based on the

availability of the metal in various

environments and the length of time the

metal is retained in an organism. One of

these commenters stated that

‘‘persistence is the length of time an

element or compound is available to

and/or is retained in an organism or an

ecological community, and that the

mobility of metals [such as lead]

deposited in soils or aquatic sediments

becomes an important question when

discussing persistence, since they are

not persistent in biota unless they reach

those environmental compartments and

are cleared more slowly than they

accumulate.’’

EPA disagrees with the commenter’s

definition of persistence. In the PBT

chemical rulemaking (64 FR 58666),

EPA adopted a policy for use in

classifying a toxic chemical as persistent

under EPCRA section 313. In the

proposed rule to lower the reporting

thresholds of lead and lead compounds

(64 FR 42222), EPA used this same

policy to determine whether lead and

lead compounds are persistent. Most of

these comments address the issue of

persistence generically rather than

specifically to lead and lead

compounds. EPA responded to these

generic issues in the PBT chemical

rulemaking (64 FR 58676) and in

sections 2a–f of the associated Response

to Comments document (Ref. 15). EPA

is discussing these issues here as

background for the individual issues

specific to lead and lead compounds in

order to assist in understanding EPA’s

responses. Persistence is the length of

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4509

time a chemical can exist in the

environment before being destroyed by

natural processes (64 FR 698 and 64 FR

42227). The environmental media for

which persistence is measured or

estimated include air, water, soil, and

sediment. 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. Persistence in the environment

as a whole, however, is a distinct

concept. It is based on 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 properties and

reactivity. For overall persistence, only

irreversible transformation contributes

to net loss of a chemical substance. With

regard to metals, although metals and

metal compounds, such as 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 itself cannot be

destroyed. A metal by its very nature

cannot be destroyed and, therefore, is

persistent in the environment as the

metal or a metal compound.

The primary purpose of the

persistence criterion is to establish how

long a chemical substance will remain

in the environment. The greater the

length of time a substance persists in the

environment, the greater is the potential

for all forms of life to be exposed to the

substance. Persistence is not limited to

the duration of time a chemical is

present in an organism and EPA does

not believe it would be appropriate to

incorporate this concept into its

definition of persistence. It should be

noted that, unlike the commenter’s

definition of persistence, EPA’s

definition of persistence does not

specifically address the longevity of a

substance in an organism. Persistence of

a substance in the environment as a

whole, or even in a particular

environmental medium, is

fundamentally unrelated to the

substance’s biological persistence (i.e.,

length of time a chemical exists in an

organism before being destroyed or

excreted). Although there are a few

factors (physicochemical factors; e.g.,

water solubility, reactivity) that have a

similar influence on environmental

persistence as they do on the biological

persistence of a substance, there are a

number of other factors that influence

biological persistence but not

environmental persistence. These other

factors are organism specific, and are

related to the anatomical and

physiological characteristics of the

organism. The Agency believes its

environmental persistence criterion

should not be extended to include

biological persistence because the

factors that influence the two

persistence types are largely unrelated.

Biological persistence in a given

organism does not provide any

information as to how long a substance

will remain in the environment, and

therefore is not relevant to the definition

of persistence for EPCRA section 313.

One commenter claims that there is a

serious flaw in the Agency’s reasoning

in characterizing all elements, including

metals, as being persistent. Specifically,

this commenter claims that this

reasoning implies that because elements

are non-destructible, then any

compounds that contain a particular

element is also non-destructible. The

commenter acknowledges that EPA

makes the statement in the proposed

lead rule that ‘‘specific metal

compounds may or may not be

persistent, depending on the form of the

metal and environmental conditions,

but the elemental metal itself obviously

meets the definition of persistence.’’

The commenter claims that this

statement begs the questions as to why

EPA is not evaluating specific metal

compounds when the Agency

acknowledges that metal compounds

differ in their ‘‘persistence’’ and also

differ substantially with respect to

toxicity and bioaccumulative potential.

The commenter states that the above

quoted statement could just as easily

read ‘‘. . . specific carbon compounds

may or may not be persistent,

depending on the form of carbon and

environmental conditions, but the

elemental carbon itself obviously meets

the definition of persistence.’’ The

commenter asserts that, according to

EPA, this would mean that all organic

compounds are persistent because they

contain carbon and carbon is persistent.

The commenter states that the Agency

does not adopt such reasoning regarding

elemental carbon because it would

render the PBT chemical assessment

methodology useless as an assessment

tool. The commenter recommends that

the Agency not apply the persistence

assessment methodology to metals for

the same reasons.

Another commenter believes that

EPA’s criteria for persistence as it

applies to characterizing the persistence

of metals is unfair. Specifically, this

commenter interprets EPA’s persistence

assessment methodology as saying ‘‘...

since any metal is persistent in the

environment by definition, every

compound of that metal is evaluated

and regulated by EPA like the parent

metal, even if there are no data on that

compound’s persistence, even if the

persistence in the environmental

medium of its concern is very short, and

even if that compound’s bioavailability

is insignificant.’’

The Agency believes that both of

these commenters have misinterpreted

the PBT assessment methodology EPA

applied to lead and lead compounds.

With respect to the commenter who

questioned why EPA is not evaluating

the persistence of compounds

individually, EPA disagrees that it is

either scientifically required, or

necessary for purposes of EPCRA

section 313, to evaluate the persistence

of each lead compound individually.

lead compounds are listed under

EPCRA section 313 as a category; this

means that all of the individual

chemical compounds share common

chemical characteristics, such that it is

scientifically reasonable to conclude

that lead compounds exhibit common

toxicological properties/exhibit similar

toxicity. For lead compounds, as for all

metal compounds listed in an EPCRA

section 313 metals category, the relevant

common chemical property is the metal,

because the toxic constituent is the

metal itself, and this is what defines the

category. Thus, in evaluating the

persistence of lead compounds as an

EPCRA section 313 chemical category,

the relevant issue for purposes of

EPCRA section 313 is the persistence of

lead rather than the persistence of the

other chemical constituents of the

compounds in the category.

Similarly, EPA believes that this

commenter’s analogy to carbon and

organic compounds is misguided.

Organic compounds differ significantly

from metal compounds in that the

presence of carbon in a compound is not

a controlling feature in the way that a

metal contained in a metal compound is

controlling. For example inorganic

arsenic compounds are classified as

known human carcinogens (Ref. 18).

The toxicity is specific to the fact that

the compounds contain arsenic and not

to the other parts of the arsenic

compounds. This is not the case with all

groups of carbon compounds. For

example, classes of organic chemicals

that contain oxygen such as ketones,

alcohols, ethers, and carboxylic acids

exhibit significantly different physical

and chemical properties and toxic

effects. This is due to the differing

arrangement of the carbon and oxygen

within the compound. Even chemicals

within the same class of organic

chemicals, e.g., ketones, may not exhibit

the same toxicity or similar physical

4510 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

chemical properties. Further, while one

arsenic compound will be converted in

the environment or in vivo, it will not

be converted into a substance that does

not contain arsenic. In the environment

or in vivo degradation of one member of

a group of organic chemicals, e.g.,

ketones, carboxylic acids, will not

consistently be converted into another

chemical of the same class. They will

often be converted into a different class

of organic chemical.

Thus, while the Agency agrees that

elemental carbon is persistent, the

Agency would not conclude that all

organic substances are persistent simply

because they contain carbon. This is

because the toxic effects of organic

compounds are attributable to the

structure of the compounds and not the

carbon contained in the compounds.

Thus EPA would not list a chemical

category consisting of carbon and all

carbon containing compounds, nor

would it make a determination using the

PBT assessment methodology that such

compounds are PBT chemicals because

they contain carbon. The same is true

for any other element that is not toxic.

This approach is consistent with the

Agency’s approach to listing chemical

categories, where, in the absence of data

on a particular member of the category,

EPA adds a chemical category, such as

a metal compound category, based on

their common chemical characteristics,

and without demonstrating separately

that each individual member of the

category meets the section 313(d)(2)

criteria. The D.C. Circuit specifically

upheld this approach with respect to

listing categories, finding that EPA’s

action was reasonable (Troy v. Browner,

120 F.3d 277, 288-89 (D.C. Cir. 1997).

In addition, the commenters imply

that in using the PBT rule assessment

methodology EPA would conclude that

all metals and their compounds are

persistent and bioaccumulative, and

therefore the Agency would require that

all metals and their compounds that are

listed on the EPCRA section 313 list of

toxic chemicals have reduced reporting

thresholds. The Agency would like to

emphasize that while all metals persist,

many metals and their compounds

would not be characterized by EPA as

bioaccumulative and toxic. For a listed

toxic chemical to be considered a PBT

chemical, the toxic chemical must be

sufficiently persistent and sufficiently

bioaccumulative.

Several commenters disagree with the

Agency’s rationale for characterizing all

metals as being persistent, and believe

that the issue of persistence has little or

no relevance to metals.

The Agency disagrees with the

commenters’ statement that the issue of

persistence has little or no relevance to

metals. EPA believes that persistence is

relevant to the hazard potential of

metals such as lead for the same reason

persistence is relevant to the hazard

potential of organic chemicals: for a

chemical that persists in the

environment, there is a greater potential

for exposure and, therefore, a greater

potential for the chemical to cause

toxicity in an exposed organism or

individual. However, in this rulemaking

the Agency did not rely on the property

of persistence by itself in lowering

reporting thresholds for lead and lead

compounds, nor does persistence alone

necessarily mean that a substance is or

can be a hazard to human health and the

environment. As stated above, to be

classified as a PBT chemical, a chemical

must: (1) Be an EPCRA section 313

listed toxic chemical; (2) be sufficiently

persistent; and (3) be sufficiently

bioaccumulative. In this rulemaking

EPA is addressing lead and lead

compounds which are EPCRA section

313 listed toxic chemicals and is also

considering the bioaccumulation

potential of these chemicals.

One of the commenters believes that

metals do not necessarily persist, and

that the definition of persistence in

relation to metals should be qualified to

mean how long a metal can remain in

a particular form or species (e.g.,

oxidation state). This commenter also

recommends that the Agency should

examine data pertaining to certain

properties of metals to assess

persistence in accordance with this

definition, and to allow for the

identification of those metals and metal

species which are the most/least

resistant to change and which are the

most or least bioavailable. The

properties raised by the commenters

include: transformation/dissolution,

oxidation, corrosion, sulfide binding,

and first hydrolysis constant.

EPA agrees with the commenter’s

statement that metals, including lead,

can exist as different species and

compounds. These different species

pertain to the oxidation states or, more

specifically, the number of electrons

missing from the outer orbital of the

metal atom. Lead, for example, can exist

in a neutral species, Pb0 (no electrons

are missing from the outer electron

orbital of the lead nucleus), or as lead

compounds in one of two oxidation

states: Pb∂2 or Pb∂4 (2 and 4 electrons

are missing from the outer electron

orbital, respectively). As stated in the

proposed rule, these species can convert

from one to another under certain,

commonly encountered environmental

conditions. See also Unit VI.C.5. of this

preamble. While there may be a

conversion from one lead compound to

another lead compound or to metallic

lead, or from metallic lead to a lead

compound (either in the Pb∂2 or Pb∂4

oxidation states), there is no possible

conversion either in the environment or

in vivo that will convert (or degrade)

metallic lead or any lead compound into

a substance that does not contain lead.

Any conversion will always result in the

presence of lead or a compound that

contains lead. Conversion of a metal

atom from one oxidation state to another

does not change the number of protons

in the nucleus of the atom and,

therefore, does not change the metal

into another metal or element. In the

case of lead, each species of lead (Pb0,

Pb∂2, and Pb∂4) is still lead because

each contain the same number of

protons (82) within their nuclei (See

Refs. 19 and 20).

EPA disagrees with the commenter’s

assertion that the Agency consider

transformation/dissolution, oxidation,

corrosion, sulfide binding, and first

hydrolysis constant in determining

whether metal compounds are

persistent. These are factors which

address the conversion of one metal

compound to another, which is

irrelevant in determining whether metal

compounds are persistent. While these

are factors which control the

transformation of one metal compound

to another compound of the same metal,

they are not factors which result in the

destruction of the metal. There are no

environmental factors which can or will

result in the destruction of the metal.

Therefore, EPA believes that the

commenter’s definition of persistence is

not an appropriate alternative to EPA’s

definition.

One commenter who agrees with

EPA’s definition of persistence and, in

particular the Agency’s characterization

of lead as being persistent states that the

persistency of lead poses a significant

threat to human health and the

environment because this property

allows lead to remain in the

environment without being broken

down by natural processes. This

commenter disagrees with other

commenters who claim that metals are

not persistent or that persistence of

toxic metals should not be of concern.

This commenter believes that

persistence enables a substance like lead

to travel through ecosystems and

through different media and, as such,

threatens human health and the

environment far beyond the geographic

vicinity of the source from which it has

been released.

The Agency agrees with the

commenter’s statement that lead is

persistent. The Agency also agrees that

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4511

the persistence property of a substance

contributes to the ability of the

substance to be distributed through

ecosystems and through different media

to areas beyond the geographic vicinity

from where the substance entered the

environment. The property of

persistence, however, pertains to

longevity of a substance, and does not

bestow an ability for the substance to

partition throughout environmental

media. However, the opportunity for

exposure to a substance that is capable

of partitioning throughout

environmental media may be greater if

the substance is also persistent, since

the substance will remain in the

environment for a longer period than a

substance that is not persistent

2. What comments did EPA receive on

the availability and bioavailability of

metal compounds? Commenters suggest

that EPA consider environmental

availability (which they term

‘‘bioavailability’’) in lieu of

bioaccumulation. Many of these

commenters assert that unless a metal

compound is readily available in the

environment, it will not be bioavailable

or bioaccumulate. Some attempt to take

a risk-based approach to metals and

metal compounds in the environment

by arguing that when environmental

availability is considered, metals and

metal compounds will not be present at

levels high enough to cause adverse

effects.

As discussed in detail below, the level

of environmental availability or

bioavailability is not a surrogate for

bioaccumulation. Even metal

compounds that have limited

availability or bioavailability can

bioaccumulate. The extent of

environmental availability or

bioavailability will not affect whether

bioaccumulation will occur. For

example, lead from a sparing soluble

compound and lead from a readily

soluble compound will both

bioaccumulate. This is in contrast to the

commenters’ implication that only the

lead from the readily soluble lead

compound will bioaccumulate. Further

as discussed below, the presence of a

soluble metal compound is not the only

factor, or in many cases the determining

factor, that controls the potential for the

metal compound to bioaccumulate. A

metal compound may undergo various

transformations in the environment

resulting in a different metal compound

which has a much higher availability

and/or bioavailability. While metals and

metal compounds need to be

environmentally available and/or

bioavailable as a prerequisite to

bioaccumulation, there is not a

quantitative relationship between

environmental availability and/or

bioavailability and the degree of

bioaccumulation. Therefore, EPA

believes that availability and

bioavailability are not appropriate

substitutes for bioaccumulation.

Further, requiring a particular level

environmental availability would

effectively be establishing a risk-based

approach to lowering thresholds which

EPA believes is inappropriate for the

following reasons. The availability of

lead in the environment will vary

depending upon environmental

conditions. Choosing one level of

environmental availability and applying

that individually to each metal

compound is neither practical nor

scientifically supportable because: (1)

As discussed above environmental

availability is not necessarily reflective

of bioavailability; and (2) the

environmental availability of a metal

compound depends upon local

environmental conditions. There is no

‘‘best’’ or adequately representative set

of national environmental conditions.

Further, the TRI program is primarily a

hazard based program. Risks that may

be acceptable at the national level may

not be acceptable at a regional or local

level.

EPA considers availability in the

environment and bioavailability for

metal and metal compounds for

purposes of bioaccumulation only to

determine whether it is impossible for

the metal and metal compounds to

bioaccumulate, i.e., a compound that is

both environmentally and biologically

inert cannot bioaccumulate. EPA

believes that there are data that indicate

that lead and lead compounds are

available in the environment, are

bioavailable, and bioaccumulate, e.g.,

data in humans and fish advisories.

However, several commenters

contended at public meetings on EPA’s

PBT chemical rulemaking that metals

and metal compounds, such as lead and

lead compounds, are not available in the

environment and thus, cannot

bioaccumulate. To address these

comments, EPA chose to conduct an

environmental fate assessment to

describe the environmental availability

of lead and lead compounds. Qualitative

environmental fate assessments are

generally part of a hazard assessment for

a chemical. The qualitative

environmental fate assessment for lead

and lead compounds, however, was not

developed, nor was it intended, to be

part of an exposure assessment or risk

assessment.

Several commenters claim that EPA

should consider bioavailability in its

assessment of metals and metal

compounds, such as lead and lead

compounds. These commenters contend

that not all metal compounds and lead

compounds in particular are

bioavailable. According to the

commenters, unless a compound is in a

form that is bioavailable, it will present

little risk to human health and the

environment. One commenter made the

following statement:

Because of metals’ natural persistence, the

weight of scientific opinion holds that

bioavailability is a more appropriate criterion

for assessing the environmental and health

hazards associated with metals. While

toxicity is obviously a relevant measure for

assessing the hazard posed by a substance,

the substance must be available for uptake

[bioavailable] before it can exhibit an adverse

effect. Bioavailability varies significantly

among different species of metals, including

lead compounds, and also is influenced by

environmental media. Bioavailability can

only occur if soluble metal compounds are

released. Thus, the rate at which metals

transform to soluble/bioavailable species is

critical for hazard identification. Simply

stated, the natural persistence of metals with

toxic properties poses no special hazard if

those metals generally are present in

environmental media in forms that cannot be

taken up by plants and animals.

Other commenters expressed similar

views. These commenters believe that

the availability of lead from lead

compounds differs among lead

compounds, and that lead is unavailable

from certain lead compounds.

Therefore, in the opinion of the

commenters, lead compounds from

which lead is not available and/or

bioavailable cannot be PBT chemicals,

and should not be included in this

rulemaking.

The Agency disagrees with the

commenters assertions that: (1) EPA did

not consider bioavailability of lead in its

assessment of lead and lead compounds

as bioaccumulative substances; and (2)

that bioavailability is only possible for

released soluble metal compounds.

The basis for the Agency’s

disagreement with these comments

concerns the commenters use of the

terms ‘‘availability’’ and

‘‘bioavailability’’, which differs

significantly from EPA’s definition of

these terms. The commenters are using

the term bioavailability interchangeably

with availability, when in fact these two

terms have totally different meanings

and cannot be used interchangeably. In

addition, the commenters have

incorrectly concluded that: (1) If lead is

not available in the environment, it is

not bioavailable and will not

bioaccumulate or cause toxicity; (2) lead

is only bioavailable when in its ionic

oxidation state; and (3) only those lead

compounds that are water soluble as

released are bioavailable. To respond to

4512 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

these comments, the Agency needs to

first clarify the distinction between

‘‘availability’’ of a metal, and

‘‘bioavailability’’ of a metal or metal

compound, and the factors that

influence availability and bioavailability

of a metal or metal compound.

Availability of a metal is the extent to

which a metal, in either its neutral

(MG0) or ionic (MG∂x) oxidation state,

can reach a state of atomic

disaggregation. Inorganic metal

compounds that are water soluble will

completely dissociate in aqueous media,

liberating the metal in its ionic

oxidation state. In aqueous solution the

metal atoms of the molecules of these

substances are completely disaggregated

from the rest of their molecular

constituents. In this disaggregated state

the metal is completely available. Water

solubility is not a prerequisite, however,

for a metal to become available from a

metal compound. In the environment a

metal can become available from

organometallic substances or inorganic

metal compounds that are poorly

soluble in water, by undergoing

environmental transformations that

cause the metal atoms to dissagregate

and become available. Environmental

transformations that cause metals to

become available are summarized

below, and discussed in greater detail in

Unit V.A. of the proposed lead rule (64

FR 42227-42228), and in The

Environmental Fate of Lead and Lead

Compounds (Ref. 2).

The extent to which a metal can

become available from a metal

compound in environmental media is

dependent upon: (1) The

physicochemical properties of the metal

and the metal compound; (2) the

structural characteristics of the metal

compound; and (3) environmental

factors, including, but not limited to:

presence of aerobic or anaerobic

bacteria, pH, moisture content, and

organic matter content of soil or

sediments. Some or all of these

environmental factors can vary between

specific terrestrial or aquatic

environments. For different compounds

that contain the same metal, the relative

availability of the metal from each

compound can vary within the same

terrestrial or aquatic environment. It is

also true that the availability of a metal

from the same metal compound can

vary between specific terrestrial or

aquatic environments. Some metal

compounds are more susceptible to

environmental transformations and

subsequent release of the metal than are

other metal compounds.

Bioavailability is the extent to which

a substance is absorbed by an organism,

and distributed to an area(s) within the

organism. This is important because the

substance can then exert a toxic effect

or accumulate. As with availability, the

physicochemical and structural

characteristics of a substance play an

important role in determining whether

the substance is bioavailable and the

extent to which it is bioavailable. Unlike

availability, however, whether a

substance is bioavailable and the extent

to which it is bioavailable in a given

organism also depends upon the

anatomy and physiology of the

organism, the route of exposure, and the

pharmacokinetics of the substance in

the organism (i.e., the extent to which

the substance is or can be absorbed by

the organism from the exposure site, its

distribution and metabolism within the

organism, and its excretion from the

organism). It is important to stress that

bioavailability does not by itself mean

that a substance is a hazard to human

health or the environment. A substance

that has 100% bioavailability does not

pose a hazard to human health or the

environment if it is not intrinsically

toxic. Conversely, for substances that

are intrinsically toxic it is not necessary

for the substance to be 100%

bioavailable to cause toxicity.

Depending upon the extent of exposure,

toxic potency, and the nature of the

toxic effect, even substances that have

low bioavailability can still pose a

hazard to human health or the

environment. Similarly, a substance

does not have to have 100%

bioavailability in order for it to

bioaccumulate. For some compounds,

even very limited bioavailability (that is

a very small percentage is bioavailable)

can result in concern if it is

bioaccumulated. Lead and lead

compounds are one example.

Polychlorinated biphenyls (PCBs) are

another (64 FR 706).

Absorption of a substance is a critical

component of its bioavailability.

Absorption is the movement of a

chemical substance from its site of

exposure on a terrestrial or aquatic life

form into its systemic circulation

(bloodstream) or, in the case of

unicellular organisms such as algae,

inside the cell comprising the organism.

In any case, absorption of a substance

from any exposure site involves its

passage across the biological membranes

that compose the exposure site.

Chemicals can cross a cell membrane by

several mechanisms. These are: (1)

Passive permeation (diffusion) through

the membrane; (2) passive transport

through membrane channels or pores;

(3) active transport; facilitated transport;

or (4) phagocytosis (also pinocytosis and

endocytosis) (Ref. 21). Whether a

substance can or will be absorbed, and

the degree to which it can be absorbed

depends largely upon the

physicochemical properties of the

substance, the anatomical makeup of the

exposed organism and the site of

exposure (Ref. 21). Substances released

to the environment that are not

absorbable by terrestrial or aquatic

species may be transformed in the

environment to metabolites that are

absorbable and, hence, bioavailable.

An important point to stress regarding

the bioavailability of metals is that

availability of a metal is not a

prerequisite for its bioavailability.

Metals can be bioavailable in either

their neutral (MG0) or ionic (MG∂x)

oxidation states; or as part of an intact

inorganic or organic compound. When

in ionic oxidation states many metals

are generally absorbed by active

transport processes. Here, cellular

membrane-bound proteins carry the

metal across the cell membrane and into

the cell. While it would seem that most

metal ions are sufficiently small and

water soluble to simply pass through

membrane channels, their hydrated

ionic radii are usually too large to

permit their passage by this mechanism.

Metals in their neutral or ionic

oxidation states may be taken up by

organisms by phagocytic processes as

well. Organometallic substances are

substances in which the metal is bonded

to carbon-containing substituents. These

substances can be absorbed intact by

passive diffusion. The absorption of

poorly water soluble inorganic metallic

substances can occur via phagocytosis,

or by other mechanisms. In terrestrial or

aquatic life forms that have digestive

systems that secrete strong acids, a

poorly water soluble inorganic metallic

substance or a metal in its neutral

oxidation state can react (following oral

exposure to the substance) with the acid

to form a water soluble salt of the metal.

Under these circumstances the metal is

made available within the digestive

system, and is absorbed in its ionic

oxidation state. See Refs. 21, 22, 23, and

24.

The distribution, metabolism, and rate

of excretion of a metal or metal

compound depends upon the nature of

the metal or metal compound, and the

anatomy, physiology and genetic

makeup of the organism. Metals

absorbed in their neutral or ionic

oxidation state be excreted unchanged

or react with endogenous substances to

form a metal compound in vivo.

Organometallic substances are typically

more lipid soluble than is the metal in

its neutral or ionic oxidation state, and

can be distributed more readily to areas

of the organism that otherwise may be

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4513

poorly accessible by the metal in its

neutral or ionic oxidation state.

Organometallic substances may also

undergo metabolic transformations in

vivo in which the metal is liberated from

its organic constituents. The same is

true for inorganic metallic substances

absorbed intact. See Refs. 24, 25, and 26.

Generally the ionic oxidation states of

metals are the most available and, for

many life forms, the most bioavailable.

For aquatic species the bioavailability of

a metal is expected to be greater from

those metal compounds in which the

metal is readily available in aquatic

environments than from metal

compounds or complexes in which the

metal is not readily available in aquatic

environments. This is because the metal

is in a completely disaggregated state

and dissolved in the aqueous media of

the aquatic environment, which favors

uptake of the metal by aquatic

organisms since they are typically

immersed in the aqueous media.

However, aquatic species can also

absorb intact metal compounds (e.g.,

organometallic substances). Thus,

metals may be bioavailable from metal

compounds or metal complexes even

where the metal is not available in

aquatic environments. Many aquatic

organisms such as mussels, clams, and

oysters, for example, consume as food

organic materials suspended in aqueous

media. These molluscs use short,

hairlike locomotory organelles (cilia) to

take in suspended organic materials

from the water. Water currents sweep

the suspended organic materials into the

open shells, where they become

fastened to a film of mucus. The cilia

sweep the mucus to the mouth of the

mussel. Soft, fingerlike organs push the

mucus and organic materials into the

mouth of the mussel, where it is taken

in and digested. As stated by EPA in the

proposed rule regarding lead and lead

compounds, and by many commenters,

lead dissolved in aqueous media may be

removed from solution through sorption

to suspended organic matter. Although

no longer available, the lead in these

suspended complexes may still be

bioavailable in aquatic life forms that

consume solid organic materials as food.

Another example is that fish can absorb

organometallic substances (intact) via

passive diffusion through their gill

membranes. See Refs. 24, 27, and 28.

The availability of a metal from the

same metal compound may vary in

different terrestrial or aquatic locations.

Differences in environmental conditions

lead to differences in the environmental

fate of the compound in different

environments. In an aquatic

environment that contains metal ions of

the same metal, the bioavailability of the

metal in different aquatic species may

vary even though the availability of the

metal to each species is the same (i.e.,

the concentration of the metal in its

ionic oxidation state is the same

throughout the aquatic environment).

These differences in bioavailability in

different aquatic species are due to the

differences in anatomy, physiology, and

pharmacokinetic differences among the

species. For different compounds that

contain the same metal, the

bioavailability of the metal ion in a

given organism within a particular

terrestrial or aquatic location may vary

among different compounds. For a given

organism, differences in bioavailability

of a metal among compounds that

contain the metal may be ascribed to

differences in the physicochemical

properties of the metal compounds and

pharmacokinetic differences.

