24066 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

XI. Submission to Congress and the

Comptroller General

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 this final

rule in theFederal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 27, 2001.

Anne E. Lindsay,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and

371.

2. Section 180.1214 is added to

subpart D to read as follows:

§ 180.1214 Bacillus thuringiensis Cry3Bb1

protein and the genetic material necessary

for its production in corn; exemption from

the requirement of a tolerance.

Bacillus thuringiensis Cry3Bb1

protein and the genetic material

necessary for its production in corn are

exempt from the requirement of a

tolerance when used as plant-pesticides

in the food and feed commodities of

field corn, sweet corn and popcorn.

Genetic material necessary for its

production means the genetic material

which comprise genetic material

encoding the Cry3Bb1 protein and its

regulatory regions. Regulatory regions

are the genetic material, such as

promoters, terminators, and enhancers,

that control the expression of the

genetic material encoding the Cry3Bb1

protein.This exemption from the

requirement of a tolerance will expire

on May 1, 2004.

3. Section 180.1215 is added to

subpart D to read as follows:

§ 180.1215 Bacillus thuringiensis Cry2Ab2

protein and the genetic material necessary

for its production in corn or cotton;

exemption from the requirement of a

tolerance.

Bacillus thuringiensis Cry2Ab2

protein and the genetic material

necessary for its production in corn or

cotton are exempt from the requirement

of a tolerance when used as plantpesticides in the food and feed

commodities of field corn, sweet corn,

popcorn, cotton seed, cotton oil, cotton

meal, cotton hay, cotton hulls, cotton

forage, and cotton gin byproducts.

Genetic material necessary for its

production means the genetic material

which comprise genetic material

encoding the Cry2Ab2 protein and its

regulatory regions. Regulatory regions

are the genetic material, such as

promoters, terminators, and enhancers,

that control the expression of the

genetic material encoding the Cry2Ab2

protein. This exemption from the

requirement of a tolerance will expire

on May 1, 2004.

[FR Doc. 01–11917 Filed 5–10–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR PART 372

[OPPTS–400134A; FRL–6722–9]

RIN 2025–AA00

Chromite Ore from the Transvaal

Region of South Africa; Toxic

Chemical Release Reporting;

Community Right-to-Know

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is granting a petition to

delete both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

chromite ore processing residue (COPR)

from the reporting requirements 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).

These chemicals are currently reported

as part of the category ‘‘chromium

compounds’’ on the list of toxic

chemicals in section 313(c) of EPCRA.

The action is based on EPA’s conclusion

that this particular chromite ore from

the Transvaal Region and the unreacted

ore component of the COPR (in the case

of this delisting decision, COPR

includes the solid waste remaining after

the aqueous extraction of oxidized

chromite ore that has been combined

with soda ash and kiln roasted at

approximately 2,000 °F) meet the

deletion criterion under EPCRA section

313(d)(3). By promulgating this rule,

EPA is relieving facilities of their

obligation to report releases of and other

waste management information on

chromite ore mined in the Transvaal

Region of South Africa and the

unreacted ore component of the COPR

that occurred during the 2000 reporting

year, and for activities in the future.

EFFECTIVE DATE: This rule is effective

May 11, 2001.

FOR FURTHER INFORMATION CONTACT:

Daniel R. Bushman, Petitions

Coordinator, (202) 260–3882, e-mail:

bushman.daniel@epa.gov, for specific

information on this document, or for

more information on EPCRA section

313, the Emergency Planning and

Community Right-to-Know Hotline,

Environmental Protection Agency, Mail

Code 5101, 1200 Pennsylvania Ave.,

Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations 24067

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 notice is also available

on EPA’s Web site at http://

www.epa.gov/tri.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this notice if you kiln roast chromite ore

in the production of chromium

chemicals or if you process chromite ore

(e.g., metal finishers, leather tanning,

etc.). 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; industry

codes 4911 (limited to facilities that combust coal and/or oil for the purpose of generating power for

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

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

oil for the purpose of generating power for distribution in commerce); or 4953 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. section 6921 et seq.),

or 5169, or 5171, or 7389 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis)

Federal Government Federal facilities

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. To determine whether your

facility would be affected by this action,

you should carefully examine the

applicability criteria in part 372, subpart

B of Title 40 of the Code of Federal

Regulations (CFR). If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed in the preceding FOR FURTHER

INFORMATION CONTACT section.

B. How Can I Get Additional

Information or Copies of this Document

or Other Support Documents?

1. Electronically. You may obtain

electronic copies of this document from

the EPA internet Home Page at http://

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

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

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

/www.epa.gov/fedrgstr/.

2.In person. The Agency has

established an official record for this

action under docket control number

OPPTS–400134. 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. Introduction

A. What is the Statutory Authority for

this Action?

This action is being taken under

EPCRA sections 313(d) and (e)(1), 42

U.S.C. 11023. EPCRA is also referred to

as Title III of the Superfund

Amendments and Reauthorization Act

of 1986 (SARA) (Pub. L. 99–499).

B. What is the General Background for

this Action?

Section 313 of EPCRA requires certain

facilities manufacturing, processing, or

otherwise using listed toxic chemicals

in amounts above reporting threshold

levels, to report their environmental

releases of such chemicals annually.

