[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Rules and Regulations]
[Pages 9138-9180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3454]



[[Page 9137]]

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Part II





Environmental Protection Agency





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40 CFR Parts 148, 261, et al.



Hazardous Waste--Nonwastewaters From Productions of Dyes, Pigments, and 
Food, Drug, and Cosmetic Colorants; Mass Loadings-Based Listing; Final 
Rule

  Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / 
Rules and Regulations  

[[Page 9138]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 148, 261, 268, 271, and 302

[RCRA-2003-0001; FRL-7875-8]
RIN 2050-AD80


Hazardous Waste Management System; Identification and Listing of 
Hazardous Waste; Dyes and/or Pigments Production Wastes; Land Disposal 
Restrictions for Newly Identified Wastes; CERCLA Hazardous Substance 
Designation and Reportable Quantities; Designation of Five Chemicals as 
Appendix VIII Constituents; Addition of Four Chemicals to the Treatment 
Standards of F039 and the Universal Treatment Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is today listing as 
hazardous nonwastewaters generated from the production of certain dyes, 
pigments, and FD&C colorants. EPA is promulgating this regulation under 
the Resource Conservation and Recovery Act (RCRA), which directs EPA to 
determine whether these wastes pose a substantial present or potential 
hazard to human health or the environment when they are improperly 
treated, stored, transported, disposed of or otherwise managed. This 
listing sets annual mass loadings for constituents of concern, such 
that wastes would not be hazardous if the constituents are below the 
regulatory thresholds. If the wastes meet or exceed the regulatory 
levels for any constituents of concern, the wastes must be managed as 
listed hazardous wastes, unless the wastes are either disposed in a 
landfill unit that meets certain liner design criteria, or treated in a 
combustion unit as specified in the listing description. This rule also 
adds five toxic constituents to the list of hazardous constituents that 
serves as the basis for classifying wastes as hazardous. In addition, 
this rule establishes Land Disposal Restrictions (LDR) treatment 
standards for the wastes, and designates these wastes as hazardous 
substances subject to the Comprehensive Environmental Response, 
Compensation, and Liability Act (CERCLA). This rule does not adjust the 
one pound statutory reportable quantity (RQ) for the waste.

DATES: This final rule is effective on August 23, 2005.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. RCRA-2003-0001. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information may not be publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the RCRA Docket, EPA/DC, EPA West, Room B102, 1301 Constitution 
Ave., NW, Washington, DC. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the RCRA Docket is (202) 566-0270. This Docket 
Facility is open from 8:30 a.m.-4:30 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: For general information, review our 
website at http://www.epa.gov/epaoswer/hazwaste/id/dyes/index.htm. For 
information on specific aspects of the rule, contact Robert Kayser, 
Hazardous Waste Identification Division, Office of Solid Waste (5304W), 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (703) 308-7304; fax number: 
(703) 308-0514; e-mail address: [email protected]. For technical 
information on the CERCLA aspects of this rule, contact Ms. Lynn 
Beasley, Office of Emergency Prevention, Preparedness, and Response, 
Emergency Response Center (5204G), U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone 
number: (703) 603-9086; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: 

Readable Regulations

    Today's preamble and regulations are written in ``readable 
regulations'' format. The authors tried to use active rather than 
passive voice, plain language, a question-and-answer format, the 
pronouns ``we'' for EPA and ``you'' for the owner/generator, and other 
techniques to make the information in today's rule easier to read and 
understand. This format is part of our efforts toward regulatory 
improvement. We believe this format helps readers understand the 
regulations, which should then increase compliance, make enforcement 
easier, and foster better relationships between EPA and the regulated 
community.

                        Acronyms Used in the Rule
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             Acronym                             Definition
------------------------------------------------------------------------
BDAT.............................  Best Demonstrated Available
                                    Technology.
BIODG............................  Biodegradation.
CAA..............................  Clean Air Act.
CARBN............................  Carbon absorption.
CAS..............................  Chemical Abstract Services.
CBI..............................  Confidential Business Information.
CCL..............................  Compacted clay liner.
CERCLA...........................  Comprehensive Environmental Response
                                    Compensation and Liability Act.
CFR..............................  Code of Federal Regulations.
CHOXD............................  Chemical or electrolytic oxidation.
CMBST............................  Combustion.
CoC..............................  Constituent of concern.
CI...............................  Colour Index.
CPMA.............................  Color Pigments Manufacturers
                                    Association.
CWA..............................  Clean Water Act.
CWTP.............................  Centralized wastewater treatment
                                    plant.
ED...............................  Environmental Defense (previously the
                                    Environmental Defense Fund or EDF).
E.O..............................  Executive Order.
EP...............................  Extraction Procedure.

[[Page 9139]]

 
EPA..............................  Environmental Protection Agency.
EPACMTP..........................  EPA's Composite Model for Leachate
                                    Migration with Transformation
                                    Products.
EPCRA............................  Emergency Planning and Community
                                    Right-To-Know Act.
ETAD.............................  Ecological and Toxicological
                                    Association of Dyes and Organic
                                    Pigments Manufacturers.
EU...............................  European Union.
fb...............................  Followed by.
FDA..............................  Food and Drug Administration.
FD&C.............................  Food, Drug and Cosmetic.
FR...............................  Federal Register.
GCL..............................  Geosynthetic clay liner.
GC/MS............................  Gas Chromatography/Mass Spectroscopy.
GM...............................  Geomembrane.
GSCM.............................  General Soil Column Model.
HELP.............................  Hydrologic Evaluation of Landfill
                                    Performance.
HGDB.............................  Hydrogeologic Database.
HPLC.............................  High Performance Liquid
                                    Chromatography.
HQ...............................  Hazard Quotient.
HSWA.............................  Hazardous and Solid Waste Amendments.
ICR..............................  Information Collection Request.
kg/yr............................  Kilogram/year.
LDR..............................  Land Disposal Restriction.
mg/kg............................  Milligram per kilogram.
mg/L.............................  Milligram per liter.
MSW..............................  Municipal Solid Waste.
MT...............................  Metric ton.
NAICS............................  North American Industrial
                                    Classification System.
OMB..............................  Office of Management and Budget.
OSW..............................  Office of Solid Waste.
OSWER............................  Office of Solid Waste and Emergency
                                    Response.
POTW.............................  Publicly owned treatment works.
ppm..............................  Parts per million.
PRA..............................  Paperwork Reduction Act.
QA...............................  Quality Assurance.
QC...............................  Quality Control.
RCRA.............................  Resource Conservation and Recovery
                                    Act.
RFA..............................  Regulatory Flexibility Act.
RFSA.............................  Regulatory Flexibility Screening
                                    Analysis.
RQ...............................  Reportable Quantity.
SAB..............................  Science Advisory Board.
SBA..............................  Small Business Administration.
SBREFA...........................  Small Business Regulatory Enforcement
                                    Fairness Act.
SIC..............................  Standard Industry Code.
SW-846...........................  Test Methods for Evaluating Solid
                                    Wastes.
TRI..............................  Toxic Release Inventory.
UCLM.............................  Upper confidence limit of the mean.
UMRA.............................  Unfunded Mandates Reform Act.
U.S.C............................  United States Code.
UTS..............................  Universal Treatment Standard.
WETOX............................  Wet air oxidation.
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Contents of This Final Rule

I. Overview
    A. Who Will Be Affected by This Final Rule?
    B. What Are the Statutory Authorities for This Final Rule?
    C. How Does the ED v. Johnson Consent Decree Impact This Final 
Rule?
II. Summary of Today's Action
III. Summary of Proposed Rule
    A. What Wastes Did EPA Propose To List as Hazardous?
    B. How Was This Proposal Different From Prior Hazardous Waste 
Listing Determinations?
    C. Which Constituents Did EPA Propose To Add to Appendix VIII of 
40 CFR Part 261?
    D. What Was the Proposed Status of Landfill Leachate From 
Previously Disposed Wastes?
    E. What Were the Proposed Treatment Standards Under RCRA's Land 
Disposal Restrictions Standards?
    F. What Risk Assessment Approach Was Used for the Proposed Rule?
IV. What Is the Rationale for Today's Final Rule?
    A. Final Listing Determination
    1. Toluene-2,4-diamine
    2. Use of Clay-Lined and Composite-Lined Landfills
    3. Status of Wastes That Are Combusted
    4. Scope of Listing Definition
    5. Waste Quantities
    6. Prevalence of Constituents of Concern
    7. Availability of Analytical Methods for Constituents of 
Concern
    8. Risk Assessment
    9. Implementation
    10.Exemption for Non-Municipal Landfills
    B. Final ``No List'' Determination for Wastewaters
    C. What Is the Status of Landfill Leachate Derived From Newly-
Listed K181 Wastes?
    D. What Are the Final Treatment Standards Under RCRA's Land 
Disposal Restrictions for the Newly-Listed Hazardous Wastes?
    1. What Are EPA's Land Disposal Restrictions (LDRs)?
    2. How Does EPA Develop LDR Treatment Standards?
    3. What Are the Treatment Standards for K181?
    E. Is There Treatment Capacity for the Newly Listed Wastes?

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    1. Introduction
    2. What Are the Capacity Analysis Results for K181?
V. When Must Regulated Entities Comply With the Provisions in 
Today's Final Rule?
    A. Effective Date
    B. Section 3010 Notification
    C. Generators and Transporters
    D. Facilities Subject to Permitting
    1. Facilities Newly Subject to RCRA Permit Requirements
    2. Existing Interim Status Facilities
    3. Permitted Facilities
    4. Units
    5. Closure
VI. State Authority and Compliance
    A. How Are States Authorized Under RCRA?
    B. How Does This Rule Affect State Authorization?
VII. CERCLA Designation and Reportable Quantities
    A. How Does EPA Determine Reportable Quantities?
    B. What Is the RQ for the K181 Waste?
    C. When Would I Need To Report a Release of These Wastes Under 
CERCLA?
    D. How Would I Report a Release?
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    1. Summary of Proposed Rule Findings: Costs, Economic Impacts, 
Benefits
    2. Public Comments and Agency Responses
    3. Revised Findings
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    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 and Safety Risks
    H. Executive Order 12898: Environmental Justice
    I. Executive Order 13211: Actions Affecting Energy Supply, 
Distribution, or Use
    J. National Technology Transfer and Advancement Act
    K. The Congressional Review Act (5 U.S.C. 801 et seq., as Added 
by the Small Business Regulatory Enforcement Fairness Act of 1996)

I. Overview

A. Who Will Be Affected by This Final Rule?

    Today's final action will affect those who handle the wastes that 
we are adding to EPA's list of hazardous wastes under the RCRA program. 
This regulation could directly impact businesses that generate and 
manage certain organic dyes and/or pigment production wastes. In 
addition, manufacturers that do not make dyes or pigments, but that 
generate wastes containing selected constituents of concern, may be 
indirectly impacted. This is because we are adding new treatment 
standards for four chemicals, and we are adding five new constituents 
to the list of hazardous constituents on Appendix VIII of part 261. 
Thus, these actions may result in indirect impacts on these 
manufacturers. In addition, landfill owners/operators who previously 
accepted these wastes may be indirectly impacted. This action may also 
affect entities that need to respond to releases of these wastes as 
CERCLA hazardous substances. Impacts on potentially affected entities, 
direct and indirect, are summarized in section VIII of this Preamble. 
The document, ``Economic Assessment for the Proposed Loadings-Based 
Listing of Non-Wastewaters from the Production of Selected Organic 
Dyes, Pigments, and Food, Drug, and Cosmetic Colorants,'' November 2003 
(hereafter known as the Economic Assessment Document) presents a 
comprehensive analysis of potentially impacted entities. Further 
updated analysis is also presented in the ``Revised Impacts 
Assessment.'' \1\ These documents are available in the docket for 
today's rule. A summary of potentially affected businesses is provided 
in the table below.
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    \1\ Memorandum from Lyn D. Luben to the RCRA Docket, July 21, 
2004.

 Table 1.--Summary of Facilities Potentially Affected by the U.S. EPA's 2005 Dyes and/or Pigments Manufacturing
                                            Waste Listing Final Rule
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                                                                                            Estimated number of
              SIC code                     NAICS code            Industry sector name      relevant facilities*
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Directly Impacted:
    2865...........................  325132-1..............  Synthetic Organic Dyes.....  31.
                                     325132-4..............  Synthetic Organic Pigments,
                                                              Lakes, and Toners.
Indirectly Impacted:
    2800 (except 2865).............  325 (except 325132)...  Chemical Manufacturing.....  Less than 50
                                                                                           facilities total.**
    4953...........................  562212................  Solid Waste Landfills and
                                                              Disposal Sites,
                                                              Nonhazardous.
    5169...........................  42269.................  Other Chemicals and Allied
                                                              Products (wholesale) .
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SIC--Standard Industrial Classification.
NAICS--North American Industry Classification System.
*Note: The figures in this column represent individual facilities, not companies. A total of 22 companies are
  expected to be impacted under this NAICS.
**Estimate based on 13 expanded scope facilities plus no more than 37 separate solid waste landfills (562212)
  potentially receiving wastes of concern.

    The list of potentially affected entities in the above table may 
not be exhaustive. Our aim is to provide a guide for readers regarding 
entities likely to be regulated by this action. This table lists those 
entities that we are aware of that potentially could be affected by 
this action. However, this action may affect other entities not listed 
in the table. To determine whether your facility is regulated by this 
action, you should examine 40 CFR parts 260 and 261 carefully in 
concert with the final rules amending these regulations that are 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 person listed in the preceding section entitled FOR FURTHER 
INFORMATION CONTACT.

B. What Are the Statutory Authorities for This Final Rule?

    Today's hazardous waste regulations are promulgated under the 
authority of Sections 2002(a), 3001(b), 3001(e)(2), 3004(d)-(m) and 
3007(a) of the Solid Waste Disposal Act, 42 U.S.C. 6912(a), 6921(b) and 
(e)(2), 6924(d)-(m) and 6927(a), as amended several times, most 
importantly by the Hazardous and Solid

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Waste Amendments of 1984 (HSWA). These statutes commonly are referred 
to as the Resource Conservation and Recovery Act (RCRA), are codified 
at Volume 42 of the United States Code (U.S.C.), Sections 6901 to 
6992(k) (42 U.S.C. 6901-6992(k)).
    Section 102(a) of the Comprehensive Environmental Response, 
Compensation, and Liability Act of 1980 (CERCLA), 42 U.S.C. 9602(a) is 
the authority under which the CERCLA aspects of this rule are 
promulgated.

C. How Does the ED v. Johnson Consent Decree Impact This Final Rule?

    HSWA established deadlines for completion of a number of listing 
determinations, including for dyes and pigment production wastes (see 
RCRA section 3001(e)(2)). Due to competing demands for Agency resources 
and shifting priorities, these deadlines were not met. As a result, in 
1989, the Environmental Defense Fund (EDF, currently Environmental 
Defense or ED) filed a lawsuit to enforce the statutory deadlines for 
listing decisions in RCRA section 3001(e)(2). (Environmental Defense v. 
Johnson, D.D.C. Civ. No. 89-0598, subsequently referred to in this 
notice as the ED consent decree.) To resolve most of the issues in the 
case, in 1991 ED and EPA entered into a consent decree which has been 
amended several times to revise the deadlines for EPA action. Paragraph 
1.h.(i) (as amended in December 2002) of the consent decree addresses 
the organic dyes and pigment production industries:

    EPA shall promulgate final listing determinations for azo/
benzidine, anthraquinone, and triarylmethane dye and pigment 
production wastes on or before February 16, 2005* * * These listing 
determinations shall be proposed for public comment on or before 
November 10, 2003.

    Furthermore, paragraph 6.e. (as amended) stipulates that:

    On or before November 10, 2003, EPA's Administrator shall sign a 
notice of proposed rulemaking proposing land disposal restrictions 
for dye and pigment wastes proposed for listing under paragraph 
1.h.(i). EPA shall promulgate a final rule establishing land 
disposal restrictions for dye and pigment wastes listed under 
paragraph 1.h.(i) on the same date that it promulgates a final 
listing determination for such wastes.

    Today's final rule satisfies EPA's duty under paragraphs 1.h and 
6.e of the ED consent decree to finalize listing determinations and 
land disposal restrictions for the specified organic dyes and/or 
pigment production wastes.

II. Summary of Today's Action

    In today's notice, EPA is promulgating regulations that add one 
waste generated by the dyes and/or pigments manufacturing industries to 
the list of hazardous waste in 40 CFR 261.32:

    K181--Nonwastewaters from the production of dyes and/or pigments 
(including nonwastewaters commingled at the point of generation with 
nonwastewaters from other processes) that, at the point of 
generation, contain mass loadings of any of the constituents 
identified in paragraph (c) of this section that are equal to or 
greater than the corresponding paragraph (c) levels, as determined 
on a calendar year basis. These wastes will not be hazardous if the 
nonwastewaters are: (i) Disposed in a subtitle D landfill unit 
subject to the design criteria in Sec.  258.40, (ii) disposed in a 
subtitle C landfill unit subject to either Sec.  264.301 or Sec.  
265.301, (iii) disposed in other subtitle D landfill units that meet 
the design criteria in Sec.  258.40, Sec.  264.301, or Sec.  
265.301, or (iv) treated in a combustion unit that is permitted 
under subtitle C, or an onsite combustion unit that is permitted 
under the Clean Air Act. For the purposes of this listing, dyes and/
or pigments production is defined in paragraph (b)(1) of this 
section. Paragraph (d) of this section describes the process for 
demonstrating that a facility's nonwastewaters are not K181. This 
listing does not apply to wastes that are otherwise identified as 
hazardous under Sec. Sec.  261.21-261.24 and 261.31-261.33 at the 
point of generation. Also, the listing does not apply to wastes 
generated before any annual mass loading limit is met.

This listing provides a flexible approach that focuses the regulation 
on wastes that present a risk to human health and the environment. All 
quantities of wastes generated during a calendar year up to the mass 
loading limits are not listed hazardous waste. Only wastes subsequently 
generated that meet or exceed the annual limits would potentially 
become hazardous waste. However, the listing includes a conditional 
exemption for wastes that are disposed of in a subtitle D or subtitle C 
landfill unit that meet the design standards specified in the listing 
description and for wastes treated in certain combustion units with the 
specified permits. Therefore, wastes that are below the mass loading 
limits, or wastes that meet the conditional exemption as described in 
the regulation, are excluded from the listing from their point of 
generation, and would not be subject to any RCRA subtitle C management 
requirements for generation, storage, transport, treatment, or disposal 
(including the land disposal restrictions).
    EPA is listing this waste as hazardous based on the criteria set 
out in 40 CFR 261.11. As described in the November 25, 2003 proposed 
rule (68 FR 66164), we assessed and considered these criteria to 
determine whether nonwastewaters and wastewaters from the manufacture 
of dyes and/or pigments warranted listing. We evaluated the risks 
potentially posed by these residuals using quantitative risk assessment 
techniques.
    After assessing public comments submitted in response to our 
proposal, we are finalizing the K181 hazardous waste listing, with 
several modifications. The final rule continues to establish mass-
loading limits for seven of the eight proposed constituents of concern 
(CoCs), and continues to allow for the contingent exemption of wastes 
that meet or exceed these limits but that are managed in landfill units 
that are subject to the design criteria of either Sec.  258.40, Sec.  
264.301, or Sec.  265.301. We revised the exemption to also include 
wastes that are disposed in other non-municipal landfills (industrial 
landfills) that meet the liner design requirements in Sec.  258.40, 
Sec.  264.301 or Sec.  265.301. We also added an exemption for wastes 
that are treated in combustion units that are either permitted under 
subtitle C, or that are onsite units permitted under the Clean Air Act 
(CAA). We are not, however, finalizing the proposed mass-loading levels 
for toluene-2,4-diamine; neither are we adding this constituent to 
Appendix VII of part 261 or to part 268.20 or 268.40 of the Land 
Disposal Restriction (LDR) standards.
    Upon the effective date of today's final rule, wastes meeting the 
K181 listing description will become hazardous wastes and must be 
managed in accordance with RCRA subtitle C requirements, unless the 
wastes are to be managed in a manner that complies with the contingent 
management exemptions contained in the listing description. Residuals 
from the treatment, storage, or disposal of this newly listed hazardous 
waste also will be classified as hazardous waste pursuant to the 
``derived-from'' rule (40 CFR 261.3(c)(2)(i)). Also, any mixture of a 
listed hazardous waste and a solid waste is itself a RCRA hazardous 
waste (40 CFR 261.3(a)(2)(iii) and (iv), ``the mixture rule''). We are 
not promulgating any exemption for treatment residuals from the 
derived-from rule for the reasons set out in the proposed rule (68 FR 
66199). The mass-based approach already builds in an exemption for 
wastes that are generated with constituent masses below the loading 
limit, are disposed of in landfills with liner design requirements, or 
are treated in certain combustion units. Once a waste meets the 
classification for K181, any treatment residuals remain hazardous 
wastes, unless delisted under Sec.  260.22.

[[Page 9142]]

    Today's rule also takes final action on our proposed decision not 
to list as hazardous, as discussed in the proposal, wastewaters from 
the production of dyes and/or pigments.
    Descriptions of wastes from the production of dyes and/or pigments 
can be found in the document entitled ``Background Document for 
Identification and Listing of Wastes from the Production of Organic 
Dyes and Pigments,'' November 2003 (hereafter referred to as the 
Listing Background Document), available in the docket for the 
rulemaking. Responses to public comments submitted on the November 25, 
2003 proposal can be found in the ``Response to Comments Background 
Document--Hazardous Waste Listing Determination for Dyes and/or 
Pigments Manufacturing Wastes (Final Rule),'' dated February 2005 
(hereafter referred to as the ``Response to Comments Background 
Document''), also available in the docket. In addition, a number of 
commenters incorporated comments submitted in prior rulemakings into 
their 2003 public comments. Our responses to these ``incorporated'' 
comments are also available in the docket for today's final rule in a 
document entitled, ``Background Document--Responses to Incorporated 
Historical Comments on Prior Rulemakings,'' dated February 2005.
    We are also promulgating other changes to the RCRA regulations as a 
result of this final listing determination. These changes include 
adding constituents to Appendices VII and VIII of part 261, and setting 
land disposal restrictions for the newly listed waste. We are adding 
the following seven constituents to Appendix VII of 40 part CFR 261 due 
to the fact that these constituents serve as the basis for the new 
listing: Aniline, o-anisidine, 4-chloroaniline, p-cresidine, 2,4-
dimethylaniline, 1,2-phenylenediamine, and 1,3-phenylenediamine. We are 
adding the following five constituents to Appendix VIII of 40 CFR part 
261 as ``hazardous constituents'' because scientific studies show the 
chemicals have toxic, carcinogenic, mutagenic, or teratogenic effects 
on humans or other life forms (see Sec.  261.11(a)(3)): o-anisidine, p-
cresidine, 2,4-dimethylaniline, 1,2-phenylenediamine, and 1,3-
phenylenediamine.\2\ Section IV.D of today's rule describes the changes 
to the land disposal restrictions establishing treatment standards for 
the specific constituents in the newly-listed waste.
---------------------------------------------------------------------------

    \2\ For toxicity information, see section 7 of the ``Risk 
Assessment Technical Background Document for the Dye and Pigment 
Industries Listing Determination,'' November 2003 in the docket.
---------------------------------------------------------------------------

    Also, as a result of this final rule, this listed waste becomes a 
hazardous substance under CERCLA. Therefore, in today's rule we are 
designating these wastes as CERCLA hazardous substances. These changes 
are described in section VII of today's final rule.

III. Summary of Proposed Rule

A. What Wastes Did EPA Propose To List as Hazardous?

    In the November 25, 2003 proposed rule (68 FR 66164), EPA proposed 
to list one waste generated by the dyes and/or pigments manufacturing 
industry as hazardous waste under RCRA:

    K181: Nonwastewaters from the production of dyes and/or pigments 
(including nonwastewaters commingled at the point of generation with 
nonwastewaters from other processes) that, at the point of 
generation, contain mass loadings of any of the constituents 
identified in paragraph (c)(1) of this section that are equal to or 
greater than the corresponding paragraph (c)(1) levels, as 
determined on a calendar year basis. These wastes would not be 
hazardous if: (i) The nonwastewaters do not contain annual mass 
loadings of the constituent identified in paragraph (c)(2) of this 
section at or above the corresponding paragraph (c)(2) level; and 
(ii) the nonwastewaters are disposed in a Subtitle D landfill cell 
subject to the design criteria in Sec.  258.40 or in a Subtitle C 
landfill cell subject to either Sec.  264.301 or Sec.  265.301. For 
the purposes of this listing, dyes and/or pigments production is 
defined in paragraph (b)(1) of this section. Paragraph (d) of this 
section describes the process for demonstrating that a facility's 
nonwastewaters are not K181. This listing does not apply to wastes 
that are otherwise identified as hazardous under Sec. Sec.  261.21-
24 and 261.31-33 at the point of generation. Also, the listing does 
not apply to wastes generated before any annual mass loading limit 
is met.

    A summary of the proposed listing determination is presented below. 
More detailed discussions are provided in the preamble to the proposed 
rule and in the Background Documents included in the docket for the 
proposed rule.
    In connection with the proposed K181 listing, EPA proposed to amend 
Appendix VIII of 40 CFR part 261 to add o-anisidine, p-cresidine, 2,4-
dimethylaniline, 1,2-phenylenediamine, and 1,3-phenylenediamine to the 
list of hazardous constituents.
    We proposed to establish treatment standards for K181. We also 
proposed to add the following constituents to the Universal Treatment 
Standards (UTS) Table in 268.24 and to the F039 treatment standards 
applicable to hazardous waste landfill leachate: o-anisidine, p-
cresidine, 2,4-dimethylaniline, toluene-2,4-diamine, and 1,3-
phenylenediamine. The effect of adding these constituents to the UTS 
Table (in addition to the requirements for treatment of these 
constituents in K181 wastes) would be to require all characteristic 
hazardous wastes that contain any of these constituents as underlying 
hazardous constituents above their respective UTS levels to be treated 
for those constituents prior to land disposal.
    We also proposed to add K181 to the list of CERCLA hazardous 
substances.

B. How Was This Proposal Different From Prior Hazardous Waste Listing 
Determinations?

    In previous hazardous waste listings promulgated by EPA, we 
typically describe the scope of the listing in terms of the waste 
material and the industry or process generating the waste. However, we 
proposed to use a newly developed ``mass loadings-based'' approach for 
listing dyes and/or pigment production wastes. In a mass loadings-based 
listing, a waste would be hazardous once a determination is made that 
it contains any of the constituents of concern (CoC) at or above the 
specified mass-based levels of concern.
    In the proposed rule, we identified CoCs likely to be present in 
nonwastewaters which may pose a risk above specified mass loading 
levels. Using risk assessment tools developed to support our hazardous 
waste identification program, we assessed the potential risks 
associated with the CoCs in plausible waste management scenarios. From 
this analysis, we developed ``listing loading limits'' for each of the 
CoCs.
    We proposed that if you generate any dyes and/or pigment production 
nonwastewaters addressed by the proposed rule, you would be required 
either to determine whether or not your waste is hazardous or assume 
that it is hazardous as generated under the proposed K181 listing. 
(Note, we proposed that if wastes are otherwise hazardous due to an 
existing listing in Sec. Sec.  261.31-261.33 or the hazardous waste 
characteristics in Sec. Sec.  261.21-261.24, the listing under K181 
would not apply.) We proposed a three-step determination process. The 
first step was a categorical determination where you would determine 
whether your waste falls within the categories of wastes covered by the 
listing (e.g., nonwastewaters generated from the production of dyes 
and/or pigments that fall within the product classes of azo, 
triarylmethane, perylene or anthraquinone) and whether any of the 
regulated constituents could be in your waste. We proposed that if you

[[Page 9143]]

determine under this first step that your waste meets the categorical 
description of K181 and that your waste may contain any K181 
constituent, you would then in the second step determine whether your 
waste meets the numerical standards for K181 (e.g., compare the mass 
loadings of the regulated constituents in your waste to the numerical 
standards). Your waste would be a listed hazardous waste if it contains 
any of the CoCs at a mass loading equal to or greater than the annual 
hazardous mass limit identified for that constituent (unless the waste 
is eligible for a conditional exemption under step three). Under the 
proposed approach, all waste handlers could manage as nonhazardous all 
wastes generated up to the mass loading limit, even if the waste 
subsequently exceeds one or more annual mass loading limits. Finally, 
in the third step, we proposed that you would be able to determine 
whether your waste is eligible for a conditional exemption from the 
K181 listing. We proposed that you would need to demonstrate that your 
waste does not exceed a higher mass loading limit for one constituent 
and that it is being disposed of in a landfill subject to design 
standards set out in Sec.  258.40, Sec.  264.301, or Sec.  265.301.
    The 2003 proposal (and today's final rule) differs markedly from 
two prior proposed listing determinations for the dyes and/or pigment 
manufacturing wastes. On December 22, 1994, we previously proposed 
traditional listings of five specific wastes from these industries (59 
FR 66072). On July 23, 1999, we subsequently proposed to list an 
additional two wastes using a concentration-based listing approach (64 
FR 40192). The 2003 proposal, and the final rule promulgated today, 
completely supercede the prior 1994 and 1999 proposals. See 68 FR 66171 
for further discussion of the early background of this listing 
determination.

C. Which Constituents Did EPA Propose To Add to Appendix VIII of 40 CFR 
Part 261?

    EPA proposed to add five constituents to the list of hazardous 
constituents at 40 CFR part 261. These chemicals and their Chemical 
Abstract Services (CAS) numbers are:

o-anisidine (CAS No. 90-04-0),
p-cresidine (CAS No. 120-71-8),
2,4-dimethylaniline (CAS No. 95-68-1),
1,2-phenylenediamine (CAS No. 95-54-5), and
1,3-phenylenediamine (CAS No. 108-45-2).

We proposed these chemicals as CoCs for the proposed K181 listing. 
Based on our assessment of the available toxicity data, we believed 
that these chemicals met the Sec.  261.11(a) criteria for inclusion on 
Appendix VIII. Therefore, we proposed to add them to Appendix VIII of 
40 CFR part 261.

D. What Was the Proposed Status of Landfill Leachate From Previously 
Disposed Wastes?

    We proposed to amend the existing exemption from the definition of 
hazardous waste for landfill leachate generated from certain previously 
disposed hazardous waste (40 CFR 261.4(b)(15)) to include leachate 
collected from non-hazardous waste landfills that previously accepted 
the proposed K181 waste. We proposed to temporarily defer the 
application of the proposed new waste code to such leachate to avoid 
disruption of ongoing leachate management activities.
    The Agency proposed the deferral because information available to 
EPA at the time indicated that the wastes proposed to be listed as 
hazardous have been managed previously in non-hazardous waste 
landfills. Leachate derived from the treatment, storage, or disposal of 
listed hazardous wastes is classified as hazardous waste by the 
derived-from rule in 40 CFR 261.3(c)(2). Without such a deferral, we 
were concerned about forcing pretreatment of leachate even though 
pretreatment is neither required by nor needed under the Clean Water 
Act (CWA).