As mentioned above, metals or metal

compounds released to the environment

from anthropogenic sources are affected

by prevailing environmental conditions,

meaning broadly the wide variety of

physical, chemical and biological

processes that act upon them. These

processes collectively determine the

metal compounds in which the metal

can exist in the environment. Lead can

enter the environment as available or

bioavailable compounds, or as

compounds that are not available or

bioavailable. However, lead that enters

the environment as compounds that are

not available or bioavailable can be

converted in the environment to

compounds that are available or

bioavailable. As mentioned above, the

ionic oxidation states of metals are

generally the most available and, for

many organisms, the most bioavailable.

Hence, environmental factors that affect

the availability of a metal may indirectly

affect the bioavailability of metal. It is

therefore important to consider those

factors that influence the availability of

a metal in the environment, when

assessing physical or biological

properties of the metal. However, as also

discussed above, availability of a metal

is not a prerequisite for its

bioavailability. Interconversion of

inorganic metal compounds can be quite

rapid and as a result the metal

compound in which the metal is

released may not be the predominant

metal compound post-release.

Availability of a metal from an

organometallic compound or insoluble

inorganic compound is affected by

many factors and its determination is

complex, but many of the more

important variables are discussed below

for lead. A detailed discussion of the

environmental fate of lead, that is

illustrative of many of the more

important environmental variables that

affect availability and bioavailability of

metals in general is provided in Unit

V.A. of the proposed rule (64 FR 42227-

42228), in The Environmental Fate of

Lead and Lead Compounds (Ref. 2), and

below.

In some instances, 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. 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.) Cation exchange capacity (CEC,

related to soil clay content) and pH also

influence the capacity of soil to

immobilize lead. Using organic

chelation as a model, the total capacity

of soil to immobilize lead can be

predicted by a linear relationship

equation. Using this model to predict

saturation capacity from CEC and pH it

can be shown that a decrease in pH from

5.5 to 4.0 will reduce estimated soil

capacity 1.5 times, thereby increasing

the concentration of available lead in

soil water (Ref. 2).

A number of field studies demonstrate

the enhanced mobility of lead in soils

under a range of environmental

conditions. In all of these studies

variables including pH, soil organic

matter content and the chemical species

of lead present played a significant role

in increasing soil lead mobility. Limited

data also indicate that organo lead

compounds may be converted into

water-soluble lead compounds in soil.

Degradation products of tetramethyl and

tetraethyl lead, the trialkyl lead oxides,

are expected to be significantly more

mobile in soils than the parent

compounds (Ref. 2).

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 (μg/L) in hard water and

approximately 500 μg/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. 29).

Concentrations as high as 330 μg/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

4514 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

having these properties is common in

runoff areas of New York state and New

England.

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. 30 and 31).

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.

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.

It can be concluded that many

processes commonly observed in the

environment result in the release of lead

ion, which is available and bioavailable

lead. These processes may occur in soil

and aquatic environments with low pH

and low levels of organic matter. Under

these conditions, the solubility of lead

is enhanced and in the absence of

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. A decrease

in soil pH can cause sorbed lead to

desorb, and increase lead availability in

soil water.

A few commenters contend that

bioavailability is only possible for

released soluble metal compounds. This

position is incorrect: EPA has

concluded that metal compounds,

including lead compounds, that are

released as metal compounds that are

not soluble or bioavailable may be

converted in the environment into metal

compounds that are available or

bioavailable. Furthermore, as discussed

above, a metal compound may not be

soluble, but may, nonetheless, be

bioavailable.

Several commenters contend that EPA

should consider each member of a metal

compounds category (such as lead

compounds) individually because the

availability will vary from metal

compound to metal compound within a

category and some metal compounds

will not be available at all.

EPA disagrees. As discussed above in

Unit VI.C.1. with respect to evaluating

persistence for metal compound

categories, the Agency believes that it is

reasonable to evaluate metal compound

categories, such as lead compounds, as

a category rather than individually.

Moreover, in the case of lead

compounds, the bioavailability of a lead

compound is not necessarily dependant

upon the availability of lead from the

compound. That is, the parent lead

compound may be bioavailable as is or,

if not itself bioavailable, could be

converted in the environment into a

compound that is bioavailable or from

which lead is bioavailable. As EPA has

discussed elsewhere in this preamble,

the environmental fate assessment

indicates that there are many conditions

under which lead from lead compounds

can become available in the

environment. Further, most lead

compounds provide bioavailable lead

when ingested. In addition, regardless of

the relative environmental availability

of lead from one lead compound to

another, the lead compounds all add to

the environmental loading of lead.

Thus, even if under the same

environmental conditions the lead from

compound A is 10 times less available

than the lead from compound B,

compound A would introduce the same

amount of available lead if its releases

are 10 times greater. If lead compounds

are evaluated individually based on

relative environmental availability then

the additive effect of the loading of lead

from these compounds would be

ignored.

Two commenters criticize EPA for not

using the latest tools for assessing the

availability of metals, including those

tools in which the Agency was or is

involved with developing. These

commenters mention several Agency

efforts that pertain to availability and

the assessment of metals. These include

the Environmental Sediment Guidelines

and the Biotic Ligand Model

development for the Water Quality

Criteria.

The environmental processes that

determine the complexation, speciation,

and ultimately the availability of lead in

the environment have been considered

and addressed elsewhere in this

preamble. In conducting its assessment

of the availability of lead in the

environment, EPA reviewed the

available documentation on both the

simultaneously extracted metals/acid

volatile sulfide (SEM/AVS)

methodology and the Biotic Ligand

Model (BLM). EPA believes that the

SEM/AVS methodology as applied to

the Environmental Sediment

Guidelines, and the BLM as applied to

water quality criteria show great

promise for use in conducting sitespecific assessments of those metals for

which it has been validated. However,

to date neither the SEM/AVS

methodology nor the BLM have been

validated for lead, nor have the

substantive technical comments

provided by the EPA Science Advisory

Board been incorporated into these

approaches. In addition, EPA does not

believe that a means currently exists to

incorporate these methodologies into

the technical analysis supporting a

nationally applied regulation such as

this rulemaking. While at this stage of

their development these methods may

be useful in site-specific assessments,

they cannot be applied to support

national Agency programs such as the

TRI Program because of the variability

in environmental conditions throughout

the United States. On the other hand,

the PBT methodology, as used by EPA

in the characterization of lead as a PBT

chemical, can be used to provide

technical support to national regulatory

programs such as the TRI Program

because this methodology incorporates

the environmental processes that

determine the complexation, speciation,

and the availability of lead in the

environment, but does not require sitespecific input. EPA believes that the

PBT model is an appropriate

methodology for assessing the

persistence of metals, including lead.

3. What comments did EPA receive on

the bioaccumulation of metals and

metal compounds? Numerous

commenters suggest that for metals and

metal compounds bioaccumulation is

not a relevant endpoint of concern.

They contend that for metals and metal

compounds: (1) Bioaccumulation is

mitigated by environmental factors; (2)

that metals and metals compounds are

often essential nutrients and thus

organisms have developed mechanisms

to control their accumulation; (3) that

BCF values for metals are dependent

upon the concentration of the metal;

and (4) that metals do not

bioaccumulate at the concentration

levels associated with toxicity. As

discussed in detail in the following

comment responses, EPA does not

believe that any of the issues raised by

the commenters call into question EPA’s

scientific and policy reasons for

considering bioaccumulation for lead

and lead compounds. Not all metals are

essential nutrients and even those that

are can be accumulated to unsafe levels.

In particular, lead is not an essential

nutrient. While some metal BCF values

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4515

vary with metal concentration this does

not change the fact that the metals do

bioaccumulate. In addition,

bioaccumulation does not need to occur

at concentrations that cause toxicity to

be of concern, and in fact testing of

bioaccumulation should not be

conducted at concentrations that are

detrimental to the test organism.

Moreover, where there is extensive

human data showing significant

bioaccumulation of a listed toxic

chemical, such as here, the

bioaccumlation of the metal is obviously

of concern. Therefore, EPA believes that

bioaccumulation potential is a relevant

endpoint of concern for metals,

especially for lead and lead compounds.

Several commenters contend that the

extent to which a metal bioaccumulates

in aquatic organisms is dependent upon

the metal’s concentration in the aqueous

habitat of the organism. Specifically,

this commenter states that the BAF or

BCF of a substance is inversely related

to its concentration in the surrounding

aqueous medium: that is, BAFs and

BCFs become larger as the external

concentration of the substance

decreases. Thus, according to the

commenter, because a metal’s BCF or

BAF value in a given aquatic organism

will vary depending upon

concentration, a single BAF or BCF

value cannot be used to define whether

a metal bioaccumulates. In effect the

commenter is disagreeing with EPA’s

definition of BCF and BAF since the

definitions do not require that all

concentrations of the chemical result in

the same BCF or BAF.

The Agency is in general agreement

with the commenters’ position that for

a substance that bioaccumulates in

aquatic species the degree to which it

does so (i.e., the BAF and BCF of the

substance) is related in part to the

external concentration of the substance.

The Agency also believes, however, that

external concentration is not the only

factor that influences bioaccumulation.

As discussed previously, the propensity

of a substance to bioaccumulate in a

species depends largely upon the

pharmacokinetics of the substance in

that species. For further discussion on

pharmacokinetics and bioavailability

and bioconcentration see Unit VI.C.2.

In addition, the Agency believes that

when analyzing test data, the

conclusion that bioaccumulation

decreases as external concentration of a

substance increases may be erroneous. It

is quite possible that as the

concentration of the test substance is

increased, biochemical changes that are

precursor events to toxicity are initiated.

While the increased concentration may

not be sufficient to cause death to the

organism, the initiation of the precursor

events may cause a stasis in cell growth

or function, and interfere with the

organism’s ability to absorb the metal. In

a species where this is the case, it would

therefore incorrectly appear that the

bioaccumulation of the metal decreases

as external concentrations increase.

Thus, the Agency is in general

agreement with the commenter’s

position that, for a substance that

bioaccumulates in aquatic species, the

degree to which it does so is related to

the external concentration of the

substance. The Agency, however, does

not agree that the relationship for metal

is always truly inversely related: i.e.,

that as external concentration increases

bioaccumulation decreases. This is not

a general phenomenon for all metals

and metal compounds in all organisms

as suggested by the commenter.

When discussing BCF and BAF

values, distinction needs to be made

between BAF or BCF values that are

measured in a laboratory from those that

are measured in an actual

environmental setting. The Agency’s

definition of BCF and BAF (64 FR

42229) pertain to determinations of BAF

and BCF under controlled experimental

conditions where exposure of the

aquatic species to the chemical is kept

relatively constant (i.e., external

concentration of the substance remains

relatively constant). Thus, assays

performed in laboratories to determine

BAFs and BCFs are conducted under

controlled conditions, and any sources

of variability in conditions are

minimized or eliminated. In a laboratory

assay the test concentration is usually

set at some percentage below the acute

LC50 (the concentration lethal to 50% of

the test organisms following acute

exposure); often 1⁄10 of the LC50 of the

metal is used. While there is no reason

BCF tests cannot be conducted at other

concentrations of the test chemical, it

would serve no scientific purpose to use

concentrations at which the test

organism becomes stressed or dies

before the test assay is completed or

before the organism has the opportunity

to bioaccumulate the test chemical. In

an actual environmental setting,

however, conditions can be variable. No

commenter to this rule provided

scientific data showing that these BCF

values would not be found in the

environment. Consequently, EPA

believes that appropriately conducted

bioaccumulation tests conducted at

even at one concentration of lead are

valid indicators of the potential for lead

to bioaccumulate.

Two commenters claim that EPA

dismisses the notion that bioavailable

metals are often intentionally

bioaccumulated as beneficial nutrients

or are otherwise safely metabolized by

plants and animals through biological

mechanisms. One of the commenters

states that while metals can

bioaccumulate, the manner and rate at

which they do so varies based upon the

nutritional needs of the organism,

external concentration of the metal, and

speciation of the metal. The commenter

also states that the bioaccumulation of

metals is fundamentally different than

the process by which organic

compounds bioaccumulate.

EPA acknowledges that some metals

are nutrients in some organisms,

including humans, or are otherwise

necessary for the subsistence of

organisms. Thus, some metals need to

be bioaccumulated by the organism.

Clearly, such metals need to be

bioavailable in the organisms that

require these metals. As discussed in

greater detail elsewhere in this

document and as alluded to by one of

the commenters, in many organisms the

absorption or uptake of metals across

cell membranes involves active (i.e.,

energy-requiring) processes, whereas

absorption or uptake of organic

substances is usually the result of

passive diffusion across cell

membranes. Active transport processes

give the organism some ability to

regulate the uptake of metals. It is also

important to note that active transport

across cell membranes is not the only

means by which a metal can be

absorbed. Organometallic substances,

for example, are often absorbed by

passive diffusion. Metals and metal

containing substances may also be taken

up by organisms through phagocytic

processes. In addition, as one of the

commenters states, metal speciation and

concentration are factors that can

influence uptake of metals into an

organism.

While active transport processes are

involved with the uptake of metals

needed by the organisms, these

processes do not always discriminate

those metals that are needed by the

organism from those metals that are

harmful to the organism. Thus,

organisms also have the ability to take

up or absorb metals that are not

nutrients and that are not necessary for

subsistence. Thus, the processes that

organisms use to absorb or take up

needed metals do not necessarily

prohibit or protect them from taking up

toxic metals. In addition, even needed

metals can be toxic to the organism if

over exposure occurs. It is well

established that metals that are not

needed by an organism can be taken up

by the organism, and bioaccumulated by

the organism. lead and mercury, for

4516 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

example, are not known to be essential

metals in any species. Yet the uptake

and bioaccumulation of these metals by

organisms, including humans, is well

established. EPA has therefore

determined, insofar as commenters are

suggesting that EPA consider the

nutrient value of metals in this

rulemaking, that such comments are

irrelevant because lead has no known

nutritive value to any species. The

results of the studies investigating the

bioconcentration of lead and lead

compounds in aquatic organisms

summarized in Table 1 (64 FR 42230) of

the proposed lead rule and the table in

Reference 10 of the proposed rule show

that lead is taken up and

bioaccumulated by many different

aquatic organisms. Also, as discussed in

Unit VI.D.3., EPA’s fish advisory data

base demonstrates that many species of

fish and shellfish from various aquatic

environments in different regions of the

country contain lead (see http://

fish.rti.org) indicating that fish and

shellfish bioaccumulate lead under

realistic environmental conditions.

Two commenters stated that

bioaccumulation of metals does not

necessarily indicate the presence of, or

a potential for adverse effects. At the

outset, EPA stresses that lead and lead

compounds are EPCRA section 313

listed toxic chemicals. Therefore, as

stated in the proposed rule and

elsewhere in this preamble, the toxicity

of lead and lead compounds is not at

issue in this rulemaking. These

commenters state that bioaccumulation

of a substance is not an indicator of

hazard, and should not be used as a

hazard assessment criterion.

The Agency agrees that the ability of

a substance to bioaccumulate does not

by itself necessarily indicate the

presence of, or potential for adverse

effects. The Agency believes, however,

that the concept of bioaccumulation is

relevant to the hazard characterization

of metals for the same reasons that it is

relevant to the hazard characterization

of organic substances: that low-level or

sub-toxic exposures to a toxic substance

that bioaccumulates could eventually

lead to exposures of concern in the

organism that bioaccumulates it or

increased exposure potential for

predator species. The Agency would

also like to emphasize that while

bioaccumulation of lead in a given

aquatic organism may not necessarily be

toxic to the organism, the accumulated

lead may serve as a source of lead

exposure and toxicity to predator

species, including humans.

Thus, the high bioaccumulation

potential of lead, an EPCRA section 313

listed toxic chemical, within an

organism is anticipated to contribute a

greater total body burden relative to a

chemical with lower bioaccumulation

potential, thereby increasing any

toxicity to the organism. High

bioaccumulation also increases lead

exposure to other organisms that are

predators of the organism that has

accumulated the lead.

4.What comments did EPA receive on

the relationship of its persistence and

bioaccumulation criteria to

international criteria? Two commenters

claim that numerous international

organizations such as the Organization

for Economic Cooperation and

Development (OECD) have approached

the classification of PBT chemicals in a

manner that calls into question EPA’s

use of persistence and bioaccumulation

criteria for accurately identifying the

human and environmental health

hazards of metals. One of the

commenters claims that the OECD

Advisory Group on Harmonization of

Classification and Labeling (which

includes EPA participants) has made the

following conclusion: ‘‘...For inorganic

compounds and metals, the concept of

degradability as applied to organic

compounds has limited or no meaning.

Rather, the substance may be

transformed by normal environmental

processes to either increase or decrease

the bioavailability of the toxic species.’’

The commenter recommends that EPA

reconsider its characterization of lead as

a PBT chemical because, in the opinion

of the commenter, there is a lack of

scientific support for assessing a metal’s

PBT characteristics to determine its

potential hazard to human health and

the environment.

The Agency believes the commenter

has misunderstood OECD’s position on

the applicability of general PBT criteria

to metals. The quote is taken from the

OECD document entitled Harmonized

Integrated Hazard Classification System

for Human Health and Environmental

Effects of Chemical Substances. (Ref. 32)

The pronouncements on metals are

contained in paragraphs 22 and 23 of

that document. Paragraph 22 reads as

follows:

For inorganic compounds and metals,

the concept of degradability as applied

to organic compounds has limited or no

meaning. Rather the substance may be

transformed by normal environmental

processes to either increase or decrease

the bioavailability of the toxic species.

Equally, the use of bioaccumulation

data should be treated with care.

Specific guidance will be [but has not

yet been] provided on how these data

for such materials may be used in

meeting the requirements of the

classification criteria.

By ‘‘degradability as applied to

organic compounds’’ OECD means

molecular degradation, most often by

microbial degradation and/or hydrolysis

or other abiotic processes, to

progressively simpler organic chemical

structures, leading eventually to

inorganic substances like carbon

dioxide and water. It is important to

note that paragraph 22 does not in any

way suggest that metals are not

persistent. Moreover, it does not suggest

that OECD hazard classification criteria

cannot be applied to metals, only that

‘‘care’’ (e.g., professional judgment) is

required in the interpretation of data

relative to the classification criteria. In

fact, EPA agrees that in order for a metal

to bioaccumulate in an organism it must

either be environmentally available or

bioavailable. In response to the

allegations that lead is not

environmentally available, as part of the

proposed rule, the Agency analyzed

information on the environmental fate

of lead, and, as noted above, determined

that lead has the potential to become

available from lead compounds under

commonly encountered environmental

conditions. In addition, as explained in

Unit VI.D.3, EPA determined that lead

and lead compounds are bioavailable.

Therefore, the Agency’s assessment of

lead as a PBT chemical is consistent

with the OECD’s intent.

EPA does not interpret the above

quote to indicate that OECD’s position

is that its or any PBT chemical criteria

are not applicable to lead. As the

commenter correctly states, EPA is a

member of the OECD Advisory Group

on Harmonization of Classification and

Labeling. OECD does not recommend

that metals and metal compounds be

excluded from consideration as PBT

chemicals, as the commenter implies.

More specifically, OECD has not

concluded that metals and metal

compounds have no potential to

bioaccumulate because they are never

released as bioavailable compounds; or

cannot be converted to bioavailable

compounds under any foreseeable

circumstances. On the contrary, EPA

believes that the preceding language

indicates that OECD’s position is that

any substance judged to be potentially

bioavailable, whether organic or

inorganic, should not be excluded as a

candidate from some form of regulatory

action. As discussed in Units VI.C.2.

and VI.D.1., it is realistic to expect that,

in general, released metals such as lead

can encounter conditions in which they

are (or can become) available at levels

sufficient to bioaccumulate. Therefore,

the Agency’s use of the PBT criteria in

its assessment of lead is consistent with

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4517

OECD’s position on the general

applicability of PBT criteria to metals.

5.What comments did EPA receive on

its metals policy? Some commenters

contend that EPA should not consider

all members of the lead compounds

category to be PBT chemicals because

availability and bioavailability of the

lead portion will vary among the

compounds. These commenters further

state that the toxicity can only be

evaluated on a compound-by-compound

basis and is dependent on

bioavailability.

Members within the lead compounds

category listed on the EPCRA section

313 list of toxic chemicals have a

common moiety that bestows toxicity,

i.e., lead. Consequently, it is reasonable

to anticipate that once released into the

environment: (1)The metal moiety in

each member of the category will

become available as a result of abiotic

and/or biotic processes or (2) each

member of the category will either be

bioavailable or will convert into a

compound that is bioavailable. For

example, different inorganic lead

compounds that are released into acidic

surface waters will result in the

formation of similar soluble inorganic

lead compounds. Variation in the level

of availability or bioavailability does not

negate the consistency of effect across

the members of the category.

EPA would like to remind the

commenters that a mechanism already

exists under EPCRA section 313 to

address concerns for any metal

compound for which the data show that

the metal can never become available.

Thus, the issue of availability, which is

broader than the issue of a compound’s

potential to bioaccumulate, was

addressed previously for EPCRA section

313 chemical assessments through

EPA’s policy and guidance concerning

petitions to delist individual members

of the metal compound categories listed

under EPCRA section 313 (May 23,

1991, 56 FR 23703). If a petitioner has

information demonstrating that a

particular lead compound does not

cause toxicity as the intact lead

compound, and will not cause lead to be

available in the environment to express

its toxicity, they can submit a petition

pursuant to EPCRA section 313(e)(1) to

delete that specific lead compound from

the EPCRA section 313 list of toxic

chemicals. Under the metals policy EPA

considers whether the metal from a

metal compound can ever become

bioavailable under abiotic or biotic

conditions. An assessment of the

availability and bioavailability of a lead

compound would include processes

such as: hydrolysis at various pHs;

solubilization in the environment at

various pHs; photolysis; aerobic

transformations (both abiotic and

biotic); anaerobic transformations (both

abiotic and biotic); bioavailability when

the compound is ingested

(solubilization in and/or absorption

from the gastrointestinal tract and

solubilization in various organs); and

bioavailability when the material is

inhaled (solubilization in and/or

absorption from lungs, especially taking

into account the likelihood that the

compound will lodge in the lungs and

be converted a soluble compound by the

lung’s defense mechanism).

If the commenters have information

demonstrating that a particular lead

compound does not cause toxicity as the

intact lead compound, and will not

cause lead to be available in the

environment to express the toxicity of

the metal, the commenters can submit a

petition pursuant to EPCRA section

313(e)(1) to delete that specific lead

compound from the EPCRA section 313

list of toxic chemicals. EPA would

address such a petition in accordance

with the Agency’s longstanding stated

policy and guidance concerning

petitions to delist individual members

of the metal compounds categories (May

23, 1991, 56 FR 23703).

6.What comments did EPA receive

that pertain to natural vs. industrially

produced lead and lead compounds?

Some commenters contend that natural

forms of lead, as opposed to industrially

produced lead compounds, should not

be classified as PBT chemicals. Other

commenters state that because lead

occurs naturally, industrial activities

involving lead do not change the total

amount of lead in the earth: these

activities only affect the form and

location of the lead in the environment.

These commenters believe that the

forms of lead that are produced by

industrial activity tend to be more

hazardous and should be regulated more

strictly than the natural forms, such as

trace amounts of lead in natural

minerals.

EPA disagrees that natural lead

compounds should be treated

differently than industrially produced

lead compounds. While the comment

was made specifically for lead it is

general to all metals and metal

compounds. Both naturally occurring

and industrially produced lead and lead

compounds, meet the persistence and

bioaccumulation criteria. EPA’s analysis

of the environmental fate of lead

demonstrates that it is reasonable to

anticipate that under environmental

conditions lead can become available

from lead compounds, and that whether

lead or lead compounds are obtained

naturally or produced industrially does

not change the potential for availability

of lead. Whether a chemical comes

directly from the ground or from a

manufacturing plant will not affect

whether the chemical is toxic,

persistent, and bioaccumulative. These

are the result of the inherent properties

of the chemical, not from their origin

(all other things being equal).

The Agency recognizes that lead and

certain lead compounds occur naturally.

EPA agrees that industrial activities

involving lead do not change the total

amount of lead in the earth, and that

industrial activities involving lead only

affect the type of lead compound and its

location in the environment. The

Agency believes, however, that while

industrial activities do not increase the

total quantity of lead in the earth,

industrial activities transport lead and

lead compounds from one environment

to another environment in which the

likelihood of exposure to lead in aquatic

and terrestrial species, and humans is

increased. As discussed in the PBT

rulemaking (64 FR 688-729),

environmental conditions can vary

greatly among geographic locations,

even those that are in close proximity to

one another. There may be certain

geographical areas in which the

environmental conditions are such that

lead availability from a naturally

occurring lead compound may be equal

to or greater than that from an

industrially produced lead compound.

D.What Comments Did EPA Receive

Concerning the Persistence and

Bioaccumulation of Lead and Lead

Compounds?

In the proposed rule to lower the

thresholds of lead and lead compounds,

EPA discussed its scientific basis for

preliminarily characterizing lead and all

lead compounds as highly persistent

and highly bioaccumulative. To

summarize, the data on lead’s

persistence in the environment, the

observed high bioaccumulation values

in aquatic organisms, and lead’s ability

to accumulate in humans were the basis

for EPA’s preliminary conclusion that

lead and lead compounds are highly

persistent and highly bioaccumulative.

EPA has also evaluated the

bioavailability of lead and lead

compounds and has concluded that lead

is bioavailable. In the proposed rule the

Agency specifically requested public

comment on its discussion of the

scientific information concerning: (1)

The fate, transport and availability of

lead in the environment and how this

information should be considered in

classifying lead as a PBT chemical (Unit

V.A.); (2) the bioaccumulation of lead in

aquatic organisms, and how this

4518 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

information should be evaluated in

assessing the bioaccumulative potential

of lead and lead compounds (Unit V.B.);

(3) the bioaccumulation of lead in

humans, and how this information

should be considered in classifying lead

and lead compounds as highly

bioaccumulative (Unit V.C.); and (4)

abiotic factors (e.g. soil chemistry; pH;

water hardness; presence of organic

matter in aqueous media) that can

diminish the bioavailability of lead in

aquatic species.

The Agency received many comments

regarding EPA’s technical basis for

preliminarily characterizing lead and

lead compounds as highly persistent,

and highly bioaccumulative. These

comments were extensively reviewed

and considered by the Agency in

finalizing the rule. While some of the

commenters agreed with the Agency’s

characterization of lead and lead

compounds as highly persistent and

highly bioaccumulative, the majority of

the commenters disagreed. Most of the

comments were similar in content, and

pertained to general or specific issues

dealing with persistence,

bioaccumulation and toxicity, as well as

EPA’s use of persistence and

bioaccumulation data pertaining to lead

and lead compounds in characterizing

these chemicals as PBT substances.

Lead and lead compounds are included

on the EPCRA section 313 list of toxic

chemicals. EPA is not responding to

comments on the toxicity of lead and

lead compounds, because their

inclusion on the EPCRA section 313 list

of toxic chemicals is not at issue in this

rulemaking. After consideration of all

comments submitted in response to the

proposed lead rule, EPA concludes that

lead is highly persistent and, at the

least, bioaccumulative and defers its

determination as to whether lead is

highly bioaccumulative. An explanation

for EPA’s conclusion that lead is at least

bioaccumulative is provided below. The

basis for EPA’s conclusion that lead is

highly persistent is provided elsewhere.

