27266 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

waste, or require you to meet additional

conditions to claim a conditional

exemption, for serious or repeated

noncompliance with any requirement(s)

of subpart N of this part.

§ 266.360 If you lose the transportation

and disposal conditional exemption for a

waste, can the exemption be reclaimed?

(a) You may reclaim the

transportation and disposal exemption

for a waste after you have received a

return receipt confirming that we have

received your notification of the loss of

the exemption specified in § 266.355(a)

and if:

(1) You again meet the conditions

specified in § 266.315 for the waste; and

(2) You send a notice, by certified

delivery, to us that you are reclaiming

the exemption for the waste. Your

notice must be signed by your

authorized representative certifying that

the information provided is true,

accurate, and complete. The notice

must:

(i) Explain the circumstances of each

failure.

(ii) Certify that each failure that

caused you to lose the exemption for the

waste has been corrected and that you

again meet all conditions for the waste

as of the date you specify.

(iii) Describe plans you have

implemented, listing the specific steps

that you have taken, to ensure that

conditions will be met in the future.

(iv) Include any other information you

want us to consider when we review

your notice reclaiming the exemption.

(b) We may terminate a reclaimed

conditional exemption if we find that

your claim is inappropriate based on

factors including, but not limited to: you

have failed to correct the problem; you

explained the circumstances of the

failure unsatisfactorily; or you failed to

implement a plan with steps to prevent

another failure to meet the conditions of

§ 266.315. In reviewing a reclaimed

conditional exemption under this

section, we may add conditions to the

exemption to ensure that transportation

and disposal activities will protect

human health and the environment.

[FR Doc. 01–11408 Filed 5–15–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 261 and 268

[FRL–6975–2]

RIN 2050–AE07

Hazardous Waste Identification Rule

(HWIR): Revisions to the Mixture and

Derived-From Rules

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: Today’s action finalizes the

retention of the mixture rule and the

derived-from rule in the Resource

Conservation and Recovery Act (RCRA),

with two revisions. The mixture and

derived-from rules ensure that

hazardous wastes that are mixed with

other wastes or that result from the

treatment, storage or disposal of

hazardous wastes do not escape

regulation and thereby cause harm to

human health and the environment.

EPA is finalizing two revisions to the

mixture and derived-from rules. These

revisions would narrow the scope of the

mixture and derived-from rules,

tailoring the rules to more specifically

match the risks posed by particular

wastes. The first revision is an

expanded exclusion for mixtures and/or

derivatives of wastes listed solely for the

ignitability, corrosivity, and/or

reactivity characteristics. The second

revision is a new conditional exemption

from the mixture and derived-from rules

for ‘‘mixed wastes’’ (that is, wastes that

are both hazardous and radioactive).

DATES: These final regulations are

effective on August 14, 2001.

ADDRESSES: Supporting materials are

available for viewing in the RCRA

Information Center (RIC), located at

Crystal Gateway I, First Floor, 1235

Jefferson Davis Highway, Arlington, VA.

The Docket Identification Number is F–

2001–WHWF–FFFFF. The RIC is open

from 9 a.m. to 4 p.m., Monday through

Friday, excluding federal holidays. To

review docket materials, it is

recommended that the public make an

appointment by calling 703 603–9230.

The public may copy a maximum of 100

pages from any regulatory docket at no

charge. Additional copies cost $0.15/

page. The index and some supporting

materials are available electronically.

See the ‘‘Supplementary Information’’

section for information on accessing

them.

FOR FURTHER INFORMATION CONTACT: For

general information, contact the RCRA

Hotline at 800 424–9346 or TDD 800

553–7672 (hearing impaired). In the

Washington, DC, metropolitan area, call

703 412–9810 or TDD 703 412–3323.

For more detailed information on

specific aspects of this rulemaking,

contact Tracy Atagi, Office of Solid

Waste 5304W, U.S. Environmental

Protection Agency, 1200 Pennsylvania

Avenue, NW., Washington, DC 20460–

0002, 703–308–8672,

atagi.tracy@epa.gov.

SUPPLEMENTARY INFORMATION: The index

and many of the supporting materials

are available on the Internet. You can

find these materials at <http://

www.epa.gov/epaoswer/hazwaste/id/

hwirwste/index.htm>.

Affected Entities

Entities potentially affected by this

action are generators of industrial

hazardous waste, and entities that treat,

store, transport and/or dispose of these

wastes. This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action.

SIC code NAICS code List of potentially affected US Industrial Entities

Revision to 40 CFR 261.3 Definition of hazardous waste

2800 ........................................................ 32xxxx .................................................... Chemicals & allied products manufacturing.

2819 ........................................................ Five possible codes ............................... Industrial inorganic chemicals manufacturing.

2821 ........................................................ 325211 ................................................... Plastics materials & resins manufacturing.

2833 ........................................................ 325411 ................................................... Medicinal chemicals & botanicals manufacturing.

2834 ........................................................ 325412 ................................................... Pharmaceutical preparations manufacturing.

2851 ........................................................ 32551 ..................................................... Paints & allied manufacturing.

2869 ........................................................ Five possible codes ............................... Industrial organic chemicals manufacturing.

2879 ........................................................ 32532 ..................................................... Pesticides & agricultural chemicals manufacturing.

3089 ........................................................ Four possible codes .............................. Plastics products manufacturing.

3241 ........................................................ 32731 ..................................................... Hydraulic cement products manufacturing.

3479 ........................................................ Four possible codes .............................. Fabricated metal coating & allied services

3711 ........................................................ Five possible codes ............................... Motor vehicle & passenger car bodies manufacturing.

4212 ........................................................ 562111 & 562112 .................................. Local trucking services (industrial waste shipment).

4953 ........................................................ Five possible codes ............................... Refuse (industrial waste) treatment/disposal services.

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27267

SIC code NAICS code List of potentially affected US Industrial Entities

7389 ........................................................ 36 possible codes .................................. Business services.

7532 ........................................................ 811121 ................................................... Auto repair & auto paint shops.

9511 ........................................................ 92411 ..................................................... Waste management.

9711 ........................................................ 811121 ................................................... National security (military bases).

Explanatory Notes:

(1) SIC= 1987 Standard Industrial Classification system (US Department of Commerce’s traditional code system last updated in 1987).

(2) NAICS= 1997 North American Industrial Classification System (US Department of Commerce’s new code system as of 1997).

(3) Refer to the Internet website http://www.census.gov/epcd/www/naicsdev.htm for additional information and a cross-walk table for the SIC

and NAICS codes systems.

This table lists those entities that EPA

believes could be affected by this action,

based on industrial sectors identified in

the economic analysis in support of this

final rule. A total of about 120 entities

are expected to benefit from the

proposed revisions to 40 CFR 261.3 in

the 17 industrial sectors listed above,

but primarily in the chemicals and

allied products sector (i.e., SIC code 28,

or NAICS code 325). Other entities not

listed in the table also could be affected.

To determine whether your facility is

regulated by this action, you should

examine 40 CFR parts 260, 261 and 268

carefully in concert with the amended

rules found at the end of this Federal

Register document. If you have

questions regarding the applicability of

this action to a particular entity, consult

the persons listed in the preceding FOR

FURTHER INFORMATION CONTACT section.

ACRONYMS

Acronym Definition

3MRA ........................................................................................................ Multimedia, Multipathway and Multireceptor Risk Assessment

APA ........................................................................................................... Administrative Procedures Act

BDAT ........................................................................................................ Best Demonstrated Available Technology

CERCLA ................................................................................................... Comprehensive Environmental Response, Compensation and Liability

Act

CFR .......................................................................................................... Code of Federal Regulations

CMA .......................................................................................................... Chemical Manufacturers Association

CWA ......................................................................................................... Clean Water Act

DOT .......................................................................................................... Department of Transportation

EPA ........................................................................................................... Environmental Protection Agency

HSWA ....................................................................................................... Hazardous and Solid Waste Amendments of 1984

HWIR ........................................................................................................ Hazardous Waste Identification Rule

ICR ............................................................................................................ Information Collection Request

IRIS ........................................................................................................... Integrated Risk Information System

LDR ........................................................................................................... Land Disposal Restriction

LLMW ....................................................................................................... Low Level Mixed Wastes

LLRWDF ................................................................................................... Low Level Radioactive Waste Disposal Facility

MACT ........................................................................................................ Maximum Achievable Control Technology

NPDES ..................................................................................................... National Pollution Discharge Elimination System

NRC .......................................................................................................... Nuclear Regulatory Commission (NRC)

NTTAA ...................................................................................................... National Technology Transfer and Advancement Act

OMB .......................................................................................................... Office of Management and Budget

ORD .......................................................................................................... Office of Research and Development

OIRM ........................................................................................................ Office of Information and Resources Management

OSW ......................................................................................................... Office of Solid Waste

OSWER .................................................................................................... Office of Solid Waste and Emergency Response

PBMS ........................................................................................................ Performance Based Measurement System

QA/QC ...................................................................................................... Quality Assurance / Quality Control

RCRA ........................................................................................................ Resource Conservation Recovery Act

RFA ........................................................................................................... Regulatory Flexibility Act

RfD ............................................................................................................ Reference Dose

RfC ............................................................................................................ Reference Concentration

RIC ............................................................................................................ RCRA Docket Information Center

SBREFA ................................................................................................... Small Business Regulatory Enforcement Fairness Act

TC ............................................................................................................. Toxicity Characteristic

TCLP ......................................................................................................... Toxicity Characteristic Leaching Procedure

TDD .......................................................................................................... Telecommunications Device for the Deaf

TSDF ........................................................................................................ Treatment, Storage, and Disposal Facility

UMRA ....................................................................................................... Unfunded Mandates Reform Act

UTS ........................................................................................................... Universal Treatment Standards

Outline

Background

I. What law authorizes these rules?

II. Which hazardous waste identification

rules is EPA finalizing today?

III. What is the legal history of these rules?

IV. How do the final rules compare to those

proposed on November 19, 1999?

V. When will the final rules become

effective?

VI. What other changes to the hazardous

waste identification rules is EPA

continuing to pursue?

27268 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

Major Comments

VII. What were the major comments on

retaining the mixture and derived-from

rules, and how has EPA responded to

them?

A. Need for the mixture and derived-from

rules

B. Legality of the mixture and derived-from

rules

C. Regulatory cost of the mixture and

derived-from rules

VIII. What were the major comments on the

revision to 40 CFR 261.3 to exclude

wastes listed solely for ignitability,

corrosivity, and/or reactivity, and how

has EPA responded to them?

A. Eligibility of waste listed for the toxicity

characteristic

B. Toxicity of wastes listed for ignitability,

corrosivity, and/or reactivity

C. Eligibility of F003 solvents for this

exclusion

D. Applicability of Land Disposal

Restrictions (LDRs) to excluded wastes

E. Applicability of contained-in policy to

excluded wastes

IX. What were the major comments on the

revision to 40 CFR 261.3 for mixed

wastes, and how has EPA responded to

them?

X. What were the major comments on the

proposals submitted by the Chemical

Manufacturers Association (CMA), and

how has EPA responded to them?

A. Expanding the current headworks

exclusion

B. Excluding hazardous waste leachate

C. Excluding hazardous waste aggressive

biological treatment residues

D. Excluding hazardous waste combustion

residues

E. Expanding the current de minimis

exclusion

State Authorization

XI. How will today’s regulatory changes be

administered and enforced in the States?

Administrative Requirements

XII. How has EPA fulfilled the administrative

requirements for this rulemaking?

A. Executive Order 12866: Determination

of Significance

B. Regulatory Flexibility Act

C. Paperwork Reduction Act (Information

Collection Request)

D. Unfunded Mandates Reform Act

E. Executive Order 13132: Federalism

F. Executive Order 13175: Consultation

and Coordination with Indian Tribal

Governments

G. Executive Order 13045: Protection of

Children from Environmental Health

Risks and Safety Risks

H. National Technology Transfer and

Advancement Act of 1995

I. Executive Order 12898: Environmental

Justice

J. Congressional Review Act

Technical Correction

XIII. What technical correction is EPA

making in today’s rulemaking?

Background

I. What Law Authorizes These Rules?

These rules are promulgated under

the authority of Sections 2002(a), 3001,

3002, 3004, and 3006 of the Solid Waste

Disposal Act of 1970, as amended by the

Resource Conservation and Recovery

Act of 1976 (RCRA), as amended by the

Hazardous and Solid Waste

Amendments of 1984 (HSWA), 42

U.S.C. 6912(a), 6921, 6922, 6924, 6926.

II. Which Hazardous Waste

Identification Rules Is EPA Finalizing

Today?

Today, EPA is finalizing retention and

revision of the mixture and derivedfrom rules, previously set forth in 40

CFR 261.3(a)(2)(iii), 261.3(a)(2)(iv) and

261.3(c)(2)(i), and proposed at 64 FR

63382 (November 19, 1999). The

mixture and derived-from rules are a

part of the RCRA rules that define

which wastes are considered to be

hazardous and therefore subject to

RCRA Subtitle C rules. The mixture and

derived-from rules identify as hazardous

those wastes that originate from RCRA

hazardous waste listed under 40 CFR

part 261 (referred to as ‘‘listed

hazardous wastes’’). Under the mixture

rule, a mixture of a solid waste with one

or more listed hazardous wastes is a

hazardous waste. Under the derivedfrom rule, any solid waste generated

from the treatment, storage, or disposal

of a listed hazardous waste remains

regulated as a hazardous waste. These

derived-from wastes include wastes

such as sludges, spill residues, ash,

emission control dust, and leachate

generated from listed hazardous wastes.

The mixture and derived-from rules

that are being finalized today include

two revisions to these rules. For the first

revision, we have narrowed the

applicability of the derived-from rules

by excluding derivatives of wastes listed

solely for the characteristics of

ignitability, reactivity, and/or

corrosivity when they no longer exhibit

any characteristic of hazardous waste.

Mixtures of wastes listed solely for the

characteristic of ignitability, reactivity,

and/or corrosivity which no longer

exhibit any characteristic of hazardous

waste continue to be excluded under

today’s rules. In summary, under

today’s final rules, all wastes listed

solely for an ignitability, reactivity and/

or corrosivity characteristic (including

mixtures, derived-from and as generated

wastes) are excluded once they no

longer exhibit a characteristic.

For the second revision, we are also

finalizing a conditional exemption for

certain low-level mixed waste (i.e.,

waste that is both radioactive and

hazardous) from the mixture and

derived-from rules, provided the mixed

waste is handled in accordance with 40

CFR part 266, Subpart N. This Subpart,

which is being published as a final rule

elsewhere in today’s Federal Register,

explains the eligibility requirements for

this exemption, and includes several

conditions and requirements for the

exempted waste.

III. What Is the Legal History of These

Rules?

EPA promulgated the mixture and

derived-from rules in 1980 as part of the

comprehensive ‘‘cradle to grave’’

requirements for managing hazardous

waste. 45 FR 33066 (May 19, 1980).

Numerous industries that generate

hazardous wastes challenged the 1980

mixture and derived-from rules. In

December 1991, the D.C. Circuit Court

of Appeals vacated the rules because

they had been promulgated without

adequate notice and opportunity to

comment. Shell Oil Co. v. EPA, 950 F.

2d 741 (D.C. Cir. 1991). The court,

however, suggested that EPA might

want to consider reinstating the rules

pending full notice and comment in

order to ensure continued protection of

human health and the environment.

In response to this decision, we

promulgated an emergency rule

reinstating the mixture and derivedfrom rules as interim final rules without

providing notice and opportunity to

comment. 57 FR 7628 (March 3, 1992).

We also promulgated a ‘‘sunset

provision’’ which provided that the

mixture and derived-from rules would

remain in effect only until April 28,

1993. Shortly after, we published a

proposal containing several options for

revising the mixture and derived-from

rules. See 57 FR 21450 (May 20, 1992).

The May 1992 proposal and the time

pressure created by the ‘‘sunset

provision’’ generated significant

controversy. In response, Congress

included in EPA’s fiscal year (FY) 1993

appropriation several provisions

addressing the mixture and derivedfrom rules. Public Law No. 102–389,

106 Stat. 1571. First, Congress nullified

the sunset provision by providing that

EPA could not promulgate any revisions

to the rules before October 1, 1993, and

by providing that the reinstated

regulations could not be ‘‘terminated or

withdrawn’’ until revisions took effect.

However, to ensure that we could not

postpone the issue of revisions

indefinitely, Congress also established a

deadline of October 1, 1994 for the

promulgation of revisions to the mixture

and derived-from rules. Congress made

this deadline enforceable under RCRA’s

citizen suit provision, section 7002.

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27269

1However, under 40 CFR 268.7(a)(7)(a) generator

must still put a one-time notification in the facility

files describing the waste generation, regulatory

exclusion, and disposition of the waste(s).

According to 40 CFR 268.7(a)(8), this notification

must be kept for at least three years.

On October 30, 1992, we published

two notices, one removing the sunset

provision, and the other withdrawing

the May 1992 proposal. (See 57 FR

49278, 49280). We had received many

comments criticizing the May 1992

proposal. The criticisms were due, in a

large part, to the very short schedule

imposed on the regulation development

process itself. Commenters also feared

that the proposal would result in a

‘‘patchwork’’ of differing State programs

because some states might not adopt the

revisions. This fear was based on the

belief that States would react in a

negative manner to the proposal and

refuse to incorporate it into their

programs if finalized. Finally, many

commenters also argued that the risk

assessment used to support the

proposed exemption levels failed to

provide adequate protection of human

health and the environment because it

evaluated only the risks of human

consumption of contaminated

groundwater and ignored other

pathways that could pose greater risks.

Based on these concerns, and based on

EPA’s desire to work through the

individual elements of the proposal

more carefully, we withdrew the

proposal.

Subsequently, a group of waste

generating industries challenged the

March 1992 action that reinstated the

mixture and derived-from rules without

change. Mobil Oil Corp. v. EPA, 35 F.3d

579 (D.C. Cir. 1994). The court rejected

this challenge, holding that the fiscal

year (FY) 1993 appropriations act made

the challenge moot because it prevented

both us and the courts from terminating

or withdrawing the interim rules before

we revised them, even if we failed to

meet the statutory deadline for the

revisions.

We did not meet Congress’ October 1,

1994 deadline for revising the mixture

and derived-from rules. In early October

1994, several groups of waste generating

and waste managing industries filed

citizen suits to enforce the October 1

deadline for revising the mixture and

derived-from rules. Two of the cases

were consolidated and a third was

dismissed with the plaintiffs being

added as intervenor to the consolidated

cases. Environmental Technology

Council v. Browner, C.A. No. 94–2119,

94–2436 (TFH) (D.D.C.). The U.S.

District Court for the District of

Columbia entered a consent decree

resolving the consolidated cases. The

consent decree, as subsequently

amended, required the Administrator to

sign a proposal to revise the mixture

and derived-from rules by November 13,

1995 and a notice of final action on the

proposal by February 13, 1997, and it

also specified that the deadlines in the

1992 appropriations act do not apply to

any rule revising the separate

regulations that establish jurisdiction

over media contaminated with

hazardous wastes. On November 13,

1995, the Administrator signed the

proposed Hazardous Waste

Identification Rule to revise the mixture

and derived-from rules, which was

published in the Federal Register on

December 21, 1995. (60 FR 66344). It

proposed a set of exemption levels for

hundreds of hazardous constituents,

many of which were based on a

complex multipathway risk assessment.

The notice also proposed to revise the

derived-from rule to exclude wastes

listed because they exhibited the

characteristics of ignitability, corrosivity

and/or reactivity from the definition of

hazardous waste, and solicited comment

on the concept of providing a separate

exemption for hazardous wastes mixed

with low level radioactive wastes.

We received extensive comments,

many critical, on the 1995 proposal,

particularly with respect to the

scientific risk assessment supporting the

proposed concentration-based

exemption from the mixture and

derived-from rules. As a result of the

comments, we concluded that

considerable work needed to be done to

resolve the complex scientific and

technical issues raised. On April 11,

1997, the District Court entered an order

amending the consent decree in

Environmental Technology Council v.

Browner. The amended decree provided

us with additional time to perform

further scientific risk assessment work

and required us to ask for comment on

specific issues. On November 19, 1999,

we published a proposal requesting

comment on revisions to the mixture

and derived-from rules, and discussed

and requested comment on the issues

specified in the consent decree. Today’s

final rulemaking completes our legal

obligation regarding revisions to the

mixture and derived-from rules.

IV. How Do the Final Rules Compare to

Those Proposed on November 19, 1999?

As we proposed, we are retaining both

the mixture and derived-from rules, and

the revisions to those rules that we are

finalizing today are for the most part the

same as those we proposed in November

1999. Our rationale and basis for today’s

final rulemaking is set forth in Sections

VII, VIII, and IX of this preamble.

The first revision amends the

regulations under 40 CFR 261.3 for

wastes listed in 40 CFR part 261,

subpart D solely because they exhibit a

characteristic of hazardous waste. Under

current regulations, such listed wastes

as generated or treated are considered

hazardous under RCRA Subtitle C, even

when the waste does not exhibit a

characteristic, unless they are delisted.

However, mixtures are considered nonhazardous if the waste no longer

exhibits any characteristic.

In the November 19, 1999 notice, we

proposed to amend the scope of and

expand the applicability of the current

exclusion. The notice proposed a

clarifying change to the scope of the

exclusion to include those wastes listed

in part 261, subpart D only for a

characteristic of ignitability corrosivity,

or reactivity. The notice also proposed

to expand the applicability of the

exclusion so all these materials would

be excluded from hazardous waste

regulation if they are decharacterized

and meet the appropriate treatment

standards. The notice stated that most of

the currently regulated waste eligible for

this exclusion is listed as F003, but

would also include certain K-, P- and Ulisted wastes (See 64 FR 63390–63391,

November 19, 1999).

The exclusion applies when a

generator determines that the waste,

whether as generated or after treatment,

does not exhibit any characteristic. This

exclusion is self implementing, with no

additional recordkeeping and reporting

requirements.1 EPA is finalizing this

exclusion as it was proposed. With

respect to the applicability of land

disposal restrictions (LDR) in Part 268,

EPA is clarifying that when a waste has

been listed solely because it exhibits a

characteristic of ignitability, corrosivity,

and/or reactivity AND that waste does

not exhibit any hazardous waste

characteristic at the point of generation,

then that waste is not subject to the LDR

requirements. Wastes that are

characteristic at the point of generation

and then are subsequently

decharacterized are still subject to LDR

requirements. For information on the

major public comments and EPA’s

responses and rationale for this

exclusion, please see Section VIII of this

preamble. For discussion of the LDR

issue in particular, please see Section

VIII.D.

The second revision to the mixture

and derived-from rules involves mixed

waste (i.e., wastes that are both

hazardous and radioactive). Under this

revision, mixed waste is conditionally

exempt from the mixture and derivedfrom rules, provided the mixed waste is

27270 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

2An ‘‘exemption level’’ in this context is a

specific chemical concentration. If all chemicals in

a waste are below their exemption levels, then the

waste would be considered non-hazardous.

handled in accordance with 40 CFR part

266, Subpart N.

The regulatory language in 40 CFR

part 266, Subpart N, which we are

promulgating in a separate final rule

published elsewhere today,

conditionally exempts hazardous waste

mixed with low-level radioactive wastes

(low-level mixed wastes/LLMW) from

the storage, treatment in tank,

transportation, and disposal

requirements of RCRA. In addition,

hazardous waste mixed with Naturally

Occurring and/or Accelerator-produced

Radioactive Material (NARM mixed

waste) can be exempted from

transportation and disposal

requirements. The Nuclear Regulatory

Commission (NRC) or its Agreement

State licensed LLMW generators can

store, or treat LLMW in storage tanks

without RCRA Subtitle C permits if all

exemption conditions are met. Treated

LLMW or NARM mixed waste could be

disposed at a low level radioactive

waste disposal facility (LLRWDF)

regulated by the NRC or its Agreement

State if all exemption conditions are

met. The rationale for conditionally

exempting LLMW from the mixture and

derived-from rules is the same as that

for creating the conditional exemption

from the RCRA regulatory definition of

hazardous waste for LLMW.