E. What Were the Proposed Treatment Standards Under RCRA's Land 
Disposal Restrictions Standards?

    We proposed, where possible, to apply existing universal treatment 
standards (UTS) for the proposed K181 constituents of concern (CoCs). 
We proposed to apply the UTS to these wastes because the waste 
compositions were found to be similar to other wastes for which 
applicable treatment technologies have been demonstrated.
    We found that there is significant structural similarity among many 
of the CoCs, including those for which we had not previously set 
technology-specific standards. We proposed that all CoCs for these 
wastes can be treated with equal effectiveness (i.e., destroyed or 
removed so as to be no longer detectable) by similar methods of 
treatment. We proposed combustion as the most effective BDAT treatment 
for nonwastewater forms of these wastes. For wastewaters derived from 
K181, we proposed a treatment train of wet air oxidation (WETOX) or 
chemical oxidation (CHOXD) followed by carbon adsorption (CARBN), or 
application of combustion (CMBST) as BDAT for the CoCs for which 
treatment standards had not previously been developed.
    We also assessed the potential of developing numerical standards 
for those constituents with current technology-based treatment 
standards and those CoCs in K181 that lack current treatment 
requirements. Commenters to the July 23, 1999 listing proposal (64 FR 
40192) suggested that EPA establish numerical standards, because they 
allow any treatment, other than impermissible dilution, to be used to 
comply with the land disposal restrictions. We found that there was 
adequate documentation in existing SW-846 \3\ methods 8270, 8315, and 
8325 to calculate numerical standards for the CoCs, with the exception 
of 1,3-phenylenediamine; 1,2-phenylenediamine; and 2,4-dimethylaniline. 
For 1,3-phenylenediamine and 2,4-dimethylaniline, we proposed to 
transfer the numerical standards of similar constituents as the 
universal treatment standards.
---------------------------------------------------------------------------

    \3\ Manual of test methods from EPA/OSW: ``Test Methods for 
Evaluating Solid Waste, Physical/Chemical Methods,'' SW-846; see 
http://www.epa.gov/epaoswer/hazwaste/test/sw846.htm.
---------------------------------------------------------------------------

    For 1,2-phenylenediamine, we found during past method performance 
evaluations that it can be difficult to achieve reliable recovery from 
aqueous matrixes and precise measurements. Therefore, for this 
constituent, we proposed that wastewaters be treated by CMBST; or CHOXD 
followed by BIODG or CARBN; or BIODG followed by CARBN, and all 
nonwastewaters would be treated by CMBST. We noted that if data 
adequate for the development of a numerical standard were presented in 
comments, the Agency might promulgate a numerical standard as an 
alternative, or as the treatment requirement.
    We indicated, however, that if these numerical standards were shown 
in comments not to be achievable or otherwise appropriate, we would 
adopt methods of treatment as the exclusive treatment standard. Under 
this technology only approach, all nonwastewaters identified as K181 
would be treated by CMBST, and all derived from wastewaters would be 
treated by either WETOX or CHOXD, followed by CARBN or CMBST.
    We also proposed to add the constituents in K181 with numerical 
treatment standards to the Universal Treatment Standards listed at 40 
CFR 268.48. As a result, characteristic wastes that also contain these 
constituents would require additional treatment before disposal, if 
constituent

[[Page 9144]]

concentrations exceed the proposed levels.
    We proposed to amend the CoCs in F039 as necessary to include the 
constituents identified in K181 not already specified in F039. F039 
applies to landfill leachates generated from multiple listed wastes in 
lieu of the original waste codes. F039 wastes are subject to numerical 
treatment standards equivalent to the universal treatment standards 
listed at 40 CFR 268.48. Without this change in existing regulations, 
F039 landfill leachates may not receive proper treatment for the 
constituents of K181.
    The proposed treatment standards reflected the performance of best 
demonstrated treatment technologies, and were not based on the listing 
levels of concern derived from the risk assessment for dyes and/or 
pigments wastes. In that risk assessment, our analysis focused on the 
plausible management practices for only the dyes and pigment 
industries. As a result, our models did not attempt to assess all 
possible pathways, because the plausible management practice (disposal 
in a municipal subtitle D landfill) provides a certain level of control 
over some potential release pathways. In addition, our assessment of 
potential releases modeled engineered barriers in the form of various 
types of liner systems.
    As discussed in the proposal, it was not appropriate to use the 
mass loading levels derived from these risk assessments as levels at 
which threats to human health and to the environment are minimized. 
Because there remained significant uncertainties as to what levels of 
hazardous constituents in these wastes would minimize threats to human 
health and to the environment posed by these wastes' land disposal, we 
chose to develop treatment standards for these wastes based on 
performance of the Best Demonstrated Available Technology for these 
wastes. HWTC III, 886 F. 2d at 361-363 (accepting this approach). For 
the same reason, we found that these technology-based treatment 
standards were not more stringent than the risk-based levels at which 
we could find that threats to human health and to the environment are 
minimized.

F. What Risk Assessment Approach Was Used for the Proposed Rule?

    For the proposed rule, we conducted a risk assessment to calculate 
the maximum mass loading of individual constituents that could be 
present in dye and pigment waste and remain below a specified level of 
risk to both humans and the environment.
    To establish these listing levels, we: (1) Selected constituents of 
potential concern in waste from dye and/or pigment production, (2) 
evaluated plausible waste management scenarios, (3) calculated exposure 
concentrations by modeling the release and transport of the 
constituents from the waste management unit to the point of exposure, 
and (4) calculated waste constituent loadings that are likely to pose 
an unacceptable risk. In addition, we conducted a screening level 
ecological risk assessment to ensure that the mass loading limits were 
protective of the environment.
    The risk analysis for the dyes and/or pigment production wastes 
estimated the mass loading of individual constituents that can be 
present in each waste without exceeding a specified level of protection 
to human health and the environment. The risk assessment evaluated 
waste management scenarios that may occur nationwide. We selected a 
national analysis that captures variability in meteorological and 
hydrogeological conditions for this listing determination because 
facilities that manage these wastes are found in many areas of the 
country.
    For this listing determination, we defined the target level of 
protection for human health to be an incremental lifetime cancer risk 
of no greater than one in 100,000 (10-5) for carcinogenic chemicals and 
a hazard quotient (HQ) of 1.0 for non-carcinogenic chemicals. The 
hazard quotient is the ratio of an individual's daily dose of a 
constituent to the reference dose for that constituent, where the 
reference dose is an estimate of the daily dose that is likely to be 
without appreciable risk of harmful effects over a lifetime.
    To determine the allowable mass loadings for CoCs, we used a 
probabilistic analysis to calculate the exposure to nearby residents 
from disposal of those constituents in the types of waste management 
units that could be used by the dyes and pigments industries. We then 
established the allowable mass loading level such that the exposure to 
each constituent would not exceed the target level of protection for 90 
percent of the nearby residents including both adults and children. 
Thus, the allowable mass loadings met a target cancer risk level of 10-
5 or hazard quotient of one for 90 percent of the receptor scenarios we 
evaluated.
    In this probabilistic analysis, we varied sensitive parameters for 
the distributions of data that were available. The parameters varied 
for this analysis include waste management unit size, parameters 
related to the location of the waste management unit such as climate 
and hydrogeologic data, location of the receptors relative to the waste 
management units, and exposure factors such as intake rates and 
residence times.
    The preamble to the proposed rule (see 68 FR 66181, November 25, 
2003) and the Risk Assessment Technical Background Document for the Dye 
and Pigment Industries Listing Determination (hereafter known as the 
Risk Assessment Background Document) provide more detail on this risk 
assessment.

IV. What Is the Rationale for Today's Final Rule?

A. Final Listing Determination

    We are promulgating today a final listing for nonwastewaters 
generated from the production of dyes and/or pigments. As explained 
below, we are revising the listing language slightly from the proposal 
in response to comments. The final listing description follows:

    K181: Nonwastewaters from the production of dyes and/or pigments 
(including nonwastewaters commingled at the point of generation with 
nonwastewaters from other processes) that, at the point of 
generation, contain mass loadings of any of the constituents 
identified in paragraph (c) of this section that are equal to or 
greater than the corresponding paragraph (c) levels, as determined 
on a calendar year basis. These wastes will not be hazardous if the 
nonwastewaters are: (i) Disposed in a Subtitle D landfill unit 
subject to the design criteria in Sec.  258.40, (ii) disposed in a 
Subtitle C landfill unit subject to either Sec.  264.301 or Sec.  
265.301, (iii) disposed in other Subtitle D landfill units that meet 
the design criteria in Sec.  258.40, Sec.  264.301, or Sec.  
265.301, or (iv) treated in a combustion unit that is permitted 
under Subtitle C, or an onsite combustion unit that is permitted 
under the Clean Air Act. For the purposes of this listing, dyes and/
or pigments production is defined in paragraph (b)(1) of this 
section. Paragraph (d) of this section describes the process for 
demonstrating that a facility's nonwastewaters are not K181. This 
listing does not apply to wastes that are otherwise identified as 
hazardous under Sec. Sec.  261.21-24 and 261.31-33 at the point of 
generation. Also, the listing does not apply to wastes generated 
before any annual mass loading limit is met.

    EPA is listing nonwastewaters from the production of dyes and/or 
pigments as hazardous because this wastestream meets the criteria set 
out at 40 CFR 261.11(a)(3) for listing a waste as hazardous. As 
described in the proposal (68 FR 66179), the criteria provided in 40 
CFR 261.11(a)(3) include eleven factors for determining ``substantial 
present or potential hazard to human health or the environment.'' Most 
of these factors were incorporated into EPA's risk assessment, as 
discussed

[[Page 9145]]

further below. The risk analyses conducted in support of our proposed 
listing determination are presented in detail in the Risk Assessment 
Background Document, which is in the docket for today's rule.
    We considered the toxicity of the chemicals potentially present in 
these wastes (Sec.  261.11(a)(3)(i)). We found that the CoCs are toxic 
chemicals with established health-based benchmarks for cancer and 
noncancer endpoints.\4\ We considered constituent concentrations (Sec.  
261.11(a)(3)(ii)) and the quantities of waste generated (Sec.  
261.11(a) (3)(viii)) in establishing mass loading limits for specific 
CoCs. Thus, the listing description for K181 includes mass loading 
limits for specific CoCs that present risk to consumers of groundwater. 
In setting the mass loading limits, we used fate and transport models 
to determine the potential for migration, persistence, and degradation 
of the hazardous constituents and any degradation products (Sec. Sec.  
261(a)(3)(iii), 261.11(a)(3)(iv), and 261.11(a)(3)(v)).\5\ 
Bioaccumulation of the constituents (Sec.  261.11(a)(3)(vi)) is not 
relevant to the key exposure pathway EPA assessed (consumption of 
groundwater).
---------------------------------------------------------------------------

    \4\ Risk Assessment Background Document, Section 7.
    \5\ Risk Assessment Background Document, Sections 4 and 5.
---------------------------------------------------------------------------

    As discussed in the proposal (68 FR 66178), we considered two other 
factors, plausible mismanagement and other regulatory actions 
((Sec. Sec.  261.11(a)(3)(vii) and 261.11(a)(3)(x)) in establishing the 
waste management scenario(s) modeled in the risk assessment. We 
considered mass loading limits based on two plausible waste management 
scenarios, clay-lined and composite-lined landfills. We are 
promulgating a final listing with mass loading limits for wastes in a 
clay-lined landfill, and a conditional exemption for wastes managed in 
landfills that are subject to (or otherwise meet) the liner design 
requirements specified in the listing description for municipal 
landfills (Sec.  258.40) or hazardous waste landfills (Sec.  264.301 or 
Sec.  265.301). We are also adding an exemption for wastes treated in 
certain permitted combustion units. Thus, if generators of wastes 
potentially subject to the K181 listing use landfills meeting these 
design standards, or treat the waste in the specified combustion units, 
then the loading limits set forth in K181 would not apply and the waste 
would not be hazardous.
    We also considered one factor beyond the risk assessment, that is, 
whether damage cases indicate impacts on human health or the 
environment from improper management of the wastes of concern (Sec.  
261.11(a)(3)(ix)).\6\ We concluded that the wastes in the damage cases 
may include wastes not in the scope of today's rule, and that the cases 
reflect management scenarios that are not currently common or plausible 
(see 68 FR 66189). Thus, while the damage cases indicated that some 
dyes and/or pigment production wastes may sometimes pose risks, EPA 
relied on its quantitative risk assessment in formulating today's final 
rule.
---------------------------------------------------------------------------

    \6\ The final factor allows EPA to consider other factors as 
appropriate (Sec.  261.11(a)(3)(xi)), however we did not consider 
such factors.
---------------------------------------------------------------------------

    Significant comments submitted on this proposal and the supporting 
analyses are summarized below. The Response to Comment Background 
Document provides all of the comments and our responses to them.
1. Toluene-2,4-diamine
    Toluene-2,4-diamine was one of the eight constituents of concern 
(CoC) for which EPA proposed a Sec.  261.31(c)(1) mass loading limits. 
We also proposed a higher mass loading limit for toluene-2,4-diamine 
under Sec.  (c)(2) that would have identified a mass loading limit 
above which wastes would no longer be eligible for a contingent 
management exemption and would have been a hazardous waste. Toluene-
2,4-diamine was the only CoC for which we proposed a Sec.  261.32(c)(2) 
level.
    Commenters argued that it is inappropriate to use toluene-2,4-
diamine as a CoC because it is ``not typically or frequently used in 
dyes production'' (Ecological and Toxicological Association of Dyes and 
Organic Pigments Manufacturers or ETAD) and is ``not used in any color 
pigment facility for the production of color pigments'' (Color Pigments 
Manufacturing Association or CPMA). In the proposal, we described data 
collected from the Toxic Release Inventory (TRI), the Colour Index 
(CI), and two facilities' websites that potentially link use of 
toluene-2,4-diamine to facilities known to manufacture dyes and/or 
pigments. The commenters have addressed these potential links. Based on 
these arguments, we believe the commenters have successfully 
demonstrated that toluene-2,4-diamine is rarely used. Only one dye 
manufacturer reported using this constituent, and this use does not 
generate any waste containing this CoC; it is not used at all by any 
pigment manufacturers. (See Response to Comments Background Document 
for more detailed discussion regarding the use, or lack of use of 
toluene-2,4-diamine.) As a result, we do not believe it is appropriate 
to include toluene-2,4-diamine as a basis for listing K181 in today's 
final rule. Accordingly, we have removed this constituent from the 
proposed Sec.  261.31(c)(1) standards, and have deleted entirely the 
proposed Sec.  261.32(c)(2) standard in this action.
2. Use of Clay-Lined and Composite-Lined Landfills
    We proposed to list nonwastewaters from dye and/or pigment 
manufacturing that met or exceeded mass loading limits for eight 
constituents of concern. These ``baseline'' loading limits were based 
on our risk assessment of management of the waste in a clay-lined 
landfill. We also proposed to conditionally exempt wastes managed in 
landfills subject to liner regulations for municipal or hazardous waste 
landfills, if the mass of one constituent of concern (toluene-2,4-
diamine) was below a specified mass loading limit. The basis for this 
conditional exemption was a risk assessment of wastes managed in a 
composite-lined landfill.
    A number of dye and pigment manufacturers submitted comments 
stating that they do not use unlined or clay-lined landfills, and most 
indicated that their waste is managed in landfills that have 
``synthetic liners.'' The trade association for the dye manufacturers 
(ETAD) surveyed their members and stated that there is ``no use of 
unregulated clay-lined landfills or unlined landfills'' and that ``all 
known landfills currently in use are subtitle C or subtitle D landfills 
that incorporate a synthetic liner into their liner system.'' The 
association further noted that the design standards for municipal solid 
waste landfills promulgated in 1991 call for use of a composite liner 
(Sec.  258.40). The association also resubmitted a survey it originally 
submitted in 1999 in comments on the prior July 23, 1999 proposal, 
claiming that this showed all identified liner systems included a 
synthetic liner. The trade association for pigment manufacturers (CPMA) 
also surveyed their members and stated that their members do not use 
unlined or clay-lined landfills, but rather use ``synthetic lined 
industrial landfills'' and ``synthetic lined municipal landfills'' for 
their nonwastewaters. Based on this information, commenters argued that 
the risk assessment EPA used to establish mass loading limits for K181 
should have been based on composite-lined landfills with a synthetic 
liner.
    We continue to believe that the clay-lined landfill is an 
appropriate scenario for the baseline mass loading limits for K181 for 
several reasons. First, as noted

[[Page 9146]]

in the proposal, our data show that the industries use municipal solid 
waste (MSW) landfills, and the liner requirements in Sec.  258.40 are 
not applicable to existing units in operation since before October 9, 
1993, or certain exempt units (Sec.  258.1(f)(1)). Thus, our data 
indicate that disposal of dye and pigment wastes into older clay-lined 
MSW landfills in operation is a plausible management scenario (see 
proposal at 68 FR 66191). In addition, the information provided by the 
commenters is insufficient to rebut this finding for these industries. 
In fact, the information provided by the commenters shows that 
industrial landfills are in use by some pigment manufacturers. There 
are no Federal liner requirements that are in place for such units. 
While many states have regulations for these type of industrial 
landfills, the requirements for liners appear variable and do not 
necessarily provide the same level of protection as the standards for 
municipal solid waste landfills in Sec.  258.40. Finally, while 
commenters claimed that the landfills currently in use by respondents 
to their surveys have ``synthetic'' liners, they did not confirm that 
all landfills in use had composite liners that met the standards set 
out in Sec.  258.40.
    The specific landfill information resubmitted by ETAD was for 
seventeen landfills relevant to dye manufacturers only, and thus not 
representative of the landfills that could be used throughout the dye 
and pigment industries. (EPA estimated that there were about 2,300 MSW 
landfills in operation in 2000.) Furthermore, ETAD originally submitted 
this information in response to the proposed listing decision in 1999 
for only three wastestreams generated by the dye and pigment 
industries; as such, ETAD did not clarify if other landfills may have 
been in use for other wastestreams. Finally, the limited information 
provided in this submission shows that the type of liner system was not 
specified for some landfills, and thus, it is not clear if the liner 
systems are composite liners that would meet the Sec.  258.40 
requirements.
    We proposed mass loading limits based on two specific types of 
lined and fills, clay-lined and composite-lined landfills. We are 
promulgating a final listing with a conditional exemption for wastes 
managed in landfill units that meet the liner design requirements 
specified in the listing description (Sec.  258.40, 264.301 or 
265.301).\7\ Unlike the proposal, the final rule no longer sets a mass 
loading limit for toluene-2,4-diamine, and thus there are no testing 
requirements associated with this exemption. If generators of wastes 
potentially subject to the K181 listing use composite-lined municipal 
or subtitle C landfills, then the mass loading limits set forth in K181 
would not apply and the waste would not be hazardous. (The final 
listing also includes an exemption for combustion, as discussed in the 
following section). Therefore, given the uncertainties in the types of 
liner systems that may be in place in landfills used by dye and pigment 
manufacturers, and based on the information available that indicates 
this is a plausible management scenario, we believe that it is 
appropriate to base the mass-loading limits on a clay-lined landfill.
---------------------------------------------------------------------------

    \7\ Note that in the final rule we have replaced the term 
``landfill cell'' with ``landfill unit.'' We made this change so 
that the terminology used in this rule is more consistent with the 
use of the term ``unit'' in the RCRA regulations for landfills (Part 
258 and in Sec. Sec.  264.301 and 265.301).
---------------------------------------------------------------------------

3. Status of Wastes That Are Combusted
    While we proposed a conditional exemption for wastes managed in 
units meeting the liner design criteria for municipal or hazardous 
waste landfills, we proposed that wastes that met or exceeded the 
baseline listing levels would be hazardous if treated by combustion. 
However, we solicited comment in the preamble on the option to exempt 
wastes going to combustion, provided the units are permitted under 
subtitle C or have other relevant permits under the Clean Air Act 
(CAA).
    The comments generally supported the option of exempting wastes 
destined for combustion. Commenters stated that EPA should exempt 
wastes being combusted or include combustion in the contingent 
management practices qualifying for an exemption from the listing. 
Surveys submitted by the trade associations (ETAD and CPMA) confirmed 
that some facilities treated nonwastewaters by combustion, and other 
comments by specific companies stated they want to have the option of 
incineration in the future. Commenters pointed out that the proposed 
approach would mean that wastes that met or exceeded the baseline 
listing levels and are incinerated would be hazardous, while the same 
waste would be nonhazardous if it is managed in a landfill meeting 
appropriate criteria. Commenters contended that this would encourage 
facilities to shift from combustion to disposal in landfills, even for 
wastes with high organic content. Commenters suggested that wastes 
going to ``permitted'' combustion units should be exempt, because 
permitting authorities consider input fuels for commercial boilers and 
combustion units.
    Commenters stated that regulating incineration in the absence of a 
risk assessment or data is not warranted, and that combustion provides 
at least as much protection for the environment as a synthetic-lined 
landfill. Commenters cited the preamble discussion in the proposal, 
which stated that previous analyses for other wastes determined that 
potential risks from the release of constituents through incineration 
would be several orders of magnitude below potential air risks from 
releases from tanks or impoundments. Commenters also noted that EPA had 
concluded that combustion was effective and protective in setting BDAT 
standards for K181. One commenter submitted a risk assessment for 
combustion of their waste, which was previously submitted in their 
comments on the 1994 proposal, and indicated that the risks are below 
levels of concern.
    After reviewing the comments and the available information, we have 
decided to exempt wastes treated in certain combustion units from the 
K181 listing. As we noted in the proposed rule, we expect risks from 
combustion of the key constituents of concern to be relatively low, 
based on the relatively low air risks exhibited by these constituents 
from treatment in tanks and surface impoundments. Analyses in previous 
listing determinations have shown that air risks arising from releases 
of constituents not destroyed in combustion are much lower than risks 
from releases of constituents from tanks and surface impoundments (68 
FR 66196). Thus, while we did not model the specific dye and pigment 
wastes at issue in this rule, we believe that risks from combustion 
would be relatively low.
    As commenters pointed out, by exempting wastes going to certain 
landfills, but not wastes treated by combustion, we would effectively 
be encouraging landfill disposal over combustion. The exemption for 
landfill disposal may therefore cause some facilities with organic 
waste having significant fuel (BTU) value to change from combustion 
(either offsite or onsite) to disposal in landfills, to take advantage 
of the landfill exemption. Exempting wastes treated in appropriate 
combustion units would avoid this unintended outcome of the listing.
    As noted in the proposal, we found ten facilities reporting in the 
TRI that they send wastes off site for combustion (e.g., incineration, 
energy recovery). All of the treatment facilities are RCRA Subtitle C 
facilities. Because this is a management practice we believe is

[[Page 9147]]

especially appropriate for waste with high organic content, we have 
decided to include an exemption for wastes treated in Subtitle C 
combustion units. To the extent that these wastes are already managed 
as hazardous because they exhibit a hazardous waste characteristic or 
meet another hazardous waste listing description, today's final rule 
will have no impact on them, because the K181 listing does not apply to 
wastes that are hazardous for other reasons (see the listing 
description).
    We are more concerned about the combustion of dye and pigment 
wastes in units that are not subject to Subtitle C regulations. We know 
of only two facilities that use onsite thermal treatment of dye or 
pigment production wastes. One of these facilities indicated that it 
does not produce any in-scope wastes containing any of the CoCs. The 
other facility generates a still bottom that may exceed the mass 
loading limit for aniline. This facility resubmitted a risk assessment 
previously included in comments on the 1994 proposal in an attempt to 
show no significant risk for its onsite boiler. The risk assessment, 
while specific to this one combustion unit, provides information on the 
unit that indicates that it has relatively high destruction and removal 
efficiency (>99% in this case for the CoC known to be present, 
aniline). This particular unit is also permitted by the state under the 
CAA, and the permit contains specific limitations on the release of the 
key CoC (40 kg/year).\8\ Therefore, in this specific case, the state 
regulatory authority has evaluated and controlled the releases of this 
CoC through this permit. We find the comments submitted by the company 
compelling, given that the waste has high organic content (98.7%) and a 
high fuel value. Therefore, we have also decided to include an 
exemption for onsite combustion units (units that are located at the 
site of generation) that are permitted under the CAA. We are limiting 
the exemption to onsite combustion units because: (1) Currently we have 
no information that offsite combustion is occurring in non-subtitle C 
units, and (2) we lack information on whether any permits for non-
subtitle C offsite units would necessarily address all potential CoCs. 
Offsite combustion units are likely to accept a wide variety of other 
wastes, and seem less likely to address the specific constituents of 
concern for dye and pigment production wastes. We have less information 
on the various kinds of existing or potential permits relevant to 
offsite combustion units that may be used for dye and pigment wastes. 
Permits for offsite units under the CAA would not necessarily consider 
the CoCs for the dye and pigment wastes (e.g., of the seven CoCs, only 
aniline and o-anisidine are Hazardous Air Pollutants under the CAA), 
whereas permits for onsite units are likely to be more specific for the 
dye and pigment industries.
---------------------------------------------------------------------------

    \8\ See the air permit for BASF in the docket for this rule.
---------------------------------------------------------------------------

4. Scope of Listing Definition
    Commenters identified several issues related to the scope of the 
proposed listing, as summarized below, and discussed in more detail in 
the Response to Comments Background Document.
    a. Perylenes and Anthraquinones. One trade association commented 
that EPA erred in including perylenes in the proposed listing because 
Paragraph l.h.(i) of the ED consent decree (as amended in December 
2002) states that ``EPA shall promulgate final listing determinations 
for azo/benzidine, anthraquinone, and triarylmethane dye and pigment 
production wastes.'' The commenter argued that perylenes are not a 
subclass of the anthraquinone category, and that none of the eight CoCs 
are used as raw materials in the manufacture of perylene color 
pigments.
    We note, as discussed previously in the proposal, that the ED 
consent decree (under which today's listing determination is mandated) 
further specifies that ``The anthraquinone listing determination shall 
include the following anthraquinone dye and pigment classes: 
anthraquinone and perylene'' (68 FR 66173). Therefore, we must make 
listing determinations that cover any corresponding wastes, regardless 
of whether or not perylenes are properly classified as anthraquinones. 
Furthermore, as discussed in the proposal and in the Response to 
Comments Background Document, we are not differentiating between dye 
manufacture and pigment manufacture. While the pigments industry may 
not use the K181 CoCs for manufacturing perylene pigments as contended 
by the commenter, it is possible that the dyes industry may still use 
some of them for perylene dyes. Note that ETAD and its member dye 
manufacturers did not provide comments in this respect. Finally, we 
note that the consent decree does not limit EPA's authority to list 
wastes, but merely identifies those wastes for which EPA must make a 
listing determination.
    Another commenter argued that none of the eight CoCs are used to 
produce anthraquinone dyes or pigments and, therefore, EPA should 
remove anthraquinone dyes and pigments from the proposed rule. The 
commenter further pointed out that in the 1994 proposal (59 FR 66072), 
EPA proposed a no-list decision for wastewater from the production of 
anthraquinone dyes and pigments, and in the 1999 proposal (64 FR 
40192), EPA proposed a no-list decision for wastewater treatment sludge 
from the production of anthraquinone dyes and pigments. As discussed in 
the proposal, EPA identified the constituents by developing a list of 
chemicals that could reasonably be expected to be associated with 
wastes from the production of various classes of dyes and pigments, 
including anthraquinone dyes and pigments. See 68 FR at 66180-66182, 
and ``Background Document: Development of Constituents of Concern for 
Dyes and Pigments Listing Determination'' in the docket. This commenter 
did not provide any documentation to support its argument that none of 
the eight CoCs are used to produce anthraquinone dyes or pigments, or 
otherwise specifically address the information and findings presented 
in the proposal. In addition, none of the other companies or trade 
associations made similar claims. Finally, we note that, as discussed 
in the 2003 proposal (68 FR 66171-2), our 2003 proposed rule completely 
supercedes the 1994 and 1999 proposals. In any case, unlike the 1999 
concentration-based listing in which we evaluated specific waste types 
from the production of individual dyes/pigments classes,\9\ the 2003 
proposal grouped all of the wastes that are identified in the ED 
consent decree into wastewaters and nonwastewaters.
---------------------------------------------------------------------------

    \9\ Spent filter aids, triarylmethane sludges and anthraquinone 
sludges were deferred from the 1994 proposed listing decisions for 
11 of the wastes covered in the ED consent decree (59 FR 66072, 
December 22, 1994). EPA did not take final action on either of the 
1994 and 1999 proposals.
---------------------------------------------------------------------------

    Moreover, some of the listing constituents might be present in the 
dyes and/or pigments production nonwastewaters as a result of reaction 
byproducts, impurities in raw materials, or as a result of degradation 
of raw materials or products. Therefore, we believe it is appropriate 
to retain both perylene and anthraquinone production within the scope 
of this final K181 listing. If, however, as the commenter suggests, the 
CoCs are not present in the generators' wastes, then the wastes would 
not be considered the K181 listed waste.
    b. Post-Production. Two commenters stated that the proposed rule 
does not adequately define ``production'' of dyes and/or pigments, and 
that some wastes covered by the ED consent decree could

[[Page 9148]]

be generated from certain types of ``post-production'' activities. They 
contended that the listing should not apply to ``post-production'' 
activities, in reference to 68 FR 66173 in which the Agency stated that 
the proposed rule does not apply to the end-users of dyes and/or 
pigments and similarly does not apply to post-production formulation 
and packaging. One commenter suggested that EPA should include the 
appropriate clarifications in the CFR language that defines the scope 
of the proposed listing.
    In response to the commenters' request for clarification, we are 
adding the following language to the final rule at the end of the 
Listing Specific Definitions in Sec.  261.32(b)(1): ``Wastes that are 
not generated at a dyes and/or pigments manufacturing site, such as 
wastes from the off-site use, formulation, and packaging of dyes and/or 
pigments, are not included in the K181 listing.'' Thus, we are 
specifically including this in the regulatory language to clarify that 
we are not including in K181 those wastes that are not generated at a 
dyes and/or pigments manufacturing site. However, wastes resulting from 
the blending, formulation, preparation, processing (grinding, 
dispersing, drying, finishing, filtering, purification, product 
standardization, etc.), dust collection, packaging and any other 
operations related to in-scope dyes and/or pigments that occur on site 
at the covered dyes and/or pigments manufacturers are potentially 
within the scope of today's final listing, if they meet the relevant 
criteria. Note that, as required under the ED consent decree, we 
addressed a variety of dyes and/or pigment waste streams in this 
listing determination. The ED consent decree states that ``Listing 
determinations under paragraph 1(h) of this Decree shall include the 
following wastes, where EPA finds such wastes are generated: spent 
catalysts, reactor still overhead, vacuum system condensate, process 
waters, spent adsorbent, equipment cleaning sludge, product mother 
liquor, product standardization filter cake, dust collector fines, 
recovery still bottoms, treated wastewater effluent, and wastewater 
treatment sludge.'' Some of the wastes identified in the ED consent 
decree (such as product standardization filter cake and dust collector 
fines) can be generated from various ``post-production'' activities at 
the dyes and/or pigments facilities.
    c. Commingling. We described in the proposal (68 FR 66195) that the 
scope of the listing covers commingled wastes with mass contributions 
from other processes (i.e., that other process wastes commingled with 
in-scope process wastes would be covered by the proposed K181 listing). 
We requested comment, however, on an alternative approach which would 
allow facilities to count only those mass loadings associated with azo/
triarylmethane/perylene/anthraquinone dyes and/or pigments manufacture 
when assessing whether their wastes meet or exceed the K181 listing 
levels. One commenter, a trade association, favored this alternative 
approach. This commenter reasoned that not allowing facilities to count 
only those mass loadings associated with covered production will result 
in ``an artificial incentive to inefficiently segregate wastes, 
potentially increasing risks associated with their management.'' 
However, this commenter did not elaborate or provide any specifics.
    We have carefully considered the commenter's argument, but we have 
decided to retain the proposed approach. The dye and pigment industries 
use batch processes and numerous raw materials to produce a wide 
variety of products, thereby generating various nonwastewaters.\10\ 
Therefore, we believe it would not only be more difficult for the 
facilities to implement the proposed alternative approach (i.e., 
tracking and keeping adequate documentation of all the mass 
contributions prior to commingling), but it would also be very 
difficult for the regulating authorities to make their own 
determinations for oversight and enforcement purposes. For this reason 
and the reasons stated at 68 FR 66195, we have decided to take the more 
straightforward approach of structuring the mass-based K181 listing as 
proposed, and not to adopt the alternative approach. Therefore, the 
K181 listing covers mass contributions from other processes when in-
scope and out-of-scope waste sources are commingled, and the entire 
commingled volume is included in the waste quantity and mass loading 
calculations. On the other hand, if the in-scope waste sources contain 
none of the K181 listing constituents, the commingled volume is not 
subject to the K181 listing even though its mass loadings may meet or 
exceed the K181 listing levels.
---------------------------------------------------------------------------

    \10\ ETAD also indicated in its comment that ``Dyes production 
involves batch processes, numerous distinct products and highly 
variable waste streams * * *'' and that ``The production mix and 
scale is entirely subject to somewhat unpredictable customer 
demand.''
---------------------------------------------------------------------------

    As discussed in the proposal, a facility might choose to segregate 
K181 sources from non-K181 sources, so that nonwastewaters from 
noncovered processes would not be subject to the K181 listing. One 
trade association felt that the general concept of segregating waste 
which has no in-scope K181 contribution is reasonable.\11\
---------------------------------------------------------------------------

    \11\ Facilities might also choose to treat the K181 listing 
levels as valuable pollution prevention goals and engage in process 
modifications designed to reduce mass loadings (irrespective of 
their source) below the K181 loading limits.
---------------------------------------------------------------------------

    To help clarify these concepts, we present below several examples 
of how wastes might be commingled. (See also the examples previously 
presented in the proposal at 68 FR 66205-66207.)

