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, 9138-9180 [05-3454]
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9138
Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Rules and Regulations
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 https://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 https://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:
kayser.robert@epa.gov. 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:
beasley.lynn@epa.gov.
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
Acronym
Definition
BDAT .................
BIODG ...............
CAA ...................
CARBN ..............
CAS ...................
CBI .....................
CCL ...................
CERCLA ............
CFR ...................
CHOXD ..............
CMBST ..............
CoC ...................
CI .......................
CPMA ................
CWA ..................
CWTP ................
ED ......................
E.O. ...................
EP ......................
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Best Demonstrated Available Technology.
Biodegradation.
Clean Air Act.
Carbon absorption.
Chemical Abstract Services.
Confidential Business Information.
Compacted clay liner.
Comprehensive Environmental Response Compensation and Liability Act.
Code of Federal Regulations.
Chemical or electrolytic oxidation.
Combustion.
Constituent of concern.
Colour Index.
Color Pigments Manufacturers Association.
Clean Water Act.
Centralized wastewater treatment plant.
Environmental Defense (previously the Environmental Defense Fund or EDF).
Executive Order.
Extraction Procedure.
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Rules and Regulations
9139
ACRONYMS USED IN THE RULE—Continued
Acronym
Definition
EPA ...................
EPACMTP .........
EPCRA ..............
ETAD .................
EU ......................
fb ........................
FDA ...................
FD&C .................
FR ......................
GCL ...................
GC/MS ...............
GM .....................
GSCM ................
HELP .................
HGDB ................
HPLC .................
HQ .....................
HSWA ................
ICR ....................
kg/yr ...................
LDR ...................
mg/kg .................
mg/L ...................
MSW ..................
MT .....................
NAICS ................
OMB ..................
OSW ..................
OSWER .............
POTW ................
ppm ....................
PRA ...................
QA .....................
QC .....................
RCRA ................
RFA ...................
RFSA .................
RQ .....................
SAB ...................
SBA ...................
SBREFA ............
SIC .....................
SW–846 .............
TRI .....................
UCLM ................
UMRA ................
U.S.C. ................
UTS ...................
WETOX .............
Environmental Protection Agency.
EPA’s Composite Model for Leachate Migration with Transformation Products.
Emergency Planning and Community Right-To-Know Act.
Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers.
European Union.
Followed by.
Food and Drug Administration.
Food, Drug and Cosmetic.
Federal Register.
Geosynthetic clay liner.
Gas Chromatography/Mass Spectroscopy.
Geomembrane.
General Soil Column Model.
Hydrologic Evaluation of Landfill Performance.
Hydrogeologic Database.
High Performance Liquid Chromatography.
Hazard Quotient.
Hazardous and Solid Waste Amendments.
Information Collection Request.
Kilogram/year.
Land Disposal Restriction.
Milligram per kilogram.
Milligram per liter.
Municipal Solid Waste.
Metric ton.
North American Industrial Classification System.
Office of Management and Budget.
Office of Solid Waste.
Office of Solid Waste and Emergency Response.
Publicly owned treatment works.
Parts per million.
Paperwork Reduction Act.
Quality Assurance.
Quality Control.
Resource Conservation and Recovery Act.
Regulatory Flexibility Act.
Regulatory Flexibility Screening Analysis.
Reportable Quantity.
Science Advisory Board.
Small Business Administration.
Small Business Regulatory Enforcement Fairness Act.
Standard Industry Code.
Test Methods for Evaluating Solid Wastes.
Toxic Release Inventory.
Upper confidence limit of the mean.
Unfunded Mandates Reform Act.
United States Code.
Universal Treatment Standard.
Wet air oxidation.
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?
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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
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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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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Rules and Regulations
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 NonWastewaters 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.
TABLE 1.—SUMMARY OF FACILITIES POTENTIALLY AFFECTED BY THE U.S. EPA’S 2005 DYES AND/OR PIGMENTS
MANUFACTURING WASTE LISTING FINAL RULE
SIC code
Estimated number of
relevant facilities*
NAICS code
Industry sector name
325132–1 ...........................
325132–4 ...........................
Synthetic Organic Dyes .................................................
Synthetic Organic Pigments, Lakes, and Toners.
31.
Indirectly Impacted:
2800 (except 2865) ......
325 (except 325132) .........
Chemical Manufacturing ................................................
Less than 50 facilities
total.**
4953 ..............................
562212 ...............................
5169 ..............................
42269 .................................