We are largely finalizing the mixed

waste exemption from the mixture and

derived-from rules as proposed.

However, to address public comments

on the need for more clarity of this

exemption, we have revised the

regulatory language and have moved it

to its own subsection (40 CFR 261.3(h)).

As used in section 261.3(h), the term

‘‘eligible radioactive mixed waste’’

refers to hazardous waste containing

radioactive waste that meets the

eligibility criteria and conditions of part

266, subpart N. In addition, we have

made some changes to the new Subpart

N from what we proposed. Those

changes are explained in the mixed

waste final rule, published elsewhere in

the Federal Register today. For

information on the public comment

regarding the exemption, and EPA’s

responses please see Section IX of this

preamble.

V. When Will the Final Rules Become

Effective?

Today’s rules become effective August

14, 2001. Pursuant to section 3010(b)(1)

of RCRA, the Administrator finds that

the regulated community does not need

six months to come into compliance

with today’s rulemaking, because

today’s action retains rules already in

effect, and expands an exclusion that

reduces regulatory burden.

VI. What Other Changes to the

Hazardous Waste Identification Rules

Is EPA Continuing To Pursue?

EPA continues to pursue an

exemption from hazardous waste

management that we discussed in the

November 19, 1999 HWIR Federal

Register notice (64 FR 63382). That

exemption, also known as the

Hazardous Waste Identification Rule

(HWIR) exemption, would exempt listed

hazardous wastes that meet chemicalspecific exemption levels 2 from the

definition of hazardous waste. The

HWIR exemption would help address

concerns that the mixture and derivedfrom rules result in over-regulation,

since listed hazardous waste remains

under Subtitle C jurisdiction regardless

of constituent concentration or presence

in the waste, either before or after

treatment. This concern was

exacerbated with the passage of HSWA

in 1984. HSWA set Land Disposal

Restrictions (LDR) requiring best

demonstrated available technology

(BDAT) treatment for all listed

hazardous wastes prior to disposal. In

cases where a specific listed

wastestream contained relatively

innocuous constituents, or very low

concentrations, BDAT treatment

requirements were felt to be overly

protective, and unnecessarily expensive.

The Agency believes that an HWIR

exemption process would help reduce

the potential over-regulation of low risk

hazardous waste while, at the same

time, reducing the time and resource

burden on industry and government. An

exemption process would also reduce

the burden on the ongoing delisting

program. In the 1995 HWIR proposal,

we estimated cost savings ranging from

$75 million to $99 million, based on

exemption levels proposed at that time.

Given that the modeling for exemption

levels is undergoing major revision, it is

not possible at this time to estimate the

cost savings from a future constituentbased exemption.

We plan to develop the HWIR

exemption levels based on results from

the Multi-media, Multi-pathway and

Multi-receptor risk assessment (3MRA)

Model. The model evaluates

simultaneous chemical exposures across

several environmental media and

multiple exposure pathways to human

and ecological receptors in order to

estimate the health and ecological

effects in the vicinity of waste disposal

units that may receive exempt listed

hazardous waste. We presented the

underlying methodology and

assumptions for the 3MRA Model in the

Federal Register (64 FR 63382,

November 19, 1999). However, because

of technical difficulties arising from the

complexity of the modeling effort, we

were unable to propose exemption

levels in that notice. Since then, we

have made numerous revisions to

correct and improve the model.

On July 18, 2000, EPA made available

in a Notice of Data Availability (NODA)

the model results for 36 chemicals,

using an updated version of the model

(65 FR 44491). The NODA, and

referenced background information

placed in the docket, explained

technical changes made to the model

since the November 19, 1999 Federal

Register notice. Finally, the NODA

extended the comment period for the

November 19, 1999 HWIR exemption

discussion until October 16, 2000.

We are currently reviewing the public

comments and will decide if further

revisions to the HWIR risk assessment

(3MRA) model are necessary. We also

are continuing independent testing and

external peer review of the HWIR risk

assessment model.

In addition to the HWIR risk

assessment, the November 19, 1999

Federal Register notice discussed

options for implementing the HWIR

exemption. We also plan to review the

comments relating to implementation.

Before using the revised risk assessment

to support a final rulemaking on the

HWIR exemption, we will publish a

proposal to allow public comment on a

unified package.

In another effort to better calibrate

risk and regulatory standards, the

Agency is also developing two targeted

exemptions from the hazardous waste

mixture and derived-from rules: one for

certain solvents destined for wastewater

treatment and discharge under the Clean

Water Act, and another for slagged

combustion residues from hazardous

waste combustors. Other targeted

exemptions are being assessed for later

development (see Section X of this

preamble for further discussion). We

also plan to continue on-going efforts to

streamline the existing delisting

process.

Major Comments

VII. What Were the Major Comments on

Retaining the Mixture and DerivedFrom Rules, and How Has EPA

Responded to Them?

EPA received several dozen

comments on the issue of retaining the

mixture and derived-rules for both the

1995 and 1999 HWIR proposals. Below

is a summary of three major issue areas

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27271

raised in the comments, and EPA’s

responses. For more detailed comment

responses, please see Hazardous Waste

Identification Rule: Revisions to the

Mixture and Derived-From Rules

Response to Comments Document.

A. Need for the Mixture and DerivedFrom Rules

(1)(a) Summary of the Comments on the

Need for the Mixture and Derived-From

Rules

EPA received comments from 38

commenters in response to both the

1995 and the 1999 HWIR proposals

specifically concerning the necessity of

the mixture and derived-from rules. Of

those comments, 14 were received from

industry, seven were from industry

associations, eight were from State

Agencies, five were from waste

management companies, two were from

waste management associations, one

was from a Federal Agency and one was

from a consultant.

The States and waste management

associations supported the retention of

the mixture and derived-from rules,

while the industry commenters

generally believed that the mixture and

derived-from rules were unnecessary. A

summary of the specific issues raised by

commenters is provided below.

Twelve commenters explicitly

supported the retention of the mixture

and derived-from rules. Many of the

State commenters said that the rules

were necessary to capture mixtures and

derivatives of listed hazardous wastes in

the universe of regulated hazardous

wastes in order to protect human health

and the environment. The commenters

noted that without these rules, it would

be possible to alter a particular waste to

the point that it no longer meets the

listing description without detoxifying,

immobilizing, or otherwise actually

treating the waste. One industry

association commenter also supported

the retention of the mixture and

derived-from rules, noting that although

it is not a perfect solution, the approach

has been used for the last 15 years in a

generally effective manner.

One waste management association

commenter also strongly supported the

retention of the mixture and derivedfrom rules. The commenter believed the

mixture and derived-from rules were

necessary because they prevented many

wastes that clearly were hazardous and

that posed substantial threats to human

health and the environment from

escaping RCRA controls only because

they are mixtures or derivatives that no

longer fit an original listing description.

The commenter noted that generators

send their listed hazardous wastes to

treatment facilities for initial treatment

to reduce the toxicity and/or mobility of

some, but not all, toxic constituents in

the waste. The commenter also agreed

that EPA’s experience with delisting

petitions further supported the rationale

for the mixture and derived-from rules.

Twenty-six commenters did not

support the retention of the mixture and

derived-from rules. Some asserted that

eliminating the derived-from rule would

be a common sense reform of RCRA to

reduce unnecessary over-regulation of

many wastes. Many industry

commenters and industry associations

commented that the mixture and

derived-from rules unnecessarily

continue to regulate low-risk material

resulting in significant waste

management costs with no associated

environmental benefit, thus also

affecting the credibility of EPA. Several

of the comments cited EPA’s 1992

HWIR proposal, saying that ‘‘millions of

tons of mixtures and derived-from

residuals that must be managed as

hazardous waste * * * may actually

pose quite low hazards.’’ (57 FR 21451,

May 20, 1992). The Department of

Defense acknowledged the need to

retain the mixture and derived-from

rules; however, the commenter noted

that the mixture and derived-from rules

have been a source of over-regulation for

low-risk wastes.

Several commenters asserted that the

mixture and derived-from rules have no

continued viability, particularly in light

of the technological advances that have

developed since the rules were first

promulgated in 1980. They noted that

since 1980, the regulated community

has made considerable improvements in

the treatment, storage, and disposal of

hazardous waste. In their view, the

result is that the risks that formerly may

have been associated with the

management of hazardous waste have

been reduced significantly or

eliminated, such that the universe of

waste that may have warranted Subtitle

C regulation in 1980 has been reduced

significantly. Six commenters agreed

with the U.S. Court of Appeals

observation in Shell Oil Co. v. EPA, 590

F.2d 741, 752 (D.C. Cir. 1991) that, ‘‘the

derived-from rule becomes

counterintuitive as applied to processes

designed to render wastes

nonhazardous. Rather than presuming

that these processes will achieve their

goals, the derived-from rule assumes

their failure.’’ Commenters also noted

that the hazardous waste characteristics,

particularly the Toxicity Characteristic,

would continue to ensure proper

management of high risk wastes under

RCRA.

Several commenters stated that when

compared to established standards, a

waste material is either hazardous or it

is not and it is not necessary to consider

the origin of the material. The

consultant noted that the mixture rule is

completely unnecessary and isn’t

scientifically appropriate because if the

compound or element in the waste

needs to be controlled in a certain

environment, it doesn’t matter what the

source is. Therefore, a regulation should

set the limit for that environment for

that compound or element and the

mixture and derived-from rules should

be eliminated. One commenter believed

that the continued inflexible application

of the mixture and derived-from rules

has served only to bring to light the selfdefeating complexity of the program.

(1)(b) EPA Response To Comments on

the Need for the Mixture and DerivedFrom Rules

EPA acknowledges that the mixture

and derived-from rules apply regardless

of the concentrations and mobilities of

hazardous constituents in the waste. We

have implemented and will continue to

pursue actions to reduce any

overregulation of low-risk wastes arising

from the mixture and derived-from

rules. Nevertheless, EPA believes that

retention of the mixture and derivedfrom rules are necessary to ensure

protection of human health and the

environment. When EPA determines

that a waste should be listed as

hazardous, we consider several different

factors, including the toxicity of the

chemicals in the waste, the persistence

of those toxic chemicals, and the degree

to which the chemicals bioaccumulate

in the environment. As discussed

below, the act of mixing a hazardous

waste with another waste, or storing,

treating, and disposing of that waste

does not necessarily remove the hazard

posed by these toxic chemicals. Under

RCRA, EPA has an obligation to ensure

that the risk posed by a hazardous waste

is controlled from the cradle to the

grave. Both the mixture and derivedfrom rules are needed to make sure that

this obligation is carried out.

Concerns About Deliberate Evasion

When EPA originally promulgated the

mixture and derived-from rules in 1980,

one of our main concerns was that,

without these rules, generators could

deliberately evade regulation by taking

advantage of a ‘‘loophole’’ in the

hazardous waste identification process.

(45 FR 33084, 33095 (May 19, 1980)).

Specifically, we believed that without

the mixture and derived-from rules,

generators could potentially alter their

waste so that it no longer meets the

27272 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

3The Revised Air Characteristic Study (EPA 530–

R–99–019a) published August 1999 suggests that

potential risks emanating from wastewaters

managed in wastewater treatment tanks may be of

regulatory concern and may represent a regulatory

gap because of the existing exclusions for

wastewater treatment units from control

requirements.

4The current federal National Pollution Discharge

Elimination System (NPDES) program under the

CWA does not require permitting authorities to

issue permits for discharges of wastewater to

groundwater (See 40 CFR 122.1 and 122.2). The

exception is those instances in which a discharge

to surface water may occur via a hydrologic

connection between a groundwater and surface

water. In addition, some states have chosen to

exceed federal program requirements and do issue

such permits. See also U.S. EPA NDPES. Permit

Writers’ Manual, United States Environmental

Protection Agency, Office of Water, December 1996.

EPA–833–B–96–003.

listing description without detoxifying,

immobilizing, or otherwise effectively

treating the waste.

Despite the progress that has been

made in environmental compliance in

the past twenty years, this concern

remains, and the comments of EPA’s coregulators, the State governments, echo

this continuing concern. EPA agrees

with those industry comments that

claim many companies are more

environmentally aware and responsible

than they were in the past. However,

there will always be some entities who

might try and exploit gaps in the

regulatory system. Absent the mixture

and derived-from rules, there would be

a potentially significant gap in the

coverage of the hazardous waste listings.

For example, without a ‘‘mixture’’

rule, generators of hazardous wastes

could potentially evade regulatory

requirements by mixing listed

hazardous wastes with other hazardous

wastes or nonhazardous solid wastes to

create a ‘‘new’’ waste that arguably no

longer meets the listing description, but

continues to pose a serious hazard.

Similarly, without a ‘‘derived-from’’

rule, hazardous waste generators and

hazardous waste treatment, storage, and

disposal facilities (TSDFs) could

potentially evade regulation by

minimally processing or managing a

hazardous waste and claiming that the

resulting residue is no longer the listed

waste, despite the continued hazards

that could be posed by the residue even

though it does not exhibit a

characteristic. A hazardous waste

regulatory system under which it could

be argued that hazardous waste could

leave the system as soon as it was

modified to any degree by being mixed

or marginally treated would be

ineffective and unworkable. Such a

system could act as a disincentive to

adequately treat, store and dispose of

listed hazardous waste.

In addition, as explained below, even

if generators or TSDFs do not

deliberately try to evade hazardous

waste regulations, certain waste

mixtures and derived-from wastes could

pose substantial present or potential

hazards if mismanaged. We, therefore,

continue to believe that the mixture and

derived-from rules are necessary to

capture wastes that would pose

unacceptable risks to human health and

the environment.

Regulating Hazardous Waste Mixtures

Mixing hazardous waste with another

waste may dilute, and sometimes mask,

the concentrations of toxic constituents

in the listed waste, but does not

necessarily address the hazards posed

by these constituents. Some of the

comments focused on diluted

wastewaters as an example of mixtures

that are potentially ‘‘low risk.’’ Of the

‘‘millions of tons’’ of waste that EPA

estimated would be exempted under the

1995 HWIR proposal because they may

pose low risks, 99% of the waste by

volume is wastewater (60 FR 66415,

December 21, 1995). Wastewaters are

generally disposed either in an

underground injection control well

regulated under the Safe Drinking Water

Act (SDWA)or to the environment under

the Clean Water Act (CWA). Because

discharged hazardous wastewaters must

meet CWA standards, some commenters

believe that these wastewater mixtures

should be excluded from hazardous

waste regulation prior to their discharge.

We have several concerns with this

argument. The management of

wastewater mixtures is already largely

exempt from most RCRA requirements.

The two main requirements that remain

under RCRA are that the wastewaters

must be managed in tanks, and the

treatment sludge must be managed as a

hazardous waste once removed from the

tank. Continued management of these

wastewaters in tanks is usually needed

to avoid infiltration to groundwater of

concentrations of toxic constituents that

pose unacceptable risks. Even when

they meet their CWA discharge limits,

mismanaged wastes could pose

unacceptable risks through the

groundwater pathway, which is not

addressed by the CWA. Sludges from

wastewater treatment need to be

managed as hazardous waste, because

they can contain the same persistent

and toxic chemicals (e.g., heavy metals)

that originated in the wastewaters. Each

of these points is discussed in more

detail below.

RCRA section 1004(27) already

excludes industrial wastewater

discharges subject to CWA section 402

regulation from the definition of ‘‘solid

waste’’ under RCRA. See also, 40 CFR

261.4(a)(2). In addition, wastewater

treatment units, as defined in 40 CFR

260.10 (i.e., tanks), are excluded from

almost all RCRA regulation (see 40 CFR

264.1(g)(6); 265.1(c)(10); and

270.1(c)(2)(v)). RCRA has historically

deferred to the Clean Water Act and its

oversight in properly regulating

hazardous wastewaters discharged by

CWA wastewater treatment systems or

other point sources subject to CWA

discharge requirements, including

storage in wastewater treatment units

prior to discharge. However, with the

exception of sewage sludge, the CWA

does not apply to sludges which are a

byproduct of wastewater treatment. To

the extent treatment of listed hazardous

wastewaters generates sludges, those

sludges are considered hazardous by the

derived-from rule (as discussed below).

Furthermore, to the extent that

additional hazards may be associated

with wastewaters managed in such

systems (including risks via inhalation

pathway and risks via groundwater

ingestion when treatment takes place in

surface impoundments),3 the Agency

considers such wastes as hazardous and

within RCRA jurisdiction until

discharged. While wastewaters must

meet CWA requirements at the point of

discharge, they can still have high

concentrations of constituents during

the management of the waste.

Even after hazardous wastewaters

have been treated to meet CWA

standards, they could still have the

potential to pose unacceptable risks to

human health and the environment

when managed in surface

impoundments or other retention ponds

(or otherwise managed on the land, i.e.,

during a spill) prior to discharge to the

receiving water body. Both surface

impoundments and retention ponds can

have high potential for discharge of the

wastewaters they contain to underlying

groundwater (see RCRA sections

1002(b)(7) and 3005(j)). Discharge

treatment requirements based on State

water quality standards are calculated

by taking the nature of the effluent and

the receiving water body into account.

An effluent treated to meet water quality

standards for a surface water body could

leach into groundwater, depending on

the hydrogeology of the site, if

subsequently held in a surface

impoundment or retention pond prior to

discharge. This leachate could undergo

a lesser degree of dilution in

groundwater than in the intended

surface water body, potentially posing

unacceptable risks to groundwater users

through a drinking water well. This risk

is not accounted for under the current

federal CWA standards.4 Therefore, EPA

continues to believe that retaining

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27273

5These wastes would still be subject to the

hazardous waste characteristics of 40 CFR Part 261,

Subpart C, but, as explained later in this preamble

section, such coverage would not address all the

unacceptable risks potentially posed by the

chemicals in these wastes.

6 Development Document for Final Effluent

Limitations Guidelines and Standards for the

Landfills Point Source Category, EPA–821–R–99–

019, U.S. EPA, January 2000.

7These wastes would still be subject to the

hazardous waste characteristics of 40 CFR Part 261,

Subpart C, but, as explained later in this preamble

section, such coverage would not address all the

unacceptable risks potentially posed by the

chemicals in these wastes.

jurisdiction over hazardous wastewaters

under RCRA prior to their NPDESpermitted discharge is necessary to

ensure protection of human health and

the environment.

Another reason why these

wastewaters should not be categorically

designated as non-hazardous prior to

discharge is because that would

effectively exclude their treatment

sludges as well (by avoiding the

application of the derived-from rule).5

As explained below in more detail,

treatment sludges from these dilute

wastes cannot be assumed to be low

risk. In fact, treatment sludges can

contain high levels of the very

chemicals (e.g., heavy metals) that

caused the original waste to be listed. In

these cases, the hazard that was

identified as the original basis of listing

has not been removed; it has merely

been transferred to another type of

waste matrix (i.e., from a water to a

solid).

In sum, EPA has excluded (through

the wastewater treatment unit

exclusions) hazardous wastewaters from

regulation where we believe there is a

reasonable basis to do so, grounded in

the protection of human health and the

environment, and the statute excludes

from RCRA jurisdiction industrial

wastewater discharges subject to CWA

discharge permits. But based on the

available data, EPA believes that a

blanket wastewater exclusion from

regulation is not warranted. Instead,

EPA will continue to develop

approaches (e.g., targeted exemptions

and HWIR exemption levels) to address

wastewaters that are be considered low

risk.

Regulating Derived-From Wastes

As explained in 40 CFR 261.3(c)(2)(i),

any solid waste derived from the

treatment, storage, or disposal of a

hazardous waste is also considered a

hazardous waste. Specific examples of

these derived-from wastes include

sludges, spill residues, ash, emission

control dust, and leachate. For derivedfrom wastes that change location but are

otherwise unmodified, the question of

their continued regulation is more

straightforward. Because such waste

would have the same levels of toxic

constituents and presumably the same

potential exposure patterns as the waste

that was evaluated for the original

hazardous listing determination, it

would pose the same unacceptable risk

as the original waste.

Other types of derived-from wastes

may have a different physical form than

the original waste, but still present the

same chemical hazard. Leachate derived

from the disposal of hazardous waste,

for example, can contain the same

chemicals as found in the original

waste. When EPA analyzed leachate for

purposes of promulgating effluent

guidelines for landfill leachate (65 FR

3007, January 19, 2000), we found that

wastewater generated as a result of a

particular industrial operation can have

a similar pollutant profile to leachate

generated by a landfill receiving the

bulk of their waste from that same

operation (65 FR 3008, 3012, January 19,

2000). During treatment, chemicals in

hazardous wastewater are transferred to

the sludge, which is disposed of in the

captive landfill. Once the sludge is

disposed in a landfill, persistent

chemicals in this sludge can then

transfer to the leachate, which, when

managed in a wastewater treatment unit,

transfers them once more to sludge.

Although changed in form, the

treatment sludge (and leachate) could

still pose similar unacceptable risks as

the originally listed waste, depending

on actual concentrations and exposure

patterns.

We also found considerable

differences between the leachate

samples from hazardous and those from

non-hazardous waste landfills in both

numbers of constituents of concern and

their concentrations. Hazardous waste

landfill leachate contained a greater

number of constituents than nonhazardous waste landfill leachate, and

constituents found in both hazardous

and non-hazardous waste landfill

leachate were generally present in

hazardous waste landfill leachate at

concentrations an order of magnitude

higher than those found in nonhazardous waste landfill leachate.6

Absent a risk assessment, it is not

possible to determine whether the levels

of these constituents pose unacceptable

risk. However, the presence of such

constituents creates a continuing

concern regarding leachate derived from

hazardous waste.

The other broad category of derivedfrom waste are treatment residues. At

least six commenters cited the D.C.

Circuit Court of Appeals observation in

Shell Oil Co. v. EPA, 590 F.2d at 752

that ‘‘the derived-from rule becomes

counterintuitive as applied to processes

designed to render wastes

nonhazardous.’’ However, the

presumption that treatment always

renders hazardous waste nonhazardous

is overly simplistic. This presumption

does not take into account all products

of treatment. Even treatment that

operates properly is often designed to

isolate a hazardous residual. For

example, wastewater treatment designed

to produce a sufficiently clean effluent

for discharge is also designed to move

the hazardous constituents from the

wastewater into the sludge. The

resulting de-watered sludge, while

much lower in volume than the original

hazardous wastewater, has the potential

to have much greater concentrations of

hazardous chemicals. As explained

above, once the sludge is disposed in a

landfill, persistent chemicals in this

sludge can then transfer to the leachate,

which, when managed in a wastewater

treatment unit, transfers them once

more to sludge.

The derived-from rule thus ensures

that the chemicals in the originally

listed waste that are transferred to

another matrix when the waste is

managed remain under RCRA Subtitle C

control. Without the derived-from rule,

a hazardous wastewater could be treated

so that hazardous constituents are

moved to the sludge. If the generator

could claim that the resulting sludge,

regardless of chemical concentration, no

longer meets the listing description,

then that sludge could be handled as

non-hazardous waste, and placed in an

unlined industrial landfill, or sent to a

land application unit.7 The resulting

leachate would not necessarily be

collected. Instead, those chemicals that

first caused the waste to be listed could

potentially now enter the environment

and, depending on the actual chemical

concentrations and exposure patterns,

could pose unacceptable risks.

Other types of treatment, which result

in combining wastes with different

chemical concentrations, can result in

dilution of those chemicals, but may not

adequately address the hazard they

could pose. As mentioned earlier in the

discussion on regulating mixtures,

combining wastewaters for centralized

treatment is often a legitimate treatment

practice, but the diluting effect of such

treatment does not address the transfer

of persistent chemicals to the sludge.