    Example 1: In-scope wastes without CoCs, commingled with out-of-
scope wastes.
    Facility A produces numerous chemical products including a small 
amount of azo dyes. This facility uses none of the K181 CoCs in the 
manufacture of azo dyes, and it finds no CoCs in the dye 
manufacturing process wastewaters based on recent analytical 
results. Thus, according to the procedure in Sec.  261.32(d)(1), the 
facility determines that any resulting treatment sludge is not K181. 
The in-scope azo dye process wastewaters are commingled and co-
treated with a much larger volume of nonhazardous wastewaters 
generated from the production of various out-of-scope chemicals in a 
centralized wastewater treatment plant (CWTP) prior to discharge to 
a publicly owned treatment works (POTW). The facility uses aniline 
in some of the other out-of-scope chemical production processes. The 
facility determines that the resultant wastewater treatment sludges, 
though found to contain aniline above the listing level, are not 
subject to K181 because the azo dye process wastewaters treated in 
the plant do not contain any of the CoCs. The facility also 
determines that other nonwastewaters (including filtration sludges, 
spent filter aids, and other process solids) generated from dye 
manufacturing also do not contain any CoCs, based on its knowledge 
of the feed raw materials (including major and minor ingredients, 
and impurities) and the manufacturing processes (reaction, chemical 
degradation, waste generation, etc.). The facility documents its 
findings, and appropriately manages all the CWTP sludges and dye 
process nonwastewaters (also determined to be not characteristically 
hazardous and not meeting any other listing descriptions) as 
nonhazardous.
    Example 2: In-scope wastes with traces of CoCs, co-managed with 
out-of-scope wastes.
    Facility B is an organic pigment manufacturer operating a number 
of in-scope and out-of-scope production process lines. The facility 
generates a total of 450 metric tons per year (MT/yr) of 
nonwastewaters, consisting of 350 MT/yr of sludge from the 
facility's onsite wastewater treatment system and as much as 100 MT/
yr of production waste solids generated from all onsite processes 
combined. Historically, all the nonwastewaters were stored in 
dumpsters and periodically shipped off site for disposal in a 
Subtitle D landfill. Following the promulgation of the K181 listing, 
the facility carefully examines the material safety data

[[Page 9149]]

sheets and finds traces of p-cresidine in some of the raw materials 
used. Based on the material purity information, the facility uses 
its knowledge and, based on mass balance (see Sec.  261.32(d)(2) for 
generated quantities less than 1,000 MT/yr), determines that a 
maximum of 30 kg/yr of p-cresidine could be released to and 
contained in the combined volume of nonwastewaters generated for the 
year. Since the annual mass loading of p-cresidine is less than the 
K181 listing level of 660 kg/yr, the facility concludes that its in-
scope nonwastewaters are not a K181 waste. The facility thus 
documents its findings, and appropriately continues to ship the 
commingled wastes to a subtitle D landfill.
    Example 3: Segregation of wastes destined for disposal in a 
municipal landfill; total in-scope waste quantities over 1,000 MT/
yr.
    Facility C uses some of the CoCs in its production of various 
organic dyes and pigments covered by the K181 listing. It commingles 
and co-treats all the manufacturing process wastewaters on site, 
generating 1,200 MT/yr of wastewater treatment sludge. In addition, 
it generates 50 MT/yr of process wastes with high organic content 
(still bottoms). Therefore, this facility's manufacturing and 
treatment processes yield a total of 1,250 MT/yr of in-scope 
nonwastewaters. Given that the K181 listing allows nonwastewaters to 
be disposed in a municipal landfill subject to the Sec.  258.40 
design criteria regardless of constituent levels in the wastes, the 
facility decides to send all the wastewater treatment sludges to a 
municipal landfill subject to Sec.  258.40. The still bottoms, 
however, would not be managed in the same manner due to their high 
liquid content.
    The still bottoms do not exhibit any of the hazardous waste 
characteristics nor meet any other listing descriptions. Because the 
total annual waste quantity of dyes/pigments nonwastewaters 
generated by all the processes would exceed 1,000 MT/yr, the 
facility considers the options of either: (1) Complying with the 
annual testing requirements of Sec.  261.32(d)(3) and, if the CoCs 
are below the mass-loading levels, sending the still bottom waste 
offsite for combustion in a nonhazardous combustion unit, or (2) 
sending the waste offsite to a subtitle C combustion unit. The 
facility suspects that the still bottom waste will exceed the mass 
loading limits for several constituents. Rather than going to the 
expense of confirming this through testing representative samples of 
the waste, the facility decides to send the waste off site for 
treatment at a subtitle C combustion facility. Thus, this waste is 
also exempt from the K181 listing because it is treated in a 
combustion unit permitted under Subtitle C.
5. Waste Quantities
    As described in the proposal at 68 FR 66176-66177, we estimated 
facility by facility nonwastewater quantities (for 37 active organic 
dyes and/or pigment production facilities known to the Agency at the 
time) by using engineering estimates of wastewater treatment sludge 
generation rates and, wherever possible, facility-specific information 
provided in portions of RCRA Section 3007 surveys and public comments 
that were not claimed as confidential business information (CBI). We 
then used the average of the estimated annual waste quantities (1,894 
MT/yr) and a high-end waste constituent concentration of 5,000 parts 
per million (ppm) to calculate a mass loading cutoff of 10,000 
kilograms per year (kg/yr); that is, we assumed it would be highly 
unlikely to find the CoC above this level in typical dyes and/or 
pigment production nonwastewaters (see discussion at 68 FR 66186).\12\ 
In addition, we used the estimated waste quantities for cost and 
economic analyses of the potential impacts of the proposed listing, and 
for waste treatment and management capacity analyses. Below we address 
the public comments on our use of the estimated waste quantities for 
establishing the proposed mass loading levels. Comments on our use of 
the estimated waste quantities for economic impacts and waste 
management capacity analyses are addressed separately in section VIII 
and section IV.E, respectively.
---------------------------------------------------------------------------

    \12\ That is, a constituent of concern was eliminated if the 
calculated allowable loading from risk modeling exceeds 10,000 kg/
yr.
---------------------------------------------------------------------------

    Two trade associations and several dyes/pigments manufacturers 
submitted comments on the Agency's estimates of waste quantities 
generated by the organic dyes and pigments industries. They argued that 
our waste quantity estimates were overstated, and thus our estimates of 
possible amounts of CoCs present in the wastes were too high.
    Subsequent to the November 25, 2003 proposal, ETAD conducted a 
confidential survey of 15 organic dye production facilities, and 
submitted as part of their comments masked waste quantity data from the 
survey.\13\ Based on its survey results, ETAD contended that the 
proposed rule greatly exaggerates the quantity of proposed K181 wastes 
generated at dyes production facilities and therefore, the proposed 
mass loading cutoff of 10,000 kg/yr should be revised. ETAD also 
indicated in its survey summary that two dye production facilities use 
none of the proposed K181 listing constituents in dyes production. 
Furthermore, ETAD confirmed that two dye manufacturers ceased operation 
during the past year.
---------------------------------------------------------------------------

    \13\ The survey waste quantity results initially included in 
ETAD's February 23, 2004 comments and attachments are annual 
quantities of nonwastewaters relating to the manufacturing of in-
scope dyes (i.e., specifically covered by the proposed rule). In 
response to our inquiry, ETAD later submitted an amended summary of 
waste quantities that include the other wastestreams commingled with 
the in-scope wastes.
---------------------------------------------------------------------------

    CPMA similarly conducted a confidential survey of 21 organic 
pigment manufacturers following the proposal, and provided masked waste 
quantity summary data for both total and in-scope nonwastewaters as 
part of their comments. CPMA commented that, based on its survey, EPA's 
estimates of nonwastewater quantities overestimate the amount of 
nonwastewater generated by the pigments industry by at least 400 
percent, and that the actual amount of nonwastewaters generated by the 
dyes and pigments production industries is much less than one-half the 
amount estimated by the Agency.
    Six organic dyes and/or pigments manufacturers also presented their 
waste quantities and disputed the Agency's estimates for their 
facilities. Several other pigment manufacturers mirrored CPMA's comment 
that the Agency overestimated the waste quantities generated by the 
industries by at least 400 percent, although they did not specifically 
provide their own waste quantities. Several manufacturers informed us 
that their in-scope manufacturing processes do not contribute any of 
the proposed K181 constituents to their wastes.
    We reviewed the waste quantity information and data provided by the 
commenters, but found some data discrepancies and deficiencies that 
limit use of the data. Our findings are summarized below:

--Two dye manufacturers have closed.
--The organic pigment manufacturing operation of one dye and pigment 
production facility was recently sold to a pigments manufacturer.
--Two facilities use none of the proposed K181 listing constituents.
--Three facilities do not generate any nonwastewater.
--CPMA's survey encompassed wastes generated in 2002, while ETAD did 
not specify the time period covered by its survey. As such, these two 
sets of survey quantity data may not be fully compatible.
--Three facilities making both dyes and pigments products responded to 
both ETAD and CPMA surveys. However, for the reported waste quantities 
possibly associated with these facilities, there appears to be some 
discrepancies between ETAD's and CPMA's masked annual quantity data.
--Three known Food, Drug and Cosmetic (FD&C) colorant production 
facilities were not covered by either the ETAD or CPMA survey.

    We removed from the database the two facilities using none of the

[[Page 9150]]

proposed K181 listing constituents, as well as the three facilities 
generating zero waste quantities, because they would not be impacted by 
the proposed rule. Next, we made assumptions in trying to match the 
masked data points for the three facilities that responded to both the 
ETAD and CPMA surveys in order to account for the overlap, using 
publicly available data and our best judgement. To revise our previous 
estimates of facility-specific waste quantities, we adopted the 
specific waste quantity data provided by the commenting dyes/pigments 
manufacturers, made assumptions based on certain comments, and applied 
the estimated annual revenues to match the masked waste quantities with 
facilities. Finally, we added the three facilities not covered by 
either the CPMA or ETAD survey, using waste quantities we estimated for 
these facilities. The consolidated data points created a set of annual 
waste quantities with high uncertainties for the potentially impacted 
dyes/pigment facilities.
    In any case, we have analyzed the commenters' data and concluded 
that the average estimated waste quantity we used for the proposed rule 
(i.e., 1,894 MT/yr) is well within the distributions of values reported 
in comments; the estimated value of 1,894 MT/yr is comparable to the 
80th percentile value (1,815 MT/yr) of the consolidated data set 
described above. For a detailed analysis of the commenters' data, see 
the Response to Comments Background Document, available in the public 
docket for today's final rule.
    Based on our analysis of the commenters' waste quantity data, and 
in view of the data uncertainty in the ETAD and CPMA surveys, we 
continue to believe that it is reasonable to retain the proposed mass 
loading cutoff of 10,000 kg/yr for eliminating constituents from 
consideration.
6. Prevalence of Constituents of Concern
    Commenters submitted critiques of each of the CoCs, arguing that 
they do not warrant inclusion in the final listing. With the exception 
of the arguments submitted for toluene-2,4-diamine (as discussed in a 
prior section of this notice), EPA has concluded that our basis for 
setting standards for the seven CoCs is valid. The comments for these 
seven CoCs and our responses are summarized below, and provided in more 
detail in the Response to Comments Background Document in the docket 
for today's final rule.
    a. Aniline. We proposed to include aniline as a CoC because it is 
widely reported to be used in the manufacture of dyes and/or pigments. 
We detected aniline in a variety of wastes in our analysis of waste 
samples, it is reported to be an intermediate in the production of 
various products reported by U.S. manufacturers in the Colour Index, it 
is reported in the TRI by various known dye and/or pigment 
manufacturers, it was reported to be a waste component in the RCRA 
Sec.  3007 survey and in comments on our 1994 proposal, and is a known 
intermediate for various products reported as available on the Web 
sites of various U.S. dye and/or pigment manufacturers (see the Listing 
Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that seven dye manufacturers use 
aniline in their processes, and that four pigment manufacturers use 
this CoC. Twelve pigment survey respondents also indicated that it is 
present in their wastes. Further, although CPMA stated that less than 
25 percent of U.S. pigment manufacturers use aniline, nine pigment 
manufacturers individually commented that aniline is actually used or 
is likely present in their production of pigments. These data confirm 
our position at proposal that aniline is used widely in the manufacture 
of dyes and pigments.
    ETAD argued that the available analytical data does not support a 
conclusion that aniline is likely to be present in dye wastes at levels 
exceeding the proposed listing level. One commenter (BASF) noted that 
the maximum concentration of aniline in wastewater treatment sludges 
reported in the proposal (31,000 ppm) was from their process, and 
reflects a process waste that was eliminated from their manufacturing 
process in 1996.
    While we agree with ETAD and BASF that the available analytical 
data (as described in the proposal) are older, these data do provide a 
snapshot in time of the composition of wastes from the manufacture of 
dyes and/or pigments. BASF did not provide a profile of their currently 
generated wastes, so it is not possible to ascertain whether other 
wastes generated from their process(es) are as contaminated as the 
stream that was eliminated in 1996. BASF did, however, provide in their 
comments a risk assessment of releases from their onsite boiler.\14\ 
This risk assessment contains limited waste characterization data which 
depicts aniline concentrations in their boiler feed even higher than 
the levels observed in most of the available analytical data (1.45% 
aniline). We note also that the commenters focused solely on the 
analytical data available for wastewater treatment sludges; we reported 
in the proposal three additional samples of ``other nonwastewaters'' 
that contain aniline, with a maximum value of 180,000 ppm.\15\
---------------------------------------------------------------------------

    \14\ See Comment RCRA-2003-0001-0258.
    \15\ See the aggregated EPA data in Appendix I of the Background 
Document for Identification and Listing of Wastes from the 
Production of Organic Dyes and Pigments, which is in the docket for 
today's rule.
---------------------------------------------------------------------------

    ETAD also argued that if EPA's estimated average waste quantity is 
adjusted to reflect the results of their survey, the 10,000 kilograms/
year (kg/yr) screening level would be lower, eliminating aniline as a 
potential CoC. As discussed more fully in section IV.A.5, we believe 
that the waste quantity that we used in the development of the proposal 
is well within the distribution of waste quantities reported by 
commenters, and we accordingly have not adjusted it.
    After considering the commenters' concerns, we believe that it is 
appropriate to retain the mass-loading levels for aniline in today's 
final rule.
    b. o-Anisidine. We proposed to include o-anisidine as a CoC because 
it is widely reported to be used in the manufacture of dyes and/or 
pigments. We detected o-anisidine in several wastes in our analysis of 
waste samples, it is reported to be an intermediate in the production 
of various products reported by U.S. manufacturers in the Colour Index, 
it is reported in the TRI by known dye and/or pigment manufacturers, 
azo dyes derived from it are subject to regulation by the European 
Union (EU), and it is a known intermediate for products reported as 
available on the Web sites of several U.S. dye and/or pigment 
manufacturers (see the Listing Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that three dye manufacturers and 
two pigment manufacturers use o-anisidine in their processes. Further, 
five CPMA survey respondents reported this CoC being present in their 
wastes as a contaminant. Six pigment manufacturers (which represent 11 
facilities manufacturing in-scope pigments) also indicated in their 
individual comments that o-anisidine is actually used or likely to be 
present in their pigment processes.
    ETAD argued that o-anisidine is only used or generated at 3 of 15 
dye production facilities. CPMA stated that it is only used in the 
production of pigments by less than 25 percent of U.S. pigment 
manufacturers. We believe, however, that these usage rates are not 
insignificant, particularly for an

[[Page 9151]]

industry known to manufacture a wide variety of products over time and 
between companies using batch operations. Further, as noted above, six 
pigment manufacturers also reported using or generating this CoC. 
Therefore, the available information indicates that o-anisidine is 
likely to be present in dye/pigment wastes, and it is reasonable to 
keep this as a constituent of concern. Moreover, even if o-anisidine 
were considered infrequently used, EPA would still consider that o-
anisidine met the listing criteria set out in Sec.  261.11.
    ETAD noted that o-anisidine was only detected in one sample, and 
that the sample is outdated and of limited value as it was qualified as 
a ``J'' value \16\ and difficult to differentiate from 2-/4-
aminoaniline. We agree that the particular analytical result noted is 
an insufficient basis by itself to include o-anisidine in the K181 
listing. However, we have other sources that confirm that this 
constituent is used by a number of generators in the manufacture of 
relevant colorants. We note that o-anisidine was also tentatively 
identified in four wastewater samples in the data summary presented in 
the proposal's Listing Background Document, and that the ETAD and CPMA 
surveys confirm that this constituent is still in use at a number of 
their members' facilities.
---------------------------------------------------------------------------

    \16\ ``J'' values are chemical concentrations that were detected 
below the analytical reporting limit, but above the limit of 
detection for the method used. See OSW's methods manual, especially 
Chapter 1, Quality Control; ``Test Methods for Evaluating Solid 
Waste, Physical/Chemical Methods, SW-846.''
---------------------------------------------------------------------------

    ETAD noted that o-anisidine was not reported in the RCRA Sec.  3007 
survey. We note that the survey data used to support the proposal 
represented a limited subset of the census survey (i.e., those surveys 
without CBI claims), and may not be fully indicative of waste 
composition.
    ETAD also argued that there is no evidence that either the 
calculated theoretical average concentration of o-anisidine (58 ppm) or 
the average waste volume of 1,894 MT/yr (described in the proposal's 
Listing Background Document) occurs in dyes production wastes. We agree 
that the data available to the Agency do not identify specific wastes 
that would exceed the listing levels. Nevertheless, given the format of 
the proposed rule (i.e., a mass loadings-based listing), we believe 
that such data are not critical. Instead, we have demonstrated that the 
range of both expected waste quantities and organic waste constituent 
concentrations are broad enough that CoC levels in real wastes could 
potentially exceed the K181 loading limits.
    ETAD further asserts that their newly collected data show that the 
median volume of o-anisidine is zero, and the maximum reported volume 
is less than one percent of the proposed mass loading. We do not 
believe these statistics are particularly meaningful. First, the 
commenter provided very little information about the nature of its 
data. For example, it is unclear what year the data reflect, or even if 
they represent the same calendar year among ETAD's survey respondents. 
Also, ETAD provided no information regarding the variability of these 
data over time (e.g., were the data representative of typical 
operations? Are there relevant trends in the use of raw materials?). In 
an industry that produces a very diverse range of products from plant 
to plant and from year to year, we would not expect that the majority 
of manufacturers would utilize any one of the K181 constituents at any 
given time. Thus, the commenter's findings of a median value of zero is 
not surprising or relevant. Similarly, the commenter did not provide 
sufficient information regarding their assertion that there are no dye 
manufacturers whose mass loading of o-anisidine in their wastes exceed 
1 percent of the K181 limit for us to remove this constituent from the 
listing, given all the information supporting this constituent. The 
commenter did not provide any information on how the survey respondents 
determined mass loadings of o-anisidine or other constituents in their 
waste, so we have no way of judging the validity of such claims. We 
also expect that any given facility's raw material slate will change 
over time in response to market demands for different colors and 
product characteristics. Retaining this constituent in the listing 
provides a clear incentive for generators to make choices in their 
manufacturing processes to avoid excessive levels of o-anisidine in 
their wastes. We note that there are three facilities that reported o-
anisidine in Form A under TRI. Form A is used for chemicals with 
releases below 500 pounds per year (as well as other restrictions 
related to usage volume). The K181 mass loading level for o-anisidine 
is 110 kg, or 242 pounds, thus it is possible that these three 
facilities are above or near the K181 level.
    Finally, ETAD also argued that because the groundwater modeling 
results indicated that the time-to-impact is more than 250 years for o-
anisidine, this constituent should be excluded from the listing. As 
discussed later with respect to the comments on the risk assessment, we 
do not believe this is an unreasonable time frame.
    In conclusion, we have determined that our basis for including o-
anisidine in the listing is sound, and we are finalizing the o-
anisidine level as proposed.
    c. 4-Chloroaniline. We proposed to include 4-chloroaniline as a CoC 
because it is reported to be used in the manufacture of dyes and/or 
pigments. We detected 4-chloroaniline in a variety of wastes in our 
analysis of waste samples, it is reported in the TRI by a known dye 
and/or pigment manufacturer, and azo dyes derived from it are subject 
to regulation by the EU (see the Listing Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that two dye manufacturers use 
4-chloroaniline in their processes, and that one pigment manufacturer 
also uses this CoC, although not in a process covered by the scope of 
the proposed K181 listing.
    ETAD argued that 4-chloroaniline is only used or generated at 2 of 
15 dye production facilities. We believe that this is not an 
insignificant response, particularly for an industry known to 
manufacture a wide variety of products over time at companies using 
batch operations. Therefore, the available information indicates that 
4-chloroaniline is likely to be present in dye/pigment wastes, and it 
is reasonable to keep this as a constituent of concern. Moreover, even 
if 4-chloroaniline were considered infrequently used, EPA would still 
consider that 4-chloroaniline met the listing criteria set out in Sec.  
261.11.
    ETAD noted that 4-chloroaniline was only detected in two samples. 
We point out, however, that 4-chloroaniline was also identified in two 
wastewater samples and one ``other nonwastewater'' sample in the data 
summary presented in the proposal's Listing Background Document, and 
that CPMA had reported the presence of this constituent in three split 
samples of the noted data. In addition, several commenters on prior 
proposals for these wastes described the presence of this CoC in their 
wastes. Further, the ETAD survey confirms that this constituent is 
currently in use at several of their members' facilities.
    ETAD also pointed out that the referenced TRI data are limited to a 
single report in a single year. Bayer, the company that reported this 
TRI release, explained in their comments that 4-chloroaniline is not 
used by any covered dyes process and was never present in

[[Page 9152]]

the wastewater or wastewater treatment sludge generated at the facility 
of interest (Bushy Park, SC). While this may be the case, it is not 
clear whether 4-chloroaniline is used in pigment production at this 
site as the pigment operations were sold to Sun Chemical in January 
2003.\17\
---------------------------------------------------------------------------

    \17\ http://www.timesleader.com/mld/timesleader/5122083.htm.
---------------------------------------------------------------------------

    In addition, ETAD argued that the Agency's basis for regulating 
this constituent is weak because there are no references to the use of 
this chemical in the Colour Index, or in the RCRA Sec.  3007 survey. We 
acknowledge both points, but note that the Colour Index, while very 
useful, provides an incomplete compendium of intermediates used in the 
production of dyes and pigments, particularly for those products that 
have only recently been brought to market. Furthermore, the information 
presented in the Colour Index is limited by certain confidentiality 
concerns manufacturers may have for colorants produced. In our research 
of products reported by manufacturers on their Web sites and those 
listed in the Colour Index, there were many products for which no 
intermediate information was available. Further, the Colour Index does 
in fact identify a number of manufacturers that produce colorants 
derived from 4-chloroaniline (e.g., CI 37510, 37610), although none of 
them appear to be based in the U.S. This information implies that a 
market exists for these products, and U.S. manufacturers might produce 
these colorants. With respect to the lack of Sec.  3007 survey data, we 
have previously described the incomplete nature of the survey data 
available for use in the proposed rule.
    Furthermore, ETAD argued that there is no evidence that either the 
calculated theoretical average concentration of 4-chloroaniline (2,534 
ppm) or the average waste volume of 1,894 MT/yr (described in the 
proposal's Listing Background Document) occurs in dyes production 
wastes. ETAD asserts that their newly collected data show that the 
median volume of 4-chloroaniline is zero, and the maximum reported 
volume is less than one percent of the proposed mass loading. We refer 
the reader to our earlier responses to similar comments on o-anisidine.
    Finally, ETAD also argued that if EPA's estimated average waste 
quantity is adjusted to reflect the results of their survey and the 
assumed plausible maximum constituent concentration (5,000 ppm) were 
more reasonable, the 10,000 kg/yr screening level would be lower, 
eliminating 4-chloroaniline as a potential CoC. As discussed more fully 
in section IV.A.5, we believe that the waste quantity that we used in 
the development of the proposal is well within the distribution of 
waste quantities reported by commenters, and we accordingly have not 
adjusted it. Similarly, we believe that the assumed plausible maximum 
constituent concentration is appropriate, noting that we considered 
analytical data for both ``wastewater treatment sludge'' and ``other 
nonwastewaters,'' while the commenter appears to be focused only on the 
wastewater treatment sludge data. The data for ``other nonwastewaters'' 
show several constituents with concentrations in the thousands of parts 
per million.
    In conclusion, we have determined that our basis for including 4-
chloroaniline in the listing is sound, and we are finalizing the 4-
chloroaniline level as proposed.
    d. p-Cresidine. We proposed to include p-cresidine as a CoC because 
it is reported to be used in the manufacture of dyes and/or pigments. 
p-Cresidine is reported to be an intermediate in the production of 
various products reported by U.S. manufacturers in the Colour Index, it 
is reported in the TRI by a known dye and/or pigment manufacturer, azo 
dyes derived from it are subject to regulation by the EU, and it is a 
known intermediate for several products reported as available on the 
website of a U.S. dye and/or pigment manufacturer (see the Listing 
Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that four dye manufacturers use 
p-cresidine in their processes, and that two pigment manufacturers also 
use this CoC (although these uses may be from onsite dye manufacture).
    ETAD argued that p-cresidine is only used or generated at 4 of 15 
dye production facilities. As noted previously, we believe that this is 
not insignificant, particularly for an industry known to manufacture a 
wide variety of products over time at companies using batch operations. 
Two pigment facilities were reported by CPMA to also use or generate 
this CoC. Therefore, the available information indicates that p-
cresidine is likely to be present in dye/pigment wastes, and it is 
reasonable to keep this as a constituent of concern. Moreover, even if 
p-cresidine were considered infrequently used, EPA would still consider 
that p-cresidine met the listing criteria set out in Sec.  261.11.
    ETAD also argued that p-cresidine should be removed as a basis for 
the listing in part because there are no sampling and analysis data or 
RCRA section 3007 survey data demonstrating its presence in wastes. We 
acknowledge that p-cresidine was not detected in any of the samples 
collected in support of the 1994 rulemaking. However, the sampling was 
conducted at a subset of the manufacturing sites in operation at that 
time, and thus it is likely that these data are an incomplete profile 
of potential waste composition. In fact, the commenter's own data 
indicate that four dye manufacturers currently use p-cresidine as an 
intermediate, and thus the likelihood that this CoC exists in wastes at 
these sites is high. As mentioned previously, the Sec.  3007 data 
presented in the proposal represents that portion of the data which 
were not subject to any confidentiality claims and, therefore, does not 
represent a complete profile of reported waste constituents.
    In addition, ETAD argued that the TRI data does not support 
inclusion of p-cresidine because only one Form R and one Form A were 
submitted. However, we believe that it is significant that the TRI data 
confirm that current manufacturers of impacted colorants do use and 
release this CoC, supporting our basis for including p-cresidine in the 
K181 listing.
    Further, ETAD argued that there is no evidence that either the 
calculated theoretical average concentration of p-cresidine (348 ppm) 
or the average waste volume of 1,894 MT/yr (described in the proposal's 
Listing Background Document) occurs in dyes production wastes. ETAD 
asserts that their newly collected data show that the median volume of 
p-cresidine is zero, and the maximum reported volume is less than one 
percent of the proposed mass loading. We refer the reader to our 
earlier responses to similar comments on o-anisidine.
    Moreover, ETAD also argued that if EPA's estimated average waste 
quantity is adjusted to reflect the results of their survey and the 
assumed plausible maximum constituent concentration (5,000 ppm) were 
more reasonable, the 10,000 kg/yr screening level would be lower, 
eliminating p-cresidine as a potential CoC. We refer the reader to our 
earlier response to a similar comment on 4-chloroaniline.
    Finally, ETAD argued that because the groundwater modeling results 
indicated that the time-to-impact is more than 250 years for p-
cresidine, this constituent should be excluded from the listing. As 
discussed later with respect to the comments on the risk assessment, we 
do not believe this is an unreasonable time frame.