Solid Waste Landfills and Disposal Sites, Nonhazardous.
Other Chemicals and Allied Products (wholesale).
Directly Impacted:
2865 ..............................
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
1 Memorandum from Lyn D. Luben to the RCRA
Docket, July 21, 2004.
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Rules and Regulations
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
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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 § 258.40, (ii) disposed in a subtitle C
landfill unit subject to either § 264.301 or
§ 265.301, (iii) disposed in other subtitle D
landfill units that meet the design criteria in
§ 258.40, § 264.301, or § 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 §§ 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
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9141
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 § 258.40, § 264.301, or § 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 § 258.40,
§ 264.301 or § 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
§ 260.22.
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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, 4chloroaniline, p-cresidine, 2,4dimethylaniline, 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 § 261.11(a)(3)): oanisidine, p-cresidine, 2,4dimethylaniline, 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
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.
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18:48 Feb 23, 2005
Jkt 205001
specific constituents in the newly-listed
waste.
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 § 258.40 or in a
Subtitle C landfill cell subject to either
§ 264.301 or § 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 §§ 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, 2,4dimethylaniline, 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: oanisidine, p-cresidine, 2,4dimethylaniline, toluene-2,4-diamine,
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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
§§ 261.31–261.33 or the hazardous
waste characteristics in §§ 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
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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 § 258.40,
§ 264.301, or § 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
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our assessment of the available toxicity
data, we believed that these chemicals
met the § 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 nonhazardous 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
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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 1,3phenylenediamine; 1,2phenylenediamine; and 2,4dimethylaniline. For 1,3phenylenediamine and 2,4dimethylaniline, we proposed to
transfer the numerical standards of
similar constituents as the universal
treatment standards.
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
3 Manual of test methods from EPA/OSW: ‘‘Test
Methods for Evaluating Solid Waste, Physical/
Chemical Methods,’’ SW–846; see https://
www.epa.gov/epaoswer/hazwaste/test/sw846.htm.
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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 technologybased 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.
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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
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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 § 258.40, (ii) disposed in a Subtitle C
landfill unit subject to either § 264.301 or
§ 265.301, (iii) disposed in other Subtitle D
landfill units that meet the design criteria in
§ 258.40, § 264.301, or § 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 §§ 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
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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 (§ 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
(§ 261.11(a)(3)(ii)) and the quantities of
waste generated (§ 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 (§§ 261(a)(3)(iii),
261.11(a)(3)(iv), and 261.11(a)(3)(v)).5
Bioaccumulation of the constituents
(§ 261.11(a)(3)(vi)) is not relevant to the
key exposure pathway EPA assessed
(consumption of groundwater).
As discussed in the proposal (68 FR
66178), we considered two other factors,
plausible mismanagement and other
regulatory actions ((§§ 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
(§ 258.40) or hazardous waste landfills
(§ 264.301 or § 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
4 Risk Assessment Background Document,
Section 7.
5 Risk Assessment Background Document,
Sections 4 and 5.
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improper management of the wastes of
concern (§ 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.
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 § 261.31(c)(1)
mass loading limits. We also proposed
a higher mass loading limit for toluene2,4-diamine under § (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 § 261.32(c)(2) level.
Commenters argued that it is
inappropriate to use toluene-2,4diamine 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-2,4diamine 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-2,46 The final factor allows EPA to consider other
factors as appropriate (§ 261.11(a)(3)(xi)), however
we did not consider such factors.
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9145
diamine.) As a result, we do not believe
it is appropriate to include toluene-2,4diamine as a basis for listing K181 in
today’s final rule. Accordingly, we have
removed this constituent from the
proposed § 261.31(c)(1) standards, and
have deleted entirely the proposed
§ 261.32(c)(2) standard in this action.
2. Use of Clay-Lined and CompositeLined 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 (§ 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 claylined landfill is an appropriate scenario
for the baseline mass loading limits for
K181 for several reasons. First, as noted
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in the proposal, our data show that the
industries use municipal solid waste
(MSW) landfills, and the liner
requirements in § 258.40 are not
applicable to existing units in operation
since before October 9, 1993, or certain
exempt units (§ 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 § 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 § 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 § 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
(§ 258.40, 264.301 or 265.301).7 Unlike
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’’
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the proposal, the final rule no longer
sets a mass loading limit for toluene-2,4diamine, 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.
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
in the RCRA regulations for landfills (Part 258 and
in §§ 264.301 and 265.301).