These facilities also must report

pollution prevention and recycling data

for such chemicals, pursuant to section

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

313 of EPCRA established an initial list

of toxic chemicals that was comprised

of more than 300 chemicals and 20

chemical categories. Chromium

compounds (which include chromite

ore) were included on the initial list.

Section 313(d) authorizes EPA to add or

delete chemicals from the list, and sets

forth criteria for these actions. EPA has

added and deleted chemicals from the

original statutory list. Under section

313(e)(1), any person may petition EPA

to add chemicals to or delete chemicals

from the list. Pursuant to EPCRA section

313(e)(1), EPA must respond to petitions

within 180 days, either by initiating a

rulemaking or by publishing an

explanation of why the petition is

denied.

EPCRA section 313(d)(2) states that a

chemical may be listed if any of the

listing criteria are met. Therefore, in

order to add a chemical, EPA must

demonstrate that at least one criterion is

met, but does not need to examine

whether all other criteria are also met.

Conversely, in order to remove a

chemical from the list, EPA must

demonstrate that none of the criteria are

met.

EPA issued a statement of petition

policy and guidance in the Federal

Register of February 4, 1987 (52 FR

3479), to provide guidance regarding the

recommended content and format for

submitting petitions. On May 23, 1991,

(56 FR 23703), EPA issued guidance

regarding the recommended content of

petitions to delete individual members

of the section 313 metal compounds

categories. EPA has also published a

statement clarifying its interpretation of

the section 313(d)(2) and (3) criteria for

modifying the section 313 list of toxic

chemicals (59 FR 61432, November 30,

1994) (FRL–4922–2).

III. What Does this Petition and Related

Past Petitions Request of the Agency?

A. What Does this Petition Request?

On January 26, 1998, EPA received a

petition from Elementis Chromium LP

(ECLP) (formerly American Chrome &

Chemicals, Inc.) requesting that EPA

delete from the chromium compounds

24068 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations

category both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR. COPR is the solid waste

remaining after aqueous extraction of

oxidized chromite ore that has been

combined with soda ash and kiln

roasted at approximately 2,000 °F.

Elementis believes that the chemical

and toxicological properties of chromite

ore mined in the Transvaal Region of

South Africa and the unreacted ore

component of the COPR do not meet the

statutory listing criteria of EPCRA

313(d)(2) and therefore should be

removed from the reporting

requirements of EPCRA section 313 and

PPA section 6607. The EPCRA section

313 list of toxic chemicals includes a

category listing for chromium

compounds, thus, all chromium

compounds are subject to the annual

reporting requirements of EPCRA

section 313 and PPA section 6607. This

petition decision is specific to chromite

ore mined in the Transvaal Region of

South Africa and the unreacted ore

component of the COPR from this

particular process.

B. What Other Petitions for Chromium

Compounds Have Been Filed?

EPA has received two other petitions

requesting the deletion of certain

chromium compounds. On January 8,

1990, a petition to delist chromium

antimony titanium buff rutile (CATBR)

from the EPCRA section 313 list of toxic

chemicals was denied based on EPA’s

determination that CATBR is a potential

carcinogen via inhalation (55 FR 650).

Based on test data on chromium (III)

oxide, EPA determined that CATBR, an

insoluble crystalline chromium (III)

compound, could be retained in the

lung and taken up by cells. EPA denied

this petition due to the determination

that CATBR was a potential carcinogen,

and that it could reasonably be

anticipated to cause cancer in humans.

Since then, EPA published a

statement of policy and guidance for

petitions under EPCRA section 313 (56

FR 23703, May 23, 1991). In that notice,

EPA set forth its policy concerning

petitions to delist individual members

of the metal compound categories. In

response to concerns with respect to

individual members of categories that

do not meet the toxicity criteria of

section 313, EPA has stated that it will

‘‘grant petitions on individual members

providing that the petitioner establishes

and EPA concludes that the intact

species does not meet the criteria of

section 313(d)(2), and that the metal ion

will not become available at a level that

can be expected to induce toxicity.’’

On November 22, 1991, a petition to

delist Chromium (III) Oxide from the

EPCRA section 313 list of chemicals was

denied based on the evidence that

chromium (III) oxide may be oxidized to

carcinogenic chromium (VI) compounds

in soil (56 FR 58859). The petition

response also discussed the possibility

that chromium (III) oxide is a potential

carcinogen via inhalation.

IV. What is EPA’s Summary of its

Proposed Action?

Following a review of the petition

(Ref. 1), EPA granted the petition and

issued a proposed rule in the Federal

Register of February 23, 1999 (64 FR

8774) (FRL–6030–6) proposing to delete

both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR from reporting under the EPCRA

section 313 chromium compounds

category. EPA’s proposal was based on

its preliminary conclusion that both

chromite ore mined in the Transvaal

Region of South Africa and the

unreacted ore component of the COPR

met the deletion criteria of EPCRA

section 313(d)(3). With respect to

deletions, EPCRA provides at section

313(d)(3) that ‘‘[a] chemical may be

deleted if the Administrator determines

there is not sufficient evidence to

establish any of the criteria described in

paragraph [(d)(2)(A)–(C)].’’ In the

proposed rule, EPA preliminarily

concluded that, while many concerns

exist for the hazards associated with

soluble Cr(III) compounds and all Cr(VI)

compounds, these concerns do not

appear to be pertinent to the chromite

ore from the Transvaal Region of South

Africa and the unreacted ore component

of the COPR. The available data indicate

that this particular chromite ore does

not leach chromium of any oxidation

state nor does it oxidize to produce any

Cr(VI) compounds under any biotic or

abiotic processes. EPA preliminarily

determined that there are no human

health or environmental hazard

concerns for this particular chromite ore

that meet the toxicity criterion of

EPCRA section 313(d)(2)(A), (B), or (C).