Finally, treatment that reduces the

amount of organic chemicals in a waste

does not typically address the risk from

27274 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

8U.S. EPA Evaluation of Hazardous Waste

Delisting Program, December 2000; and Analysis of

the Delisting Petition Data Management System,

U.S. EPA, September 1998). EPA Docket 99–WH2P–

FFFFF.

9EPA 2000. Releases of Hazardous Constituents

Associated with Mixture and Derived-from Wastes

(An Update) U.S. EPA, April 2000.

metals in the waste. For example,

biological treatment and incineration,

which are among the most aggressive

forms of treatment, are designed to

reduce or destroy organic chemicals.

However, these types of treatment do

not address heavy metals and may form

chemical by-products (e.g., dioxins) that

could pose unacceptable risks, if not

managed properly. For example,

baghouses on combustion devices serve

to collect hazardous constituents that

would otherwise be emitted to the air

from the combustion process, and the

dust that is removed from the baghouses

predictably contains metals that were in

the original waste. In response to

industry comments, EPA will explore

specific approaches for dealing with

biological treatment residues and has

already begun considering an alternative

approach to address combustion

residues (See Sections X.C. and X.D. of

this preamble.) EPA will also continue

to develop approaches (e.g., targeted

exemptions and HWIR exemption

levels) to exempt other waste streams

that are currently captured by the

derived-from rules but pose low risks.

Historic Information on Mixture and

Derived-From Wastes

As we discussed in the 1999 proposal,

EPA’s experience with the delisting

program further supports retaining the

mixture and derived-from rules as a

necessary part of hazardous waste

identification. Generators can petition

EPA under 40 CFR 260.22 to exclude a

waste produced at a particular facility

from the definition of hazardous waste.

Such petitions must demonstrate that

the waste does not meet any of the

criteria for which it was listed nor has

other attributes that might result in the

waste being hazardous.

Over the 20-year period from 1980

through 1999, EPA reviewed over 900

petitions to delist wastes, and granted

delistings to 136 waste streams

generated at 115 separate facilities. Most

of the petitions (i.e., more than 600)

were withdrawn or mooted before the

review was complete; 108 were denied.

Most of these denials were based on

lack of information. In at least 13 of the

36 cases where enough information is

available in the source documentation

to determine whether a waste was a

mixture or derivative, we denied

delisting petitions for mixtures or

residuals of listed waste because risk

analyses indicated that the toxicity and

leaching potential of hazardous

chemicals in those wastes posed

unacceptable risk to human health.

These mixture and derived-from wastes

had potentially hazardous levels of a

wide range of chemicals including

barium, cadmium, chromium, lead,

mercury, nickel, benzene,

benzo(a)pyrene, cyanide, chloroform,

1,1-dichloroethane, 1,1-

dichloroethylene, 2,4-dinitrotoluene,

methylene chloride, trichloroethylene,

and vinyl chloride.8

We have also identified possible

damage cases associated with mixture

and derived-from wastes. For example,

there are Superfund sites that contain

mixture and derived-from wastes (See

50 FR 658). We have identified at least

twenty sites that may have involved the

mismanagement of mixture and derivedfrom wastes.9 The sites identified

include cases of extensive

contamination of soils and groundwater

with metals (e.g., arsenic, lead,

mercury), cyanide, and organics (e.g.,

benzene, toluene, and xylenes). It is

very difficult to identify the full range

of damage cases that specifically involve

waste mixtures or derivatives since

neither EPA nor other parties track or

categorize waste based on its status

under the mixture or derived from rules.

The legislative history of RCRA also

provides examples of damage cases

caused from disposal of mixture and

derived-from hazardous wastes. In

introducing the purpose of Subtitle C,

the House Committee on Interstate and

Foreign Commerce cited seven pages of

damage cases, stating, ‘‘The most

effective way of illustrating the dangers

of improper hazardous waste disposal is

perhaps to cite actual instances of

damage caused by current hazardous

waste disposal practices. The following

section is merely illustrative of the

problem. Far more cases could be cited,

even more have gone unreported.’’ H.R.

Rep. No. 94–1491 (94th Cong. 2d Sess.

1976) 17–23. Of the 59 instances

described in the House Committee

Report, at least 40 involved spills,

leachate or runoff from landfills,

lagoons or waste storage facilities.

Leachate and run-off are derived-from

wastes, as are spills from storage and

disposal facilities, and some of the

sources contained mixtures of

hazardous and non-hazardous solid

wastes.

Intrinsic Chemical Properties of RCRA

Hazardous Waste ‘‘Mixtures’’ and

‘‘Derived-From’’ Wastes

We also analyzed the information in

EPA’s National Hazardous Waste

Constituent Survey (NHWCS) Database

to assess the intrinsic physical and

chemical properties of RCRA hazardous

waste ‘‘mixtures’’ and ‘‘derived-from’’

wastes. The purpose of the NHWC

Survey was to collect descriptive

information about the identity and

measured concentrations of chemical

constituents contained in RCRA

hazardous wastes. The NHWCS was a

one-time, voluntary participation mail

survey we administered in 1996,

providing a single-year ‘‘snapshot’’ of

the intrinsic physical and chemical

properties of RCRA hazardous wastes. It

is EPA’s most comprehensive and

current database about hazardous waste

constituents. We benchmarked the 1996

survey to data already collected in our

1993 Biennial Reporting System (BRS)

database—which contains data provided

by the 1993 universe of RCRA

hazardous waste large quantity

generators—by pre-loading survey

questionnaires with the known 1993

BRS data for the NHWC survey

facilities, and asking facilities to verify

the known BRS data, as well as to

provide new data about the known

chemical constituents in the RCRA

hazardous wastes they managed

(constituent data are not contained in

the BRS database). This analysis is

presented as a technical supplement to

this rulemaking for purpose of public

understanding of the intrinsic nature of

these two groups of wastes, which we

currently regulate as RCRA hazardous.

This supplemental analysis corroborates

the substance of our proposed rule (64

FR 63382–63461, Nov. 19, 1999).

Although the survey results apply to

a subset of the total universe of waste

and should not be extrapolated to the

larger universe of RCRA hazardous

waste generators, the information

provides valuable insight into the types

and levels of chemicals that could be

present in such wastes. A large number

of waste streams captured in the

NHWCS were identified by their

generators as mixtures of solid waste

and hazardous waste or derived-from

hazardous wastes. The analysis revealed

that potentially hazardous chemical

constituents, have been and can be

present in wastes mixed with or

derived-from, RCRA hazardous wastes.

Although this analysis is not a

quantitative risk assessment, this

conclusion is supported by the presence

of persistent, bioaccumulative, and toxic

(PBT) chemicals in these two waste

groups, some of which are at relatively

high concentrations. Consequently, we

continue to be concerned about the

potential risks posed by the

mismanagement of RCRA hazardous

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27275

waste ‘‘mixtures’’ and ‘‘derived-from’’

wastes.

For more information about this

analysis, please see the background

document Analysis of RCRA ‘‘Mixtures

and Derived-from’’ Hazardous Waste

Constituent Data, which is available to

the public from the RCRA Docket. The

NHWCS database is available to the

public via the Internet at http://

www.epa.gov/epaoswer/hazwaste/id/

hwirwste/economic.htm.

Regulatory Coverage by the Toxicity

Characteristic

EPA also does not agree with

comments that the mixture and derivedfrom rules are not necessary because the

Toxicity Characteristic (TC) provides

regulatory coverage of these wastes. The

TC currently sets regulatory levels for

only 40 chemicals. (see 40 CFR 261.24).

On the other hand, the hazardous waste

listings are based on hundreds of

different chemicals. (see Appendix VII

to 40 CFR Part 261). In addition, the TC

levels are the result of laboratory

analyses to predict whether a waste is

likely to leach chemicals into

groundwater at hazardous levels, not the

result of a comprehensive risk

assessment. Depending on the actual

constituents in a waste and their

concentrations, wastes with constituents

that fall below TC levels can still pose

unacceptable risks to human health and

the environment if mismanaged. (55 FR

11799). EPA has listed wastes based on

the presence of constituents below the

TC levels. For example, in the final

listing decision for spent hydrotreating

and hydrorefining catalysts from

refinery operations, we analyzed the

potential risk from arsenic and benzene

using input leachate concentrations

capped at TC regulatory levels. The

results of this analysis suggested

unacceptable risks posed by these

wastestreams from concentrations below

the TC regulatory levels (63 FR 42154).

The mixture and derived-from rules are

necessary for capturing such wastes that

could pose unacceptable risks from

chemicals without TC levels and for

risks not addressed by the TC approach.

Conclusion

When EPA determines that a waste is

capable of posing a hazard to human

health or the environment when

improperly managed, that determination

is based on consideration of several

different factors, including the toxicity,

persistence, degradability in nature, the

potential of chemicals to bioaccumulate

in tissue, flammability, corrosiveness,

and other hazardous characteristics and

related factors. The act of mixing,

storing, disposing or even treating the

waste does not guarantee removal of the

hazard posed by these chemicals, nor

does it remove EPA’s obligation to

ensure that the hazards presented by the

waste continue to be controlled from the

cradle to the grave, even when it is

transferred to another waste matrix.

Nevertheless, EPA will continue to

develop approaches to exempt low-risk

wastes from full Subtitle C regulation, as

appropriate. Since the original

promulgation of the mixture and

derived-from rules, we have invited

suggestions as to better ways of

handling the difficult issues associated

with the mixing, treating, storing,

disposing, and otherwise managing

waste following its generation. See 45

FR 33095 (May, 19, 1980). We have

considered and are continuing to pursue

suggestions for targeted exemptions

(e.g., the CMA suggestions discussed at

Section X of the preamble) as well as a

risk-based exit level approach to

identifying low-risk wastes.

B. Legality of the Mixture and DerivedFrom Rules

EPA received comments in response

to both the 1995 and 1999 HWIR

proposals on RCRA Subtitle C

jurisdiction over mixtures and

derivatives from the management of

listed hazardous wastes. Of the 42

commenters who specifically

commented on the statutory authority

for these rules, 38 were received from

industry (including utilities and trade

associations), two were from waste

management companies, one was from a

waste management association and one

was from an individual commenter.

Almost all these comments expressed

the view that EPA lacked statutory

authority to promulgate these rules,

although other commenters who

generally supported retention of the

mixture and derived-from rules

expressed the view that these wastes are

properly under RCRA Subtitle C

jurisdiction.

The waste management association

agreed that EPA had statutory authority

under RCRA to promulgate the mixture

and derived-from rules in 1980, and that

EPA also had ample authority to retain

the basic rules now without change. The

commenter, citing Shell Oil Corp. v.

EPA, believed that the rules were

consistent with EPA’s legal authority

under RCRA section 3001 to determine

when wastes are hazardous based on

listing criteria, and under RCRA

sections 3002–3004 to impose

regulatory standards until wastes have

ceased to pose a hazard to the public.

As noted, most commenters expressed

the view that EPA is acting beyond its

statutory authority by retaining the

mixture and derived-from rules. These

comments asserted three main points:

(1) Mixture and derived-from wastes do

not meet the statutory definition of

hazardous under RCRA section 1004(5);

(2) EPA has not met the requirements

under section 3001, 42 U.S.C. Section

6921 and 40 CFR 261.10 and 261.11 for

designating wastes as hazardous; and (3)

EPA has no authority under sections

3002–3004 of RCRA to designate wastes

as hazardous. A summary of each of

these specific issues raised by

commenters, and EPA’s response to

these issues, is provided below. For

more information on these comments

and EPA’ responses, please see

Hazardous Waste Identification Rule:

Revisions to the Mixture and

Derived-From Rules Response to

Comments Document.

(1)(a) Comment: Mixture and DerivedFrom Wastes Do Not Meet the Statutory

Definition of Hazardous Under RCRA

Section 1004(5)

Numerous commenters from

industries, industry associations, utility

companies, utility company associations

and waste management companies

generally believed that the mixture and

derived-from rules were too broad and

swept in many wastes which did not

meet the statutory definition of

hazardous wastes, and that the derivedfrom rule in particular was not

supported by statutory authority. One

commenter even felt that the derivedfrom rule was a ‘‘legal fiction’’ because

treatment residuals must be managed as

if the treatment had not occurred.

Commenters noted that EPA only was

authorized under the Resource

Conservation and Recovery Act (RCRA)

to designate as hazardous waste those

solid wastes that EPA determined may

(1) cause, or significantly contribute to

an increase in mortality or serious

illness, or (2) pose a substantial present

or potential hazard to human health or

the environment when improperly

managed (RCRA section 1004(5), 42

U.S.C. 6903(5)). Commenters expressed

the view that EPA can regulate under

Subtitle C only those solid wastes that

EPA determined pose substantial

hazards per the language in Section

1004(5) of RCRA. Many commenters

also noted that, in their view, many of

these wastes pose minimal or no threat

to the environment and public health.

The majority of these commenters

believed that EPA made no attempt to

demonstrate that derived-from wastes

met the statutory definition of

hazardous waste. Instead, these

commenters believed EPA simply drew

conclusions that these materials were

27276 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

10U.S. EPA Evaluation of Hazardous Waste

Delisting Program, December 2000. 11Congressional report language accompanying

EPA’s FY 2001 appropriations act directs EPA to

submit the HWIR model to an independent peer

review, and respond publicly to the findings of the

peer review prior to using it to establish regulatory

determinations. S. Rep. No. 106–410 at 90 (2000) ).

EPA is currently in the process of preparing for that

peer review.

hazardous waste, even though many

derived-from wastes had not met the

statutory definition of hazardous waste.

They also noted that EPA has admitted

that many derived-from wastes pose

little risk to human health or the

environment. Therefore, they claim that

the derived-from rule was not a legally

valid approach to regulating materials

that result from the management of

hazardous waste.

(1)(b) EPA Response

While we agree that the mixture and

derived-from rules capture some waste

that may actually pose quite low hazard,

we have implemented and continue to

pursue approaches (such as today’s

revisions) to exclude such waste from

full Subtitle C regulation. Nevertheless,

these rules are a necessary component

of cradle-to-grave waste management, to

protect human health and the

environment from unacceptable risks.

EPA does not agree with comments that

mixtures and derivatives do not meet

the definition of ‘‘hazardous waste’’ in

section 1004(5) of RCRA, nor do we

agree that Congress did not intend these

wastes to be regulated under Subtitle C

of RCRA.

The definition of hazardous waste is

a broad definition which encompasses

solid wastes or combinations of solid

wastes which, because of their

‘‘quantity, concentration, or physical,

chemical, or infectious characteristics

may * * * pose a substantial present or

potential hazard to human health or the

environment when improperly treated,

stored, transported or disposed of, or

otherwise managed.’’ Because they

originate from waste that has already

been determined to be hazardous, EPA

has a reasonable basis to conclude that

mixtures and derivatives could also

pose a potential or present hazard to

human health or the environment if not

properly managed. The original listing

of the waste already establishes the

reasons, i.e., the ‘‘quantity,

concentration, or physical, chemical, or

infectious characteristics’’ for having

identified the listed waste as hazardous.

It is reasonable to conclude, without

information to the contrary, that both

mixtures and derivatives of such wastes

may pose a substantial potential or

present hazard to human health or the

environment if not properly managed,

and therefore fall under the definition of

hazardous waste in RCRA section

1004(5).

Nothing in the section 1004(5)

definition of hazardous waste requires

EPA to prove that every member of a

category of waste poses a hazard. In fact,

many waste listings describe categories

or ‘‘classes’’ of hazardous wastes

because they cover a range of materials

that are not identical in composition.

EPA also does not agree with

commenters’ assertion that wastes

derived from the treatment, storage, or

disposal of listed hazardous wastes in

particular do not meet the section

1004(5) definition. As explained in

section VII.A.2, residuals from the

treatment of hazardous wastes can

contain higher concentrations of the

chemicals that led to the hazardous

waste listing in the first place, and

therefore may pose a present or

potential hazard to human health or the

environment if improperly managed.

Indeed, the objective of many forms of

treatment is precisely to isolate and

collect hazardous constituents, often in

concentrated form, for further

management. For example, de-watering

of waste, e.g., to make it easier to

transport, is a form of treatment that

often does not significantly change the

character of the waste other than to

leave it in a more compact and

concentrated form. At the more

aggressive end of the treatment

spectrum, baghouses on hazardous

waste combustion devices collect

hazardous constituents that would

otherwise be emitted to the air from the

combustion process, creating dust that

predictably contains any metals that

were in the original wastes as well as

products of incomplete combustion.

Congress specifically expressed concern

in RCRA about treatment residues

created by federal and state pollution

control laws, RCRA 1002(b)(3). The

potential for persistent hazardous

constituents in treatment residues and

the Congressional findings in the RCRA

statute support EPA’s conclusion that

residuals from the treatment, storage

and disposal of listed hazardous waste

may pose a substantial present or

potential hazard.

EPA acknowledges that not all

mixtures and derivatives pose hazards

to human health and the environment

(see, e.g. 57 FR 21451). There are

mechanisms to address this fact, and we

are continuing to pursue approaches to

exempt low-risk wastes. First, RCRA

and EPA regulations provide for the

delisting of listed hazardous waste.

RCRA 3001(f); 40 CFR 261.20 and 40

CFR 261.22. Since the federal delisting

program took effect in 1980, EPA has

excluded an estimated 45 million tons

of waste, resulting in an estimated

cumulative cost savings between $1.1

billion and $1.3 billion dollars (in 1999

dollars). In 2000 alone, we estimate cost

savings of approximately $105.4

million.10 In the 1995 HWIR proposal,

EPA stressed the continued need for the

delisting program, although we also

acknowledged that it had not provided

an efficient solution to the regulation of

low-risk wastes. However, as discussed

in Section VIII.C of this preamble, since

the delisting program was delegated to

the EPA Regions on October 10, 1995,

a number of innovations have been

adopted that have greatly improved the

efficiency and effectiveness of the

delisting program. EPA will continue

these efforts and others in order to keep

improving the delisting process.

In addition, as EPA has identified

specific mixtures and derived-from

wastes which no longer meet the

definition of hazardous waste, and has

therefore established a number of

exclusions in 40 CFR 261.3. Currently,

there are over a dozen types of

hazardous waste mixtures and residuals

excluded or conditionally exempted

under section 261.3. See the ‘‘Table of

Revisions to 40 CFR 261.3’’ in Section

VII.C.2 of this notice for a list of these

exclusions. This is in addition to other

exclusions and conditional exclusions

set forth in 40 CFR 261.4 as well in

other parts of the hazardous waste

regulations.

Furthermore, as discussed in Section

VI of this notice, EPA is continuing

work to develop exit levels for listed

hazardous wastes, so that listed wastes

can become ‘‘delisted’’ automatically,

under a self-implementing procedure.

But, as also explained in Section VI of

this notice, that is a complex

undertaking and, despite best efforts,

EPA is not able at this time to propose

a technically supported concentrationbased exemption.11 Also, as explained

in Section X of this preamble, we are

also investigating and will actively

pursue other specific exemption

proposals.

EPA continues to believe, as it did in

1980, that it would be virtually

impossible to try to identify all possible

waste mixtures and treated wastes and

assess their hazards individually. EPA’s

rule reasonably retains jurisdiction over

both broad classes and places the

burden of proof on the regulated

community to show that a particular

waste has ceased to present a hazard.

Even if all listed hazardous waste

mixtures and derivatives could not be

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27277

said to meet the statutory hazardous

waste definition, at the very least it is

reasonable and consistent with RCRA to

presume that mixtures and derivatives

of listed hazardous wastes remain

hazardous under the definition, unless

that presumption is rebutted through

the delisting process. As discussed

further in the next section, Congress

established clear standards for

hazardous waste identification, but did

not speak specifically to the issue of the

circumstances under which mixtures

and derivatives of listed hazardous

wastes should be regulated. Under these

circumstances, EPA must interpret and

implement the statute in a way that

effectuates the statutory objectives. The

mixture and derived-from rules are the

only implementation approach that EPA

is aware of at this time that effectuates

the protective purposes of RCRA.

(2)(a) Comment: EPA Has Not Met the

Requirements Under Section 3001, 42

U.S.C. 6921 and 40 CFR 261.10 and

261.11 for Designating Wastes as

Hazardous

These commenters also disagreed

with EPA’s claim of authority under

section 3001 (60 FR at 66348, 64 FR

63390). The commenters believed that

EPA had not followed the required

procedures or made the findings

required by RCRA to identify ‘‘mixture

and derived-from wastes’’ as hazardous.

They noted that sections 3001(a) and (b)

outline a two-step process for

classifying wastes as hazardous. EPA

first must specify criteria to determine

if the waste is ‘‘hazardous,’’ 42 U.S.C.

6921(a), which is defined as presenting

a substantial present or potential hazard

to human health or the environment 42

U.S.C. 6904(5). Once the criteria are

established—as they have been in 40

CFR 261.10 and 261.11—the

commenters stated that EPA must apply

these criteria to identify a characteristic

of hazardous waste or to list a waste as

hazardous. In these commenters’ view,

the mixture and derived-from rules

identify a broad class of wastes as

hazardous without regard to the criteria

established by EPA. Also, they noted

that the proposal did not discuss how

mixtures and derived-from wastes pose

a substantial present or potential threat

to human health or the environment,

nor did EPA discuss concentration

levels, mobility, persistence, or any

other objective factors of hazardousness

that are listed in the statute or the

regulations.

In addition, numerous commenters

from industries, industry associations,

utility companies and utility company

associations disagreed with EPA

identifying mixture and derived-from

wastes as a ‘‘class’’ under 40 CFR 261.11

(60 FR at 66348, 64 FR at 66390). They

believed that such identification

required a finding that EPA had reason

to believe that individual wastes within

the class ‘‘typically or frequently are

hazardous’’ under the definition at

RCRA section 1004(5) (see 40 CFR

261.11(b)). Commenters noted that

EPA’s own longstanding practice was

that, in a class-wide listing

determination, ‘‘typically or frequently’’

meant that more than 50 percent of the

samples taken from that class exhibited

some or all of the 40 CFR 261.11(a)

criteria (see, e.g., 56 FR 48020, Sept. 23,

1991 and 45 FR 33114, May 19, 1980).

The commenters stated that EPA

historically has required that samples of

a waste class contain concentrations of

toxic constituents at 100–1000 times

specified health-based numbers to be

considered as posing a ‘‘substantial

hazard’’ under 40 CFR 261.11(a)(3) (see,

e.g., 56 FR. 48018, Sept. 23, 1991 and

57 FR 21453, May 20, 1992). They noted

that EPA generally requires that wastes

typically and frequently contain toxic

constituents at ‘‘many times’’ healthbased levels and that such constituents

be mobile and persistent. The current

proposal made no reference to these

prior practices, nor did it offer evidence

that EPA collected or analyzed any

samples or otherwise attempted to

demonstrate that 50 percent—or any

substantial percentage—of mixtures or

treatment residues met any of the

specific criteria of § 261.11(a). Also,

they commented that the proposal

offered nothing responsive to the 100–

1000 times health-based numbers

requirement. In addition, they noted

that the class must have ‘‘sufficient

uniformity’’ to apply the criteria in 40

CFR 261.11 (45 FR 33114). The

commenters felt that it was obvious that

the class of mixture and derived-from

wastes was anything but uniform, a

point admitted by EPA (45 FR 33095–

96, ‘‘the potential combinations of listed

wastes and other wastes are infinite’’).

Therefore, the class did not have the

requisite uniformity needed to be

classified as hazardous.

(2)(b) EPA Response

EPA does not agree with comments

that the Agency lacks statutory authority

under RCRA Section 3001 for either the

mixture rule or the derived-from rule.

We have the statutory authority to

promulgate these rules as part of the

authority to ‘‘develop and promulgate

criteria for identifying the

characteristics of hazardous waste and

for listing hazardous waste.’’ Among the

criteria are the provisions of 40 CFR

261.3, which provide generally

applicable criteria for the identification

of hazardous waste. The mixture and

derived-from rules are included in

section 261.3(a)(2), which states that a

solid waste is a hazardous waste if ‘‘[i]t

meets any of the following criteria.’’