In the PBT chemical rulemaking, EPA

described bioaccumulation as ‘‘the

process by which organisms may

accumulate chemical substances in their

bodies’’ (64 FR 703) and defined the

term as the ‘‘net accumulation of a

substance by an organism as a result of

uptake from all environmental sources.’’

(64 FR 703) EPA has a concern for those

toxic chemicals that are

bioaccumulative and a particular

concern for that subset of PBT

chemicals that are highly

bioaccumulative.

There are extensive, high quality

human data (64 FR at 42230-31) that

clearly indicate that lead and lead

compounds bioaccumulate in humans,

i.e., humans accumulate lead as a result

of uptake from environmental sources.

These data include bioaccumulation

data on a number of subpopulations of

humans, such as children, pregnant

women, postmenopausal women, and

men. Therefore, these human data

support EPA’s conclusion, as discussed

below, that lead and lead compounds

are bioaccumulative. EPA believes that

these data would tend to support a

finding that lead is also highly

bioaccumulative because (1) the data are

human data and (2) these data

conclusively demonstrate that lead

bioaccumulates in humans. EPA

believes that these two factors are

relevant to a determination that lead

and lead compounds are highly

bioaccumulative because human data

are generally more compelling than

animal data, particularly where there

are multiple, high quality studies on a

broad range of individuals. Thus, these

data are sufficiently conclusive that

there is no question that lead and lead

compounds bioaccumulate in humans.

While evaluation of these data might

affect EPA’s conclusion as to whether

lead and lead compounds are highly

bioaccumulative, EPA recognizes that it

did not clearly articulate in the

proposed rule how human data would

be used to distinguish between

bioaccumulative and highly

bioaccumulative chemicals. Because of

this, EPA is deferring at this time the

classification of lead and lead

compounds as highly bioaccumulative

solely on the basis of the extensive

human data.

A number of industry commenters

have contended that BCFs and BAFs

measured for metals (including lead),

and in particular essential elements, are

not representative of the potential of

these substances to bioaccumulate. They

claim that the variability of the

measured BCFs/BAFs with changing

water concentration of the chemical

makes it difficult to determine the most

representative BCF/BAF value for a

particular species. Specifically, these

commenters contend that there is an

inverse relationship between the

measured BCF/BAF values and water

concentration. Some commenters assert

that only the values measured at higher

water concentrations should be used,

i.e., the lower BCF/BAF values. Other

commenters contend that BCFs and

BAFs are not meaningful measures for

the bioaccumulation of metals and,

therefore, cannot be used.

EPA disagrees that this is the best

characterization of the bioaccumulation

data for metals, including lead, in

aquatic species. While this type of

relationship may exist for some species

and/or some metals, for other species

and/or metals other relationships are

observed: (1) Constant BCFs/BAFs with

increasing water concentration; (2)

increasing BCFs/BAFs with increasing

water concentration; and (3) varying

BCFs/BAFs values with constant water

concentration.

EPA disagrees that the BCF/BAF data

cannot be used to determine the

potential for lead, which is not an

essential element, to bioaccumulate.

EPA recognizes that some data suggest

that the relationship between

bioaccumulation and water

concentration of lead could be

characterized as inverse for some

organisms, such as fish, algae, and

phytoplankton. Such a characterization,

however, is incorrect for invertebrates

such as snails and bivalves because

there is little variation in BCF value

with changing water concentration for

these species. Further, EPA does not

believe that even where the data suggest

an inverse relationship, this precludes

the use of BCFs and BAFs in assessing

the bioaccumulative potential of lead.

EPA notes that even for some species in

which an inverse relationship is

suggested (e.g., algae and

phytoplankton), if EPA were to use the

BCF or BAF at the highest water

concentration measured (i.e., the lowest

measured BCF/BAF value) the BCF/BAF

values remain over 5,000.

EPA has determined that the data on

oysters, snails, algae, phytoplankton,

and blue mussels, as well as the human

data, clearly support a conclusion that

lead and lead compounds are

bioaccumulative, and also believes that

this information tends to support a

finding that lead is highly

bioaccumulative. However, during the

public comment period and during

inter-Agency review, questions were

raised challenging the sufficiency of the

data to support the conclusion that lead

and lead compounds are highly

bioaccumulative. Before determining

whether lead and lead compounds are

highly bioaccumulative, EPA believes

that it would be appropriate to seek

external scientific peer review from its

Science Advisory Board, and EPA

intends to do so. The external peer

review would address the question of

whether lead and lead compounds

should be classified as highly

bioaccumulative. The external peer

review would address the issue of how

lead and other, as yet unclassified,

metals such as cadmium, should be

evaluated using the PBT chemical

framework, including which types of

data (and which species) are most

suitable for these determinations. After

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4519

the completion of the external scientific

peer review, EPA will consider and take

appropriate action, which could include

characterizing lead and lead compounds

as highly bioaccumulative and lowering

the reporting thresholds for lead and

lead compounds to 10 pounds.

Therefore, at this time, EPA concludes

that lead is, at the least,

bioaccumulative and defers its

determination as to whether lead is

highly bioaccumulative until further

review.

1. What comments did EPA receive on

the environmental fate of lead and lead

compounds? In the lead proposed rule

(64 FR 42227) the Agency provided a

qualitative environmental fate

assessment of lead and lead compounds.

Qualitative environmental fate

assessments are generally part of a

hazard assessment for a chemical. The

qualitative environmental fate

assessment was not developed, nor was

it intended, to be part of an exposure

assessment or risk assessment.

An environmental fate assessment for

a metal and metal compounds, such as

lead and lead compounds, describes the

physical, chemical, and biological

processes acting upon the metal and

metal compound in the environment

and the result of these processes. 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 Agency received many comments

on its assessment of the environmental

fate of lead and lead compounds and the

influence of environmental fate on the

environmental availability of lead and

lead compounds. Commenters contend

that normal environmental processes

control the availability of lead and lead

compounds in water, soil and sediments

and concluded that under most

environmental conditions lead from

lead and lead compounds would not be

available for uptake by organisms due to

processes including the pH dependent

formation and precipitation of insoluble

lead compounds in surface waters, and

sorption of lead to organic matter and

inorganic constituents in soil, surface

waters and sediments.

EPA disagrees with these commenters

and concludes that processes commonly

observed in the environment can result

in the formation of available lead where

it can be bioaccumulated by organisms.

EPA believes that these processes may

occur in soil environments with low pH

and low levels of clay and organic

matter. Lead sorption to soils has been

shown to be pH dependent. Decreasing

pH can result in increasing

concentrations of lead in soil water with

greater availability for uptake by biota.

In acidic aquatic environments, low

levels of suspended solids and

dissolved organic matter can result in

increased levels of lead ion in solution

where it can be taken up by biota.

One commenter believes that the

environmental fate data that EPA used

and cites in the proposed rule falls short

of what is necessary for a scientifically

valid approach to assessing the

transformation, specification, and

availability of lead in the environment.

The commenter argues that the data

cited by EPA indicate that very little of

the lead released to the environment is

likely to be present in a ‘‘bioavailable

form’’ (i.e., EPA concluded that less

than 1% of lead in soil may be water

soluble).

EPA disagrees with the commenter’s

characterization of EPA’s assessment of

the environmental fate of lead and lead

compounds. EPA asserts that it used

reliable data from a variety of credible

sources in concluding that lead can be

available for uptake by organisms in the

environment and that lead is

environmentally available. EPA refers

the commenter to the discussions of the

transformation, speciation, availability

and bioavailability of lead in the

environment provided in The

Environmental Fate of Lead and Lead

Compounds (Ref. 2) and elsewhere in

the RTC document for this final rule

(Ref. 1). EPA disagrees with the

commenter’s interpretation of the

statement ‘‘EPA concludes that less than

1% of lead in soil may be water soluble’’

to mean or indicate that very little of the

lead released into the environment is

likely to be present in a ‘‘bioavailable

form’’. Simple water solubility is not a

prerequisite for a metal to become

available from a metal compound. It is

well established that certain

environmental conditions can increase

the solubility of a metal compound.

Further, as discussed in Unit VI.C.2. of

this preamble and in the RTC document

(Ref. 1), availability of a metal is not a

prerequisite for its bioavailability.

Metals may be bioavailable from metal

compounds or metal complexes that are

not water soluble or in which the metal

is not otherwise available. A classic

example that illustrates these points are

the well documented incidents of

childrens’ exposure to lead from

consumption of soil that contains lead.

While less than 1% of lead in soil is

typically present as a lead compound

that is water soluble (i.e., more than

99% is present as lead compounds that

are water insoluble or bound to soils),

the lead in soils is still bioavailable in

humans.

EPA has concluded that lead released

to the environment, whether under

conditions where it is available or not,

can reasonably be expected to be

bioavailable in organisms. EPA’s

statement ‘‘that less than 1% of lead in

soil may be water soluble’’ should not

be interpreted to mean that the levels of

lead in soils that is available are

inconsequential or negligible. On the

contrary, because exposure to even low

levels of lead are expected to result in

its bioaccumulation in many organisms,

these levels are still of concern. It

should be noted that if 1 percent of soil

lead is soluble (i.e., available), this

would mean that levels as high as 200

parts per billion (ppb) could be found in

soil water (lead is present in many soils

at 20 parts per million (Ref. 2) and one

percent of this is 200 ppb.)

One commenter believes that the

bioavailability of lead and lead

compounds is only prevalent in those

situations in which an organism would

be exposed to continuous, localized

influxes of lead compounds, such as

near a lead smelter or a highway. The

commenter believes that the proximity

to sources of lead, such as smelters or

highways (influenced by use of leaded

fuels), is a prerequisite to high

concentrations of the metal in the

environment, and thus its potential to

bioaccumulate. The commenter cites

studies that provide data that show high

levels of lead in waters and soils that are

in close proximity to sources of lead

releases (e.g., smelters, vehicular

exhaust), and bioaccumulated lead in

freshwater algae, invertebrates, and fish

collected near industrialized areas,

ponds with high numbers of lead shot,

urban areas, lead mines and tailings

ponds. The commenter states that

although lead may be considered

ubiquitous in the environment, its

ecological impacts would appear to be

significantly influenced by the

proximity to sources of lead releases

and the public should be aware of this.

While the commenter used the term

bioavailability, based on the context of

the comment, EPA believes the

commenter used the term

interchangeably with the term

environmental availability.

While the concentrations of lead in

the environment are more likely to be

higher in areas that are in close

proximity to facilities that manufacture,

process, or otherwise use lead and/or

lead compounds, EPA disagrees with

the commenter’s contention that the

availability of lead is only possible in

such areas. EPA does not agree with the

commenter’s position that in order to be

exposed to lead an organism needs to be

in close proximity to points where lead

4520 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

is released into the environment. As

discussed in Unit V.A. of the proposed

rule (64 FR 42227), and in The

Environmental Fate of Lead and Lead

Compounds (Ref. 2) many factors

influence the mobility and disposition

of lead in the environment. Under many

environmental conditions lead may

become mobile rather than remain

stationary. Depending upon prevailing

conditions and the method of

environmental release, lead may travel

within environmental media to areas

that are not in close proximity to the

point of release. Hence, EPA believes

that the presence of lead in the

environment, and therewith its

availability, is not confined to the areas

where lead is released from

anthropogenic sources. In addition, any

release of lead is important to local

communities, because of lead’s

persistence and bioaccumulative

properties. Although EPA disagrees

with the commenter’s conclusions, the

commenter’s statement that the

ecological impacts of lead are

influenced by the nearness to a source

of release still provides support for the

actions that EPA is taking in this

rulemaking.

a. What comments did EPA receive on

the abiotic factors that may affect the

environmental availability of lead?

Several commenters stated that EPA

either did not, or should have

considered speciation, transformation

and bioavailability in its assessment of

the persistence of lead and lead

compounds. Some of the commenters

contend that in most environments lead

is either not available or is transformed

into forms that are less available. A

number of the commenters claimed that

the environmental conditions in which

lead is mobile or available are rare.

EPA disagrees with the commenters

claim that the Agency did not consider

speciation, transformation and

bioavailability in its characterization of

lead and lead compounds as PBT

chemicals. As discussed in detail in:

Unit V. of the proposed lead rule (64 FR

42222–42243); in The Environmental

Fate of Lead and Lead Compounds (Ref.

2); elsewhere in this preamble; and in

the RTC document (Ref. 1), EPA

performed a comprehensive assessment

of the environmental fate of lead. The

environmental fate assessment

embodied an analysis of the

environmental variables that affect

speciation, transformation, and the

availability of lead. These

environmental variables include: pH;

redox conditions; water hardness;

dissolved organic carbon content; and

soil properties including cation

exchange capacity, organic carbon

content, iron and manganese oxide and

phosphorus content. As discussed in

Unit VI.D.3., EPA has evaluated the

bioavailability of lead and lead

compounds and has concluded that lead

is bioavailable. From its analysis of the

environmental fate of lead, EPA

concluded that environmental

conditions exist in the United States in

which lead may become available or

that can increase the availability of lead,

even from compounds in which lead, as

released into the environment, is not

available. From its analysis of the

bioavailability of lead, EPA concluded

that lead is bioavailable in many aquatic

species, and in humans. EPA also

concluded that lead compounds that are

not available or bioavailable as released

may be converted to lead compounds

that are available or bioavailable. Thus,

after an evaluation of the available data,

EPA has determined that the weight of

scientific evidence indicates that it is

reasonable to conclude that lead in the

environment will be available and/or

bioavailable from lead and lead

compounds.

EPA disagrees with the commenters

who claim that the environmental

conditions in which lead is mobile or

available for uptake are rare. As detailed

in Unit VI.C. of this preamble and in the

RTC document (Ref. 1), EPA conducted

several analyses of large databases

containing information on the

properties of rivers, streams, lakes, and

soils in the United States, with a focus

on the properties known to contribute to

the availability of lead. Acidity is a

particularly important determinant of

lead availability: acid conditions (pH <

7) increase lead availability. In water,

the solubility and, hence, availability of

lead increases linearly as acidity is

increased (i.e., from pH 6 to 3). EPA

determined that waters of sufficient

acidity to favor lead availability,

especially in the Mid-Atlantic region of

the United States, are not rare. In fact,

estimates indicated that almost 11,000

kilometers of streams could have a pH

of < 5.5. In addition, as detailed

elsewhere is this document, a query of

EPA’s STORET water quality database

indicated that in 1998 pH values of

between 5.5 and 5.1 were found in 52

watersheds in the United States. Finally,

the commenter asserts that acidic soils

in which lead is likely to be available

are rare. EPA’s analysis of the database

of the Soil Survey Laboratory, National

Soil Survey Center, discussed in Units

VI.C.1. and VI.D.1. of this preamble,

found more than 10,000 surface soil

samples with low cation exchange

capacity and pH values of less than 5.5.

One commenter supports EPA’s

concern for cross media transport of

chemicals, but believes that it is

misleading for EPA to imply that lead is

predisposed to find the medium in

which it will be transformed into forms

that have the ‘‘greatest bioavailability

(in) man’’. The commenter agrees that

lead cannot be destroyed but, equates

this attribute to most elements on the

periodic table.

The commenter incorrectly asserts

that EPA suggested that lead and lead

compounds are released only to, or

preferentially partitions to, those

environments that are most favorable to

enhancing availability or bioavailability

of lead. EPA disagrees with the

commenter. EPA has not made the claim

that lead and lead compounds are

released only into those environments

where conditions are most favorable to

the formation of the most soluble lead

compounds. In EPA’s discussion of the

environmental fate of lead and lead

compounds, EPA assessed the

availability of the lead and lead

compounds under a variety of

conditions in water, sediments and soil.

As discussed elsewhere, EPA believes

that there are many environmental

conditions in which lead and lead

compounds will be available and/or

bioavailable.

b. What comments did EPA receive on

the availability of lead in surface waters

and sediments. One commenter stated

that there are many studies that indicate

that lead does not persist in soluble and

bioavailable forms in aquatic

environments. The commenter cited

work reported by May and McKinney

(Ref. 33) which, according to the

commenter, has shown that the majority

of lead entering natural waters will be

precipitated to sediments as carbonates

or hydroxides (i.e., will be unavailable).

The commenter states that even in

acidic lake waters, ‘‘which according to

EPA’s own reports are rare’’, lead can

precipitate out of the water, and cites

work by White and Driscoll (Ref. 34) to

support this position. Another

commenter states that there is strong

evidence to suggest that under

conditions where organic material is

present in the water column of an

aquatic environment, the organic

material will act to reduce the amount

of potentially soluble and bioavailable

lead. The commenter believes that the

wide distribution of organic matter

suggests that the potential for the

reduction of soluble lead by

complexation with organic material is

high.

EPA disagrees with the argument that

soluble and/or bioavailable lead

compounds are irreversibly transformed

into insoluble and un-bioavailable lead

compounds. EPA discusses below and

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4521

elsewhere that many lead compounds

that form as a result of conditions in the

aquatic environment (e.g., lead-organic

matter complexes, inorganic

precipitates, carbonates and hydroxides

) are not necessarily permanently

sequestered as a non-available lead

compound, but are subject to processes

that can result in their release back into

solution. A review of the discussion of

the fate of lead in natural waters in May

and McKinney (Ref. 33) revealed a

single sentence that says: ‘‘Upon

entering natural waters, most lead is

precipitated to the sediment bed as

carbonates and hydroxides.’’ While this

statement is true for some surface waters

in the United States, EPA has concluded

for the reasons discussed below and

elsewhere in this preamble and in the

RTC document (Ref. 1) that lead

solubility is greater and precipitation as

carbonate and hydroxide is less in

acidic waters with low hardness.

White and Driscoll (Ref. 34) observed

temporal and spatial variations in the

concentration and transport of lead in

the acidic Darts Lake in the

Adirondacks of New York. Deposition of

particulate lead was strongly correlated

with aluminum and organic carbon

deposition. Increasing metals deposition

was observed during periods of

increasing pH. The flux of lead into the

lake was related to stream hydrology,

pH and lead concentration. Stream pH

varied seasonally, with a steady pH of

5.1 until spring snowmelt, where pH

levels dropped to a minimum of 4.8 in

April/May. Increases in pH occurred

throughout the summer reaching a

maximum of 5.4 in August. High flow

periods in the fall and spring were

marked by increases in the

concentration of dissolved lead in the

inlet and outlet streams. Lead flux to

and from the lake was greatest during

spring and fall periods of high lead

concentrations, elevated water

discharge, and low pH. The authors

explain that even in acidic lake water

containing a variety of particle types,

oxides and organic films may determine

the surface properties of suspended

particulate matter. The solid matrix in

the lake was probably composed of

inorganic hydrous oxides (coatings) and

adsorbed or coprecipitated organic

matter. The interaction of lead with this

matrix appears to be pH sensitive.

Changes in pH may affect lead

partitioning between the solid and

solution through a number of possible

mechanisms: matrix formation/

dissolution, sorption/desorption of

organic complexes and inorganic

complexes, and hydrogen ion exchange

reactions.

Contrary to the commenter’s

interpretation, EPA believes that the

study by White and Driscoll (Ref. 34)

provides evidence that even in the

presence of dissolved organic carbon,

soluble lead may be present in the water

column of acidic waters, possibly

through a process of sedimentation and

decomposition of organic matter and/or

dissolution of redox sensitive hydrous

oxides.

Two commenters contend that the

majority of lead entering aquatic

systems will be removed from solution

and become bound to sediments and/or

suspended particulate matter. They

believe that the lead that partitions to

sediments is not expected to be readily

bioavailable. The commenters contend

that the availability of lead in sediments

is controlled by several

physicochemical factors including pH,

organic carbon (particulate and

dissolved), iron and manganese

oxyhydroxides, and sulfides. In aerobic

sediments, the main factors that drive

the formation of insoluble lead are

particulate organic carbon and iron/

manganese oxyhydroxides. In anaerobic

sediments, which represent the

overwhelming majority of sediments,

acid-volatile sulfides (AVS) are the main

binding factor.

The commenter contends that if the

concentration of AVS is greater than

that of lead that is simultaneously

extracted from the sediments, the lead

will not be environmentally available.

Further they state that EPA is currently

considering using this concept to derive

national sediment quality criteria for

lead and other metals such as zinc,

cadmium, and copper. In addition, the

commenter contends that although

events such as storms or dredging may

cause a re-suspension of sediments

(thus temporarily changing the

physicochemical properties of the

sediment), several studies have shown

that these events do not have a large

impact on the binding of metals such as

lead to the sediments, and found that no

significant release of lead occurred from

dredged sediments being suspended in

waters. The commenters claim that

other studies have shown only a small

portion of metals are released from

sediment due to re-suspension and

oxidation of the sediments.

EPA agrees that the environmental

processes that determine the

complexation, speciation, and

ultimately the availability of lead in the

environment should be considered in its

present analysis and asserts that these

have been considered. EPA believes that

the AVS methodology shows great

promise for use in conducting sitespecific assessments of metals for which

it has been validated. To date, the AVS

methodology has not been validated for

lead, nor have the generally favorable,

albeit substantive technical comments

provided by the EPA Science Advisory

Board been incorporated into the

methodology. Finally, EPA does not

believe that a means currently exists to

incorporate the AVS methodology into

the technical analysis supporting a

nationally applied regulation such as

this rule.

EPA disagrees with the commenter’s

conclusions regarding sediment-bound

metals, and the commenter’s inference

that once lead becomes bound to

sediments it is no longer available. EPA

has found that several researchers have

investigated the impact of the oxidation

of sediment constituents on the release

of sediment-bound metals and found

that metal availability can increase

under these conditions. For example,

Zhuang et al. (Ref. 35) found that the

aeration of sediment resulted in the

rapid oxidation of a major binding

constituent, acid-volatile sulfide. In

experiments conducted over a 1 month

duration, the concentration of cadmium

increased 200-400 percent. The

oxidation of AVS occurred rapidly with

a concomitant decrease in pH, and the

release of cadmium from the solid to the

liquid phase continued for

approximately 2 weeks. The authors

noted that aeration of sediments results

in only a portion of the associated

cadmium, and presumably other toxic

metals, being released to water.

Sedimentary iron and manganese are

transformed to their oxyhydroxides by

the oxidation of sulfide. Following the

formation of iron and manganese

oxyhydroxide, the binding of cadmium

is transferred towards these solid

phases. Approximately 50% of the

cadmium bound in sediments is

associated with the extractable iron and

manganese components of the sediment

following aeration. In addition,

oxidation of the sulfidic phase releases

other metals that compete with

cadmium for available binding sites.

EPA believes that it is important to note

the following from the authors’

conclusions:

Prediction of biological availability of

metals in sediments based on the

relationship between metal and AVS

concentrations may be underestimated

if the sediment is subject to aeration.

Thus, experimental data exist that

indicate that cadmium, and presumably

other toxic metals including lead, bound

to sediments can become available. The

data also suggest that contrary to what

the commenter believes, the AVS

methodology does not always provide

an accurate estimate of lead availability

4522 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

when certain, realistic environmental

conditions exist.

Other studies demonstrated the

availability of lead in aquatic

environments. Mahoney et al. (Ref. 36)

examined the partitioning of metals,

including lead, to organic carbon in 14

different freshwater sediment samples.

The metal sorption due to acid volatile

sulfide was subtracted from the total

sorbed metal to determine the metal

bound to other sediment phases

(primarily organic carbon). The results

indicated that organic carbon partition

coefficients for lead were reduced by a

factor of 10 with a decrease in pH from

pH 7 to pH 6. The authors fit the

sorption data to the Langmuir model.

The results were consistent with a

surface complexation model where

binding sites are occupied by either

protons (H∂) or metal ions. At lower

pHs, the protons compete favorably for

the sites, whereas at higher pHs where

protons are fewer in number, free metal

is removed from solution by organic

carbon sorption. This study illustrates

that in sediment water systems at pH

values in the physiological range, lead

can be available for uptake by organisms

even in the presence of organic carbon.

Another commenter states organic

matter, using as an example humic

acids, present in freshwater and marine

sediments and in the aqueous phases

are capable of complexing variable

amounts of metals. The commenter

states that most lead entering natural

waters is sorbed onto organic ligands

and precipitated as insoluble complexes

to the sediments as lead carbonate and

hydroxide (Ref. 37). The commenter

also states that the lead from these

complexes may be mobilized and

released back into the water column, but

only when the pH is decreased

suddenly or the ionic composition of

the water changes. The commenter

claims that both natural soluble organics

(e.g., dicarboxylic and amino acids) and

synthetic soluble organics (e.g., ethylene

diaminetetraacectic acid (EDTA)) act as

chelators (i.e., sequestering agents) of

lead, and reduce the toxicity of heavy

metals such as lead because chelated

forms of metals are less toxic than their

free, non-complexed forms. The

commenter cites work by Canterford

and Canterford (1980), which shows

that EDTA reduced the toxicity of lead

to the diatom, Ditylum brightwellii.

EPA believes that the data in Eisler

(Ref. 37) cited by the commenter

supports EPA’s contention that lead can

be available in the sediment/water

environment under low pH conditions.

EPA has discussed the role of organic

matter and pH in decreasing the

availability of lead and lead compounds

in the aquatic environment elsewhere in

this preamble (see also Ref. 2). EPA

recognizes the important role of organic

matter and pH on the availability of lead

and lead compounds in the aquatic

environment and the effect of pH on the

sorptive behavior of organic matter.

However, EPA has commented

elsewhere that waters with low organic

matter and low pH are widely

distributed throughout the United

States. EPA believes that lead can be

available in such environments. In

addition, while EPA believes that lead

sorbed onto organic matter may be

temporarily unavailable, EPA does not

agree that lead sorbed onto organic

matter is no longer bioavailable. Many

aquatic species (e.g., mussels, fish)

consume orally as part of their diet

organic matter in their environment.

Lead sorbed to organic matter may be

bioavailable in organisms that consume

the organic matter. The same holds true

for terrestrial species. Lead sorbed to

soils, for example, is bioavailable in

humans (See Unit VI.D.2. of this

preamble).

c. What comments did EPA receive on

the availability of lead in soils. One

commenter claims that EPA’s data on

the fate of lead in terrestrial

environments do not support the

Agency’s conclusion that lead is

expected to be bioavailable when in

terrestrial environments. The

commenter states that EPA fails to

provide information about the

probability of the natural occurrence of

the conditions that could result in the

formation of soluble/bioavailable lead

species.

EPA believes that soils possessing

properties that are conducive to the

increased mobility of lead are by no

means uncommon. In order to

determine the extent to which soil

samples collected across the United

States possess such properties, EPA

conducted a query of the database of the

Soil Survey Laboratory (SSL), National

Soil Survey Center. The database

currently contains analytical data for

more than 20,000 pedons of U. S. soils

and about 1,100 pedons from other

countries. Most of the data were

obtained over the last 40 years. Of these,

about 75 percent are less than 20 years

old. Coverage is for all 50 states, Puerto

Rico, Virgin Islands, Trust Territories,

and some foreign nations. The search

was designed to identify soils with a pH

of less than 5.5 and a cation exchange

capacity (CEC) of less than 10

milliequivalents (meq) /100 grams. The

results of this search identified more

than 10,000 samples that meet the

criteria.

Many investigators have studied the

speciation, mobility, and availability of

lead in soils. The EPA concludes from

this body of work that although lead

binds to many soils, under many natural

environmental conditions it will, or at

least can be expected to be available for

uptake by organisms. Reddy, et al. (Ref.