A more detailed discussion of the

technical information can be found in

the proposed rule and the supporting

EPA technical reports (Refs. 2, 3, 4, 5,

6, and 7) and other references contained

or cited in the docket.

V. What is EPA’s Response to the

Submitted Petition and Rationale?

A. What is EPA’s Response to the

Submitted Petition?

EPA is granting the ECLP petition by

delisting both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR from the reporting requirements

under the EPCRA section 313 chromium

compounds category. Note that this

delisting does not include any of the

Cr(III) or Cr(VI) compounds that are also

part of the COPR. This delisting only

applies to the unreacted ore component

of the COPR.

B. What is EPA’s Rationale for the

Delisting?

EPA has concluded that the

assessment set out in the proposed rule

should be affirmed. The available data

indicate that the chromite ore from the

Transvaal Region of South Africa and

the insoluble Cr(III) unreacted ore

component of the COPR do not leach

ionic chromium of any oxidation state

nor do they oxidize to produce Cr(VI)

compounds under any biotic or abiotic

processes. EPA has determined that

there are no human health or

environmental hazard concerns for this

particular chromite ore that meet the

toxicity criterion of EPCRA section

313(d)(2)(A), (B), or (C). EPA believes

that the deletion of this particular

chromite ore and the unreacted ore

component of the COPR is consistent

with the Agency’s published guidance

on how it willreview petitions to delete

members of EPCRA section 313 metal

compound categories (56 FR 23703, May

23, 1991). Specifically, chromium is not

available or bioavailable from this

particular chromite ore or the unreacted

ore component of the COPR through any

biotic or abiotic processes and there is

no evidence that the intact chromite ore

or the unreacted ore component of the

COPR causes any adverse effects that

meet the EPCRA section 313(d)(2)(A),

(B), or (C) toxicity criterion. EPA is

therefore modifying the current

chromium compounds listing to exclude

both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR. However, EPA is not removing

any other Cr(III) compounds or any

Cr(VI) compounds from the chromium

compounds category. As EPA has

previously determined, if Cr(III) is

available from a chromium compound,

it can be converted to Cr(VI) compounds

in the environment (56 FR 58859,

November 22, 1991). While EPA is

delisting this specific chromite ore and

the unreacted ore component of COPR

from reportingunder EPCRA section

313, all other chromium compounds

contained in the COPR will continue to

be reportable.

Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations 24069

VI. What are EPA’s Responses to the

Public Comments?

A. What Comments Did EPA Request in

the Proposed Rulemaking?

EPA requested both general and

specific comments in the proposal to

delist both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR from the list of toxic chemicals

subject to the reporting requirements

under EPCRA section 313 and PPA

section 6607. EPA requested specific

comments on three issues relating to

chromium compounds, including: (1)

Possible carcinogenicity of insoluble

crystalline chromium (III) compounds

via inhalation and uptake in the lung

cell by phagocytosis; (2) possible

indirect effects of chromium (III)

competing with other cations in ligand

sites in siderophore complexes; and (3)

the availability of toxicity and fate

information that would support

excluding all chromite ores from

reporting under EPCRA section 313.

B. What Comments Did EPA Receive in

Support of the Proposed Rulemaking?

EPA received comments from five

organizations supporting EPA’s

proposal to delist both chromite ore

mined in the Transvaal Region of South

Africa and the unreacted ore component

of the COPR from the list of toxic

chemicals subject to the reporting

requirements under EPCRA section 313

and PPA section 6607. The five

commenters are: Elementis Chromium;

Exponent Environmental Group;

Chemical Land Holdings Inc.; Collier,

Shannon, Rill, and Scott (representing

the Specialty Steel Industry of North

America (SSINA)); and Occidental

Chemical Corporation.

1. Did EPA receive comments relating

to EPA’s finding that the carcinogenicity

potential is insignificant for insoluble

crystalline chromium (III) compounds

that may enter lung cells via

phagocytosis? Several commenters

agreed with EPA that while insoluble

crystalline Cr(III) may be taken up in

cells via phagocytosis, there is no

evidence of carcinogenicity. One

commenter provided additional

literature to support this point. Another

commenter noted several studies that

suggest a potential for biologically

available Cr(III) to oxidize to Cr(VI) in

the presence of peroxy or oxygen

radicals. The commenter stated that

oxidation under such conditions is

unlikely, however, since Cr(III) readily

forms a variety of inert complexes in

vivo. Another commenter stated that

bacterial genotoxicity studies have been

found to be overwhelmingly negative,

and that mammalian and avian studies

have also been found to be negative,

concurring that Cr(III) is not

carcinogenic via inhalation based on

available testing and sampling data.