[[Page 9153]]

    In conclusion, we have determined that our basis for including p-
cresidine in the listing is sound, and we are finalizing the p-
cresidine level as proposed.
    e. 2,4-Dimethylaniline. We proposed to include 2,4-dimethylaniline 
as a CoC because it is reported to be used in the manufacture of dyes 
and/or pigments. We detected 2,4-dimethylaniline in several wastes, it 
was reported to be a waste component in the RCRA Sec.  3007 survey, and 
it is a known intermediate for several products reported as available 
on the websites of several U.S. dye and/or pigment manufacturers (see 
the Listing Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposed 
rule provided recent survey data that two dye manufacturing facilities 
report the use of this CoC, and confirming the presence of 2,4-
dimethylaniline in wastes at two pigment manufacturing facilities. Six 
pigment manufacturers indicated in their individual comments that this 
constituent is actually used or likely present in their production of 
pigments.
    ETAD argued that 2,4-dimethylaniline is only used or generated at 2 
of 15 dye production facilities. CPMA stated that it is only used in 
the production of pigments by less than 25 percent of U.S. pigment 
manufacturers. We believe, however, that these usage rates are not 
insignificant, particularly for an industry known to manufacture a wide 
variety of products over time and at companies using batch operations. 
Further, we note that CPMA has confirmed that this CoC is a waste 
component at two pigment facilities, and that six pigment manufacturers 
have specifically confirmed that 2,4-dimethylaniline is relevant to 
their processes and/or wastes. Therefore, the available information 
indicates that 2,4-dimethylaniline is likely to be present in dye/
pigment wastes, and it is reasonable to keep this as a constituent of 
concern. Moreover, even if 2,4-dimethylaniline were considered 
infrequently used, EPA would still consider that 2,4-dimethylaniline 
met the listing criteria set out in Sec.  261.11.
    ETAD argued that our basis for including this constituent is 
weakened because this CoC was not detected in nonwastewaters. While we 
confirm this specific observation, we note that 2,4-dimethylaniline was 
detected in wastewaters by EPA, and CPMA reported this chemical in 
split sample analyses. These data support EPA's finding that this 
constituent may reasonably be expected to be present in some wastes 
from the production of dyes and/or pigments.
    ETAD also suggests that our basis for including this constituent as 
a basis for the listing is weakened because we presented no linkages to 
the TRI, the Colour Index (or similar sources), or the EU ban for this 
constituent. First, we would note that 2,4-dimethylaniline is not 
listed in section 313 of the Emergency Planning and Community Right-to-
Know Act (EPCRA), and thus is not subject to TRI reporting. With 
respect to the Colour Index, this source does in fact identify a number 
of manufacturers that produce azo colorants derived from 2,4-
dimethylaniline (e.g., CI 14900, 16150, 29105), although none of them 
appear to be based in the U.S.\18\ This information implies that a 
market exists for these products, and U.S. manufacturers might in the 
future choose to produce these colorants. Finally, with respect to the 
EU ban [Directive for a Community Ban on Azocolourants (76/769/EEC, 
Annex I, point 43)], as discussed in the proposal, this constituent has 
been studied for possible inclusion in a related ban of certain 
compounds in cosmetics and is regulated as a class 2 carcinogen in 
Germany.\19\
---------------------------------------------------------------------------

    \18\ One U.S. company, Bernscolor (Poughkeepsie, NY), is listed 
in the Colour Index as marketing CI 16150, however, neither trade 
association identified this facility as manufacturing in-scope dyes 
and/or pigments.
    \19\ Studied by EU in the context of Directive 76/768/EEC: 
SCCNFP/0495/01, Opinion of the Scientific Committee on Cosmetic 
Products and Non-Food Products Intended for Consumers concerning 
``The Safety Review of the Use of Certain Azo-Dyes in Cosmetic 
Products,'' 2/27/02. http://europa.eu.int/comm/food/fs/sc/sccp/out155_en.pdf.
---------------------------------------------------------------------------

    In addition, ETAD argued that there is no evidence that either the 
calculated theoretical average concentration of 2,4-dimethylaniline (53 
ppm) or the average waste volume of 1,894 MT/yr (described in the 
proposal's Listing Background Document) occurs in dyes production 
wastes. We refer the reader to our earlier response to a similar 
comment on o-anisidine.
    Furthermore, ETAD asserts that their newly collected data show that 
the median volume of 2,4-dimethylaniline is zero, and the maximum 
reported volume is less than one percent of the proposed mass loading. 
We refer the reader to our earlier response to a similar comment on o-
anisidine.
    Finally, ETAD argued that because the groundwater modeling results 
indicated that the time-to-impact is more than 250 years for 2,4-
dimethylaniline, this constituent should be excluded from the listing. 
As discussed later with respect to the comments on the risk assessment, 
we do not believe this is an unreasonable time frame.
    In conclusion, we have determined that our basis for including 2,4-
dimethylaniline in the listing is sound, and we are finalizing the 2,4-
dimethylaniline level as proposed.
    f. 1,2-Phenylenediamine. We proposed to include 1,2-
phenylenediamine as a CoC because it is reported to be used in the 
manufacture of dyes and/or pigments. We detected 1,2-phenylenediamine 
in several wastes in our analysis of waste samples, it is reported to 
be an intermediate in the production of various products reported by 
U.S. manufacturers in the Colour Index, it was reported in the TRI by 
known dye and/or pigment manufacturers, and it is a known intermediate 
for several products reported as available on the websites of several 
U.S. dye and/or pigment manufacturers (see the Listing Background 
Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that two dye manufacturers use 
1,2-phenylenediamine in their processes, and that two pigment 
manufacturers also use this CoC. Two pigment manufacturers also 
indicated in their individual comments that it is present in their 
wastes (although possibly not from in-scope pigment processes).
    ETAD argued that 1,2-phenylenediamine is only used or generated at 
2 of 15 dye production facilities. We believe that this is not 
insignificant, particularly for an industry known to manufacture a wide 
variety of products over time at companies using batch operations. In 
addition, CPMA has confirmed that this CoC is a waste component at two 
pigment facilities, and that it is used in the production of pigments 
at two facilities. Therefore, the available information indicates that 
1,2-phenylenediamine is likely to be present in dye/pigment wastes, and 
it is reasonable to keep this as a constituent of concern. Moreover, 
even if 1,2-phenylenediamine were considered infrequently used, EPA 
would still consider that 1,2-phenylenediamine met the listing criteria 
set out in Sec.  261.11.
    ETAD also argued that the TRI data does not support inclusion of 
1,2-phenylenediamine because only one Form A was submitted for one 
year. While it is true that only one Form A was reported, the TRI data 
confirm that there is current use and release of this CoC, supporting 
our basis for including 1,2-phenylenediamine in the K181 listing.
    In addition, ETAD argued that 1,2-phenylenediamine should not be

[[Page 9154]]

included as a basis for this listing in part because there are no RCRA 
Sec.  3007 survey data demonstrating its presence in wastes. As 
mentioned previously, the Sec.  3007 data presented in the proposal 
represent that portion of the data which were not subject to any 
confidentiality claims and, therefore, does not represent a complete 
profile of reported waste constituents. In fact, ETAD's (and CPMA's) 
own data indicate that a number of dye and/or pigment manufacturers 
currently use 1,2-phenylenediamine as an intermediate, providing 
further confirmation that this CoC exists in wastes at these sites.
    Furthermore, ETAD noted that 1,2-phenylenediamine was only detected 
in one sample, and that the sample is outdated and of limited value as 
it was qualified as a ``J'' value, and difficult to differentiate from 
1,4-phenylenediamine and o-anisidine. We agree that the particular 
analytical result noted is insufficient by itself to be a basis to 
include 1,2-phenylenediamine in the K181 listing. However, we have 
other sources of information that confirm that this constituent is used 
by a number of generators in the manufacture of relevant colorants. We 
note that 1,2-phenylenediamine was also tentatively identified in four 
wastewater samples in the data summary presented in the proposal's 
Listing Background Document. Two comments on the earlier proposed 
listing determination for these wastes also refer to the use or 
presence of this constituent in the wastes of concern. In addition, the 
ETAD and CPMA surveys confirm that this constituent is currently in use 
at a number of their members' facilities.
    Moreover, ETAD argued that there is no evidence that either the 
calculated theoretical average concentration of 1,2-phenylenediamine 
(375 ppm) or the average waste volume of 1,894 MT/yr (described in the 
proposal's Listing Background Document) occurs in dyes production 
wastes. We refer the reader to our earlier response to a similar 
comment on o-anisidine.
    ETAD also asserts that their newly collected data show that the 
median volume of 1,2-phenylenediamine is zero, and the maximum reported 
volume is less than one percent of the proposed mass loading. We refer 
the reader to our earlier response to a similar comment on o-anisidine.
    Finally, ETAD argued that if EPA's estimated average waste quantity 
is adjusted to reflect the results of their survey and the assumed 
plausible maximum constituent concentration (5,000 ppm) were more 
reasonable, the 10,000 kg/yr screening level would be lower, 
eliminating 1,2-phenylenediamine as a potential CoC. We refer the 
reader to our earlier response to a similar comment on 4-chloroaniline.
    In conclusion, we have determined that our basis for including 1,2-
phenylenediamine in the listing is sound, and we are finalizing the 
1,2-phenylenediamine level as proposed.
    g. 1,3-Phenylenediamine. We proposed to include 1,3-
phenylenediamine as a CoC because it is reported to be used in the 
manufacture of dyes and/or pigments. Specifically, 1,3-phenylenediamine 
is reported to be an intermediate in the production of various products 
reported by U.S. manufacturers in the Colour Index, it was reported in 
the TRI by a known dye and/or pigment manufacturer, it was reported to 
be a waste component in the RCRA Sec.  3007 survey, and it is a known 
intermediate for several products reported as available on the websites 
of several U.S. dye and/or pigment manufacturers (see the Listing 
Background Document).
    In addition, ETAD and CPMA comments on the November 2003 proposal 
provided recent survey data indicating that three dye manufacturers use 
1,3-phenylenediamine in their processes, and that one pigment 
manufacturer indicated that it is present in their wastes (although not 
from in-scope pigment processes).
    ETAD argued that 1,3-phenylenediamine is only used or generated at 
three of 15 dye production facilities. We believe that this is not 
insignificant, particularly for an industry known to manufacture a wide 
variety of products over time at companies using batch operations. In 
addition, the available RCRA Sec.  3007 survey results indicate that 
this constituent was reported by industry in at least 17 in-scope 
discrete wastestreams. Therefore, the available information indicates 
that 1,3-phenylenediamine is likely to be present in dye/pigment 
wastes, and it is reasonable to keep this as a constituent of concern. 
Moreover, even if 1,3-phenylenediamine were considered infrequently 
used, EPA would still consider that 1,3-phenylenediamine met the 
listing criteria set out in Sec.  261.11.
    ETAD also argued that 1,3-phenylenediamine should not be included 
as a basis for the listing in part because there are no sampling and 
analysis data demonstrating its presence in wastes. We acknowledge that 
1,3-phenylenediamine was not detected in any of the samples collected 
in support of the 1994 rulemaking. However, the sampling was conducted 
at a subset of the manufacturing sites in operation at that time, and 
thus it is likely that these data are an incomplete profile of 
potential waste composition. The commenter's own data indicate that 
three dye manufacturers currently use 1,3-phenylenediamine as an 
intermediate, providing further confirmation that this CoC exists in 
wastes at these sites.
    In addition, ETAD also argued that there is no evidence that either 
the calculated theoretical average concentration of 1,3-
phenylenediamine (634 ppm) or the average waste volume of 1,894 MT/yr 
(described in the proposal's Listing Background Document) occurs in 
dyes production wastes. We refer the reader to our earlier response to 
a similar comment on o-anisidine.
    Furthermore, ETAD asserts that their newly collected data show that 
the median volume of 1,3-phenylenediamine is zero, and the maximum 
reported volume is less than 10 percent of the proposed mass loading. 
We refer the reader to our earlier response to a similar comment on o-
anisidine, and note that ``10 percent'' is not insignificant--process 
changes or stepped up production volumes might increase this maximum 
value to exceed the K181 loading limit.
    Finally, ETAD argued that if EPA's estimated average waste quantity 
is adjusted to reflect the results of their survey and the assumed 
plausible maximum constituent concentration (5,000 ppm) were more 
reasonable, the 10,000 kg/yr screening level would be lower, 
eliminating 1,3-phenylenediamine as a potential CoC. We refer the 
reader to our earlier response to a similar comment on 4-chloroaniline.
    In conclusion, we have determined that our basis for including 1,3-
phenylenediamine in the listing is sound, and we are finalizing the 
1,3-phenylenediamine level as proposed.
7. Availability of Analytical Methods for Constituents of Concern
    Commenters contend that EPA did not adequately address the 
availability of analytical methods necessary to implement the proposed 
rule. The commenters pointed out that EPA's economic analysis suggested 
that four proposed constituents (toluene-2,4-diamine, 1,2-
phenylenediamine, 1,3-phenylenediamine, and 2,4-dimethylaniline) lack 
established analytical methods. Most commenters were especially 
concerned with the lack of a verified method for one of the four 
constituents, toluene-2,4-diamine. One commenter also expressed concern 
specifically over the lack of methods for

[[Page 9155]]

1,2-phenylenediamine. Commenters questioned the adequacy of the methods 
for analyzing another proposed constituent (aniline). They referred to 
previous studies that indicated gas chromatography methods may cause 
false positive readings for aniline, because another chemical sometimes 
present (acetoacetanilide) often breaks down into aniline in the 
analysis.
    We continue to believe that adequate analytical methods exist for 
most CoCs. However, as described previously, we have decided to no 
longer include toluene-2,4-diamine as a constituent of concern for 
K181. Therefore, analysis of this chemical will not be necessary. 
Concerning 1,2-phenylenediamine, we noted the problems with this 
constituent in the proposed rule (68 FR 66194). We have reexamined the 
available EPA methods and determined that, while some methods (e.g., 
SW-846 method 8321B) show promise, the recoveries remain low. Thus, we 
have decided to allow generators to use their knowledge of the waste 
instead of determining the level of this constituent through testing. 
We have revised the final K181 regulatory language to reflect this 
change in the testing requirements by inserting (d)(3)(ii), which 
reads:

    (d)(3)(ii) If 1,2-phenylenediamine is present in the wastes, the 
generator can use either knowledge or sampling and analysis 
procedures to determine the level of this constituent in the wastes. 
For determinations based on use of knowledge, the generator must 
comply with the procedures for using knowledge described in 
paragraph (d)(2) and keep the records described in paragraph 
(d)(2)(iv) of this section. For determinations based on sampling and 
analysis, the generator must comply with the sampling and analysis 
and recordkeeping requirements described below in this section.

    We believe that the other constituents have adequate methods. While 
2,4-dimethylaniline is not included as an analyte in EPA's SW-846 
manual of methods, the chemical has been measured in dye and pigment 
waste samples by both EPA \20\ and by industry.\21\ As the 2003 BDAT 
background document indicated, the standard EPA gas chromatography/mass 
spectrum method (GC/MS method 8270) should be effective for this 
constituent. We are also confident that this GC/MS method is adequate 
for 1,3-phenylenediamine. This is further supported by an EPA technical 
paper showing that 1,3-phenylenediamine can be determined using GC/MS 
methods.\22\ As noted by the commenters, this same technical paper 
describes the breakdown of the chemical acetoacetanilide to aniline 
during GC/MS analysis. While this could theoretically present 
difficulties in determining a precise concentration of aniline in 
wastes that also contain acetoacetanilide, generators may deal with 
this potential problem in several ways. The technical paper cited above 
shows that aniline may also be determined by other methods, i.e., High 
Performance Liquid Chromatography (HPLC) methods. HPLC methods do not 
require the high temperatures needed for GC/MS analysis; thus, the 
presence of acetoacetanilide should not present any problems. 
Alternatively, a generator could conduct the GC/MS analysis, 
recognizing that some of the aniline detected may arise from the 
breakdown of acetoacetanilide. If the measured aniline in the waste is 
still below the aniline loading limit for K181, then the waste would 
not be a hazardous waste due to aniline. Because the loading limit for 
aniline is rather high (9,300 kg/yr), there would have to be a high 
level of acetoacetanilide present in the waste to cause any significant 
problem. In any case, the generators have the option of using the HPLC 
method if they believe that aniline levels would approach the mass 
loading limit, and if they know that the waste contains 
acetoacetanilide.
---------------------------------------------------------------------------

    \20\ See the aggregated EPA data in Appendix I of the Background 
Document for Identification and Listing of Wastes from the 
Production of Organic Dyes and Pigments, which is in the docket for 
today's rule.
    \21\ See final table in the industry data attached to the Letter 
from J. Lawrence Robinson, President of the CPMA, to Ed Abrams of 
EPA, regarding aggregated test data resulting from analyses of the 
split samples, April 20, 1994, in the docket for today's rule.
    \22\ See the technical paper attached to the Letter from J. 
Lawrence Robinson, President of the CPMA, to Ed Abrams of EPA, 
regarding aggregated test data resulting from analyses of the split 
samples, April 20, 1994, in the docket for today's rule.
---------------------------------------------------------------------------

8. Risk Assessment
    The Agency received comments on a number of issues that focused on 
the risk analysis that EPA conducted for the proposed K181 listing 
determination. The most significant of these comments, summarized 
below, pertain to the General Soil Column Model, biodegradation rates, 
infiltration rates, well distance, hydraulic conductivity, simulation 
durations and exposure parameters. We have developed responses for all 
of the public comments received on the proposed rule. The verbatim 
comments and our responses are provided in the Response to Comments 
Background Document in the docket for today's rule.
    a. General Soil Column Model (GSCM). The landfill model that we 
used approximates the dynamic effects of the gradual filling of active 
landfills. The Generic Soil Column Model (GSCM) is a critical submodel 
or algorithm that predicts the fate and transport of constituents 
within the landfill and partitions contaminants to three phases: 
adsorbed (solid), dissolved (liquid), and gaseous.
    Commenters contended that the GSCM is under review by the EPA's 
Science Advisory Board (SAB) and that the SAB panel identified 
significant errors that are expected to produce erroneous results. The 
commenters expected that the SAB panel would recommend that EPA not use 
the GSCM to make any regulatory decisions until a more thorough 
evaluation, including reanalysis of the underlying model code is 
completed. As a result, the commenters argued that it is unacceptable 
for EPA to use the GSCM to make regulatory decisions for the dyes 
manufacturing industry. The commenters noted that EPA has performed 
limited comparison simulations between the GSCM and another model 
(MODFLOW-SURFACT). While the results from this comparison indicated 
that the two simulations yield similar results, the commenters stated 
that the tests completed by EPA represent only a simple and potential 
worst-case scenario that does not test soil zone complexity. Although 
uniform soil zone properties are expected to result in maximum 
leaching, the commenters argued that EPA should also complete an 
evaluation of the GSCM under conditions with significant heterogeneity.
    We continue to believe that the use of the GSCM is appropriate and 
does not produce erroneous results. In the final SAB report,\23\ the 
SAB acknowledged that 3MRA--in its current state--could be used to 
support regulatory decisions for national exit concentrations. However, 
the SAB also recognized that 3MRA is the product of a collection of 
submodels (which includes the GSCM) and that any regulatory decisions 
that rely on 3MRA will reflect the uncertainty and the limitations of 
these models. The SAB panelists conducted a thorough evaluation of the 
GSCM and agreed with the EPA's thoughts on the strengths and 
limitations of the GSCM. The SAB pointed out that the GSCM--as compared 
to some of the legacy models in 3MRA--``is relatively untested and has 
some potential (italics added) theoretical inadequacies.'' The SAB 
review goes on to report on several model evaluation studies (e.g.,

[[Page 9156]]

conducting model-to-model studies and comparing estimated and 
experimental data) conducted by EPA, suggesting that these types of 
studies are important steps in building confidence in the model and 
increasing our understanding of the limitations of the GSCM.
---------------------------------------------------------------------------

    \23\ Report of the U.S. EPA Science Advisory Board Review Panel; 
EPA's Multimedia, Multipathway, and Multireceptor Risk Assessment 
(3MRA) Modeling System; EPA-SAB-05-003, November 2004 (http://www.epa.gov/sab/fiscal04.htm).
---------------------------------------------------------------------------

    One of the major theoretical issues raised by the SAB was the 
concern with the GSCM's ability to produce reliable leachate profiles 
for short time scales; that is, less-than-annual chemical concentration 
profiles for leachate. However, the Agency's risk assessment of waste 
from dye and/or pigment manufacture is based on long-term chronic 
exposures and, therefore, the concentrations at the point of exposure 
are averaged according to the exposure duration for each receptor. In 
particular, the comparison between the GSCM and MODFLOW/SURFACT (a 
widely used flow and transport simulator) demonstrated that long-term, 
average leachate concentration profiles generated by the GSCM were 
similar to those generated by the more robust solution technique used 
in MODFLOW-SURFACT. Thus, the comparison between the GSCM and MODFLOW-
SURFACT demonstrated that the theoretical limitations in the GSCM do 
not appear to be significant when generating annual averages for the 
purposes of estimating long-term potential risks to humans and 
ecological receptors for the dyes and pigments assessment.
    b. Biodegradation. Within the landfill, we simulated losses of mass 
through anaerobic biodegradation (i.e., degradation processes that 
occur in an oxygen-free environment). In the absence of biodegradation 
data for seven organic chemicals, we used surrogate information for 
similar compounds. Commenters generally supported the use of surrogates 
and the appropriateness of considering biodegradation in anaerobic 
landfill conditions. However, commenters believed that EPA 
overestimated concentrations at receptor wells, because EPA used the 
maximum half-life from the available data (i.e., we used the slowest 
degradation rates). Commenters suggested that it would be more 
appropriate to use average values for the half-life.
    We continue to believe that our use of the maximum half-life for 
biodegradation is appropriate to ensure that the mass-loading levels 
are protective to compensate for the uncertainties inherent in the 
data. We used anaerobic degradation rates that were available in our 
primary reference,\24\ and when degradation data were not available, we 
used degradation rates based on surrogate chemicals. This reference 
provides ranges of half lives in environmental media and the Agency 
acknowledges there is considerable uncertainty associated with these 
data. Where available, the authors use preferred data from experimental 
values. However, in cases where experimental values were not available, 
scientific judgements were made in order to estimate a value. The 
amount of biodegradation that occurs will also vary depending on 
various site-specific environmental parameters, including temperature, 
pH, and available biomass. In light of these uncertainties, we believe 
that it is prudent to use the high value in the range of values 
presented rather than to use an average value as suggested by the 
commenters.
---------------------------------------------------------------------------

    \24\ Howard, P.H., R.S. Boethling, W.F. Jarvis, W.M. Meylan, 
E.M. Michalenko, and H.T. Printup (ed.). 1991. Handbook of 
Environmental Degradation Rates. Lewis Publishers.
---------------------------------------------------------------------------

    c. Landfill Infiltration Rates. Our modeling for landfills included 
analyses for both clay liner and composite liner scenarios. For the 
clay-liner scenario, we used the existing databases of landfill 
infiltration rates and ambient regional recharge rates calculated using 
the Hydrologic Evaluation of Landfill Performance (HELP) water-balance 
model. For the composite liner scenario, we used empirical 
distributions of infiltration rates for composite-lined landfills 
compiled in a recent report (TetraTech report).\25\
---------------------------------------------------------------------------

    \25\ ``Characterization of Infiltration Rate Data to Support 
Groundwater Modeling Efforts,'' Draft Final. TetraTech, Inc. 
September 28, 2001.
---------------------------------------------------------------------------

    The commenters stated that they identified several errors and 
inconsistencies with the infiltration estimates used to predict 
downgradient concentrations. The commenters indicated that the 
composite liner infiltration rates EPA used in the modeling analysis 
were not consistent with the infiltration rates shown in the TetraTech 
report. The commenters claimed that EPA incorrectly used infiltration 
rates for the single synthetic liner instead of the infiltration rates 
for the composite liner. One commenter noted that the Risk Assessment 
Background Document provides a leak density variable, as well as an 
infiltration rate for landfills, suggesting that infiltration rates 
through the liner are calculated. Thus, the commenter suggested that 
EPA clarify exactly how leachate curves are estimated. The commenter 
also stated that the HELP model is not an appropriate tool to determine 
liner percolation rates because (1) the HELP model is intended to be 
used as a landfill design tool to evaluate the merits of different 
design alternatives, and (2) the HELP model has been found to 
overestimate infiltration rates at landfills and to erroneously predict 
the timing of events.
    As we described in the proposal, we based the composite liner 
scenario on infiltration rates extracted from the TetraTech report for 
composite lined landfill units, i.e., units with a combination of 
geomembrane (GM) and clay liners (compacted clay, CCL, or geosynthetic 
clay, GCL). We screened the data to yield a data set of forty 
infiltration rates. The composite liner scenario represented only those 
rates from the screened set of rates and, thus, we did not use rates 
from single synthetic liners in this analysis. We then generated the 
specific values used for modeling the composite liner scenario through 
interpolation using the available forty infiltration rates. Thus, the 
interpolated values are a representative distribution of the forty 
rates and do not reflect single synthetic liners. Finally, we also note 
that we are not using the composite liner results to set mass-loading 
levels since we have decided to no longer include toluene-2,4-diamine 
as a constituent of concern for K181.
    Regarding the HELP model, the Agency used the model to determine 
infiltration rates through capped unlined and clay lined landfills 
hypothetically sited at each of the 102 climate stations available in 
the model. Neither permeability nor leak density were included as 
parameters in these simulations. EPA used the HELP model, in 
conjunction with data from climate stations across the United States, 
to develop recharge and infiltration rate distributions for different 
liner designs.\26\ Further, the landfills modeled in this analysis were 
consistent with standard design practices, and similar to the type of 
landfill HELP was designed to simulate. The Agency used the HELP model 
to estimate long-term infiltration rates based on the historical data 
available with the model. Recent evaluations of actual leachate 
generation rates have shown that the HELP model can also be a very good 
approximation of actual conditions.
---------------------------------------------------------------------------

    \26\ See Appendix A of the EPA's Composite Model for Leachate 
Migration with Transformation Products (EPACMTP)--Parameters/Date 
Background Documents (2003).
---------------------------------------------------------------------------

    d. Well Distance. The commenters contended that the information on 
well distance from EPA's National Survey of Municipal Landfills is not 
representative of disposal practices in the dye industry. The 
commenters'

[[Page 9157]]

review of the survey used to estimate well distance indicated that EPA 
only collected well distance information if a well was located within 
one mile of the landfill. The commenters contended that the survey 
results used by EPA are significantly skewed and any distribution 
calculated from these results will not be representative of municipal 
landfills, but only those municipal landfills with well distances less 
than one mile. The commenters suggested that EPA should have limited 
the well distance information to those facilities currently used by dye 
manufacturers, and resubmitted a survey of landfills originally 
submitted in comments on the previous 1999 proposed rule. According to 
the data supplied, seven of sixteen landfills have no nearby wells or 
have wells greater than one mile from the landfill boundary. Based on 
this information, the commenters argued that the Agency's well distance 
distribution was irrelevant for the dye industry and thereby 
overestimated potential migration of constituents from the landfill to 
the receptor well.
    We believe that the use of a national distribution of landfill 
characteristics is appropriate. The populations of concern to EPA are 
those with private wells near landfills, and the selected distribution 
covers that population. The data supplied by the commenters are 
incomplete with respect to coverage of all facilities in the dyes and/
or pigments industries and, therefore, may not be representative of 
disposal facility characteristics that could be used. The Agency 
adopted an approach to use a nationwide risk assessment methodology 
that has been applied in previous listing determinations, and this 
approach has been subject to peer review. As noted in our response to 
comments on landfill liners in section IV.A.2, the specific landfill 
information submitted by the commenters was for a small number of 
landfills relevant to dye manufacturers only, and would not be 
representative of the landfills that could be used (EPA estimated that 
there are about 2,300 MSW landfills in operation in 2000). Moreover, 
disposal locations, in addition to well locations, can change over 
time. Therefore, we used probabilistic analyses in an attempt to 
incorporate the variability and uncertainty in the data.
    e. Hydraulic Conductivity Values. The commenters questioned a 
number of hydraulic conductivity values used in the regional 
hydrogeologic database. The commenters believed that these ``extremely 
high'' hydraulic conductivity values are implausible and skewed the 
model results. The commenters contended that this would over predict 
concentrations at the receptor well, and significantly under predict 
the travel time to the receptor well. Moreover, they believed that 
these high hydraulic permeabilities are not representative of any 
shallow or deep zone aquifer system in the United States.
    It is the Agency's position that the hydrogeologic database (HGDB) 
is the best data source available to characterize subsurface parameters 
for conducting nationwide, probabilistic, groundwater pathway analyses. 
The hydraulic conductivity values used in this analysis were compiled 
under the auspices of the American Petroleum Institute and the National 
Well Water Association.\27\ The objective of the data compilation was 
to provide the Agency an up-to-date, screened datasource for 
probabilistic modeling. Hydraulic conductivity values from site 
investigations at 400 hazardous waste sites were collected, subjected 
to internal review, and were subsequently published in a peer-reviewed 
journal.
---------------------------------------------------------------------------

    \27\ Newell, C.J., L.P. Hopkins, and P.B. Bedient. 1989. 
Hydrogeologic Database for Ground Water Modeling. American Petroleum 
Institute, Washington, DC; and Newell, C.J., L.P. Hopkins, and P.B. 
Bedient. 1990. A hydrogeologic database for ground water modeling. 
Ground Water 28(5):703-714.
---------------------------------------------------------------------------

    The groundwater velocity at a specific location, such as a receptor 
well, has regional and local contributions. Regional groundwater 
velocities are proportional to hydraulic conductivity, while local 
velocities are governed by areal recharge and are almost independent of 
hydraulic conductivity. Of the entire hydraulic conductivity database, 
there are only two values equal to 2.21 x 10\7\ m/yr. These values are 
relatively high but not implausible for fractured sedimentary rocks 
(Region 2). Regions 4, 5, and 6 (Sand and Gravel; Alluvial Basins, 
Valleys, and Fans; and River Valleys and Flood Plains, respectively) 
have four hydraulic conductivity values which are in excess of 10\5\ m/
yr. These values, although relatively high, are also not implausible. 
For example, literature references indicate that values of hydraulic 
conductivities for gravelly deposits may range from 10\4\ to 10\7\ m/
yr.\28\ We also note that these values make up an extremely small 
fraction of the values in the data base, thereby reflecting the 
likelihood of their occurrence nationally. This is consistent with the 
nationwide probabilistic approach we used in the risk evaluation.
    f. Simulation Durations. The commenters pointed out that for 
several chemicals (o-anisidine, p-cresidine, and 2,4-dimethylaniline), 
the groundwater time to impact is more than 250 years. The commenters 
stated that simulations over this time period are computationally 
intensive and generate results that are unrealistic and not 
interpretable, because we cannot predict human behaviors that influence 
exposure or land uses so far in the future. Commenters suggested that 
EPA should limit the results to the maximum concentration within the 
next 100 years.
---------------------------------------------------------------------------

    \28\ See Freeze, R.A., J.A. Cherry. 1979. Groundwater; Prentice 
Hall, Englewood Cliffs, New Jersey, and Driscoll, F.G. 1986. 
Groundwater and Wells, Second Edition; Johnson Screens, Publisher, 
St. Paul, Minnesota.
---------------------------------------------------------------------------

    As a matter of policy, the Agency has adopted long time frames for 
assessing risks in the hazardous waste listing program because it 
allows peak concentrations to be observed at most receptor locations. 
This time frame is consistent with other listing determinations.\29\ 
The EPACMTP computer model, developed by the Agency, can perform the 
simulation over these time frames in a computationally efficient manner 
on modern computers. It is well documented in the scientific literature 
that groundwater travel can span hundreds to thousands of years.
---------------------------------------------------------------------------

    \29\ Paints Listing Determination; February 13, 2001; 66 FR 
10093; Inorganic Chemical Manufacturing Listing Determination; 
September 14, 2000; 65 FR 55697.
---------------------------------------------------------------------------