38) studied the speciation of lead in

water extracts from soil samples from

the Powder River Basin in Wyoming.

Dissolved concentrations of lead were

found to be 0.003 to 0.046 mg/L.

Chemical speciation indicated that at

near neutral pH, dissolved metal

concentration in soil water extracts was

dominated by dissolved organic carbonmetal complexes. At low pH, dissolved

metal concentration in soil water

extracts was dominated by free ionic

oxidation states, (e.g., Pb∂2). The results

suggest that as soil pH decreased, the

availability and mobility of lead ions

increased due to the lead compound in

which the metal is present in soil

solutions. Wang and Benoit (Ref. 39)

investigated the mechanisms controlling

the mobility of lead in soils of a

northern hardwood forest ecosystem.

The authors observed that about 50% of

total filtrate lead (passing through a 0.45

um filter) was found to be in the

colloidal form below the soil surface

organic layer. Colloidal lead

concentrations in deeper horizons were

less than 10% of the concentrations in

the surface layer. Less than 10% of the

dissolved lead was found to be

complexed to organic substances. A

calculated distribution of inorganic lead

species indicated that at the pH of the

soil solutions tested (4.0 to 4.7), free,

dissolved ionic Pb∂2 dominated and

other complexes and ligands were

negligible. Low pH resulted in Pb∂2

desorption from soil solids. However,

because both colloidal and dissolved

lead were effectively removed during

transport down the soil profile,

mobilized lead from the surface organic

layer was retained in lower soil

horizons. Although this study suggests

that under the conditions investigated,

lead does not migrate to an appreciable

extent through the soil profile, EPA

believes it gives a strong indication that

lead may be available in the acidic

organic surface horizon.

The effects of redox potential and pH

on the solubility of lead in

contaminated soil were investigated by

Chuan et al. (Ref. 40). Lead was

sparingly soluble at pH 8.0 and more

soluble at pH 5.0; solubility increased

considerably at pH 3.3. At the same pH,

solubility increased as the redox

potential decreased. However the effect

of pH was more significant than redox

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4523

potential. It was proposed that lead in

soil was primarily adsorbed to ironmanganese (Fe-Mn) oxyhydroxides and

the pH dependent adsorption and

dissolution of the Fe-Mn oxyhydroxides

under reducing conditions controlled

the solubility of lead in soil. EPA

believes that the indication of increased

lead solubility at pH 5 suggests that in

many soils lead could be available for

uptake by organisms.

Murray et al. (Ref. 41) analyzed the

distribution of lead in surface and

subsurface soils at an outdoor shooting

range in southeastern Michigan that had

been in operation for 50 years. It was

found that the distribution of lead in the

subsurface corresponded to that in the

surface soil horizon, suggesting that lead

was mobilizing and migrating

downward through the vadose zone.

Mobilization of lead appeared to be

occurring despite the clay-rich nature of

the soils, and was thought to be due to

the transformation of metallic lead into

soluble lead carbonate and lead sulfate.

Both compounds were found in crust

material coating shot pellets found

below a depth of about 5 cm at the site,

thus implying a reaction between the

metallic lead and the soil. The evidence

of the apparent mobility of lead under

conditions thought to decrease mobility

further indicates that lead is available

for uptake in soils.

Laperche et al. (Ref. 42) studied the

use of soil phosphorous amendments as

a means of reducing the availability of

lead in contaminated soils. In this study

soil contaminated with lead was treated

with natural and synthetic

phosphorous, and the bioavailability of

lead in plants was determined in plant

uptake studies with sudax (Sorghum

bicolor). The lead content in the shoot

tissue decreased as the quantity of

added phosphorous increased, due to

the formation of insoluble lead

phosphate compound pyromorphite.

However, lead and phosphorus contents

in the roots increased as the quantity of

added phosphorus increased. The

formation of pyromorphite on root

surfaces was also observed. It is

important to note that in the absence of

phosphorous amendments, lead content

in the shoot was 170 mg lead/kg dry

weight, whereas with the most effective

phosphorus treatment, lead content in

the shoot was 3 mg lead/kg dry weight.

This strongly suggests that in soils with

low phosphorus content, lead can be

available for uptake by plants.

One commenter believes EPA does

not adequately address the important

role of cation exchange capacity of soils

as it relates to the availability of lead

and lead compounds. The commenter

states that at pHs of 5 to 9, clays possess

surfaces that are predominantly negative

and to which charge-compensating

cations are adsorbed. The commenter

claims that these cations are not

permanently bound to the clays and are

being exchanged by other cations,

including heavy metals such as lead,

copper, and cadmium.

EPA has discussed the effects of pH

and cation exchange capacity on the

availability of lead in soils in Unit

VI.C.2. of this preamble and in the RTC

document (Ref. 1). EPA recognizes the

important role of cation exchange

capacity of soils in the availability of

lead and lead compounds, and the effect

of pH on the sorptive behavior of clays.

The cation exchange capacity of soils is

related to the clay content of the soil.

Soils with low clay content and low

cation exchange capacity are common

and widely distributed. EPA has

concluded that lead can be available in

such soils.

A commenter summarized research

results published by Zimdahl and

Skogerboe (Ref. 43), and stated that the

research showed that soils have a strong

capacity to immobilize lead, and that

lead tends to become associated with

the organic fraction of soil particles. The

commenter states that the authors

concluded that this sorption is less

likely to be affected by low pH

(acidification) than would acid ion

precipitates (carbonates, phosphates,

sulfates, chlorides). The commenter also

claims that these investigators

concluded that plant uptake studies

strongly support their conclusions about

the immobilization of lead and its

sorption to organic matter in the soil.

EPA reviewed the publication by

Zimdahl and Skogerboe (Ref. 43). In the

discussion section of this publication

the authors provide the following

overview regarding the behavior of lead

in soils:

* * * the movement of lead in the soil

profile and its ultimate fate may be

determined by one or more of several

processes. These depend largely on the

dissolution of the lead particles in the ground

water. The lead dissolved may be leached

through the soil profile if it remains in a

soluble form. It may be immobilized by soil

microorganisms, precipitation, sorption or

ion-exchange interaction with soil entities

(e.g., clays) or fixation by materials such as

organic matter. It may also be taken up by

plants, thereby entering the food chain. ...

The significance of this possibility is

reflected in the demonstrated toxicity of lead

to corn, beans, lettuce, and radishes in lower

concentrations in slightly acidic soil. These

and other studies suggest that lead in soil can

reach the soil plant root interface and be

taken up by plants.

In their investigation of the factors

controlling the mobility of lead in soils

the authors developed a correlation

function based on the soil properties

determined to be most strongly

correlated with soil immobilization of

lead (pH and cation exchange capacity).

Precipitation by carbonate and sorption

by hydrous metal oxides appeared to be

of secondary importance. They

concluded that lead will be twice as

mobile (i.e., available) in soil with a pH

of 4.1 and a CEC of 13 meq/100 g as in

a soil with a pH of 6.8 and a CEC of

meq/100 g. EPA believes the findings of

Zimdahl and Skogerboe do not conflict

with EPA’s environmental fate analysis

of lead and lead compounds. EPA agrees

that the authors determined that some

soils have the capacity to decrease the

mobility of lead, but equally as

important, the study provided a means

to estimate the effect that a soil’s

properties can have on decreasing its

capacity to immobilize lead, thereby

increasing availability.

One commenter disagrees with the

contention of other commenters that

lead and lead compounds should not be

considered persistent because when

released to the soils they will not be

bioavailable. The commenter asserts

that because metals released into the

environment do not always immediately

become bound to particles, nor do they

remain bound given pH and other

changes, and because metals bound to

soil particles are ingested by young

children, there are strong reasons to be

concerned solely about the persistence

of toxic metals.

EPA agrees with the commenter that

lead released to the environment may

not become immediately bound and that

there are environmental conditions that

will increase the availability of lead in

soils. One example is the effect of pH on

lead compounds. For example, lead

when part of a compound which has

low solubility at neutral to basic pH will

be converted into soluble compounds

when subject to acid mine drainage. The

soluble lead compounds will be mobile

and may travel through the

environment. When these compounds

experience higher pH their mobility will

decrease and the availability will

decrease. However, the availability in

many cases will be greater than in the

original lead compound. The lead may

be part of a lead compound (e.g.,

carbonate) in which it is much more

available than in the original lead

compound, even if the pH is the same

because the lead will be part of a

different molecule and this molecule

will react to the environment differently

than the original lead compound.

Another commenter contended that

EPA should have used the Multimedia

Equilibrium Criterion (EQC) model to

4524 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

estimate overall environmental

persistence and partitioning of lead. The

commenter stated that in the PBT

chemical rulemaking, the Agency

discussed how it used this model to

evaluate the overall environmental

persistence of toxic chemicals subject to

the proposal (64 FR 702–703). The

commenter believes that the EQC model

is ideally suited to model the

environmental partitioning and

persistence of lead.

The commenter is correct in stating

that EPA used the EQC model to

evaluate persistence and partitioning of

toxic chemicals described in the PBT

chemical rulemaking. EPA did not use

the EQC model for metals in the PBT

chemical rulemaking. EPA agrees that

the EQC model is a valuable tool for

determining the multimedia fate and

transport of chemicals in the

environment. As described in the PBT

chemical rulemaking, however, the EQC

model was only used to model

environmental persistence and

partitioning of organic chemicals, and

not of metals. In the PBT chemical

rulemaking, EPA based its

determination of whether a toxic

chemical is persistent based on half-lifes

for specific media. For organic

chemicals EPA used the EQC model to

determine if it were possible that a toxic

chemical that is persistent in one

medium significantly partitions to

another medium in which the toxic

chemical rapidly degrades thus

providing an overall environmental

half-life less than the established

criteria. The commenter is also correct

in stating that the Agency did not use

the EQC model to evaluate the

environmental persistence and

partitioning of lead and lead

compounds. As EPA explained in both

the PBT chemical rulemaking and the

proposed lead rule, metals are persistent

because the metal cannot be destroyed.

While the EQC model can be used to

model the partitioning of a metal and its

compounds from one medium to

another medium in the environment, it

does not model the destruction of the

metal because that cannot occur.

The Agency would like to point out,

however, that Mackay et al. (Ref. 44)

used lead as an example of a ‘‘class 2’’

(nonvolatile) substance for an EQC

model run. Because lead is classified as

a ‘‘class 2’’ chemical, the EQC model

treats volatilization of lead from water

to air and from soil to air as negligible.

Mackay used an infinitely long

degradation half-life for lead (i.e., lead

is persistent and is not destroyed).

When an infinitely long degradation

half life is used (as was used by Mackay,

et al. for lead in all media) only nondestructive removal processes such as

loss from the air compartment by

deposition of airborne particles to soil

and water, soil runoff, advection in

sediment (loss from the model

environment by burial of sedimentbound lead), and transport of sediment

bound lead particles out of the model

environment are important. The overall

environmental persistence of lead

estimated by the model reflects the time

necessary for lead to be physically

transported from the model

environment, not destroyed. Thus the

model, in essence, provides information

on the partitioning and movement of

lead, but inevitably indicates that lead

will be persistent in all media.

The EQC level III modeling results for

lead showed the importance of

deposition from the air compartment to

soil and water, at a rate that exceeds the

advection rate (rate of non-destructive

transport out of the model

environment). The main removal

mechanism according to the model was

advection (burial) in sediment, followed

by soil runoff and advection in water.

The buildup of the chemical in the

model environment was about 1.7 × 1010

kg and its overall persistence was 5.6 ×

106 hours (634 years), which is

essentially infinite duration. In

addition, at steady state the model

predicted that lead concentration in the

water compartment of the model

environment would be 4.27 ug/L. For

lead the important transport parameters

are those controlling atmospheric

deposition and sediment-water

exchange. EPA believes that,

considering the results above and the

discussion of the availability of lead in

water, soil and sediments provided

elsewhere in these responses to

comments, the use of the EQC model

would not have provided any

information counter to EPA’s position

that lead and lead compounds are PBT

chemicals. Thus, even if EPA had used

the EQC model to estimate the

environmental persistence and fate of

lead, EPA would have drawn the same

conclusions stated in the proposed rule.

In addition, the Agency would like to

emphasize that as discussed in the PBT

chemical rulemaking the EQC model

was only used as a secondary means to

evaluate persistence and partitioning of

organic chemical substances, and that

unless all of the data inputs to the

model were reliable it would not be

used by the Agency to override

persistence data from individual media.

2.What comments did EPA receive on

the bioaccumulation data for lead and

lead compounds? Some commenters

contend that EPA failed to consider the

results of more recent studies that

indicate that the accumulation of lead in

aquatic organisms is low and that the

concentrations of lead found in the

environment are lower than previously

measured. Commenters also questioned

the relevance of laboratory

bioaccumulation studies on lead to the

bioaccumulation of lead under

environmental conditions claiming that

under ‘‘realistic conditions’’ lead does

not bioaccumulate significantly in

organisms. As discussed in detail in this

section, none of these issues change

EPA’s conclusions about the validity of

the data. With regard to the results of

more recent studies, these studies do

not provide information that changes

EPA’s conclusions that lead and lead

compounds are bioaccumulative. EPA

also believes that the laboratory

bioaccumulation studies for lead are

relevant to the potential for lead to

bioaccumulate, which is confirmed by

the observed bioaccumulation of lead in

the environment.

As discussed in Unit VI.B. of this

preamble, bioaccumulation is a general

term that is used to describe the process

by which organisms may accumulate

chemical substances in their bodies. The

propensity of a substance to

bioaccumulate in a species depends

largely upon the pharmacokinetics of

the substance in that species. That is,

the extent to which a substance can

bioaccumulate in an organism depends

upon: (1) Whether the organism can

absorb the substance; (2) the extent to

which the substance is distributed and

metabolized within the organism; and

(3) how readily the organism can excrete

the substance. The pharmacokinetics of

a substance, and therefore the

propensity for it to bioaccumulate, can

(and often does) vary greatly among

different species, even among species

within the same trophic level. This is

because species differ in their anatomy,

physiology, and genetic makeup. These

are important variables that govern the

propensity for a substance to

bioaccumulate, in addition to the

substance’s physicochemical and other

properties. It is well established that a

given substance can have different BAF

(or BCF) values in different species.

Data presented in Table 1 of the

proposed rule (64 FR 42230) indicates

that lead has different BAF (or BCF)

values in different species.

In the proposed lead rule EPA

preliminarily concluded that lead and

lead compounds are highly

bioaccumulative based upon the

Agency’s review of the bioaccumulation

data for lead and lead compounds in

aquatic species and in humans. Those

who commented on EPA’s assessment of

the bioaccumulative properties of lead

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4525

and lead compounds commented on the

aquatic data used by EPA and did not

comment on or refute the extensive data

in humans. A number of commenters

disagreed with the scientific basis that

EPA used to support the use of

bioaccumulation measurements for lead

and lead compounds because they

believe EPA’s scientific basis: does not

use relevant data; is insufficient; does

not have a sound scientific foundation;

or does not present a balanced view of

the scientific literature. Other

commenters address the issue of

bioaccumulation generically, rather than

specifically to lead and lead

compounds. EPA responded to the

generic issues in the earlier PBT

chemical rulemaking (64 FR 58676) and

in the associated Response to Comments

document (Ref. 15). However, EPA is

discussing some general issues here as

background for the more specific issues

related to lead and lead compounds in

order to facilitate EPA’s responses.

Further, while some commenters agree

that lead and lead compounds

bioaccumulate, they contend that they

are not highly bioaccumulative. A

discussion of both the aquatic data and

the human data used by EPA, and the

issues raised by commenters on EPA’s

use of these data are provided below. As

discussed earlier, after having reviewed

and considered all the comments, EPA

is finalizing this rule with a finding that

lead and lead compounds are

bioaccumulative, and is deferring its

original conclusion that lead is highly

bioaccumulative.

a. What comments did EPA receive on

the aquatic bioaccumulation data for

lead? Aquatic species have their own

unique roles in ecosystems and are

important for the subsistence of other

species, including consumer and

predator species. Thus, the propensity

of lead to bioaccumulate in aquatic

species is of concern. Among other

things, aquatic species comprise

components of the food chain that lead

to humans. For example, green algae are

primary producers in aquatic

ecosystems in that, through

photosynthesis, they produce oxygen

and synthesize carbohydrates and other

foodstuffs (Ref. 45). These substances

are used by consumer species which in

turn serve as the food source for

predator species, including fish. Fish in

turn, serve as a food source for wild

mammals, birds, and man. The survival

of a number of terrestrial species,

including humans, is at least partially

dependent upon aquatic organisms. The

Agency for the purposes of EPCRA

section 313 believes all aquatic

organisms to be equally relevant when

evaluating properties of chemicals to

aquatic life forms: i.e., an alga is viewed

just as important as an oyster or a fish.

EPA’s scientific assessment of lead

and lead compounds is based upon

relevant data and has a sound scientific

foundation. EPA believes that the

scientific basis that the Agency used to

support its conclusion that lead and

lead compounds bioaccumulate in

aquatic species is more than sufficient,

and presents a balanced view of the

scientific literature. The effects of lead

and lead compounds on aquatic and

terrestrial organisms has been studied

extensively since the mid-1920s. A

particularly active period for lead

research was during the 1970s and

1980s, when dozens of studies were

completed. In fact lead was one of the

first chemicals extensively tested and

monitored in water pollution and water

quality studies. Thus, there are a

plethora of studies available that

investigated the environmental fate,

availability, bioconcentration and

bioaccumulation of lead and lead

compounds. The Agency believes that

these studies are relevant to an

assessment of lead as a PBT substance,

and many of these were reviewed by the

Agency for the proposed rule. Each

study reviewed by EPA in the

development of this rule involving

bioconcentration or bioaccumulation

testing, was initially assessed by the

Agency for quality. Not unexpectedly,

the studies were found to vary in quality

and test results to the subject organisms.

Studies that were found to be most

consistent with OPPT test guidelines

were deemed valid and selected for use

in the assessment. These studies

covered a variety of different test

species.

The results of EPA’s assessment of the

bioaccumulation of lead and lead

compounds in aquatic organisms are

summarized in Table 1 of the proposed

rule and in references therein (64 FR

42230). As can be seen from Table 1, the

BCF values from these studies range

from 390 to over 12,000, additional

information on BCF values for lead and

lead compounds are contained in EPA’s

support document (Ref. 6). For a

number of aquatic organisms that

include: freshwater invertebrates such

as mollusks, insects, and daphnid

crustaceans; freshwater algae and

phytoplankton; marine mollusks, a

crustacean, and algae, lead and lead

compounds bioconcentrate to levels

above the baseline BCF criterion of

1,000 and, for some organisms, at or

above 5,000. These values are viewed by

the Agency as indicators of the potential

for increased exposure due to significant

bioaccumulation that could occur in

other organisms in the environment that

have not been tested. Based on these

data EPA concludes that lead and lead

compounds are bioaccumulative, and

believes that these data tend to support

a finding of highly bioaccumulative.

Where a range of lead BCF values was

available for a specific organism, EPA

evaluated the scientific validity of the

studies reporting BCF values and relied

upon those studies that were valid and

scientifically sound. If valid BCF values

meeting, or surpassing, the

bioaccumulation criterion used by EPA

in this rulemaking (i.e., BCF or BAF

values greater than 1000) were

identified for a species, EPA relied on

these values as evidence that lead meets

the EPCRA section 313 bioaccumulation

criterion. Although some species may

have a range of reported BCF values, in

some cases crossing the

bioaccumulation criterion, a study

reporting a lower value does not

invalidate scientifically sound studies

reporting higher values.

The results of the majority of the

studies that investigated the

bioaccumulation of lead and lead

compounds are in general agreement.

Thus, although EPA did not review

every published lead study as part of its

assessment for the proposed rule, the

scientific data EPA used to support its

assessment of lead and lead compounds

were valid, represented the majority of

all available data on lead, and provided

a representative sample of the available

knowledge on lead.

One commenter notes EPA’s

definitions of BAF and BCF on page

42229 of the proposed lead rule. EPA

defines 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.’’ EPA defines

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.’’ The

commenter questions the portions of

EPA’s definitions of BCFs and BAFs that

state that the ratios do not change

substantially over time (64 FR 42229).

Specifically, the commenter claims that

‘‘such ratios have little scientific

relevance in themselves.’’ The

commenter states that available data

indicate that the lead BCF may not be

a constant for different exposures,

species or trophic levels.

EPA agrees with the commenter’s

statement that a BCF may not be

4526 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

constant for different species or trophic

levels. The Agency also agrees with the

commenter’s statement that the BAF

and BCF of a substance measured in the

same species can vary with the level of

exposure (the concentration of the

substance in ambient water). The

Agency, however, believes the

commenter has misunderstood the

portions of its definitions of BCFs and

BAFs that state that the ‘‘ratios do not

change substantially over time’’ (64 FR

42229). The definitions of these terms

pertain to determinations of BAF and

BCF under controlled experimental

conditions or field studies, where

exposure of the aquatic species to the

chemical is kept relatively constant. The

phrase ‘‘ratios do not change

substantially over time’’ does not refer

to different experiments conducted at

different concentrations of the test

chemical. Thus, the fact that lead BCF

values may not be constant for different

exposures, species or trophic levels does

not mean that lead does not

bioaccumulate.

A number of commenters claim that

EPA disregarded scientific data or did

not use current scientific evidence in its

assessment of the aquatic

bioaccumulation potential of lead and

lead compounds. Most of these

commenters point out that EPA based

its assessment of lead and lead

compounds on studies published no

later than the 1980s. These commenters

are concerned that the studies EPA used

are ‘‘out-of-date’’; flawed; were not

conducted using modern day analytical

techniques; and assert that the data

provided in these studies should not

have been used by EPA in its

assessment. These commenters also

claim that environmental studies

pertaining to lead and lead compounds

published in the 1990s indicate that

lead and lead compounds are not

persistent or bioaccumulative in aquatic

species.

While some commenters criticize the

Agency for basing its assessment on the

studies referenced in the Federal

Register notice and in the technical

support document entitled

Bioaccumulation/Bioconcentration

Assessment for Lead and Lead

Compounds (Ref. 6), none of these

commenters provide persuasive

criticism of the studies used by EPA, or

of a particular data point from a study

used by EPA. In many cases it is not

clear from their comments specifically

which studies and data these

commenters feel are untrustworthy. It is

difficult, therefore, for EPA to provide

specific responses to these commenters.

In addition, although many of the

commenters claim that EPA did not use

current scientific evidence, very few of

the commenters provide citations to

specific studies that contain more

current or more recent scientific data.

The Agency recognizes that it did not

use results from studies published

during the 1990’s in its assessment of

lead and lead compounds. EPA

disagrees with the commenters,

however, that the studies used in its

analysis are ‘‘out-of-date’’, or that the

data are not sufficiently current such

that they should not have been used in

the assessment. As with all studies used

by EPA, the studies EPA used in its

assessment of lead and lead compounds

were initially reviewed by EPA for

scientific credibility, and found to be

scientifically valid. Many of the current

methods used for biological analyses

and conducting ecotoxicity tests are

essentially the same as those used in the

studies cited by EPA in the proposed

rule. In addition, on a more general

level, the Agency does not believe that

the quality of a study should be judged

by the year it was published, or that the

results of a more recently published

study necessarily has greater scientific

validity than a similar study published

earlier. The Agency maintains its

longstanding position that when

conducting a scientific assessment it is

scientifically unacceptable to

discriminate between study results by

the age of the study: the selection of

studies for any scientific assessment

must be based on scientific merit.

While the Agency did not rely on the

specific results from the additional

studies referenced and discussed by one

commenter to assess the

bioaccumulation of lead and lead

compounds in developing the proposed

rule, the studies published in the 1990s

which were referenced by the

commenters provide no significant

additional information beyond the

studies used by EPA in the proposed

rule, nor do the results from these

studies lead EPA to reconsider the

characterization of lead and lead

compounds as bioaccumulative.

One commenter claims that more

recent aquatic bioaccumulation studies

indicate that previously reported

concentrations of metals in

environmental waters are erroneously

high due to sample contamination (i.e.,

that earlier studies on the concentration

of lead in the environment over

estimated the actual concentrations of

lead in the environment). The

commenter believes that this means that

previously reported BAF and BCF

values would appear lower than if the

concentrations of lead had not been

overestimated. The commenter states

that because of the earlier ‘‘erroneous Pb

measurements in water’’, researchers

used higher lead levels in their

bioaccumulation studies than they

otherwise would have used. The

commenter states that no experiments

have been conducted at levels close to

the actual lead concentrations in

‘‘natural waters.’’ The commenter also

stated that no data exists on actual lead

concentrations for waters associated

with highly contaminated sites where

the results of the experiments

conducted at concentrations above

natural waters might apply. The

commenter states that recent studies use

lead concentrations 3 to 6 orders of

magnitude above actual background

lead concentrations and that although

the data cited by EPA are from studies

much closer to levels in natural waters

they are still 2 to 4 orders of magnitude

greater than typical values of lead in

natural waters. According to the

commenter this caused higher levels of

lead to occur in the organism than

would be observed under ‘‘actual

concentrations of Pb in natural waters.’’

The commenter tries to invalidate the

concerns for bioaccumulation by

claiming that, even though the BAFs/

BCFs used by EPA are high, the absolute

amount of lead that would

bioaccumulate in organisms is low and

does not pose a risk.

EPA disagrees with the commenter’s

argument that only BAF or BCF values

measured at ‘‘actual concentrations of

Pb in natural waters’’ are relevant to the

bioaccumulation potential of lead and

lead compounds. At its foundation the

commenter’s argument is flawed

because under EPCRA section 313 the

Agency is collecting data on releases of

lead and lead compounds to the

environment which are expected to

raise lead concentrations above natural

background levels. BCF studies that

used lead concentrations above natural

background levels are valid since they

demonstrate that lead can

bioaccumulate at lead concentrations

that may result from industrial releases.

Thus the fact that the experiments on

bioaccumulation were conducted at lead

levels in excess of those found in

‘‘natural waters’’ does not, in itself,

invalidate the results of those studies.

As noted in Unit VI.C.3., testing

guidelines for bioaccumulation do not

state that chemicals should be tested at

natural background concentrations, only

that the concentrations should be below

a level that is detrimental to the test

organism. Therefore, even if better data

had been available on the background

concentrations of lead that does not

mean that bioaccumulation studies

would have been conducted at those

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4527

concentrations. In addition, the

commenter admits that higher

bioaccumulation values would have

been reported in earlier studies if better

data on the concentration of lead in the

water had been available. EPA fails to

see how even higher bioaccumulation

values undermine EPA’s determination

that lead and lead compounds are

bioaccumulative. EPCRA section 313 is

not a risk-based program, and the

Agency is not required to demonstrate a

specific risk in order to classify a

substance as a PBT chemical. The

EPCRA section 313 bioaccumulation

criteria does not include a requirement

that a chemical must bioaccumulate to

some specific absolute amount within

an organism in order to meet the

criteria. Therefore, EPA disagrees that

lead has not been shown to

bioaccumulate to a level sufficient for

inclusion as a PBT chemical. Even if

such evidence were needed, it is

available. EPA’s database of Fish and

Wildlife Advisories (http://fish.rti.org)

contains 26 advisories for various fish

and shellfish, see Unit VI.D.3. This

indicates that lead and lead compounds

can and do bioaccumulate in aquatic

organisms to absolute levels that are of

concern for human consumption.