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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
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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
8 See the air permit for BASF in the docket for
this rule.
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9147
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
4. Scope of Listing Definition
identified the constituents by
Commenters identified several issues
developing a list of chemicals that could
related to the scope of the proposed
reasonably be expected to be associated
listing, as summarized below, and
with wastes from the production of
discussed in more detail in the
various classes of dyes and pigments,
Response to Comments Background
including anthraquinone dyes and
Document.
pigments. See 68 FR at 66180–66182,
a. Perylenes and Anthraquinones. One and ‘‘Background Document:
trade association commented that EPA
Development of Constituents of Concern
erred in including perylenes in the
for Dyes and Pigments Listing
proposed listing because Paragraph
Determination’’ in the docket. This
l.h.(i) of the ED consent decree (as
commenter did not provide any
amended in December 2002) states that
documentation to support its argument
‘‘EPA shall promulgate final listing
that none of the eight CoCs are used to
determinations for azo/benzidine,
produce anthraquinone dyes or
anthraquinone, and triarylmethane dye
pigments, or otherwise specifically
and pigment production wastes.’’ The
address the information and findings
commenter argued that perylenes are
presented in the proposal. In addition,
not a subclass of the anthraquinone
none of the other companies or trade
category, and that none of the eight
associations made similar claims.
CoCs are used as raw materials in the
Finally, we note that, as discussed in
manufacture of perylene color pigments. the 2003 proposal (68 FR 66171–2), our
We note, as discussed previously in
2003 proposed rule completely
the proposal, that the ED consent decree supercedes the 1994 and 1999
(under which today’s listing
proposals. In any case, unlike the 1999
determination is mandated) further
concentration-based listing in which we
specifies that ‘‘The anthraquinone
evaluated specific waste types from the
listing determination shall include the
production of individual dyes/pigments
following anthraquinone dye and
classes,9 the 2003 proposal grouped all
pigment classes: anthraquinone and
of the wastes that are identified in the
perylene’’ (68 FR 66173). Therefore, we
ED consent decree into wastewaters and
must make listing determinations that
nonwastewaters.
cover any corresponding wastes,
Moreover, some of the listing
regardless of whether or not perylenes
constituents might be present in the
are properly classified as
dyes and/or pigments production
anthraquinones. Furthermore, as
nonwastewaters as a result of reaction
discussed in the proposal and in the
byproducts, impurities in raw materials,
Response to Comments Background
or as a result of degradation of raw
Document, we are not differentiating
materials or products. Therefore, we
between dye manufacture and pigment
believe it is appropriate to retain both
manufacture. While the pigments
perylene and anthraquinone production
industry may not use the K181 CoCs for within the scope of this final K181
manufacturing perylene pigments as
listing. If, however, as the commenter
contended by the commenter, it is
suggests, the CoCs are not present in the
possible that the dyes industry may still generators’ wastes, then the wastes
use some of them for perylene dyes.
would not be considered the K181 listed
Note that ETAD and its member dye
waste.
manufacturers did not provide
b. Post-Production. Two commenters
stated that the proposed rule does not
comments in this respect. Finally, we
adequately define ‘‘production’’ of dyes
note that the consent decree does not
and/or pigments, and that some wastes
limit EPA’s authority to list wastes, but
merely identifies those wastes for which covered by the ED consent decree could
EPA must make a listing determination.
9 Spent filter aids, triarylmethane sludges and
Another commenter argued that none
anthraquinone sludges were deferred from the 1994
of the eight CoCs are used to produce
proposed listing decisions for 11 of the wastes
anthraquinone dyes or pigments and,
covered in the ED consent decree (59 FR 66072,
therefore, EPA should remove
December 22, 1994). EPA did not take final action
on either of the 1994 and 1999 proposals.
anthraquinone dyes and pigments from
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.
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be generated from certain types of ‘‘postproduction’’ 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 § 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
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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.
As discussed in the proposal, a
facility might choose to segregate K181
sources from non-K181 sources, so that
nonwastewaters from noncovered
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.’’
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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
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 § 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 cotreated 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
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.
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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 § 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 pcresidine is less than the K181 listing level
of 660 kg/yr, the facility concludes that its inscope 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 inscope 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 inscope nonwastewaters. Given that the K181
listing allows nonwastewaters to be disposed
in a municipal landfill subject to the § 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 § 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 § 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.
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.
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
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
12 That is, a constituent of concern was
eliminated if the calculated allowable loading from
risk modeling exceeds 10,000 kg/yr.