EPA agrees with the commenters and

restates that the carcinogenicity data

from the available studies of inhaled,

insoluble, crystalline trivalent

chromium compounds are inadequate to

support listing this particular chemical

under EPCRA Section 313 (Ref. 8).

2. What comments did EPA receive

relating to the possible indirect effects of

Cr(III) on siderophore complexes and

the availability of studies (in vivo) that

address the competition of Cr(III) with

other ions? Several commenters contend

that, since in vivo biological effects of

Cr(III) are unknown and unreported, the

ability of Cr(III) to inhibit the ability of

cells to uptake iron in vitro is not

relevant. Another commenter responded

to the possible indirect effects of Cr(III)

on siderophore complexes by referring

to the binding of DNA material to Cr(III).

The commenter noted, however, that

Cr(III) is impermeable to cell

membranes and that Cr(VI) is

transported into the cell then reduced to

Cr(III) before any toxic effects are

observed. Thecommenter concludes that

this reduction of Cr(VI) to Cr(III) should

not be misinterpreted ‘‘as evidence that

Cr(III) is responsible for the adverse

effects of Cr(VI) * * *.’’

EPA notes that the commenters

focused on the potential cationic

exchange as a possible mechanism for

carcinogenicity. In requesting comments

on the possible indirect effects of Cr(III)

on siderophore complexes, EPA was not

necessarily implying a concern for

carcinogenicity. Rather, EPA’s primary

concern for siderophoric ion exchange

relates to environmental exposures to

heavy metal cations displaced from soils

that are exposed to soluble chromium

ions (64 FR 8778). As was stated in the

proposal, EPA has determined that there

are inadequate data to determine the

potential carcinogencity of Cr(III) (Ref.

8).

In addition to the direct leaching as a

function of water solubility, metal ions

have been found to be transported via

macromolecules and siderphoric

complexes. The addition of certain

metal ions to contaminated soil plots or

experimental samples produce

equilibrium effects on the ability of

these materials to ‘‘carry’’ the heavy

metal cations. In certain studies, metals

ions (specifically zinc (II) and cadmium

(II)) have been found to compete for

sites and exchange ions ‘‘even when

only a few percentage of all surface sites

were occupied’’ (Ref. 9).

EPA requested comment in the

proposed rule to determine if releases of

chromium, particularly from COPR

sites, would exchange with the existing

metal contaminants and thereby cause

both a direct and indirect environmental

release (e.g., elevated chromium levels)

(Ref. 10). EPA did not receive any

comments on this topic. The Agency

believes, however, that the chromium in

this specific chromite ore and

corresponding unreacted ore portion of

the COPR is neither available nor

soluble and therefore these issues will

have no bearing on the delisting of these

two chemical compounds based on the

current available information (56 FR

23703).

3. What comments did EPA receive

relating to whether all chromite ore and

COPR behaves similarly to the chromite

ore from the Transvaal Region of South

Africa and the unreacted ore portion of

the COPR remaining from the process

described in the proposed rule? EPA

received comments that addressed four

aspects of this topic including:

conversion of Cr(III) to Cr(VI); biological

activity of Cr(III); carcinogenic effects of

Cr(III); and environmental fate of

chromium compounds. In general, the

commenters state specific known

chemical characteristics for individual

chemicals and apply them to the entire

class. A broad structure-activity

relationship (SAR) approach to justify

delisting insoluble Cr(III) chemicals in

general appears to be the overall goal of

the approach submitted by commenters.

The SAR approach examines the

structure of a chemical to predict the

chemical’s toxicity.

Although the Agency requested

comments on the ‘‘availability of

toxicity and fate information that would

support excluding all chromite ores

from reporting under EPCRA section

313,’’ EPA proposed to delist only the

chromite ore mined in the Transvaal

region of South Africa and the

associated unreacted chromite ore

component of the COPR. The Agency is

delisting only these two chemicals.

EPA’s purpose for soliciting information

regarding the broader class of chromite

ore was to gather information to

determine whether a future rulemaking

including other chemicals would be

appropriate.

In response to the comments received,

the Agency believes that test results for

a variety of Cr(III) compounds

(including toxicity, oxidation, and fate)

are insufficient to support any broad

determinations concerning chromium

compounds. The chromium compounds

category listing is based on the well

established toxicity of chromium. As

EPA stated in its EPCRA section 313

24070 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations

metals policy, the Agency will consider

delisting a chemical or chemical

compound if the intact metal compound

is not toxic and the metal from that

compound cannot become available

through any abiotic or biotic process (56

FR 23703). In reviewing the four areas

of concern described by commenters,

including conversion of Cr(III) to Cr(VI);

biological effects of

Cr(III);carcinogenicity of Cr(III); and

environmental fate of chromium

compounds, the commenters did not

submit sufficient evidence to support

the delisting of all chromite ores or any

other specific Cr(III) compound.

For example, commenters submitted

data for chromium trioxide. Chromium

trioxide is insoluble and has chemical

characteristics attributed to this class of

insoluble chromium compounds.

However, in 1991, EPA denied a

petition to delist this chemical (58 FR

58859, Nov. 22, 1991) due to availability

of the Cr(III), and the potential of Cr(III)

to oxidize to Cr(VI). The four individual

comments and corresponding EPA

responses follow.

a. What comments did EPA receive

relating to the conversion of Cr(III) to

Cr(VI)? One commenter contends that

studies show that chromium oxide (the

component of concern in chromite ore)

does not oxidize to form hexavalent

chromium under biological conditions.