Furthermore, the commenter’s

contention that previously reported lead

concentrations in ambient waters may

be erroneously high only serves to

support the conclusion that lead and

lead compounds are at least

bioaccumulative. The commenter agrees

that if the previously reported lead

concentrations in ambient waters are in

fact erroneously high, then the

previously reported BAF and BCF

values for lead and other metals are

erroneously low (because the BAF and

BCF values are determined by dividing

tissue lead concentrations by

environmental water concentrations).

Thus, if the commenter’s claim about

the water concentrations is true, then

the propensity for lead and lead

compounds to bioaccumulate in aquatic

species is actually greater than

originally estimated. Based on the

commenter’s concern for the validity of

the water concentrations and the BAF

and BCF values reported for lead and

lead compounds, EPA re-reviewed the

studies it used in its original assessment

of lead and lead compounds. EPA is

satisfied that the lead water

concentrations, BCF values, and BAF

values reported in these studies are

valid. However, as noted above, EPA is

deferring on a final conclusion

regarding the classification of lead as

highly bioaccumulative based on the

data in these studies, and is concluding

in this rule that lead is bioaccumulative.

Two commenters contend that the

extent to which a metal such as lead

bioaccumulates is dependent upon its

concentration in the aqueous habitat of

the organism. The commenters state that

in most cases where bioaccumulation

was noted, the organisms were exposed

to artificially elevated lead

concentrations in laboratory settings,

often where abiotic factors were

manipulated to increase lead

availability.

The Agency agrees that environmental

transformations and the uptake of lead

by biota are highly variable and

complex. However, these variabilities

and complexities can be minimized by

testing in the laboratory using a valid

method. As discussed in the proposed

rule, valid laboratory BCF tests have

shown that lead and lead compounds

have BCF values in some species well

over 1,000. In some of the lead assays,

several of the tested species (e.g.,

mollusks, algae) have very high BAF or

BCF values, i.e., 5,000 or greater,

indicating that these organisms

accumulate or concentrate lead to high

levels and eliminate lead very slowly.

Thus, in organisms such as these, it

would seem logical that the BAF or BCF

values obtained at different test

chemical concentrations would

probably not vary by much. Further,

based on its assessment of lead and lead

compounds the Agency has concluded

that external concentration is only one

of several factors that govern the

propensity for these substances to

bioaccumulate in a given species. As

discussed in more detail Unit VI.C.3,

pharmacokinetic factors are operative as

well.

EPA does not believe that

bioaccumulation of lead was

documented mostly in cases where the

concentrations of lead in the

surrounding water were artificially

elevated in laboratory settings. This was

not the case, for example, in the

freshwater and marine algal field

studies where BAF or BCF values above

10,000 were documented in actual

aquatic environments and the lead

levels were not artificially controlled. In

addition, the fish advisories discussed

in Unit VI.D.3. were based on concerns

for lead levels in fish and other species

that did not occur as a result of

artificially elevated lead concentrations

in laboratory settings.

One commenter states that EPA’s

contention that relatively small releases

of lead and lead compounds have the

potential to bioaccumulate and cause

significant adverse environmental

impacts is not supported by the

scientific literature. Another commenter

stated that the preponderance of

evidence shows that only under very

limited conditions will lead and lead

compounds be available to

bioaccumulate and cause toxic impacts

to ecosystems.

EPA disagrees. As discussed

elsewhere in this document, there are

many studies that show that there are

several environmental factors (e.g., pH

range of 3 to 6; soils that have low

cation exchange capacity; low soil

organic matter content) that increase the

availability of lead and that, either

individually or in combination,

commonly exist throughout many

geographical locations within the

United States. However, even if the

conditions under which lead is

available were very limited this would

not mean that lead would not

bioaccumulate. Also, because lead and

lead compounds are EPCRA section 313

listed toxic chemicals that EPA has

determined are persistent and

bioaccumulative, even small releases of

lead and lead compounds into the

environment persist and have the

potential to bioaccumulate and cause

significant adverse environmental

impacts. Further, EPA notes the data on

the bioaccumulation of lead and lead

compounds in human (see Unit

VI.D.2.b.) and the fish advisories for

lead (see Unit VI.D.3.).

b. What comments did EPA receive on

the human bioaccumulation data for

lead and lead compounds? In Unit V.C.

(pages 42230–42231) of the proposed

rule, EPA provides a brief summary of

available data on the pharmacokinetics

of lead in humans. As stated in the

proposed rule, EPA concluded that

there is a substantial amount of

evidence that shows that humans

bioaccumulate lead. Unlike the

assessment as to whether lead

bioaccumulates in aquatic species,

which was based on lead

bioaccumulation factor (BAF) and

bioconcentration factor (BCF) values

measured in aquatic species in

laboratory or field studies, the

assessment of whether lead

bioaccumulates in humans cannot be

based on an analysis of BAF or BCF

values because such values are not

available for humans. The assessment of

whether lead bioaccumulates in humans

was based on the Agency’s review of the

references cited in Unit V.C. of the

proposed rule, which provide a

substantial amount of data and

information regarding exposure of

humans to lead, and the

pharmacokinetics of lead in humans.

From its review of these references, EPA

concluded that humans, particularly

4528 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

children, bioaccumulate lead to a

significant degree. The propensity of

lead to bioaccumulate in humans is

known to result in toxicity to humans,

especially infants and children. While

the EPCRA section 313 PBT chemical

criteria does not require that toxicity

must occur in the same species in which

the substance bioaccumulates, or result

from bioaccumulation of the substance,

those chemicals that persist in the

environment, bioaccumulate in humans,

and are toxic to humans are particularly

problematic in regard to human health.

The following information on the

accumulation of lead in humans is

discussed in the references cited in the

proposed rule (Refs. 8, 10, 11, 14, and

25).

Exposure of the general population to

lead occurs primarily via the oral and

inhalation routes, and data show that in

humans lead is absorbed from the

gastrointestinal tract and the lung.

Absorption of lead from the

gastrointestinal tract varies with age.

Adults absorb approximately 10% of

orally ingested lead, and usually retain

less than 5% of what is absorbed.

Children absorb up to 40% of ingested

lead, and retain more than 5% of the

absorbed quantity. Infants retain over

30% of the quantity absorbed following

oral exposure. Research indicates that

the differences in the extent to which

lead is absorbed orally between adults

and infants and children may be due to

the increased need for calcium in

infants and children. In infants,

children, and adults, a transport

mechanism is involved with the

absorption of calcium from the

gastrointestinal tract. Infants and

children, because they are growing

rapidly, utilize calcium for bone

formation and growth. Dietary needs for

calcium are therefore higher in infants

and children than in adults and,

consequently, calcium is more

efficiently absorbed orally by infants

and children than it is by adults.

Evidence indicates that lead may be

competing with calcium for the

transport mechanism involved with

absorption of calcium, which could

explain why lead is absorbed from the

gastrointestinal tract more efficiently in

infants and children than it is in adults.

Following inhalation exposure, lead is

well absorbed from the lung by all

human subpopulations. About 90% of

lead particles in ambient air that are

deposited in the lung are small enough

to be retained within the lung. Lead

retained within the lung is essentially

completely absorbed from the lung.

In humans, lead is known to

bioaccumulate in bone. Following

absorption, lead is distributed initially

to the blood and soft tissues (especially

the kidney, liver and bone marrow). The

biological half-life of lead in blood is

generally from 1 to 2 months. Some of

the lead in the blood is excreted,

predominately in the urine. The extent

and rate of excretion is limited,

however. Eventually, lead that is not

excreted is redistributed from the blood

to teeth and bone. Once in bone, the

biological half-life of lead can extend

beyond 20 years. Following daily

exposure to lead, a steady state blood

level of lead is achieved after about six

months. (A steady state in blood lead is

reached when the daily intake of lead

approximates the amounts excreted in

the urine and partitioned to bone.) Once

steady state is reached, the blood level

of lead remains essentially constant.

However, because the rate and extent of

urinary excretion of lead is limited, the

concentration of lead in bone tends to

continue to increase even though daily

exposure remains constant. Also, if the

amount of daily intake should increase,

the time to accumulate higher levels of

lead in the blood and soft tissues

shortens disproportionately since renal

excretion and deposition into bone

occurs too slowly to prevent an

accumulation in the blood and soft

tissue.

The fraction of lead in bone increases

with age from about 70% of total body

lead in childhood to as high as 95% of

the total body lead during old age.

While lead bioaccumulates in bone, lead

in bone can remobilize back to the

blood. The extent to which lead in bone

remobilizes to blood and other tissues is

related to conditions that involve

calcium resorption from bone. Any

conditions that cause calcium to be

resorbed from bone into the systemic

circulation or other soft tissue will

cause lead to resorb from bone. These

conditions include: advanced age;

osteoporosis; pregnancy; and lactation.

Hence, lead stored in bone from

exposures that occurred years, even

decades, earlier may serve as an internal

source of lead exposure later in life. lead

previously accumulated in bone may

contribute as much as 50% of blood

lead.

Lead in maternal blood can enter the

fetus. Lead in fetal tissue is proportional

to maternal blood concentration.

Inorganic lead (i.e., Pb0, Pb∂2, Pb∂4)

does not readily cross the blood brain

barrier, and therefore only a small

amount of inorganic lead accumulates

in the brains of adult humans. Once in

the central nervous system, however,

lead accumulates in gray matter. The

highest concentrations are in the

hippocampus, followed by the

cerebellum, cerebral cortex, and

medulla. Fetuses, infants and children

less than 4 years of age are more

predisposed to accumulate inorganic

lead in the brain than are adults because

in these subpopulations the blood brain

barrier is not completely formed. In

addition to the ability of infants and

children to absorb lead more efficiently

from the gastrointestinal tract than

adults, it is well established that infants

and children are also more sensitive and

susceptible than are adults to the

neurotoxic effects caused by lead.

Mobilization of lead from bone into the

blood is of particular concern during

pregnancy or lactation.

Based on EPA’s findings that in

humans lead bioaccumulates in bone,

that the concentration of lead in bone

tends to continue to increase over the

course of a lifetime, and that lead stored

in bone from exposures that occurred

previously may serve as an internal

source of lead exposure later in life,

EPA has concluded that lead

significantly bioaccumulates in humans.

In the proposed rule EPA asked for

public comment on the scientific

information concerning the

bioaccumulation of lead in humans, and

how this information should be

considered in classifying lead and lead

compounds as highly bioaccumulative.

Several organizations or individuals

provided comments to EPA’s request,

however none of these comments

addressed the scientific information

presented by EPA concerning the

bioaccumulation of lead in humans, or

how this information should be

considered in classifying lead and lead

compounds as bioaccumulative much

less as highly bioaccumulative. While

EPA believes that it could have reached

a determination of bioaccumulative

based on the human data alone, EPA

concludes that lead and lead

compounds are clearly and properly

categorized as bioaccumulative based on

the aquatic and human data. EPA

further believes that these data would

tend to support a finding of highly

bioaccumulative.

c. What other general comments did

EPA receive on the bioaccumulation of

lead? One commenter claimed that

EPA’s reasoning that lead

bioaccumulates is based on many

variables, and is not realistic. This

commenter refers to EPA’s frequent use

of the words ‘‘may’’ or ‘‘can’’ throughout

the proposal: ‘‘EPA believes that

processes * * * 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.’’

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4529

The Agency disagrees with this

commenter. As described above, EPA’s

characterization of lead as a highly

bioaccumulative substance is based on

the Agency’s scientific assessment.

Also, EPA’s use of words such as ‘‘may’’

or ‘‘can’’ is justifiable. EPA’s TRI

program is a national program and is not

limited to specific locations or regions

of the country. As discussed in detail in

the proposed rule and elsewhere in this

document, environmental conditions

have a direct influence on the

availability of lead and, hence, an

indirect influence on the bioavailability

and bioaccumulation of lead in aquatic

organisms. Environmental conditions

vary substantially across the United

States and hence the availability of lead

in the environment is likely to vary

accordingly. To encompass the fact that

environmental conditions vary, and that

this rulemaking decision will be

implemented at the national level, EPA

believes its use of words such as ‘‘can’’

or ‘‘may’’ in the proposed lead rule is an

accurate characterization of the

scientific data. Despite the variations in

environmental conditions EPA has

concluded that there are many

conditions in the United States where

lead is available to bioaccumulate. In

addition, lead is bioavailable even

under environmental conditions where

the lead ion may not be readily available

in the environment.

Further, there are sufficient

experimental data in aquatic organisms,

fish advisories, and extensive data in

humans, all of which indicate that lead

and lead compounds do bioaccumulate.

Thus, EPA disagrees with the comment

that the Agency’s conclusion that lead

bioaccumulates is unrealistic. To the

contrary, EPA has concluded that the

available evidence indicates that lead

and lead compounds will

bioaccumulate in many actual

environments.

Several commenters state that there

are numerous literature citations that

show that lead does not biomagnify in

aquatic food chains, and, in

experimental trophic chains lead

accumulated in decreasing

concentration from the lowest to the

highest trophic levels. One commenter

concludes that bioaccumulation is not

relevant unless lead is transferred up

the food chain to humans, and that a

concept more meaningful than BCF is

needed to evaluate the potential risk

from lead to public health from

ingestion of fish.

EPA disagrees with the commenter’s

conclusion that bioaccumulation is not

relevant unless lead is transferred up

the food chain to humans and that BCFs

[and BAFs] are not meaningful.

‘‘Transfer up the food chain’’ is really a

biomagnification concern which EPA

addressed in the final PBT chemical

rule (64 FR 58682) and associated

Response to Comment document (Ref.

15, section 2.d), stating that such a

process is not relevant to the issue of

whether a chemical bioaccumulates.

Bioaccumulation is a concern for the

organism that bioaccumulates it and any

organism that eats such organisms.

While available data may indicate that

lead does not biomagnify, this has no

bearing on the characterization of lead

as a bioaccumulative substance because

biomagnification is not required in

order to have a concern for a chemical

that bioaccumulates. While EPA does

not have to make such a connection, the

commenters’ own information provides

evidence of a transfer up the food chain.

The commenter stated that about 60% of

the lead in phytoplankton is assimilated

by mussels and that mussels have high

BCF values. EPA identified

phytoplankton as having high

bioaccumulation values so there is the

potential for movement of lead in the

food chain based on this information. In

addition, EPA’s database of Fish and

Wildlife Advisories (http://fish.rti.org)

contains 26 advisories for various

aquatic organisms including shellfish.

3. What comments did EPA receive on

the bioavailability of lead. Contrary to

some commenters’ claims that EPA did

not consider relevant data regarding

bioavailability, EPA emphasizes that the

Agency did consider the bioavailability

of lead in its evaluation of lead and lead

compounds. In addition to the

principles described above in Unit

VI.C.2. that address the availability and

bioavailability of metals, EPA also relied

on empirical data regarding the

availability and bioavailability of lead.

EPA refers specifically to the test data

cited in the proposed rule and in the

references to the proposed rule that

clearly show that lead is bioavailable

(Table 1 of the proposed rule (64 FR

42230), and references therein). The fact

that lead is detectable in the tissues of

snails, algae, plankton, rainbow trouts,

blue mussels, oysters, and lobsters

exposed to lead provides compelling

scientific evidence that lead is

bioavailable in these species.

In addition to these test data, EPA

examined its public National Listing of

Fish and Wildlife Advisories database

(see http://fish.rti.org/) to see whether

lead has been detected in fish under

actual environmental conditions. The

individual states have the primary

responsibility for protecting residents

from the health risks of consuming

contaminated noncommercially caught

fish and wildlife. Individual counties

monitor local fish and wildlife for the

presence of chemical contaminants,

including lead. Fish consumption

advisories warn the public that high

concentrations of chemical

contaminants have been found or are

suspected in fish from local waters and

that consumption of these fish may pose

health risks. The advisories may

recommend to limit or avoid

consumption of specific fish species, or

to limit or avoid consumption of fish

from specific water bodies. It is

important to emphasize that while a

single advisory has one geographic

location (e.g., a portion of a river or

lake), it can contain information about

several fish species (e.g., carp,

largemouth bass, shrimp), several

pollutants (e.g., mercury and PCBs), and

several ‘‘populations’’ (e.g., no

consumption for at risk subpopulations

such as pregnant women and/or

restricted consumption for general

populations). There are 26 reports that

show that lead is or has been detected

in different aquatic species located in

various areas within the United States.

The fact that lead is detected in fish

shows that lead is bioavailable in fish

under actual and varying environmental

conditions. Being within the purview of

state and local governments, there is

some variation in fish advisory policies

and procedures across the United States.

Thus, not all counties monitor fish and

wildlife for chemical contaminants, and

some counties may not monitor for lead

contamination. Therefore, there may be

additional geographical locations within

the United States, not listed in the

National Listing of Fish and Wildlife

Advisories database, where the fish are

contaminated with lead.

Some commenters state that EPA

should evaluate each individual

member of the lead compounds category

on a case-by-case basis because the

availability of lead from lead

compounds differs among lead

compounds and lead is unavailable

from certain lead compounds. As

explained in Unit VI.C.1., the Agency

has concluded that there is a scientific

basis for evaluating lead compounds as

a category rather than individually

because the bioavailability of a lead

compound is not necessarily dependent

upon the availability of lead from the

compound. That is, the parent lead

compound may be bioavailable as is or,

if not itself bioavailable, could be

converted in the environment into a

another lead compound that is

bioavailable or from which lead is

bioavailable. As discussed in Unit

VI.D.1, EPA’s environmental fate

assessment indicates that there are

4530 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

many conditions under which lead from

lead compounds can become available

in the environment. Further, most lead

compounds provide bioavailable lead

when ingested. Thus, after an evaluation

of the available data, EPA has

determined that the weight of scientific

evidence indicates that it is reasonable

to conclude, based upon similarities

between the compounds, that lead in

the environment will be available and/

or bioavailable from all lead

compounds.

In addition, regardless of the relative

environmental availability of lead from

one lead compound to another, the lead

compounds all add to the

environmental loading of lead. Thus,

even if under the same environmental

conditions the lead from compound A is

10 times less available than the lead

from compound B, compound A would

introduce the same amount of available

lead if its releases are 10 times greater.

If lead compounds are evaluated

individually based on relative

environmental availability then the

additive effect of the loading of lead

from these compounds would be

ignored.

E. What Comments Did EPA Receive on

Its Proposed Threshold for Lead and

Lead Compounds?

EPA received a range of comments on

the thresholds proposed for lead and

lead compounds similar to those it

received on the thresholds proposed for

the PBT chemicals in its earlier

rulemaking. Many commenters

contended that EPA should not consider

burden in choosing thresholds. They

believe that EPA should set a threshold

of 1 pound for lead because it was

proposed as falling within the subset of

PBT chemicals that are both highly

persistent and highly bioaccumulative.

Numerous commenters believe that the

threshold for reporting should be zero.

Other commenters believe that burden

should have been a greater

consideration in EPA’s choice of

reporting thresholds. Many of these

commenters also stated that EPA should

set thresholds based on some percentage

of releases that would be reported.

With few exceptions, the comments

EPA received failed to take into account

the analyses EPA laid out in the final

PBT chemical rule. As explained in the

preamble to that rule, the analyses in

that rulemaking relied on the

characteristics and policy

considerations surrounding PBT

chemicals in general. The analyses were

not dependant on the specific chemical

properties of the particular, individual

chemicals addressed in that rulemaking,

but were tied more closely to the overall

characteristics of PBT chemicals

generally. For example, as part of the

explanation for the Agency’s decision to

establish two categories of thresholds an

order of magnitude apart, EPA noted:

EPA then considered the relative degree of

persistence and bioaccumulation between the

two classes of chemicals. EPA wanted to

establish two sets of revised thresholds with

the same approximate relationship to each

other, as the relative exposure potentials of

PBT chemicals to that subset of highly

persistent and highly bioaccumulative PBT

chemicals. Simply stated, chemicals with

half-lifes of 6 months or greater and a BAF/

BCF of 5,000 or greater have a higher

exposure potential than chemicals with halflifes of 2 months or greater and a BAF/BCF

of 1,000 or greater. However, although, as

discussed below, EPA could establish a

qualitative relationship, the Agency could

not reliably quantify the relative exposure

potential across the board for all of the

members of both classes. Therefore, in

attempting to translate the qualitative

exposure potential of PBT chemicals to that

subset of PBT chemicals that are highly

persistent and highly bioaccumulative into a

qualitative threshold relationship, EPA

considered both the attributes of these

chemicals and factors specific to thresholds.

64 FR 58690.

And as EPA also explicitly noted in

the preamble, EPA established the

revised thresholds with the intention

that they would be generally applicable

to future members of the two PBT

categories. See 64 FR 58691. Thus,

absent some strong technical or policy

concern to the contrary-a topic on

which the public would have the

opportunity to present information and

otherwise provide comments—the

revised thresholds were anticipated to

be applicable to future candidate PBT

chemicals. EPA requested commenters

to submit such technical and policy

concerns in its proposed rule for lead

and lead compounds. See 64 FR 42224.

This, the commenters have failed to do.

In addition, in the proposed lead rule,

EPA identified an additional factor for

use in determining whether a chemical

is, at the least, bioaccumulative. EPA

explained that there is clear and

convincing evidence that lead is

bioaccumulative in humans. EPA also

requested comment on the human data

and on how such data should be

considered in determining whether a

chemical should be classified in that

subset of PBT chemicals that are highly

bioaccumulative. Therefore, consistent

with the factors laid out in its previous

rulemaking, and with its determination

that lead and lead compounds are

highly persistent and bioaccumulative

toxic chemicals, EPA is setting the

thresholds for lead and lead compounds

at 100 pounds. As discussed elsewhere,

following its review of the comments,

EPA is deferring on its proposal to

classify lead and lead compounds as

highly bioaccumulative.

Consistent with EPA’s approach to

revise thresholds for PBT chemicals,

EPA began with the premise that for

lead and lead compounds, assuming no

unique circumstances, a threshold of

either 100 or 10 pounds would be

warranted. The choice of threshold was

dependent on whether the data

indicated that lead and lead compounds

were PBT chemicals, or fell within the

subset of highly persistent and highly

bioaccumulative toxic chemicals. In this

rulemaking EPA has concluded, through

application of PBT criteria as discussed

in the PBT final rule and the proposed

lead rule, that lead and lead compounds

are highly persistent and

bioaccumulative. At this time, EPA is

deferring on a final conclusion as to

whether lead and lead compounds are

highly bioaccumulative, and is deferring

on whether lead and lead compounds

are appropriately classified in that

subset of toxic chemicals that are highly

persistent and highly bioaccumulative.

Thus, based on EPA’s conclusions, a

100 pound threshold for lead and lead

compounds is warranted.

EPA has considered the same factors

for lead and lead compounds that it had

considered for the individual PBT

chemicals included in its previous

rulemaking. To determine whether the

additional reporting burden associated

with lowering the thresholds for lead

and lead compounds presented any

unique concerns, and to ensure that the

100 pound threshold would capture

significant information from a range of

covered industry sources, EPA analyzed

the number of reports that would be

submitted by each industry sector for

the following potential thresholds: 1

pound, 10 pounds, 100 pounds, and

1,000 pounds.

EPA’s analysis confirmed that 100

pound threshold achieves the

appropriate balance of the various

factors laid out in the preamble to the

final PBT rule. EPA therefore finds that

establishing the threshold at 100 pounds

will not be unduly burdensome, and

ensures that the resulting reporting will

provide the public with information

from a range of covered industry sectors,

and that the information will contribute

significantly to providing the public

with a comprehensive picture of toxic

chemical releases and potential

exposures to humans and ecosystems.

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4531

F. What Comments Did EPA Receive on

Its Proposed Treatment of Lead

Contained in Stainless Steel, Brass, and

Bronze Alloys?

The commenters on this issue

generally agree with EPA’s proposed

limitation on the reporting of lead

contained in stainless steel, brass, and

bronze alloys, but felt that it should be

expanded. Some commenters suggest

that all alloys should be included, while

others cited various types of alloys that

they believed should also be included,

e.g., aluminum, copper, zinc, tin, iron,

all steels, carbon and low alloy steels,

leaded steel, and galvanized and drawn

steel wire. Some commenters also

suggest that other metals be included in

a broader alloy reporting exemption and

that the exemption should be for all

reporting, not just for the lower

reporting thresholds. Some commenters

claim that EPA’s reasoning in drafting

the alloys exemption is that lead

incorporated into an alloy does not pose

the same hazard as unincorporated lead,

is not bioavailable, does not exert toxic

effects, is not available for exposure,

and that this reasoning holds true for

lead contained in other alloys.

Commenters also contend that alloys

have significantly different

bioavailability, bioaccumulation, and

toxicity characteristics than other forms

of metals, and thus should be treated

separately. Some comments state that an

alloys exemption would enhance the

ability of TRI to provide meaningful

information to the public regarding the

risk associated with the release and

handling of toxic materials. Several

commenters requested an exemption for

the use of lead and lead compounds in

wire soldering operations. Some

commenters state that lead contained in

primary aluminum and aluminum

alloys is incidental and that the

concentrations are significantly lower

than that found in stainless steel, bronze

and brass alloys, which intentionally

contain lead, and therefore lead in

aluminum alloys should not be

regulated any more stringently than

those alloys. One commenter states that

EPA failed to demonstrate that lead is

bioavailable in any metal alloy and

illegitimately provided a preferential

exemption only to certain metal alloys.

The commenter contends that EPA has

failed to show any rational basis for

excluding other metal alloys from such

an exemption and that limiting the

exemption to stainless steel, brass, and

bronze alloys is arbitrary and capricious

and should be expanded to all, metal

alloys, including aluminum alloys.

EPA does not believe that it currently

has any information that would support

a decision to extend to other types of

alloys, its deferral of a decision on a

lower threshold for lead when

contained in stainless steel, brass, and

bronze alloys. EPA’s proposed deferral

was based on the fact that it is currently

evaluating a previously submitted

petition, as well as comments received

in response to previous petition denials,

that requested the Agency to revise the

EPCRA section 313 reporting

requirements for certain metals

contained in stainless steel, brass, and

bronze alloys. Contrary to the

commenter’s allegations, EPA has not

determined that lead is neither toxic nor

bioavailable when contained in these or

any other alloys. Nor did EPA imply

that lead or other metals contained in

these or any other alloys are less

hazardous than metals not contained in

alloys, or that lead or other metals

cannot exert toxic effects, or that lead or

other metals are not available for

exposure when contained in an alloy.

Rather, the deferral is simply based on

the fact that for stainless steel, brass,

and bronze alloys, EPA is currently

reviewing whether there should be any

reporting changes. In light of that

review, EPA has decided to maintain

the status quo for lead when contained

in these alloys until the review is

complete.

Lead is an EPCRA section 313 listed

toxic chemical, and lead contained in

all alloys are therefore subject to the

EPCRA section 313 reporting

requirements. As discussed above, EPA

did not illegitimately provide a

preferential exemption only to stainless

steel, brass, and bronze alloys. EPA is

merely maintaining the status quo with

respect to the alloys that are the subject

of the pending review. Other alloys are

not part of that review. Because the

commenters have submitted no

information or data that would allow

the Agency to conclude that lead in all

other alloys are similarly situated, in

light of its scientific findings in this rule

with respect to lead and lead

compounds, EPA has no basis for

extending its deferral.

