United States Office of
Environmental Protection Solid Waste
Agency Washington, D.C. 20460 October 2001
v>EPA Response to Comments Document
Hazardous Waste Listing
Determination for Inorganic
Chemicals Industry Wastes
(Final Rule)
Volume I:
Responses to Comments ICMP-00001
through ICMP-00012
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Public Comments on the
Inorganic Chemical Manufacturing Listing Determination
(Proposed September 14, 2000)
Comment ICMP-00001, Chemical Products Corporation 1-2
Comment ICMP-00002, Monsanto 1-6
Comment ICMP-00003, Chemical Products Corporation 1-7
Comment ICMP-00004, American Chemistry Council 1-10
Comment ICMP-00005, DuPont 1-12
Comment ICMP-00006, Lead Industry Association 1-14
Comment ICMP-00007, Color Pigments Manufacturers Association 1-16
Comment ICMP-00008, Kerr-McGee 1-20
Comment ICMP-00009, American Chemistry Council - Titanium Dioxide Panel 1-34
Comment ICMP-00010, Association of Battery Recyclers 1-43
Comment ICMP-00011, OxyChem 1-47
Comment ICMP-00012, National Mining Association 1-48
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Comment ICMP-00001, Chemical Products Corporation
Comment 1-1: CPC fully agrees with EPA's conclusion as stated in the Federal Register
proposed rule, "We have evaluated the wastes, waste management practices, and potential
risk exposure pathways associated with the barium carbonate production processes and
propose not to list any wastes from this industry as hazardous under Subtitle C of RCRA.
Some wastes in this industry are D002 or D005 characteristic hazardous wastes, which are
both currently subject to RCRA Subtitle C regulation and managed in compliance with those
regulations. For other wastes, not identified as characteristic hazardous wastes, we have
identified no risks of concern associated with the current management of these wastes that
would warrant listing. These wastes do not meet the criteria listed under 40 CFR
261.11 (a)(3) for listing a waste as hazardous." CPC does, however, wish to request
corrections, clarifications, and explanations of some of the text in this section.
Response 1-1: EPA acknowledges CPC's support of the proposed rule.
Comment 1-2: We believe that EPA was incorrect in referring to the AWQC for selenium as
a "standard" twice in this FR notice; both occurrences were in the paragraph addressing the
treated barium wastes from Chemical Products Corporation. EPA stated, "In addition, we
found only one exceedence of AWQC standards among the SPLP leaching data for treated
barium wastes. Selenium was found at a level of 0.04-0.06 mg/L, which exceeds the
AWQC standard (0.0050 mg/L) by a factor of 8 to 12." AWQCs are not "standards"; they
have not been issued by EPA under the Administrative Procedure Act. The drinking water
standard for selenium is 0.05 mg/l. Both the MCL and the MCLG for selenium are 0.05
mg/l, thus the level found in the SPLP extract from the barium leaching waste is at the level
of the drinking water standard.
EPA should specifically retract the references to the AWQC as a "standard" and fully explain
AWQCs in this notice by citing statements found in other EPA documents. We suggest that
the statements, "These water quality criteria are not regulations and do not impose legally
binding requirements on EPA, States, Tribes or the public." (EPA 822-Z-99-001, National
Water Quality Criteria - Correction, April 1999). and "Section 304(a) of the Clean Water
Act, 33 U.S.C. 1314(a)(1), requires the Environmental Protection Agency (EPA) to publish
and periodically update ambient water quality criteria. These recommended criteria provide
guidance for States and Tribes in adopting water quality standards under section 303(c) of
the CWA" (EPA-822-F-98-006, Compilation of National Recommended Water Quality
Criteria and EPA's Process for Deriving New and Revised Criteria, December 1998).
Response 1-2: We agree with the commenter's clarification of the status of the AWQC. We are
providing the following clarification the preamble: The Agency mistakenly referred to a selenium
"standard" (0.0050 mg/L) in the barium carbonate section of the preamble for the proposed rule.
This selenium level is more appropriately referred to as EPA's recommended Ambient Water
Quality Criteria (AWQC) for protection of freshwater organisms from chronic effects (63 FR
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68353 as corrected at 64 FR 19781). EPA issues the criteria for selenium and other constituents
under the authority of the Section 304(a) of the Clean Water Act (CWA), 33 U.S.C. 1314(a)(l).
These recommended criteria provide guidance for States and Tribes in adopting water quality
standards under section 303(d) of the CWA (EPA-822-F-98-006, Compilation of National
Recommended Water Quality Criteria and EPA's Process for Deriving New and Revised Criteria,
December 1998).
Comment 1-3: CPC requests that EPA present a Health Based Limit (HBL) for selenium in
concert with the AWQC for selenium as EPA has done elsewhere in this proposed rule when
AWQCs have been presented. Appendix B to the "Barium Carbonate Listing Background
Document for the Inorganic Chemical Listing Determination" in the docket for this proposed
rule shows a "Health Based Limit: drinking water ingestion" for selenium of 0.078 mg/L and
an "AWQC: Human Health" for selenium of 0.17 mg/L in addition to the AWQC cited in the
text of this proposed rule. The selenium concentration in the SPLP leachate from CPC's
treated barium waste is well below these health-based values.