    Therefore, we do not agree that simulations over a 250-year time 
period will generate results that are unrealistic and not 
interpretable. Furthermore, the commenter did not provide any reason 
why arbitrarily restricting the modeling to a 100-year time frame would 
be more appropriate. The Agency agrees that future changes in human 
behavior and environments are subject to uncertainty. However, the 
Agency's probabilistic approach in conjunction with relatively 
conservative assumptions is designed to provide a reasonable level of 
protection for future generations.
    g. Exposure Parameters. Commenters stated that EPA has selected 
maximum values for several exposure parameters for the probabilistic 
analyses, and that use of maximum values overestimates potential risk.
    Ingestion and inhalation rates: Commenters argued that EPA's 
current ranges for groundwater ingestion rates are overly conservative 
and that EPA overestimated the amount of water ingested by potential 
adult receptors. The commenters noted that the maximum values used by 
EPA are higher than the 99th percentile value presented in EPA's 
Exposure Factors

[[Page 9158]]

Handbook (EPA 1997a).\30\ The commenters also argued that EPA 
overestimates maximum inhalation rates for adult and child residents, 
noting that the maximum rate used by EPA exceeds the 99th percentile 
inhalation rates for men and women given in EPA guidance (EPA (2000), 
Options for Development of Parametric Probability Distributions for 
Exposure Factors).
---------------------------------------------------------------------------

    \30\ U.S. EPA Exposure Factors Handbook, August 1997; EPA/600/P-
95/002Fa. http://www.epa.gov/ncea/pdfs/efh/front.pdf.
---------------------------------------------------------------------------

    We do not agree that the water ingestion and inhalation rates we 
used are overly conservative. The maximum values were used to truncate 
the distribution during sampling using a statistical software package. 
A large range was used in order to prevent the shape of the data 
distributions from being distorted. For groundwater ingestion, the 
mean, 50th, 90th, 95th, and 99th percentiles from the sampled data were 
verified by comparing them against the data provided in EPA's Exposure 
Factors Handbook. Similarly for inhalation, the simulated 99th 
percentile value for the adult inhalation rate we used was consistent 
with the values cited in the above document. In addition, the 
probabilistic analyses use values throughout the distribution of 
parameter values. The maximum value is only one point on the 
distribution curve, and thus, has a minor impact on the overall 
modeling results.
    Exposure Duration: The commenters contended that EPA used exposure 
durations that are inappropriate for the receptors identified. The 
commenters argued that EPA overestimated the period of exposure, 
thereby arbitrarily increasing the risk estimates calculated. The 
commenters pointed out that the exposure duration for a child varied 
between one and 50 years, even though the greatest length of potential 
exposure is five years for a one-to five-year-old. Commenters stated 
that EPA correctly holds all other inputs within the one-to five-year 
age bracket; therefore, EPA's methodology could result in modeling a 
22-year-old that has the body weight and ingestion rate of a five-year-
old.
    EPA does not agree that the exposure duration is inappropriate for 
the receptors identified. The exposure duration used in the analysis is 
selected once for each receptor at the beginning of each iteration. As 
we described in the proposal (68 FR 66182-66183), we evaluated a child 
whose exposure begins at a random age between one and six years old. We 
then aged the child for the number of years defined by the randomly 
selected exposure duration. As children mature, their physical 
characteristics and behavior patterns change. Depending on the exposure 
duration selected, a receptor (e.g., a 1-to 5-year-old) ages through 
successive age groups (also known as cohorts). Other exposure 
parameters (i.e., body weight, inhalation rate, drinking rate) are held 
constant while a receptor is in a given age cohort, but are selected 
again as a receptor enters the successive age cohort. For example, a 
receptor initiated at age three would have a constant 1- to 5-year-old 
body weight at ages 3, 4, and 5. At age 6, a new body weight would be 
selected from the 6- to 11-year-old body weight distribution to be used 
for the duration spent in this cohort (and so on). A 22-year-old would 
have a body weight selected from the adult body weight distribution, 
not that of a 1- to 5-year-old.
    Indoor air exposures: The commenters believe that the shower model 
used by EPA overestimates potential exposure and risk. The commenters 
claim that EPA used several overly conservative exposure parameters, 
including the time in the bathroom. Commenters contended that it is 
highly unlikely that individuals regularly spend four hours in the 
bathroom showering and in related activities, and suggested that the 
total duration should not exceed a plausible value (e.g., one hour 
total). The commenters also argued that EPA assumed that the entire 
constituent concentration is available for uptake and did not consider 
that only a fraction of that inhaled may be available and absorbed.
    EPA does not believe that the indoor air exposure parameters are 
overly conservative. During the Monte Carlo simulation, the 
distributions for the time spent in showering and related activities 
are sampled independently, such that the combined shower exposure used 
in the Monte Carlo simulation is significantly lower than four hours. 
For example, the 50th percentile value of the combined shower exposures 
results in a duration of 32 minutes in the bathroom; the 99th 
percentile value of the combined shower exposures results in a total 
duration of 83 minutes in the bathroom. These are not implausible 
values. The commenters did not suggest any alternative exposure periods 
for the showering scenario, so we cannot compare any suggested values 
to those we used in our analysis. We note, however, that the mean, 
50th, 90th, 95th, and 99th percentiles were verified by comparing them 
against the data provided in EPA's Exposure Factors Handbook. In 
addition, shower inhalation exposure was a determining exposure pathway 
for only two constituents (naphthalene and dichlorobenzene) and neither 
of these two constituents served as a basis for listing K181. Drinking 
water ingestion was the determining pathway for all other constituents.
    In order to be protective of human health, EPA assumes that the 
entire constituent concentration in indoor and ambient air is available 
for respiratory uptake, unless chemical-specific data indicate 
otherwise. Data on the fraction absorbed from inhalation are not 
frequently available, and the commenter did not provide any such data. 
However, when data are available, the fraction absorbed is incorporated 
into the cancer and noncancer inhalation benchmarks.
    Monte Carlo Distributions: In the Monte Carlo analysis, the Agency 
used distributions to describe several exposure parameters, including 
body weight, exposure duration, and drinking water intake. The 
commenters contended that EPA failed to follow its own guidance when 
developing these distributions, noting that the document Guiding 
Principles for Monte Carlo Analysis (EPA 1997c) stated ``risk assessors 
should never depend solely on goodness-of-fit tests to select the 
analytic form for a distribution.'' The commenters pointed out that for 
the distributions used in the exposure assessment, the Agency did not 
complete any graphical analyses of the data to ensure that the 
distributions selected were consistent with the results of the 
statistical analyses. The commenters also stated that EPA did not 
provide enough information to support the distribution selected for 
drinking water ingestion (a gamma distribution) instead of a lognormal 
distribution, as described in EPA's Exposure Factors Handbook.
    We agree that graphical representations are often useful and we 
have provided such graphical representations for key exposure 
parameters in the Response to Comment document. However, as part of our 
analysis for the proposal, EPA conducted a thorough review of sampled 
data to ensure that the selected percentiles were representative of the 
data. Regarding the specific distribution selected for drinking water 
ingestion, the gamma model provided a better fit. In any case, we found 
no significant difference between using the gamma versus the log normal 
distributions for this data set. For example, using a gamma 
distribution for drinking water intake of adults, the 50th and 90th 
percentile simulated values are 1,272 mL/day and 2,302 mL/day, compared 
to

[[Page 9159]]

1,252 mL/day and 2,268 mL/day for the log normal distribution.
9. Implementation
    EPA received comments on a number of issues concerning the proposed 
implementation approach for the K181 listing determination. The most 
significant issues include: (1) EPA's alternative to consider all 
wastes generated during the year to be hazardous if the mass loading 
limit for a CoC in the wastes is met or exceeded at any time during the 
year; (2) not allowing higher quantity waste generators the option of 
using knowledge of their wastes to demonstrate that the wastes are 
nonhazardous; (3) use of the maximum detected concentration or a 
concentration based on the 95th percentile upper confidence limit of 
the mean to determine the mass of a CoC; (4) EPA's onsite recordkeeping 
requirements to support a nonhazardous determination for the wastes; 
and (5) EPA's annual follow-up testing requirements to verify that 
wastes remain nonhazardous. The Agency's responses to these comments 
are summarized below. The verbatim comments and our responses to all 
comments are provided in the Response to Comments Background Document.
    a. Alternative Option for Wastes Which Meet or Exceed Mass Loading 
Limit. EPA took comment on an alternative option that would consider 
all wastes generated during the year to be hazardous if the mass 
loading limit for a CoC in the wastes is met or exceeded at any time 
during the year. Commenters on the proposed rule did not support this 
option. They argued that this alternative is not necessary or practical 
for several reasons. First, waste quantities determined to be 
nonhazardous based on the results of the risk assessment would be 
subject to hazardous waste regulation. Second, it would require the 
waste generators to accurately forecast customer demand for products 
and the amount of constituents in wastes over a one year period from 
highly variable waste streams that often result from batch 
manufacturing processes. Third, customers may have to be turned away 
and potential new products put on hold if a company's forecast for the 
mass of any CoC in its wastes is approached before the end of the 
calendar year and the wastes have been disposed in a nonhazardous 
landfill. Finally, waste management facilities (for nonhazardous 
wastes) may not accept such nonhazardous wastes if the wastes may later 
be declared hazardous.
    EPA generally agrees with the concerns stated by the commenters on 
the alternative option. We noted some of these concerns in the proposed 
rule as part of our request for comment on this option. Specifically, 
we agree that the alternative approach would cause significant 
difficulties for waste management facilities that might accept initial 
batches of wastes as nonhazardous, but later find that these wastes are 
declared hazardous. As a result, the generators may have difficulty in 
finding waste management facilities that would accept wastes as 
nonhazardous under this approach. Therefore, we are finalizing the 
proposed approach, which considers all K181 potential wastes generated 
up to the mass loading limits of the CoCs to be nonhazardous and allows 
these wastes to be managed as nonhazardous. In other words, the K181 
listing would apply to only the portion of wastes that meets or exceeds 
the mass loading limits for any of the K181 CoCs in a calendar year.
    While the K181 listing only applies to wastes that meet or exceed 
the mass loading limits, the Agency notes that the annual mass loading 
limits, the landfill design requirements, and treatment in specified 
combustion units are conditions of the listing. Dyes and/or pigments 
nonwastewaters become K181 wastes unless a generator fulfills one of 
these conditions. If one or more of these conditions are not met, EPA 
or authorized states could bring enforcement actions for violations of 
hazardous waste requirements against anyone who has not managed the 
waste in compliance with applicable Subtitle C requirements. 
Furthermore, EPA can take action under section 7003 of RCRA if the 
management of dyes and/or pigment nonwastewaters may pose an imminent 
and substantial endangerment to human health or the environment. Thus, 
we advise generators to properly store nonwastewaters that are 
potentially hazardous under the K181 listing. At a minimum, we 
encourage generators to store all wastes in proper containers (i.e., 
such that wastes are not placed directly on the ground) prior to 
disposal.
    b. Using Knowledge of Wastes To Demonstrate that Wastes are 
Nonhazardous. EPA proposed that waste generators who generate or expect 
to generate 1,000 metric tons per year or less of K181 categorized 
wastes would have the option of using knowledge of their wastes to 
demonstrate that their wastes are nonhazardous. On the other hand, we 
proposed that generators who generate more than 1,000 metric tons per 
year (MT/yr) of K181 would be required to use the more extensive 
procedures in Sec.  261.32(d)(3), which include a requirement to test 
for constituents reasonably expected to be present. Commenters objected 
to EPA's proposal that would limit who could use knowledge of their 
wastes to demonstrate that their wastes are nonhazardous. They stated 
that all waste generators should have the option of using knowledge to 
demonstrate that their wastes are nonhazardous, irrespective of how 
much waste they generate. This is because, in most cases, commenters 
believe that testing of wastes by generators is unnecessary and 
burdensome. They pointed out that waste generators have sufficient 
knowledge about their wastes to make appropriate determinations for any 
quantity of wastes that they generate. They also noted that the wastes 
do not contain many of the proposed CoCs for K181 and, when present, 
they are not likely to exceed threshold quantities. Finally, the 
commenters emphasized that, if toluene-2,4-diamine is not present in 
the wastes and the wastes are being disposed in lined landfills, then 
the testing requirements are irrelevant and should be deleted.
    We proposed and are finalizing that all manufacturers can use 
knowledge of their wastes to determine which K181 constituents of 
concern are reasonably expected to be present in their wastes. However, 
we do not agree that manufacturers who generate more than 1,000 MT/yr 
should have the option to use knowledge to determine the level of K181 
CoCs present in their wastes. This is in part because, as stated in the 
proposal, we believe that the larger quantities of wastes have the 
potential for posing greater environmental risks than smaller 
quantities of wastes if a nonhazardous determination based on knowledge 
turns out to be inaccurate (see 68 FR 66202). In addition, as discussed 
previously (section IV.A.6), we believe that the information available 
indicates that the constituents of concern are present in dye/pigment 
production wastes, and that the levels of the constituents have the 
potential to exceed the annual mass loading limits. Therefore, we 
believe that it is reasonable to require larger quantity waste 
generators to test their wastes. Test data represent the best 
information that can be obtained on the concentrations of CoCs present 
in the waste and for use in determining the mass loading levels for 
CoCs, because waste testing provides a direct indication of constituent 
levels. It should also be noted that, based on the conditional nature 
of the final listing

[[Page 9160]]

determination, the generators who generate more than 1,000 metric tons 
per year of K181 would only have to test their wastes if they are 
managing them in a landfill that does not meet the liner standards 
identified in the listing. That is, if such generators are managing 
their wastes in lined landfills that are subject to (or otherwise meet) 
Sec.  258.40, 264.301 or 265.301, there is no need to determine the 
levels of K181 CoCs and thus no need to test. Finally, we note that if 
facilities generating 1,000 MT/yr or less use some level of waste 
analysis data to determine the levels of CoCs present, they are still 
only subject to the requirements in Sec.  261.32(d)(2), and not the 
more extensive testing requirements in Sec.  261.32(d)(3).
    We are adding further language in the regulations to clarify when 
the generators are required to evaluate their wastes and to demonstrate 
their wastes are not hazardous. We have revised the beginning of Sec.  
261.32(d) to make it clear that only generators that do not dispose of 
the wastes in landfill units that meet the design requirements in the 
listing description are required to evaluate their wastes for CoCs 
under Sec.  261.32(d)(1) through Sec.  261.32(d)(3). Generators that 
dispose of their wastes in landfills meeting the specified design 
requirements do not have to evaluate their wastes, however they must 
document the disposal in an appropriate landfill (Sec.  261.32(d)(4)). 
Furthermore, we added language to the beginning of Sec.  261.32(d)(3) 
to clarify that all steps in this subparagraph must be completed.
    c. Use of the Maximum Detected Concentration or a Concentration 
Based on the 95th Percentile Upper Confidence Limit of the Mean. EPA 
proposed that waste generators use the maximum detected concentration 
or, if multiple samples are collected, use either the maximum 
concentration or a concentration based on the 95th percentile upper 
confidence limit of the mean (UCLM) in order to determine the mass of a 
CoC in the waste. Commenters did not support the use of the maximum 
concentration, since they believe it is overly conservative and would 
overstate the mass loading generated by a facility. The commenters also 
considered the use of a concentration based on the 95th percentile UCLM 
as complicated and open to interpretation. Instead of requiring the use 
of the maximum concentration or a concentration based on the 95th 
percentile UCLM, commenters suggested that waste generators should be 
allowed to use rolling averages, or average concentrations, or median 
concentrations.
    To ensure protection of human health and the environment, we want 
to be reasonably conservative and see that generators use the most 
appropriate concentrations of CoCs to calculate the mass of each CoC in 
the wastes. Therefore, the use of rolling averages, average 
concentrations, or median concentrations would not be appropriate. 
Rolling averages and average concentrations are based on the simple 
average of the measured concentrations, with no statistical measure of 
the confidence limit associated with these concentrations. Therefore, 
the use of simple averages would not account for the possibility of a 
wide variability in the levels of CoCs in the waste. The median is 
simply the middle value in the data (i.e., one-half of the values are 
above the median, and one-half are below it) and may not be 
representative of the average concentration of a CoC in the waste.
    The use of maximum sample concentration is appropriate when the 
waste generator takes insufficient samples of a particular amount of 
waste. In general, because potential K181 wastes are likely to be 
highly variable, waste generators should be taking multiple samples to 
properly characterize the wastes. For multiple samples, the waste 
generator may use the maximum detected concentration or a concentration 
based on the 95th percentile upper confidence limit of the mean for a 
CoC. The upper confidence limit approach takes into account the 
variability of the waste and provides a measure of confidence that the 
mean concentration is below the upper bound of the confidence limit. 
Thus, using the 95th percentile upper confidence limit of the mean for 
a CoC gives a greater degree of confidence that its mass in the waste 
is below the mass loading limit. The 95th percentile upper confidence 
limit calculation, although it requires some statistical analysis, is 
relatively simple to calculate and has been used in other parts of the 
RCRA program (e.g., see the implementation of the Comparable/Syngas 
Fuel Exclusion under 40 CFR 261.38(c)(8)(iii)(A)). [Use of the 95th 
percentile upper confidence level provides assurance that the mass 
loadings established in the regulation will be protective of human 
health and the environment.]
    d. Onsite Recordkeeping Requirements. EPA proposed onsite 
recordkeeping requirements to support a nonhazardous determination. 
These included keeping records on waste sampling and analysis. 
Commenters questioned the need for waste analysis and onsite 
recordkeeping requirements associated with waste analysis if toluene-
2,4-diamine is not present in the waste and the wastes are being 
disposed in a lined landfill. The commenters stated that EPA, at most, 
should require records of wastes limited to proof of transportation to 
the appropriate landfill.
    As described previously, the Agency has reviewed the comments on 
toluene-2,4-diamine and has decided to no longer include toluene-2,4-
diamine as a constituent of concern for K181. As a result of this 
decision, one of the two conditions that were proposed for the dyes 
and/or pigment nonwastewaters to be considered nonhazardous under the 
landfill exemption has been eliminated. The only remaining condition 
for these wastes to be considered nonhazardous in the final listing is 
for the wastes to be disposed in a landfill unit that meets the liner 
design standards specified in the listing description. (As discussed in 
section IV.A.3, the listing also includes an exemption for combustion.) 
Therefore, as long as the wastes are being disposed in these types of 
landfills, the waste generators do not have to test or maintain records 
associated with waste sampling or testing. The Agency agrees that 
records demonstrating that each shipment of waste was received by an 
acceptable type of landfill must be maintained.
    A generator claiming that it is not subject to the listing would 
have to maintain sufficient documentation to demonstrate that it has 
not exceeded the relevant annual mass loading limits, that it has sent 
its waste to a landfill meeting the liner design standards specified 
under the conditional exemption, or that the waste was treated in a 
permitted combustion unit as specified in the listing description. EPA 
believes that it is critical for generators to have documentation 
demonstrating that the waste is below the mass loading limits, or that 
shipments of waste have been (or will be) sent to landfills meeting the 
specified design requirements or combustion units as specified in the 
listing. Paragraphs (d)(1), (d)(2), (d)(3) and (d)(4) of Sec.  261.32 
of the rule require generators of dyes and/or pigment nonwastewaters 
from the listed product classes to keep records under the authority of 
sections 2002 and 3007 of RCRA. Failure to comply with the 
recordkeeping requirements could result in an enforcement action by EPA 
under section 3008 of RCRA or by an authorized State under similar 
State authorities. Without adequate documentation, the regulating 
agency may presume that the generator is not complying with the 
requirements for

[[Page 9161]]

demonstrating that the wastes are nonhazardous.
    Note that in the final rule, we are also clarifying that the 
requirement for keeping records on site for three years under 
paragraphs (d)(2) and (d)(3) refers to the three most recent calendar 
years by including more specific text in Sec.  261.32(d)(2)(iv) and 
Sec.  261.32(d)(3)(x) (i.e., ``Keep the following records on site for 
the three most recent calendar years in which the hazardous waste 
determinations are made''). We believe this clarification makes the 
recordkeeping requirement more consistent with the calendar year basis 
of the annual loading limits.
    Below we provide examples to illustrate the types of records that 
need to be kept on site for two facilities, one that sends all wastes 
to a municipal landfill, and another that tests their waste.

    Example 1: Facility D is a producer of a variety of in-scope 
organic dyes and pigments, generating 2,000 metric tons per year of 
wastewater treatment sludges. The generated wastes do not exhibit 
any hazardous waste characteristic nor meet any other listing 
descriptions. While the total quantity of wastes exceeds 1,000 MT/
yr, the facility decides to send all of the wastes to a municipal 
landfill where the receiving units meet the liner design criteria of 
Sec.  258.40. Therefore, the facility has no obligation to test for 
the presence of CoCs. To comply with the recordkeeping requirements 
of Sec.  261.32(d)(4), the facility keeps records on site for three 
years to show that shipments of the wastes received by the landfill 
are disposed of properly. These records include documentation of the 
types of wastes shipped, shipping records from the transporter and 
the landfill documenting receipt of the waste shipment, and 
documentation from the landfill or state indicating that the 
landfill units meet the Sec.  258.40 design standards.
    Example 2: Facility E is a producer of in-scope organic dyes and 
pigments generating 3,500 MT/yr of process sludges. Facility E would 
like to manage as much as possible of the 3,500 MT as nonhazardous 
(e.g., dispose of the waste in an industrial landfill that does not 
meet the liner criteria specified in the listing description), as 
long as the wastes are below the mass-loading limits in Sec.  
263.32(c). Since the total volume of nonwastewaters exceeds 1,000 
MT/yr, the facility must follow the procedures set forth in Sec.  
263.32(d)(3) to determine the status of its nonwastewaters.

    Therefore, the facility first determines that one of the K181 
listing constituents is expected to be present in the facility's wastes 
(4-chloroaniline). This determination is based on the raw materials 
used for manufacturing, the impurities likely present in the process 
feeds, and the production chemistry involved. The facility documents 
this finding using the MSDS sheets for the materials used, the process 
reaction information reviewed, and the results of past analyses 
performed.
    The facility develops a sampling and analysis plan that includes 
the requirements of Sec.  263.32(d)(3)(iii) for characterizing the 
levels of the K181 constituents present in the wastes destined for 
disposal in an industrial landfill that does not meet the liner 
requirements. The facility collects and analyzes representative waste 
samples according to the developed sampling and analysis plan and the 
Sec.  263.32(d)(3)(iv) testing requirements. The analytical results 
show that the annual amount of waste contains up to 6,800 kg/yr of 4-
chloroaniline. The facility maintains on site the sampling and analysis 
plan, documents showing the analytical results and the accompanying 
quality assurance/quality control (QA/QC) data, and records showing the 
waste batches and quantities represented by the test results.
    The facility keeps a running total of the 4-chloroaniline mass 
loadings determined throughout the year and documents the calculations 
performed. The facility manages those batches with cumulative mass 
loadings of less than 4,800 kg/yr of 4-chloroaniline as nonhazardous 
waste, and ships them to an industrial landfill that does not meet the 
design requirements of Sec.  258.40, Sec.  264.301, or Sec.  265.301. 
The facility is careful to document the mass loadings in those batches. 
The facility ships the remaining waste to a municipal landfill subject 
to the Sec.  258.40 design criteria. The facility keeps all of the 
above waste determination and management records on site for three 
years.
    e. Annual Follow-up Testing Requirements. EPA proposed that waste 
generators continue to perform waste analysis annually after the wastes 
have been determined to be nonhazardous for the purpose of verifying 
that the wastes remain nonhazardous. However, we also proposed that the 
annual testing requirements for the wastes could be suspended if the 
annual running total mass levels for the CoCs during any three 
consecutive years based on the sampling and analysis results for the 
CoCs in the wastes are determined to be nonhazardous. We also proposed 
that following a significant process change (i.e., if it could result 
in significantly higher levels of the CoCs for K181 in the wastes and 
greatly increase the potential for the wastes to become hazardous), the 
annual testing requirements for the wastes would be reinstituted. 
Commenters questioned the need for annual testing requirements over a 
period of at least three years. They believe that, after a 
demonstration that the wastes are nonhazardous for one year, annual 
follow-up testing requirements are not necessary, unless there is a 
significant change in the process. Also, if there is a significant 
process change, the commenters believe that a one year repeat 
demonstration should be considered sufficient to demonstrate that the 
wastes remain nonhazardous. In addition, commenters believe that there 
is no reason for annual testing of wastes disposed in lined landfills, 
if they do not contain toluene-2,4-diamine or if the concentration of 
toluene-2,4-diamine in the wastes does not change. Finally, commenters 
pointed out that EPA, in other hazardous waste exclusions, required an 
initial demonstration and repeat demonstration only when there is a 
significant change in the process that generates the wastes.
    The Agency notes that toluene-2,4-diamine is no longer a 
constituent of concern for the K181 waste listing. Therefore, any waste 
generator that is disposing of these wastes in a landfill unit subject 
to the liner design criteria specified in the listing description, is 
not required to test or conduct repeat testing under the conditional 
final listing for the dyes and/or pigments nonwastewaters. However, any 
large waste generator that tests their wastes and is not disposing of 
them in this type of landfill (or treating the waste by combustion as 
specified in the listing) is subject to the testing requirements (as 
proposed) in today's final rule at Sec.  261.32(d)(3). This is because 
the wastes produced by the dyes and/or pigments industries using batch 
processes can be highly variable.\31\ As a result, we do not believe 
that testing for one year is sufficient to demonstrate that the waste 
would remain nonhazardous over a sufficiently long period of time. 
Thus, the Agency is requiring test data to show that the dyes and/or 
pigment wastes are nonhazardous for three consecutive years to provide 
a greater degree of confidence in the waste determination. The follow-
up testing can only be suspended if it is demonstrated that the wastes 
are nonhazardous for three consecutive years.
---------------------------------------------------------------------------

    \31\ As ETAD indicated in its comment that ``Dyes production 
involves batch processes, numerous distinct products and highly 
variable waste streams * * * ''
---------------------------------------------------------------------------

10. Exemption for Non-Municipal Landfills
    The proposed rule included an exemption for wastes disposed in 
landfill units that are subject to the liner design requirements in 
Sec.  258.40. This

[[Page 9162]]

was based on our risk analysis that demonstrated that wastes disposed 
in landfills with composite liners did not present significant risks 
for K181 dye and pigment wastes. (In the proposal, we also included a 
mass-loading limit for toluene-2,4-diamine for composite-lined units, 
but as noted previously, we are dropping this constituent in the final 
rule.) We also sought comment on the option of including in the 
exemption wastes that are disposed in other non-municipal landfills 
(industrial landfills) that meet the liner design requirements in Sec.  
258.40 or Subtitle C landfills. One commenter indicated that, since 
lined landfills do not pose a significant risk for disposal of the 
waste, manufacturers generating potential K181 waste should have the 
option of utilizing synthetic membrane lined industrial landfills which 
are as protective as lined municipal landfills. The commenter suggested 
that the generators could be responsible for assuring that a landfill 
is designed with an appropriate synthetic liner system.
    After considering this issue fully, we agree that it would be 
appropriate to include industrial landfill units (e.g., non-municipal 
landfill units) in the landfill exemption for the K181 listing, 
provided the units meet the specified liner design standards. While the 
available information indicates that generators are using primarily 
municipal landfills for disposal of dyes and pigment manufacturing 
wastes, comments submitted (see CPMA comments, Appendix B) indicate 
that industrial landfills are in use to some extent. We do not wish to 
preclude use of commercial industrial landfills that meet the liner 
standards for municipal landfills in Sec.  258.40 (or for subtitle C 
landfills). As the commenter suggested, the generator would be 
responsible for documenting that the landfill meets the specified liner 
standards. States have regulations governing the design of non-
municipal non-hazardous landfills.\32\ Thus landfill operators are 
likely to have certifications or permit conditions available to provide 
to generators who wish to use such landfills instead of municipal 
landfill units. As described previously in the discussion on 
recordkeeping requirements, generators wishing to qualify for the 
exemption are required to maintain records to show that they are using 
an appropriate landfill unit, whether the unit is a municipal landfill, 
subtitle C landfill, or an industrial landfill. Therefore, we are 
finalizing the listing to include an exemption for wastes disposed in 
subtitle D landfills that meet the design requirements in Sec.  258.40, 
Sec.  264.301, or Sec.  265.301. The landfill exemption in the K181 
listing now reads as follows (the final rule also includes an exemption 
for certain combustion units, as well):
---------------------------------------------------------------------------

    \32\ Association of State and Territorial Solid Waste Management 
Officials (``ASTSWMO''), Non-Municipal, Subtitle D Waste Survey.

    These wastes will not be hazardous if the nonwastewaters are: 
(i) Disposed in a subtitle D landfill unit subject to the design 
criteria in Sec.  258.40, (ii) disposed in a subtitle C landfill 
unit subject to either Sec.  264.301 or Sec.  265.301, (iii) 
disposed in other subtitle D landfill units that meet the design 
criteria in Sec.  258.40, Sec.  264.301, or Sec.  265.301, or (iv) 
treated in a combustion unit that is permitted under subtitle C, or 
an onsite combustion unit that is permitted under the Clean Air Act.

B. Final ``No List'' Determination for Wastewaters

    The Agency proposed not to list as hazardous wastewaters from the 
production of dyes and/or pigments. We received numerous comments 
supporting this proposal, and no adverse comments on this proposed 
decision. We have not independently learned of any new information 
requiring us to change our position on these wastes. Therefore, we are 
making a final decision not to list wastewaters from the production of 
dyes and/or pigments.

C. What Is the Status of Landfill Leachate Derived From Newly-Listed 
K181Wastes?

    As noted in the proposed rule, actively managed landfill leachate 
and gas condensate generated at non-hazardous waste landfills derived 
from previously-disposed and newly-listed wastes could be classified as 
K181. We proposed to temporarily defer the application of the new waste 
code to such leachate to avoid disruption of ongoing leachate 
management activities while the Agency decides if any further 
integration is needed of the RCRA and CWA regulations consistent with 
RCRA section 1006(b)(1).
    We are finalizing the revisions to the temporary deferral in Sec.  
261.4(b)(15) with no change from the proposed rule. Commenters 
generally supported the proposed deferral. However, two commenters 
stated that EPA should make the deferral permanent. One of the 
commenters stated that the various approaches used by EPA in listings, 
including the mass loadings approach proposed for the current dyes and 
pigments waste listing, creates uncertainty for the municipal landfill 
operator regarding leachate management. The other commenter also urged 
EPA to expand this deferral to include leachate that is derived from a 
surface impoundment.
    As we noted in the proposal, we believe a temporary deferral is 
warranted. We believe that it is appropriate to defer regulation on a 
case-by-case basis to avoid disrupting leachate management activities, 
and to allow us to decide whether any further integration of the two 
programs is needed.\33\ While the commenter suggested there were 
``uncertainties'' in leachate management requirements, no specific 
problems were identified. In any case, a broader exemption for landfill 
leachate is beyond the scope of the current rulemaking. Similarly, we 
see no need to expand the deferral to include leachate from surface 
impoundments, as well as landfills. The issues raised by this commenter 
relate to the management of leachate from closed surface impoundments 
located on site. We believe that these issues are site-specific and are 
best left to the local regulatory agency. Therefore, we are not 
expanding the deferral to include impoundment leachate.
---------------------------------------------------------------------------

    \33\ EPA's Office of Water examined the need for national 
effluent limitations guidelines and pretreatment standards for 
wastewater discharges (including leachate) from certain types of 
landfills (see proposed rule at 63 FR 6426, February 6, 1998). EPA 
decided such standards were not required and did not issue 
pretreatment standards for Subtitle D landfill wastewaters sent to 
POTWs (see 65 FR 3008, January 19, 2000).
---------------------------------------------------------------------------

    One commenter sought clarification on our use of the term ``active 
management,'' in the context of our statement in the proposal that 
``The Agency often uses the term `active management' as a catch-all 
term to describe the types of activities that may trigger RCRA subtitle 
C permitting requirements.'' (See 68 FR 66199, Footnote 57). The 
commenter noted that actions not requiring a permit may be active 
management and wanted to clarify that active management would include 
situations like 90-day storage of excavated K181 waste, which does not 
require a permit. The commenter is correct. We did not mean to imply 
that active management can only occur for actions requiring a RCRA 
subtitle C permit. In the case of a typical listed waste, excavated 
wastes stored in 90-day containers (e.g., roll-off bins) would indeed 
be considered ``active management'' and carry the hazardous waste code 
designation. For the K181 listing, however, the only excavated wastes 
that could carry the K181 designation would be wastes that meet or 
exceed the mass loadings of any of the specified constituents. 
Furthermore, if the excavated waste is disposed in a suitable landfill 
that is subject to or

[[Page 9163]]

meets the specified design criteria, or treated by combustion as 
specified in the listing description, then the waste would be exempt 
from the listing.