In addition, several commenters believe

that the oxidation of Cr(III) to Cr(VI)

requires relatively harsh conditions that

do not occur naturally in biological

systems (i.e., the presence of strong

oxidants or low pH levels).

EPA disagrees with the commenters.

There are environmental conditions that

will oxidize Cr(III) to Cr(VI) (e.g., those

used by the petitioner in the leaching

studies including soil having a high

manganese oxide content and low pH).

The commenters did not provide

adequate evidence to conclude that the

findings of the petitioner could be

extended to any other chromium

containing compound. This delisting

decision applies only to the chromite

ore and the unreacted chromite ore

component of COPR that were tested by

the petitioner. After reviewing the

petitioner’s studies, EPA concluded that

the chromite ore and COPR tested were

both insoluble and are not biologically

available. Arguments that Cr(III) does

not readily oxidize in the body unless

under harsh conditions is not sufficient

to claim that the chromium present from

other sources will not oxidize or will

not pose human health or

environmental hazards.

Commenters submitted no evidence to

justify this conclusion for any other

chromium containing compounds.

There is only evidence for the specified

ore and the unreacted ore portion of the

COPR associated with that particular

processing described previously. All

other data comparisons are speculative

and unsatisfactory for delisting. The

Agency would, therefore, require data

from similar testing (compared to that

done in support of this delisting

petition) on any other ore or COPR from

another process in order to remove it

from the EPCRA section 313 list of toxic

chemicals. The particular chromite ore

and the unreacted ore component of

COPR discussed in this action were

studied in depth. Samples were

subjected to a variety of tests that

provided conclusive evidence that these

materials would not produce hexavalent

chromium via oxidation in the

environment. There was no evidence

that Cr(III) was available through either

abiotic or biotic processes. The

petitioner based their argument on the

testing data provided in the original

submission.

b.What comments did EPA receive

relating to the biological activity of

Cr(III)? Several commenters suggest that

the biological activity of Cr(III)

compounds are not associated with

adverse health effects due principally to

the inability of Cr(III) to pass through

cell membranes. The commenters cite

the daily requirement of chromium as

an essential element fornutritional

health as evidence for the stability of

Cr(III) in the body. The commenters

reported that Cr(VI) intracellular

reduction to form Cr(III), suggested to be

the active toxicant in the proposed rule,

would have to form via other chromium

oxidation states (i.e., Cr(IV) and Cr(V)).

The commenters contend that it is these

highly reactive forms of chromium that

are responsible for the adverse

biological reactivity. Therefore, the

commenters conclude that all Cr(III)

compounds are biologically unreactive.

EPA agrees with the commenters that

insoluble Cr(III) in vivo is unlikely to

pass through the cellular membrane.

EPA also agrees that Cr(VI) readily

passes through the cell membrane, and

produces a variety of potentially

hazardous products following reduction

to an active species other than Cr(III).

EPA stated in the proposed rule that

Cr(III) is an essential mineral that has

not been demonstrated to have

carcinogenic, genotoxic, or adverse

health effects under the conditions

discussed. With regard to the biological

reactivity of Cr(III) compounds with

hydroxy or peroxy radicals, EPA agrees

that the oxidative conditions described

by the commenters maynot be present in

biological systems. These facts do not

support delisting all Cr(III) compounds.

It simply reinforces the notion that

Cr(III) once in the body may not pose a

hazard to human health. As stated in the

response in Unit VI.B.3.a., there are

other concerns for Cr(III) compounds.

c.What comments did EPA receive

relating to the carcinogenic effects of

Cr(III)? Several commenters contend

that the presentation of the historical

review of chromium compounds is

misleading. To date, EPA has

historically not ruled on the

carcinogenicity of Cr(III) compounds

and, as more data has become available,

the Agency has determined that

insoluble Cr(III) compounds (the

chemical class as a whole) have not

been found to becarcinogenic via

inhalation. The commenters state that

the overall scientific view reflects the

conclusion that Cr(III) is not

carcinogenic or genotoxic. They

contend, however, that the presentation

of the historical review on chromium

compounds, while providing context, is

misleading. The commenters imply that

past references to potential

carcinogenicity will be misinterpreted

to imply some hidden potential concern

for insoluble Cr(III) compounds.

EPA disagrees that the presentation of

the historical treatment and concerns for

Cr(III) as part of the record for the

chromium compounds category is

misleading. In the past, EPA has stated

that there was a potential human health

concern for the carcinogenic effects of

Cr(III). EPA has since made the

determination that there is no evidence

to support a concern for

thecarcinogenicity of inhaled insoluble

Cr(III) compounds. There are, however,

other concerns for chromium (including

certain forms of Cr(III)). This delisting

will also be part of that historical record

and will help inform the public of those

remaining concerns for the human

health and environmental hazards of

chromium.

In the review of the current scientific

evidence, EPA has determined that

there is no evidence to support a

concern for carcinogenicity of inhaled

insoluble Cr(III) compounds. Should

new credible scientific evidence

indicate that a hazard exists, the Agency

would have to consider reversing this

determination. If new data support the

delisting of other forms of Cr(III),EPA

would consider eliminating such

chemicals from reporting. EPA

considers the listing and delisting of

chemicals a dynamic process that can

change as new information is obtained.