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 inscope 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.
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9149
dye manufacturers ceased operation
during the past year.
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
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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-2,4diamine (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
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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 § 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
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Comment RCRA–2003–0001–0258.
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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
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 oanisidine 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
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.
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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
§ 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-/4aminoaniline. We agree that the
particular analytical result noted is an
insufficient basis by itself to include oanisidine 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 oanisidine 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.
ETAD noted that o-anisidine was not
reported in the RCRA § 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 oanisidine (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 loadingsbased 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
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.’’
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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 oanisidine in their wastes. We note that
there are three facilities that reported oanisidine 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
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9151
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 4chloroaniline 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
§ 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 4chloroaniline is not used by any covered
dyes process and was never present in
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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
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 § 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 4chloroaniline (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 § 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 4chloroaniline (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
17 https://www.timesleader.com/mld/timesleader/
5122083.htm.
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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 4chloroaniline in the listing is sound,
and we are finalizing the 4chloroaniline 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. pCresidine 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 pcresidine were considered infrequently
used, EPA would still consider that pcresidine met the listing criteria set out
in § 261.11.
ETAD also argued that p-cresidine
should be removed as a basis for the
listing in part because there are no
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Fmt 4701
Sfmt 4700
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 pcresidine as an intermediate, and thus
the likelihood that this CoC exists in
wastes at these sites is high. As
mentioned previously, the § 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 pcresidine 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 pcresidine (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.
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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 § 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 2,4dimethylaniline 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 2,4dimethylaniline is relevant to their
processes and/or wastes. Therefore, the
available information indicates that 2,4dimethylaniline is likely to be present
in dye/pigment wastes, and it is
reasonable to keep this as a constituent
of concern. Moreover, even if 2,4dimethylaniline were considered
infrequently used, EPA would still
consider that 2,4-dimethylaniline met
the listing criteria set out in § 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 2,4dimethylaniline 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.
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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 2,4dimethylaniline (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
In addition, ETAD argued that there is
no evidence that either the calculated
theoretical average concentration of 2,4dimethylaniline (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 oanisidine.
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.
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.
https://europa.eu.int/comm/food/fs/sc/sccp/
out155_en.pdf.
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9153
In conclusion, we have determined
that our basis for including 2,4dimethylaniline in the listing is sound,
and we are finalizing the 2,4dimethylaniline level as proposed.
f. 1,2-Phenylenediamine. We
proposed to include 1,2phenylenediamine 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 1,2phenylenediamine 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 1,2phenylenediamine is likely to be
present in dye/pigment wastes, and it is
reasonable to keep this as a constituent
of concern. Moreover, even if 1,2phenylenediamine were considered
infrequently used, EPA would still
consider that 1,2-phenylenediamine met
the listing criteria set out in § 261.11.
ETAD also argued that the TRI data
does not support inclusion of 1,2phenylenediamine 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 1,2phenylenediamine should not be
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included as a basis for this listing in
part because there are no RCRA § 3007
survey data demonstrating its presence
in wastes. As mentioned previously, the
§ 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 1,2phenylenediamine as an intermediate,
providing further confirmation that this
CoC exists in wastes at these sites.
Furthermore, ETAD noted that 1,2phenylenediamine 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 1,2phenylenediamine 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 1,2phenylenediamine (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-
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phenylenediamine as a potential CoC.
We refer the reader to our earlier
response to a similar comment on 4chloroaniline.
In conclusion, we have determined
that our basis for including 1,2phenylenediamine in the listing is
sound, and we are finalizing the 1,2phenylenediamine level as proposed.
g. 1,3-Phenylenediamine. We
proposed to include 1,3phenylenediamine 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 § 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 inscope pigment processes).
ETAD argued that 1,3phenylenediamine 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 § 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 1,3phenylenediamine is likely to be
present in dye/pigment wastes, and it is
reasonable to keep this as a constituent
of concern. Moreover, even if 1,3phenylenediamine were considered
infrequently used, EPA would still
consider that 1,3-phenylenediamine met
the listing criteria set out in § 261.11.
ETAD also argued that 1,3phenylenediamine 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 1,3phenylenediamine 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
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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 oanisidine.
Furthermore, ETAD asserts that their
newly collected data show that the
median volume of 1,3phenylenediamine 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 1,3phenylenediamine as a potential CoC.
We refer the reader to our earlier
response to a similar comment on 4chloroaniline.