Response 1-3: We have decided not to list barium carbonate wastes. Therefore, the fact that
CPC's waste may be below the FffiL for selenium has no impact on our RCRA listing decision and
we are taking no position on this issue in today's rulemaking.
Comment 1-4: It is our understanding that the AWQC for selenium is being reviewed and is
likely to be revised in the near future. If this is the case, we ask that EPA specifically state
that the AWQC for selenium is under review and may be changed, as was done in "National
Water Quality Criteria - Correction, April 1999" in reference to the selenium GLI.
Response 1-4: The Agency plans to issue a draft revision of the selenium AWQC for peer review
and public comment in March 2002. The Agency plans to issue the final revision in April 2003.
Comment 1-5: Even though the RED for selenium presented in EPA's IRIS database is nearly
a decade old, it appears to us to be well-considered and based upon sound science. A
human "No Observed Adverse Effect Level" was identified and then this value was divided by
a factor of 3 to protect sensitive populations.
A preliminary review of the recently-published information concerning selenium, however,
indicates that selenium intakes at, or above, the RfD may be beneficial to human health.
This element appears to be unusual in that the essential concentration in the human diet and
the concentration at which mild toxicity (garlic breath and deformation of finger and toe nails)
occurs are quite close (Navarro-Alarcon et al., 2000). Human health appears to suffer as
chronic selenium intake levels decline.
In EPA's periodic update of ambient water quality criteria for selenium, we ask that EPA
carefully review recent information showing supplementation with selenium appears to boost
cell-mediated immune responses in addition to protecting against oxidative damage. Both
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animal and epidemiological studies have indicated that selenium could constitute a dietary
factor with protective action against cirrhosis, cancer, diabetes, and cardiovascular
pathologies (Navarro-Alarcon et al., 2000; Hughes, 1999). Human studies have linked
increased selenium intake to a reduction in respiratory tract infections (Girodon et al., 1999)
and an improvement in asthma control (Godden et al., 1999). Beck et al. (1998)
demonstrated that selenium-deficient mice infected with the coxsackievirus B3 developed an
increased myocarditis compared with adequately fed mice. The deficiency in selenium was
associated with a conversion of the virus from a benign to a virulent strain.
Response 1-5: We have decided not to list barium carbonate wastes. Therefore, the fact that the
new studies may suggest that a less stringent HBL is appropriate is not relevant. We have already
determined that the selenium in these wastes presents no significant risks under the current HBL.
In addition, a revision to the ambient water quality criteria is well beyond the scope of this
rulemaking.
Comment 1-6: In explaining why selenium levels in the SPLP extract from barium carbonate
production waste equal to the drinking water standard are not of concern, EPA states in the
FR proposed rule, "Given the distance over which leachate from the treated barium wastes
would need to travel before reaching the river, dilution and attenuation during transport in
local groundwater, and further dilution in the Etowah River, we believe the levels of selenium
in the leachate would decrease to a level which would no longer pose a risk to the
environment." We ask that EPA present specific evidence confirming this assertion. The test
well sampled by EPA in June, 1999 immediately downgradient from the landfill in question
exhibited a much lower selenium concentration in the groundwater than the SPLP extract from
the treated barium carbonate leaching waste; selenium was found at the much lower
concentrations of 0.03 mg/l in unfiltered water and 0.01 mg/l in filtered water collected
from the down-gradient test well. This information clearly demonstrates the accuracy of EPA's
conclusion.
Response 1-6: Our conclusions, which were described in the preamble to the proposal, were made
based on our expert judgement of the facts involved. No modeling was conducted.
Comment 1-7: The AWQC information relating to selenium in "National Water Quality
Criteria - Correction, April 1999" includes several footnotes. Two of the footnotes are: "L -
The CMC = 1/[(f1/CMC1) + (f2/CMC2)] where f1 and f2 are the fractions of total selenium
that are treated as selenite and selenate, respectively, and CMC1 and CMC2 are 185.9
ug/l and 12.83 ug/l respectively", and "R- This value was announced (61 FR
58444-58449, November 14, 1996) as a proposed GLI 303(c) aquatic life criterion. EPA
is currently working on this criterion and so this value might change substantially in the near
future."
As shown in footnote "L" quoted above, the lower oxidation state for selenium has a much
higher CMC than the higher oxidation state (if all of the selenium is present as selenate, the
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CMC is 12.83 ug/l, whereas if all of the selenium is present as selenite, the CMC is 185.9
ug/l - more than 14 times higher). Since CPC's barium carbonate leaching waste results
from a process conducted in a reducing environment, all of the selenium present would be
expected to be in the lower oxidation state rather than the higher one. We believe that the
likelihood of selenium being present in the lower oxidation state should be mentioned as
further evidence that the level of selenium found in the SPLP of CPC's barium carbonate
waste poses no risk to the environment.