There is nothing misleading in

educating the public about what had

been believed and what new facts have

caused a change in EPA’s assessment.

Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations 24071

d.What comments did EPA receive

relating to environmental fate of

chromium compounds? One commenter

contends that it is inappropriate to

compare the oxidation of soluble

chromium compounds that occur

naturally in the presence of manganese

oxides under specified conditions with

the environmental fate of chromite ore.

The commenter maintains that the

environmental conditions of such soils

are equally likely to reduce Cr(VI) as

they would oxidize Cr(III), and that this

equilibrium favors Cr(III) formation (i.e.,

if Cr(III) ions were released by chromite

ore or the processing residue, they

would not pose an environmental or

human health hazard under typical

conditions). No references were

provided by this commenter.

Several commenters agree that

chromite ore does not readily oxidize

under natural conditions. These

commenters further elaborate on the

health impacts of residues from

chromite ore processing in New Jersey

stating that the New Jersey residues are

characteristically different from that

generated by the petitioner, yet no

‘‘appreciable health effect that may be

attributable to chromium’’ has been

identified. The commenters state that in

addition to health risks, ecological risks

associated with the residues from

chromite ore processing in New Jersey

were also evaluated. The commenters

contend that from the data, it is clear

that chromium ions migrate from areas

high in process residue to contaminate

adjacent areas, and while mobile, it

appearsthat much of this migratory

chromium is tightly bound to the soil.

However, the commenters claim that

there did not appear to be a correlation

between levels of chromium in the soil

samples and the ability of this tightly

associated metal (soil:Cr complexation)

to dissociate and bind to the available

biota.

Another commenter contends that

residues from chromite ore processing

differ substantially by noting that

certain chromium remediation activities

are still on-going due to the concern for

the exposure to hexavalent chromium

contamination from process residue fill

sites. This commenter reiterates the idea

suggested by the other commenters that

these residues (and by inference that

certain sources of chromite ore and

other chromite ore process residues) are,

in fact, different. The commenters state

that the chromite ore and unreacted

COPR discussed in the petition are not

considered a risk to human health or the

environment.

EPA does not believe that the

commenters have provided sufficient

information to conclude that other

chromite ore sources or other chromite

ore processing residues share the same

properties as the chromite ore and

unreacted ore component of COPR that

are the subject of this rulemaking. EPA

believes that these comments support

the Agency’s position that all

Cr(III)compounds are not identical.

With regard to chromite ore processing

residues, such as the COPR that is the

subject of this rulemaking, EPA notes

that it contains at least three

components: (1) Unreacted chromite ore

(the portion that will be delisted for ore

originating from the Transvaal Region);

(2) Cr(III) present as a result of reduction

treatment of unleached Cr(VI) (still

reportable under the chromium

compounds category of EPCRA section

313); and (3) the unreduced Cr(VI) from

oxidized Cr(III) (also still reportable

under the chromium compounds

category of EPCRA section 313). Other

chromite ore processing residues are

also likely to contain various amounts of

chromium compounds other than the

unreacted ore component and thus may

be sources ofenvironmentally available

chromium.

EPA believes that the information

discussed in the proposed rule

concerning the observed oxidation of

soluble Cr(III) to Cr(VI) by manganese

rich soils is a concern and that such

conversions can lead to environmentally

available and bioavailable forms of

chromium. The fact that under certain

conditions this conversion may result in

an equilibrium that favors the Cr(III)

form does not change the fact the Cr(VI)

can be produced. In addition, since the

publication of the proposed rule, EPA

has reviewed a study that has addressed

the potential of a second pathway for

the oxidation of Cr(III) to Cr(VI) in the

presence of ferric salts which further

supports EPA’sconcerns for the

conversion of Cr(III) to Cr(VI) (Ref. 11).

The Agency therefore reasserts its

position that, under the appropriate

conditions, Cr(III) can readily oxidize to

form Cr(VI) in the environment.

The Agency agrees with the

commenters that the ability of Cr(III) to

be oxidized in the environment to Cr(VI)

is not relevant to the consideration of

whether or not to delist chromite ore

from the Transvaal region of South

Africa and the unreacted ore component

of the COPR. However, this oxidation is

irrelevant only because the petitioner

conclusively demonstrated that the

chromium in these compounds is

unavailable for chemical reaction and

therefore does not produce Cr(VI) under

the oxidizing conditions. In order to

extend such a determination to other

chromium compounds the

unavailability of the chromium and lack

of oxidation would have to be clearly

demonstrated for these other chromium

compounds.

B. What Comments Did EPA Receive

That Did Not Support this Proposal to

Delist?

EPA did not receive any comments

that were critical of its proposal to delist

both chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

COPR from the list of toxic chemicals

subject to the reporting requirements

under EPCRA section 313 and PPA

section 6607.

VII. What is the Effective Date of this

Final Rule?

This action becomes effective May 11,

2001. Thus, the last year in which

facilities had to file a Toxics Release

Inventory (TRI) report for both chromite

ore mined in the Transvaal Region of

South Africa and the unreacted ore

component of the COPR was 2000,

covering releases and other activities

that occurred in 1999.