In conclusion, we have determined
that our basis for including 1,3phenylenediamine in the listing is
sound, and we are finalizing the 1,3phenylenediamine 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-2,4diamine, 1,2-phenylenediamine, 1,3phenylenediamine, and 2,4dimethylaniline) 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
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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 2,4dimethylaniline 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
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.
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method is adequate for 1,3phenylenediamine. 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.
9155
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.,
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.
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 (https://www.epa.gov/sab/fiscal04.htm).
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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.
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 halflife 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
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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.
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
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
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.
25 ‘‘Characterization of Infiltration Rate Data to
Support Groundwater Modeling Efforts,’’ Draft
Final. TetraTech, Inc. September 28, 2001.
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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 toluene2,4-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.
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’
26 See Appendix A of the EPA’s Composite Model
for Leachate Migration with Transformation
Products (EPACMTP)—Parameters/Date
Background Documents (2003).
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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
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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.
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 × 107 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 105 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 104 to 107 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
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.
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.
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9157
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.
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.
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
29 Paints Listing Determination; February 13,
2001; 66 FR 10093; Inorganic Chemical
Manufacturing Listing Determination; September
14, 2000; 65 FR 55697.
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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).
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
30 U.S. EPA Exposure Factors Handbook, August
1997; EPA/600/P–95/002Fa. https://www.epa.gov/
ncea/pdfs/efh/front.pdf.
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characteristics and behavior patterns
change. Depending on the exposure
duration selected, a receptor (e.g., a 1to 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
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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
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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.
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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
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required to use the more extensive
procedures in § 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
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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) § 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 § 261.32(d)(2), and not
the more extensive testing requirements
in § 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 § 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
§ 261.32(d)(1) through § 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 (§ 261.32(d)(4)). Furthermore,
we added language to the beginning of
§ 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.
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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
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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 toluene2,4-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 § 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
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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
§ 261.32(d)(2)(iv) and § 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
§ 258.40. Therefore, the facility has no
obligation to test for the presence of CoCs. To
comply with the recordkeeping requirements
of § 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
§ 258.40 design standards.
Example 2: Facility E is a producer of inscope 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 § 263.32(c).
Since the total volume of nonwastewaters
exceeds 1,000 MT/yr, the facility must follow
the procedures set forth in § 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
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information reviewed, and the results of
past analyses performed.
The facility develops a sampling and
analysis plan that includes the
requirements of § 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
§ 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 § 258.40,
§ 264.301, or § 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 § 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
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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-2,4diamine 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
§ 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.
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 § 258.40. This
31 As ETAD indicated in its comment that ‘‘Dyes
production involves batch processes, numerous
distinct products and highly variable waste streams
* * * ’’
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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 compositelined 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 nonmunicipal landfills (industrial landfills)
that meet the liner design requirements
in § 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 § 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 nonmunicipal 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
32 Association of State and Territorial Solid Waste
Management Officials (‘‘ASTSWMO’’), NonMunicipal, Subtitle D Waste Survey.
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exemption for wastes disposed in
subtitle D landfills that meet the design
requirements in § 258.40, § 264.301, or
§ 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):
These wastes will not be hazardous if the
nonwastewaters are: (i) Disposed in a subtitle
D landfill unit subject to the design criteria
in § 258.40, (ii) disposed in a subtitle C
landfill unit subject to either § 264.301 or
§ 265.301, (iii) disposed in other subtitle D
landfill units that meet the design criteria in
§ 258.40, § 264.301, or § 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 nonhazardous 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 § 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
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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 sitespecific and are best left to the local
regulatory agency. Therefore, we are not
expanding the deferral to include
impoundment leachate.
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 90day 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
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).
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2. How Does EPA Develop LDR
Treatment Standards?
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).
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
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—oanisidine, p-cresidine—there is
adequate documentation in existing
SW–846 methods 8270, 8315, and 8325
to calculate numerical standards.
Finally, for two other constituents—2,4dimethylaniline and 1,3phenylenediamine—we are transferring
the numerical standards of similar
constituents as the universal treatment
standards.
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.
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9163
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 1,2phenylenediamine, 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
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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 1,2phenylenediamine 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 ..............................................................................................................
o-Anisidine (2-methoxyaniline) ........................................................................
4-Chloroaniline .................................................................................................
p-Cresidine .......................................................................................................
2,4-Dimethylaniline (2,4-xylidine) .....................................................................
1,2-Phenylenediamine .....................................................................................
62–53–3
90–04–0
106–47–8
120–71–8
95–68–1
95–54–5
1,3-Phenylenediamine .....................................................................................