With respect to the request for an

exemption for lead soldering, EPA does

not believe that the commenter’s

allegation that lead may not be released

during these processes, such as wire

soldering, provides an adequate basis

for excluding that activity from

threshold determinations and release

reporting requirements. Under EPCRA

section 313, whether an activity must be

counted towards an EPCRA section 313

reporting threshold is based on whether

the activities fall within the definition

of manufacturing, processing, or

otherwise use, not on whether the

activity actually, or potentially, results

in releases. Additionally, because even

low amounts of releases are of concern

for PBT chemicals like lead and lead

compounds, it is not appropriate to

exclude a reportable activity merely

because releases from that activity may

be relatively low.

In addition, this rulemaking is

specific to lead and is not the

appropriate forum to address the issue

of limitations or exemptions for other

metals contained in these or other

alloys; nor was comment on such issues

requested in the proposed rule. EPA

will be issuing a report on its review of

the data for stainless steel, brass, and

bronze alloys and will be asking for

comments on the report.

The comment that an alloys

exemption would enhance the ability of

TRI to provide meaningful information

to the public regarding the risk

associated with the release and handling

of toxic materials is not relevant to the

issue of whether or not there should be

reporting changes for any alloys. As

EPA has previously discussed (64 FR

58592), EPCRA section 313 is a hazardbased program, not a risk-based

program. As such, EPCRA section 313

does not directly provide any risk

information to its users, but rather

provides basic release and other waste

management information on chemicals

that meet the criteria in EPCRA section

313(d)(2). Congress established these

criteria as the sole standard for listing

decisions. Therefore, any final

determination on whether there should

be changes to the reporting of alloys will

be based on whether the alloys meet the

criteria of EPCRA section 313(d)(2).

One commenter stated that EPA’s

limitation on the reporting of lead

contained in alloys should apply to all

alloys to be consistent with that

proposed for cobalt and vanadium in

the January 1999 proposal for other PBT

chemicals.

EPA disagrees that it must extend its

deferral to all lead alloys to be

consistent with its past actions on cobalt

and vanadium. With respect to cobalt,

in the October 29, 1999 final PBT

chemical rule (64 FR 58666), EPA only

changed the reporting requirements for

vanadium not cobalt. Regarding

vanadium, the original vanadium listing

contained the qualifier ‘‘fume or dust;’’

thus the status quo was that unless the

vanadium alloy was converted to a fume

or dust form, the vanadium in any alloy

was not reportable. In the October 29,

1999 final rule, EPA added all forms of

vanadium, except vanadium contained

in alloys, to the list of TRI chemicals.

EPA deferred its decision to add

vanadium contained in alloys until it

4532 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

had resolved the pending petition. EPA

explained its decision as follows: ‘‘At

this time, while EPA is in the process

of a scientific review of the issues

pertinent to alloys, the Agency is not

prepared to make a final determination

on whether vanadium in vanadium

alloys meet the EPCRA section 313(d)(2)

toxicity criteria’’ (64 FR 58711).

At the time EPA made its

determination with respect to

vanadium, EPA chose not to add

vanadium contained in any alloys to the

EPCRA section 313 list of toxic

chemicals. This decision excluded from

a listing decision more than just the

three classes of alloys specifically

addressed in the alloys project out of

concern that the project could be

expanded to similar alloys. However, at

the time of the lead proposal, EPA

identified a potential concern with

proposing a similarly broad deferral for

lead since lead is used in many types of

alloys that are not similar to stainless

steel, brass, and bronze alloys. Because

these other alloys, such as lead solder,

are not being reviewed, and are

currently subject to reporting under

EPCRA section 313, EPA believes that

the Agency has no basis to defer

lowering thresholds for these other

alloys. In light of the Agency’s

conclusions with respect to lead, EPA

will review its October 29, 1999,

vanadium decision and determine

whether vanadium contained in alloys,

other than the three classes of alloys

currently under review by the Agency,

should be added to the EPCRA section

313 list of toxic chemicals.

None of the commenters who

supported a limitation for lead in other

alloys submitted any data on which the

Agency could rely to create such a

limitation, or to extend the alloys

review to encompass lead when

contained in alloys other than stainless

steel, brass, or bronze. As explained

above, EPA believes that it has no basis

to defer lowering thresholds for other

alloys that are not currently being

reviewed. If the commenter has data to

support a revision to the reporting

requirements for lead when contained

in alloys other than stainless steel,

brass, and bronze the commenter can

submit it as part of a petition to delist

lead contained in such alloys from the

EPCRA section 313 list of toxic

chemicals.

One commenter contends that EPA

has exempted steel, brass and bronze

alloys from reporting for lead with the

implication being that these alloys do

not yield sufficient lead to be a

significant risk. The commenter stated

that there are many products containing

trace amounts of lead which are at least

as stable as bronze or steel alloys. The

commenter contends that EPA provides

no explanation for why these other

products were not also provided an

exemption and that EPA sets forth an

artificial and unfair distinction. The

commenter cites colored plastics, vinyl

siding, ceramics, paints and inks as

examples of products that do not leach

lead in sufficient quantity to pose a risk

to the community. The commenter

contends that there is an assumption

implicit in the proposed rule, that steel

alloys containing lead are sufficiently

safe and non-toxic to avoid reporting

under the TRI, while all other forms of

lead, lead compounds and thousands of

products which may contain trace

quantities of lead and lead compounds

are not and that this is unsubstantiated

in the record for this rulemaking.

EPA is not providing an ‘‘exemption’’

to lead contained in stainless steel, brass

and bronze alloys. As EPA discussed in

other responses in these section, EPA is

merely deferring a final decision on

lowering thresholds for lead contained

in these alloys until the scientific

review of the alloys petition is

complete. EPA has made no

determination, implicit or otherwise,

that lead contained in any alloy is safe,

non-toxic, or without significant risk.

Lead contained in other non-alloy

products is currently reportable and

since these other non-alloys are not part

of the review of stainless steel, brass,

and bronze alloys EPA did not include

any similar deferral for these other

products. With regard to these other

lead containing products, if the

commenter has data that indicate that

the lead contained in these products

cannot become available through any

abiotic or biotic processes, then they

may wish to provide these data in a

petition to have the lead in such

products delisted from the EPCRA

section 313 listed toxic chemicals. In

addition, under certain conditions,

some of the products mentioned by the

commenter (such as vinyl siding,

colored plastics, and ceramics) may be

eligible for the article exemption (see 40

CFR § 372.38 (b)) and thus would not be

subject to reporting in any case.

Two commenters requested that lead

and lead compounds contained in glass,

ceramic enamels, and ceramicware be

excluded from reporting. One

commenter stated that EPA’s limitation

on the reporting of lead in stainless

steel, brass, and bronze alloys, is

apparently justified because alloys have

significantly lower potential for

bioavailability, bioaccumulation, and

toxicity than other forms of metals and

are less likely to affect organisms than

non-alloy forms of metals and that these

compounds are extremely stable and

virtually unable to interact with

organisms. The commenter contends

that ceramic enamels share similar

properties with alloys and that the way

that they are manufactured and used

results in little or no releases or

exposures. The commenter stated that

these enamels are as insoluble as

possible and bind the lead compounds

in such a way that their use in glazing

and decorating ceramicware or glass

would strictly limit the potential

exposure of the community to releases

from a glazing or decorating process.

As discussed in detail in the

responses contained in the previous

section, EPA has not determined that

lead is neither toxic nor bioavailable

when contained in these or any other

alloys. Nor did EPA imply that lead or

other metals contained in these or any

other alloys are less hazardous than

metals not contained in alloys, or that

lead or other metals cannot exert toxic

effects, or lead or other metals are not

available for exposure. EPA is merely

deferring a final decision on lead

contained in these alloys until the

Agency completes it current review of

the alloys petition. The commenter has

provided no data to support expanding

its alloys review to these materials so

the basis for the deferral for lead in

certain alloys does not apply to these

other materials. If the commenter has

data to support such an extension, then

they may wish to provide this data in

a petition to have the lead in such

products delisted from the EPCRA

section 313 listed toxic chemicals. In

addition, under certain conditions, glass

and ceramic products may be eligible

for the article exemption (see 40 CFR

§ 372.38 (b)) and thus would not be

subject to reporting in any case.

VII. What Are the Results of EPA’s

Economic Analysis?

EPA has prepared an economic

analysis of this action, which is

contained in a document entitled

Economic Analysis of the Final Rule to

Modify Reporting of Lead and Lead

Compounds Under EPCRA Section 313

(Ref. 46). This document is available in

the public version of the official record

for this rulemaking. The analysis

assesses the costs, benefits, and

associated impacts of the rule, including

potential effects on small entities. The

major findings of the analysis are briefly

summarized here including responses to

some of the major comments EPA

received.

A. What Is the Need for the Rule?

Federal regulations exist, in part, to

address significant market failures.

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4533

Markets fail to achieve socially efficient

outcomes when differences exist

between market values and social

values. Two causes of market failure are

externalities and information

asymmetries. In the case of negative

externalities, the actions of one

economic entity impose costs on parties

that are ‘‘external’’ to any market

transaction. For example, a facility may

release toxic chemicals without

accounting for the consequences to

other parties, such as the surrounding

community, and the facility’s decisions

will fail to reflect those costs. The

market may also fail to efficiently

allocate resources in cases where

consumers lack information. For

example, where information is

insufficient regarding toxic releases,

individuals’ choices regarding where to

live and work may not be the same as

if they had more complete information.

Since firms ordinarily have little or no

incentive to provide information on

their releases and other waste

management activities involving toxic

chemicals, the market fails to allocate

society’s resources in the most efficient

manner.

This action 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 facilityspecific 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 wellbeing. 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 1998, EPA

received TRI data on the release and

other waste management of over a

billion pounds of lead and lead

compounds from approximately 1,900

facilities. EPA believes that there are

many additional facilities 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 estimate the total multi-media

releases or other waste management

quantities from these additional

facilities without additional TRI

reporting. Since even small amounts or

concentrations 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 action, 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 are the Potential Costs of this

Action?

This action will result in the

expenditure of resources that, in the

absence of the regulation, could be used

for other purposes. The cost of the rule

is the value of these resources in their

best alternative use. Most of the costs of

the rule will result from requirements

on industry. Approximately 9,800

facilities are expected to submit

additional Form R reports on an annual

basis as a result of this action. The

estimated composition of this reporting,

by industry, is shown in Table 1. This

table also displays the estimated costs

for this action, which includes costs of

compliance determination for all

potentially affected facilities, and rule

familiarization, report completion, and

mailing/recordkeeping for facilities that

are expected to file additional reports.

Aggregate industry costs in the first year

for the selected alternative are estimated

to be $80 million; in subsequent years

they are estimated to be $40 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

satisfy reporting requirements by

updating or modifying information from

the previous year’s report. EPA is

expected to expend $1.2 million in the

first year, and $775,000 in subsequent

years for programmatic, compliance

assistance, and enforcement activities as

a result of the rule.

TABLE 1. SUMMARY OF ESTIMATED ADDITIONAL REPORTING BY INDUSTRY

SIC Code—Industry Estimated Number of Additional

Reports

Estimated Industry Costs (thousand

$ per year)

First Yr. Sub. Yr.

10—Metal Mining 127 $756 $459

12—Coal Mining 314 $1,782 $1,163

20—Food 291 $2,857 $1,380

21—Tobacco 29 $170 $106

22—Textiles 184 $1,359 $761

4534 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

TABLE 1. SUMMARY OF ESTIMATED ADDITIONAL REPORTING BY INDUSTRY—Continued

SIC Code—Industry Estimated Number of Additional

Reports

Estimated Industry Costs (thousand

$ per year)

First Yr. Sub. Yr.

23—Apparel 16 $1,339 $371

24—Lumber 107 $1,998 $744

25—Furniture 60 $958 $377

26—Paper 211 $1,938 $894

27—Printing 41 $2,646 $755

28—Chemicals 497 $3,327 $1,968

29—Petroleum 95 $589 $364

30—Plastics 84 $1,685 $613

31—Leather 18 $185 $87

32—Stone/Clay/Glass 186 $1,889 $898

33—Primary Metals 1,945 $11,931 $7,049

34—Fabricated Metals 267 $3,865 $1,577

35—Machinery 53 $3,083 $892

36—Electrical Equipment 3,501 $25,957 $12,737

37—Transportation Equipment 347 $2,462 $1,409

38—Measure./Photo. 7 $723 $197

39—Miscellaneous 58 $1,103 $380

4911/4931/4939—Electric Utilities 574 $3,025 $2,069

4953—Refuse Systems 107 $561 $385

5169—Chemical Wholesale 0 $299 $75

5171—Bulk Petroleum 616 $3,539 $2,293

7389—Solvent Recovery Services 78 $417 $283

Total 9,813 $80,441 $40,287

A number of commenters contend

that EPA’s analysis of affected industry

sectors for the proposed rule failed to

include sectors that would be affected

by the rule. These commenters suggest

that the following industries would be

affected by the rule: metalworkers;

glaziers; lead crystal glassware

manufacturers; animal feed producers;

metal platers; brass and copper

fabricators; stained glass manufacturers;

organ makers and manufacturers of

other musical instruments; dye makers

and manufacturers of dye-containing

products including businesses in the

leather, garment, and textile industries;

pigments and coatings companies; metal

finishers; medical and dental equipment

manufacturers; makers of sporting and

recreational equipment; precision metal

components, mirrors, stabilizers,

fertilizer; and numerous ceramic

decorative art manufacturers and

studios; art pottery and art pottery

supply firms; ink formulators; print

shops; product painting/coating/

refinishing businesses; and packaging or

packaging coating firms, and other

businesses that use or manufacture

materials that contain small amounts of

lead.

In the economic analysis for the

proposed rule (Ref. 16), EPA estimated

the additional TRI reporting that would

be expected from a number of industry

groups that are subject to EPCRA section

313 at four lower reporting thresholds

considered for lead and lead

compounds. EPA also identified other

industry groups, which are also subject

to EPCRA section 313, but for which

EPA lacked sufficient information to

generate quantitative estimates of

additional reporting. In the proposed

rule, and in a subsequent notice

announcing public meetings, EPA

solicited additional information to allow

EPA to quantify the number of

additional reports in all industry groups

that are subject to EPCRA section 313.

In response, EPA received comments

that varied greatly in detail and utility

for making quantitative estimates of

additional reporting.

In some cases, in addition to asserting

that an industry sector would be

affected by the rule, commenters also

provided detailed information on the

activity in the industry sector associated

with lead or lead compounds, the

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4535

amount or concentration of lead

associated with industrial materials, the

lead usage per employee, the prevalence

of the lead-related activity within the

industry, or other information that

allowed EPA to confirm the potential for

additional reporting in that industry at

the various proposed lower reporting

thresholds. This information, in

conjunction with additional research

and industry contacts, allowed EPA to

revise or generate estimates for many of

the additional industry sectors that

commenters identified. These sectors

include galvanizers, stained glass

manufacturers, metal finishers, animal

feed producers, organ manufacturers,

and other industry sectors described in

Appendix A of the economic analysis of

the final rule (Ref. 46).

In other cases, commenters asserted a

potential impact on an industry without

providing information that would allow

EPA to confirm the potential for

additional reporting as a result of the

rule, or to make a quantitative estimate

of additional reporting at any of the

lower reporting threshold options that

EPA considered. Table A-73 in the

economic analysis of the final rule lists

industries that may be affected by the

rule, but for which existing data are

inadequate to make a quantitative

estimate of additional reporting.

EPA fully considered the information

from the commenters on the potential

for additional reporting from industries

that were not identified in the economic

analysis of the proposed rule, or for

which EPA was unable to make

quantitative estimates at the time of the

proposal. As a result of the comments,

EPA revised its estimates for a number

of potentially affected industry groups.

The revised estimates are described in

Appendix A of the economic analysis of

the final rule. While the estimates of

additional reporting for some industry

groups changed substantially as a result

of the comments, the net effect on EPA’s

estimates of additional reporting was

less pronounced because estimates for

some industry sectors increased while

others decreased. (Additional details are

available in Appendix A of the

economic analysis of the final rule.)

With regard to the potential for

additional reporting, a number of

commenters cite the following footnote

to Table A-45 in Appendix A of the

economic analysis of the proposed rule:

Zero facilities are predicted to report

for lead due to natural gas combustion

given the uncertainty regarding

concentration data for lead in natural

gas. Assuming available concentration

data are accurate, an estimated 35,376

additional facilities would report at the

proposed threshold.

The commenters note that this

estimate for natural gas users would

greatly increase the number of

additional reports that EPA estimated

for the proposed rule. Although one

commenter notes that EPA explained

that ‘‘concentration data for natural gas

are considered unreliable,’’ the

commenters ask that EPA explain why

it chose to reject the available

concentration data for lead in natural

gas, but not the data it used for lead in

other fuels.

The footnote cited by the commenters

reflects EPA’s assessment of the quality

of available information on the presence

of lead as a trace contaminant in natural

gas at the time of proposal. Because of

uncertainties about the presence or

absence of lead as a trace contaminant

in natural gas, EPA did not include any

reporting due solely to natural gas

combustion in its quantitative estimates

of additional lead and lead compound

reporting at the lower reporting

threshold options.

For the economic analysis of the

proposed rule, EPA consulted two

references for information on lead in

natural gas: Locating and Estimating Air

Emissions from Sources of Lead and

Lead Compounds (Ref. 47) and Study of

HAP Emissions from Electric Utility

Steam Generating Units: Final Report to

Congress (Ref. 48). These references

provided emission factors for lead from

natural gas combustion based on a very

limited number of observations. The

observed emissions of lead do not

necessarily indicate that lead was

present as a trace contaminant in

natural gas. For example, the lead

measured in emissions from natural gas

combustion may have originated from

lead-containing oil residues in

combined-cycle combustion units. In

this case, the effect on additional

reporting would have been captured in

EPA’s estimate of reporting due to lead

levels in residual or distillate fuel oil.

Due to this uncertainty about the origin

of lead emissions from natural gas

combustion, EPA estimated the

potential number of additional reports

based on the lead emission factor for

natural gas, but did not include these

reports in the quantitative estimate of

additional reporting at the lower

reporting threshold options. For other

fuels, EPA was able to locate typical

concentration values for lead contained

in those fuels a trace contaminant.

Therefore, for fuels other than natural

gas, EPA included estimates of

additional reporting due to fuel

combustion at the lower reporting

threshold options.

As a result of public comments on

this issue, EPA sought additional

information to verify if lead is found as

a contaminant in natural gas. EPA

located a report that characterizes the

presence of hazardous air pollutants in

natural gas (Ref. 49). According to this

report, lead was not detected at a

detection limit of 0.9 micrograms per

cubic meter of natural gas. Assuming, as

an illustrative example, that lead was

present at the detection limit

concentration, the facility at the 90th

percentile of manufacturing facilities

using natural gas would only have a

lead throughput of 0.05 lbs per year

based on natural gas throughput data

presented in the economic analysis of

the final rule. Because the currently

available data reviewed by EPA on trace

levels of lead and lead compounds in

natural gas indicate that very few, if

any, facilities would be affected by any

of the lower reporting threshold options

as a result of natural gas combustion,

EPA has estimated in the economic

analysis of the final rule that no

additional reports on lead and lead

compounds will be submitted solely as

a result of natural gas combustion.

Commenters assert that EPA

underestimated the burden associated

with the proposed rule because they

believe that EPA’s estimates of burden

consider only those facilities expected

to file reports under the proposed lower

reporting thresholds. The commenters

state that many facilities will be affected

by the rule because they will have to

make threshold determinations, even

though they will not exceed the

reporting threshold. The commenters

contend that these facilities will incur

the unit costs that EPA has quantified in

the Economic Analysis for compliance

determination and rule familiarization.

The commenters contend that because

the proposed thresholds are very low

and material use varies from year to

year, these determinations would occur

annually, not just in the first year.

In estimating the cost of the rule, EPA

considered facilities that make

threshold determinations but do not

exceed the reporting threshold. EPA

estimated the costs to facilities of

determining whether a report must be

filed for lead and/or lead compounds as

part of ‘‘compliance determination.’’

EPA agrees that a compliance

determination will be made annually at

all facilities with 10 or more employees

that are in SIC codes subject to reporting

under EPCRA section 313, and the

economic analysis of the rule reflects

this.

Compliance determination should

occur annually at all facilities with 10

or more employees that are in SIC codes

subject to reporting under EPCRA

section 313. In this respect, compliance

4536 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

determination for lead and lead

compounds is similar to compliance

determination for all other EPCRA

section 313 chemicals. However, lead

and lead compounds are a small part of

the list of over 600 EPCRA section 313

chemicals. Therefore, it is reasonable to

expect that the typical incremental

compliance determination costs

specifically for lead and lead

compounds at a lower reporting

threshold would be less than current

compliance determination costs for the

entire list of EPCRA section 313

chemicals.

Compliance determination costs are

described in Chapter 4 of the economic

analysis. The economic analysis of the

final rule estimates that compliance

determination for the changes in TRI

reporting will take an average of 1.6

hours in the first year of reporting and

0.4 hours in subsequent years. These

estimates are incremental to the time

currently required each year for

compliance determination for other

EPCRA section 313 chemicals. The

lower burden hour estimate for

subsequent years reflects the decline in

burden hours after the necessary inputs

to the threshold calculation are

identified at each facility.

EPA does not agree that facilities will

incur ‘‘rule familiarization’’ costs after

the first year of reporting, especially if

these facilities do not exceed any

applicable reporting thresholds. Rule

familiarization is related to the time that

facilities spend learning how to fill out

the reporting form. Once a facility

determines that a report is not required,

the subsequent costs of reporting (rule

familiarization, report completion, and

mailing/recordkeeping) are not

incurred. Facilities are expected to incur

costs of rule familiarization only if they

are reporting under EPCRA section 313

for the first time. At a minimum, rule

familiarization involves reading the

instructions to the Toxic Chemical

Release Inventory Reporting Form R,

however, it may also involve consulting

EPA guidance documents, attending a

training course, and/or calling the

EPCRA technical hotline. In subsequent

years, staff are already familiar with the

requirements that apply to their facility,

apart from any minor changes to

interpretive guidance that may occur in

the intervening year.

C. 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. EPCRA

section 313 has empowered the Federal

government, State governments,

industry, environmental groups and the

general public to participate in an

informed dialogue about the

environmental impacts of toxic

chemicals in the United States. EPCRA

section 313’s publicly available data

base provides quantitative information

on toxic chemical releases and other

waste management practices. Since the

TRI program’s inception in 1987, the

public, government, and the regulated

community have had the ability to

understand the magnitude of chemical

releases in the United States and to

assess the need to reduce the uses 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 under

EPCRA section 313 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 reporting under EPCRA

section 313: those resulting from the

actions required by the rule (such as

reporting and recordkeeping), and those

derived from follow-on activities that

are not required by the rule. Benefits of

activities required by the rule include

the value of improved knowledge about

the release and waste management of

toxic chemicals, which leads to

improvements in understanding,

awareness and decision-making. It is

expected that this rule will generate

such benefits by providing readily

accessible information that otherwise

would not be available to the public.

The rule will benefit ongoing research

efforts to understand the risks posed by

lead and lead compounds and to

evaluate policy strategies that address

those risks.

The second type of benefit derives

from changes in behavior that may

result from the information reported

under EPCRA section 313. These

changes in behavior, including

reductions in releases of and changes in

the waste management practices for

toxic chemicals may yield health and

environmental benefits. These changes

in behavior come at some cost, and the

net benefits of the follow-on activities

are the difference between the benefits

of decreased chemical releases and

transfers and the costs of the actions

needed to achieve the decreases.

Commenters point out that EPA has

not quantified the benefits of the

proposed rule. The commenters assert

that not quantifying the benefits of the

rule severely inhibits the public’s ability

to evaluate and comment upon this

proposed rule.

EPA notes that the state of knowledge

about the economics of information is

not highly developed. Because of the

inherent uncertainty in the subsequent

chain of events following TRI reporting,

EPA has not attempted to predict the

exact changes in behavior that result

from the information, or the resultant

monetized benefits. 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, does provide a

qualitative discussion along with

illustrative examples of how the

proposed rule will improve the

availability of information on lead and

lead compounds. EPA described how

consumers, industry, the financial and

business community, academics,

environmental groups, communities,

and the media are expected to use the

results of TRI reporting on lead and lead

compounds. Based on the number and

variety of comments, it appears that this

information was adequate to allow the

public to evaluate and comment on the

benefits of the proposed rule.

A number of commenters request that

EPA quantify the releases expected to be

captured by the proposed rule and

address whether a substantial majority

of lead and lead compounds releases are

already captured by current TRI

reporting. Other commenters state that

EPA cannot estimate the quantity of

lead and lead compounds that are

released or transferred without the

additional data that would be collected

by the rule. These commenters assert

that estimates about releases or transfers

would be ‘‘fundamentally flawed’’ due

to a reliance on unsupported

assumptions about facility operations,

not on actual data. The commenters

note that while it is possible to estimate

how many facilities might be impacted

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4537

by having to report a particular

substance, estimating quantities at a

particular facility is extremely difficult

because of differences in operations

even among facilities in a narrowlydefined four-digit SIC code. The

commenters express a concern that any

release estimate made by EPA of an

‘‘average’’ facility is likely to be highly

inaccurate and biased toward known

sources of lead releases, and that those

communities with large numbers of

facilities with small releases would be

adversely affected by this approach.

EPA agrees with the commenters who

describe the practical difficulties in

making reasonable, reliable estimates of

the quantity of lead and lead

compounds that are released or

transferred without the additional

reporting data that would be collected

by the rule. EPA has not estimated the

total national releases to all media for

this rule (and in previous TRI rules)

because EPA believes that there is

insufficient information on the

numerous processes and associated

waste management techniques in the

affected sectors to generate a

comprehensive release estimate.

Existing data do not support estimates

of releases and other waste management

activities to multiple environmental

media from the full range of facilities

that may be affected by the rule because

most of the data required for the

analysis would only be available after

the rule is in place. For the affected

industry sectors, up-to-date multi-media

release estimates for facilities that

would be affected by the rule do not

exist. Even where release estimates are

available for an industry sector, most are

derived from national activity levels and

emission factors rather than from

facility-level information. To the extent

that release estimates are available, they

tend to cover only a single medium such

as air. EPA does not believe that there

is sufficient information to make

reasonable predictions of the multimedia releases and other waste

management information that will be

reported as a result of EPCRA section

313 rulemakings.

Historical attempts to estimate the

releases expected to be reported to TRI

prior to actual reporting have been

imprecise to the point of being

misleading, particularly in respect to

estimates of releases per report or per

facility. EPA notes that there were

various reports and studies about air

emissions of toxic chemicals prior to

TRI, but the collection of facility-level

data showed that actual releases were

much different from what had been

anticipated. EPA has not seen any

evidence to indicate that the TRI

releases that will be reported as a result

of the this action can be predicted any

more accurately now than the quantities

reported as a result of the original TRI

rule could have been predicted prior to

1987.

Aside from the general issue of

uncertainty in the estimates of aggregate

releases, predictions of releases per

facility or per report (or dollars of

reporting cost per pound of releases) are

likely to be misleading due to the biases

built into the estimates. The predicted

number of reports (and thus costs) is

generally an overestimate, since EPA’s

economic analyses use conservative

estimates to avoid underestimating true

costs. On the other hand, predictions of

releases will tend to underestimate

emissions, because while there may be

information available on releases of

some chemicals from some sectors, such

estimates will not include other sources

where releases are not identified until

more detailed data (such as TRI data)

are collected. Combining the two sets of

estimates compounds the problem.