Response 1-7: We have decided not to list barium carbonate wastes. Therefore, the fact that the
selnium may have a lower oxidation state in the environment at the commenter's facility is not
relevant. We have already determined that the selenium in these wastes presents no significant
risks.
Comment 1-8: We further wish to bring to your attention a minor typographical error in this
proposed rule. This proposed rule contains the statement, "The barite ore feedstock facility
also produces molten sulfur or sodium hyposulfate from hydrogen sulfide gas piped from the
barium carbonate manufacturing process." We produce sodium hydrosulfide rather than
sodium hyposulfate
Response 1-8: We acknowledge the correction. However, it has no relevance to our proposed
and final decision not to list any barium carbonate wastes.
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Comment ICMP-00002, Monsanto
Comment 2-1: Specifically, we support and are in full agreement with the agency's
determination for not listing any wastes from the Phosphorus Trichloride process as
hazardous wastes. The agency has performed a detailed analysis of the wastes generated
from the Phosphorus Trichloride process and has confirmed our long standing believe that
our Phosphorus Trichloride process wastes do not meet the criteria set out at 40 CFR
261.11 (a)(3) for listing a waste as hazardous. We agree that they do not pose any risk of
concern associated with the current management of these wastes.
Response 2-1: EPA acknowledges Monsanto's support of the proposed rule.
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Comment ICMP-00003, Chemical Products Corporation
Comment 3-1 a: Chemical Products Corporation (CPC) believes that, in the case of
manganese, EPA has not met the requirements for placing a substance in Appendix VII and
Appendix VIII. Specifically, CPC believes that sound science demonstrating that manganese
in waste presents a hazard to human health or the environment is lacking.
EPA's IRIS database bases its Oral Reference Dose determination on "many large
populations consuming normal diets over an extended period of time with no adverse health
effects." (quoted from the manganese Substance File). These data represent only a lower
bound on safe dose because a "lowest observed adverse effect" dose could not be identified.
Quoting the IRIS Substance File again, "While several studies have determined average
levels of manganese in various diets, no quantitative information is available to indicate
toxic levels of manganese in the diet of humans. Because of the homeostatic control
humans maintain over manganese, it is generally not considered to be very toxic when
ingested with the diet."
The document written by ATSDR personnel, Johnson and DeRosa (1997), included with these
comments, characterizes the sound science relating to manganese toxicity as consisting of
four studies; all four of these studies are inhalation studies rather than oral ingestion studies.
They state ATSDR-identified research needs for manganese as "a) Dose-response data for
acute- and intermediate-duration oral exposures (the subchronic study should include
reproductive histopathology and an evaluation of immunologic parameters including Mn
effects on plaque-forming cells (SRBC), surface markers (D4:D8 ratio), and delayed
hypersensitivity reactions, b) Toxicokinetic studies on animals to investigate uptake and
absorption, relative uptake of differing Mn compounds, metabolism of Mn, and interaction
of Mn with other substances following oral exposure, c) Epidemiologic studies on the health
effects of Mn (special emphasis end points include neurologic, reproductive, developmental,
immunologic, and cancer)". In the June 22, 1996 Federal Register (61 FR125), at page
33517, ATSDR provides only a chronic inhalation Minimal Risk Level (MRL) for manganese
in the table of MRL values presented there. The July 30, 1997 Federal Register (62FR146),
at page 40827, details the same research needs in describing the ATSDR Substance-Specific
Applied Research Program; it also identifies needed research relating to manganese
exposure including, "Relative bioavailability of different manganese compounds and
bioavailability of manganese from soil." Thus, we can only conclude that ATSDR has
determined that there are no existing scientific studies demonstrating the toxic, carcinogenic,
mutagenic or teratogenic effects of oral ingestion of manganese on humans or other life
forms.
Response 3-1 a: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
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Comment 3-1 b: An Oral Reference Dose contained in EPA's IRIS database be based upon
studies that determine a "Lowest Observed Adverse Effect Level" in conjunction with a "No
Observed Adverse Effect Level". This is not the case for the manganese substance file. The
IRIS manganese substance file includes the statement, "Donaldson (1987) provides a
summary of this documented toxicity of manganese to humans, which has been primarily
limited to workers exposed by inhalation. In contrast to inhaled manganese, ingested
manganese has rarely been associated with toxicity." Inhalation of manganese in the
workplace has been studied; this form of manganese and route of exposure are specific to
particular occupational environments.
EPA's IRIS Substance File for manganese further states, "it is also recognized that manganese
uptake and elimination are under homeostatic control, generally allowing for a wide range
of dietary intakes considered to be safe." This is supported by Greger (1999) who states,
"Manganese balance and excretion data are not useful biomarkers of manganese exposure
but demonstrate that the body is protected against manganese toxicity primarily by low
absorption and/or rapid presystemic elimination of manganese by the liver."