108–45–2
0.81
0.010
0.46
0.010
0.010
CMBST; or CHOXD fb
(BIODG or CARBN); or
BIODG fb CARBN
0.010
14
0.66
16
0.66
0.66
CMBST; or CHOXD fb
(BIODG or CARBN); or
BIODG fb CARBN
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, 2,4dimethylaniline, and 1,3phenylenediamine. 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 toluene2,4-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 § 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
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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 analysisrelated 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
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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 newlylisted 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
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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
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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 newlylisted 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
§ 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 § 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
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9165
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 § 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-bycase 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.
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B. Section 3010 Notification
Under RCRA § 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 § 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), pretransport procedures (40 CFR 262.30
through 262.34), generator accumulation
(40 CFR 262.34), record keeping and
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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 § 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.
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.
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.
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
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
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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)).
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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 60day 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
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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
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9167
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 selfimplementing.
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
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§ 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
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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.
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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
Constituents in K181 waste
stream
Constituent RQ
(kg)
(40 CFR 302.4)
Aniline ..................................
o-Anisidine ...........................
4-Chloroaniline ....................
p-Cresidine ..........................
2,4-Dimethylaniline ..............
1,2-Phenylenediamine .........
1,3-Phenylenediamine .........
5000 (2270)
100 (45.4)
1000 (454)
1* (0.454)
1* (0.454)
1* (0.454)
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: pcresidine; 2,4-dimethylaniline; 1,2phenylenediamine; and 1,3phenylenediamine. 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
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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; 1,2phenylenediamine; and 1,3phenylenediamine 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 tollfree 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-toKnow 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
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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
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9169
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.
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 LoadingsBased 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.
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
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.
35 Less than 750 total employees at the corporate
level.
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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.
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
36 Response to Comments Document: Hazardous
Waste Listing Determination for Dyes and/or
Pigments Manufacturing Wastes (Final Rule),
February 2005.
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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).
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
37 PR Newswire, 2004 (March 26), Synalloy
Corporation Announces Fourth Quarter Results
Financial Services News.
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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. Facilityspecific 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
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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
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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
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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
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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
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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.
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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
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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 quantitybased implementation approach also
helped mitigate potential impacts to
small entities.
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.
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.
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
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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.
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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
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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
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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).
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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.
For the reasons set out in the preamble,
title 40, chapter I of the Code of Federal
Regulations is amended as follows:
I
PART 148—HAZARDOUS WASTE
INJECTION RESTRICTIONS
1. The authority citation for part 148
continues to read as follows:
I
Authority: Sec. 3004, Resource
Conservation and Recovery Act, 42 U.S.C.
6901, et seq.
2. Section 148.18 is amended by
revising paragraph (l) and adding
paragraph (m) to read as follows:
I
§ 148.18 Waste-specific prohibitions—
newly listed and identified wastes.
*
*
*
*
*
(l) Effective August 23, 2005, the
waste specified in 40 CFR 261.32 as
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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
§ 148.4.
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
3. The authority citation for part 261
continues to read as follows:
I
Authority: 42 U.S.C. 6905, 6912(a), 6921,
6922, 6924(y), and 6938.
Subpart A—[Amended]
4. Section 261.4 is amended by
revising paragraph (b)(15) to read as
follows:
I
§ 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,
Industry and EPA
hazardous waste No.
*
5. Section 261.32 is amended by:
a. Designating the existing text and
table as paragraph (a),
I b. In the table by adding a new entry
in alphanumeric order (by first column)
under the heading ‘‘Organic Chemicals’’,
I c. Adding paragraphs (b), (c) and (d).
The revisions and additions read as
follows:
I
I
§ 261.32 Hazardous wastes from specific
sources.
(a) * * *
Hazard
code
*
*
Organic Chemicals
*
*
*
*
*
*
*
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 § 258.40, (ii) disposed in a Subtitle C landfill unit subject to either § 264.301 or
§ 265.301, (iii) disposed in other Subtitle D landfill units that meet the design criteria in § 258.40,
§ 264.301, or § 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 §§ 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
VerDate jul<14>2003
Subpart D—[Amended]
Hazardous waste
*
*
K181 ............................
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.
*
*
*
*
*
18:48 Feb 23, 2005
Jkt 205001
*
*
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,
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*
*
*
(T)
*
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.
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Constituent
Aniline .......................
o-Anisidine ................
4-Chloroaniline ..........
p-Cresidine ...............