D. What Are the Final Treatment Standards Under RCRA's Land Disposal 
Restrictions for the Newly-Listed Hazardous Wastes?

1. What are EPA's Land Disposal Restrictions (LDRs)?
    The RCRA statute requires EPA to establish treatment standards for 
all wastes destined for land disposal. These are the so called ``land 
disposal restrictions'' or LDRs. For any hazardous waste identified or 
listed after November 8, 1984, EPA must promulgate LDR treatment 
standards within six months of the date of identification or final 
listing (RCRA section 3004(g)(4), 42 U.S.C. 6924(g)(4)). RCRA also 
requires EPA to set as these treatment standards ``* * * levels or 
methods of treatment, if any, which substantially diminish the toxicity 
of the waste or substantially reduce the likelihood of migration of 
hazardous constituents from the waste so that short-term and long-term 
threats to human health and the environment are minimized.'' RCRA 
section 3004(m)(1), 42 U.S.C. 6924(m)(1). Once a hazardous waste is 
prohibited, the statute provides only two options for legal land 
disposal: Meet the treatment standard for the waste prior to land 
disposal, or dispose of the waste in a land disposal unit that 
satisfies the statutory no migration test. A no migration unit is one 
from which there will be no migration of hazardous constituents for as 
long as the waste remains hazardous. RCRA sections 3004 (d), (e), (f), 
and (g)(5).
    We are finalizing the prohibitions and treatment standards for the 
K181 wastes which we are listing as hazardous. The date of the 
prohibition and treatment standard is August 23, 2005.
2. How Does EPA Develop LDR Treatment Standards?
    In an effort to make treatment standards as uniform as possible, 
while adhering to the fundamental requirement that the standards must 
minimize threats to human health and the environment, EPA developed the 
so called Universal Treatment Standards (codified at 40 CFR 268.48). 
Under the UTS, whenever technically and legally possible, the Agency 
adopts the same technology-based numerical limit for a hazardous 
constituent, regardless of the type of hazardous waste in which the 
constituent is present. See 63 FR 28560 (May 26, 1998); 59 FR 47982 
(September 19, 1994). The UTS, in turn, reflects the performance of 
Best Demonstrated Available Treatment (BDAT) technologies of the 
constituents in question. EPA is also authorized in section 3004(m) to 
establish methods of treatment as a treatment standard. Doing so 
involves specifying an actual method by which the waste must be treated 
(unless a variance or determination of equivalency is obtained). Given 
this constraint, EPA prefers to establish numerical treatment 
standards, which leaves the option of using any method of treatment 
(other than impermissible dilution) to achieve the treatment standard.
    EPA also finds that the treatment standards established in today's 
rule are not established below levels at which threats to human health 
and the environment are minimized. See Hazardous Waste Treatment 
Council v. EPA, 886 F. 2d 355, 362 (D.C. Cir. 1990). That case held 
that the statute can be read to allow either technology-based or risk-
based standards, and further held that technology-based LDR treatment 
standards are permissible so long as they are not established ``beyond 
the point at which there is no `threat' to human health or the 
environment.'' Id. at 362. EPA's finding that today's standards are not 
below a ``minimize threat'' level is based on the Agency's inability at 
the present time to establish concentration levels for hazardous 
constituents which represent levels at which threats to human health 
and the environment are minimized. See 63 FR at 28560 (May 26, 1998) 
explaining at greater length why these difficulties remain. Thus, the 
Agency continues to find that technology-based standards remain the 
best approach for the national treatment standards for these wastes 
since such standards eliminate as much of the inherent uncertainty of 
hazardous waste land disposal and so fulfill the Congressional intent 
in promulgating the land disposal restrictions provisions. 55 FR at 
6642 (Feb. 26, 1990).
3. What Are the Treatment Standards for K181?
    Of the seven CoCs that form the basis of the final listing, two of 
them--aniline and 4-chloroaniline--have an existing UTS. For two of the 
other CoCs--o-anisidine, p-cresidine--there is adequate documentation 
in existing SW-846 methods 8270, 8315, and 8325 to calculate numerical 
standards. Finally, for two other constituents--2,4-dimethylaniline and 
1,3-phenylenediamine--we are transferring the numerical standards of 
similar constituents as the universal treatment standards.
    In the proposal, we had stated that if the numerical standards for 
these constituents were shown in comments not to be achievable or 
otherwise appropriate, we might adopt methods of treatment as the 
exclusive treatment standard. We did not receive any such comments 
suggesting that these numerical standards were not achievable or 
otherwise appropriate. Therefore, we are finalizing the proposed 
numerical treatment standards for these six CoCs.
    For the remaining constituent of concern, 1,2-phenylenediamine, we 
stated in the proposed rule that in past method performance 
evaluations, we have found it difficult to achieve reliable recovery 
from aqueous matrixes and precise measurements. Therefore, we proposed 
technology-specific LDR treatment standards for this constituent. We 
also noted that if commenters submitted data adequate for us to develop 
a numerical standard, then we might promulgate a numerical standard in 
addition to, or in lieu of, the technology standard.
    Because we did not receive data on 1,2-phenylenediamine, we are 
maintaining the technology-specific standard as the LDR treatment 
standard, with one change. We are expanding the treatment options for 
K181 nonwastewaters to include, in addition to combustion (CMBST), a 
treatment train of chemical oxidation (CHOXD) followed by BIODG 
(biodegradation) or CARBN (carbon adsorption) and a treatment train of 
BIODG followed by CARBN. We are making this change based on a comment 
we received on the proposed rule. The commenter asserted that the 
proposed LDR standard of CMBST has the potential to significantly 
disrupt the company's on-site biosolids disposal. More specifically, 
because of the mixture and derived-from rule, if the facility were to 
accept into its wastewater treatment facility wastes that meet the 
nonwastewater definition of K181, and it contains 1,2-phenylenediamine, 
the biosolids resulting from treatment would have to be combusted.
    In the above scenario, we do not believe it makes sense to 
establish a treatment standard that would require the wastewater 
treatment biosolids to be combusted. As the commenter points out, and 
with which we agree, if a facility were to introduce a nonwastewater 
into its wastewater treatment system, the nonwastewater would 
immediately become a wastewater (by LDR definition) and would be 
amenable to treatment by a wastewater treatment system. Therefore, we 
are adding to the LDR treatment

[[Page 9164]]

standard for 1,2-phenylenediamine a treatment train of CHOXD followed 
by BIODG or CARBN and a treatment train of BIODG followed by CARBN. 
Note that the treatment standard for K181 wastes containing 1,2-
phenylenediamine now is identical for wastewaters and nonwastewaters. 
We have revised the BDAT Background Document to reflect this change and 
placed it in the docket for today's rule.
    The following table summarizes the final treatment standards for 
the constituents of concern.

                            Table IV-I.--Treatment Standards for Constituents in K181
----------------------------------------------------------------------------------------------------------------
            Constituents of concern                CAS No.       Wastewater  (mg/L)      Nonwastewater  (mg/kg)
----------------------------------------------------------------------------------------------------------------
Aniline.......................................      62-53-3                      0.81                        14
o-Anisidine (2-methoxyaniline)................      90-04-0                     0.010                      0.66
4-Chloroaniline...............................     106-47-8                      0.46                        16
p-Cresidine...................................     120-71-8                     0.010                      0.66
2,4-Dimethylaniline (2,4-xylidine)............      95-68-1                     0.010                      0.66
1,2-Phenylenediamine..........................      95-54-5                          CMBST; or CHOXD fb        CMBST; or CHOXD fb
                                                                           (BIODG or CARBN); or      (BIODG or CARBN); or
                                                                            BIODG fb CARBN            BIODG fb CARBN
1,3-Phenylenediamine..........................     108-45-2                     0.010                     0.66
----------------------------------------------------------------------------------------------------------------
Note: ``fb'' means ``followed by.''

    In this final rule, we are also finalizing the following 
provisions, all of which are consistent with the proposed rule. See the 
Response to Comments Background Document for other LDR-specific issues 
raised in comments.

--We are adding the CoCs in K181 with numerical treatment standards to 
the Universal Treatment Standards listed at 40 CFR 268.48, which 
results in the addition of four new chemicals to the list: o-anisidine, 
p-cresidine, 2,4-dimethylaniline, and 1,3-phenylenediamine. Adding 
these constituents to the UTS list will ensure that, if they are 
present in a characteristic waste, they will be treated prior to land 
disposal, which in turn will minimize any risks they present to human 
health and the environment. (Note: Because toluene-2,4-diamine is not 
being included as a constituent of concern for this waste, it will no 
longer be added to the UTS list at 40 CFR 268.48.)
--We are adding to F039 those constituents identified in K181 not 
already specified in F039 (the same constituents named above for 
addition to the UTS list). F039 applies to landfill leachates generated 
from multiple listed wastes in lieu of the original waste codes. F039 
wastes are subject to numerical treatment standards equivalent to the 
universal treatment standards listed at 40 CFR 268.48. Making this 
change ensures F039 landfill leachates receive proper treatment for the 
CoCs in K181.
--For debris contaminated with K181 waste, the provisions in Sec.  
268.45 apply. This means debris contaminated with K181 would be 
required to be treated prior to land disposal, using specific 
technologies from one or more of the following families of debris 
treatment technologies: extraction, destruction, or immobilization. If 
such debris is treated by immobilization, it remains a hazardous waste 
and must be managed in a hazardous waste facility. Residuals generated 
from the treatment of debris contaminated with K181 would remain 
subject to the treatment standards being finalized today.
--We are prohibiting K181 wastes from underground injection. Therefore, 
K181 wastes may not be injected underground, unless they meet the LDR 
treatment standards or are injected into a Class 1 well from which it 
has been determined that there will be no migration of hazardous 
constituents for as long as the wastes remain hazardous.

E. Is There Treatment Capacity for the Newly Listed Wastes?

1. Introduction
    Under the land disposal restrictions (LDR) determinations, the 
Agency must demonstrate that adequate commercial capacity exists to 
manage listed hazardous wastes in compliance with the LDR treatment 
standards before the Agency can restrict the listed waste from further 
land disposal. The Agency performs capacity analyses to determine the 
effective date of the LDR treatment standards for the proposed listed 
wastes. This section summarizes the results of EPA's capacity analysis 
for the wastes covered by today's rule. For a detailed discussion of 
capacity analysis-related data sources, methodology, and analysis 
results for the wastes covered in this rule, see ``Background Document 
for Capacity Analysis for Land Disposal Restrictions: Newly Identified 
Dye and Pigment Manufacturing Wastes (Final Rule), February 2005'' 
(i.e., the Capacity Background Document), available in the RCRA docket 
established for today's final rule.
    EPA's decisions on whether to grant a national capacity variance 
are based on the availability of alternative treatment or recovery 
technologies capable of achieving the prescribed treatment standards. 
Consequently, the methodology focuses on deriving estimates of the 
quantities of newly-listed hazardous waste that will require either 
commercial treatment or the construction of new onsite treatment or 
recovery technology as a result of the LDRs. The resulting estimates of 
required commercial capacity are then compared to estimates of 
available commercial capacity. If adequate commercial capacity exists, 
the waste is prohibited from further land disposal, unless it meets the 
LDR treatment standards prior to disposal. If adequate capacity does 
not exist, RCRA Section 3004(h)(2) authorizes EPA to grant a national 
capacity variance for the waste for up to two years or until adequate 
alternative treatment capacity becomes available, whichever is sooner.
2. What Are the Capacity Analysis Results for K181?
    In the proposed rule, EPA estimated nonwastewater quantities 
applying engineering estimates of wastewater treatment sludge 
generation rates and, wherever possible, using information provided in 
non-CBI portions of the RCRA section 3007 surveys and public comments 
in response to the 1994 and 1999 proposed rules for dyes and pigments 
production wastes. EPA received comments in response to the November 
25, 2003 proposed rule (68 FR 66164), which stated that the Agency 
overestimated the amount of

[[Page 9165]]

nonwastewaters generated by the dyes and pigments production industry. 
We reviewed the information submitted by commenters on waste 
characteristics, quantities, and management practices. EPA found some 
data discrepancies and deficiencies that limit the use of the submitted 
data (see discussion on waste quantities in section IV.A.5). However, 
we believe the additional data from the commenters provide useful 
information on the likely waste quantities generated. Therefore, we 
have analyzed the commenters' data and revised our estimated waste 
quantities affected by this rule. We recognize that the actual quantity 
of waste requiring commercial treatment will probably be smaller due to 
waste-specific assessments of actual K181 CoC loadings, use of the 
contingent management exemptions, facility closures, changes in product 
formulations, or waste management practices. We also recognize the 
batch process nature of this industry and the speed at which facilities 
may change product formulations. Even relying on the larger quantities 
estimated for the proposed rule, we find more than adequate waste 
management capacity exists to accommodate wastes that would be treated 
or disposed as a result of today's rule.
    As described in section IV.D.3 above, EPA is finalizing numerical 
treatment standards or methods of treatment as the treatment standards 
for the CoCs of the newly listed K181 waste. We expect that the CoCs in 
the nonwastewater or wastewater (if K181-derived wastewater is 
generated) forms of K181 are amenable to the treatment by combustion or 
other technologies in a treatment train. EPA estimates that, at most, 
approximately 36,000 metric tons per year of nonwastewater forms of 
K181 may require alternative commercial treatment and be managed off 
site at a commercial hazardous waste treatment facility. Furthermore, 
EPA anticipates that much less than 36,000 metric tons per year of the 
wastes may require combustion capacity because not all of these wastes 
are expected to exceed the mass loading limits. Furthermore, these 
wastes would not be hazardous if the nonwastewaters are disposed in a 
landfill unit that meets liner design criteria specified in the listing 
description, or are treated in certain combustion units. Therefore, 
these wastes will not require treatment to meet LDR treatment 
standards. In any case, we estimate that the commercially available 
combustion capacity for sludge, solid, and mixed media/debris/devices 
is approximately 0.5 million tons per year and, therefore, sufficient 
to treat the newly listed waste which may require treatment. We also 
expect that adequate landfill capacity exists for managing residuals 
from treating these wastes. Also, there is adequate wastewater 
treatment capacity available should the need for treatment of the 
wastewater form of K181 wastes arise. In addition, we are not listing 
wastewaters generated at these facilities, so there is no need for 
additional treatment of wastewater from the production of dyes and/or 
pigments (other than K181-derived wastewaters). No commenters 
challenged either the variance determination or available treatment or 
disposal capacity for nonwastewater or wastewater forms of K181 wastes. 
Therefore, we conclude that sufficient treatment or disposal capacity 
is available to manage newly-listed K181 wastes.
    As discussed in section IV.D, we are also finalizing the addition 
of the CoCs in K181 with numerical standards to the constituent listed 
in F039 and the universal treatment standards. EPA does not anticipate 
that waste volumes subject to the treatment standards for F039 or 
characteristic wastes would increase because of the addition of these 
organic constituents to F039 and the UTS lists. Based on available 
data, waste generators already appear to be required to comply with the 
treatment requirements for other organic constituents in F039 and 
characteristic wastes. We received no comments, data, or information to 
warrant any change of this conclusion. Therefore, we expect that 
additional treatment due to the addition of the constituents to the 
F039 and UTS lists will not be required. When changing the treatment 
requirements for wastes already subject to LDR (including F039 wastes), 
EPA no longer has authority to use RCRA Sec.  3004(h)(2) to grant a 
capacity variance to these wastes. However, EPA is guided by the 
overall objective of section 3004(h), namely that treatment standards 
which best accomplish the goal of RCRA Sec.  3004(m) (to minimize 
threats posed by land disposal) should take effect as soon as possible, 
consistent with availability of treatment capacity.
    For soil and debris contaminated with K181, as indicated in the 
proposed rule, we believe that the vast majority of contaminated soil 
and debris, if any, will be managed on site and, therefore, would not 
require substantial commercial treatment capacity. Thus, we proposed 
not to grant a national capacity variance for hazardous soil and debris 
contaminated with this newly listed waste. EPA received no comments 
regarding this issue. There also were no data showing mixed radioactive 
wastes or underground injected wastes associated with the newly listed 
K181 based on the public information used in the proposed rule. Thus, 
we also proposed not to grant a national capacity variance for mixed 
radioactive waste (i.e., radioactive wastes mixed with K181) or waste 
being injected underground. EPA did not receive comments indicating 
that the newly listed wastes are underground injected or that they are 
mixed with radioactive wastes or with both radioactive wastes and soil 
or debris.
    Therefore, EPA is finalizing its decision not to grant a national 
capacity variance for wastewater and nonwastewater forms of K181 
wastes. We also are finalizing our decision not to grant a national 
capacity variance for hazardous soil and debris contaminated with the 
newly listed wastes, radioactive wastes mixed with K181 or contaminated 
soil or debris of K181, or K181 wastes being injected underground. The 
customary time period of six months is sufficient to allow facilities 
to determine whether their wastes are affected by this rule, to 
identify onsite or commercial treatment and disposal options, and to 
arrange for treatment or disposal capacity, if necessary. Therefore, 
LDR treatment standards for the affected wastes covered under today's 
rule become effective when the listing determinations become 
effective--the earliest possible date. This conforms to RCRA Sec.  
3004(h)(1), which indicates that land disposal prohibitions must take 
effect immediately when there is sufficient protective treatment 
capacity available for the waste.
    Finally, EPA may consider a case-by-case extension to the effective 
date based on the requirements outlined in 40 CFR 268.5, which includes 
a demonstration that adequate alternative treatment, recovery, or 
disposal capacity for the petitioner's waste cannot reasonably be made 
available by the effective date due to circumstances beyond the 
applicants' control, and that the petitioner has entered into a binding 
contractual commitment to construct or otherwise provide such capacity.

V. When Must Regulated Entities Comply With the Provisions in Today's 
Final Rule?

A. Effective Date

    The effective date of today's rule is August 23, 2005. These 
provisions, promulgated under HSWA authorities, will take effect in 
both the federal regulations and authorized state programs at that 
time.

[[Page 9166]]

B. Section 3010 Notification

    Under RCRA Sec.  3010, the Administrator may require all persons 
who handle hazardous wastes to notify EPA of their hazardous waste 
management activities within 90 days after the wastes are identified or 
listed as hazardous. This requirement may be applied even to those 
generators, transporters, and treatment, storage, and disposal 
facilities (TSDFs) that have previously notified EPA with respect to 
the management of other hazardous wastes. The Agency has decided to 
waive this notification requirement for persons who handle wastes that 
are covered by today's hazardous waste listing and already have (1) 
notified EPA that they manage other hazardous wastes, and (2) received 
an EPA identification number. The Agency has waived the notification 
requirement in this case because it believes that most, if not all, 
persons who manage the wastes listed as hazardous in today's rule 
already have notified the Agency and received an EPA identification 
number. However, any person who generates, transports, treats, stores, 
or disposes of this newly listed waste and has not previously received 
an EPA identification number must obtain an identification number 
pursuant to 40 CFR 262.12 to generate, transport, treat, store, or 
dispose of these hazardous wastes by May 25, 2005, for K181.
    Note that nonwastewaters would not become newly listed K181 wastes 
if the constituent mass loadings do not meet the levels in Sec.  
261.32(c). If the wastes meet or exceed the mass loading limits, the 
wastes would also not be listed K181, provided the nonwastewaters are 
disposed in a landfill unit or treated in combustion unit as specified 
in the listing description. Persons who generate only wastes that meet 
one of these conditions need not notify EPA or obtain an identification 
number, because the waste would not be K181.

C. Generators and Transporters

    Persons who generate newly identified hazardous wastes may be 
required to obtain an EPA identification number if they do not already 
have one (as discussed in section V.B above). If person(s) generate 
these wastes after the effective date of this rule, they will be 
subject to the generator requirements set forth in 40 CFR part 262. 
These requirements include standards for hazardous waste determination 
(40 CFR 262.11), compliance with the manifest (40 CFR 262.20 through 
262.23), pre-transport procedures (40 CFR 262.30 through 262.34), 
generator accumulation (40 CFR 262.34), record keeping and reporting 
(40 CFR 262.40 to 262.44), and import/export procedures (40 CFR 262.50 
through 262.60). The generator accumulation provisions of 40 CFR 262.34 
allow generators to accumulate hazardous wastes without obtaining 
interim status or a permit only in certain specified units (container 
storage units, tank systems, drip pads, or containment buildings). 
These regulations also place a limit on the maximum amount of time that 
wastes can be accumulated in these units. If K181 wastes are managed in 
units that are not tank systems, containers, drip pads, or containment 
buildings as described in 40 CFR 262.34, accumulation of these wastes 
is subject to the requirements of 40 CFR parts 264 and 265, and the 
generator is required to obtain interim status and seek a permit (or 
modify interim status or a permit, as appropriate). Also, persons who 
transport newly identified hazardous wastes will be required to obtain 
an EPA identification number (if they do not already have one) as 
described above and will be subject to the transporter requirements set 
forth in 40 CFR part 263.
    Nonwastewaters that do not meet the mass loading levels in Sec.  
261.32(c) are not listed K181. Furthermore, in cases where the wastes 
meet or exceed the mass loading limits, the wastes would also not be 
listed K181, provided the nonwastewaters are disposed in a landfill 
unit or treated in a combustion unit as specified in the listing 
description. Therefore, persons who generate or transport wastes that 
meet either of these conditions are not subject to the regulations 
governing hazardous waste generation and transport in part 262 and 263.

D. Facilities Subject to Permitting

    The listing for dyes and/or pigment wastes, K181, in today's rule 
is issued pursuant to HSWA authority. Therefore, EPA will regulate the 
management of the newly listed hazardous waste until states are 
authorized to regulate these wastes.
1. Facilities Newly Subject to RCRA Permit Requirements
    Facilities that treat, store, or dispose of K181 wastes that are 
subject to RCRA regulation for the first time by this rule (that is, 
facilities that have not previously received a permit pursuant to 
section 3005 of RCRA and are not currently operating pursuant to 
interim status), might be eligible for interim status (see section 
3005(e)(1)(A)(ii) of RCRA). To obtain interim status based on 
treatment, storage, or disposal of such newly identified wastes, 
eligible facilities are required to comply with 40 CFR 270.70(a) and 
270.10(e) by providing notice under section 3010 and submitting a Part 
A permit application no later than August 23, 2005. Such facilities are 
subject to regulation under 40 CFR part 265 until a permit is issued.
    In addition, under section 3005(e)(3) and 40 CFR 270.73(d), not 
later than August 24, 2006, land disposal facilities newly qualifying 
for interim status under section 3005(e)(1)(A)(ii) also must submit a 
part B permit application and certify that the facility is in 
compliance with all applicable groundwater monitoring and financial 
responsibility requirements. If the facility fails to submit these 
certifications and a permit application, interim status will terminate 
on that date.
2. Existing Interim Status Facilities
    Pursuant to 40 CFR 270.72(a)(1), all existing hazardous waste 
management facilities (as defined in 40 CFR 270.2) that treat, store, 
or dispose of the newly listed K181 wastes and are currently operating 
pursuant to interim status under section 3005(e) of RCRA, must file an 
amended part A permit application with EPA no later than the effective 
date of today's rule, (i.e., August 23, 2005). By doing this, the 
facility may continue managing the newly listed wastes, pending final 
disposition of the permit application. If the facility fails to file an 
amended part A application by that date, the facility will not receive 
interim status for management of the newly listed hazardous wastes and 
may not manage those wastes until the facility receives either a permit 
or a change in interim status allowing such activity (40 CFR 
270.10(g)).
3. Permitted Facilities
    Facilities that already have RCRA permits must request permit 
modifications if they want to continue managing newly listed K181 
wastes (see 40 CFR 270.42(g)). This provision states that a permittee 
may continue managing the newly listed waste by following certain 
requirements, including submitting a Class 1 permit modification 
request by the date on which the waste or unit becomes subject to the 
new regulatory requirements (i.e., the effective date of today's rule), 
complying with the applicable standards of 40 CFR parts 265 and 266 and 
submitting a Class 2 or 3 permit modification request within 180 days 
of the effective date.
    Generally, a Class 2 modification is appropriate if the newly 
listed wastes will be managed in existing permitted units or in newly 
regulated tanks, container units, or containment

[[Page 9167]]

buildings, and will not require additional or different management 
practices than those authorized in the permit. A Class 2 modification 
requires the facility owner to provide public notice of the 
modification request, a 60-day public comment period, and an informal 
meeting between the owner and the public within the 60-day period. The 
Class 2 process includes a ``default provision,'' which provides that 
if the Agency does not reach a decision within 120 days, the 
modification is automatically authorized for 180 days. If the Agency 
does not reach a decision by the end of that period, the modification 
is authorized for the life of the permit (see 40 CFR 270.42(b)).
    A Class 3 modification is generally appropriate if management of 
the newly listed wastes requires additional or different management 
practices than those authorized in the permit or if newly regulated 
land-based units are involved. The initial public notification and 
public meeting requirements are the same as for Class 2 modifications. 
However, after the end of the 60-day public comment period, the Agency 
will grant or deny the permit modification request according to the 
more extensive procedures of 40 CFR Part 124. There is no default 
provision for Class 3 modifications (see 40 CFR 270.42(c)).
    Under 40 CFR 270.42(g)(1)(v), for newly regulated land disposal 
units, permitted facilities must certify that the facility is in 
compliance with all applicable 40 CFR part 265 groundwater monitoring 
and financial responsibility requirements no later than August 24, 
2006. If the facility fails to submit these certifications, authority 
to manage the newly listed wastes under 40 CFR 270.42(g) will terminate 
on that date.
4. Units
    Units in which newly listed hazardous wastes are generated or 
managed will be subject to all applicable requirements of 40 CFR part 
264 for permitted facilities or 40 CFR part 265 for interim status 
facilities, unless the unit is excluded from such permitting by other 
provisions, such as the wastewater treatment tank exclusion (40 CFR 
264.1(g)(6) and 265.1(c)(10)) and the product storage tank exclusion 
(40 CFR 261.4(c)). Examples of units to which these exclusions could 
never apply include landfills, land treatment units, waste piles, 
incinerators, and any other miscellaneous units in which these wastes 
may be generated or managed.
5. Closure
    All units in which newly listed hazardous wastes are treated, 
stored, or disposed after the effective date of this regulation that 
are not excluded from the requirements of 40 CFR parts 264 and 265 are 
subject to both the general closure and post-closure requirements of 
subpart G of 40 CFR 264 and 265 and the unit-specific closure 
requirements set forth in the applicable unit technical standards 
subpart of 40 CFR part 264 or 265 (e.g., Subpart N for landfill units). 
In addition, EPA promulgated a final rule that allows, under limited 
circumstances, regulated landfills, surface impoundments, or land 
treatment units to cease managing hazardous waste, but to delay 
subtitle C closure to allow the unit to continue to manage nonhazardous 
waste for a period of time prior to closure of the unit (see 54 FR 
33376, August 14, 1989). Units for which closure is delayed continue to 
be subject to all applicable 40 CFR parts 264 and 265 requirements. 
Dates and procedures for submittal of necessary demonstrations, permit 
applications, and revised applications are detailed in 40 CFR 
264.113(c) through (e) and 265.113(c) through (e).

VI. State Authority and Compliance

A. How Are States Authorized Under RCRA?

    Under section 3006 of RCRA, EPA may authorize qualified States to 
administer their own hazardous waste programs in lieu of the federal 
program within the State. Following authorization, EPA retains 
enforcement authority under sections 3008, 3013, and 7003 of RCRA, 
although authorized states have primary enforcement responsibility. The 
standards and requirements for State authorization are found at 40 CFR 
part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of 
1984 (HSWA), a State with final RCRA authorization administered its 
hazardous waste program entirely in lieu of EPA administering the 
federal program in that State. The federal requirements no longer 
applied in the authorized State, and EPA could not issue permits for 
any facilities in that state, since only the state was authorized to 
issue RCRA permits. When new, more stringent federal requirements were 
promulgated, the State was obligated to enact equivalent authorities 
within specified time frames. However, the new federal requirements did 
not take effect in an authorized State until the State adopted the 
federal requirements as State law.
    In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which 
was added by HSWA, new requirements and prohibitions imposed under HSWA 
authority take effect in authorized States at the same time that they 
take effect in unauthorized States. EPA is directed by the statute to 
implement these requirements and prohibitions in authorized States, 
including the issuance of permits, until the State is granted 
authorization to do so. While States must still adopt HSWA-related 
provisions as State law to retain final authorization, EPA implements 
the HSWA provisions in authorized States until the States do so.
    Authorized States are required to modify their programs only when 
EPA enacts federal requirements that are more stringent or broader in 
scope than existing federal requirements. RCRA section 3009 allows the 
States to impose standards more stringent than those in the federal 
program (see also 40 CFR 271.1). Therefore, authorized States may, but 
are not required to, adopt federal regulations, both HSWA and non-HSWA, 
that are considered less stringent than previous federal regulations.

B. How Does This Rule Affect State Authorization?

    We are finalizing today's rule pursuant to HSWA authority. The 
listing of the new K-waste is promulgated pursuant to RCRA section 
3001(e)(2), a HSWA provision. Therefore, we are adding this rule to 
Table 1 in 40 CFR 271.1(j), which identifies the Federal program 
requirements that are promulgated pursuant to HSWA and take effect in 
all States, regardless of their authorization status. The land disposal 
restrictions for these wastes are promulgated pursuant to RCRA section 
3004(g) and (m), also HSWA provisions. Table 2 in 40 CFR 271.1(j) is 
modified to indicate that these requirements are self-implementing.
    States may apply for final authorization for the HSWA provisions in 
40 CFR 271.1(j), as discussed below. Until the States receive 
authorization for these more stringent HSWA provisions, EPA would 
implement them. The procedures and schedule for final authorization of 
State program modifications are described in 40 CFR 271.21.
    Section 271.21(e)(2) of EPA's State authorization regulations (40 
CFR part 271) requires that States with final authorization modify 
their programs to reflect Federal program changes and submit the 
modifications to EPA for approval. The deadline by which the States 
would need to modify their programs to adopt this regulation is 
determined by the date of promulgation of a final rule in accordance 
with

[[Page 9168]]

Sec.  271.21(e)(2). Once EPA approves the modification, the State 
requirements would become RCRA Subtitle C requirements.
    States with authorized RCRA programs already may have regulations 
similar to those in this final rule. These State regulations have not 
been assessed against the Federal regulations finalized today to 
determine whether they meet the tests for authorization. Thus, a State 
would not be authorized to implement these regulations as RCRA 
requirements until State program modifications are submitted to EPA and 
approved, pursuant to 40 CFR 271.21. Of course, States with existing 
regulations that are more stringent than or broader in scope than 
current Federal regulations may continue to administer and enforce 
their regulations as a matter of State law. In implementing the HSWA 
requirements, EPA will work with the States under agreements to avoid 
duplication of effort.