Response 3-lb: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 3-1 c: Although toxicity has not been demonstrated in infants, the IRIS Substance
File expresses concern for infants fed formula that may have a higher concentration of
manganese than human milk. A report by Kawamura et al. (1941) is the only epidemiologic
study describing toxicologic responses in humans consuming large amounts of manganese
dissolved in drinking water. The most severe symptoms were observed in adults, while
children appeared to be unaffected. This argues against the assumption that infants might
be more susceptible to high oral doses of manganese.
Response 3-1 c: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 3-2: In light of the lack of a sound scientific basis for this proposed rulemaking,
CPC respectfully requests that EPA withdraw its proposal to place manganese on Appendix
VII and Appendix VIII in 40 CFR 261, and also withdraw its proposal to establish a Universal
Treatment Standard for manganese.
[note: see original comment for attachments]
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Response 3-2: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
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Comment ICMP-00004, American Chemistry Council
Request for Comment Period Extension
On behalf of the members of the American Chemistry Council1, I am requesting that you
formally extend the comment period on the recently proposed Inorganic Chemical
Manufacturing Wastes listing determination2 for 30 days, to December 13, 2000.
In the September notice, the Agency proposes to add manganese to RCRA Appendix VII and
Appendix VIII as well as establish wastewater and nonwastewater LDR treatment standards
for the metal. Most important to ACC members would be the addition of manganese to the
list of Universal Treatment Standards and F039 multi-source leachate.
Including manganese in the RCRA program could have significant effects on ACC members.
Because of its presence in catalysts and in steel reaction vessels and piping, many
operations may unexpectedly find manganese in their wastestreams at levels identified in the
proposal. In addition, since manganese, much like iron, is a common element in nature and
its chemical fate depends on the acidity and redox conditions of the surroundings,
identification of manganese as a hazardous constituent could have serious ramifications for
remediation - regardless of whether the manganese originates in the remediation waste or
the natural environment.
Since the proposal to include manganese was buried in a very process-specific notice, we
are only beginning to assess the potential effect of this proposal on operations outside
inorganic chemical manufacturing. Several companies and industries, until recently unaware
of the inclusion of manganese, are evaluating the potential effects of the proposal. Others
are collecting data on manganese toxicity to assess the justification for its inclusion and the
validity of the specific levels proposed.
n~he American Chemistry Council represents the leading companies engaged in the
business of chemistry. Council members apply the science of chemistry to make innovative
products and services that make people's lives better, healthier and safer. The Council is
committed to improved environmental, health and safety performance through Responsible
CareŽ, common sense advocacy designed to address major public policy issues, and health
and environmental research and product testing. The business of chemistry is a $435 billion
enterprise and a key element of the nation's economy. It is the nation's largest exporter,
accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more
in research and development than any other business sector.
Hazardous Waste Management System; Identification and Listing of Hazardous
Waste: Inorganic Chemical Manufacturing Wastes; Land Disposal Restrictions for Newly
Identified Wastes; and CERCLA Hazardous Substance Designation and Reportable
Quantities. 65 FR 55684, September 14, 2000.
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We recognize that EPA is under court order to finalize the inorganic listing determination by
October 31, 2001. We have no interest in causing EPA to miss that deadline. However,
we cannot support EPA finalizing listing determinations that have not been carefully
considered.
Response 4-1: EPA denied ACC's request for an extension of the comment period on November 6,
2000. However, we are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
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Comment ICMP-00005, DuPont
Request for Comment Period Extension
On behalf of E.I. du Pont de Nemours and Company ("DuPont"), this letter requests a thirty
(30) day extension of the public comment period -- to December 13, 2000 -- on EPA's
recent proposed K178 listing of wastes from the production of titanium dioxide by the
chloride-ilmenite process. 65 Fed. Reg. 55,684 (Sept. 14, 2000). This brief extension is
essential in order for DuPont to comment meaningfully on EPA's proposal. The basis for this
request is summarized below.
Since the proposal was published six weeks ago, DuPont has been actively engaged in
reviewing the proposal and developing detailed technical comments for submission to EPA.
DuPont has met twice with your staff since the proposal date -- once on October 6 for a
clarification of certain issues and again on October 26 for a technical discussion of certain
waste streams proposed for listing. Given the number of important issues raised by the
proposal, DuPont's comments are likely to be extensive.
DuPont is actively engaged in an extensive data collection effort In order to provide EPA with
meaningful comments on the proposed K178 listing. Although DuPont expects to be able to
submit partially validated results by the current deadline of November 13, the data
validation process will likely continue for another 2-3 weeks beyond that date. Thus, the
requested brief extension to December 13, 2000 will allow the orderly submission and
consideration by EPA of fully validated analytical results for constituents of concern.
DuPont acknowledges and appreciates the recent agreement by your staff to consider data
submitted by November 13 for which data validation results will be completed and
submitted some time after November 13. The requested brief extension of the comment
period to December 13 will further insure that the data are submitted in the most
appropriate and useful format, which in turn will help conserve EPA resources.