These rules ensure that listed hazardous

wastes that are mixed with other wastes

or treated in some fashion do not escape

regulation as hazardous waste until EPA

has made some determination that they

no longer threaten human health or the

environment. This section also includes

the exclusions from the definition of

hazardous waste, including those

promulgated today, where EPA has

made specific findings on the record

that the excluded wastes are no longer

hazardous under the criteria set forth in

the exclusions. We will continue to

pursue additional approaches to exempt

low-risk wastes, as appropriate.

The commenters’ position rests

largely on the assumption that mixtures

and derivatives of wastes are entirely

new and distinct substances from the

originally listed waste, leading to the

apparent conclusion that EPA must

make a separate, record-based finding of

hazardousness for each of the infinite

variations of mixtures and derivatives

generated from the wastes EPA has

listed. EPA disagrees. In upholding the

‘‘contained-in policy,’’ the U.S. Court of

Appeals for the D.C. Circuit deferred to

EPA’s conclusion that a listed

hazardous waste cannot be presumed to

change character when it is mixed with

an environmental medium. Chemical

Waste Management v. EPA, 869 F.2d

1526, 1539 (1989). We believe that the

same reasoning applies to the mixture

rule. Similarly, as discussed in Section

VII.A.2, waste management residuals

can contain constituents from the

originally listed waste at even higher

concentrations than the original waste

and, therefore, may pose a hazard.

Indeed, EPA views the mixture and

derived-from rules as applications of the

general principle that ‘‘a hazardous

waste will remain a hazardous waste’’

unless it is excluded through a

regulatory process. 40 CFR 261.3(c)(1).

See Chemical Waste Management, 869

F.2d at 1539 (upholding contained-in

policy as interpretation of § 261.3(c)(1)).

EPA’s approach is consistent with

Congress’ intention that hazardous

waste be regulated for the long term

under a comprehensive regulatory

program. One of the findings upon

which the 1976 RCRA legislation was

based was that ‘‘hazardous waste

presents, in addition to the problems

associated with nonhazardous solid

waste, special dangers to health and

requires a greater degree of regulation

than does nonhazardous solid waste.’’

27278 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

Public Law No. 94–580, section 1002(5).

With enactment of the Hazardous and

Solid Waste Amendments (HSWA) in

1984, Public Law No. 98–616, Congress

strengthened that provision and added

three more findings: ‘‘the placement of

inadequate controls on hazardous waste

management will result in substantial

risks to human health and the

environment; if hazardous waste

management is improperly performed in

the first instance, corrective action is

likely to be expensive, complex , and

time consuming; certain classes of land

disposal facilities are not capable of

assuring long-term containment of

certain hazardous wastes * * *’’. RCRA

section 1002(b)(5), (6), (7). Similarly,

when RCRA was enacted in 1976,

Congress stated one of the objectives of

the Act was ‘‘regulating the treatment,

storage, transportation, and disposal of

hazardous wastes which have adverse

effects on health and the environment.’’

Public Law No. 94–580, 1003(a)(4). This

provision too was replaced with a

stronger statement by HSWA, that an

object of the statute is ‘‘assuring that

hazardous waste management practices

are conducted in a manner which

protects human health and the

environment.’’ (Emphasis added.) RCRA

1003(a)(4). Further, HSWA added as

national policy that hazardous waste

‘‘should be treated, stored, or disposed

of so as to minimize the present and

future threat to human health and the

environment.’’ RCRA 1003(b). It is clear

that Congress’ principal objective under

Subtitle C was protecting against threats

to human health and the environment

caused by hazardous waste. We

acknowledge that such a goal does not

imply that all mixtures and derivedfrom wastes must be regulated under

full Subtitle C requirements, regardless

of the potential risks they pose, but we

believe that it is reasonable to regulate

these wastes until it is shown that such

wastes do not pose a hazard.

The D.C. Circuit Court of Appeals has

characterized RCRA as establishing ‘‘a

‘‘cradle-to-grave’’ regulatory structure

overseeing the safe treatment, storage

and disposal of hazardous waste.’’

United Technologies Corp. v. EPA, 821

F.2d 714, 716 (D.C. Cir. 1987). The

mixture and derived-from rules are a

necessary part of this approach, by

maintaining jurisdiction over mixtures

and derivatives of already listed waste.

Without these rules, as explained in

Section VII.A.(2), the ‘‘cradle-to-grave’’

structure would have a major loophole,

undermining the objectives of RCRA.

The delisting provision supports the

mixture and derived-from rules as a

means to address wastes that could pose

unacceptable risks. In amending RCRA

section 3001 in 1984, Congress enacted

subsection (f) to require the Agency to

‘‘consider factors (including additional

constituents) other than those for which

the waste was listed’’ if the Agency ‘‘has

a reasonable basis to believe that such

additional factors could cause the waste

to be a hazardous waste.’’ The

legislative history shows that Congress

was concerned that both as generated

wastes and wastes resulting from

treatment were exiting the Subtitle C

system while still hazardous. ‘‘The

delisting process allows petitioners

(usually individual hazardous waste

generators or treatment facilities) the

opportunity of showing that their wastes

are significantly different—because of

treatment, or because they are generated

in a different process—from listed

wastes of the same type. * * * Under

this amendment, there would no longer

be a risk that delisting a waste means

releasing waste which may still be

hazardous from regulation.’’ H.R. Rep.

No. 98–198 Part I (May 17, 1983).

Congress made this change because it

believed that under its previously

existing delisting regulations, EPA

allowed wastes that remained hazardous

to exit the Subtitle C system. S. Rep. No.

98–284 (Oct. 28, 1983). The language

and legislative history reflect Congress’

assumption that treatment derivatives

from listed wastes would remain subject

to Subtitle C absent a delisting.

The land disposal restrictions (LDR)

provisions of the statute further

demonstrate that the mixture and

derived-from rules are consistent with

Congress’ intent. The statute authorizes

EPA to promulgate regulations

establishing levels or methods of

treatment, ‘‘if any,’’ that substantially

diminish the toxicity or mobility of the

hazardous waste, and provide that the

waste may thereafter be disposed of in

a land disposal facility that ‘‘meets the

requirements of [Subtitle C].’’ RCRA

section 3004(m). This section

demonstrates two things. (1) Congress

contemplated the possibility that there

may be hazardous wastes for which no

form of treatment would be adequate;

and (2) Congress assumed that waste

that was treated according to the

promulgated treatment standards would

nonetheless still be disposed of in a

Subtitle C (hazardous waste) facility.

This provision is at odds with the

commenters’ assertion that, once

treated, a hazardous waste becomes a

fundamentally different waste and is

unregulated unless EPA undertakes a

separate rulemaking to list the treated

waste.

Other provisions of the 1984

amendments to RCRA relating to land

disposal provide further support for the

mixture and derived-from rules. See,

e.g., section 3004(o) (establishing

minimum technological requirements

for land-based hazardous waste

management units); section 3004(p)

(establishing groundwater monitoring

requirements); section 3005(c)(3)

(requiring 5-year permit reviews for

land disposal facilities); section

3005(e)(2), (3) (establishing interim

status termination dates for certain noncompliant land disposal facilities);

section 3005(i), (j) (establishing specific

additional requirements for certain

land-based units); section 1002(b)(7)

(finding that certain classes of land

disposal facilities are not capable of

assuring long-term containment). Some

commenters suggest that treatment

residuals from listed hazardous wastes

do not remain hazardous. We believe it

is unlikely Congress would have created

such stringent requirements for land

disposal, if it intended for treatment

residuals to escape Subtitle C

regulation.

Taken to the extreme, the view that

mixtures containing listed wastes

should not be regulated as hazardous

wastes would imply that most listed

hazardous wastes, even if they reached

a management unit in ‘‘pure’’ form,

would cease to be hazardous once they

entered the unit, since most units

contain mixtures of different wastes.

However, the RCRA statute clearly

assumes that units would not only

receive, but continue to contain,

hazardous waste. See, e.g. section

3005(j)(11) and (12)(A), Moreover, the

comprehensive requirements mandated

for hazardous waste management units,

including the technical standards of

section 3004 and the permitting regime

of section 3005, could be undermined if

facilities receiving listed hazardous

wastes could argue that their

management units are subject to this

scheme only as long as they are

receiving the waste, but that they

become exempt thereafter since the

units do not contain hazardous waste.

Various provisions in RCRA appear to

contemplate that at least some

hazardous waste mixtures and

derivatives would themselves be

hazardous. See, e.g., section

3004(d)(2)(A), (B) (addressing liquid

hazardous wastes, ‘‘including free

liquids associated with any solid or

sludge,’’ suggesting that liquid

derivatives of hazardous waste would

themselves be hazardous). Another

example is the language in section

3005(b), which requires permit

applicants to provide information

regarding hazardous wastes and

‘‘combinations of * * * hazardous

waste and any other solid waste’’ to be

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27279

managed at the permitted facility, as

well as information regarding the site at

which the ‘‘products of treatment’’ of

hazardous waste will be managed.

Finally, the appropriations act

provision that EPA is implementing

with today’s rule requires that the

mixture and derived-from rules would

continue in effect while EPA developed

revisions to the regulations. Public Law

No. 102–389, 106 Stat. 1571 (October

1992). That provision instructed EPA to

‘‘promulgate revisions to paragraphs

(a)(2)(iv) and (c)(2)(i) of 40 CFR 261.3,

as reissued on March 3, 1992 * * *’’.

Congress expressed no intent that these

rules be rescinded or replaced.

We also disagree with commenters’

assertion that the mixture and derivedfrom rules violate the ‘‘two-step

process’’ of section 3001(a) and (b) for

hazardous waste identification. It is true

that the statute requires EPA to

promulgate criteria for hazardous waste

identification (section 3001(a)) and,

based on those criteria, to identify

characteristics of hazardous waste and

to list hazardous wastes (section

3001(b)). In general, EPA has done this

in separate steps. See 40 CFR part 261,

Subpart B (criteria) and Subparts C and

D (characteristics and lists). However,

the statute does not preclude EPA from

creating self-implementing criteria, as

EPA has done with the mixture and

derived-from rules. EPA does not

interpret 3001(b) as imposing an

obligation on EPA to undertake a

separate waste identification rulemaking

step following the development of selfimplementing criteria. Alternatively, the

mixture and derived-from rules could be

viewed as a simultaneous exercise of

EPA’s 3001(a) and 3001(b) authority.

Nothing in the statute prevents EPA

from simultaneously, in combined

regulations, establishing the criteria for

waste identification, and identifying the

characteristics of hazardous waste and

listing waste.

We agree with commenters who point

out that EPA has not used the class

listing process under 40 CFR 261.11(b)

to list mixtures and derived-from wastes

as a class. However EPA does not agree

that mixtures and derivatives must be

individually listed or identified as

hazardous wastes before being subject to

Subtitle C jurisdiction. As previously

stated, mixtures and derivatives are

identified as hazardous waste by virtue

of containing or coming from wastes

that have been listed pursuant to the

criteria in 40 CFR 261.11. EPA cannot

presume that the hazardous constituents

that are the basis of the original listing

are always eliminated or rendered

nontoxic simply because a waste is

mixed with other wastes or managed in

some fashion.

(3)(a) Comment: EPA Has No Authority

Under Sections 3002–3004 of RCRA To

Designate Wastes as Hazardous

Several commenters from industries,

industry associations, utility companies,

utility company associations and waste

management companies also disagreed

with EPA’s claim of authority under

sections 3002–3004 of RCRA. They

argued that these sections of RCRA

provide for hazardous waste

management standards for generators,

transporters, and treatment, storage and

disposal facilities, not for identifying

hazardous wastes. Instead, that role is

unambiguously carried out by section

3001. 42 U.S.C. 6921, and in previous

promulgations and in litigation, EPA

relied primarily on section 3001 to

justify the mixture and derived-from

rules.

(3)(b) EPA Response

In citing sections 3002–3004 in the

discussion of EPA’s statutory authority,

we did not intend to imply that these

sections by themselves provide statutory

authority for the mixture and derivedfrom rules. Rather, our intent was to

explain that these sections inform the

process of identifying hazardous waste

under section 3001 because the purpose

of identifying a solid waste as hazardous

is to ensure that it is managed properly.

The statute directs EPA to regulate

hazardous waste generators (section

3002(a)), hazardous waste transporters

(section 3003(a)), and hazardous waste

treatment, storage, and disposal

facilities (section 3004(a)) ‘‘as necessary

to protect human health and the

environment.’’ It is our view that this

informs the decision of when waste

should be identified as hazardous and

therefore subject to the regulatory

requirements of Subtitle C . In deciding

whether to identify a waste as

hazardous under section 3001, EPA

considers whether Subtitle C controls

on the waste are necessary to protect

human health and the environment. We

have therefore consistently interpreted

section 3001 to give us broad flexibility

in fashioning criteria for hazardous

wastes to enter or exit the Subtitle C

regulatory system. See, Military Toxics

Project v. EPA, 146 F.3d 948, 958 (D.C.

Cir. 1998). As discussed above, this

interpretation is consistent with the

statutory purpose of protecting human

health and environment by establishing

a comprehensive hazardous waste

regulatory program. (RCRA sections

1002, 1003).

In addition to providing the context in

which the determination of whether a

waste ‘‘should be subject to the

requirements of Subtitle C,’’ sections

3002–3004 allow us to continue to

impose requirements on waste handlers

until wastes have ‘‘cease[d] to pose a

hazard to the public.’’ Shell Oil Co. v.

EPA, 959 F.2d 741, 754 (D.C. Cir. 1991).

See also Chemical Manufacturers Assoc.

v. EPA, 919 F.2d 158, 162–65 (D.C. Cir.

1990) (EPA may regulate the disposal of

nonhazardous wastes in a hazardous

waste impoundment under section

3004) and Chemical Waste

Management, Inc. v. EPA, 976 F.2d 2, 8,

13–14 (D.C. Cir. 1992) (EPA may require

further treatment of wastes under

section 3004 even though they cease to

exhibit a hazardous characteristic).

Without the mixture and derived-from

rules, EPA could not effectively carry

out its obligation under sections 3002–

3004 to protect human health and the

environment. Thus, in addition to the

specific authority of section 3001, the

mixture and derived-from rules are

authorized under section 2002(a)(1),

which empowers the Administrator to

‘‘prescribe * * * such regulations as are

necessary to carry out his functions’’

under RCRA.

C. Regulatory Cost of the Mixture and

Derived-From Rules

(1) Summary of Comments on the

Regulatory Cost of the Mixture and

Derived-From Rules

EPA received comments from five

commenters in response to both the

1995 and the 1999 HWIR proposals

concerning the regulatory cost of the

mixture and derived-from rules. Of

those comments, four were received

from industries, and one was from an

industry association. The commenters

generally argued that the rules

constituted over-regulation of low-risk

wastes causing high costs and heavy

burdens with little benefit to human

health and the environment. A summary

of the specific issues raised by

commenters is provided below.

One industry commenter argued that

the rules have added significant costs to

the operation of manufacturing facilities

throughout the nation, while providing

insignificant benefits to human health

and the environment. The commenter

noted that the generation of large

quantities of hazardous wastewaters

based solely on the practice of efficient,

centralized wastewater treatment has

led the company to evaluate the

segregation of hazardous and nonhazardous wastewaters, to prevent the

attachment of a ‘‘hazardous’’ label to

those non-hazardous wastewaters. Such

a segregation would require a second

treatment facility and much re-piping,

27280 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

12U.S. EPA Evaluation of Hazardous Waste

Delisting Program, December 2000.

with the net result that millions of

dollars would be expended and there

would be no improvement in the

wastewaters ultimately discharged to

the environment through two, rather

than one, discharge points. All that

would be achieved is an apparent

reduction in hazardous waste generation

which does not, in reality, represent a

decrease in waste generation, treatment

or discharge, but rather a reporting game

and artificial waste minimization driven

by EPA requirements. It is this kind of

‘‘game’’ that compromises the

credibility of both EPA and the

regulated community and imposes a

significant burden on the regulated

community.

Another industry commenter noted

that managing the residuals as if they

were listed hazardous waste was

significantly more expensive than

managing the waste in accordance with

solid waste regulations. For example, in

1995 transportation and disposal of ash

from a hazardous solids incinerator cost

approximately $185,000. In comparison,

the ash could be managed in a state

permitted Subtitle D landfill as nonhazardous waste for about $25,000.

Another industry stated that these rules

have resulted in significant expense that

has diverted resources away from

greater environmental opportunities.

One association commenter stated

that the rules frequently cause waste

codes to be carried through and applied

to wastes that are fundamentally

different from the original waste

considered in the development of the

listing classification. The commenter

noted that there are many instances in

which the risk associated with the

original listed waste simply does not

carry through in the same way, and that

the composition and nature of any risk

posed by these materials often bears

little or no relationship to the original

listed waste. Specific examples cited

include (1) Wastewaters where most of

the arsenic has been precipitated and

removed, (2) debris from hazardous

waste refractories undergoing repair,

and (3) wastewaters that had received

ethylene oxide as part of an emergency

incident. The costs and impacts of this

automatic waste-code carry-through are

quite significant. Much of the industry

operates through smaller ‘‘batch’’

processes, while the regulations are

crafted for a continuous manufacturing

process. And, in many operations,

delisting the mixture is not an option,

as the facility can only store the mixture

on-site for 90 days, which is not enough

time for a delisting.

An industry association also stated

that the costs imposed by the rules from

a number of member companies are easy

to identify: on-site storage costs,

paperwork and administrative costs,

higher shipping and transportation

costs, and higher treatment, storage and

disposal costs. And, these are the same

types of costs analyzed and tallied by

EPA in documenting the cost savings it

attributes to the modified exemption for

hazardous wastes listed solely for a

characteristic of ignitability, corrosivity

and/or reactivity. The commenter also

stated that another significant cost of the

current regulatory regime was the extra

time and effort required to evaluate and

apply the rules in the real world. Even

after 20 years, facilities still have

difficulty evaluating when, whether and

why certain waste streams must be

managed as Subtitle C hazardous wastes

under this approach.

2. Response to Comments on Regulatory

Cost of the Mixture and Derived-From

Rules

We agree that the mixture and

derived-from rules have captured wastes

that could safely be managed outside of

RCRA Subtitle C regulation. As

explained below, we have addressed

specific cases of such over-regulation

through targeted rulemaking in the past,

and we will continue to explore options

for exempting wastes that do not

warrant Subtitle C regulation. However,

we do not agree that hazardous waste

regulation of mixture and derived-from

waste provides no additional protection

of human health and the environment.

For example, as we discuss in Section

VII.A, wastewaters prior to discharge

may contain constituents at levels that

could pose unacceptable risks if they are

mismanaged. Furthermore, the mixture

and derived-from rules address crossmedia transfer of persistent hazardous

chemicals from the wastewater to the

treatment sludge.

One way of reducing the regulatory

burden available to individual waste

generators is the delisting process.

Generators have the option of

petitioning the Agency under 40 CFR

260.20 and 40 CFR 260.22 to exclude

their wastes from the lists of hazardous

wastes in subpart D of part 261 if they

believe those wastes no longer pose risk

to human health and the environment.

Since the delisting program was

delegated to the EPA Regions on

October 10, 1995, a number of

innovations have been adopted that

have greatly improved the efficiency

and effectiveness of the delisting

program. In particular, EPA Region VI’s

award-winning program has created a

process that produces a decision within

an average of 180 days, provides a

streamlined application checklist,

proactively coordinates with State

personnel, and includes a user-friendly,

stand-alone software program that

produces an updated, state-of-the art

assessment of risks associated with

delisting a petitioned waste. In addition,

EPA and the applicant now work

together to develop an initial

application that can be approved

without the need for major revisions,

which is a major factor in reducing the

processing time. EPA will continue

these efforts and others in order to keep

improving the delisting process. Since

1980, EPA has excluded an estimated 45

million tons of waste, resulting in an

estimated cumulative cost savings

between $1.1 billion and $1.3 billion (in

1999 dollars). In 2000 alone, we

estimate cost savings of approximately

$105.4 million.12

In addition, EPA has taken steps since

the mixture and derived-from rules were

promulgated in 1980 to further reduce

the scope, and therefore the cost, of

these rules when appropriate. As one

commenter to the 1999 proposal pointed

out, eighteen months after the original

mixture and derived from rules, EPA

promulgated the first of several

exclusions for low-risk waste from the

definition of hazardous waste. Over the

past twenty years, EPA has developed

exclusions and/or tailored regulations to

reduce the regulatory cost for more than

a dozen types of hazardous waste

mixtures and residuals. (see table

below)

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27281

13Agency for Toxic Substances and Disease

Registry. (1990). Draft Toxicological Profile for

Ethylene Oxide.

14National Institute for Occupational Safety and

Health. (1989). Ethylene Oxide Sterilizers in Health

Care Facilities, Engineering Controls and Work

Place Practices. DHHS (NIOSH) No. 89–115.

REVISIONS TO 40 CFR 261.3 THAT HAVE REDUCED THE REGULATORY COST OF THE MIXTURE AND DERIVED-FROM

RULES

CFR citation Hazardous waste(s) affected Year promulgated (FR citation)

40 CFR 261.3(a)(2)(iv)(A) and (B) ..................... Certain solvents managed in wastewater

treatment systems.

1981 (46 FR 56582)

40 CFR 261.3(a)(2)(iv)(C) .................................. Certain petroleum wastes discharged to the

refinery oil recovery sewer.

1981 (46 FR 56582) Additional wastes added

in 1998 (63 FR 42184)

40 CFR 261.3(a)(2)(iv)(D) .................................. De minimis losses of commercial chemical

product.

1981 (46 FR 56582)

40 CFR 261.3(a)(2)(iv)(E) .................................. Certain laboratory wastewaters ....................... 1981 (46 FR 56582)

40 CFR 261.3(a)(2)(iv)(F) and (G) .................... Certain carbamate wastewaters ...................... 1995 (60 FR 7848)

40 CFR 261.3(a)(2)(v) ....................................... Used oil ............................................................ 1992 (57 FR 41611)

40 CFR 261.3(c)(2)(ii)(A) ................................... Certain waste pickle liquor sludges ................. 1984 (49 FR 23284)

40 CFR 261.39(c)(2)(ii)(B) ................................. Wastes derived from burning certain oil-bearing wastes as fuel.1987 (52 FR 11819)

40 CFR 261.3(c)(2)(ii)(C) ................................... Wastes derived from high temperature metals

recovery of certain hazardous wastes.

1992 (57 FR 37263)

40 CFR 261.3(c)(2)(ii)(D) ................................... Certain types of biological treatment sludge ... 1995 (60 FR 7848)

40 CFR 261.3(c)(2)(ii)(E) ................................... Certain types of catalyst inert support media .. 1998 (63 FR 42184)

40 CFR 261.3(f) ................................................. Certain types of debris contaminated with a

hazardous waste.

1992 (57 FR 37264)

In each of these revisions to 40 CFR

261.3, EPA considered the case-specific

circumstances of the waste affected and,

through the formal rulemaking process,

determined that these wastes merited

special consideration under the

hazardous waste identification rules. In

many cases, these wastes still warranted

enough concern to impose specific

management and other implementation

requirements. For example, the solvent

exclusions in 40 CFR 261.3(a)(2)(iv)(A)

and (B) require that (1) these wastes are

managed in a system the discharge of

which is subject to regulation under

either section 402 or section 307(b) of

the Clean Water Act, and (2) the total

weekly usage of these solvents divided

by the average weekly flow of the

wastewater into the treatment works

would not exceed a specific regulatory

level (either 1 ppm or 25 ppm).

Under today’s final rule, EPA has

continued the effort to reduce the

burden from the mixture and derivedfrom rules where appropriate by

excluding wastes listed solely for

ignitability, corrosivity, and/or

reactivity, once the waste no longer

exhibits any of the hazardous waste

characteristics (40 CFR 261.3(g)). We are

also finalizing a conditional exemption

for mixed waste from the mixture and

derived-from rules, provided the mixed

waste is handled in accordance with 40

CFR part 266, Subpart N. (40 CFR

261.3(h))

Finally, over the past twenty years

EPA has promulgated numerous rules

establishing exclusions or conditional

exemptions from the solid and

hazardous waste definitions, and from

regulatory requirements for particular

wastes and management practices.