VII. CERCLA Designation and Reportable Quantities

    CERCLA (Comprehensive Environmental Response, Compensation, and 
Liability Act of 1980) defines the term ``hazardous substance'' to 
include RCRA listed and characteristic hazardous wastes. When EPA adds 
a hazardous waste under RCRA, the Agency also will add the waste to its 
list of CERCLA hazardous substances. EPA establishes a reportable 
quantity, or RQ, for each CERCLA hazardous substance. EPA provides a 
list of the CERCLA hazardous substances along with their RQs in Table 
302.4 at 40 CFR 302.4. If you are the person in charge of a vessel or 
facility that releases a CERCLA hazardous substance in an amount that 
equals or exceeds its RQ, then you must report that release to the 
National Response Center (NRC) pursuant to CERCLA section 103. You also 
may have to notify State and local authorities.

A. How Does EPA Determine Reportable Quantities?

    Under CERCLA section 102(b)(1), hazardous substances are assigned a 
reportable quantity of one pound, unless and until EPA changes the RQ 
by regulation. EPA has wide discretion to adjust the RQ of the 
hazardous substance(s). The Agency's methodology involves an evaluation 
of the intrinsic physical, chemical, and toxic properties. The 
intrinsic properties, called ``primary criteria,'' are aquatic 
toxicity, mammalian toxicity (oral, dermal, and inhalation), 
ignitability, reactivity, chronic toxicity, and potential 
carcinogenicity. EPA evaluates the data for a hazardous substance for 
each primary criterion. To adjust the RQs, EPA ranks each criterion on 
a scale that corresponds to an RQ value of 1, 10, 100, 1,000, or 5,000 
pounds. For hazardous substances evaluated for potential 
carcinogenicity, each substance is assigned a hazard ranking of 
``high,'' ``medium,'' or ``low,'' corresponding to RQ levels of 1, 10, 
and 100 pounds, respectively. For each criterion, EPA establishes a 
tentative RQ. A hazardous substance may receive several tentative RQ 
values based on its particular intrinsic properties. The lowest of the 
tentative RQs becomes the ``primary criteria RQ'' for that substance.
    After the primary criteria RQs are assigned, EPA further evaluates 
substances for their susceptibility to certain degradative processes. 
These are secondary adjustment criteria. The natural degradative 
processes are biodegradation, hydrolysis, and photolysis (BHP). If a 
hazardous substance, when released into the environment, degrades 
rapidly to a less hazardous form by one or more of the BHP processes, 
EPA generally raises its RQ (as determined by the primary RQ adjustment 
criteria) by one level. Conversely, if a hazardous substance degrades 
to a more hazardous product after its release, EPA assigns an RQ to the 
original substance equal to the RQ for the more hazardous substance.
    The standard methodology used to adjust the RQs for RCRA hazardous 
waste streams differs from the methodology applied to individual 
hazardous substances. The procedure for assigning RQs to RCRA waste 
streams is based on the results of an analysis of the hazardous 
constituents of the waste streams. The constituents of each RCRA 
hazardous waste stream are identified in 40 CFR part 261, Appendix VII. 
EPA first determines an RQ for each hazardous constituent within the 
waste stream using the methodology described above. The lowest RQ value 
of these constituents becomes the adjusted RQ for the waste stream. 
When there are hazardous constituents of a RCRA hazardous waste stream 
that are not CERCLA hazardous substances, the Agency develops an RQ, 
called a ``reference RQ,'' for these constituents in order to assign an 
appropriate RQ to the waste stream (see 48 FR 23565, May 25, 1983). In 
other words, the Agency derives the RQ for waste streams based on the 
lowest RQ of all the hazardous constituents, regardless of whether they 
are CERCLA hazardous substances.

B. What Is the RQ for the K181 Waste?

    In today's final rule, EPA is assigning a one-pound RQ to the K181 
waste. The RQ for each constituent contained in the waste is presented 
in the table below.

      Table VIII-1.--RQs for Constituents Identified in K181 Waste
------------------------------------------------------------------------
                                           Constituent RQ (kg)  (40 CFR
    Constituents in K181 waste stream                 302.4)
------------------------------------------------------------------------
Aniline.................................  5000 (2270)
o-Anisidine.............................  100 (45.4)
4-Chloroaniline.........................  1000 (454)
p-Cresidine.............................  1* (0.454)
2,4-Dimethylaniline.....................  1* (0.454)
1,2-Phenylenediamine....................  1* (0.454)
1,3-Phenylenediamine....................  1* (0.454)
------------------------------------------------------------------------
*RQ of 1 pound assigned to this constituent because we have not yet
  developed a ``waste constituent RQ'' for this substance.

    As noted in the proposed rule (68 FR 66213), we are not adjusting 
the RQ for K181 at this time because we have not yet developed a 
``reference RQ'' for the following CoCs in this waste: p-cresidine; 
2,4-dimethylaniline; 1,2-phenylenediamine; and 1,3-phenylenediamine. 
Therefore, the RQ for K181 will be one pound. As noted elsewhere in 
this notice, we have dropped toluene-2,4-diamine as a constituent of 
concern for K181. While this chemical has an existing RQ, EPA does not 
expect that its RQ will be considered should the Agency decide to 
propose any further adjustment to the RQ for K181 wastes.
    Note, however, that all quantities of wastes generated during a 
calendar year up to the mass loading limits are not listed K181 waste; 
only wastes subsequently generated that meet or exceed the annual 
limits would be hazardous waste. Wastes that are below the mass loading 
limits are excluded from the listing from their point of generation, 
and would not be subject to the CERCLA reporting requirements.
    Commenters urged EPA not to adopt the statutory RQ, but rather to 
adjust the RQ for K181 waste. They noted that EPA's risk analysis for 
the proposal indicates that a higher RQ is warranted. Commenters stated 
that it is counterintuitive for a company to be able to dispose of tons 
of dyes and/or pigment production wastes as nonhazardous in a landfill, 
yet have to report a release of just one pound of K181 waste to the 
environment. They noted that EPA conceded that it would be unreasonable 
to expect the CoCs to be present at concentrations higher than 5,000 
parts per million.
    While we agree with the commenters that an adjustment of the RQ may 
be

[[Page 9169]]

warranted based on the mass loading limits and the landfill disposal 
exclusion established in the final rule, until we develop waste 
constituent RQs for p-cresidine; 2,4-dimethylaniline; 1,2-
phenylenediamine; and 1,3-phenylenediamine the RQ for K181 will remain 
at the statutory one-pound level. We will consider adjusting the RQ for 
K181 after we develop these constituent RQs; however, the RQ for K181 
will remain one pound until such an adjustment is made.

C. When Would I Need To Report a Release of These Wastes Under CERCLA?

    Today's final hazardous waste listing is based on the mass loadings 
of the hazardous constituents in the wastes. An RQ of one-pound is 
assigned for the waste based on the lowest RQ of the hazardous 
constituents in the waste. Notification is required under CERCLA when a 
waste meeting the listing description and threshold for that hazardous 
waste is released into the environment in a quantity that equals or 
exceeds the RQ for the waste.
    For CERCLA reporting purposes, the Clean Water Act mixture rule (40 
CFR 302.6) may be adapted to apply to releases of this waste when the 
quantity (or mass limit) of all of the K181 hazardous constituents in 
the waste are known and the waste meets the K181 listing description 
(i.e., any of the K181 mass loading levels are met or exceeded). In 
such a case, notification is required where an amount of waste is 
released that contains an RQ or more of any hazardous substance 
contained in the waste. When the quantity (or mass limit) of one or 
more of the K181 hazardous constituents is not known, notification is 
required when the quantity of K181 waste released equals or exceeds the 
RQ for the waste stream.

D. How Would I Report a Release?

    To report a release of K181 (or any other CERCLA hazardous 
substance) that equals or exceeds its RQ, you must immediately notify 
the National Response Center (NRC) as soon as you have knowledge of 
that release. The toll-free telephone number of the NRC is 1-800-424-
8802; in the Washington, DC, metropolitan area, the number is (202) 
267-2675.
    You may also need to notify State and local authorities. The 
Emergency Planning and Community Right-to-Know Act (EPCRA) requires 
that owners and operators of certain facilities report releases of 
CERCLA hazardous substances and EPCRA extremely hazardous substances 
(see the list in 40 CFR part 355, Appendix A) to State and local 
authorities. After the release of an RQ or more of any of those 
substances, you must report immediately to the community emergency 
coordinator of the local emergency planning committee for any area 
likely to be affected by the release, and to the State emergency 
response commission of any State likely to be affected by the release.

VIII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 [58 FR 51735 (October 4, 1993)], the 
Agency, in conjunction with the Office of Management and Budget (OMB), 
must determine whether a regulatory action is ``significant'' and 
therefore subject to OMB review and the requirements of the Executive 
Order. The Order defines ``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;
    (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 the rights and obligations of 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 
the Executive Order.
    Pursuant to the terms of this Executive Order, we have found that 
this final action does not represent an economically significant 
regulatory action, as defined under point number one above. The total 
nationwide costs associated with this final action are estimated to be 
less than $3 million per year. Furthermore, this final rule is not 
expected to adversely effect, 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. The annualized benefits associated with today's rule have 
not been monetized, but are believed to be less than $100 million. 
However, this final rule has been determined to potentially raise novel 
legal or policy issues due to the unique mass loading-based approach 
used in the risk assessment modeling. As a result, it has been 
determined that this rule is a ``significant regulatory action,'' as 
identified under point number four above. Therefore, this action was 
submitted to OMB for review. Any substantive changes made in response 
to OMB review have been documented in the public record. The following 
paragraphs briefly summarize findings presented in the Economic 
Assessment \34\ conducted for the Proposed Rule, substantive economic 
related issues brought up in stakeholder comments and Agency responses, 
and revised findings in support of the final action.
---------------------------------------------------------------------------

    \34\ Economic Assessment for the Proposed Loadings-Based Listing 
of Non-wastewaters from the Production of Selected Organic Dyes, 
Pigments, and Food, Drug, and Cosmetic Colorants, Final Report, 
November 2003.
---------------------------------------------------------------------------

1. Summary of Proposed Rule Findings: Costs, Economic Impacts, Benefits
    The impacts of our proposed action were presented in two supporting 
documents: Economic Assessment for the Proposed Loadings-Based Listing 
of Non-Wastewaters from the Production of Selected Organic Dyes, 
Pigments, and Food, Drug, and Cosmetic Colorants, Final Report, 
November 2003, and Regulatory Flexibility Screening Analysis for the 
Proposed Loadings-Based Listing of Non-Wastewaters from the Production 
of Selected Organic Dyes, Pigments, and Food, Drug, and Cosmetic 
Colorants, Final Report, November 2003.
    We identified a total of 37 facilities in the November 2003 
Economic Assessment that were expected to be impacted by the proposed 
action. These facilities were found to be operated by 29 different 
companies. Of these companies, 15 were categorized as ``small 
businesses'' under the Small Business Administration size 
definition.\35\ We estimated the total quantity of potentially affected 
waste to range from 44,215 to 68,368 metric tons per year. Aggregate 
nationwide compliance costs were estimated to range from $0.6 million/
year to $4.3 million/year, depending upon assumptions regarding total 
waste quantity affected and presence of targeted constituents. 
Corporate level economic impacts were negligible, ranging from 
virtually zero to 0.52 percent of gross annual revenues. We determined 
that there were no significant economic impacts on any small entities.
---------------------------------------------------------------------------

    \35\ Less than 750 total employees at the corporate level.
---------------------------------------------------------------------------

    Benefits of the proposed action were presented in a general 
qualitative assessment. Types of benefits included the potential for 
reduced or avoided human health damage cases, avoided or

[[Page 9170]]

reduced acute events, avoided or reduced resource damage, and avoided 
or reduced response costs. Depending upon actual or future exposure 
patterns, the primary benefits identified in the preamble to the 
proposed rule were associated reductions in human health and 
environmental effects from targeted releases. Increased waste 
minimization practices were discussed as upstream benefits potentially 
stimulated by the proposed action.
2. Public Comments and Agency Responses
    a. Summary of Substantive Cost, Economic, and Benefits Issues, and 
Responses. The Agency received 25 public comments on the proposed rule. 
Nearly all of these addressed some aspect related to cost of 
compliance, economic impacts, and/or benefit of the rule, as proposed. 
Related to these issues, there were four categories of crucial concern 
presented by the commenters: industry profile/characterization, waste 
quantities, analytical costs, and benefits (i.e., need for the rule). A 
summary of these issues and the Agency's responses are presented below. 
Stakeholder comments are addressed in more detail in the Agency's 
response-to-comment document,\36\ available in the docket established 
for today's action.
---------------------------------------------------------------------------

    \36\ Response to Comments Document: Hazardous Waste Listing 
Determination for Dyes and/or Pigments Manufacturing Wastes (Final 
Rule), February 2005.
---------------------------------------------------------------------------

    b. Industry Profile/Characterization. Numerous commenters indicated 
that the profiles presented in the Economic Assessment were overly 
optimistic concerning the projected growth and general health of the 
dyes and pigment industries. Additional plant closures were noted. In 
addition, several commenters noted that products affected by the 
proposed rulemaking, e.g., azo dyes and pigments, tend to be 
experiencing lower growth rates and profitability margins than other 
product lines from the dyes and pigments industries.
    Our determination of average annual growth and industry health, as 
presented in the November 2003 Economic Assessment, was based on the 
best publicly available information at the time. However, upon detailed 
review of the public comments, and review of public information sources 
available after proposal, we find that our assumption of revenues 
increasing by an average of 3 percent per year was overly optimistic. 
This may be especially true for dye manufacturers where production has 
been plagued by downward trends in the textile industry, coupled with 
pressure from inexpensive imports.\37\ However, we have no reliable 
source of information that would indicate that product production 
quantities (as opposed to gross revenues) for affected dye 
manufacturers are substantially different from estimates presented in 
the Economic Assessment. Thus, we expect waste quantities generated 
from this production, and corresponding waste management costs to be 
relatively unaffected. As discussed in section VIII.A.2.c below (see 
also the July 21, 2004 Revised Impacts Assessment memo), we believe 
that our low-end estimate of waste quantity generated per year reflects 
a reasonable approximation of adjusted quantities based on comments. 
Thus, economic impacts estimated under this scenario may be considered 
a reasonable worst case estimate when unadjusted for revenue 
projections. We also developed economic impact estimates based on a 
linear reduction in compliance costs corresponding to adjusted waste 
quantities, and assuming gross revenues were 100 percent (2-fold) 
overstated. Economic impacts under this scenario were found to still be 
less than 1 percent of annual gross revenues (see section VIII.A.3; 
more details are provided in the July 21, 2004 Revised Impacts 
Assessment memo).
---------------------------------------------------------------------------

    \37\ PR Newswire, 2004 (March 26), Synalloy Corporation 
Announces Fourth Quarter Results Financial Services News.
---------------------------------------------------------------------------

    c. Waste Quantities. Commenters indicated that waste quantities 
presented in the November 2003 Economic Assessment were substantially 
overestimated. New information was provided regarding potentially 
affected quantities of nonwastewaters. Some of this information was 
facility-specific. Most information, however, was derived from 
association survey responses. These new survey data were linked to 
individual facilities by number only. None of the waste quantity 
information provided in comments was claimed as confidential business 
information.
    The November 2003 Economic Assessment (EA) presented both high and 
low estimates for potentially affected nonwastewaters. We recognize 
that the total ``high estimate'' quantity, as presented in the EA 
represents an overestimation. However, our ``low estimate'' appears to 
represent a good approximation of total quantity, as compared to data 
presented by the commenters. This ``low estimate'' is approximately 22 
percent greater than the total quantity derived from commenter data. 
The waste quantities presented in the EA were based only on information 
that was publically available at the time.
    We accept, with modifications, the waste quantity information 
provided by the manufacturers/associations. Facility-specific 
quantities, where available by facility name, are generally accepted, 
as identified. For the other facilities, we have derived waste quantity 
estimates based on the survey response information correlated to 
facility revenue rankings. These derived waste quantities are based 
only on the publicly available data, and reflect our best attempt to 
assign the available quantity data from the comments with specific 
facilities (applying our revenue ranking estimates, as needed). Revised 
cost, economic impact, and benefit estimates have been developed based 
on this new waste quantity information (see below under Revised 
Findings).
    d. Analytical Costs. Commenters expressed concern relating to some 
of our assumptions and determinations regarding analytical costs, 
especially as they related to waste characterization, process 
knowledge, and new method development. Commenters indicated a perceived 
need to take a large number of samples due to the batch operations. 
There was also concern that processor knowledge would have to be 
buttressed by at least limited sampling in order to have adequate proof 
that wastes generated were eligible for the exclusion. For wastes that 
are determined by the generator to be nonhazardous, commenters raised 
the concern that landfills may refuse the waste, or require 
certification to track the annual mass loadings. Commenters also raised 
technical issues relating to the development of analytical methods for 
sampling the CoCs to be added to 40 CFR Part 261 Appendix VIII. 
Specifically, there were concerns that the development of appropriate 
analytical methods would be more complex and costly than estimated in 
the proposal.
    In the November 2003 Economic Assessment, we included sampling and 
analysis costs for facilities assumed to be generating greater than 
1,000 metric tons of potentially impacted nonwastewaters per year. 
Facilities generating less than 1,000 metric tons/year were assumed to 
use operator knowledge. While the rule as proposed did not require any 
specific number of samples, sampling procedure, or analytical methods 
for waste characterization or determination of mass-loading limits, the 
Economic Assessment applied conservative assumptions for the 
development of cost estimates. We assumed 15 samples per

[[Page 9171]]

wastestream for initial characterization, and an additional five 
samples per year (including the first year) to assess stream 
fluctuations. Annual retesting is assumed to continue for three 
consecutive years to cover variations in processes and products. It was 
also assumed that the three-year time period would allow the generator 
to determine if any process fluctuations, waste changes, or minor 
process changes may alter the waste stream characterization from 
nonhazardous to hazardous.
    We believe our assumptions for waste stream characterization and 
annual retesting reflect a very conservative cost scenario for 
facilities generating greater than 1,000 metric tons of potentially 
affected nonwastewaters per year. For facilities generating less than 
1,000 metric tons, process knowledge may be used. Proper documentation 
of the process used to generate the waste (e.g., raw materials, 
quantities, reactions, and typical constituent concentrations) is 
expected to be adequate to demonstrate full process knowledge. 
Facilities that are uncomfortable with this approach may choose to 
purchase insurance or implement a testing procedure. However, the 
Agency is not requiring such options.
    We believe that the potential for landfills to require 
certification to track the annual mass loadings is highly unlikely (and 
was not raised in comments by any waste management firm), particularly 
in light of our modification of the proposal to remove the proposed 
(c)(2) requirements that would have prohibited subtitle D landfilling 
once a waste's mass loading of toluene-2,4-diamine exceeded the 
proposed (c)(2) limit. However, if for some reason a particular 
landfill were to reject the waste outright, other subtitle D landfills 
are prevalent. Additional costs from switching subtitle D landfills 
would be minimal due to the relatively high number of available 
subtitle D landfills within similar transportation distances.
    For the development of analytical methods for sampling the CoCs to 
be added to 40 CFR part 261 Appendix VIII, we assumed that the industry 
would utilize common laboratories to share the costs for developing 
analytical procedures. All facilities are assumed to use one of three 
contracting analytical laboratories to perform the analyses. The 
development costs were spread across all dye and pigment manufactures 
generating more than 1,000 metric tons and selected ``expanded scope'' 
facilities known (at the time of the proposal) to generate waste with 
constituent(s) of concern. EPA identified three laboratories that would 
independently develop the analytical methods, for a total development 
cost of $61,171 ($20,390 per laboratory). A five-year capital recovery 
factor at 7 percent (0.24389) was applied to the development cost. 
Development costs were spread equally across all facilities generating 
waste with the CoCs.
    The annual development cost per dye and pigment facility was 
estimated at $1,083 (assuming the waste must be sampled for all CoCs). 
In addition to this annual development cost, the analytical cost 
(assuming all eight proposed constituents) is estimated to be $1,089 
per sample. Thus, assuming five samples per year, total annual costs 
would be $1,306 per sample [this is based on five samples at $1,089/
sample, plus $1,083 passed through development costs, equals $6,530. 
Dividing this by five samples per year equals $1,306 per sample]. This 
total analytical cost per sample is within the range of $1,000 to 
$3,000 per sample, as identified by commenters. With the elimination of 
toluene-2,4-diamine from the list of CoCs, analytical method 
development costs will be lower because generators can avoid all 
testing requirements by certifying that their wastes are being managed 
in landfill units that meet the liner design requirements (or treated 
by combustion) as specified in the listing description. Furthermore, 
the method costs would also be reduced because we have modified the 
regulations to allow use of knowledge for the problematic analyte, 1,2-
phenylenediamine.
    Therefore, the Agency believes that the analytical costs and 
assumptions applied in our proposed action, as summarized above, 
represent a very conservative (high) cost estimate and will maintain 
these costs for estimating impacts associated with the final action. 
Today's final action does not require any specific number of samples, 
sampling type, or analytical methods. The actual number of samples 
necessary to appropriately represent the waste will be determined by 
the generator.
    e. Benefits. Commenters expressed concern over the lack of concrete 
benefit estimates in support of the proposed rulemaking. Several 
commenters questioned the need for the regulation due to the lack of 
quantified and monetized benefits, resulting in a perceived 
unsubstantiated actual risk to humans or the environment from the 
existing management of these wastes. Commenters noted that the wastes 
of concern are currently managed in lined landfills with little or no 
risk documented by the risk assessment for this scenario. Commenters 
noted that there were few facilities that generate wastes with the 
CoCs, and that the only constituent of concern that resulted in 
substantial risk to human health and the environment under current 
management practices was toluene-2,4-diamine, which they argued should 
be (and has been) deleted. Furthermore, commenters believed that the 
overestimation of waste quantities, as discussed above, results in 
exaggerated benefits associated with compliance management.
    The Agency believes that, to the extent that dye, pigment and FD&C 
colorant wastes are managed in landfills that do not meet the liner 
requirements in 40 CFR 258.40, 264.301, or 265.301, waste management 
practices have the potential to contaminate groundwater, resulting in 
greater risk to human health and the environment. To the extent that 
all wastes are managed in compliant landfills, there would be minimal 
benefit from the listing. However, the Agency is uncertain of industry 
claims that all wastes are so managed, nor is it clear that without the 
regulatory action, current waste management practices would not change 
to higher risk landfilling.
3. Revised Findings
    We have revised our cost, economic impact, and benefits estimates 
for the final rule. These revisions are based on the new waste quantity 
information presented in public comments, and rule modifications. The 
scope and impacts of this final action do not warrant the completion of 
a full revised Economic Assessment and Regulatory Flexibility Screening 
Analysis (RFSA).
    The total potentially affected nonwastewater quantity presented in 
the November 2003 Economic Assessment (EA) ranged from 44,215 metric 
tons/year to 68,368 metric tons/year. Aggregate annual compliance costs 
associated with these quantities ranged from $0.6 million/year to $4.3 
million/year for the proposed regulatory approach (Economic Assessment, 
Table 5-1). Corresponding economic impacts were found to range from 
negligible to 0.52 percent, when measured as the ratio of compliance 
costs to gross corporate revenues (Economic Assessment, Table 5-7). 
Cost estimates associated only with the low waste quantity estimate 
(44,215 metric tons), ranged from $0.6 million/year to $2.9 million/
year, with corresponding economic impacts ranging from negligible to 
0.29 percent.
    The revised total waste quantity, as derived from public comments, 
is estimated at 36,142 metric tons/year. The cost and economic impact 
findings

[[Page 9172]]

associated with our ``low estimate'' waste quantity (44,215 MT/yr), as 
presented above, may be considered a reasonable approximation of 
impacts associated with the final rule. However, more refined estimates 
may be developed assuming a linear relationship between total waste 
quantity and cost/economic impacts. Under this scenario, total costs 
and economic impacts would decline by approximately 18 percent, 
corresponding to the decline in total waste quantity (44,215 MT/yr to 
36,142 MT/yr). Under this approach, the total compliance costs for the 
final rule would range from an estimated $0.49 million per year to 
$2.38 million/year, with economic impacts ranging from negligible to 
0.238 percent of gross corporate revenues. These findings assume all 
other cost parameters are unchanged (e.g., analytical assumptions, 
transportation costs, administrative). In reality, the more refined 
cost and economic impact estimates would be even lower due to the 
elimination of toluene-2,4-diamine as a CoC for the final rule and the 
likely use by industry of the conditional exemptions.
    Some commenters have suggested that our estimated gross annual 
corporate revenue estimates may be overstated due to overly optimistic 
growth projections for the affected industries, as derived from some of 
our public sources. This issue pertains primarily to private or 
privately held companies where no independent revenue source was 
identified (see Economic Assessment, Table 5-3). An overestimate of 
gross revenues would be reflected in an artificially low economic 
impact estimate. We assessed this possibility and found that, even 
under the most highly impacted scenario, impacts would remain less than 
1 percent (see July 21 memo, Revised Impacts Assessment).
    Reduced waste quantities, as discussed above, would correspond to 
reduced benefits from compliant management. However, we continue to 
believe that, to the extent that affected dye, pigment and FD&C 
colorant wastes may be managed in landfills not compliant with 40 CFR 
section 258.40, 264.301 or 265.301, these wastes have the potential to 
contaminate groundwater, resulting in unacceptable risk to human health 
and the environment.

B. Paperwork Reduction Act

    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 (PRA), 44 U.S.C. 3501 et seq. The 
information collection requirements are not enforceable until OMB 
approves them. The Information Collection Request (ICR) Supporting 
Statement prepared by EPA (available in the public docket for this 
final rule) has been assigned EPA ICR number 1189.13
    The effect of listing the wastes described earlier is to subject 
certain wastes generated by the dyes and pigments industries to 
management and treatment standards under the Resource Conservation and 
Recovery Act (RCRA). This final rule represents an incremental increase 
in burden for generators and subsequent handlers of the newly listed 
wastes, and affects the existing RCRA information collection 
requirements for the Land Disposal Restrictions.
    In addition to complying with the existing subtitle C recordkeeping 
and reporting requirements for the newly listed waste stream, EPA is 
requiring that facilities generating organic dyes and/or pigment 
nonwastewaters to be able to document their compliance with the new 
K181 demonstration (through use of knowledge or testing) and 
recordkeeping requirements, as well as the conditions provided for 
exemption from the scope of the conditional hazardous waste listing 
promulgated today. This requirement is necessary to ensure that in-
scope nonwastewaters are managed in a manner that is safe for human 
health and the environment.
    As a result of the final rule, EPA estimates that up to 33 
facilities may be subject to an additional burden for existing and new 
RCRA information collection requirements for the newly listed wastes. 
We have estimated the annual hour and cost burden for these facilities 
to comply with the existing and new recordkeeping and reporting 
requirements associated with generating and managing K181 wastes. The 
hourly recordkeeping burden from the new requirements ranges between 
6.5 and 20.40 hours per respondent per year. This burden includes time 
for reading the regulations, determining whether organic dyes and/or 
pigment production nonwastewaters exceed regulatory listing levels, and 
keeping documentation on site, as specified. We estimate that these 
facilities would incur an annual burden of approximately 563 hours and 
$123,776 in carrying out new information collection requirements. We 
also estimated that these facilities would incur an annual burden of 
approximately 2 hours and $86,102 in carrying out existing information 
collection requirements. See the ICR Supporting Statement for details.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes 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. When this ICR is approved by 
OMB, the Agency will publish a technical amendment to 40 CFR part 9 in 
the Federal Register to display the OMB control number for the approved 
information collection requirements contained in this final rule.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) of 1980, as Amended by the 
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 
U.S.C. 601 et seq., generally requires an agency to prepare a 
regulatory flexibility analysis of any rule subject to notice and 
comment rulemaking requirements under the Administrative Procedures Act 
or any other statute. This is required 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. The Agency 
has determined that no small organizations or small governmental 
jurisdictions are impacted by today's final rulemaking.
    For purposes of assessing the impacts of today's final 
determination on businesses, a small business is defined either by the 
number of employees or by the annual dollar amount of sales/revenues. 
The level at which an entity is considered small is determined for each 
North American Industry Classification System (NAICS) code by the Small 
Business Administration (SBA). Organic dye and pigment manufacturers 
are classified under NAICS 325132. The SBA has

[[Page 9173]]

determined that manufacturers classified under this NAICS code are 
``small businesses'' if their total corporate employment is less than 
750 persons.
    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. The small 
entities directly regulated by this final rule are organic dye and 
pigment manufacturers classified under NAICS 325132. We have determined 
that all potentially impacted small businesses are projected to 
experience compliance cost impacts of less than 1 percent of gross 
annual revenues. Based on the available information, there are ten 
potentially affected firms that constitute small entities under the 
size definition established by the SBA. Assuming all ten companies 
generate wastes containing any of the constituents of concern, no 
company would experience impacts greater than 0.29 percent of annual 
gross revenues (see July 21, 2004 memo: Revised Impacts Assessment).
    Although this final rule will not have a significant economic 
impact on a substantial number of small entities, EPA nonetheless has 
tried to reduce the impact of this rule on small entities. Today's 
final action was designed to mitigate economic impacts to small 
entities while, at the same time ensuring full protection of human 
health and the environment. This was accomplished through our 
innovative mass-based approach for the determination of regulatory 
levels. Our waste quantity-based implementation approach also helped 
mitigate potential impacts to small entities.

D. Unfunded Mandates Reform Act

    Signed into law on March 22, 1995, the Unfunded Mandates Reform Act 
(UMRA) supersedes Executive Order 12875, reiterating the previously 
established directives while also imposing additional requirements for 
federal agencies issuing any regulation containing an unfunded mandate.
    Today's final rule is not subject to the requirements of sections 
202, 204 and 205 of UMRA. In general, a rule is subject to the 
requirements of these sections if it contains ``Federal mandates'' that 
may result in the expenditure by State, local, and tribal governments, 
in the aggregate, or by the private sector, of $100 million or more in 
any one year. Today's final rule does not result in $100 million or 
more in expenditures. The aggregate annualized compliance costs for 
today's rule are projected to be less than $3 million.
    Today's rule is not subject to the requirements of section 203 of 
UMRA. Section 203 requires agencies to develop a small government 
Agency plan before establishing any regulatory requirements that may 
significantly or uniquely affect small governments, including tribal 
governments. EPA has determined that this rule will not significantly 
or uniquely affect small governments.

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'' are 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.''
    Today's final rule does not have federalism implications. No State 
or local governments own or operate potentially impacted organic dye 
and/or pigment manufacturing facilities. Furthermore, this action will 
not impose excessive enforcement or review requirements. Thus, this 
rule 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 the Order. Executive Order 13132 does not 
apply to this final rule.