Since estimated pounds of releases are

underestimated and reports are

overestimated, pounds per report are

biased significantly downward.

Likewise, estimates of dollars of

reporting cost per pound of releases

(which varies as the inverse of pounds

per report) will be biased significantly

upward.

EPA does not believe that inaccurate

or incomplete estimates of releases and

other waste management activities

would aid the decision-making process

for the rule. Therefore, EPA has not

estimated the releases and other waste

management activities that would be

reported as a result of the rule.

Commenters assert that the cost of the

rule would outweigh the benefits

because the proposed 10 pound

reporting threshold for lead and lead

compounds will not capture

‘‘significant’’ amounts of releases, while

substantially burdening thousands of

facilities.

Although the reporting threshold for

lead and lead compounds in this action

is 100 pounds, EPA does not agree with

the comment. The commenters do not

define what constitutes ‘‘significant’’

amounts of releases of lead and lead

compounds. Absent this definition, it is

unclear what amount of unreported

releases the commenters believe would

justify the cost of additional reporting.

The implication of the comment is that

there is minimal benefit to any reporting

that does not constitute a large

proportion of total national releases.

EPA does not agree. EPA notes that the

inherent persistence, bioaccumulation,

and toxicity of lead and lead

compounds create concern about human

health and environmental effects in

even the smallest amounts or

concentrations. EPA believes that

information on small amounts of lead or

lead compounds (either in absolute or

relative terms) is important. Even if a

single facility or industry is not

responsible for a high percentage of total

national loadings, the releases from that

facility or industry may still be of

concern to the public. The percentage of

total national releases that an individual

facility or industry represents does not

reflect the potential human health and

environmental effects of even small

amounts of lead and lead compounds,

especially when multiple facilities

release lead and lead compounds that

persist and bioaccumulate. EPA also

believes that focusing exclusively on

releases ignores the value of other data

elements on TRI reporting form, such as

quantities of waste otherwise managed

on-site and transferred for off-site

management and qualitative

information on source reduction

activities.

Aside from the issue of whether

comprehensive release estimates for

such a rulemaking can reliably be

predicted, EPA notes that pounds of

releases and other waste management

activities (even if known) are not a

reasonable proxy for the benefits of the

information being provided. This is

because the benefits of an informational

regulation are not systematically related

to the magnitude of the data elements

being reported. For example, automobile

manufacturers are required to provide

information about fuel economy on the

stickers for new cars. Assuming that the

quantity reported is a direct measure of

the value of the information would lead

to the mistaken conclusion that there is

100 percent difference in the benefit of

requiring the information to be provided

on a car that gets 15 miles per gallon

compared to another car that gets 30

miles per gallon. To use another

example, nutritional labels are required

on food packages. Assuming that the

benefits of information provision are

linearly related to the quantity that is

reported would yield the conclusion

that if one product has 6 grams of fat per

serving and another has 2 grams, the

benefit of the nutritional labeling

requirement are three times higher for

the former than the latter.

One of the central purposes of TRI

data is to inform the public about

releases and other waste management of

EPCRA section 313 listed toxic

chemicals in their community and

nationally so that the public can form its

own conclusions about risks. The

amount of releases and other waste

4538 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

management activities that a community

may find relevant or useful will vary

depending on numerous factors specific

to that community, such as the toxicity

of the various chemicals, potential

exposure to these toxic chemicals, and

the number of other facilities in the area

that release EPCRA section 313 listed

toxic chemicals. Section 313(h) of

EPCRA states that the data are ‘‘to

inform persons about releases and other

waste management activities 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.’’ Pounds of releases

and other waste management activities

reported does not measure how the data

perform these functions, and thus is not

a measure of benefits. EPA disagrees

with the implicit assumption by

commenters that the benefits of

information from different facilities is

strictly and systematically related to the

quantity reported as being released.

Finally, EPA notes that while the

proposed reporting threshold for lead

and lead compounds was 10 pounds,

the final rule (and associated economic

analysis) reflect a reporting threshold of

100 pounds. This further reduces the

relevance of the comment.

D. What are the Potential Impacts of

This Action on Small Entities?

In accordance with the Regulatory

Flexibility Act (RFA) and the Agency’s

longstanding policy of always

considering whether there may be a

potential for adverse impacts on small

entities, the Agency has evaluated the

potential impacts of this rule on small

entities.

This rule may affect both small

businesses and small governments. No

small non-profit organizations are

expected to be affected by the rule. For

the purpose of its small entity impact

analysis for the final rule, EPA defined

a small business using the small

business size standards established by

the Small Business Administration

(SBA) at 13 CFR part 121. [On October

1, 2000, the new SBA size standards for

small businesses based on the North

American Industry Classification

System (NAICS) took effect (65 FR

30836, May 15, 2000). These replaced

the previous size standards established

under the Standard Industrial

Classification (SIC) system. EPA has

concluded that the conversion to the

new classification system will have no

substantive impact on the conclusions

of the Agency’s small entity impact

analysis for this action (Ref. 53)]. EPA

defined small governments using the

RFA definition of jurisdictions with a

population of less than 50,000. EPA

analyzed the potential cost impact of the

rule on small businesses and

governments separately in order to

obtain the most accurate assessment for

each. EPA then aggregated the analyses

for the purpose of determining whether

it could certify that the rule will not

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 this certification statement.

EPA believes that the statutory test for

certifying a rule and the statutory

consequences of not certifying a rule all

indicate that certification

determinations should be based on an

aggregated analysis of the rule’s impact

on all of the small entities subject to it.

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. Potential small

entity impacts were calculated for both

the first year of reporting and

subsequent years. First year costs are

typically higher than continuing costs

because firms must familiarize

themselves with the requirements. Once

firms have become familiar with how

the reporting requirements apply to

their operations, costs fall. EPA believes

that subsequent year impacts present

the best measure to judge the impact on

small entities because these continuing

costs are more representative of the

costs firms face to comply with the rule.

The incremental burden of the

additional reporting at the facility level

is low. This burden is associated with

labor that will be expended by facility

staff to conduct the reporting activities

to file one TRI report. By statutory

requirement, the smallest possible

facility that could be affected by this

action must have the equivalent of at

least 10 full-time employees. On a

yearly basis, this means that there are at

least 20,000 labor hours expended at the

smallest potentially affected facility (10

FTEs x 50 wks/year/employee x 40

hours/wk = 20,000 labor hours/year).

EPA estimates that typical reporting

burdens as a result of this rule will be

up to 110 hours per facility (in the first

year of reporting for a first-time TRI

reporter), and that in subsequent years

typical reporting burden will be

approximately 50 hours. Based on these

reporting burdens, the average impact of

TRI reporting ranges from 0.25 to 0.55

percent of available labor hours for the

smallest facility affected by this rule.

The impact would be even less for

facilities with more than 10 full-time

employees, or for facilities that take less

than the average time to report.

EPA examined annual compliance

costs as a percentage of annual company

sales to assess the potential impacts of

this rule on small businesses. Based on

its estimates of additional reporting as a

result of the rule, the Agency estimates

that approximately 5,700 businesses

will be affected by the rule, and that

approximately 4,100 of these businesses

are classified as ‘‘small’’ based on the

applicable SBA size standards. EPA

estimates that fewer than 250 small

businesses (approximately 5% of all

affected small businesses) will bear

annual costs between 1–3% of annual

revenues in the first reporting year, and

that no small businesses will bear

annual costs above 1% of annual

revenues in subsequent reporting years.

These results are not significantly

different from those derived in the

economic analysis of the proposed rule;

the main difference is a ‘‘non-zero’’

result for the number of small

businesses predicted to experience an

annual cost impact above 1% of annual

revenues in the first year of reporting.

These estimates, and their derivation,

are described in the economic analysis

of the final rule (Ref. 46).

A number of commenters submitted

comments on EPA’s methodology for

assessing small entity impacts in the

economic analysis of the proposed rule.

One commenter asserts that the

Agency’s analysis of potential impacts

of the proposed rule on small business

is lacking because it does not examine

the large number of industrial sectors

that may be affected by this reporting

requirement. The commenter states that

EPA’s findings about the widespread

and persistent nature of lead in the

environment are not in accord with the

‘‘very limited effort’’ to identify affected

sectors (especially small business

sectors).

EPA disagrees with the commenter’s

characterization of the effort made to

identify affected sectors. In the

economic analysis for the proposed rule,

EPA made quantitative estimates of the

number of additional TRI reports that

would be expected at four lower

reporting thresholds for lead and lead

compounds from industry groups that

are subject to EPCRA section 313 and

for which EPA could locate the

information necessary to make

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4539

quantitative estimates of facility level

lead usage. EPA also identified a

number of industry groups which are

also subject to EPCRA section 313, but

for which EPA lacked data on lead

throughput to generate quantitative

estimates of additional reporting.

In the proposed rule, and in a

subsequent notice announcing public

meetings, EPA solicited additional

information to allow EPA to quantify

the number of additional reports in all

industry groups that are subject to

EPCRA section 313. EPA fully

considered information from the

commenters on the potential for

additional reporting from industries that

were not identified in the economic

analysis of the proposed rule, or for

which EPA was unable to make

quantitative estimates at the time of the

proposal. As a result of the comments,

EPA revised its estimates for a number

of potentially affected industry groups.

The revised estimates are described in

Appendix A of the economic analysis of

the final rule. While the estimates for

some industry groups changed

substantially as a result of the

comments, EPA’s estimate of the total

number of additional reports remained

relatively stable. At a 100 pound

reporting threshold for lead and lead

compounds, EPA estimates that

approximately 9,800 facilities will

submit additional reports.

EPA’s economic analysis of the

proposed rule modeled the revenue

characteristics of affected firms to

evaluate the potential impact on small

businesses. Commenters assert EPA’s

analysis produced biased results by

combining manufacturing industries

(SIC codes 20–39) that are unrelated in

most aspects. Commenters assert that

EPA made faulty assumptions by

‘‘grouping together small business with

large manufacturers.’’ One commenter

asserts that EPA’s analysis considered

the aggregate cost of the proposal to

each industry group surveyed, ignoring

individual businesses with costs above

and below the aggregate value.

In the economic analysis of the

proposed rule EPA modeled revenues

for small firms with low, medium and

high revenues in the manufacturing

industries (i.e., SIC codes 20–39). EPA’s

RFA/SBREFA guidance states that ‘‘In

assessing the impact of a rule on small

businesses, it may be appropriate to

analyze the rule’s impact on each kind

of business separately, particularly

where the rule may impose significantly

higher costs on some kinds of

businesses than on others’’ (Ref. 50).

However, there is no guidance as to the

specific SIC code level that is

appropriate (e.g., 2-digit vs. 3-digit vs. 4-

digit vs. 5-digit, etc.). For the small

entity analysis of the proposed rule,

EPA analyzed impacts separately for the

following ‘‘kinds of businesses’’:

mining, manufacturing, electric utilities,

commercial hazardous waste treatment,

chemical and allied products-wholesale,

petroleum bulk terminals, and solvent

recovery services. EPA does not believe

that this approach biased the results of

the small entity impact analysis for the

proposed rule.

EPA did not group small businesses

together with large businesses in the

manufacturing industry as the

commenter asserts. EPA constructed

separate revenue models for large firms

and small firms. For small firms within

each industry group, EPA compared

typical reporting costs with the

revenues available to small firms with

low, medium, and high revenues. EPA’s

analysis was not based on an aggregate

cost to each industry group, but rather

on the cost to individual firms. For the

economic analysis of the final rule, EPA

developed revenue profiles at the 2-digit

SIC code level (20, 21, 22, etc.) for small

businesses within the manufacturing

industries to provide for additional

disaggregation. This approach was taken

to address the comment that EPA would

reach a different determination if impact

estimates for the manufacturing SIC

codes were presented at a greater level

of disaggregation. Contrary to the

comments on this issue, the

disaggregated analysis does not change

the ultimate conclusion about small

entity impacts.

In the small entity impact analysis for

the proposed rule, revenues of

potentially affected small businesses

were modeled using revenue data for

small businesses that own or operate

facilities that currently report to TRI on

any chemical. EPA developed separate

revenue profiles based on ‘‘small’’

current filers and ‘‘large’’ current filers.

Within these profiles, EPA looked at

companies with low, medium, and high

revenues. Commenters contend that

EPA’s use of current TRI filers as a

representative cohort for estimating the

proposed rule’s impacts on small

businesses is flawed since current TRI

filers may not be representative of

facilities that report to TRI for the first

time as a result of the rule. The

commenters assert that facilities

reporting as a result of this rule are very

different in terms of size and revenues

from their counterparts that currently

use lead, or other EPCRA section 313

listed toxic chemicals, in amounts

greater than 25,000 pounds. The

commenters contend that current TRI

filers are, for the most part, the largest

members of their sectors with the

highest revenues. As a result, the

commenters contend that EPA

underestimated the proposal’s impact

on small businesses. The commenters

state a belief that an assessment of the

rule’s potential impact on small

businesses should not be based upon its

impact on current TRI filers. The

commenters suggest an alternative

methodology of assessing how the

smallest facilities in each potentially

impacted small business sector would

be impacted by the proposed rule in

order to make a SBREFA determination.

EPA disagrees that using small

businesses that own current TRI filers as

a representative cohort for estimating

the proposed rule’s impacts on small

businesses is flawed methodology for

assessing whether the rule would have

a significant economic impact on a

substantial number of small entities.

First, it should be noted that current TRI

filers span the range of employment,

from companies with 10 employees to

those with thousands of employees. As

noted in the economic analysis for the

proposed rule, almost 70 percent of

current TRI reporters are small

businesses. Therefore, small businesses

have substantial representation in

current TRI reporting. Second,

additional reporting on lead and lead

compounds will not be limited to small

facilities, or to facilities filing their first

TRI reports. Additional reporting on

lead is expected to come from facilities

with a mix of size characteristics,

including large facilities that currently

report other EPCRA section 313

chemicals but not lead. Third, current

TRI filers in the manufacturing

industries tend to be found in capitalintensive industries rather than in laborintensive industries. Based on EPA’s

research, it appears that most facilities

that file additional lead reports will also

be from capital-intensive industries like

the ones that predominate in current

TRI reporting. Since additional lead

reporting will come mainly from: (1)

Current filers (who file on other

chemicals) and (2) new filers in capitalintensive industries, EPA believes that it

is valid to assume that first-time filers

under this rule will be like current filers

in terms of employment and revenue.

To evaluate the possibility that firsttime TRI filers in the manufacturing

sector would be so dissimilar to current

TRI filers as to change EPA’s small

entity impact findings, EPA conducted

a sensitivity analysis (Ref. 51) to

estimate the potential impact on the

smallest facilities in each potentially

impacted small business sector for the

proposed reporting threshold. This

analysis estimated the average potential

impact of the proposed rule on facilities

4540 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

in various employment size classes

within each of the twenty 2-digit

manufacturing SIC codes (and certain 4-

digit SIC codes). The analysis revealed

that average potential impacts are higher

for facilities with fewer employees and

lower annual revenues, but the potential

cost impact is still less than 1 percent

of average annual revenues for every

employment size class in every

manufacturing SIC code.

Even information submitted to EPA

by industry does not indicate that a

substantial number of small businesses

would have costs above 1% of annual

revenues. In an informal survey

conducted by the IPC the Association

Connecting Electronics Industries, IPC

asked its member companies in the

printed wiring board industry to

indicate if the proposed rule would

result in regulatory costs exceeding 1%

of annual revenues (Ref. 52). IPC

received 300 responses, of which 260

were from self-identified small

businesses. Of these 260, only 5 claimed

that the proposed rule would impose

costs greater than 1% of their annual

revenues. This survey indicates that less

than 2% of affected small businesses in

this sector believe that they would

experience an economic impact of

greater than 1% of annual revenues as

a result of the proposed rule.

Furthermore, IPC’s survey was based on

the proposed reporting threshold of 10

pounds. This final rule incorporates a

reporting threshold of 100 pounds,

which will result in less regulatory

impact to facilities in this sector.

To further address the issue of

differing revenue characteristics

between current and first-time TRI

filers, EPA revised its method for

modeling the revenues of affected small

businesses. In the small entity impact

analysis for the final rule, EPA modeled

revenues of small first-time filers using

revenue data for small businesses that

own facilities that do not currently file

TRI reports. EPA modeled revenues of

small current filers using revenue data

on small businesses that own current

TRI-filing facilities. Contrary to the

comments on this issue, using this

method to model revenues does not

change the ultimate conclusion about

small entity impacts.

A commenter asserts that EPA’s

conclusion about the impact of the rule

on small businesses was based on an

erroneous assumption about the

percentage of additional reports that

would be received from new filers. The

commenter asserts that EPA ‘‘seriously’’

underestimated the number of first-time

filers to TRI that would result from the

proposed rule. The commenter notes

that approximately 10% of printed

wiring board facilities currently report

to TRI and few of the facilities report for

lead, but that this proposal would

trigger lead reporting for virtually all

companies. In this industry,

approximately 80% to 90% would have

to report to the TRI for the first time.

The commenter notes that EPA

estimated that first-time filers under the

rule would comprise only 38.3% of

affected manufacturing facilities.

The estimate for first-time TRI filers

cited by the commenter is an average for

the entire manufacturing sector. For

individual SIC codes within

manufacturing (such as printed wiring

boards), the percentage of first-time TRI

filers may be higher or lower. For the

economic analysis of the final rule, the

estimate of first-time filers was revised

based on an SIC code-by-SIC code

approach that assumes current TRI filers

will file the first additional reports in

each SIC code, and that the remaining

additional reports will be filed by

facilities that are new to TRI reporting

(i.e., first-time filers). Rather than using

an average number of new filers for

manufacturers as a class, this approach

estimates the number of new filers at the

2-, 3-, or 4-digit SIC code level. Using

the revised approach, the total estimated

percentage of first-time filers increased

to approximately 40% of all affected

facilities, with substantial variation at

the 2-digit SIC code level as indicated

by the commenters. Therefore, EPA does

not believe that the number of first-time

filers was ‘‘seriously’’ underestimated in

the economic analysis of the proposed

rule.

In assessing the potential impact of

the rule on small entities, EPA searched

for situations in which the annual cost

of reporting for a business would exceed

a small fraction of annual revenues.

Commenters assert that 1% of annual

sales (one of the indicator values used

by EPA) is not a good measure of

impacts on small businesses. The

commenters assert that the 1% metric is

arbitrary and argue that it may not be a

good measure of impact across different

industry sectors. The commenters state

that some industries may have profits

that are only a few percent of total

revenue, in which case, costs that are

close to one percent of revenue would

be a very large percent of profit, while

other industries may have profits that

are a much higher percent of revenue.

Contrary to the commenters’ claim,

EPA did justify its choice of revenuebased impact metric for assessing small

entity impacts. As EPA stated at 64 FR

42238, ‘‘EPA used annual compliance

costs as a percentage of 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.’’

The commenters suggest that EPA

should use profits as a measure of

impact. EPA, however, believes that

there are several advantages to the use

of revenue data. The advantage of using

revenue to measure impacts is that it is

a stable, easily accessible, and easily

understood measure which provides a

basis for comparing this rule to other

rules. Unlike profit information, the

definition is consistent and not subject

to the widely varying accounting

definitions and interpretations of terms

that affect ‘‘profit’’ measures. Another

advantage is that revenue data, unlike

profit data, are widely available. The

proportion of firms for which revenue

data are available generally greatly

exceeds the proportion of firms for

which profit data are available. Many

information sources, including the

Census of Manufactures, collect and

publish revenue data but not profit data.

Furthermore, revenue data are easily

understood. For example, if the impact

of compliance costs on a firm is 1% of

revenue, a firm would need to raise its

prices 1% to cover the costs of the

regulation. This is a clear, easy to

understand measure that can help

decision-makers determine whether

additional measures to reduce the

impact of a regulation are warranted. In

addition, EPA has a long history of

using the relationship between the

annual cost of compliance with a

regulation and total annual revenue of

the firm to determine whether a

regulation may have a significant

economic impact on substantial number

of small entities.

EPA believes that the revenue-based

impact calculation used in the analysis

of this rule is preferable to a profit-based

calculation because it is simple to apply

and based on readily available data,

which allows consistent application of

the methodology from rule to rule.

Although the commenters suggest other

metrics such as profit margins, they do

not provide any indication of how this

data could be obtained or what impact

levels would indicate a ‘‘significant’’

impact. The commenters note that profit

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4541

margins are variable, but do not provide

profit margin data for all affected

industry sectors.

In addition to small businesses, the

rule is also expected to affect certain

small governments. To assess the

potential impacts of the final rule 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 8

publicly owned electric utility facilities,

operated by a total of 8 municipalities,

may be affected by the rule. Of these, an

estimated 7 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. Therefore, 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) because only certain

small businesses are expected to

experience impacts above 1% of

revenues in any year.

VIII. What are the References Cited in

this Final Rule?

1. Response to Comments Received on

the August 3, 1999 Proposed Rule (64

FR 42222) to Lower the EPCRA Section

313 Reporting Thresholds for Lead and

Lead Compounds. Office of Information

Analysis and Access, U.S.

Environmental Protection Agency,

Washington, DC (2000).

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. Rand, GM. Fundamentals of

Aquatic Toxicology, 2nd. Ed. Taylor

Francis, Washington, DC, (1995), 1125

pp.

4. Meylan, WM, Howard, PH, and

Boethling, RS. ‘‘Improved Method for

Estimating Bioconcentration Factor

from Octanol/Water Partition

Coefficient’’ Environ. Toxicol. Chem.

18:664-672.

5. Merlini, M. and Pozzi, A. 1977.

Lead and Freshwater Fishes. Part 1.

Lead Accumulation and Water pH.

Environ. Pollut. 12:167-172.

6. 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.

7. USEPA. Ambient Water Quality

Criteria for Lead. 1984. EPA 440/5-84-

027, Office of Water, U.S.

Environmental Protection Agency,

Washington, D.C., 1985, 81 pp.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. Rabinowitz, MB, et. al., Kinetic

Analysis of Lead Metabolism in Healthy

Humans. Journal of Clinical

Investigation. 1976, 58:260-270.

15. USEPA, OPPT, 1999. Response to

Comments Received on the January 5,

1999 Proposed Rule (64 FR 688) to

Lower the EPCRA Section 313 Reporting

Thresholds for Persistent,

Bioaccumulative Toxic (PBT) Chemicals

and to Add Certain PBT Chemicals to

the EPCRA Section 313 List of Toxic

Chemicals and Response to Comments

Received on the May 7, 1997 Proposed

Rule (62 FR 24887) to Add a Category

of Dioxin and Dioxin-like Compounds

to the EPCRA Section 313 List of Toxic

Chemicals. Office of Pollution

Prevention and Toxics, U.S.

Environmental Protection Agency,

Washington, DC.

16. USEPA, OPPT. Economic Analysis

of the Proposed Rule to Modify the

Reporting Requirements for Lead and

Lead Compounds under EPCRA Section

313, May 1999.

17. HHS. Eighth Report on

Carcinogens, 1998 Summary, US

Department of Health and Human

Services, National Toxicology Program,

1998.

18. USEPA. Integrated Risk

Information System (IRIS). ‘‘Arsenic,

Inorganic,’’ at http://www.epa.gov/iris/

subst/0278.htm. Downloaded June 2000.

19. Masterton, WL, Slowinski, EJ.

Chemical Principles, 3rd. Ed. Saunders,

WB. Philadelphia, PA (1973), pp 29–30.

20. Ihde, AJ. The Development of

Modern Chemistry. Dover Publications,

Inc. Garden City, NY (1984), pp 499–

507.

21. DeVito, S.C. ‘‘Absorption Through

Cellular Membranes.’’ In: Handbook of

Property Estimation Methods for

Chemicals, Environmental and Health

Sciences (Chapter 11); Boethling, RS,

and Mackay, D. (Eds.), Lewis Publishers,

New York, NY (2000), pp 261–278.

22. Roane, TM, and Pepper, IL.

‘‘Microorganisms and Metal Pollutants.’’

In: Environmental Microbiology

(Chapter 17); Maier, RM, Pepper, IL, and

Gerba, CP. (Eds.), Academic Press, New

York, NY (1999), pp 403–423.

23. Ogen, S, Rosenbluth, S, Eisenberg,

A. 1967. ‘‘Food Poisoning Due to

Barium Carbonate in Sausage.’’ Isr. J.

Med. Sci., 3:565–568.

24. HSDB 2000. Hazardous

Substances Data Bank: record on Lead

(chemical abstracts #7439–92–1).

National Library of Medicine, Bethesda,

MD.

25. Goyer, RA. ‘‘Toxic Effects of

Metals.’’ In: Casarett & Doull’s

Toxicology, the Basic Science of Poisons

(Chapter 23), 5th Edition, Klaassen, CD.

(Ed), McGraw Hill, New York, NY

(1996), pp 691–736.

26. HSDB 2000. Hazardous

Substances Data Bank: record on

tetraethyl lead (chemical abstracts #78–

00–2). National Library of Medicine,

Bethesda, MD. (See section titled

Metabolism/Pharmacokinetics;

Metabolism/Metabolites).

27. Malius, DC, and Ostrander, GK.

1991. ‘‘Perspectives in Aquatic

Toxicology.’’ Ann. Rev. Pharmacol.

Toxicol., 31:371–399.

28. Keeton, WT. ‘‘Nutrient

Procurement and Processing.’’ In:

Biological Sciences, 2nd Edition, W.W.

Norton and Company, Inc., New York,

NY. (1972), pp 161–164.

29. USEPA/ORD. Air Quality Criteria

for Lead. Research Triangle Park, NC.

EPA Office of Research and

Development, Office of Health and

4542 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

Environmetnal Assessment. 1986. EPA

600/8–83–028bF.

30. Bondarenko, GP. 1968. An

experimental study of the solubility of

galena in the presence of fulvic acids.

Geochem. Int. 5:525–531.

31. Lowering, TG. (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.

32. OECD. Harmonized Integrated

Hazard Classification System for Human

Health and Environmental Effects of

Chemical Substances.

33. May, TW, and McKinney, GL.

1981. Cadmium, Lead, Mercury, Arsenic

and Selenium Concentrations in

Freshwater Fish, 1976–77 National

Pesticides Monitoring Program.

Pesticides Monitoring Journal 15:14–38.

34. White, JR, and Driscol, CT. 1985.

Lead cycling in an Acidic Adirondack

Lake. Environ. Sci. Technol. 19:1182–

1187.

35. Zhuang, Y, Allen, HE, Fu, G. 1994.

Environ. Toxicol. Chem, 13: 717–724.

36. Mahony, JD, Di Toro, DM,

Gonzalez, AM, Curto, M, Dilg, M, De

Rosa, LD, and Sparrow, LA. 1996.

Partitioning of Metals to Sediment

Organic Carbon. Environ Toxicol Chem.

15:2187–2197.

37. 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.

38. Reddy, KJ, Wang, L, and Gloss, SP.

1995. Solubility and mobility of copper,

zinc and lead in acidic environments.

Plant and Soil 171:53–58.

39. Wang, EX, and Benoit, G. 1996.

Mechanisms controlling the mobility of

lead in the spodosols of a northern

hardwood forest ecosystem. Environ Sci

Technol 30: 2211–2219.

40. Chuan, MC, Shu, GY, and Liu, JC.

1996. Solubility of heavy metals in a

contaminated soil: effects of redox

potential and pH. Water, Air and Soil

Pollution 90:543–556.