These exemptions are part of EPA’s

overall effort to avoid unnecessary

regulation of waste.

EPA plans to continue work on other

types of hazardous waste exemptions,

including the additional targeted

exemptions for certain categories of

wastes and management practices, and

the concentration-based exemptions

(HWIR exemption) discussed in the

November 19, 1999 proposal. We also

plan to continue on-going efforts to

streamline the existing delisting

program.

In regard to the specific examples of

over-regulation claimed by one

commenter (see comment # WH2P–

00035, page 10), it is difficult for EPA

to fully evaluate these cases without

more specific data. For example, in the

case of wastewaters where most of the

arsenic has been precipitated and

removed, it is not clear whether there

are any other hazardous constituents of

concern in the treatment sludge, and

whether the residual arsenic might still

pose a risk (depending on waste volume

and management method). In the case of

contaminated bricks from hazardous

waste refractories undergoing repair, it

would appear that the exclusion for

debris [40 CFR 261.3(f)] could address

this concern. Finally, for wastewaters

that had received ethylene oxide as part

of an emergency incident, while it is

true that ethylene oxide eventually

breaks down to ethylene glycol, this

reaction is not instantaneous. When

released into water, ethylene oxide will

primarily be lost by three processes:

volatilization, hydrolysis and

biodegradation. The half-lives of these

reactions range from a few hours to up

to 20 days.13 Ethylene oxide itself is

toxic, and if these wastewaters were

automatically considered nonhazardous, they could present a

substantial risk, depending on actual

concentrations and exposure patterns.

Both low level chronic exposure and

acute high levels of ethylene oxide can

lead to a broad spectrum of neurological

effects. Also, inhalation studies have

shown that exposure to ethylene oxide

can result in a wide range of

carcinogenic effects, and NIOSH

considers ethylene oxide to be a

potential occupational carcinogen.14

Therefore, EPA does not agree that such

a mixture should be automatically

excluded from hazardous waste

regulation. More importantly, since the

purpose of this rulemaking is not to

evaluate individual wastestreams, EPA

does not believe this example

demonstrates that the mixture and

derived-from rules themselves are

unnecessary as a general matter.

EPA understands that the RCRA

regulations, in particular the waste

identification regulations, can be

difficult to understand. We have

attempted to use plain language in

drafting today’s revised regulatory

language, and will continue to make

regulatory language more accessible to

readers in the future. In addition, we

believe that the mixture and derivedfrom rules are more straightforward than

the alternative of having to evaluate

each combination and permutation of

27282 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

listed waste on a case-by-case basis. We

believe this alternative would create

uncertainty for the regulated

community, state agencies, the public,

and the courts, as various stakeholders

press conflicting views as to whether a

particular waste does or does not

continue to meet the listing description.

VIII. What Were the Major Comments

on the Revision to 40 CFR 261.3 To

Exclude Wastes Listed Solely for

Ignitability, Corrosivity, and/or

Reactivity, and How Has EPA

Responded to Them?

Most commenters generally supported

revisions to 40 CFR 261.3 to various

degrees. Chemical-producing industries

as well as Federal government agencies

who commented were unanimous in

support. Most states supported the

proposed revisions to the rules to

varying degrees. Below are summaries

of the major comment issue areas for

this proposed exclusion. For more

detailed comment responses, please see

Hazardous Waste Identification Rule:

Revisions to the Mixture and DerivedFrom Rules Response to Comments

Document.

A. Eligibility of Waste Listed for the

Toxicity Characteristic

(1) Comments on Eligibility of Waste

Listed for the Toxicity Characteristic

EPA received comments from 12

commenters in response to both the

1995 and the 1999 proposals concerning

inclusion of wastes listed solely for the

toxicity characteristic in the expanded

exclusion. Of those comments, four

were received from industry, two were

from industry associations, four were

from utility companies or utility

company associations, one was from a

Federal Government Agency, and one

was from an industry consultant. A

summary of the specific issues raised by

commenters is provided below.

While supporting the proposed

exclusion, these commenters urged EPA

to modify the proposal so the exclusion

would apply to wastes listed due to any

of the four characteristics, including the

toxicity characteristic. Commenters

asserted that it was not logical to limit

the exclusion for derived-from wastes to

three of the four characteristics,

regardless of the fact that no listed

wastes are listed solely on the basis of

the toxicity characteristic. One

commenter stated that it appears as if

EPA suspects that wastes containing TC

constituents below the toxicity

characteristic are not really safe. A few

commenters noted that in the future,

wastes that may be listed solely for the

toxicity characteristic should be eligible

for the exclusion. Another commenter

also noted that the proposed regulatory

language does not provide for any

additional hazardous waste

characteristics that might be

promulgated in the future. Commenters

suggested that EPA replace references to

ignitability, corrosivity, and reactivity in

the proposed regulatory language for 40

CFR 261.3(g) with references to any

characteristic of hazardous waste

identified in subpart C, reflecting the

approach and language used in the

current mixture rule.

Several commenters noted that EPA

did not offer an explanation for omitting

wastes listed solely because they exhibit

the characteristic of toxicity from

eligibility for the proposed exclusions

that would be granted by 40 CFR

261.3(g). EPA did explain that, since no

listings to date have been based on the

toxicity characteristic, EPA was

proposing to limit the new revision to

the derived-from rule to wastes listed

because they exhibit only the

characteristics of ignitability,

corrosivity, or reactivity. However, the

commenters believed it is confusing to

give no explanation for proposing the

elimination of an existing exclusion

from the mixture rule, even if no wastes

now exist that are eligible for the

exclusion. Therefore, the commenters

recommended that the preamble for the

final rule contain such an explanation.

(2) EPA Response to Comments on the

Eligibility of Waste Listed for the

Toxicity Characteristic

EPA does not agree that wastes listed

solely for the toxicity characteristic (TC)

should be eligible for the exclusion. As

we discussed in the 1995 HWIR

proposal, wastes may still pose some

risk concerns even when TC

constituents are present below TC levels

(60 FR 66369, December 21, 1995).

The hazards that the TC regulation

addresses, carcinogenicity and chronic

chemical toxicity via contaminated

groundwater/drinking water, have fewer

clear thresholds than the other

characteristics. Wastes that exhibit the

characteristics of ignitability, corrosivity

or reactivity typically pose acute

hazards which can be addressed by

application of appropriate treatment to

decharacterize the waste. For example,

ignitable liquid waste or waste chemical

oxidizers can be treated by combustion,

and the ash treatment residue poses no

ignitability threat to landfills. Similarly,

strong acid or basic wastes, if effectively

neutralized, generate residues that pose

no threat of skin damage. Waste

explosives or highly reactive chemicals

that are denatured or reacted-out under

controlled conditions also generate

residues that pose no explosion or

reaction threat.

The TC chemicals have less clear

thresholds below which they pose little

or no hazard for several reasons. Toxic

chemicals pose a risk that is typically

dependent on a range of factors, and

assessment of hazard from toxicity is

much more complex, and involves

many more variables, than assessment

of hazard from the other three

characteristics. A waste that does not

exhibit the toxicity characteristic for a

particular chemical may nonetheless

pose a substantial hazard depending on

such factors as the volume of the waste,

the exposure route being assessed, and

the amount of dilution and attenuation

that is assumed prior to exposure. These

factors, along with others, are taken into

account in making hazardous waste

listing determinations based on toxicity.

See 40 CFR 261.11((a)(3). In addition, as

persistent chemicals move through the

environment, they can accumulate,

posing long-term chronic risks even at

levels below those set for the toxicity

characteristic. Thus, the toxicity

characteristic is not designed to capture

all of the wastes that might present a

substantial hazard for the TC

constituents. Rather, the TC is designed

to capture wastes that may pose a

substantial hazard, without the need to

conduct a waste-specific risk

assessment. In fact, when EPA

promulgated the TC regulation, we

stated that the regulation is intended to

identify ‘‘* * * broad classes of wastes

which are clearly hazardous * * *’’. We

also noted that ‘‘wastes that do not

exhibit the hazardous waste

characteristics are not necessarily nonhazardous.’’ (55 FR 11799, March 29,

1990). In identifying TC hazardous

wastes as ‘‘clearly hazardous’’ the

agency was identifying a universe of

wastes that it believed may pose high

enough risk so as to always require

classification as hazardous. In noting

that non-TC wastes are not necessarily

non-hazardous, the agency both

recognized the non-threshold (i.e.,

continuous) nature of TC constituent

risks, and recognized that wastes falling

just below the TC values may pose risks

that are just below a ‘‘clearly

hazardous’’ designation, and which may

sometimes warrant classification as

hazardous. EPA has in fact listed wastes

based on toxicity where the waste did

not fail the TCLP for the constituent of

concern. (see, for example, the final

petroleum waste listing, 63 FR 42154

(August 6, 1998)).

EPA’s decision to not exclude wastes

listed solely for the TC could potentially

affect the regulation of certain inorganic

wastes that EPA has recently proposed

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27283

to list as hazardous. (65 FR 55684,

September 14, 2000). The issue had

been purely theoretical before that point

because no waste had ever been listed

for the TC. In the inorganics listing

determination proposal, however, EPA

proposed to list baghouse filters from

antimony oxide production for the TC.

Despite the fact these wastes fail the TC

for lead and arsenic, they are not always

being managed as Subtitle C hazardous

waste, nor are these wastes always

treated to the appropriate LDR

standards. By listing them, we would

clarify their regulatory status. In the

preamble to the inorganics listing

proposal, EPA noted that proposed

revisions to the mixture and derivedfrom rules did not include an exclusion

for wastes listed for the TC (65 FR

55705). EPA did not receive any public

comments in response to this discussion

in the Inorganics Listing proposal.

B. Toxicity of Wastes Listed for

Ignitability, Corrosivity, and/or

Reactivity

(1) Comments on Toxicity of Wastes

Listed for Ignitability, Corrosivity, and/

or Reactivity

EPA received two comments in

response to the 1999 proposal

concerning the potential toxicity of

waste under the proposed expanded

exclusion to the mixture and derivedfrom rules. One was from a waste

management association and one from a

State agency. A summary of the specific

issues raised by commenters is provided

below.

The commenters believed that EPA

must evaluate the properties carefully,

especially the toxicity, of the 29

compounds proposed to be excluded.

They assert that some of these wastes

are acutely hazardous and merit a

thorough review to ensure that the

exclusion is appropriate. The waste

management association noted that EPA

had not performed an evaluation of the

negative environmental impact

associated with eliminating these codes.

Ignitable, corrosive, and reactive wastes

could contain substantial levels of toxic

constituents that could be low enough

not to exhibit a characteristic of

ignitability, corrosivity or reactivity, yet

high enough to cause environmental

damage. One damage case or Superfund

site can cause damages far in excess of

the $4.6 million estimated savings

predicted by EPA. The waste

management association further argued

that EPA’s Hazardous Waste

Characteristics Scoping Study (Nov. 15,

1996) identified numerous gaps in the

current RCRA identification of

characteristic wastes. The commenter

believed that gaps were so serious that

EPA should not be proposing to

eliminate any listing that was based on

a characteristic until the deficiencies

identified in the 1996 Scoping Study

were addressed fully. Also, EPA must

not eliminate any listing once the

characteristic is removed, because the

underlying hazardous constituent still

represents a substantial threat even after

LDR treatment.

(2) EPA Response to Comments on

Toxicity of Wastes Listed for

Ignitability, Corrosivity, and/or

Reactivity

EPA continues to believe that wastes

that were listed only for the

characteristics of ignitability,

corrosivity, and reactivity should

become excluded once they no longer

exhibit any characteristic, including the

toxicity characteristic. While it is true

that these wastes could contain

constituents that were not considered in

the original listing determination, EPA

does not believe this possibility,

without information demonstrating

some particularized basis for concern,

warrants continued regulation of the

waste under Subtitle C once it is

decharacterized. This is because of the

unique nature of listings based on the

three characteristics in question. (See

the discussion, in Section VIII.A. above,

regarding the differences between

wastes listed for the toxicity

characteristic and wastes listed for the

characteristics of ignitability, corrosivity

and reactivity). These listings are unlike

toxicity-based listings, which involve

development of detailed risk

assessments and consideration of a

range of technical factors. See 40 CFR

261.11(a)(3). In contrast, the basis for

listings based on one of these

characteristics is simply that the waste

exhibits the relevant characteristic (see

40 CFR 261.11(a)(1)).

Listings that are based on 40 CFR

261.11(a) criteria increase the clarity

and certainty of the applicability of the

Subtitle C system to these wastes. By

listing the waste, EPA clarifies that it is

hazardous without the need for a siteby-site demonstration that the waste in

fact exhibits the characteristic, thereby

simplifying implementation and

enforcement regarding these wastes.

EPA does not believe these listings

should alter the basic principle that a

characteristic waste should not be

regulated as hazardous if it no longer

exhibits the characteristic. Consistent

with this approach, EPA provided in

1981 an exemption from the mixture

rule for wastes listed for one of these

characteristics that no longer exhibits

the characteristic (see 46 FR 56582,

November 17, 1981). Today’s rule

provides a conforming change to the

derived-from rule, which, because the

1981 rule only focused on mixtures,

does not currently contain a comparable

exemption. (see 60 FR 66349, December

21, 1995). The same rationale also

supports the inclusion of as-generated

waste in today’s rule (although, since

these wastes were listed solely on the

basis of exhibiting a characteristic, EPA

expects these wastes to exhibit the

characteristic at the point of generation).

Thus, EPA does not believe that the

possibility that these wastes may

contain additional hazardous

constituents not considered in the

original listing justifies continued

regulation of the waste.

As stated earlier, EPA already

excludes mixtures of these kinds of

wastes, once the basis for listing these

wastes has been removed. In addition,

unlisted characteristic waste becomes

non-hazardous when it ceases to be

characteristic. Expanding the exclusion

to non-mixtures that similarly do not

exhibit the characteristic (particularly

treatment residuals) would still be

protective of human health and the

environment. If there is any information

that indicates that the original listing

determination should have been based

on toxicity risks, then the proper

remedy is to amend the basis for listing

the waste . The public can petition EPA

to reconsider the basis for listing any

such waste .

In regard to the toxicity of the listed

chemicals themselves, EPA has

examined the most recent toxicity data

in IRIS concerning the chemicals in the

29 wastes listed solely for a

characteristic, and does not believe

these chemicals present a particular

basis for concern. We found that

fourteen of the chemicals have RfD’s or

RfC’s available in IRIS. (This includes

the eight F003 solvents discussed

below—see Section VIII.C. of the

preamble). EPA used these RfCs and

RfDs to calculate conservative

screening-level health-based numbers

(HBN) for those chemicals, and

compared them to the relevant

Universal Treatment Standards (UTS)

these chemicals would need to meet

under Land Disposal Restrictions, in

those cases in which numerical

standards were available. For most of

those chemicals, the relevant UTS

standards are much lower than the

conservative health-based numbers

calculated for water and soil ingestion

pathways. As discussed in Section

VIII.C below, the level for one of the

chemicals, n-butyl alcohol, is not

significantly higher. Therefore EPA

believes that excluding wastes that have

27284 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

been listed solely for a characteristic of

ignitability, corrosivity, or reactivity,

when they have been decharacterized

(i.e., exhibit none of the four hazardous

waste characteristics), is protective of

human health and the environment.

However, in the future, if additional

information becomes available, we may

decide to reconsider the basis of listing

for one or more of these wastes.

C. Eligibility of F003 Solvents for This

Exclusion

(1) Comments on Eligibility of F003

Solvents for This Exclusion

EPA received comments from 17

commenters in response to the 1995 and

1999 proposals concerning the inclusion

of F003 solvents in the expanded

exclusion to the mixture and derivedfrom rules. Of those comments, five

were from State Agencies, three were

from utility companies or associations,

four were from industries, two were

from Federal Agencies, two were from

waste management associations, and

one was from an industry association. A

summary of the specific issues raised by

commenters is provided below.

About two-thirds of the commenters

supported including F003 wastes in the

proposed exclusion. However, one

industry noted that this proposed

revision would have little effect beyond

eliminating the derived-from rule for a

small number of wastes. Many

commenters noted that if the solvent

contained, before use, one or more of

the toxic solvents specifically listed in

F001, F002, F004, or F005, at 10 percent

or more by volume, it would be

regulated as that waste code. Therefore

a blanket exclusion for all categories of

F003 is appropriate because toxics,

when present, will be addressed under

other applicable waste codes. One State

and two Federal commenters stated that

any toxic solvents contained in an F003

spent solvent blend would not escape

proper treatment because of the land

disposal restrictions (LDR) program.

They also noted that solvent mixtures/

blends meeting the F003 listing

description and containing a certain

percentage of toxic solvents also will

carry the waste code F001, F002, F004

and/or F005 and therefore, be subject to

treatment requirements under the LDR

program.

Four commenters did not support

including F003 in the proposed

exclusion. They argued that the listing

description for F003 contains a

reference to other solvent wastes (F001,

F002, F004, or F005) that are listed for

toxicity. Therefore, ignitability was not

the only characteristic of concern. In

addition, certain F003 solvents

themselves may also be toxic, upon

consideration of new data developed

since 1985. Specifically, the commenter

cited a National Toxicology Program,

National Institutes of Environmental

Health Sciences, Management Statistics

Report dated January, 1999 on the

carcinogenicity of ethylbenzene (an

F003 waste).

In addition, one State noted that in

the April 30, 1992 proposal to revise the

Hazardous Waste Identification Rule,

EPA was considering a separate

rulemaking to modify the basis for

listing F003 and other wastes listed

solely for a characteristic because of

concerns about toxicity and/or

carcinogenicity. If the chemicals in

these wastes are either toxic or

carcinogenic according to EPA’s own

determinations, they should be

identified as such in 40 CFR part 261,

subpart D.

Commenters also argued that F003

wastes ‘‘often’’ contain toxic

constituents other than the solvents

themselves. One commenter noted that

EPA states in 50 FR 53317 (December

31, 1985) ‘‘In fact, solvents become

spent when they have become

contaminated with other materials, (i.e.,

heavy metals or toxic organic

compounds) and must be disposed,

reprocessed or reclaimed.’’ EPA further

states ‘‘ * * * since spent solvents

reasonably are likely to contain other

toxicants at levels of regulatory concern,

and since we have not evaluated those

wastes for these toxicants, we believe it

inappropriate to remove these solvents

from the hazardous waste list.’’ In

addition, the waste management

association commenter argued that as

part of the economic impact analysis

associated with the 1999 HWIR

proposal, there have been 51 different

hazardous constituents associated with

the F003 waste code. The commenter

believed that if EPA lacked toxicological

data on any of these constituents, then

F003 could not be eligible for the

exclusion once the ignitability

characteristic was removed and the

waste exhibited no other hazardous

waste characteristics.

(2) Response to Comments on Eligibility

of F003 Solvents for This Exclusion

EPA agrees with those comments that

support F003 waste remaining eligible

for this exclusion. Because F003 waste

that contains 10% or more of the other

F-listed solvents (F001, F002, F004, and

F005) would also bear those waste

codes, such wastes would not be eligible

for the exclusion. The exclusions

applies only to F003 wastes that do not

contain 10% or more of these other

solvents.

EPA is aware of the recent

carcinogenicity study (referenced in the

public comments) that was performed

by the National Toxicology Program on

ethylbenzene. Ethylbenzene is included

in the Agency’s on-going Integrated Risk

Information System (IRIS) project (63 FR

68285, December 10, 1998). A focus of

the IRIS project is to update selected

chemical assessments by incorporating

new scientific information and methods.

The IRIS project consists of a process

that determines the Agency’s consensus

position on the potential adverse health

effects that may result from chronic or

lifetime exposures to environmental

contaminants. The carcinogenicity

study on ethylbenzene, together with

any other recent toxicological data, will

be evaluated by the Agency as part of

this process. Until that evaluation is

completed, EPA does not believe it is

appropriate to draw regulatory

conclusions based on the referenced

study.

With respect to the commenters’ more

generalized concerns about the

possibility of toxic constituents in F003

waste, as explained above, EPA does not

believe this possibility justifies the

continued regulation of a waste that was

listed for the sole reason that it is

ignitable, where the waste is no longer

ignitable and exhibits no other

hazardous waste characteristic. F003

waste is unique among the listed

solvents: the other listed solvents were

listed on the basis of toxicity. F005

solvents were listed for both ignitability

and toxicity. In fact, EPA decided to

move two listed solvents (methanol and

methyl isobutyl ketone) that were

originally proposed to be regulated

under the F005 listing to the F003

listing because EPA determined that

they did not pose a significant toxicity

risk, although they are highly flammable

(45 FR 74884, November 12, 1980).

Since then, EPA has analyzed the

toxicity risks that might be posed by

F003 solvents when de-characterized.

The Agency has researched the most

recent data concerning the F003

solvents in the IRIS data base. None of

the solvents in the listing are classified

as carcinogens, but eight of the nine

possess reference concentrations (RfC)

and oral reference doses (RfD) for noncancer risk. EPA used these RfCs and

RfDs to calculate conservative

screening-level health-based numbers

(HBN) for those chemicals, and

compared them to the relevant

Universal Treatment Standards (UTS)

these chemicals would need to meet

under Land Disposal Restrictions. For

seven of the eight chemicals (including

ethylbenzene) the relevant UTS

standards are much lower than the

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27285

15For the water ingestion pathway, EPA assumed

a 71.8 kg adult with a 2.3 L/day intake (90th

percentile), 350 days/yr frequency. For the soil

ingestion pathway, EPA assumed a 16.6 kg child

with 400 mg/day intake (upper percentile), 350

days/yr frequency. For more information, please see

U.S. EPA Analysis of Chemicals in Wastes Listed for

Ignitability, Corrosivity, or Reactivity memorandum

to the docket from David Cozzie, Office of Solid

Waste, November 22, 2000.

16EPA’s determination was upheld at EDF v.

EPA, 210 F.3d 396 (D.C. Cir. 2000).

conservative health-based numbers

calculated for water and soil ingestion

pathways. The health-based number for

the remaining chemical, n-butyl alcohol,

is only slightly lower than the UTS

standard (3.3 mg/L water ingestion HBN

vs 5.6 mg/L wastewater UTS).15 Given

the fact that the health-based numbers

are conservative screening numbers,

EPA does not believe this difference is

of concern. Therefore EPA remains

confident that excluding ignitable F003

solvents, when they have been

decharacterized, is protective of human

health and the environment.

Commenters also claimed that F003

solvents, because they are general use

solvents, can carry with them various

constituents other than the solvents

themselves, and that this was a reason

for listing the F003 solvents in the first

place (see 50 FR 53317, December 31,

1985). EPA acknowledges that in the

1985 solvents final rule, we noted that

additional toxic contaminants would

likely be present in the spent solvent.

We also stated, however, that we did not

evaluate F003 wastes for other toxic

constituents that could be present at

levels of regulatory concern. Therefore,

toxicity was a not a basis for listing

F003 waste.

When the F003 listing was finalized

in 1985, because it was listed solely for

ignitability, mixtures of F003 waste and

solid waste were eligible for the

exemption for mixtures of waste listed

for a characteristic that no longer exhibit

any characteristic of hazardous waste.