2,4-Dimethylaniline ...
1,2Phenylenediamine
1,3Phenylenediamine
Chemical
abstracts
No.
Mass
levels
(kg/yr)
62–53–3
90–04–0
106–47–8
120–71–8
95–68–1
9,300
110
4,800
660
100
95–54–5
710
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:
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18:48 Feb 23, 2005
Jkt 205001
(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
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Fmt 4701
Sfmt 4700
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
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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.
Appendix VII to Part 261—Basis for
Listing Hazardous Waste
EPA
hazardous
waste No.
Hazardous constituents for which
listed
*
K181 ........
*
*
*
Aniline, o-anisidine, 4chloroaniline, p-cresidine, 2,4dimethylaniline, 1,2phenylenediamine, 1,3phenylenediamine.
*
*
*
*
6. Appendix VII to part 261 is amended *
*
*
*
*
by adding the following entry in
Appendix VIII to Part 261—Hazardous
alphanumeric order (by the first column)
Constituents
to read as follows.
I 7. Appendix VIII to part 261 is
amended by adding in alphabetical
sequence of common name the following
entries:
*
*
*
*
*
I
Chemical
abstracts
No.
Hazardous
waste No.
Common name
Chemical abstracts name
*
*
*
o-Anisidine (2-methoxyaniline) ..........................................
*
*
*
Benzenamine, 2-Methoxy- ...............................................
90–04–0
*
....................
*
*
*
p-Cresidine ........................................................................
*
*
*
2-Methoxy-5-methylbenzenamine ....................................
120–71–8
*
....................
*
*
*
2,4-Dimethylaniline (2,4-xylidine) ......................................
*
*
*
Benzenamine, 2,4-dimethyl- .............................................
95–68–1
*
....................
*
*
*
1,2-Phenylenediamine ......................................................
*
*
*
1,2-Benzenediamine .........................................................
95–54–5
*
....................
*
*
*
1,3-Phenylenediamine ......................................................
*
*
*
1,3-Benzenediamine .........................................................
108–45–2
*
....................
*
*
*
PART 268—LAND DISPOSAL
RESTRICTIONS
8. The authority citation for part 268
continues to read as follows:
I
Authority: 42 U.S.C. 6905, 6912(a), 6921,
and 6924.
Subpart C—Prohibitions on Land
Disposal
9. Subpart C is amended by adding
§ 268.20 and adding and reserving
§§ 268.21 through 268.29 to read as
follows:
I
§ 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
VerDate jul<14>2003
20:20 Feb 23, 2005
Jkt 205001
.
*
*
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 § 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
§ 268.44;
(4) Hazardous debris has met the
treatment standards in § 268.40 or the
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*
*
alternative treatment standards in
§ 268.45; or
(5) Persons have been granted an
extension to the effective date of a
prohibition pursuant to § 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 § 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
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disposal, and all requirements of part
268 are applicable, except as otherwise
specified.
I 10. In § 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:
§ 268.40 Applicability of treatment
standards.
*
*
*
*
*
TREATMENT STANDARDS FOR HAZARDOUS WASTES
[Note: NA means not applicable]
Regulated hazardous constituent
Waste
code
Waste description and treatment/regulatory subcategory 1
*
Wastewaters
Concentration in
mg/L 3, or technology code 4
CAS 2 No.
Common name
*
K181 ...
*
Leachate (liquids that have percolated through land disposed
wastes) resulting from the disposal
of more than one restricted waste
classified as hazardous under
Subpart D of this part. (Leachate
resulting from the disposal of one
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).
*
*
* * * * *
o-Anisidine (2-methoxyaniline) ..........
* * * * *
p-Cresidine ........................................
* * * * *
2,4-Dimethylaniline (2,4-xylidine) ......
* * * * *
1,3-Phenylenediamine ......................
* * * * *
90-04-0
0.010
0.66
120-71-8
0.010
0.66
95-68-1
0.010
0.66
108-45-2
0.010
0.66
*
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.
*
*
Aniline ...............................................
o-Anisidine (2-methoxyaniline) ..........
4-Chloroaniline ..................................
p-Cresidine ........................................
2,4-Dimethylaniline (2,4-xylidine) ......
1,2-Phenylenediamine ......................
