Hazardous Waste Management System: Identification and Listing of Hazardous Waste; Treatability Studies Sample Exclusion

SUMMARY: On July 7, 1993, the Environmental Protection Agency (EPA)

proposed revisions to the Treatability Studies Sample Exemption Rule.

The rule conditionally exempts small scale treatability studies from

Subtitle C regulation.

EPA is today issuing a final rule. The principal change to the

existing rule is to increase the quantity of contaminated media which

are conditionally exempt from Subtitle C regulation when used in

conducting treatability studies.

EFFECTIVE DATE: This rule becomes effective on February 18, 1994.

ADDRESSES: The public docket for this rulemaking is located in the RCRA

docket, located in room M2427 at the U.S. Environmental Protection

Agency, 401 M St. SW., Washington, DC 20460. The telephone number for

the docket is (202) 260-9327. The record is available for inspection by

appointment only, between the hours of 9 a.m. and 4 p.m., Monday

through Friday, excluding legal holidays. Viewers may copy up to 100

pages free of charge, after which copies cost $0.15 per page.

FOR FURTHER INFORMATION CONTACT: Questions relating to the technical

content of this rule should be directed to Jim Cummings or John

Kingscott, Technology Innovation Office (5102W), U.S. Environmental

Protection Agency at (703) 308-8796 or (703) 308-8749. Other inquiries

should be directed to the RCRA/Superfund Hotline at (800) 424-9346 or

(703) 920-9810.

SUPPLEMENTARY INFORMATION:

Outline

I. Background

II. Discussion

A. Summary of Existing Treatability Sample Exclusion Rule

B. Need and Rationale for This Rulemaking

C. Response to Major Comments

1. Quantity Limits

2. Scope of the Exemption

3. Time Limits for Sample Retention

4. Variances for Processing Additional Quantities and Extended

Time Limits

5. Treatability Studies at Federal Facilities

6. Promulgation/State Adoption

III. State Authority

IV. Effective Date

V. Regulatory Analyses

A. Executive Order 12866

B. Regulatory Flexibility Act

C. Paperwork Reduction Act

I. Background

On July 19, 1988 (52 FR 27290), EPA issued a rule that

conditionally exempted from Subtitle C hazardous waste regulation waste

samples collected for purposes of conducting small-scale treatability

studies. 40 CFR 261.4 (e)-(f). This rule was promulgated in recognition

of the inhibiting effect of the stringent Resource Conservation and

Recovery Act (RCRA) Subtitle C requirements on the development of new

treatment capacity, and the minimal public health and environmental

risks involved in conducting small-scale treatability studies. The rule

identified specific quantities of various types of wastes which could

be transported, stored and used in treatability studies without the

need for RCRA Subtitle C regulation.

On July 7, 1993 (58 FR 36367), EPA proposed amendments to the

existing rule which would increase the quantity limits for major

classes of contaminated media (specifically soil and debris) which

could be employed in treatability studies without triggering RCRA

Subtitle C requirements. The proposal was based in part on the

recognition that larger quantities of soil and debris were often needed

for treatability testing by technology developers. Larger-scale testing

also greatly increases the confidence with which remedial action

decision-makers make remedy selection decisions, thus improving CERCLA

response activities and RCRA corrective actions, see 58 FR 36367,

36370.

EPA also requested comment on the desirability of an amendment to

increase the quantity limits for other forms of remediation waste in

addition to soil and debris. The proposal also included an amendment

which would allow longer time frames for conducting treatability

studies involving bioremediation, and solicited comment on appropriate

time limits for other technologies. EPA did not request comment on, or

reopen the comment period on, the propriety of the existing exemption.

Twenty-seven comments were received in response to the proposed

rule. The comments were universally favorable regarding the need for

and desirability of increasing the treatability study quantity limits.

A substantial majority of the comments favored extending the scope

beyond soil and debris to other forms of remediation and/or hazardous

waste. General reasons offered by commenters mirror those stated in the

proposed rule, e.g., assisting technology development and increasing

confidence in remedy selection.