Expanding the exclusion to nonmixtures that similarly do not exhibit

any characteristic would still be

protective of human health and the

environment. We do not think it makes

sense to continue the anomaly of

retaining regulation for non-mixtures of

F003 wastes based on toxicity concerns

when we have no record basis to

support regulation for toxicity. Today’s

exclusion is also consistent with the

approach taken in EPA’s decision not to

list 14 spent solvent wastes, in which

EPA declined to focus on any toxic

constituents other than those in the

solvents themselves, despite the

likelihood of other toxic constituents in

the spent solvent waste. (63 FR 64372

(Nov. 19, 1998).16

D. Applicability of Land Disposal

Restrictions (LDRs) to Excluded Wastes

(1) Comments on Applicability of Land

Disposal Restrictions (LDRs) to

Excluded Wastes

EPA received comments from 20

commenters in response to both the

1995 and the 1999 proposals concerning

the applicability of LDRs to excluded

wastes. Of those comments, eight were

received from industries, four were from

industry associations, two were from

Federal Government Agencies, two were

from State Agencies, one was from a

consultant, one was from a waste

management association, one was from

a waste management company, and one

was from an individual commenter. A

summary of the specific issues raised by

commenters is provided below.

Several commenters supported the

EPA’s proposed revision to the mixture

and derived-from rules provided that

the excluded waste meets land disposal

restriction (LDR) requirements. One

industry association noted that LDR

standards assure that the waste is well

treated. One State Agency believed that

having similar wastestreams comply

with the same requirements will achieve

regulatory consistency as well as

protection of human health and the

environment.

Several commenters supported EPA’s

proposed revisions to the rules but did

not support meeting LDR requirements.

One industry commenter stated that

applying LDRs to a waste which is

excluded because it no longer meets the

hazardous waste criteria is

unnecessarily burdensome, costly and is

a contradiction of the RCRA program

requirements.

Two commenters said that the

applicability of LDRs to both wastewater

and nonwastewater forms of wastes

should be both clear and identical. They

felt that there is no justification for

managing these wastes inconsistently.

Several of the comments dealt with

whether excluded waste would need to

be treated to meet LDR treatment

standards for all underlying hazardous

constituents (UHCs) under the existing

rules. They felt that EPA should clarify

that it did not intend to revise

application of the current LDR rules

without any discussion of why such a

change would be necessary. One

commenter emphasized that EPA has

not provided a compelling case for

requiring testing for UHCs or a clear

methodology for implementing the

requirements that are proposed. They

stated that since these wastes are listed,

generators have not been required to

obtain information on underlying

hazardous constituents. Obtaining this

information would pose an undue

burden for the generator, and they

requested clarification on who would be

responsible for verifying whether the

waste in question meets the condition of

the exclusion: the generator or the

facility receiving the excluded waste.

Two industry association commenters

referenced the Land Disposal Program

Flexibility Act of 1996 (LDPFA) and its

relationship to the proposed exclusion.

Under LDPFA, solid wastes identified as

hazardous based solely on a

characteristic, are not prohibited wastes

under the Land Disposal Restrictions

program if they are managed in certain

systems including a treatment system

that subsequently discharges into waters

of the United States pursuant to a CWA

permit. The commenters further

requested that EPA revise its proposed

language modifying the mixture rule for

wastes in proposed 40 CFR

261.3(a)(2)(ii) so that the land disposal

restrictions program does not apply to

wastes that are not prohibited. They

argued that this revision is crucial to

maintain the status quo for managing

wastes listed solely for a characteristic

in land-based units. Imposing the LDR

program on such wastes would put

many surface impoundments out of

compliance because they are managing

decharacterized listed wastes in landbased units that do not meet RCRA’s

minimum technology requirements.

(2) EPA Response to Comments on

Applicability of Land Disposal

Restrictions (LDRs) to Excluded Wastes

In proposing to expand the current

exclusion for waste listed solely for a

characteristic, EPA did not intend to

change the way land disposal

restrictions (LDRs) apply to the

excluded waste. EPA agrees with those

comments that support the continued

application of LDR requirements to

mixture and derived-from wastes listed

solely for a characteristic of ignitability,

corrosivity, or reactivity after they have

become excluded. We are not imposing

any new LDR requirements in this rule.

We agree that the treatment standards

for UHC’s do not apply in all cases, and

have not changed the applicability of

these requirements. In general, wastes

that are both listed as hazardous waste

and exhibit a characteristic only need to

meet the treatment standard for the

listed waste code. (40 CFR 268.9(b)). An

exception occurs when the treatment

standard for the listed waste code does

not include a standard for the

constituent that causes the waste to

exhibit the characteristic. In this case,

the waste must meet the treatment

standards for all applicable listed and

characteristic waste codes.

27286 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

EPA disagrees with the comment that

LDRs for wastewaters and

nonwastewaters should be identical. We

continue to support the existing

different treatment standards for

wastewaters and nonwastewaters. Such

differences are based on waste

treatability and differences in the Best

Demonstrated Available Technology

applicable to the waste.

Today’s rule also does not broaden

the applicability of LDRs. The revised

language to 40 CFR 261.3 (g)(3) states,

‘‘Wastes excluded under this section are

still subject to part 268 of this chapter

(as applicable), even if they no longer

exhibit a characteristic at the point of

land disposal.’’ When the requirements

of 40 CFR part 268 would not otherwise

apply to a waste (for example, during

treatment of certain characteristic

wastes in a land-based unit), today’s

rule does not change that fact. In the

case of wastes listed solely for

ignitability, corrosivity, and reactivity

that do not exhibit a characteristic at the

point of generation, these wastes are

considered to never have been

hazardous and are not subject to 40 CFR

part 268.

E. Applicability of Contained-In Policy

to Excluded Wastes

1. Comment on Applicability of

Contained-In Policy to Excluded Wastes

One commenter, the Department of

Defense (DoD), requested that EPA

clarify the interaction of the containedin policy to the RCRA wastes that are

listed solely for ignitability, corrosivity,

and/or reactivity characteristics.

2. EPA Response to Comment on

Applicability of Contained-In Policy to

Excluded Wastes

The contained-in principle is the

basis for EPA’s longstanding

interpretation regarding application of

RCRA Subtitle C requirements to

mixtures of contaminated media and

hazardous wastes. Under the

‘‘contained-in’’ policy, EPA requires

that soil (and other environmental

media) be managed as hazardous wastes

so long as they contain listed hazardous

waste or exhibit a characteristic of

hazardous waste. EPA’s application of

the ‘‘contained-in’’ policy to regulate

media containing hazardous waste was

upheld by the D.C. Circuit Court of

Appeals in Chemical Waste

Management v. EPA, 869 F2d 1526,

1539–40 (D.C. Cir. 1989). See the LDR

Phase IV final rule 63 FR 28556, 28621

(May 26, 1998) for a detailed discussion

of the contained-in policy and the

Agency’s reason, at the time, not to

codify the contained-in policy for

contaminated soil.

Today’s final rule does not directly

affect the implementation of the

contained-in policy. However, wastes

that are contained in contaminated

media are eligible for the 40 CFR

261.3(g) exemption for wastes listed

solely for a characteristic. Therefore,

under today’s final rule, contaminated

media that contain a waste listed solely

for a characteristic would no longer

need to be managed as hazardous waste

when it no longer exhibits a

characteristic. However, consistent with

the regulation of other decharacterized

waste (and decharacterized

contaminated media), it may remain

subject to LDR requirements. (The final

rule, by providing that wastes excluded

under this section are subject to LDRs

‘‘as applicable,’’ applies the current

rules regarding LDR applicability to soil

containing hazardous waste. See, 40

CFR 268.49. For a detailed discussion of

this subject, see 63 FR 28556, 28617

(May 26, 1998).)

IX. What Were the Major Comments on

the Revision to 40 CFR 261.3 for Mixed

Wastes, and How Has EPA Responded

to Them?

A. 1999 Proposed Revision to 40 CFR

261.3 for Mixed Waste

In the 1999 proposal, EPA proposed a

change to 40 CFR 261.3 that would

exclude certain eligible mixed wastes

(i.e., wastes that are both hazardous and

radioactive) when they met the

conditions outlined in the proposed 40

CFR part 266, Subpart N, which

appeared in a separate Federal Register

Notice. 64 FR 63464 (Nov. 19, 1999).

EPA received comments from nine

commenters in response to the 1999

HWIR proposal concerning the

conditional exclusion from the mixture

and derived-from rules for mixed waste.

The commenters supported EPA’s

proposed conditional exemptions for

low-level mixed waste (LLMW). Many

of these commenters believed that such

an exemption was implicit in the mixed

waste proposal and necessary for the

proposed mixed waste conditional

exemptions to function effectively.

Many of these commenters also noted

that EPA’s proposal would help

eliminate much of the current regulatory

overlap associated with LLMW. One

commenter added that since the

implementation of LLMW management

under RCRA, it had been difficult to

find treatment/disposal capacity for its

limited quantities of mixed waste, and

the proposal would improve safety,

efficiency, cost and timeliness of LLMW

management. Several commenters

encouraged EPA to expedite its

implementation.

However, two commenters (both

Federal agencies) were concerned with

the proposed regulatory language for

implementing a conditional exemption

from the mixture and derived-from rules

for mixed waste. The commenters

believed it would be more appropriate

to pursue regulatory relief for low-level

mixed waste (LLMW) via the standards

proposed for 40 CFR part 266, Subpart

N rather than within the definition of

hazardous waste in 40 CFR 261.3. This

proposed exemption within 40 CFR

261.3 would provide an inconsistency

in the application of the MDF rules

between wastes mixed with or derivedfrom the treatment of hazardous wastes

and wastes mixed with or derived-from

the treatment of LLMWs. The

commenters noted that the proposed

regulation for the transportation/

disposal conditional exemption for

mixed waste, section 266.305, exempts

the waste from certain RCRA

requirements (provided specified

conditions are met), but does not

exempt the waste from the definition of

hazardous waste.

EPA appreciates the support

expressed for the conditional exemption

for mixed waste mixtures and derivedfrom wastes. In response to the apparent

confusion about how the proposed

regulatory language applies to these

conditionally exempt mixed wastes,

EPA has created a new section to 40

CFR 261.3, section (h), which more

carefully explains how the definition of

hazardous waste interacts with the

mixed waste conditional exemption.

B. 1995 Comments on Conditional

Exemptions for Mixed Waste

In EPA’s 1995 HWIR proposal, we

included a discussion of possible

conditional exemptions for mixed

wastes based on EPA’s HWIR modeling,

or on other conditions outlined in a

proposal developed by the Department

of Energy (DOE). EPA received

comments from 45 commenters

regarding this discussion, many of

whom urged EPA to separate mixed

waste from the HWIR rulemaking. DOE

has since withdrawn its proposal, and

EPA has developed a separate mixed

waste exemption, which is published

elsewhere in today’s Federal Register.

For a more detailed explanation of all

the mixed waste comments submitted as

part of the HWIR rulemakings, and

EPA’s response to those comments

please see Hazardous Waste

Identification Rule: Revisions to the

Mixture and Derived-From Rules

Response to Comments Document.

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27287

17CMA has since changed the name of the

organization to the American Chemistry Council

(ACC).

18Note: EPA’s surface impoundment study was

completed March 2001. See U.S. Environmental

Protection Agency. Industrial Surface

Impoundments in the United States. EPA530–R–

01–005. Washington, D.C. March 2001.

X. What Were the Major Comments on

the Recommendations Submitted by the

Chemical Manufacturers Association

(CMA), and How Has EPA Responded

to Them?

In August 1999, EPA received a paper

from the Chemical Manufacturers

Association (CMA) 17 describing five

regulatory options for revising the

mixture and derived-from rules. CMA

forwarded these options seeking

regulatory relief for some specific highvolume wastes that they believe are lowrisk and feel that EPA could propose to

exclude with very little delay. Although

we did not have sufficient time to

analyze these options in detail, we

included a discussion of them in the

1999 HWIR notice to allow for public

comment. Below is a short description

of each option, a summary of the

comments on the option, and EPA’s

response to the comments.

EPA is currently developing proposals

related to two of the suggestions that we

believe to be the most promising and

straightforward to address: expanding

the current headworks exclusion and

excluding certain combustion residues.

(see Sections X.A. and X.D.

respectively). We are also considering

additional proposals on the other

suggestions, but we believe more

analysis would first be necessary to

decide how to address specific issues

raised in the public comments. In

addition, we will consider whether

other opportunities exist for exempting

low-risk waste from full Subtitle C

regulation, including additional targeted

exemptions and efforts to streamline the

delisting program.

A. Expanding the Current Headworks

Exclusion

One option involves an expansion of

the current ‘‘headworks’’ exclusion in

40 CFR 261.3(a)(2)(iv)(A) and (B). The

headworks exclusion excludes from the

mixture rule wastewaters containing

small quantities of particular F-listed

solvents, based on the mass-balance

flow of these solvents through the

headworks of industrial wastewater

treatment systems. CMA’s options paper

requests that this exclusion be amended

in three ways.

First, CMA’s suggested revision

would allow direct monitoring of the

actual concentration of spent solvents in

untreated wastewater to demonstrate

compliance. The current requirement is

to perform a weekly mass balance of the

solvents entering the system. Losses due

to volatilization must be counted in the

mass balance determination under the

current system. We note that CMA’s

suggested wastewater monitoring would

provide accurate data at the point the

wastewater enters the treatment system,

but the losses due to volatilization

would not be counted in this approach.

Second, under CMA’s suggested

revisions, benzene, 2-ethoxyethanol, 2-

nitropropane, and 1,1,2-trichloroethane

would be incorporated into the list of

chemicals for exclusion. These four

chemicals were added to the 40 CFR

261.31 list of spent solvents in 1986 but

the exclusion does not currently include

these chemicals.

Third, under CMA’s suggested

revisions, multi-source leachate (F039)

derived solely from the disposal of the

spent solvents listed in 40 CFR 261.31

would be eligible for the exclusion.

(1) Summary of Comments on

Expanding Headworks Exclusion

EPA received comments from 13

commenters in response to the

discussion on expanding the headworks

exclusion. Of those comments, two were

received from industry, three were from

industry associations, three were from

utility companies or utility company

associations, three were from State

Agencies, one was from a Federal

Government Agency, and one was from

a waste management association. A

summary of the specific issues raised by

the commenters is provided below.

One state commenter noted that

CMAS’s suggested exclusion does not

account for volatilization, an important

factor considering the solvents involved,

if the wastewater treatment system is

not actually subject to Clean Air Act

controls. In addition, they noted that

CMA’s suggested exclusion addresses

whether and how RCRA should be

modified in the wastewater treatment

context, and they felt that this is a

matter that could be addressed

comprehensively following the

completion of the surface impoundment

study.18 One waste management

association commenter stated it was not

clear what the potential environmental

impact would be of expanding this

exclusion to additional chemicals.

The rest of the commenters supported

the CMA’s recommendations for

specific modifications to the mixture

rule to expand the headworks exclusion

in 40 CFR 261.3(a)(2)(iv)(A) and (B).

Commenters noted that subsequent to

the original headworks exclusion,

additions were made to the F code

solvent listings, but the corresponding

changes were not made to the list of

solvents in the headworks exclusion.

For consistency, benezene, 2-

ethoxyethanol, 2-nitropropane and

1,1,2-trichloroethane should be added to

the list of solvents allowed under the

headworks exclusion. One State added

that the circumstances and reasoning

that EPA used to support finalizing the

original exclusion remain valid for these

four solvents. Commenters also noted

that they believed EPA would determine

the appropriate headworks

concentration (i.e., either 1 part per

million or 25 parts per million). Also, it

is appropriate, practical, and

economical for a generator to manage

small amounts of spent solvent wastes

in a wastewater treatment system

subject to regulation under sections 402

and 307 (b) of the Clean Water Act.

Nine of the commenters supported the

use of direct monitoring of the actual

concentration of spent solvents in

untreated wastewater to demonstrate

compliance with the headworks

exclusion. Several commenters believed

direct monitoring would facilitate

documentation of compliance. A

Federal commenter noted that the

suggested changes would provide

accurate data at the point the

wastewater enters the treatment system,

but still would allow generators who

rarely discharge solvents into their

wastewater systems to use the current

method for verifying compliance.

Several commenters believed that the

mass-balance approach gives rise to a

number of problems due to the varying

degrees of precision in the underlying

measurements and, therefore, deters use

of this exclusion. Instead, direct

sampling and analysis methods are

much more straightforward to

implement and would provide more

accurate information about what

actually is being discharged to treatment

systems. A State commented that direct

monitoring provides the most definitive

information on the concentration levels

of hazardous constituents in a waste.

Direct monitoring would allow

generators to apply the exclusion to its

full intended regulatory limit. An

industry commenter recommended that

compliance with the regulatory levels be

measured on a rolling average basis

since flows may be variable. Several

commenters noted that they do not

believe that direct monitoring would

encourage volatilization. They noted

that EPA did not state directly that the

current measurement scheme needed to

account for volatilization when the

headworks exclusion was finalized and

it is not part of the current regulatory

27288 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

language. However, these comments

recognized that over the years, EPA has

explained in preamble language and

interpretive letters that it considered

accounting for volatilization losses to be

necessary to prevent facilities from

volatilizing solvents in order to be

eligible for the exclusion. In the years

subsequent to the statement, EPA has

issued a number of regulations

addressing air emissions of organics,

including the listed solvents. Because

EPA has addressed these potential air

emissions by regulations which focus

specifically on these emissions, the

commenters felt that there is no need for

the headworks exclusion to have to

account for them as well.

One State commenter did not support

the inclusion of multi-source leachate

(F039) in the headworks exclusion, even

though the leachate might be derived

from the disposal of solvent wastes. The

commenter noted that leachate might

contain any variety of hazardous

constituents, due to the presence of

characteristic wastes or non-hazardous

wastes. The commenter further noted

that it would be difficult to determine

whether the headworks exclusion, if

modified in this manner, would protect

human health and the environment

sufficiently. The commenter did state

that if the discharge is regulated under

the Clean Water Act (CWA), this may

provide a reasonable amount of

assurance with respect to exposure

paths, relating to the wastewater

discharge.

Six of the commenters supported

extending the exclusion to multi-source

leachate (F039) derived solely from the

disposal of the spent solvents in 40 CFR

261.31. A Federal commenter noted that

in many cases, leachate is contaminated

with barely detectable concentrations of

F-listed solvents, yet the leachate still is

classified as hazardous waste. By

allowing the wastewater to be

discharged for treatment to a wastewater

treatment or pre-treatment system

regulated under the CWA, EPA would

encourage remediation by lowering

treatment costs. The commenter also

stated that EPA must believe that the 1

ppm/25 ppm concentration limits

established under the existing rules are

protective of human health and the

environment, so extending those limits

to wastes derived from the land disposal

of certain listed solvents should be

adequately protective.

Several commenters noted that the

advent of the multi-source leachate

waste code simplified some hazardous

waste management by applying the

single listing code to hazardous waste

leachate. However, this streamlining did

create some unintended consequences.

Leachate generated solely from F001–

F005 solvents no longer qualified for the

headworks exclusion, even though the

composition of the leachate was

virtually identical to dilute non-leachate

F001–F005 streams. Therefore, even

though F039 leachate derived solely

from F001–F005 wastes are exactly the

same in chemical composition as the

wastes from which they are derived,

they cannot be treated in the same

treatment train. They must be segregated

and handled in separate tank-based

systems or shipped off site for treatment

and disposal causing additional cost but

providing no additional environmental

protection. One industry commenter

recommended that EPA issue a

technical correction or clarification

notice with or before promulgating the

final HWIR rule to address this problem.

Under CMA’s recommendation, the

headworks exclusion rationale for the

solvent wastes from ongoing production

processes would be applied equally to

solvent wastes leaching from a landfill.

Both are treated equally well in the

wastewater treatment plant at these low

concentrations, so there is no

justification for regulating them

differently.

(2) EPA Response to Comments on

Expanding the Headworks Exclusion

EPA agrees that there is merit in

proposing to expand the current

exclusions in 40 CFR 261.3(a)(2)(iv)(A)

and (B) (the ‘‘headworks’’ exclusion) to

include the four solvents listed in 1986:

benzene, 2-nitropropane, 2-

ethoxyethanol, and 1,1,2-

trichloroethane, and we are currently

developing a proposal on such an

expansion. In the proposal, EPA will

take into account the issues raised by

the commenters, including

environmental impacts of the expanded

exclusion, and the use of any available

surface impoundment study data. In the

meantime, we welcome any data or

additional feedback from the public on

this topic.

We will also evaluate in this proposal

the issue of measurement versus mass

balance calculation as a part of the

implementation of the headworks rule.

EPA agrees that in the past 20 years,

significant new Clean Air Act

regulations have come into effect that

may address some of the concerns about

deliberate volatilization. In developing a

proposed revision to the monitoring

requirements for the headworks rule, we

would take into account the issue raised

by the commenters, including the issues

concerning volatilization. We welcome

any additional data the public has to

support such a change.

EPA is also interested in possible

applications in which solvent-only

landfill leachate may be sent to a

wastewater treatment facility. We are

concerned, however, about possible

difficulties in determining whether a

landfill has received only solvent

wastes. As part of the investigation, EPA

would need more information

characterizing possible ‘‘solvent waste

only’’ landfills. We welcome any

additional data the public has on these

landfills.

B. Excluding Hazardous Waste Leachate

Another of the suggested regulatory

options involves leachate derived from

the land disposal of listed hazardous

waste which is subsequently managed

in a system regulated under the Clean

Water Act. CMA argues that the leachate

is both physically and chemically

dissimilar from the wastes that were

originally listed. Under the option

presented, leachate would not be

hazardous, even when generated from

the treatment, storage or disposal of

hazardous waste, unless it exhibited one

or more of the hazardous waste

characteristics of 40 CFR Part 261,

Subpart C.

(1) Comments on Excluding Hazardous

Waste Leachate

EPA received comments from eight

commenters in response to excluding

leachate. Of those comments, three were

received from industries, one was from

an industry association, three were from

State Agencies, and one was from a

waste management association. A

summary of the specific issues raised by

commenters is provided below.

The waste management association

did not support the exclusion, noting

that treatment tanks that are part of a

Clean Water Act (CWA) system already

are conditionally exempt. Thus, it was

not clear to the commenter why a more

expansive exclusion was advisable,

particularly because leachate from

hazardous wastes ‘‘may often contain

toxic constituents that are not subject to

NPDES discharge limits or water quality

standards.’’ Also, one State did not

support the exclusion noting that many

organics of concern are not covered by

the toxicity characteristic. Furthermore,

the State commenter believed that it

would be inappropriate to exclude these

wastestreams without examining the

results of the surface impoundment

study, particularly without any

supporting data on the physical/

chemical properties of the leachate and

its associated risks. Finally, these State

comments claimed that there is no

generic way to tell if these leachates will

pose a problem. They could be very

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27289

19 Development Document for Final Effluent

Limitations Guidelines and Standards for the

Landfills Point Source Category, EPA–821–R–99–

019, U.S. EPA, January 2000.

different from unit to unit depending

upon what type of waste has been

placed in the unit. The commenter also

felt that there could be an air emission

problem or the leachate could cause the

sludge to become hazardous. Instead,

the State commenter thought industries

should go through a case specific

delisting for these wastes.

One State commenter did not

understand CMA’s proposal to exclude

leachate from the derived-from rule.

Currently, F039 leachate waste is

subject to Part 268 land disposal

restriction requirements and could be

treated onsite in a tank or container

within 90 days of generation without a

permit. If this treated waste was an

industrial wastewater discharge that

was a point source discharge subject to

regulation under section 402 of the

Clean Water Act, it would be eligible for

the 261.4(a)(2) exclusion. In that case

the wastewater would not be a solid

waste. The State wondered if CMA was

proposing that F039 be exempt from

LDR requirements. If that was the case,

the State did not support such a

recommendation.

One State commenter stated that there

may be merit in excluding leachate

resulting from the land disposal of a

listed hazardous waste when the

leachate is subsequently managed in a

wastewater treatment system regulated

under the CWA. However, to make a

definitive decision, the State expressed

a need to evaluate constituent

concentration data, current management

practices, environmental injury cases

caused by the residues, and whether the

residues commonly exhibit a hazardous

waste characteristic. Since (1) the

leachate is generated from landfills

where only treated hazardous wastes are

disposed, and (2) bonafide treatment has

occurred and the residues are physically

and/or chemically different from the

hazardous wastes they were generated

from, the State believed it was

appropriate to view the residues as

newly generated wastes and impose

RCRA regulation only if the waste

exhibited a hazardous waste

characteristic.