Finally, EPA's proposal is based on the results of its risk assessments using the "EPACMTP"
computer model to predict the fate and transport of various constituents from the facilities
that would be affected by the proposed new K178 listing. 65 FR 55698-99, 55762. It is
essential that DuPont be able to review this model, and use it to evaluate new data that
DuPont is in the process of obtaining, using the same methodology that EPA used in
developing the proposed rule. To date, however, despite DuPont's previous requests,
DuPont has been unable to obtain the EPACMTP computer files from EPA and thus has been
unable to review and evaluate this model. Although your staff agreed to provide to portions
of the EPACMTP model by October 31, 2000, this will leave DuPont precious little time to
perform the required modeling and properly assess this particular model in the context of
DuPont's facilities. Thus, the requested brief extension of the public comment period, up to
and including December 13, 2000, is essential to allow adequate opportunity for DuPont to
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complete necessary review of the model and evaluate newly acquired data towards
providing EPA with meaningful comments.
Response 5-1: EPA denied DuPont's request for an extension of the comment period on November
6, 2000.
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Comment ICMP-00006, Lead Industry Association
Introduction: The following comments are submitted on behalf of Lead Industries
Association, Inc. (LIA), a not-for-profit association of producers and industrial consumers of
lead and lead products. LIA appreciates the opportunity to submit these comments on EPA's
proposal to amend RCRA classifications for hazardous waste. For reasons identified below,
LTA objects to EPA's proposal to add manganese to the list of hazardous constituents in
Appendix VIII of Part 261, and requests additional time to review the proposal so that LIA
can have a meaningful opportunity to comment.
Comment 6-1: In its proposal, EPA seeks to add manganese to the list of hazardous
constituents in Appendix VIII "based on scientific studies that demonstrate manganese has
toxic effects on humans and other life forms." (65 FR 55687). This listing would establish a
new Universal Treatment Standard (UTS) level for non-wastewater wastes of 3.6 mg/liter,
which would apply to slag, a characteristic waste produced by secondary lead smelter
members of LIA. However, by its own admission, EPA lacks studies demonstrating treatment
effectiveness for highly concentrated manganese non-wastewaters. 55 FR 55768. In fact,
EPA relies on a single sample from one waste stream to arrive at that value. This is
insufficient data to support the proposed treatment standard, and EPA needs to take a closer
look at available studies or conduct additional studies to arrive at a more reasoned
decision. Thus, LIA objects to the addition of manganese as a hazardous constituent on the
ground that there has been insufficient analysis of this issue and on the proposed treatment
standard for manganese nonwastewater wastes.
Response 6-1: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 6-2: LIA also requests an extension to submit further comments on the proposed
amendments. The widespread potential impact of these amendments on the lead industry or
other industries is not evident from the title of the proposed amendments nor from the
summary pages, and LIA learned only recently of any potential impacts. In fact, the
implications for the lead industry are not clear even after a thorough review of the entire rule,
despite the fact that the lead industry is mentioned several times within the proposal. What
is clear is that EPA did not provide adequate notice of this rule to all potential stakeholders.
EPA exacerbates this problem by stating that it plans to use the list of commenters on the
manganese issue "as the only individuals notified of potential changes to this proposed
treatment standard." 65 FR 55768. Had LIA not been alerted to this important issue, it may
never have had future opportunity to comment on changes to this manganese limit. A
similar problem exists with respect to the proposed listing of antimony oxide wastes, which
may have substantial impacts on lead smelters.
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Response 6-2: EPA denied LIA's request for an extension of the comment period. However, we
are deferring final action on all elements of our proposal that are specifically related to the waste
constituent manganese. Please see section IV.B of the preamble to today's final rule for a further
discussion of our decision to defer final action on manganese-related elements of the proposed
rule.
In addition, EPA clarifies in the preamble to the final rule that the listing will not apply to slag
generated by secondary lead smelters, even if those smelters use materials from antimony oxide
facilities as inputs. Therefore, the antimony oxide listing decisions will not impact lead smelters.
Finally, EPA points out that it routinely publishes notices of proposed rulemaking focused on
listing determinations for wastes from a particular industry or grout of industries. Any of these
notices has the potential to affect other industries. EPA is not required to extend comment periods
because such impacts are possible.
Comment 6-3: Further, LIA would like an opportunity to comment on EPA's failure to apply
the MINTEQA2 model in its proposal. EPA based its decision not to use MINTEQA2
because "a number of technical issues have been raised concerning the model and its
application." 65 FR 55698. However, EPA does not identify those technical issues in its
proposal. It is important that stakeholders have the opportunity to comment on EPA's
decision and address the "technical issues" that may exist under the MINTEQA2 model.
Response 6-3: See our response to comment 12-8.
Comment 6-4: Thus, to allow a meaningful opportunity to review the proposal and
determine the potential impacts on the lead industry, LIA requests an additional 30 days to
submit comments on this proposal, including any other issues that may be found to have an
impact on the lead industry. In the event that EPA does not grant additional time to
comment now or a further opportunity to comment at a future date, LIA submits that EPA has
not provided sufficient evidence to justify the proposed listing of manganese as a hazardous
waste.