EPA is today issuing a final rule which increases the quantity and

time limits for contaminated media to be used in treatability studies.

The rule would increase the exempt amounts from 1000 kg up to 10,000 kg

of media contaminated with non-acute hazardous waste and from 250 kg to

2500 kg of media contaminated with acute hazardous, when used in

treatability studies.

The existing case-by-case variance provision (40 CFR 261.4(e)(3))

is increased from 500 kg to 5000 kg for media contaminated with non-

acute hazardous waste and from 250 kg to 2500 kg for media contaminated

with acute hazardous waste. The existing variance provision focuses on

allowing limited additional quantities after the initial increment of

material is processed. EPA is adding criteria to the variance provision

to allow the additional quantity to be requested in advance.

EPA is also increasing the time limits for treatability studies

involving bioremediation. Treatability studies involving bioremediation

have an initial period of two years to complete testing, and under the

case-by-case variance provisions discussed below, may request up to an

additional two years.

The remainder of the preamble discusses the major comments received

on the proposed rule and EPA's response to them. All other comments are

discussed in a background document that is available in the RCRA

docket.

II. Discussion

A. Summary of the Existing Treatability Sample Exclusion Rule

The existing Treatability Sample Exclusion rule imposes limits on

the quantity of material which may be shipped, stored or treated under

the exemption. In order to qualify for the conditional exclusion,

laboratory and test facilities must comply with the following quantity

and time limitations as well as notification, reporting and record-

keeping requirements:

Shipment--The mass of each sample shipment may not exceed 1000 kg

of ``as received'' hazardous waste, 1 kg of acute hazardous waste, or

250 kg soils, water, or debris contaminated with acute hazardous waste.

40 CFR 261.4(e)(2)(ii). ``As received'' refers to the waste shipped by

the generator or sample collector as it arrives at the laboratory or

testing facility. 40 CFR 261.4(f)(3).

Storage--The laboratory or testing facility may store up to 1000 kg

of non-acute hazardous waste. This limitation can include 500 kg of

soils, water, or debris contaminated with acute hazardous waste or 1 kg

of acute hazardous waste. 40 CFR 261.4(f)(4).

Treatment--The laboratory or testing facility, on a per waste

stream per treatment process basis, may conduct treatability tests on

up to 1000 kg of non-acute hazardous waste, 250 kg of soils, water, or

debris contaminated with acute hazardous waste, or 1 kg of acute

hazardous waste. 40 CFR 261.4(e)(2)(i). The rule imposes a treatment

initiation rate limit of 250 kg per day of ``as received'' waste for

the entire laboratory or testing facility.

Time Limits--The existing exclusion requires that the laboratory or

testing facility return the sample to the generator or sample

collector, or send it to a designated facility within 90 days of

completion of the treatability study, or no more than one year from the

time the generator or sample collector shipped the sample to the

laboratory or testing facility, whichever date first occurs. 40 CFR

261.4(f)(5).

EPA did not seek comment on the propriety of these exemption levels

or criteria, but merely sought comment on amendments that would expand

the scope of the existing rule.

B. Need and Rationale for Amendments to the Existing Rule

The preamble to the proposed rule contained an extensive discussion

of the reasons the Agency felt that amendments to the existing rule

were desirable. 58 FR 36367 (July 7, 1993). Interested readers are

referred to that document for further information.

C. Response to Major Comments

1. Quantity Limits

All commenters supported an amendment to increase the quantity

limits in the exemption for soil and debris samples by at least the

quantities proposed. Almost 50% of the comments suggested adopting

higher exemption limits on either an across-the-board or a case-by-case

basis.

Commenters noted the significant challenges posed in designing and

verifying the operational performance of treatment processes.

Commenters also noted the challenges encountered in designing and

testing ancillary system components--e.g., material handling equipment

(getting the waste material into the treatment unit in an appropriate

physical state and condition), and emission control equipment. Smaller-

scale tests conducted at the laboratory or bench scale often do not

involve ancillary system components, or may not utilize sufficient

throughput to adequately test these components.