The rest of the commenters believed

that EPA should consider leachate from

hazardous waste landfills to be a newly

generated waste rather than derivedfrom waste. As a newly generated waste,

it would be subject to regulation if it

failed one or more hazardous waste

characteristics, but would no longer be

subject to hazardous waste regulation

solely because the landfill accepted

listed hazardous wastes. Several

commenters noted that most POTWs

would not accept direct discharges of

listed hazardous waste, even if the

leachate met all applicable effluent

guidelines and other standards. As a

result, several commenters noted that

they must use costly and unnecessary

incineration or other treatment at offsite facilities. In addition, the

transportation and management from

sending the wastes off-site actually may

increase environmental risks and energy

usage relative to the protective and costeffective management in industrial

wastewater systems. Several

commenters noted that both landfills

and land treatment units, as defined by

RCRA, generate a leachate when

constructed with a bottom liner.

Leachate from either type of unit should

qualify for the exclusion so long as it

did not fail for a hazardous

characteristic and the wastewater

treatment system receiving the leachate

was subject to regulation under the

CWA. Two commenters also

recommended as an alternative to

considering leachate from hazardous

waste landfills to be a newly generated

waste, that EPA make it eligible for the

headworks exclusion.

(2) EPA Response to Comments on

Excluding Hazardous Waste Leachate

At this time, EPA is still considering

the suggested regulatory exclusion for

leachate derived-from landfilled

hazardous waste as well as other

specific exemption options, but we first

need to evaluate several important

issues. As noted in the comments, most

hazardous waste leachate is regulated

under a separate waste code, F039. To

date, we have received no information

that would cause us to reconsider that

listing, although we would welcome any

data that might be helpful in such a reevaluation. However, in the most recent

EPA study of landfill leachate

characteristics (65 FR 3007, January 19,

2000), we found considerable

differences between the leachate

samples from hazardous and those from

non-hazardous landfills in both

numbers of constituents of concern and

their concentrations. Hazardous waste

landfill leachate contained a greater

number of constituents than nonhazardous waste landfill leachate, and

constituents found in both hazardous

and non-hazardous waste landfill

leachate were generally present in

hazardous waste landfill leachate at

concentrations an order of magnitude

higher than those found in nonhazardous waste landfill leachate.19 As

noted in the comments, these pollutants

can include many organic hazardous

constituents not covered by the Toxicity

Characteristic. Absent a risk assessment,

it is not possible to determine whether

the levels of these constituents pose

unacceptable risk. However, the

presence of these constituents is a

strong indication that more study would

be needed before developing an

exemption for hazardous waste leachate.

C. Excluding Hazardous Waste

Aggressive Biological Treatment

Residues

Another suggested regulatory option

involves excluding residues from the

biological treatment of listed hazardous

wastewaters. CMA argues that theses

wastes are both physically and

chemically dissimilar from the wastes

that were originally listed. In addition,

CMA notes that biological treatment can

greatly reduce or eliminate organic

chemicals. Under the options presented

in CMA’s discussion papers, these

wastes would not be hazardous, even

though they are generated from the

treatment, storage or disposal of

hazardous waste, unless they exhibit

one or more of the hazardous waste

characteristics of Subpart C of 40 CFR

part 261.

(1) Comments on Excluding Residues

From Aggressive Biological Treatment

of Hazardous Waste

EPA received comments from 10

commenters in response to the CMA

recommendation to exclude aggressive

biological treatment residues from the

derived-from rule. Of those comments,

four were received from industries, two

were from industry associations, three

were from State Agencies, and one was

from a waste management association. A

summary of the specific issues raised by

commenters is provided below.

The waste management association

did not support excluding sludges

derived from the biological treatment of

listed hazardous wastes. The commenter

noted that the sludges typically contain

concentrations of heavy metals that

warrant further treatment and Subtitle C

disposal. EPA’s listing background

document for F006 electroplating

sludges, for example, provides data on

the presence of lead, cadmium,

chromium and other toxic metals in

such wastewater treatment sludges.

Two States did not support the

exclusion, noting that these sludges can

continue to pose a threat to human

health and the environment and should

continue to be subject to the derivedfrom rule. The States also believed that

these wastes should meet land disposal

restriction (LDR) treatment standards,

just as any other listed hazardous waste

27290 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

20EPA 1990. LDR Determination of Waste Stream

Dilution, Letter from Jeffery Denit, Deputy Director,

Office of Solid Waste to Bruce Smith, Director,

Office of Hazardous Waste Programs, EPA Region

III, October 14, 1990. [FAXBACK 13414, PPC

9551.1990(06)]

21EPA 1987. K035 Listing and Inclusion of

Sludges from Biological Treatment of Creosote

Production Wastes, Letter from Bruce R. Weddle,

U.S. EPA, to Jordan Dern, Koppers Company, Inc.,

December 11, 1987. [FAXBACK 13105, PPC

9444.1987(52)].

22U.S. EPA 1991. Draft Region VIII Policy on

‘‘Aggressive Biological Treatment’’, Letter from

Robert L. Duprey, Director, Hazardous Waste

Management Division (EPA Region VIII) to Sylvia

K. Lowrance, Director, Office of Solid Waste, April

19, 1991 (Ref: 8HWM–RI)

is required to meet a treatment standard

before being disposed in a permitted

Subtitle C facility. One State noted that

EPA proposed the retention of the

mixture and derived-from rules in part

because of the potential toxicity of

wastewater treatment sludges. (See 64

FR 63389, November 19, 1999).

One State commenter noted that there

may be merit in excluding aggressive

biological treatment residues. However,

to make a definitive decision, the State

would need to evaluate constituent

concentration data, current management

practices, environmental injury cases

caused by the residues, and whether the

residues commonly exhibit a hazardous

waste characteristic. Since wastewater

treatment is a bonafide treatment

method proven to detoxify or otherwise

treat hazardous waste and the residues

are physically and/or chemically

different from the hazardous wastes

they were generated from, the State

believed it was appropriate to view the

residues as newly generated wastes and

impose RCRA regulation only if the

waste exhibited a hazardous waste

characteristic.

The rest of the commenters supported

excluding sludges derived from the

biological treatment of listed hazardous

wastes. Many commenters noted that

industrial biosludges currently are

overmanaged as hazardous wastes at a

high cost to industry. Several

commenters added that residues from

biological treatment processes have

reduced organic constituent

concentrations significantly relative to

the original waste. Commenters noted

that most listed wastewaters are 99%

water and are therefore substantially

different in terms of potential for

environmental harm than a nonwastewater form of the same waste.

Also, residues derived from aggressive

biological treatment are fundamentally

different (both chemically and

physically) from the originally listed

wastes and these residues should be

considered a new point of generation.

One commenter submitted data on the

concentration of chemicals in a

combined treatment sludge.

Additionally, commenters claimed

that in recent hazardous waste listings,

EPA has recognized that treatment

sludges do not necessarily present any

significant environmental hazard even

when there is sufficient hazard in the

waste as generated to warrant listing by

EPA (e.g., wastewater treatment sludges

from carbamates, anthraquinone, and

chlorinated aliphatics). Commenters

also noted that public reporting of these

very large volumes of derived-from

waste misleads the public over the

amount of actual hazardous waste in

their communities.

Several commenters believed that

there should not be a specific contingent

management requirement associated

with the excluded biosludge. Rather, the

sludge would be subject to state

industrial non-hazardous waste RCRA

(Subtitle D) programs, including

restrictions on industrial non-hazardous

waste landfilling, combustion and other

management options. Since industrial

biosludge resulting from an aggressive

biological treatment system is not

significantly different from sewage

sludge, the commenters expected that

any restrictions placed on the use of

sewage sludge would likewise apply to

excluded sludge.

A few commenters pointed out that

the LDR program for characteristic

wastes has over the years established

new points of generation. The

commenters noted that in the LDR

program, EPA recognized that various

treatment residuals differ from the

wastes from which they are derived and

should not continue to be regulated as

the same wastes. In at least three other

situations, EPA has made a specific

determination that the generation of

wastewater treatment biosludge

constitutes a new point of generation,

generally on the basis that the

wastewater being treated falls into one

treatability group and the resultant

sludge into another. They are: (1) Sludge

from the treatment of U154

contaminated groundwater—The sludge

is considered newly generated waste

because it is a different treatability

group than the wastewater being

treated—sludge generated from treating

non-ignitable wastewaters not derived

from hazardous waste (03/21/96 Berlow,

EPA to Day, Bryan Cave, LLP); (2) LDR

notification requirements for

wastewaters and sludges—LDR

requirements apply only to wastes that

are hazardous at the point of generation.

Non-hazardous sludges removed from a

wastewater treatment unit require no

LDR notification. The requirement to

identify and treat for underlying

hazardous constituents (UHCs) is not

applicable to wastewaters managed in

centralized wastewater treatment

systems subject to the CWA or to

sludges that are not hazardous at the

point of generation (05/01/97

Cotsworth, EPA to Dolce, Award

Environmental Inc.); and (3)

applicability of land disposal

restrictions to tank-based wastewater

treatment systems—LDRs do not apply

to waste managed in systems that are

entirely tank-based; sludge generated

from wastewater treatment belongs to a

different treatability group, and is

therefore a newly generated waste that

should be evaluated at the point of

generation (03/29/97 Berlow, EPA to

Day, Bryan Cave, LLP).

(2) EPA Response to Comments on

Excluding Residues From Aggressive

Biological Treatment of Hazardous

Waste

EPA is considering a tailored

exclusion for biological treatment

residues, but does not believe that a

blanket exclusion from the mixture and

derived-from rules is appropriate for

such wastes. Not all wastestreams are

amenable to biological treatment, and

the composition of the residuals

generated from biological treatment

would vary greatly depending on the

influent and on the efficacy of the

treatment system.

We have, in the past, determined that

biological treatment systems are

inappropriate for metals and could

result in impermissible dilution under

the LDR program.20 We have also

denied a delisting petition for K035

sludges resulting from aerated biological

treatment of creosote in a surface

impoundment in part because of

downgradient groundwater

contamination.21 In addition, we have

information that facilities have

attempted to avoid generating F037 and

F038 wastes by adding minimal aeration

to primary treatment units and claiming

the sludges from these units as

excluded.22

However, EPA believes there may be

merit to the idea of regulating certain

types of biological treatment residues

differently. As noted in the comments,

we have in the past excluded certain

types of biological treatment wastes

from regulation (see, for example, 40

CFR 261.3(c)(2)(ii)(D)). There may be

other types of waste similarly amenable

to biological treatment. Before

developing such a regulatory proposal,

EPA would first gather and analyze data

on biological treatment waste.

Therefore, any such data would be

welcomed by the Agency.

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27291

D. Excluding Hazardous Waste

Combustion Residues

Another of CMA’s suggested options

involves excluding residues from the

combustion of listed hazardous waste.

CMA argues that these wastes are both

physically and chemically dissimilar

from the wastes that were originally

listed. In addition, CMA notes that

combustion can virtually eliminate

organic chemicals. Under the options

presented in CMA’s discussion papers,

these wastes, which would include

combustion ash, slag, air pollution

control residue and scrubber water,

would not be hazardous, even though

they are generated from the treatment,

storage or disposal of hazardous waste,

unless they exhibit one or more of the

hazardous waste characteristics of 40

CFR part 261, Subpart C.

(1) Comments on Excluding Hazardous

Waste Combustion Residues

EPA received comments from 15

commenters in response to the CMA

recommendation to exclude hazardous

waste combustion residues. Of those

comments, seven were received from

industries, two were from industry

associations, four were from State

Agencies, one was from a waste

management company, and one was

from a waste management association. A

summary of the specific issues raised by

commenters is provided below.

One waste management association

and two State commenters did not

support excluding combustion residues,

noting that there is a great deal of

variability in combustion residues.

While some organic compounds are

destroyed effectively by the combustion

process, the residue may contain

persistent constituents (e.g., dioxins and

metals) that are toxic. Accordingly,

while the combustion byproducts may

be physically and chemically dissimilar

from the listed waste it is derived from,

the byproducts have toxic properties

that could cause environmental

degradation. The commenters believed

that relying on the TC by itself fails to

provide adequate protection of human

health and the environment. The

commenters mentioned that not all

metals of concern are covered by the TC.

They also noted that the TC only

measures potential risks via the

groundwater pathway, and it is not

definitive that groundwater is the

driving risk pathway for these wastes.

Because the TC approach does not

comprehensively evaluate potential

risks, wastes that do not exhibit

hazardous waste characteristics are not

necessarily non-hazardous. In addition,

one State commenter believed it was

prudent to wait for EPA’s anticipated

action on proposed combustion residues

to address the physical and chemical

properties of these wastes before any

action is taken on CMA’s proposal.

Two State commenters stated that

there may be merit in excluding

residues from the combustion of listed

hazardous wastes. However, to make a

definitive decision, one State would

need to evaluate constituent

concentration data, current management

practices, environmental injury cases

caused by the residues, and whether the

residues commonly exhibit a hazardous

waste characteristic. Since bonafide

treatment has occurred and the residues

are physically and/or chemically

different from the hazardous wastes

they were generated from, the State

believed it was appropriate to view the

residues as newly generated wastes and

impose RCRA regulation if the waste

exhibited a hazardous waste

characteristic. Another State commenter

believed an exclusion for combustion

residues could be appropriate if the

combustion takes place in a permitted

(not interim status) hazardous waste

combustion device; any listed wastes

are listed for organic hazardous

constituents only; the residual must not

exhibit any characteristics; and the

residues meet LDRs, including

standards for underlying constituents.

This approach would protect human

health and the environment fully and

would allow many combustion residues

to exit Subtitle C regulation once LDRs

are met.

The rest of the commenters believed

that EPA should consider residues from

hazardous waste combustion to be a

new point of generation. These

combustion residuals substantially

differ in their physical and chemical

makeup from the original listed

hazardous wastes from which they are

derived. Subtitle C regulation is not

needed for such combustion residuals,

especially if the residues do not exhibit

hazardous characteristics. Instead, the

residues can be managed adequately

and protectively as industrial nonhazardous waste or discharged under

the Clean Water Act. The commenters

believed that the high cost of regulating

these materials as hazardous waste

purchases little or no increased

protection of human health and the

environment. The hazardous waste

combustion process destroys virtually

all of the organics in the listed wastes

from which these residuals are derived,

and the Toxicity Characteristic limits for

metals are virtually the same as the

health-based limits EPA-established for

excluding Bevill wastes from Subtitle C

regulation. One commenter submitted

information on the operating parameters

and limits for their combustion unit and

the concentrations of the sludge from

incinerator scrubber water generated.

One industry commenter noted that in

combustion-related rulemakings, EPA

consistently has maintained that welloperated and maintained combustion

units can achieve high combustion

efficiencies and can be operated in a

manner that is protective of human

health and the environment. Therefore,

the commenter recommended the

exclusion be limited to residues from

units that continuously monitor stack

emissions of CO, and do not exceed a

CO level of 100 ppmv measured as an

hourly rolling average.

While agreeing with CMA’s proposal,

one association commenter believed it

should be extended to combustion

residues from facilities operating

pursuant to 40 CFR part 266, subpart F,

specifically residues from precious

metal reclamation operations. The

commenter noted that the recovery of

precious metals from hazardous waste is

not a TSDF operation, and the units are

not permitted under the same CFR

sections. The commenter added that

precious metal-bearing residues also are

environmentally safe for two additional

reasons: (1) Precious metal-bearing

residues must not exhibit one or more

of the characteristics of hazardous waste

and (2) the residues must contain

economically significant amounts of

precious metals (to partake of the

authority of 40 CFR 266.100(f)), and

thus such wastes will be further

reclaimed rather than disposed,

ensuring environmentally protective

management.

One commenter supported the use of

the TCLP extract concentration limits in

Appendix VII to 40 CFR part 266 as the

criteria for excluding combustion

residues. Several commenters also

believed that solid residues from

hazardous waste combustion units that

do not exhibit any toxicity characteristic

should be considered industrial nonhazardous waste. As such, the materials

would be subject to state industrial nonhazardous waste programs.

(2) EPA Response to Comments on

Excluding Hazardous Waste

Combustion Residues

EPA is considering a possible

exclusion for certain combustion

residues, but does not believe that a

blanket exclusion from the mixture and

derived-from rules is appropriate for

such wastes. Although hazardous waste

combustors must meet at least 99.99%

DRE (destruction and removal

efficiency), metals and certain organics

may only be transferred to a residue.

27292 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

23See table 1, EPA 2000. Releases of Hazardous

Constituents Associated with Mixture and Derivedfrom Wastes (An Update) U.S. EPA, April 2000.

The constituents can become

significantly concentrated in the

residue. EPA does not believe that stack

emissions are a reliable measure of the

risk posed by the combustion residue; in

fact, as technology improves the

removal capability of air pollution

control devices, the resulting residue

will likely have greater concentrations

of hazardous constituents and may pose

unacceptable risks if mismanaged. In

addition, several of the mixture and

derived-from waste damage cases that

EPA has identified are a result of

improper disposal of combustion

residues.23

In addition, EPA is particularly

concerned about the possible formation

of dioxins and furans during hazardous

waste combustion. In the September

1999 combustion rule, we noted that

there is ‘‘a considerable body of

evidence’’ to show that dioxin and furan

compounds can be formed in the postcombustion regions of hazardous waste

combustors (see 64 FR 52994). Because

of this concern, we have added these

dioxin and furan compounds to

Appendix VIII of 40 CFR part 266,

which lists products of incomplete

combustion (PICs) likely to be found in

stack effluents.

However, EPA is considering a

proposed tailored exclusion for certain

combustion residues. For example, EPA

is currently developing for public

comment a proposed exclusion that

focuses on wastes that have been

slagged to liquefaction. These slagged

wastes are unique because the high

temperatures associated with

liquefaction (2100°F, typically) appear

to eliminate organic chemicals,

including PICs, and generate a slagged

residue which is a glassy, liquid, molten

material that, when cooled, forms a

potentially durable, homogeneous, solid

mass. This combination of elimination

of organic chemicals and change in

physical form (which can reduce risk

from non-groundwater pathways) make

these slagged residues potential

candidates for de-regulation. However,

the liquefaction process does not reduce

the concentration of toxic metals in the

waste, which we would need to evaluate

for potential risks to human health and

the environment. EPA is planning to

address this issue, as well as other

possible tailored exclusions for

combustion residues, in the upcoming

proposal.

E. Expanding the Current De Minimis

Exclusion

A final regulatory option to revise the

mixture and derived-from rules would

expand a current exclusion for ‘‘de

minimis’’ losses that result from the

manufacture of commercial chemical

products. The current exclusion, found

in 40 CFR 261.3(a)(2)(iv)(D), excludes

small losses of a commercial chemical

product that can result from normal

handling of the chemicals during the

manufacturing process. The existing

exclusion applies to commercial

chemical products or intermediates,

when they are lost during the

manufacturing operation and are

subsequently managed as a wastewater

subject to regulation under the Clean

Water Act (CWA) (see 46 FR 56586).

The suggested expansion of this option

would also exclude small losses from

the normal handling of all listed

hazardous wastes (instead of just

commercial chemical products) when

managed as a wastewater under the

CWA. One rationale for the current ‘‘de

minimis’’ exclusion is that a facility has

little economic incentive to allow spills,

leaks or other losses of commercial

products. With respect to wastes, CMA

believes that tank, container and air

emission management standards of 40

CFR parts 264 and 265, subparts I, J, BB,

and CC serve to encourage safe

management of these wastes.

(1) Summary of Comments on

Expanding the Current De Minimis

Exclusion

EPA received comments from 15

commenters in response to the

suggested expansion of the de minimis

exclusion. Of those comments, six were

received from industries, four were from

industry associations, three were from

State Agencies, one was from a Federal

Government Agency, and one was from

a waste management association. A

summary of the specific issues raised by

commenters is provided below.

Three commenters did not support

the exclusion, believing that the

exclusion might serve as an incentive

for generators to spill or leak listed

wastes into non-hazardous wastewater

systems if those wastes were eligible for

an exclusion. The current exclusion

exists for commercial chemical products

and companies typically ensure that raw

materials/products are handled in a

manner which would minimize losses,

as these materials/products are valuable.

The commenters did not believe that

companies necessarily would take the

same amount of care to prevent losses

of listed wastes, if those wastes were

excluded from Subtitle C.

One State commenter supported the

exclusion. However, the State believes

that rinsate from large hazardous waste

containers that are rendered empty

should be outside the definition of a de

minimis loss. Large containers such as

tanker trucks could contain substantial

quantities (possibly hundreds of

gallons) of hazardous waste. Such a

volume of hazardous waste is outside

the scope of losses that should be

defined as de minimis and should not

be defined as such.

One industry commenter stated that it

was not clear from the preamble

discussion what was meant by ‘‘rinsate

from empty containers or from

containers that are rendered empty by

that rinsing.’’ The commenter noted that

rinsate from containers that held

hazardous waste ‘‘generally contains

concentrations of hazardous

constituents which are at least as high

as the original waste’’ and may contain

significant quantities of solids. The

quantities used to rinse containers of

this type also may be significant

depending upon the level of

contamination in the container. In some

cases it is not possible to clean a

container to the point of being empty

under the RCRA regulations and the

container has to be disposed of as

hazardous waste. The commenter

believed that this issue must be clarified

further before any exclusion could be

considered. An industry association

commenter also noted that the CMA

proposal did not identify adequately the

wastes for which the exclusion would

operate. Since RCRA-empty container

rinsate is already excluded, the

commenter believed it should be

specified that any exclusion need only

address acute hazardous waste rinsate.

The rest of the commenters supported

expanding the de minimis exclusion to

all listed wastes. Several commenters

believed that the exclusion could be

extended beneficially to cover the very

small losses from the normal handling

of all listed wastes. The stringent

regulation of hazardous waste handling

at the site of generation means that few

losses of this type would be expected to

occur. The ability to manage de minimis

losses of listed wastes as non-hazardous

would ease RCRA compliance

significantly without compromising the

integrity of the NPDES wastewater

treatment system or protection of

human health and the environment.

The commenters noted that there was

no reason to assume that a nonhazardous industrial wastewater

treatment facility was any less capable

of providing adequate treatment of the

hazardous constituents found in listed

wastes. EPA’s stringent container and

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27293

tank management standards in 40 CFR

parts 264 and 265 subparts I and J, and

air emission standards in subpart CC,

serve as powerful incentives to properly

manage these wastes to minimize the

occurrence of ‘‘de minimis’’ losses. The

Federal commenter supported the

expansion, noting that it would provide

to military installations the same level

of regulation as is currently applicable

to manufacturing industries. One

industry commenter recommended that

facilities wishing to take advantage of

this exclusion be required to develop

and implement written Best

Management Practices (BMP) for all

loading, unloading and transfer

operations which are designed to

minimize spills and prevent abuse of

the exclusion.

One commenter questioned why EPA

never has set out a scientific rationale

by which it reserves the discriminatory

use of the de minimis rule to those

engaged in the manufacturing process

and denies it to all others, including

stand-alone bulk liquid commercial

chemical storage terminals. The

commenter also suggested that de

minimis losses include those from

normal material handling operations

(e.g., spills from the unloading or

transfer of materials from bins or other

containers, leaks from pipes, valves or

other devices used to transfer materials);

minor leaks of process equipment,

storage tanks or containers, leaks from

well-maintained pump packings and

seals; sample purgings; relief device

discharges; discharges from safety

showers and rinsing and cleaning of

personal safety equipment; and rinsate

from empty containers or from

containers that are rendered empty by

that rinsing.