41. Murray, K, Bazzi, A, Carter, C,

Elhart, A, Harris, A, Kopec, M,

Richardson, J, and Socol, H. 1997.

Distribution and mobility of lead in

soils at an outdoor shooting range. J Soil

Contamination 6:79–93.

42. Laperche, V, Logan, TJ, Gaddam,

P, and Traina, SJ. 1997. Effect of apatite

amendments on plant uptake of lead

from contaminated soil. Environ Sci

Technol 31: 2745–2753.

43. Zimdahl, RL, Skogerboe, RK.

1977. Behavior of Lead in Soil. Environ

Sci Technol. 11:1202–1207.

44. Mackay, D, DiGuardo, A, Paterson,

S, and Cowan, CE. ‘‘Evaluating the

Environmental Fate of a Variety of

Types of Chemicals Using the EQC

Model.’’ Environ. Toxicol. Chem. v. 15,

(1996), pp. 1627–1637.

45. Newsome, LD, Nabholz, JV, Kim,

A. ‘‘Designing Aquatically Safer

Chemicals.’’ In: Designing Safer

Chemicals; Green Chemistry for

Pollution Prevention (Chapter 9),

DeVito, SC, and Garrett, RL. (Eds.), ACS

Symposium Series 640, American

Chemical Society, Washington, DC

(1996) pp 172–193.

46. USEPA, OPPT. Economic Analysis

of the Final Rule to Modify the

Reporting Requirements for Lead and

Lead Compounds under EPCRA Section

313, October 2000.

47. USEPA, OAQPS. Locating and

Estimating Air Emissions from Sources

of Lead and Lead Compounds. EPA–

454/R–98–006. May 1998.

48. USEPA, OAQPS. Study of

Hazardous Air Pollutant Emissions from

Electric Utility Steam Generating Units

B Final Report. EPA–453/R–98–004b.

February 1998.

49. Chao, Sherman, Crippend, Karen,

Janos, Alan. Analysis of Trace Level

Compounds in Natural Gas. Gas

Research Institute. June 1999.

50. USEPA, OP/RMD. Revised Interim

Guidance for EPA Rulewriters:

Regulatory Flexibility Act as Amended

by the Small Business Regulatory

Enforcement Fairness Act, March 29,

1999.

51. USEPA, OPPT. Note from Cody

Rice (OPPT/EETD) to Angela Hofmann

(OPPTS/RCS) regarding RFA

Certification of the TRI lead rule, March

16, 2000.

52. Comment C–812 in Docket No.

OPPTS–400140 (Lead and Lead

Compounds; Lowering of Reporting

Thresholds; Community Right-to-Know

Toxic Chemical Release Reporting;

Proposed Rules, 64 FR 42221 (Aug. 3,

1999)).

53. USEPA, OPPT. Note from Cody

Rice (OPPT/EETD) to Angela Hofmann

(OPPTS/RCS) regarding the Impact of

SBA’s Conversion for SIC to NAICS on

the TRI Lead Rule, November 3, 2000.

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 a

‘‘significant regulatory action’’. This

action was submitted to the Office of

Management and Budget (OMB) for

review, and any substantive changes

made during that review have been

documented in the public version of the

official record.

EPA’s cost-benefit analysis for the

proposed rule was contained in a

document entitled Economic Analysis of

the Proposed Rule to Modify Reporting

of Lead and Lead Compounds Under

EPCRA Section 313 (Ref. 16). The

economic analysis contains a

quantitative estimate of the costs and a

qualitative discussion of the benefits of

the proposed rule. This document, and

its supporting documentation, were

included in the public docket for review

and comment. EPA has prepared an

economic analysis of the impact of this

final rule, which is contained in a

document entitled Economic Analysis of

the Final Rule to Modify Reporting of

Lead and Lead Compounds under

EPCRA Section 313 (Ref. 42). This

document is available as part of the

public version of the official record for

this action, and is briefly summarized in

Unit VII.

Commenters assert that the proposed

rule did not meet Executive Order

12866 requirements to consider costs

and benefits, including the alternative of

not regulating. The commenters assert

that the Agency has not given adequate

consideration to the baseline option of

existing TRI reporting thresholds of

25,000 and 10,000 pounds, under which

EPA has received reporting on release

and other waste management of over

one billion pounds of lead and lead

compounds per year. The commenters

assert that the alternative of the current

reporting thresholds of 25,000 and

10,000 pounds is generally not included

in the text and tables of the preamble

and Economic Analysis.

EPA did consider the option of not

regulating, and addressed what would

happen in the absence of this rule. As

EPA noted in the Federal Register

notice for the proposed rule, ‘‘If EPA

were not to take this proposed action to

lower 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’’

(64 FR 42237). The discussion of costs

and benefits in the economic analysis

and preamble are all relative to the

baseline of not regulating beyond the

current reporting thresholds for lead

and lead compounds. Chapter 6 of the

economic analysis of the proposed rule

contains a discussion of current

reporting on lead and lead compounds

at existing reporting thresholds, as well

as a discussion of information that

would be collected as a result of the

proposed rule. Furthermore, current TRI

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4543

reporting on lead and lead compounds

was summarized in Tables A–3 and A–

4 of the economic analysis of the

proposed rule.

Commenters assert that EPA has not

met requirements of Executive Order

12866 because EPA has not quantified

benefits of the proposed rule and has

not estimated the amount of releases

expected to be reported.

EPA believes that the proposal is

consistent with Executive Order 12866,

because EPA proposed the regulation

upon a reasoned determination that the

benefits justify the costs. The

commenters imply that EPA must

quantify benefits to comply with

Executive Order 12866. However,

Executive Order 12866 recognizes that it

may not be feasible to derive

quantitative estimates of benefits in all

cases. Section (1)(a) of Executive Order

12866 states that ‘‘Costs and benefits

shall be understood to include both

quantifiable measures (to the fullest

extent that these can be usefully

estimated) and qualitative measures of

costs and benefits that are difficult to

quantify, but nevertheless essential to

consider.’’ The Executive Order goes on

to state in section (1)(b)(6) that ‘‘Each

agency shall assess both the costs and

the benefits of the intended regulation

and, recognizing that some costs and

benefits are difficult to quantify,

propose or adopt a regulation only upon

a reasoned determination that the

benefits of the intended regulation

justify its costs.’’ EPA’s economic

analysis has addressed the costs of the

proposal in a quantified manner and the

benefits in a qualitative manner.

Because the state of knowledge about

the economics of information is not

highly developed, EPA has not

attempted to quantify the benefits of the

rule as monetized net benefits. EPA

notes that Executive Order 12866 does

not require that benefits be quantified

for every regulation, or that agencies

should predict the answers to a data

collection (in this case, the ‘‘per

facility’’ releases and other waste

management of lead and lead

compounds) prior to the actual

collection of the data.

EPA notes that comparing the cost of

the reporting to the quantity of releases

that would be reported does not

compare costs and benefits. Section

313(g) of EPCRA states that the data are

intended to provide information to the

Federal, State, and local governments

and the public, including citizens of

communities surrounding covered

facilities, to inform persons about

releases of toxic chemicals to the

environment; to assist governmental

agencies, researchers, and other persons

in the conduct of research and data

gathering; to aid in the development of

appropriate regulations, guidelines, and

standards; and for other similar

purposes. The quantity of releases

reported does not measure how well the

data perform these functions, and thus

releases are not a measure of benefits.

The benefits of the rule include

improvements in understanding,

awareness, and decision making related

to the provision of information. Even if

reliable estimates of releases were

possible, pounds of releases would not

measure the value of the information

provided. Improvements in

understanding are not measured in

pounds, nor are improvements in

awareness or decision making.

While it is not possible to quantify the

benefits of the rule with monetized

estimates, EPA has qualitatively

examined the benefits of the rule. Based

on this review, EPA believes that the

benefits provided by the information to

be reported under this rule will

significantly outweigh the costs. Upon

review of this evidence, EPA has made

a reasoned determination that the

benefits of the regulation justify its

costs. Therefore, EPA believes it has

followed the principles and met the

requirements of Executive Order 12866.

B. What is the Determination Under the

Regulatory Flexibility Act?

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.), the EPA

Administrator hereby certifies that this

final rule will not have a significant

economic impact on a substantial

number of small entities. The factual

basis for this determination is presented

in the small entity impact analysis

prepared as part of the Economic

Analysis for this final rule (Ref. 46),

which is discussed in detail in Unit VII.

and contained in the public version of

the official record for this rule. Further

support for this determination can be

found in the sensitivity analysis (Ref.

51) that was conducted to assess the

analytical methods used in the small

entity impact analysis of the proposed

rule. Information relating to this

determination has been provided to the

Chief Counsel for Advocacy of the Small

Business Administration, and is

included in the public version of the

official record for this rulemaking. The

following is a brief summary of the

Agency’s factual basis for this

certification.

For the purpose of analyzing potential

impacts on small entities, EPA used the

RFA definition of small entities in

section 601(6) of the RFA. Under this

section, small entities include small

businesses, small governments, and

small non-profit organizations. [On

October 1, 2000, the SBA size standards

for small businesses based on the North

American Industry Classification

System (NAICS) took effect (65 FR

30836, May 15, 2000). These replaced

the previous size standards established

under the Standard Industrial

Classification (SIC) system. EPA has

concluded that the conversion to the

new classification system will have no

substantive impact on the conclusions

of the Agency’s small entity impact

analysis for this action (Ref. 53)]. EPA

defined a small business using the small

business size standards established by

the Small Business Administration

(SBA), which are generally based on the

number of employees or annual sales/

revenue a business in a particular

industrial sector has. EPA defined small

governments using the RFA definition

of jurisdictions with a population of less

than 50,000. No small non-profit

organizations are expected to be affected

by this final rule.

EPA estimates that approximately

4,100 small businesses will be affected

by the rule. The incremental burden of

the additional reporting at the facility

level is associated with labor that will

be expended by facility staff to conduct

reporting activities. Based on typical

reporting burdens of approximately 110

hours (in the first year of reporting for

a first-time TRI reporter) and 50 hours

in subsequent years, the impact of this

action ranges from 0.25 to 0.55 percent

of available labor hours for the smallest

affected facility. The impact would be

even less for facilities with more than 10

full-time employees, or for those that

take less than the average amount of

time to report.

EPA estimates that the final rule

would have an annual cost impact

between 1–3% of annual revenues on

fewer than 250 small businesses

(approximately 5% of all affected small

businesses) in the first year only. After

the first year of reporting, the annual

cost impact as a percentage of annual

revenues is estimated to be below 1%

for all affected small entities.

Commenters assert that this rule will

have significant impacts on small

businesses, and that EPA improperly

certified the proposed rule. The

commenters assert that a Small Business

Regulatory Enforcement Fairness Act

(SBREFA) panel must be completed to

determine the ‘‘true’’ impact of the

proposed rule on small businesses.

EPA believes that its certification of

the proposed rule as not having a

significant economic impact on a

substantial number of small entities was

proper. In the Federal Register notice

4544 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

for the proposed rule, EPA described a

quantitative small entity impact analysis

that EPA placed in the official version

of the public record. The results of this

analysis indicated that the proposed

rule would not have a significant

economic impact on a substantial

number of small entities. Based on

public comments, EPA revised this

quantitative analysis and arrived at the

same conclusion for the final rule.

Furthermore, EPA notes that while the

proposed reporting threshold for lead

and lead compounds was 10 pounds,

this final rule incorporates a reporting

threshold of 100 pounds. This threshold

further reduces the potential regulatory

impact on small entities as indicated in

the economic analysis of the final rule.

EPA does not agree with the comment

that a SBREFA panel must be completed

to determine whether this, or any,

proposed rule will have a significant

economic impact on a substantial

number of small entities. SBREFA

amended the Regulatory Flexibility Act

(RFA) to require EPA to convene a

Small Business Advocacy Review Panel

for any proposed rule for which EPA is

required to prepare an initial regulatory

flexibility analysis (IRFA). The RFA

requires that EPA prepare an IRFA for

all rules for which EPA is required by

statute to publish a notice of proposed

rulemaking unless the agency certifies

that the rule ‘‘will not, if promulgated,

have a significant economic impact on

a substantial number of small entities.’’

The panel is an additional means for

small entities to participate in the

rulemaking process, but the certification

provision of the RFA as amended by

SBREFA indicates that panels are not

appropriate for every rulemaking. The

panel requirement only applies to

proposed rules that the Agency

ultimately determines will not be

certified under the RFA.

Commenters also assert that EPA

failed to provide a ‘‘meaningful’’

opportunity for small businesses to

participate in the rulemaking process.

The commenters asserted than that EPA

did not conduct outreach to small

businesses prior to the proposal, and

that any outreach after rule proposal is

inadequate and cannot remedy EPA’s

‘‘lack of outreach’’ to small entities early

in the regulatory development process.

The commenters assert that ‘‘EPA’s

failure to contact small business sectors

early in the rulemaking process’’ led to

‘‘significant flaws’’ in EPA’s SBREFA

determination because it failed to

consider ‘‘more than two dozen small

business sectors that would be impacted

by the proposed rule’’ and failed to

consider the significance of the impact

on small businesses. Specifically the

commenters mention printed circuit

board manufacturers, metal finishers,

foundries, and dentists as affected

sectors. As a result, the commenters

contend that the Agency did not comply

with SBREFA, and violated the

analytical and outreach requirements of

the RFA. The commenters also contend

that EPA did not comply with the

Agency’s own internal guidance related

to RFA/SBREFA compliance. One

commenter contends that EPA’s failure

to conduct appropriate outreach misled

the Agency to certify that the rule has

no significant impact on small business.

Therefore, the commenter suggests that

the EPA conduct additional outreach

with small business, followed by a

thorough SBREFA panel process. The

commenter contends that outreach to

small business would have revealed that

the proposed rule affects more than

‘‘two dozen small business sectors that

the agency failed to consider.’’ As one

example, the commenter asserts that

dentists would have to report because

they accumulate lead in the form of

used x-ray film backing that they store

and recycle. The commenter also

mentions metal finishing and the

printed circuit board industry.

EPA complied with internal guidance

and the requirements of the RFA as

amended by SBREFA and conducted its

analysis in accord with the Agency’s

internal guidance. EPA’s actions

provided a meaningful opportunity for

small businesses to participate in the

rulemaking process. EPA initially

alerted the potentially affected

community to EPA’s intention to review

lead and lead compounds for lower

reporting thresholds in the proposed

rule to lower the EPCRA section 313

reporting threshold for certain PBT

chemicals that are subject to reporting

under EPCRA section 313 (64 FR 688).

That Federal Register notice stated that

‘‘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’’ (64 FR

717, January 5, 1999). As part of the PBT

rulemaking process, EPA held three

public meetings in San Francisco, CA;

Chicago, IL; and Washington, DC.

Numerous commenters on the PBT rule

requested that EPA classify lead and

lead compounds as PBT chemicals.

EPA published a notice of proposed

rulemaking for lead and lead

compounds on August 3, 1999. EPA

requested comment on this rulemaking

and provided an initial 45 day comment

period. Subsequently, EPA extended the

comment period twice for a total of 90

additional days. In addition, EPA held

public meetings with special emphasis

on potential small business impacts in

Los Angeles, CA; Chicago, IL; and

Washington, DC. EPA also met with

representatives of small business trade

organizations who expressed a desire for

additional meetings.

EPA notes that a number of small

businesses participated in the

rulemaking process by attending public

meetings and submitting comments on

the proposed rule. EPA has considered

these comments and updated its

economic analysis with information

provided by these commenters. EPA

believes that these activities, along with

the written public comment process,

provided ample opportunities for small

businesses to participate in the

rulemaking process.

EPA does not agree that its

rulemaking process led to significant

flaws in EPA’s certification that the

proposed rule would not, if

promulgated, have a significant

economic impact on a substantial

number of small businesses. EPA

conducted an extensive economic

analysis that included a quantitative

small entity impact analysis. EPA made

this analysis available as part of the

public record for the rulemaking. The

public comment process has provided

an opportunity for small businesses to

comment on this analysis, and to

provide additional information to refine

this analysis. Further, even though EPA

extended the public comment period

twice and held three public meetings,

EPA did not receive additional

information that would lead it to change

its determination.

Although some commenters assert

that EPA failed to identify certain

potentially affected sectors leading to a

flawed certification, EPA does not agree.

EPA conducted an extensive economic

analysis. Specifically, EPA did identify

printed circuit board manufacturers,

metal finishers, foundries, and other

industries as potentially affected sectors

in the economic analysis of the

proposed rule. Dentists were not

identified as potentially affected

because they are not in a SIC code that

is subject to TRI reporting. EPA cannot

evaluate the accuracy of generic

comments that assert EPA missed

potentially affected industries when

commenters do not identify these

industries by name, or provide evidence

to support the assertion for each

additional identified industry. If EPA

failed to identify certain sectors as

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4545

potentially affected, this a reflection of

the lack of publicly available

information on lead and lead

compounds. The lack of publicly

available information on lead and lead

compounds speaks more to the need for

the rule than to the quality of EPA’s

analysis.

In conclusion, EPA believes that it has

followed the requirements of the RFA

and that it has properly certified that the

rule will not have a significant impact

on a substantial number of small

entities.

C. What is the Determination Under the

Paperwork Reduction Act?

The information collection

requirements contained in this final rule

have been submitted to OMB under the

Paperwork Reduction Act (PRA) (44

U.S.C. 3501 et seq.), and in accordance

with the procedures at 5 CFR 1320.11.

OMB has approved the existing

reporting and recordkeeping

requirements for the EPA Toxic

Chemical Release Inventory Form R

(EPA Form No. 9350–1), supplier

notification, and petitions under OMB

Control No. 2070–0093 (EPA ICR No.

1363). EPA has prepared an amendment

(EPA ICR No. 1363.11) to the existing

Information Collection Request (ICR) to

include the burden associated with

lower reporting thresholds for lead and

lead compounds. A copy may be

obtained from Sandy Farmer, Office of

Information Collections, U.S.

Environmental Protection Agency

(2137), 1200 Pennsylvania Ave., NW.,

Washington, DC 20460, by calling (202)

260–2740, or electronically by sending

an e-mail message to

‘‘farmer.sandy@epa.gov.’’

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 a currently valid OMB

control number is displayed. The OMB

control numbers for EPA’s regulations,

after initial publication in the Federal

Register, are maintained in a list at 40

CFR part 9. The information

requirements contained in this final rule

are not effective until OMB approves

them.

EPCRA section 313 (42 U.S.C. 11023)

requires owners or operators of certain

facilities manufacturing, processing, or

otherwise using any of over 600 listed

toxic chemicals and chemical categories

in excess of the applicable threshold

quantities, and meeting certain

requirements (i.e., at least 10 Full Time

Employees or the equivalent), to report

certain release and other waste

management activities for such

chemicals annually. Under PPA section

6607 (42 U.S.C. 13106), facilities must

also provide information on recycling

and other waste management data and

source reduction activities. 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 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 (based on typical

unit burden estimates for Form R

completion and recordkeeping/mailing

requirements), 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 rule is estimated to result in

additional reports from approximately

9,800 respondents. Of these,

approximately 3,600 facilities are

estimated to be reporting to TRI for the

first time as a result of the rule, while

the remainder are currently reporting

facilities that will be submitting

additional reports. The 9,800

respondents will each submit an

additional Form R. This rule is

estimated to result in a total burden of

1.2 million hours in the first year, and

0.6 million hours in subsequent years, at

a total estimated industry cost of $80

million in the first year and $40 million

in subsequent years. The existing ICR

will be amended to add 790,000 burden

hours (annual average burden for the

first 3 years of ICR approval).

Under the PRA, ‘‘burden’’ means the

total time, effort, or financial resources

expended by persons to generate,

maintain, retain, or disclose or provide

information to or for a Federal agency.

This includes, where applicable, the

time needed to review instructions;

develop, acquire, install, and utilize

technology and systems for the purposes

of collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information. EPA’s burden

estimates for the rule take into account

all of the above elements, considering

that under section 313, no additional

measurement or monitoring may be

imposed for purposes of reporting.

A commenter asserts that EPA failed

to meet Paperwork Reduction Act

requirements because it has not

provided Form R reporting instructions

for the proposed changes to the TRI

reporting requirements for lead and lead

compounds. The commenter contends

that the proposed rule requires

significant changes in the information

submitted by regulated industry sectors

on the Form R. The commenter asserts

that OMB’s Information Collection

Review Handbook requires that

materials submitted for review under

the Paperwork Reduction Act must be

accompanied by the documents to be

used in the collection of information

(i.e., forms, schedules, questionnaires,

handbook, manual, interview plan or

guide, rule, regulation, or other

document), and any other explanatory

material to be given or sent to

prospective respondents. The

commenter asserts that the current Form

R reporting instructions do not provide

the guidance necessary for reporting

lead and lead compounds at the lower

reporting thresholds with elimination of

exemptions such as the de minimis

exemption and changed rules for

reporting. The commenter asserts that

EPA has not issued guidance regarding

how to comply under the proposed

lower reporting thresholds, indicated

what its plans are for issuing such

guidance, or allowed formal opportunity

for stakeholders to review and

comment.

EPA disagrees with the commenter.

EPA did not propose significant changes

in the types of information to be

reported by industry. EPA proposed

using the existing Form R for reports

that would be required under the lower

reporting threshold. Since EPA did not

propose to amend the Form R, and the

existing Form R was already approved

4546 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

by OMB, EPA was not required to

submit the Form R separately with the

ICR amendment at the proposed rule

stage. Nevertheless, the proposed ICR

amendment that EPA submitted to OMB

included a copy of the existing ICR

approved by OMB, along with a copy of

the Form R. The existing ICR also

specifically describes all of the existing

reporting elements on Form R.

EPA strongly disagrees with the

suggestion that it has circumvented the

notice and comment process. The

preamble to the proposed rule, the

economic analysis, and the proposed

ICR amendment all specifically describe

EPA’s proposal to lower reporting

thresholds, and to change the reporting

requirements so as not to allow use of

the de minimis exemption, range

reporting or Form A for reports

submitted under the lowered

thresholds. The Federal Register

provided public notice and specifically

solicited public comments on the

changes to reporting requirements and

reporting instructions that were being

considered, as well as on the Agency’s

associated burden estimates. The

Agency provided a functional

description of the changes in reporting

that would result from his rule.

Therefore, EPA was in compliance with

the PRA and with OMB requirements.

D. What are the Determinations Under

the Unfunded Mandates Reform Act

and Executive Order 13084?

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Public Law 104–4), EPA has

determined that this action does not

contain a ‘‘Federal mandate’’ that may

result in expenditures of $100 million or

more for the private sector in any 1 year,

nor will it result in such expenditures

for State, local, and tribal governments

in the aggregate. The costs associated

with this action are estimated in the

economic analysis prepared for this

final rule (Ref. 46), which is included in

the public docket and summarized in

Unit VII. of this preamble.

EPA has determined that it is not

required to develop a small government

agency plan as specified by section 203

of UMRA or to conduct prior

consultation with State, local, or tribal

governments under section 204 of

UMRA, because the rule will not

significantly or uniquely affect small

governments and does not contain a

significant Federal intergovernmental

mandate.

Finally, EPA believes this rule

complies with section 205(a) of UMRA.

The objective of this rule is to expand

the public benefits of the TRI program

by exercising EPA’s discretionary

authority to 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.

As described in Unit VI. of this

preamble, EPA considered burden in the

threshold selection. The rule also

contains reporting requirements that

will limit burden (e.g., reporting

limitations for lead 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

rule. EPA also will be assisting small

entities subject to the rule, by such

means as providing meetings, training,

and compliance guides in the future,

which also will ease the burdens of

compliance. Many steps have been and

will be taken to further reduce the

burden associated with this rule, and to

EPA’s knowledge there is no available

alternative to the rule that would obtain

the equivalent information in a less

burdensome manner. For all of these

reasons, EPA believes the rule complies

with UMRA section 205(a).

In addition, today’s rule does not

significantly or uniquely affect the

communities of Indian tribal

governments. Accordingly, the

requirements of 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 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 a significant regulatory

action, 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,

the informational benefits of the rule are

expected to have a positive impact on

the human health and environmental

impacts of minority populations, lowincome populations, and children.

F. What is the Determination under

Executive Order 13132?

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implication’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’

Under section 6 of Executive Order

13132, EPA may not issue a regulation

that has federalism implications, that

imposes substantial direct compliance

costs, and that is not required by statute,

unless the Federal government provides

the funds necessary to pay the direct

compliance costs incurred by State and

local governments, or EPA consults with

State and local officials early in the

process of developing the proposed

regulation. EPA also may not issue a

regulation that has federalism

implications and that preempts State

law, unless the Agency consults with

State and local officials early in the

process of developing the proposed

regulation.

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 4547

This final rule does not have

federalism implications. It will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. This action is

expected to have a limited impact on

municipal governments that operate

electric utilities that may be affected by

this action. EPA estimates that there are

only 13 publicly-owned electric utility

facilities that are potentially affected by

the rule. Of these 13 facilities, 8 are

expected to file one additional report as

a result of this action. Thus, the

requirements of Section 6 of the

Executive Order do not apply to this

rule.

G. What are the Determinations under

the National Technology Transfer and

Advancement Act?

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA) (15 U.S.C. 272

note) directs EPA to use voluntary

consensus standards in its regulatory

activities unless doing so would be

inconsistent with applicable law or

impractical. Voluntary consensus

standards are technical standards (e.g.,

materials specifications, test methods,

sampling procedures, etc.) that are

developed or adopted by voluntary

consensus standards bodies. The

NTTAA directs EPA to provide

Congress, through OMB, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards.

This action does not involve technical

standards, nor did EPA consider the use

of any voluntary consensus standards.

In general, EPCRA does not prescribe

technical standards for threshold

determinations or completion of EPCRA

section 313 reports. EPCRA section

313(g)(2) states that ‘‘In order to provide

the information required under this

section, the owner or operator of a

facility may use readily available data

(including monitoring data) collected

pursuant to other provisions of law, or,

where such data are not readily

available, reasonable estimates of the

amounts involved. Nothing in this

section requires the monitoring or

measurement of the quantities,

concentration, or frequency of any toxic

chemical released into the environment

beyond that monitoring and

measurement required under other

provisions of law or regulation.’’

H. What are the Requirements of the

Congressional Review Act?

The Congressional Review Act (5

U.S.C. 801 et seq.) as added by the

Small Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This action is not

a ‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 372

Environmental protection,

Community right-to-know, Reporting

and recordkeeping requirements, and

Toxic chemicals.

Dated: January 8, 2001.

Carol M. Browner,

Administrator.

Therefore, 40 CFR part 372 is

amended as follows:

PART 372—[AMENDED]

1. The authority citation for part 372

will continue to read as follows:

Authority: 42 U.S.C. 11023 and 11048.

2. In § 372.28 by adding one chemical

to paragraph (a)(1) alphabetically and to

paragraph (a)(2) by alphabetically

adding one category to read as follows:

§ 372.28 Lower thresholds for chemicals

of special concern.

(a) * * *

(1) * * *

Chemical Name CAS No. Reporting Threshold

*** ** * *

Lead (this lower threshold does not apply to lead when contained in a stainless steel,

brass or bronze alloy) 7439–92–1 100

*** ** * *

(2) * * *

Category Name Reporting Threshold

*** ** * *

Lead Compounds 100

*** ** * *

* * * * *

[FR Doc. 01–1045 Filed 1–16–01; 8:45 am]

BILLING CODE 6560–50–F