Suggestions to further increase the quantity limits ranged as high

as 25,000 kg. Other comments suggested that quantity limits higher than

those proposed be set on a case-by-case basis. These comments

identified site size, the nature of the waste and/or the remediation

technology, the concentration of hazardous constituents in the waste

matrix, and the intent of the study as possible factors to be

considered in these case-by-case determinations.

EPA is aware that the larger the scale of the technology

development or remedy selection treatability study, the more likely the

results will represent the performance of full-scale remedial

equipment. Furthermore, EPA's proposal identified the need to address

materials handling problems as a major basis for the proposed revision.

The data adduced by EPA in the proposed rule support the conclusion

that many of the technologies can be tested within the limits proposed.

Nevertheless, EPA's own data also confirm that there are situations

where additional quantities may be necessary in order to conduct

treatability studies at an appropriate scale.

The existing rule has a provision for case-by-case approval of

additional quantities. 40 CFR 261.4(e)(3). As discussed further below,

EPA is modifying the variance provision to allow advance approval, on a

case-by-case basis, of conducting studies on additional quantities of

contaminated media. Due to the potential for delay in processing case-

by-case applications, laboratory and testing facilities should

carefully consider the tradeoffs in seeking advance approval of

additional quantities.

2. Scope of the Exemption

All comments supported the basic proposal to increase the quantity

limits for soil and debris. In response to EPA's solicitation of

comment on increasing the scope of the revision beyond soil and debris,

a substantial majority of the comments recommended extending the

quantity increases to various other forms of hazardous waste. Comments

differed on the exact scope beyond soil and debris--e.g., all hazardous

waste, `remediation waste', wastewater and/or groundwater.

Reasons suggested for increasing the scope beyond soil and debris

included the difficulty of determining the boundary between sludge and

media in, for example, unlined lagoons; the low concentration of

contaminants in groundwater; the need for longer-duration continuous

flow tests; and the need to develop integrated, optimized remediation

approaches in the case of `remediation waste' in general. A number of

commenters also suggested extending the increases to all forms of

hazardous waste, which would include newly-generated industrial

hazardous wastes.

In response to these comments, and in light of EPA's own experience

regarding the variety of contaminated media encountered in cleanup

efforts, EPA is at this time modifying the scope of the exemption to

reach contaminated media, including groundwater, surface water, soils,

sediment and debris that contain listed hazardous waste or that

themselves exhibit a characteristic. However, the proposal did not

focus on samples of newly-generated waste or waste sludges, and the

Agency is not taking final action of those materials at this time. EPA

is considering additional rulemaking to address larger scale

treatability studies on other forms of hazardous waste.1

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\1\As noted by several commenters, sludges will have often

become commingled with underlying media, and present difficulty for

those attempting to collect media samples for shipment. EPA agrees

that it may be difficult to distinguish sludges from underlying

media. Where uncontainerized sludges have come into contact with

underlying media, EPA does not expect sample collectors to undertake

extraordinary efforts to assure that samples consist only of

contaminated media.

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3. Time Limits for Sample Retention

As discussed above, EPA proposed to allow up to two years for

treatability studies involving bioremediation. EPA solicited comment on

whether these time frames were sufficient, and whether testing

involving other technologies also required longer time frames. No

negative comments were received on this proposal. Comments included

suggestions that the allowable time period be even longer and/or that

additional technologies (e.g., phytoremediation and solidification/

stabilization) be eligible for longer duration studies.

With regard to the time limits, EPA believes that two years should

be adequate for most treatability testing involving

bioremediation.2 Nevertheless, as discussed below, EPA is

modifying the case-by-case variance provisions to allow up to an

additional two years for completion of such studies.

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\2\As a point of clarification, for purposes of this rule, EPA

considers phytoremediation to be a form of bioremediation.

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EPA expects that this provision will be used judiciously.