EPCRA section 313(d)(4) provides that

‘‘[a]ny revision’’ to the section 313 list

of toxic chemicals shall take effect on a

delayed basis. EPA interprets this

delayed effective date provision to

apply only to actions that add chemicals

to the section 313 list. For deletions,

EPA may, in its discretion, make such

actions immediately effective. An

immediate effective date is authorized,

in these circumstances, under 5 U.S.C.

section 553(d)(1) because a deletion

from the section 313 list relieves a

regulatory restriction.

EPA believes that where the Agency

had determined, as it has with this

chemical, that a chemical does not

satisfy any of the criteria of section

313(d)(2)(A)–(C), no purpose is served

by requiring facilities to collect data or

file TRI reports for that chemical, or,

therefore, by leaving that chemical on

the section 313 list for any additional

period of time. This construction of

section 313(d)(4) is consistent with

previous rules deleting chemicals from

the section 313 list. For further

discussion of the rationale for

immediate effective dates for EPCRA

section 313 delistings, see 59 FR 33205

(June 28, 1994).

VIII. What are the References Cited in

this Final Rule?

1. Elementis Chromium LP. Petition

to Delist Chromite Ore from SARA

313.Elementis Chromium LP (January 5,

1998).

2. USEPA. Economic Analysis of the

Proposed Deletion of Chromite Ore from

the EPCRA Section 313 List of Toxic

24072 Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations

Chemicals. OPPT/EETD/EPAB

(February 1998).

3. USEPA. Preliminary Release Report

Proposed Deletion of Chromite Ore from

the EPCRA Section 313 Toxic Release

Inventory. OPPT/EETD/CEB (March

1998).

4. USEPA. Chemistry Analysis of the

Proposed Deletion of Chromite Ore from

the EPCRA Section 313 Toxic Release

Inventory. OPPT/EETD/ICB (February

1998).

5. USEPA. Chromite Ore Delisting

Assessment of Health Hazard

Concern.OPPT/RAD/SSB (May 1998).

6. USEPA. Petition to Delist Chromite

Ore (Chromium Compounds Category):

Ecological Hazard Assessment. OPPT/

RAD/ECAB (April 1998).

7. USEPA. Environmental Fate

Summary of Chromium (Cr) in

Soils.OPPT/EETD/EAB (March 1998).

8. IRIS. U.S. Environmental Protection

Agency’s Integrated Risk Information

System file pertaining to chromium (III),

insoluble salts.

9. Engineering Bulletin: Technology

Alternatives for the Remediation of

Soils Contaminated with As, Cd, Cr, Hg,

and Pb. EPA 540–S97–500.

10. Jin, X., Bailey, G.W., Yu, Y.S., and

Lynch, A.T. ‘‘Kinetics of Single and

Multiple Metal Ion Sorption Processes

on Humic Substances.’’ Soil Science v.

161 (1996), pp. 509–519.

11. Zhang, H. and Bartlett, R. ‘‘Light

Induced Oxidation of Aqueous

Chromium(III) in the Presence of

Iron(III).’’ Environmental Science &

Technology, v. 33, 1999, pp. 588–594.

IX. What are the Regulatory

Assessment Requirements for this

Action?

A. Executive Order 12866

This action, which exempts both

chromite ore mined in the Transvaal

Region of South Africa and the

unreacted ore component of the COPR

from the list of chemicals subject to

reporting under EPCRA section 313 and

PPA section 6607, eliminates an existing

requirement to report and does not

contain any new or modified

requirements. As such, this action does

not require review by the Office of

Management and Budget (OMB) under

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993), because OMB

hasdetermined that the complete

elimination of an existing requirement

is not a ‘‘significant regulatory action’’

subject to review by OMB under E.O.

12866.

B. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.), the Agency hereby

certifies that this final rule will not have

a significant impact on a substantial

number of small entities. This

determination is based on the fact that

the elimination of the existing

requirement will also eliminate the

corresponding burden and costs

associated with that requirement. This

action will not, therefore, result in any

adverse economic impacts on the

facilities subject to reporting under

EPCRA section 313, regardless of the

size of the facility.

C. Paperwork Reduction Act

The delisting of both chromite ore

mined in the Transvaal Region of South

Africa and the unreacted ore component

of the COPR from the EPCRA section

313 list of toxic chemicals will reduce

the overall reporting and recordkeeping

burden estimate provided for the TRI

program, but this action does not

require any review or approval by OMB

under the Paperwork Reduction Act

(PRA), 44 U.S.C. 3501 et seq. EPA will

determine the total TRI burden

associated with this delisting, and will

complete the required Information

Collection Worksheet to adjust the total

TRI burden estimate approved by OMB.

The reporting and recordkeeping

burdens associated with TRI are

approved by OMB under OMB No. 2070

0093 (Form R, EPA ICR No. 1363) and

under OMB No. 2070 0143 (Form A,

EPA ICR No. 1704). The current public

reporting burden for TRI is estimated to

average 52.1 hours for a Form R

submitter and 34.6 hours for a Form A

submitter. These estimates include the

time needed for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number. The OMB control

number for this information collection

appears above. In addition, the OMB

control number for EPA’s regulations,

after initial display in the final rule, are

displayed on the collection instruments

and are also listed in 40 CFR part 9.