Response 6-4: See our response to comment 6-2 above.
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Comment ICMP-00007, Color Pigments Manufacturers Association
Introduction: I am writing on behalf of the Color Pigments Manufacturers Association. Inc.
(the "CPMA") to comment on the Proposed Rule, Identification and Listing of Hazardous
Waste, Inorganic Chemical Manufacturing Wastes, Land Disposal Restrictions for Newly
Identified Wastes and CERCLA Hazardous Substance Designations, 65 FR 55684,
September 14, 2000 (the "Proposed Rule"). The CPMA is an industry trade association
representing color pigment companies in Canada, Mexico, and the United States. CPMA
represents small, medium, and large color pigments manufacturers throughout Canada,
Mexico and United States, accounting for 95% of the production of color pigments in North
America.
Color Pigments are widely used in product compositions of all kinds, including paints, inks,
plastics, glass, synthetic fibers, ceramics, colored cement products, textiles, cosmetics, and
artists' colors. Color pigments manufacturers located in other countries with sales in
Canada, Mexico and the United States, and suppliers of intermediates to the color pigments
industry are also members of the Association.
Our Industry is very much concerned with the addition of manganese as a hazardous waste
constituent for all characteristic wastes with Universal Treatment Standards. The following
comments will address this issue and our support for EPA's decision to not list production
waste from cadmium pigment manufacturing.
Comment 7-1: Cadmium Pigments
The CPMA supports EPA's decision not to list production wastes from the production of
cadmium pigments as hazardous. The current management methods in place for processing
cadmium pigments related production wastes is protective of both the environment and
human health. These existing management systems should not be compromised by
additional restrictions which would not in any way, provide greater protection for the
environment.
Additional waste restrictions in this industry will only act to further encourage manufacturing
to move away from the United States. Nowhere is this trend away from the United States
more evident than the cadmium pigments industry where only one U.S. Manufacturer
remains in business.
Response 7-1: EPA acknowledges CPMA's support for the rulemaking.
Comment 7-2: Manganese Listing as a Hazardous Constituent
EPA solicits comments on the listing of manganese as an underlying hazardous ingredient
with a new Universal Treatment Standard ("UTS") and the impact such a listing may have on
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other wastes. The listing of manganese as a hazardous waste constituent with a UTS
appears wholly unfounded in the Proposed Rule. The preamble to the Proposed Rule
contains only conclusory statements without even reasonable references for substantiating
EPA's decision. EPA's statement that,
"The volume of wastes for which additional treatment is needed solely due to the
addition of manganese to the F039 and UTS lists are therefore expected to be very
small."55 FR 55771
would indicate that EPA has not substantiated a significant risk from the presence of
manganese in some characteristically hazardous wastes. Indeed, EPA fails to quantify or
identify any such characteristic waste. Nor does EPA quantify a significant risk posed by such
a waste in the preamble to the Proposed Rule. Additionally, EPA has not justified the
assumption that other wastes which may contain manganese have the same or similar
properties associated with the titanium dioxide production waste assessed in the Proposed
Rule.
Manganese is an essential nutrient believed critical for normal growth, bone formation and
reproduction. Since manganese is an essential human nutrient, some background level and
regular intake of this metal is required for good health. EPA fails to analyze in the preamble
any cogent rationale for the assumptions that the manganese which may be present in the
waste proposed for listing poses a significant threat to health or the environment above
background levels when treated or disposed of in its current manner.
Furthermore, the most recent "Toxicological Profile for Manganese and Compounds",
published by the Agency for Toxic Substances and Disease Registry "ATSDR"), reviews in
detail hundreds of studies in humans, animals and the environment involving manganese.
The conclusions from all of these studies provide no evidence for manganese toxicity at low
exposure levels, such as those which might be associated with the very low concentrations of
manganese envisioned by EPA's universal treatment standard.3
With respect to bioaccumulation and bioconcentration, the ATSDR manganese profile states:
3ln EPA's Integrated Risk Information System, Principle and Supporting Studies file on
Manganese, the "...EPA concludes that an appropriate reference dose for manganese is 10
mg/day (0.14 mg/kg-day). In applying the reference dose for manganese to a risk
assessment, it is important that the assessor consider the ubiquitous nature of manganese,
specifically that most individuals will be consuming about 2-5 mg Mn/day in their diet. This
is particularly important when one is using the reference dose to determine acceptable
concentrations of manganese in water and soils." In the same report, the EPA cites the World
Health Organization (WHO, 1973), when it "...concluded that 2-3 mg Mn/day is adequate
for adults and 8-9 mg/day is 'perfectly safe.'"
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"In general, these data [BCF Values] indicate that lower organisms such as algae
have larger BCFs than higher organisms. Thus, biomagnification of manganese in
the food chain does not appear to be significant (EPA 1984a)." ATSDR p. 77, Chapt.