Laboratory and testing facilities cannot exceed the limits in the rule

on the amount of material which may be stored and treated. (e.g.,

10,000 kg of media contaminated with non-acute hazardous waste plus

5000 kg if a full variance quantity request is granted). On-going

studies reduce the quantity of materials which may be stored for use in

new studies.

With regard to stabilization/solidification, EPA's experience in

the Superfund Innovative Technology Evaluation (S.I.T.E.) program

indicates that a one-year time frame is generally adequate.

Modifications discussed below which allow retaining small samples of

treated materials should address some of the concerns underlying

suggestions for allowing longer duration studies for this technology

(e.g., to ensure the long-term efficacy of the stabilization).

Several comments addressed the desirability of retaining samples of

treated material for future analysis. EPA understands that such a

provision may be useful for technologies such as solidification/

stabilization where the attributes of treated material such as

compressive strength and leachability of contaminants may change over

time, or solvent extraction where there may be issues of the long-term

biodegradability of residual solvent in treated soil.

In response to these comments, EPA is promulgating a provision

allowing up to 500 kg of treated material from a particular wastestream

from treatability studies to be stored by the laboratory or testing

facility for up to 5 years. Material archived for future analysis must

be included in the storage quantity limit for the facility--e.g., a

facility which archives two 500 kg samples from separate waste streams

may only store up to 9,000 kg (plus 5000 kg if a variance is granted)

of additional material, and must be identified as such in facility

records and reports.

4. Variances for Requesting Additional Quantities and Extended Time

Limits

Several commenters suggested that the variance provisions in the

existing rule (40 CFR 261.4(e)(3)) be increased by the same factor

applied to the base quantity allowed. For example, under the existing

rule laboratories or testing facilities could request approval for

further testing on up to an additional 500 kg from a particular

wastestream. Comments included raising the variance limit for

contaminated media by the same amount as the basic proposal. The

variance provisions allow additional quantities of materials to be used

in treatability studies on a case-by-case basis if specified conditions

are met--e.g., mechanical failure during the initial treatability study

or need to verify the results of a previously conducted study. As with

the comments relating to quantity limits in general, commenters

suggested across-the-board and case-by-case approaches to variances.

EPA finds the suggestion to allow increased quantities of

contaminated media to a set maximum on a case-by-case basis to be

reasonable. EPA is modifying the variance quantity by the same factor

by which it is increasing the basic quantity limit.

Thus, laboratory and testing facilities may request up to an

additional 5000 kg of media contaminated with non-acute hazardous

waste, or 2500 kg of media contaminated with acute hazardous waste. The

Agency considers this to be a conforming change to the general concept

of allowing larger quantity studies, and views it as a logical

outgrowth of the proposed rule.

Furthermore, as discussed above, in response to comments that

quantities beyond those proposed be allowed on a case-by-case basis,

EPA is also adding a provision that will allow laboratory and testing

facilities to apply for advance authorization for variances. Factors to

be considered in reviewing advance requests for additional quantities

include the nature of the technology, the type of process (e.g., batch

versus continuous), size of the unit undergoing testing (particularly

in relation to scale-up considerations), time/quantity of material

required to reach steady-state operating conditions, and test design

considerations such as mass balance calculations.

Finally, the case-by-case variance provision has been modified to

allow laboratory and testing facilities conducting bioremediation

treatability studies to request a variance of up to two additional

years to complete their studies.

5. Treatability Studies at Federal Facilities

Several comments requested clarification of the status of federal

facilities for purposes of eligibility for the treatability study

sample exclusion. Federal facilities are often large in size, with

numerous different contamination problems for which solutions must be

developed and applied. EPA notes that the rule identifies ``laboratory

or test facilities'' as the entities which may take advantage of the

conditional exclusion. The Agency would not consider a large federal

installation with numerous laboratories or testing sites to be a single

``laboratory or test facility'' for purposes of this rule.

Distinguishing attributes include the requirement to obtain an EPA

Identification number for each laboratory or test facility. 40 CFR

261.4(f)(2).

6. Promulgation/State Adoption

Comments on State Authorities are addressed below in the ``State

Authority'' section.