Another commenter believed that

there would be significant benefits from

allowing de minimis losses of

commercial chemical products from

laboratories to be covered by the current

regulatory exclusion. The types of

commercial chemical products being

used and tested in the laboratory also

could be expected to be amenable to

effective treatment in an on-site

wastewater treatment system. The

commenter noted that significant time,

effort and cost is involved in segregating

and capturing these types of de minimis

losses from on-site laboratories.

(2) EPA’s Response to Comments on

Expanding the Current De Minimis

Exclusion

EPA is considering the possibility of

expanding the current de minimis

exclusion for wastes managed in a

wastewater treatment system subject to

the Clean Water Act. However, EPA is

concerned about the possible negative

incentives that might result from

extending the de minimis exclusion to

wastes listed in 40 CFR 261.31 and

261.32 (F and K wastes, respectively).

As noted in the comments, there is a

direct economic incentive to ensuring

that raw materials/products are handled

in a manner which would minimize

losses, as these materials/products are

valuable. This incentive does not exist

for hazardous waste. The concept of ‘‘de

minimis’’ is also variable, depending on

the quantities of material handled and

the relationship of those quantities with

the flowrate of the facility’s wastewater

treatment plant. However, EPA realizes

that separation of small leaks of certain

hazardous wastes can sometimes be

impractical.

One possible approach would be to

base the concept of ‘‘de minimis’’ on

some fixed quantity of the waste, such

as a Reportable Quantity (RQ) in

Superfund regulations (see 40 CFR

302.4 and Table 302.4). By statute, all

hazardous wastes must be given an RQ.

EPA may pursue the concept of de

minimis related to RQs (or some fraction

or multiple thereof) as we consider this

issue further. In pursuing such a change,

EPA would do so through a proposed

rulemaking.

In conclusion, EPA is currently

developing proposals related to two of

the suggestions that we believe to be the

most straightforward to address:

expanding the current headworks

exclusion and excluding certain

combustion residues (see Sections X.A.

and X.D. respectively). We will also

consider developing additional

proposals on the other suggestions as

well as other targeted exemptions, but

we believe more analysis would first be

necessary to decide how to address

specific issues raised in the public. EPA

welcomes any information or data that

would help us in developing these

analyses.

State Authorization

XI. How Will Today’s Regulatory

Changes Be Administered and Enforced

in the States?

Under section 3006 of RCRA, EPA

may authorize qualified States to carry

out the RCRA hazardous waste program

within the State. Following

authorization, we maintain independent

enforcement authority under sections

3007, 3008, 3013, and 7003 of RCRA,

although authorized States have

enforcement responsibility. An

authorized State could become

authorized for today’s regulatory

changes by following the approval

process described under 40 CFR 271.21.

See 40 CFR part 271 for the overall

standards and requirements for

authorization.

We are finalizing the retention of the

mixture and derived-from rules. Most

states have already received

authorization for the mixture and

derived-from rules as they currently

stand. The rules are already in effect in

those authorized States. Those states

that are already authorized for the

mixture and derived-from rules do not

need to obtain authorization for those

rules again. We are also revising those

rules under the authority of sections

3001(a), 3002(a), and 3004(a) of RCRA.

These revisions will not go into effect in

authorized States until they adopt the

revisions and receive authorization from

us for the revision to their regulations.

None of today’s revisions are more

stringent or broaden the scope of the

existing Federal requirements.

Authorized States are not required to

modify their programs when we

promulgate changes to Federal

requirements that are less stringent

than, or that narrow the scope of,

existing Federal requirements. This

flexibility stems from RCRA section

3009, which allows the States to impose

(or retain) standards that are more

stringent than those in the Federal

program. (See also 40 CFR 271.1(i)).

Therefore, States are not required to

adopt the revisions to the mixture and

derived-from rules in today’s rule,

although EPA will strongly encourage

their adoption.

Administrative Requirements

XII. How Has EPA Fulfilled the

Administrative Requirements for This

Rulemaking?

Several statutes and executive orders

apply to rulemaking. Below is an

explanation of how we address the

requirements in those provisions:

A. Executive Order 12866:

Determination of Significance

Under Executive Order 12866 (58 FR

51,735 (Oct. 4, 1993)), EPA must

determine whether a regulatory action is

‘‘significant’’ and, therefore, subject to

OMB review and the other provisions of

the Executive Order. The Order defines

a ‘‘significant regulatory action’’ as one

that is likely to result in a rule that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities;

27294 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or rights and

obligations or recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in Executive Order 12866.

Pursuant to the fourth term of

Executive Order 12866, we have

determined that this rule is a

‘‘significant regulatory action’’ because

there are novel policy issues arising out

of legal mandates. As such, this action

was submitted to OMB for review.

Changes made in response to OMB

suggestions or recommendations are

documented in the docket to today’s

rule.

Although today’s final rule is not

‘‘economically significant,’’ the Agency

prepared an economics background

document in support of today’s rule,

titled Economic Assessment of the U.S.

EPA’s 2001 Final Rule Revising the

Mixture and Derived-From Rules.

There are currently 29 hazardous

waste codes within the RCRA program

listed solely for ignitability (I),

corrosivity (C), and/or reactivity (R)

characteristics. Today’s rule excludes

these wastes from RCRA Subtitle C

regulation, if such wastes are decharacterized and meet the associated

LDR treatment standards.To estimate

the potential economic impact of

excluding these 29 characteristicallylisted RCRA waste codes, we analyzed

the type and quantity of industrial

hazardous wastes contained in the two

databases: the 1986 ‘‘Generator Survey’’,

and the 1996 ‘‘National Hazardous

Waste Constituent Survey.’’ These two

databases are described in the Economic

Assessment background document.

This exclusion is expected to benefit

the relevant segment of the RCRA

regulated community by reducing the

cost of shipping and disposing these decharacterized wastes. This potential cost

savings is modeled in this study as

consisting of two components:

(1) The difference between the cost for

disposal of treatment residuals from

these 29 waste codes in hazardous

landfills (i.e., current or ‘‘baseline’’

practice), compared to the cost for

disposal in nonhazardous landfills

under this exclusion.

(2) The reduction in burden hours and

associated burden cost for no longer

requiring preparation, transmitting and

filing of truck shipment hazardous

waste manifests (EPA Form 8700–22) for

these potentially excluded wastes.

The database extractions,

computations and findings of the impact

analysis are presented in the Economic

Assessment background document. The

highlights of EPA’s estimated economic

impacts for this revision are as follows:

—236 applicable industrial hazardous

waste streams, totaling 3.6 million

tons in annual generation (before

RCRA Subtitle C hazardous waste

treatment) by an estimated 120 US

facilities.

—As generated, these waste streams

consist of 99% liquid (mainly organic

liquids) and 1% non-liquid (sludge)

waste forms.

—The 3.6 million annual tons of

applicable waste (before RCRA

Subtitle C hazardous waste

treatment), represents 1.4% of the

total RCRA hazardous waste universe

(1993 BRS large generator total

quantity = 258 million tons).

—Approximately 75% of the potentially

excluded waste streams are identified

by waste code F003 (spent nonhalogenated solvents) plus a

characteristic waste code (for

example, D001), and 19% are

identified by waste code F003 only.

—Applicable waste streams are located

in 17 four-digit level SIC code

industry sectors. 146 (62%) of the 236

applicable waste streams are

generated by industries in SIC 28

(represented also by NAICS code 325).

—There are 51 different hazardous

chemical constituents in the

wastestreams before treatment;

prevalent ones include: ethylbenzene,

toluene, methyl ethyl ketone,

methanol, ethyl acetate, xylenes,

acetone, methylene chloride, and nbutyl alcohol.

—After RCRA Subtitle C treatment

(mainly incineration), the 236

wastestreams result in the annual

disposal of about 57,400 tons of

treatment residuals, primarily in the

form of incineration ash.

—Potential annual industry waste

treatment residual disposal cost

savings is estimated at $4.593 million,

while annual reduction in truck

shipment manifesting cost is

estimated at $0.455 million. These

two cost savings components

represent a total annual cost savings

estimate of $5.048 million. Applying

–15% to +30% cost estimation

uncertainty to this point-estimate (as

explained in the background

document), produces the associated

cost savings estimation range of $4.29

to $6.56 million per year.

B. Regulatory Flexibility Act

Pursuant to the 1980 Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq., as amended by the Small Business

Regulatory Enforcement Fairness Act

(SBREFA) of 1996), whenever an agency

publishes a notice of rulemaking for any

proposed or final rule, it must prepare

and make available for public comment,

a regulatory flexibility analysis that

describes the effect of the rule on small

entities (i.e., small businesses, small

organizations, and small governmental

jurisdictions). However, a regulatory

flexibility analysis is not required if the

head of an agency certifies that the rule

will not have a ‘‘significant’’ economic

impact on a substantial number of small

entities.

SBREFA amended the Regulatory

Flexibility Act to require Federal

agencies to provide a statement of the

factual basis for certifying that a rule

will not have a ‘‘significant’’ economic

impact on a substantial number of small

entities. Regulatory Flexibility Act

(RFA), as amended by the Small

Business Regulatory Enforcement

Fairness Act of 1996 (SBREFA), 5 U.S.C.

601 et. seq.

The RFA generally requires an agency

to prepare a regulatory flexibility

analysis of any rule subject to notice

and comment rulemaking requirements

under the Administrative Procedure Act

or any other statute unless the agency

certifies that the rule will not have a

significant economic impact on a

substantial number of small entities.

Small entities include small businesses,

small organizations, and small

governmental jurisdictions.

For purposes of assessing the impacts

of today’s rule on small entities, small

entity is defined as: (1) A small business

that meets the Small Business

Administration size standards

established for industries as described

in the North American Industry

Classification System (see http://

www.sba.gov/size/NAICS-coverpage.html).; (2) a small governmental

jurisdiction that is a government of a

city, county, town, school district or

special district with a population of less

than 50,000; and (3) a small

organization that is any not-for-profit

enterprise which is independently

owned and operated and is not

dominant in its field.

After considering the economic

impacts of today’s final rule on small

entities, I certify that this action will not

have a significant economic impact on

a substantial number of small entities.

In determining whether a rule has a

significant economic impact on a

substantial number of small entities, the

impact of concern is any significant

adverse economic impact on small

entities, since the primary purpose of

the regulatory flexibility analyses is to

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27295

identify and address regulatory

alternatives ‘‘which minimize any

significant economic impact of the

proposed rule on small entities.’’ 5

U.S.C. 603 and 604. Thus, an agency

may certify that a rule will not have a

significant economic impact on a

substantial number of small entities if

the rule relieves regulatory burden, or

otherwise has a positive economic effect

on all of the small entities subject to the

rule.

The following discussion presents the

facts for EPA’s determination. EPA has

examined this rule’s potential effects on

small entities as required by the RFA/

SBREFA, and has determined that this

action will not have a significant

economic impact on a substantial

number of small entities. As discussed

in Section XII.A of this preamble, we

have prepared an economic analysis of

the potential effects of this rule, and

have determined that the rule is

expected to have a net beneficial effect

on eligible entities, in the form of

reduced environmental regulatory

compliance costs for industrial waste

management. The final rule allows

small (and other size) entities

voluntarily to exempt certain solid

wastes (i.e. mixtures and derivatives of

solid wastes listed as RCRA hazardous

solely for the ignitability, corrosivity,

and/or reactivity characteristics, which

no longer exhibit any such

characteristic, and which comply with

RCRA land disposal restrictions), from

compliance with the RCRA Subtitle C

hazardous waste regulatory system. The

economic analysis evaluates the extent

to which both small quantity and large

quantity industrial waste generators

might be potentially eligible for cost

savings under this rule, as a result of

seeking this exemption. This proposed

rule is voluntary, and the overall

economic effect of this regulation for

both small and large entities which are

eligible to participate, is expected to be

a net average annual reduction in

industry regulatory burden and

compliance costs. Consequently,

because the net economic impacts and

effects of this rule are beneficial rather

than adverse, we have concluded that

today’s final rule will relieve regulatory

burden for all small entities.

C. Paperwork Reduction Act

(Information Collection Request)

The information collection

requirements in this rule have been

submitted for approval to the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq. An Information Collection

Request (ICR) document has been

prepared by EPA (ICR No. 0801.12) and

a copy may be obtained from Sandy

Farmer by mail at OP Regulatory

Information Division; U.S.

Environmental Protection Agency

(2137); 1200 Pennsylvania Avenue NW.;

Washington, DC 20460, by E-mail at

farmer.sandy@epamail.epa.gov, or by

calling (202) 260–2740. A copy may also

be downloaded off the Internet at http:/

/www.epa.gov/icr.

Today’s revisions of 40 CFR 261.3 do

not include any new recordkeeping or

reporting requirements. However, the

revisions could reduce the burden

estimate for existing RCRA information

collection requirements, such as the

Uniform Hazardous Waste Manifest

(Form 8700–22A). As discussed in

Section XII.A. of this preamble, today’s

rule could exclude approximately

54,700 tons of treated waste residuals

(mainly incineration ash) per year.

Assuming that these now-excluded

wastes are shipped offsite for disposal,

and assuming that an average truckload

carries about 20 tons (of solids), today’s

rule could result in approximately 2,870

shipments per year that would no longer

require Uniform Hazardous Waste

Manifest. (This estimate is an upper

bound, since many hazardous waste

generators manage their waste on-site).

The RCRA Hazardous Waste Manifest

System ICR (No. 0801.12.) estimates an

annual burden of 1.29 hours per

shipment of hazardous waste. Therefore,

today’s rule could reduce the total

burden associated with manifests by

3,702 hours per year. (The current

burden associated with manifests is

estimated to be 2,920,383 hours per

year).

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, disclose, or

provide information to or for a Federal

agency. This includes 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.

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

numbers for EPA’s regulations are listed

in 40 CFR part 9 and 48 CFR chapter 15.

D. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Public

Law 104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,

and tribal governments and the private

sector. Under section 202 of the UMRA,

we generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in expenditures to State, local,

and tribal governments, in the aggregate,

or to the private sector, of $100 million

or more in any one year.

Before promulgating an EPA rule for

which a written statement is needed,

section 205 of the UMRA generally

requires EPA to identify and consider a

reasonable number of regulatory

alternatives and adopt the least costly,

most cost-effective or least burdensome

alternative that achieves the objectives

of the rule. The provisions of section

205 do not apply when they are

inconsistent with applicable law.

Moreover, section 205 allows EPA to

adopt an alternative other than the least

costly, most cost-effective or least

burdensome alternative if the

Administrator publishes, with the final

rule, an explanation why that

alternative was not adopted. Before EPA

establishes any regulatory requirements

that may significantly or uniquely affect

small governments, including tribal

governments, we must have developed

a small government agency plan under

section 203 of the UMRA. The plan

must provide for notifying potentially

affected small governments, enabling

officials of affected small governments

to have meaningful and timely input in

the development of EPA regulatory

proposals with significant Federal

intergovernmental mandates, and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

Today’s revision to the mixture and

derived-from rules is voluntary, and

because these revisions are less

stringent than the current regulations,

State governments are not required to

adopt the regulatory changes. The

UMRA generally excludes from the

definition of ‘‘Federal

intergovernmental mandate’’ duties that

arise from participation in a voluntary

federal program. The UMRA also

excludes from the definition of ‘‘Federal

private sector mandate’’ duties that arise

from participation in a voluntary federal

program. Therefore we have determined

that today’s rule is not subject to the

requirements of sections 202 and 205 of

UMRA.

27296 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

E. Executive Order 13132 (Federalism)

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 implications’’ 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.’’

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. As explained in

Section XI of this preamble, none of

today’s revisions are more stringent or

broaden the scope of the existing

Federal requirements. Therefore, States

are not required to adopt the revisions

to the mixture and derived-from rules in

today’s rules. Thus, Executive Order

13132 does not apply to this rule.

Although section 6 of Executive Order

13132 does not apply to this rule, EPA

did consult with representatives of state

governments in developing this rule,

and included representatives of state

governments as participants in the

rulemaking workgroup. For an overview

of EPA’s consultations with the States,

please see Summary of Consultations

with State Representatives for the

Hazardous Waste Identification Rule

(HWIR).

F. Executive Order 13175: Consultation

and Coordination With Indian Tribal

Governments

Executive Order 13175, entitled

‘‘Consultation and Coordination with

Indian Tribal Governments’’ (65 FR

67249, November 6, 2000), 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 final rule does not have tribal

implications. It 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.

Because today’s revision to the mixture

and derived-from rules is less stringent

than the existing program, it would not

create any mandate on Indian tribal

governments. Thus, Executive Order

13175 does not apply to this rule.

G. Executive Order 13045: Protection of

Children From Environmental Health

Risks and Safety Risks

‘‘Protection of Children from

Environmental Health Risks and Safety

Risks’’ (62 FR 19885, April 23, 1997)

applies to any rule that: (1) is

determined to be ‘‘economically

significant’’ as defined under Executive

Order 12866, and (2) concerns an

environmental health or safety risk that

we have reason to believe may have a

disproportionate effect on children. If

the regulatory action meets both criteria,

we must evaluate the environmental

health or safety effects of the planned

rule on children, and explain why the

planned regulation is preferable to other

potentially effective and reasonably

feasible alternatives considered by us.

This rule is not subject to Executive

Order 13045 because it is not an

economically significant rule as defined

by Executive Order 12866 and because

the environmental health or safety risks

addressed by this action do not present

a disproportionate risk to children.

H. National Technology Transfer and

Advancement Act of 1995

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (‘‘NTTAA’’), Public Law

104–113, section 12(d) (15 U.S.C. 272

note) directs us to use voluntary

consensus standards in our regulatory

activities unless to do so would be

inconsistent with applicable law or

otherwise impractical. Voluntary

consensus standards are technical

standards (for example, materials

specifications, test methods, sampling

procedures, and business practices) that

are developed or adopted by voluntary

consensus standards bodies. The

NTTAA directs EPA to provide

Congress, through OMB, explanations

when we decide not to use available and

applicable voluntary consensus

standards. Today’s rule does not involve

technical standards. Therefore, EPA is

not considering the use of any voluntary

consensus standards.

I. Executive Order 12898:

Environmental Justice

Under Executive Order 12898,

‘‘Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations,’’ as well as through EPA’s

April 1995, ‘‘Environmental Justice

Strategy, OSWER Environmental Justice

Task Force Action Agenda Report,’’ and

National Environmental Justice

Advisory Council, EPA has undertaken

to incorporate environmental justice

into its policies and programs. EPA is

committed to addressing environmental

justice concerns, and is assuming a

leadership role in environmental justice

initiatives to enhance environmental

quality for all residents of the United

States. The Agency’s goals are to ensure

that no segment of the population,

regardless of race, color, national origin,

or income, bears disproportionately

high and adverse human health and

environmental effects as a result of

EPA’s policies, programs, and activities.

Today’s rule is not expected to

negatively impact any community, and

therefore is not expected to cause any

disproportionately high and adverse

impacts to minority or low-income

communities versus non-minority or

affluent communities.

J. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2). This rule

will be effective August 14, 2001.

Technical Correction

XIII. What Technical Correction Is EPA

Making in Today’s Rulemaking?

In today’s final rule, we also are

correcting an error made in a previous

notice. In the final rule published June

8, 2000, ‘‘Organobromines Production

Wastes; Petroleum Refining Wastes;

Identification and Listing of Hazardous

Waste; Land Disposal Restrictions; Final

Rule and Correcting Amendments’ (65

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27297

FR 36365), the entry for listed

hazardous waste code U048 (oChlorophenol) in Table 1 of Appendix

VII to 40 CFR part 268 (‘‘Effective Dates

of Surface Disposed Wastes (Non-Soil

and Debris) Regulated in the LDRsComprehensive List’’) was inadvertently

removed. Today we are amending Table

1 of Appendix VII to 40 CFR part 268

to reinsert the entry for hazardous waste

code U048. The LDR effective date for

this waste code (all waste categories)

was August 8, 1990.

List of Subjects

40 CFR Part 261

Environmental protection, Hazardous

waste, Recycling, Waste treatment and

disposal.

40 CFR Part 268

Hazardous waste, Reporting and

recordkeeping requirements.

Dated: April 30, 2001.

Christine Todd Whitman,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I of the Code

of Federal Regulations is amended as

follows:

PART 261—IDENTIFICATION AND

LISTING OF HAZARDOUS WASTE

1. The authority citation for part 261

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921,

6922, 6924(y), and 6938.

2. Section 261.3 is amended by

removing and reserving paragraph

(a)(2)(iii) and revising paragraph

(a)(2)(iv) and the first sentence of

paragraph (c)(2)(i); and by adding

paragraphs (g) and (h) to read as follows:

§ 261.3 Definition of hazardous waste.

(a) * * *

(2) * * *

(iii) [Reserved]

(iv) It is a mixture of solid waste and

one or more hazardous wastes listed in

subpart D of this part and has not been

excluded from paragraph (a)(2) of this

section under 40 CFR 260.20 and

260.22, paragraph (g) of this section, or

paragraph (h) of this section; however,

the following mixtures of solid wastes

and hazardous wastes listed in subpart

D of this part are not hazardous wastes

(except by application of paragraph

(a)(2)(i) or (ii) of this section) if the

generator can demonstrate that the

mixture consists of wastewater the

discharge of which is subject to

regulation under either section 402 or

section 307(b) of the Clean Water Act

(including wastewater at facilities

which have eliminated the discharge of

wastewater) and;

* * * * *

(c) * * *

(2) (i) Except as otherwise provided in

paragraph (c)(2)(ii), (g) or (h) of this

section, any solid waste generated from

the treatment, storage, or disposal of a

hazardous waste, including any sludge,

spill residue, ash emission control dust,

or leachate (but not including

precipitation run-off) is a hazardous

waste. * * *

* * * * *

(g)(1) A hazardous waste that is listed

in subpart D of this part solely because

it exhibits one or more characteristics of

ignitability as defined under § 261.21,

corrosivity as defined under § 261.22, or

reactivity as defined under § 261.23 is

not a hazardous waste, if the waste no

longer exhibits any characteristic of

hazardous waste identified in subpart C

of this part.

(2) The exclusion described in

paragraph (g)(1) of this section also

pertains to:

(i) Any mixture of a solid waste and

a hazardous waste listed in subpart D of

this part solely because it exhibits the

characteristics of ignitability,

corrosivity, or reactivity as regulated

under paragraph (a)(2)(iv) of this

section; and

(ii) Any solid waste generated from

treating, storing, or disposing of a

hazardous waste listed in subpart D of

this part solely because it exhibits the

characteristics of ignitability,

corrosivity, or reactivity as regulated

under paragraph (c)(2)(i) of this section.

(3) Wastes excluded under this

section are subject to part 268 of this

chapter (as applicable), even if they no

longer exhibit a characteristic at the

point of land disposal.

(h)(1) Hazardous waste containing

radioactive waste is no longer a

hazardous waste when it meets the

eligibility criteria and conditions of 40

CFR part 266, Subpart N (‘‘eligible

radioactive mixed waste’’).

(2) The exemption described in

paragraph (h)(1) of this section also

pertains to:

(i) Any mixture of a solid waste and

an eligible radioactive mixed waste; and

(ii) Any solid waste generated from

treating, storing, or disposing of an

eligible radioactive mixed waste.

(3) Waste exempted under this section

must meet the eligibility criteria and

specified conditions in 40 CFR 266.225

and 40 CFR 266.230 (for storage and

treatment) and in 40 CFR 266.310 and

40 CFR 266.315 (for transportation and

disposal). Waste that fails to satisfy

these eligibility criteria and conditions

is regulated as hazardous waste.

PART 268—LAND DISPOSAL

RESTRICTIONS

3. The authority citation for part 268

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921,

and 6924.

Appendix VII to Part 268—[Amended]

4. Appendix VII to part 268 Table 1

is amended by adding the following

wastestream in alphanumeric order (by

the first column) to read as follows:

Waste code Waste category Effective date

*******

U048 ........................................................................................ All ............................................................................................ Aug. 8, 1990.

[FR Doc. 01–11411 Filed 5–15–01; 8:45 am]

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