5, Potential for Human Exposure, (1992)
Moreover, in setting a very restrictive total concentration treatment level for manganese in
characteristic wastes, EPA ignores the wide variations in metal solubility which can occur in
various compounds. Many compounds may contain manganese as an integral component
yet exhibit extremely low bioavailability and solubility in the environment. In setting a total
concentration standard EPA ignores this basic fact of chemistry. If a compound does not
yield bioavailable manganese, the compound cannot be toxic as a result of manganese and
EPA's risk model for manganese as applied to that low soluble compound cannot be correct.
Additionally, as noted in the ATSDR, many manganese compounds are readily adsorbed in
many environmental media including natural salts, organic material and clays. As a result,
these compounds remain immobile in the environment. The ATSDR states:
"In some cases, adsorption of manganese to soils may not be a readily reversible
process. At low concentrations, manganese may be "fixed" by clays, and will not be
released into solution readily (Reddy and Perkins 1976)." ATSDR p. 77.
With respect to manganese in the environment, EPA also fails to substantiate that
manganese has ever represented a problem which requires additional regulation to solve.
In short, EPA appears to have created a solution in search of a problem. For instance the
ATSDR states with respect to manganese levels in the ambient environment that:
"These data indicate that concentrations [of manganese] in all areas have tended to
decrease over the past three decades (EPA 1984a; Kleinman et al. 1980)." ATSDR p.
78, section 5.4.1
Manganese is also an important component of most foods. Levels may rise to as high as 4
parts per million in milk products, meats, fish and eggs. Infant formulas may contain up to
1000 parts per billion manganese. (ATSDR p. 80 section 5.4.4) We find no rationale in the
Proposed Rule which would explain EPA's decision to set waste treatment levels at
concentrations below those which are common in the food supply.
Response 7-2: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
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Comment 7-3: With respect to the economic impact of the proposal to list manganese as a
universal treatment constituent for characteristic wastes, the time allowed for comment on
this Proposed Rule would not allow our members to complete such an analysis. It is clear
however, that EPA has not even started to make a rational analysis of the impact of this
proposal. EPA states that:
"EPA does not anticipate that waste volumes subject to treatment for F039 or
characteristic wastes would significantly increase because waste generators already
are required to comply with the treatment requirements for other metals that may be
present in the wastes. The volumes of wastes for which additional treatment is
needed solely due to the addition of manganese to the F039 and UTS lists are
therefore expected to be very small." 65 FR 55771/3
This statement can only lead the reader to conclude that EPA has not investigated likely
consequences of this proposal on business. Indeed, EPA has no actual knowledge of the
waste quantities or treatment requirements impacted as a result of the Proposed Rule.
Response 7-3: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 7-4: Therefore, we request that EPA withdraw its designation of manganese as a
hazardous waste constituent.
Response 7-4: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
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Comment ICMP-00008, Kerr-McGee
Comment 8-1: Kerr-McGee Chemical LLC ("Kerr-McGee") hereby submits these
supplemental comments to its separately submitted comments on Detection of CDDs and
CDFs and Possible Re-assessment of Bevill Exemption Status.
In those comments, Kerr-McGee objected for various technical reasons to EPA's use of
sampling data for CDDs and CDFs with respect to titanium dioxide production from the
chloride process. In order to be able to investigate and comment upon this subject further,
KerrMcGee requested in writing from EPA that the agency provide the chain-of-custody report
for the CDD/CDF sample and field blank for Kerr-McGee's Hamilton, Mississippi plant. As
of today's date marking the close of the comment period. EPA has not provided this report to
Kerr-McGee, nor has it been placed in the administrative record. Kerr-McGee believes that
the unavailability of this report constitutes a further reason, in addition to those cited in its
other comments, why EPA should not use these data in any way.
Response 8-1: Kerr McGee received the chain-of-custody sheets on November 13, 2000, for the
samples and field blank collected at its Hamilton, Mississippi plant for the CDD/CDF analysis.
See Kerr McGee's Comment ICMP-L0002. The chain-of-custody sheets have been added to the
revised Sampling and Analysis Data Report for Kerr McGee which is available in the docket for
today's rule.
Comment 8-2: Summary of Comments
EPA correctly proposes not to list any wastes from the titanium dioxide chloride process as
hazardous wastes.
EPA incorrectly describes the manufacturing process employed in titanium dioxide chloride
process. EPA incorrectly refers to recycled vanadium-containing material as a waste. In
addition, EPA improperly assesses Bevill-exempt vanadium-containing waste for hazardous
waste listing purposes.
Response 8-2: EPA acknowledges Kerr McGee's support for the rule. See our response to
comment 22-3.
Comment 8-3: EPA Proposed Listing Decision
Kerr-McGee supports EPA's proposal not to list as hazardous wastes any of the wastes from
the titanium dioxide chloride process. Kerr-McGee agrees with EPA's determination that
hazardous waste listing is not warranted for these wastes.
Response 8-3: EPA acknowledges Kerr McGee's support for the rule.