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.''
    Today's final rule does not have tribal implications. This rule 
will not significantly or uniquely affect the communities of Indian 
tribal governments, nor impose substantial direct compliance costs. No 
tribal governments own or operate potentially impacted organic dye and/
or pigment manufacturing facilities. Furthermore, this action will not 
impose any enforcement or review requirements for tribal entities. 
Thus, this rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in the 
Order.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    Executive Order 13045: ``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 E.O. 12866, and (2) concerns an environmental health 
or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health or 
safety effects of the rule on children, and explain why the regulation 
is preferable to other potentially effective and reasonably feasible 
alternatives considered by the Agency.
    Today's final rule is not subject to the Executive Order because it 
is not economically significant as defined under point one of the 
Order, and because the Agency does not have reason to believe the 
environmental health or safety risks addressed by this action present a 
disproportionate risk to children. However, the Agency is particularly 
concerned with environmental threats to children.
    The topic of environmental threats to children's health is growing 
in importance as scientists, policy makers, and community leaders 
recognize the extent to which children are particularly vulnerable to 
environmental hazards. Recent EPA actions are in the forefront of 
addressing environmental threats to the health of children. Setting 
environmental standards that address combined exposures and that are 
protective of the heightened risks faced by children are both goals 
named within EPA's ``National Agenda to Protect Children's Health from 
Environmental Threats.'' Areas for potential reductions in risks and 
related health effects are all targeted as priority issues within EPA's

[[Page 9174]]

September 1996 report, Environmental Health Threats to Children.
    A few significant physiological characteristics are largely 
responsible for children's increased susceptibility to environmental 
hazards. First, children eat proportionately more food, drink 
proportionately more fluids, and breathe more air per pound of body 
weight than do adults. As a result, children potentially experience 
greater levels of exposure to environmental threats than do adults. 
Second, because children's bodies are still in the process of 
development, their immune systems, neurological systems, and other 
immature organs can be more easily and considerably affected by 
environmental hazards. The connection between these physical 
characteristics and children's susceptibility to environmental threats 
was a consideration in developing the hazardous waste listing under 
today's final action.

H. Executive Order 12898: Environmental Justice

    Executive Order 12898, ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (February 
11, 1994), is designed to address the environmental and human health 
conditions of minority and low-income populations. EPA is committed to 
environmental justice for all citizens and has assumed a leadership 
role in such initiatives. The Agency's goals are to ensure that no 
segment of the population, regardless of race, color, national origin, 
income, or net worth bears disproportionately high and adverse human 
health and/or environmental impacts as a result of EPA's policies, 
programs, and activities. We have no data indicating that today's final 
rule would result in disproportionately negative impacts on minority or 
low income communities.

I. Executive Order 13211: Actions Affecting Energy Supply, 
Distribution, or Use

    Executive Order 13211, ``Actions Concerning Regulations That Affect 
Energy Supply, Distribution, or Use'' (May 18, 2001), addresses the 
need for regulatory actions to more fully consider the potential energy 
impacts of the proposed rule and resulting actions. Under the Order, 
agencies are required to prepare a Statement of Energy Effects when a 
regulatory action may have significant adverse effects on energy 
supply, distribution, or use, including impacts on price and foreign 
supplies. Additionally, the requirements obligate agencies to consider 
reasonable alternatives to regulatory actions with adverse effects and 
impacts the alternatives might have upon energy supply, distribution, 
or use.
    This final rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355 (May 22, 2001)) because it is not an economically 
significant regulatory action under Executive Order 12866. Furthermore, 
it is not expected to have a significant adverse impact on the supply, 
distribution, or use of energy.

J. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA''), Pub L. 104-113, section 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., 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 the Agency decides 
not to use available and applicable voluntary consensus standards.
    This final rule does not involve the establishment of voluntary 
technical standards; thus, the requirements of section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 
note) do not apply.

K. The Congressional Review Act (5 U.S.C. 801 et seq., as Added by the 
Small Business Regulatory Enforcement Fairness Act of 1996)

    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 submitted a report containing this final 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 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).

List of Subjects

40 CFR Part 148

    Administrative practice and procedure, Hazardous waste, Reporting 
and record keeping requirements, Water supply.

40 CFR Part 261

    Environmental protection, Hazardous materials, Waste treatment and 
disposal, Recycling.

40 CFR Part 268

    Environmental protection, Hazardous materials, Waste management, 
Reporting and record keeping requirements, Land Disposal Restrictions, 
Treatment Standards.

40 CFR Part 271

    Environmental protection, Administrative practice and procedure, 
Confidential business information, Hazardous material transportation, 
Hazardous waste, Indians--lands, Intergovernmental relations, 
Penalties, Reporting and record keeping requirements, Water pollution 
control, Water supply.

40 CFR Part 302

    Environmental protection, Air pollution control, Chemicals, 
Emergency Planning and Community Right-to-Know Act, Extremely hazardous 
substances, Hazardous chemicals, Hazardous materials, Hazardous 
materials transportation, Hazardous substances, Hazardous wastes, 
Intergovernmental relations, Natural resources, Reporting and record 
keeping requirements, Superfund, Waste treatment and disposal, Water 
pollution control, Water supply.

    Dated: February 15, 2005.
Stephen L. Johnson,
Acting Administrator.


0
For the reasons set out in the preamble, title 40, chapter I of the 
Code of Federal Regulations is amended as follows:

PART 148--HAZARDOUS WASTE INJECTION RESTRICTIONS

0
1. The authority citation for part 148 continues to read as follows:

    Authority: Sec. 3004, Resource Conservation and Recovery Act, 42 
U.S.C. 6901, et seq.


0
2. Section 148.18 is amended by revising paragraph (l) and adding 
paragraph (m) to read as follows:


Sec.  148.18  Waste-specific prohibitions--newly listed and identified 
wastes.

* * * * *
    (l) Effective August 23, 2005, the waste specified in 40 CFR 261.32 
as

[[Page 9175]]

EPA Hazardous Waste Number K181 is prohibited from underground 
injection.
    (m) The requirements of paragraphs (a) through (l) of this section 
do not apply:
    (1) If the wastes meet or are treated to meet the applicable 
standards specified in subpart D of 40 CFR part 268; or
    (2) If an exemption from a prohibition has been granted in response 
to a petition under subpart C of this part; or
    (3) During the period of extension of the applicable effective 
date, if an extension has been granted under Sec.  148.4.

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
3. 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.

Subpart A--[Amended]

0
4. Section 261.4 is amended by revising paragraph (b)(15) to read as 
follows:


Sec.  261.4  Exclusions.

* * * * *
    (b) * * *
    (15) Leachate or gas condensate collected from landfills where 
certain solid wastes have been disposed, provided that:
    (i) The solid wastes disposed would meet one or more of the listing 
descriptions for Hazardous Waste Codes K169, K170, K171, K172, K174, 
K175, K176, K177, K178 and K181 if these wastes had been generated 
after the effective date of the listing;
    (ii) The solid wastes described in paragraph (b)(15)(i) of this 
section were disposed prior to the effective date of the listing;
    (iii) The leachate or gas condensate do not exhibit any 
characteristic of hazardous waste nor are derived from any other listed 
hazardous waste;
    (iv) Discharge of the leachate or gas condensate, including 
leachate or gas condensate transferred from the landfill to a POTW by 
truck, rail, or dedicated pipe, is subject to regulation under sections 
307(b) or 402 of the Clean Water Act.
    (v) As of February 13, 2001, leachate or gas condensate derived 
from K169-K172 is no longer exempt if it is stored or managed in a 
surface impoundment prior to discharge. As of November 21, 2003, 
leachate or gas condensate derived from K176, K177, and K178 is no 
longer exempt if it is stored or managed in a surface impoundment prior 
to discharge. After February 26, 2007, leachate or gas condensate 
derived from K181 will no longer be exempt if it is stored or managed 
in a surface impoundment prior to discharge. There is one exception: if 
the surface impoundment is used to temporarily store leachate or gas 
condensate in response to an emergency situation (e.g., shutdown of 
wastewater treatment system), provided the impoundment has a double 
liner, and provided the leachate or gas condensate is removed from the 
impoundment and continues to be managed in compliance with the 
conditions of this paragraph (b)(15)(v) after the emergency ends.
* * * * *

Subpart D--[Amended]

0
5. Section 261.32 is amended by:
0
a. Designating the existing text and table as paragraph (a),
0
b. In the table by adding a new entry in alphanumeric order (by first 
column) under the heading ``Organic Chemicals'',
0
c. Adding paragraphs (b), (c) and (d).
    The revisions and additions read as follows:


Sec.  261.32  Hazardous wastes from specific sources.

    (a) * * *

------------------------------------------------------------------------
   Industry and EPA  hazardous
            waste No.               Hazardous waste       Hazard  code
------------------------------------------------------------------------
 
                             * * * * * * *
                            Organic Chemicals
------------------------------------------------------------------------
 
                              * * * * * * *
K181............................  Nonwastewaters from  (T)
                                   the production of
                                   dyes and/or
                                   pigments
                                   (including
                                   nonwastewaters
                                   commingled at the
                                   point of
                                   generation with
                                   nonwastewaters
                                   from other
                                   processes) that,
                                   at the point of
                                   generation,
                                   contain mass
                                   loadings of any of
                                   the constituents
                                   identified in
                                   paragraph (c) of
                                   this section that
                                   are equal to or
                                   greater than the
                                   corresponding
                                   paragraph (c)
                                   levels, as
                                   determined on a
                                   calendar year
                                   basis. These
                                   wastes will not be
                                   hazardous if the
                                   nonwastewaters
                                   are: (i) disposed
                                   in a Subtitle D
                                   landfill unit
                                   subject to the
                                   design criteria in
                                   Sec.   258.40,
                                   (ii) disposed in a
                                   Subtitle C
                                   landfill unit
                                   subject to either
                                   Sec.   264.301 or
                                   Sec.   265.301,
                                   (iii) disposed in
                                   other Subtitle D
                                   landfill units
                                   that meet the
                                   design criteria in
                                   Sec.   258.40,
                                   Sec.   264.301, or
                                   Sec.   265.301, or
                                   (iv) treated in a
                                   combustion unit
                                   that is permitted
                                   under Subtitle C,
                                   or an onsite
                                   combustion unit
                                   that is permitted
                                   under the Clean
                                   Air Act. For the
                                   purposes of this
                                   listing, dyes and/
                                   or pigments
                                   production is
                                   defined in
                                   paragraph (b)(1)
                                   of this section.
                                   Paragraph (d) of
                                   this section
                                   describes the
                                   process for
                                   demonstrating that
                                   a facility's
                                   nonwastewaters are
                                   not K181. This
                                   listing does not
                                   apply to wastes
                                   that are otherwise
                                   identified as
                                   hazardous under
                                   Sec.  Sec.
                                   261.21-261.24 and
                                   261.31-261.33 at
                                   the point of
                                   generation. Also,
                                   the listing does
                                   not apply to
                                   wastes generated
                                   before any annual
                                   mass loading limit
                                   is met.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Listing Specific Definitions: (1) For the purposes of the K181 
listing, dyes and/or pigments production is defined to include 
manufacture of the following product classes: dyes, pigments, or FDA 
certified colors that are classified as azo, triarylmethane, perylene 
or anthraquinone classes. Azo products include azo, monoazo, diazo, 
triazo, polyazo, azoic, benzidine, and pyrazolone products. 
Triarylmethane products include both triarylmethane and 
triphenylmethane products. Wastes that are not generated at a dyes and/
or pigments manufacturing site, such as wastes from the offsite use, 
formulation, and packaging of dyes and/or pigments, are not included in 
the K181 listing.
    (c) K181 Listing Levels. Nonwastewaters containing constituents in 
amounts equal to or exceeding the following levels during any calendar 
year are subject to the K181 listing, unless the conditions in the K181 
listing are met.

[[Page 9176]]



------------------------------------------------------------------------
                                                     Chemical     Mass
                    Constituent                      abstracts   levels
                                                        No.      (kg/yr)
------------------------------------------------------------------------
Aniline...........................................     62-53-3     9,300
o-Anisidine.......................................     90-04-0       110
4-Chloroaniline...................................    106-47-8     4,800
p-Cresidine.......................................    120-71-8       660
2,4-Dimethylaniline...............................     95-68-1       100
1,2-Phenylenediamine..............................     95-54-5       710
1,3-Phenylenediamine..............................    108-45-2     1,200
------------------------------------------------------------------------

    (d) Procedures for demonstrating that dyes and/or pigment 
nonwastewaters are not K181. The procedures described in paragraphs 
(d)(1)-(d)(3) and (d)(5) of this section establish when nonwastewaters 
from the production of dyes/pigments would not be hazardous (these 
procedures apply to wastes that are not disposed in landfill units or 
treated in combustion units as specified in paragraph (a) of this 
section). If the nonwastewaters are disposed in landfill units or 
treated in combustion units as described in paragraph (a) of this 
section, then the nonwastewaters are not hazardous. In order to 
demonstrate that it is meeting the landfill disposal or combustion 
conditions contained in the K181 listing description, the generator 
must maintain documentation as described in paragraph (d)(4) of this 
section.
    (1) Determination based on no K181 constituents. Generators that 
have knowledge (e.g., knowledge of constituents in wastes based on 
prior sampling and analysis data and/or information about raw materials 
used, production processes used, and reaction and degradation products 
formed) that their wastes contain none of the K181 constituents (see 
paragraph (c) of this section) can use their knowledge to determine 
that their waste is not K181. The generator must document the basis for 
all such determinations on an annual basis and keep each annual 
documentation for three years.
    (2) Determination for generated quantities of 1,000 MT/yr or less 
for wastes that contain K181 constituents. If the total annual quantity 
of dyes and/or pigment nonwastewaters generated is 1,000 metric tons or 
less, the generator can use knowledge of the wastes (e.g., knowledge of 
constituents in wastes based on prior analytical data and/or 
information about raw materials used, production processes used, and 
reaction and degradation products formed) to conclude that annual mass 
loadings for the K181 constituents are below the paragraph (c) of this 
section listing levels of this section. To make this determination, the 
generator must:
    (i) Each year document the basis for determining that the annual 
quantity of nonwastewaters expected to be generated will be less than 
1,000 metric tons.
    (ii) Track the actual quantity of nonwastewaters generated from 
January 1 through December 31 of each year. If, at any time within the 
year, the actual waste quantity exceeds 1,000 metric tons, the 
generator must comply with the requirements of paragraph (d)(3) of this 
section for the remainder of the year.
    (iii) Keep a running total of the K181 constituent mass loadings 
over the course of the calendar year.
    (iv) Keep the following records on site for the three most recent 
calendar years in which the hazardous waste determinations are made:
    (A) The quantity of dyes and/or pigment nonwastewaters generated.
    (B) The relevant process information used.
    (C) The calculations performed to determine annual total mass 
loadings for each K181 constituent in the nonwastewaters during the 
year.
    (3) Determination for generated quantities greater than 1,000 MT/yr 
for wastes that contain K181 constituents. If the total annual quantity 
of dyes and/or pigment nonwastewaters generated is greater than 1,000 
metric tons, the generator must perform all of the steps described in 
paragraphs ((d)(3)(i)-(d)(3)(xi) of this section) in order to make a 
determination that its waste is not K181.
    (i) Determine which K181 constituents (see paragraph (c) of this 
section) are reasonably expected to be present in the wastes based on 
knowledge of the wastes (e.g., based on prior sampling and analysis 
data and/or information about raw materials used, production processes 
used, and reaction and degradation products formed).
    (ii) If 1,2-phenylenediamine is present in the wastes, the 
generator can use either knowledge or sampling and analysis procedures 
to determine the level of this constituent in the wastes. For 
determinations based on use of knowledge, the generator must comply 
with the procedures for using knowledge described in paragraph (d)(2) 
of this section and keep the records described in paragraph (d)(2)(iv) 
of this section. For determinations based on sampling and analysis, the 
generator must comply with the sampling and analysis and recordkeeping 
requirements described below in this section.
    (iii) Develop a waste sampling and analysis plan (or modify an 
existing plan) to collect and analyze representative waste samples for 
the K181 constituents reasonably expected to be present in the wastes. 
At a minimum, the plan must include:
    (A) A discussion of the number of samples needed to characterize 
the wastes fully;
    (B) The planned sample collection method to obtain representative 
waste samples;
    (C) A discussion of how the sampling plan accounts for potential 
temporal and spatial variability of the wastes.
    (D) A detailed description of the test methods to be used, 
including sample preparation, clean up (if necessary), and 
determinative methods.
    (iv) Collect and analyze samples in accordance with the waste 
sampling and analysis plan.
    (A) The sampling and analysis must be unbiased, precise, and 
representative of the wastes.
    (B) The analytical measurements must be sufficiently sensitive, 
accurate and precise to support any claim that the constituent mass 
loadings are below the paragraph (c) of this section listing levels of 
this section.
    (v) Record the analytical results.
    (vi) Record the waste quantity represented by the sampling and 
analysis results.
    (vii) Calculate constituent-specific mass loadings (product of 
concentrations and waste quantity).
    (viii) Keep a running total of the K181 constituent mass loadings 
over the course of the calendar year.
    (ix) Determine whether the mass of any of the K181 constituents 
listed in paragraph (c) of this section generated between January 1 and 
December 31 of any year is below the K181 listing levels.
    (x) Keep the following records on site for the three most recent 
calendar years in which the hazardous waste determinations are made:
    (A) The sampling and analysis plan.
    (B) The sampling and analysis results (including QA/QC data)
    (C) The quantity of dyes and/or pigment nonwastewaters generated.
    (D) The calculations performed to determine annual mass loadings.
    (xi) Nonhazardous waste determinations must be conducted annually 
to verify that the wastes remain nonhazardous.
    (A) The annual testing requirements are suspended after three 
consecutive successful annual demonstrations that the wastes are 
nonhazardous. The generator can then use knowledge of the wastes to 
support subsequent annual determinations.
    (B) The annual testing requirements are reinstated if the 
manufacturing or

[[Page 9177]]

waste treatment processes generating the wastes are significantly 
altered, resulting in an increase of the potential for the wastes to 
exceed the listing levels.
    (C) If the annual testing requirements are suspended, the generator 
must keep records of the process knowledge information used to support 
a nonhazardous determination. If testing is reinstated, a description 
of the process change must be retained.
    (4) Recordkeeping for the landfill disposal and combustion 
exemptions. For the purposes of meeting the landfill disposal and 
combustion condition set out in the K181 listing description, the 
generator must maintain on site for three years documentation 
demonstrating that each shipment of waste was received by a landfill 
unit that is subject to or meets the landfill design standards set out 
in the listing description, or was treated in combustion units as 
specified in the listing description.
    (5) Waste holding and handling. During the interim period, from the 
point of generation to completion of the hazardous waste determination, 
the generator is responsible for storing the wastes appropriately. If 
the wastes are determined to be hazardous and the generator has not 
complied with the subtitle C requirements during the interim period, 
the generator could be subject to an enforcement action for improper 
management.

0
6. Appendix VII to part 261 is amended by adding the following entry in 
alphanumeric order (by the first column) to read as follows.

Appendix VII to Part 261--Basis for Listing Hazardous Waste

------------------------------------------------------------------------
                                      Hazardous constituents for which
     EPA  hazardous  waste No.                     listed
------------------------------------------------------------------------
 
                                 * * * *
K181..............................  Aniline, o-anisidine, 4-
                                     chloroaniline, p-cresidine, 2,4-
                                     dimethylaniline, 1,2-
                                     phenylenediamine, 1,3-
                                     phenylenediamine.
 
                                 * * * *
------------------------------------------------------------------------

* * * * *

Appendix VIII to Part 261--Hazardous Constituents

0
7. Appendix VIII to part 261 is amended by adding in alphabetical 
sequence of common name the following entries:
* * * * *

------------------------------------------------------------------------
                                                  Chemical
         Common name               Chemical      abstracts    Hazardous
                                abstracts name      No.       waste No.
------------------------------------------------------------------------
 
                              * * * * * * *
o-Anisidine (2-                Benzenamine, 2-      90-04-0  ...........
 methoxyaniline).               Methoxy-.
 
                              * * * * * * *
p-Cresidine..................  2-Methoxy-5-        120-71-8  ...........
                                methylbenzenam
                                ine.
 
                              * * * * * * *
2,4-Dimethylaniline (2,4-      Benzenamine,         95-68-1  ...........
 xylidine).                     2,4-dimethyl-.
 
                              * * * * * * *
1,2-Phenylenediamine.........  1,2-                 95-54-5  ...........
                                Benzenediamine.
 
                              * * * * * * *
1,3-Phenylenediamine.........  1,3-                108-45-2  ...........
                                Benzenediamine.
 
                              *...............
------------------------------------------------------------------------

PART 268--LAND DISPOSAL RESTRICTIONS

0
8. The authority citation for part 268 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, and 6924.

Subpart C--Prohibitions on Land Disposal

0
9. Subpart C is amended by adding Sec.  268.20 and adding and reserving 
Sec. Sec.  268.21 through 268.29 to read as follows:


Sec.  268.20  Waste specific prohibitions--Dyes and/or pigments 
production wastes.

    (a) Effective August 23, 2005, the waste specified in 40 CFR part 
261 as EPA Hazardous Waste Number K181, and soil and debris 
contaminated with this waste, radioactive wastes mixed with this waste, 
and soil and debris contaminated with radioactive wastes mixed with 
this waste are prohibited from land disposal.
    (b) The requirements of paragraph (a) of this section do not apply 
if:
    (1) The wastes meet the applicable treatment standards specified in 
subpart D of this Part;
    (2) Persons have been granted an exemption from a prohibition 
pursuant to a petition under Sec.  268.6, with respect to those wastes 
and units covered by the petition;
    (3) The wastes meet the applicable treatment standards established 
pursuant to a petition granted under Sec.  268.44;
    (4) Hazardous debris has met the treatment standards in Sec.  
268.40 or the alternative treatment standards in Sec.  268.45; or
    (5) Persons have been granted an extension to the effective date of 
a prohibition pursuant to Sec.  268.5, with respect to these wastes 
covered by the extension.
    (c) To determine whether a hazardous waste identified in this 
section exceeds the applicable treatment standards specified in Sec.  
268.40, the initial generator must test a sample of the waste extract 
or the entire waste, depending on whether the treatment standards are 
expressed as concentrations in the waste extract of the waste, or the 
generator may use knowledge of the waste. If the waste contains 
regulated constituents in excess of the applicable subpart D levels, 
the waste is prohibited from land

[[Page 9178]]

disposal, and all requirements of part 268 are applicable, except as 
otherwise specified.

0
10. In Sec.  268.40, the Table of Treatment Standards is amended by 
revising the entry for F039 to add constituents in alphabetical 
sequence, and by adding in alphanumeric order the new entry for K181 to 
read as follows:


Sec.  268.40  Applicability of treatment standards.

* * * * *

                                                        Treatment Standards for Hazardous Wastes
                                                             [Note: NA means not applicable]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Regulated hazardous constituent
                      Waste description and   ---------------------------------------- Wastewaters Concentration in mg/   Nonwastewater Concentration in
    Waste code        treatment/regulatory                                   CAS \2\     L \3\, or technology code \4\   mg/kg \5\ unless noted as ``mg/
                         subcategory \1\               Common name             No.                                         L TCLP'', or technology code
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
F039.............  Leachate (liquids that      * * * * *                   ..........  ................................  ...............................
                    have percolated through    o-Anisidine (2-                90-04-0  0.010                             0.66
                    land disposed wastes)       methoxyaniline).           ..........  ................................  ...............................
                    resulting from the         * * * * *.................    120-71-8  0.010                             0.66
                    disposal of more than one  p-Cresidine...............  ..........  ................................  ...............................
                    restricted waste           * * * * *.................     95-68-1  0.010                             0.66
                    classified as hazardous    2,4-Dimethylaniline (2,4-   ..........  ................................  ...............................
                    under Subpart D of this     xylidine).                   108-45-2  0.010                             0.66
                    part. (Leachate resulting  * * * * *.................
                    from the disposal of one   1,3-Phenylenediamine......
                    or more of the following   * * * * *.................
                    EPA Hazardous Wastes and
                    no other Hazardous Waste
                    retains its EPA Hazardous
                    Waste Number(s): F020,
                    F021, F022, F026, F027,
                    and/or F028).
 
                                                                      * * * * * * *
K181.............  Nonwastewaters from the     Aniline...................     62-53-3  0.81                              14
                    production of dyes and/or  o-Anisidine (2-                90-04-0  0.010                             0.66
                    pigments (including         methoxyaniline).             106-47-8  0.46                              16
                    nonwastewaters commingled  4-Chloroaniline...........    120-71-8  0.010                             0.66
                    at the point of            p-Cresidine...............     95-68-1  0.010                             0.66
                    generation with            2,4-Dimethylaniline (2,4-      95-54-5  CMBST; or CHOXD fb (BIODG or      CMBST; or CHOXD fb (BIODG or
                    nonwastewaters from other   xylidine).                              CARBN); or BIODG fb CARBN         CARBN); or BIODG fb CARBN
                    processes) that, at the    1,2-Phenylenediamine......
                    point of generation,
                    contain mass loadings of
                    any of the constituents
                    identified in paragraph
                    (c) of section 261.32
                    that are equal to or
                    greater than the
                    corresponding paragraph
                    (c) levels, as determined
                    on a calendar year basis.
                                               1,3-Phenylenediamine......    108-45-2  0.010                             0.66
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

Footnotes to Treatment Standard Table 268.40

    1 The waste descriptions provided in this table do not replace 
waste descriptions in 40 CFR Part 261. Descriptions of Treatment/
Regulatory Subcategories are provided, as needed, to distinguish 
between applicability of different standards.
    2 CAS means Chemical Abstract Services. When the waste code and/or 
regulated constituents are described as a combination of a chemical 
with its salts and/or esters, the CAS number is given for the parent 
compound only.
    3 Concentration standards for wastewaters are expressed in mg/L and 
are based on analysis of composite samples.
    4 All treatment standards expressed as a Technology Code or 
combination of Technology Codes are explained in detail in 40 CFR 
268.42 Table 1-Technology Codes and Descriptions of Technology-Based 
Standards.
    5 Except for Metals (EP or TCLP) and Cyanides (Total and Amenable) 
the nonwastewater treatment standards expressed as a concentration were 
established, in part, based upon incineration in units operated in 
accordance with the technical requirements of 40 CFR part 264, Subpart 
O or 40 CFR part 265, Subpart O, or based upon combustion in fuel 
substitution units operating in accordance with applicable technical 
requirements. A facility may comply with these treatment standards 
according to provisions in 40 CFR 268.40(d). All concentration 
standards for nonwastewaters are based on analysis of grab samples.
* * * * *

0
11. The Table--Universal Treatment Standards in Sec.  268.48 is amended 
by adding in alphabetical sequence the following entries under the 
heading organic constituents:


Sec.  268.48  Universal treatment standards.

    (a) * * *

[[Page 9179]]



                                          Universal Treatment Standards
                                         [Note: NA means not applicable]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Nonwastewater
                                                                                                     standard
                                                                                    Wastewater     Concentration
                Regulated constituent common name                 CAS \1\ number     standard      in mg/kg \3\
                                                                                   Concentration   unless noted
                                                                                    in mg/L \2\      as ``mg/L
                                                                                                      TCLP''
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
o-Anisidine (2-methoxyaniline)..................................         90-04-0           0.010            0.66
 
                                                  * * * * * * *
p-Cresidine.....................................................        120-71-8           0.010            0.66
 
                                                  * * * * * * *
2,4-Dimethylaniline (2,4-xylidine)..............................         95-68-1           0.010            0.66
 
                                                  * * * * * * *
1,3-Phenylenediamine............................................        108-45-2           0.010            0.66
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    1 CAS means Chemical Abstract Services. When the waste code and/or 
regulated constituents are described as a combination of a chemical 
with its salts and/or esters, the CAS number is given for the parent 
compound only.
    2 Concentration standards for wastewaters are expressed in mg/L and 
are based on analysis of composite samples.
    3 Except for Metals (EP or TCLP) and Cyanides (Total and Amenable) 
the nonwastewater treatment standards expressed as a concentration were 
established, in part, based upon incineration in units operated in 
accordance with the technical requirements of 40 CFR Part 264, Subpart 
O, or Part 265, Subpart O, or based upon combustion in fuel 
substitution units operating in accordance with applicable technical 
requirements. A facility may comply with these treatment standards 
according to provisions in 40 CFR 268.40(d). All concentration 
standards for nonwastewaters are based on analysis of grab samples.
* * * * *

PART 271--REQUIREMENTS FOR AUTHORIZATION OF STATE HAZARDOUS WASTE 
PROGRAMS

0
12. The authority citation for Part 271 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), and 6926.


0
13. Section 271.1(j) is amended by adding the following entries to 
Table 1 and Table 2 in chronological order by date of publication to 
read as follows.


Sec.  271.1  Purpose and scope.

* * * * *
    (j) * * *

               Table 1.--Regulations Implementing the Hazardous and Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
                                                                    Federal Register
          Promulgation date              Title of regulation           reference              Effective date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Feb. 15, 2005........................  Listing of Hazards       [INSERT FEDERAL          Aug. 23, 2005
                                        Waste K181.              REGISTER PAGE NUMBERS
                                                                 FOR FINAL RULE].
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


                  Table 2.--Self-Implementing Provisions of the Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
                                          Self-implementing                                  Federal Register
            Effective date                    provision              RCRA citation              reference
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Aug. 23, 2005........................  Prohibition on land      3004(g)(4)(C) and        Feb. 24, 2005, (INSERT
                                        disposal of K181         3004(m).                 FEDERAL REGISTER PAGE
                                        waste, and prohibition                            NUMBERS).
                                        on land disposal of
                                        radioactive waste
                                        mixed with K181
                                        wastes, including soil
                                        and debris.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


[[Page 9180]]

PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION

0
14. The authority citation for Part 302 continues to read as follows:

    Authority: 42 U.S.C. 9602, 9603, and 9604; 33 U.S.C. 1321 and 
1361.


0
15. In Sec.  302.4, Table 302.4 is amended by adding the following new 
entry in alphanumeric order at the end of the table to read as follows:


Sec.  302.4  Designation of hazardous substances.

* * * * *

                      Table 302.4.--List of Hazardous Substances and Reportable Quantities
                         [Note: All comments/notes are located at the end of this table]
----------------------------------------------------------------------------------------------------------------
                                                      Statutory
          Hazardous substance              CASRN         code        RCRA waste number     Final RQ pounds (Kg)
                                                       [Dagger]
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
K181..................................  ...........            4  K181                    
Nonwastewaters from the production of
 dyes and/or pigments (including
 nonwastewaters commingled at the
 point of generation with
 nonwastewaters from other processes)
 that, at the point of generation,
 contain mass loadings of any of the
 constituents identified in paragraph
 (c) of section 261.32 that are equal
 to or greater than the corresponding
 paragraph (c) levels, as determined
 on a calendar year basis.
----------------------------------------------------------------------------------------------------------------
[Dagger] Indicates the statutory source defined by 1, 2, 3, and 4, as described in the note preceding Table
  302.4.
 
 * * * * *
  The Agency may adjust the statutory RQ for this hazardous substance in a future rulemaking;
  until then the statutory RQ applies.

* * * * *
[FR Doc. 05-3454 Filed 2-23-05; 8:45 am]
BILLING CODE 6560-50-P