*
62-53-3
90-04-0
106-47-8
120-71-8
95-68-1
95-54-5
*
0.81
0.010
0.46
0.010
0.010
CMBST; or CHOXD
fb (BIODG or
CARBN); or
BIODG fb
CARBN
*
14
0.66
16
0.66
0.66
CMBST; or CHOXD
fb (BIODG or
CARBN); or
BIODG fb
CARBN
1,3-Phenylenediamine ......................
F039 ...
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
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*
*
Nonwastewater
Concentration in
mg/kg 5 unless
noted as ‘‘mg/L
TCLP’’, or technology code
*
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
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*
*
*
*
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.
*
*
*
*
*
11. The Table—Universal Treatment
Standards in § 268.48 is amended by
adding in alphabetical sequence the
following entries under the heading
organic constituents:
I
§ 268.48
Universal treatment standards.
(a) * * *
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Rules and Regulations
UNIVERSAL TREATMENT STANDARDS
[Note: NA means not applicable]
Wastewater
standard
Concentration
in mg/L 2
CAS 1 number
Regulated constituent common name
*
*
*
*
*
o-Anisidine (2-methoxyaniline) .....................................................................................................
90–04–0
*
*
*
*
*
p-Cresidine ...................................................................................................................................
120–71–8
*
*
*
*
*
2,4-Dimethylaniline (2,4-xylidine) .................................................................................................
95–68–1
*
*
*
*
*
1,3-Phenylenediamine ..................................................................................................................
108–45–2
*
*
*
*
*
*
*
*
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
*
*
*
0.010
*
0.66
*
0.010
*
0.66
*
0.010
*
0.66
*
0.010
*
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.
*
*
*
*
*
Nonwastewater standard
Concentration
in mg/kg 3 unless noted as
‘‘mg/L TCLP’’
*
0.66
*
PART 271—REQUIREMENTS FOR
AUTHORIZATION OF STATE
HAZARDOUS WASTE PROGRAMS
12. The authority citation for Part 271
continues to read as follows:
I
Authority: 42 U.S.C. 6905, 6912(a), and
6926.
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.
I
§ 271.1
*
Purpose and scope.
*
*
(j) * * *
*
*
TABLE 1.—REGULATIONS IMPLEMENTING THE HAZARDOUS AND SOLID WASTE AMENDMENTS OF 1984
Promulgation date
Title of regulation
Federal Register reference
*
Feb. 15, 2005 .........
*
*
Listing of Hazards Waste K181 ............
*
*
[INSERT FEDERAL REGISTER PAGE
NUMBERS FOR FINAL RULE].
*
*
*
*
Effective date
*
Aug. 23, 2005
*
*
*
*
TABLE 2.—SELF-IMPLEMENTING PROVISIONS OF THE SOLID WASTE AMENDMENTS OF 1984
Effective date
Self-implementing provision
RCRA citation
Federal Register reference
*
Aug. 23, 2005 ........
*
*
Prohibition on land disposal of K181
waste, and prohibition on land disposal of radioactive waste mixed
with K181 wastes, including soil and
debris.
*
*
3004(g)(4)(C) and 3004(m) ..................
*
*
Feb. 24, 2005, (INSERT FEDERAL
REGISTER PAGE NUMBERS).
*
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9180
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Authority: 42 U.S.C. 9602, 9603, and 9604;
33 U.S.C. 1321 and 1361.
PART 302—DESIGNATION,
REPORTABLE QUANTITIES, AND
NOTIFICATION
alphanumeric order at the end of the
table to read as follows:
15. In § 302.4, Table 302.4 is amended
by adding the following new entry in
§ 302.4 Designation of hazardous
substances.
I
14. The authority citation for Part 302
continues to read as follows:
I
*
*
*
*
*
TABLE 302.4.—LIST OF HAZARDOUS SUBSTANCES AND REPORTABLE QUANTITIES
[Note: All comments/notes are located at the end of this table]
Hazardous substance
CASRN
*
*
*
*
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.
RCRA
waste
number
Statutory
code ‡
*
....................
*
4
K181
Final RQ
pounds
(Kg)
*
##
‡ 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
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Agencies
[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Rules and Regulations]
[Pages 9138-9180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3454]
[[Page 9137]]
-----------------------------------------------------------------------
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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: kayser.robert@epa.gov. 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: beasley.lynn@epa.gov.
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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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?
[[Page 9140]]
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.
---------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Estimated number of
SIC code NAICS code Industry sector name relevant facilities*
----------------------------------------------------------------------------------------------------------------
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) .
----------------------------------------------------------------------------------------------------------------
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
[[Page 9141]]
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
https://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).
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\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.
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\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).
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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
K