III. State Authority

A number of comments indicated that the efficacy of this rule

depends to a considerable extent on the availability of the exclusion

at the State level. Since the original treatability sample exclusion

rule was promulgated under RCRA and not the Hazardous and Solid Waste

Act Amendments of 1984 (HSWA), this revision is also promulgated

pursuant to RCRA. As with the existing rule, the revisions promulgated

today are not immediately effective in authorized States, since this

rulemaking does not impose requirements or prohibitions contained in

HSWA. Thus this regulation will be applicable only in those States that

do not have final authorization for the non-HSWA base RCRA program.

In a State authorized to implement the base RCRA program, the

proposed regulation would not be applicable until the State revises its

program to adopt equivalent regulations under State law. However, as

with the original rule these proposed changes are less stringent or

reduce the scope of the Federal program. Therefore, although EPA

strongly encourages timely adoption, authorized States are not required

to modify their programs to adopt regulations consistent with and

equivalent to this rulemaking. The Agency plans to work with States to

encourage timely adoption of this rule because of its benefits to the

development of treatment capacity.

IV. Effective Date

This rule is effective immediately upon publication. HSWA amended

section 3010 of RCRA to allow rules to become effective in less than 6

months when the regulated community does not need the 6-month period to

come into compliance. This is the case here, because this rule reduces

the existing requirements for laboratories and test facilities

conducting treatability studies on contaminated media. An effective

date 6 months after publication would impose unnecessary expense and

regulatory burden upon those persons the rule is designed to benefit,

and might delay the achievement of the rule's objective of improving

CERCLA response activities and RCRA corrective actions by facilitating

treatability studies. These reasons also provide a basis for making

this rule effective immediately upon final promulgation under the

Administrative Procedures Act, 5 U.S.C. 553(d).

V. Regulatory Analyses

A. Executive Order 12866

OMB has determined that this rule is not a significant rule within

the meaning of Executive Order 12866.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.,

whenever an Agency is required to publish general 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

impact of the rule on small entities (i.e., small businesses, small

organizations, and small governmental jurisdictions).

The purpose of the original rule was to eliminate time-consuming

and costly permitting requirements. This revision extends the scope of

activities which may be conducted without requirements to obtain

permits, and will thus have additional positive effects on small

entities.

This amendment will have no adverse economic impact on small

entities. In fact, it should reduce the burden imposed on small

entities that conduct treatability studies and comply with the

provisions of this rulemaking. Accordingly, I hereby certify that this

rule will not have a significant economic impact on a substantial

number of small entities. This regulation therefore does not require a

regulatory flexibility analysis.

C. Paperwork Reduction Act

This rule does not contain any new information collection

requirements subject to OMB review under the Paperwork Reduction Act,

44 U.S.C. 3501 et seq.

To the extent that this rule discusses information collection

requirements imposed under existing regulations, these requirements

have been approved by the Office of Management and Budget (OMB) under

the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and have been

assigned OMB control number 2050-0053.

List of Subjects in 40 CFR Part 261

Hazardous waste, Recycling.

Dated: February 9, 1994.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble, title 40 of the Code of

Federal Regulations is amended to read 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, and 6938.

2. Section 261.4 is amended by revising paragraphs (e)(2)(i) and

(e)(2)(ii), (e)(3), (f)(3), (f)(4), and (f)(5) to read as follows:

Sec. 261.4 Exclusions.

* * * * *

(e) * * *

(2) * * *

(i) The generator or sample collector uses (in ``treatability

studies'') no more than 10,000 kg of media contaminated with non-acute

hazardous waste, 1000 kg of non-acute hazardous waste other than

contaminated media, 1 kg of acute hazardous waste, 2500 kg of media

contaminated with acute hazardous waste for each process being

evaluated for each generated waste stream; and

(ii) The mass of each sample shipment does not exceed 10,000 kg;

the 10,000 kg quantity may be all media contaminated with non-acute

hazardous waste, or may include 2500 kg of media contaminated with

acute hazardous waste, 1000 kg of hazardous waste, and 1 kg of acute

hazardous waste; and

* * * * *

(3) The Regional Administrator may grant requests on a case-by-case

basis for up to an additional two years for treatability studies

involving bioremediation. The Regional Administrator may grant requests

on a case-by-case basis for quantity limits in excess of those

specified in paragraphs (e)(2) (i) and (ii) and (f)(4) of this section,

for up to an additional 5000 kg of media contaminated with non-acute

hazardous waste, 500 kg of non-acute hazardous waste, 2500 kg of media

contaminated with acute hazardous waste and 1 kg of acute hazardous

waste:

(i) In response to requests for authorization to ship, store and

conduct treatabilty studies on additional quantities in advance of

commencing treatability studies. Factors to be considered in reviewing

such requests include the nature of the technology, the type of process

(e.g., batch versus continuous), size of the unit undergoing testing

(particularly in relation to scale-up considerations), the time/

quantity of material required to reach steady state operating

conditions, or test design considerations such as mass balance

calculations.

(ii) In response to requests for authorization to ship, store and

conduct treatability studies on additional quantities after initiation

or completion of initial treatability studies, when: There has been an

equipment or mechanical failure during the conduct of a treatability

study; there is a need to verify the results of a previously conducted

treatability study; there is a need to study and analyze alternative

techniques within a previously evaluated treatment process; or there is

a need to do further evaluation of an ongoing treatability study to

determine final specifications for treatment.

(iii) The additional quantities and timeframes allowed in paragraph

(e)(3) (i) and (ii) of this section are subject to all the provisions

in paragraphs (e) (1) and (e)(2) (iii) through (vi) of this section.

The generator or sample collector must apply to the Regional

Administrator in the Region where the sample is collected and provide

in writing the following information:

(A) The reason why the generator or sample collector requires

additional time or quantity of sample for treatability study evaluation

and the additional time or quantity needed;

(B) Documentation accounting for all samples of hazardous waste

from the waste stream which have been sent for or undergone

treatability studies including the date each previous sample from the

waste stream was shipped, the quantity of each previous shipment, the

laboratory or testing facility to which it was shipped, what

treatability study processes were conducted on each sample shipped, and

the available results on each treatability study;

(C) A description of the technical modifications or change in

specifications which will be evaluated and the expected results;

(D) If such further study is being required due to equipment or

mechanical failure, the applicant must include information regarding

the reason for the failure or breakdown and also include what

procedures or equipment improvements have been made to protect against

further breakdowns; and

(E) Such other information that the Regional Administrator

considers necessary.

(f) * * *

(3) No more than a total of 10,000 kg of ``as received'' media

contaminated with non-acute hazardous waste, 2500 kg of media

contaminated with acute hazardous waste or 250 kg of other ``as

received'' hazardous waste is subject to initiation of treatment in all

treatability studies in any single day. ``As received'' waste refers to

the waste as received in the shipment from the generator or sample

collector.

(4) The quantity of ``as received'' hazardous waste stored at the

facility for the purpose of evaluation in treatability studies does not

exceed 10,000 kg, the total of which can include 10,000 kg of media

contaminated with non-acute hazardous waste, 2500 kg of media

contaminated with acute hazardous waste, 1000 kg of non-acute hazardous

wastes other than contaminated media, and 1 kg of acute hazardous

waste. This quantity limitation does not include treatment materials

(including nonhazardous solid waste) added to ``as received'' hazardous

waste.

(5) No more than 90 days have elapsed since the treatability study

for the sample was completed, or no more than one year (two years for

treatability studies involving bioremediation) have elapsed since the

generator or sample collector shipped the sample to the laboratory or

testing facility, whichever date first occurs. Up to 500 kg of treated

material from a particular waste stream from treatability studies may

be archived for future evaluation up to five years from the date of

initial receipt. Quantities of materials archived are counted against

the total storage limit for the facility.

* * * * *

[FR Doc. 94-3745 Filed 2-17-94; 8:45 am]

BILLING CODE 6560-50-P