D. Unfunded Mandates Reform Act and

Executive Orders 13084 and 13132

Since this action involves the

elimination of an existing requirement,

it does not impose any enforceable duty,

contain any unfunded mandate, or

otherwise have any affect on small

governments as described in the

Unfunded Mandates Reform Act of 1995

(P.L. 104–4). For the same reason, it is

not subject to the requirement for prior

consultation with Indian tribal

governments as specified in Executive

Order 13084, entitled Consultation and

Coordination with Indian Tribal

Governments (63 FR 27655, May

19,1998). Nor will this action have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999).

E. Executive Order 12898

Pursuant to Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), the Agency must consider

environmental justice related issues

with regard to the potential impacts of

this action on environmental and health

conditions in low-income populations

and minority populations. The Agency

has determined that this delisting,

which would eliminate the availability

of the TRI information on this chemical

that is made available to communities

through the TRI Community Right-toKnow program, will not result in

environmental justice related issues.

F. Executive Order 13045

Pursuant to Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997), if

an action is economically significant

under Executive Order 12866, the

Agency must, to the extent permitted by

law and consistent with the Agency’s

mission, identify and assess the

environmental health risks and safety

risks that may disproportionately affect

children. Since this action is not

economically significant under

Executive Order 12866, this action is

not subject to Executive Order 13045.

G. 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

Federal Register / Vol. 66, No. 92 / Friday, May 11, 2001 / Rules and Regulations 24073

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 to be used for

threshold determinations or completion

of EPCRA section 313 reports. EPCRA

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

provide the information required under

this section, the owner or operator of a

facility may use readily available data

(including monitoring data) collected

pursuant to other provisions of law, or,

where such data are not readily

available, reasonable estimates of the

amounts involved. Nothing in this

section requires the monitoring or

measurement of the quantities,

concentration, or frequency of any toxic

chemical released into the environment

beyond that monitoring and

measurement required under other

provisions of law or regulation.’’

X. Submission to Congress and the

Comptroller General

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 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 rule 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: February 28, 2001.

Elaine G. Stanley,

Director, Office of Information Analysis and

Access.

Therefore, 40 CFR Part 372 is

amended as follows:

PART 372—[AMENDED]

1. The authority citation for part 372

continues to read as follows:

Authority: 42 U.S.C. 11013 and 11028.

§ 372.65 [Amended]

2. Section 372.65(c) is amended by

adding the following parenthetical to

the chromium compounds listing

‘‘(except for chromite ore mined in the

Transvaal Region of South Africa and

the unreacted ore component of the

chromite ore processing residue (COPR).

COPR is the solid waste remaining after

aqueous extraction of oxidized chromite

ore that has been combined withsoda

ash and kiln roasted at approximately

2,000 °F.).’’

[FR Doc. 01–11918 Filed 5–10–01; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Part 3160

[WO–310–1310–PB–01–24 1A]

RIN 1004–AC54

Oil and Gas Leasing; Onshore Oil and

Gas Operations

AGENCY: Bureau of Land Management.

ACTION: Correcting amendment.

SUMMARY: The document contains

corrections to the amendatory

instructions of the final regulations on

protecting Federal and Indian oil and

gas resources from drainage published

in the Federal Register on January 10,

2001, (66 FR 1883) and delayed on

February 8, 2001, (66 FR 9527).

DATES: Effective April 10, 2001.

FOR FURTHER INFORMATION CONTACT:

Donnie Shaw, Fluids Minerals Group,

Bureau of Land Management, Mail Stop

401LS, 1849 ‘‘C’’ Street, NW.,

Washington, DC 20240; telephone (202)

452–0382 (Commercial or FTS). Persons

who use a telecommunications device

for the deaf (TDD) may call the Federal

Information Relay Service at 1–800–

877–8339, between 8 a.m. and 4 p.m.,

Eastern time, Monday through Friday,

excluding Federal holidays.

SUPPLEMENTARY INFORMATION: We are

clarifying the amendatory instructions

for the current regulations under

Sections 3162.2 and 3165.3. The

amendment for Section 3162.2,

paragraph (c), indicates that more than

one entity may hold interest in a lease

or own operating rights.

List of Subjects

43 CFR Part 3160

Government contracts, Hydrocarbons,

Land Management Bureau, Mineral

royalties, Oil and gas exploration,

Public lands-mineral resources,

Reporting and recordkeeping

requirements.

Dated: May 1, 2001.

Piet deWitt,

Acting Assistant Secretary, Land and

Minerals Management.

Accordingly, the Federal Register

issue of January 10, 2001 is corrected as

follows:

1. On page 1892, in the third column,

correct the amendatory instruction 12.b

for § 3162.2 to read as follows:

b. Removing in paragraph (c) the

phrase ‘‘the operating rights owner’’ and

adding in its place the phrase ‘‘the

lessee(s) and operating rights owner(s)’’;

(Note: § 3162.2(c) was redesignated as

§ 3162.2–1(b))

2. On page 1894, in the second

column, renumber instructions 13. and

14. as 15. and 16. respectively.

[FR Doc. 01–11877 Filed 5–10–01; 8:45 am]

BILLING CODE 4310–84–M