Comment 8-4: Corrections Regarding the Titanium Dioxide Chloride Process and Wastes
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Kerr-McGee owns and operates two titanium dioxide chloride process plants. One is
located in Hamilton, Mississippi, and the other, which Kerr-McGee acquired from Kemira, is
located in Savannah, Georgia. Based on its knowledge of these plants and its reading of
the Proposal and Background Document, in light of EPA's April 1998 Final Technical
Background Document: Identification and Description of Mineral Processing Section and
Waste Stream (the "Identification Document")4, Kerr-McGee requests that EPA correct a few
errors in how the process and wastes are described. These corrections do not affect EPA's
ultimate determination not to list any chloride process wastes as hazardous wastes.
Comment 8-4a: Vanadium Waste
In the Proposal, EPA describes and assesses "vanadium waste" from the chloride process.5
65 FR 55748-50. The Proposal describes vanadium oxychloride as a volatile metal
compound that exits the chlorination as "overhead vapor" in the gaseous product stream. It
describes the removal of vanadium compounds in the purification process by complexing
with mineral oil and reducing with hydrogen sulfide or by complexing with copper. It also
describes vanadium waste as being returned to the reaction area for TICI4 recovery with
remaining vanadium wastes incorporated in solids streams. A somewhat similar description
of what is called "vanadium sludge" appears in the Background Document on pages 6 and
70. The 1998 Identification Document describes the removal of "spent vanadium
oxychloride" on page 676, and the process flow diagram on page 669 shows the removal of
vanadium oxychloride from a step called "chemical treatment" and going to some
unidentified location. No process flow diagram appears in the Background Document. The
Proposal, Background Document and Identification Document all refer to this vanadium
stream as a waste, and the Proposal assesses whether to list it as a hazardous waste.
EPA's chloride process description with respect to vanadium in these three documents is
erroneous and needs to be corrected by EPA. EPA has incorrectly described material which is
being recycled as a waste and has incorrectly assessed for hazardous waste listing purposes
vanadium-containing wastes which are within the Bevill exemption, and therefore not subject
to a hazardous waste listing determination.
Contrary to what the Proposal, the Background Document and the Identification Document
indicate, there is no separate vanadium waste stream in the chloride process. The
Background Document contains no sample of this waste stream for the chloride process
4The Identification Document was prepared in connection with EPA's Phase IV Land
Disposal Restrictions, 63 FR 28555 (May 26, 1998).
5EPA also describes and assesses vanadium waste from the chloride-ilmenite process.
Kerr-McGee makes no comment on that process.
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because no such waste exists.6 Like other metal chlorides, vanadium oxychlorides are
removed from the chloride process via the cyclone.7 As illustrated by the attached chloride
process flow diagram, vanadium oxychlorides are a part of the stream that is recycled from
TICI4 purification to TICI4 condensation for the further recovery of titanium values.8 This is a
closed, internal recycle stream, and it is not a waste.
As the process flow diagram further illustrates, vanadium oxychlorides are also present in the
"crude liquid TiCI4" recycle stream that goes from TiC14 condensation to the crossover. This
recycle stream has two functions. First, it cools the gaseous product stream from the reactor
allowing unreacted solids to be removed from the product stream in the cyclone that exists
between the cross-over and TICI4 condensation.9 Second, it allows for the further recovery of
titanium values. The crude liquid TICI4 stream is also an internal, closed recycle stream,
and not a waste.
Notwithstanding the incorrect depiction of the vanadium waste stream in the 1998
Identification Document, there is no separate vanadium waste stream, and vanadium-
containing solids exiting the cyclone have always been part of the Bevill exempt chloride
process solids from titanium tetrachloride production. The inclusion of vanadium-containing
wastes within this Bevill exemption is demonstrated graphically and perhaps most clearly by
Exhibit 13-2 in EPA's July 1990 Report to Congress on Special Wastes from Mineral
Processing, a copy of which is attached hereto. This drawing shows that waste solids from
chlorination/purification of titanium bearing ores to produce titanium tetrachloride is special
mineral processing (Bevill) waste.
The application of the Bevill exemption to vanadium-containing waste is also confirmed by
the fact that it is generated during titanium tetrachloride production. As noted in the
Proposal, the Bevill exemption applies to chloride process solids from the production of
titanium tetrachloride. 65 FR 55750-51. Indeed, EPA has drawn a bright line between the
Bevill-exempt solids from titanium tetrachloride production and the non-exempt solids
6The Background Document refers to a vanadium sludge generated at the Hamilton
plant. Kerr-McGee knows of no such waste stream.
7These wastes are part of what is referred to as "chlorinator solids" (RIN 6) and (RIN 3)
in Table 3.34 of the Background Document.
8Because vanadium oxychlorides and TICI4 have similar boiling points, mineral oil is
used to concentrate vanadium oxychlorides because these compounds are more soluble
than TICI4 in this medium.
9EPA's process descriptions repeatedly omit this cyclone which remove the non-volatile
metal chlorides and unreacted coke and ore from the gaseous product stream as described
in the Proposal. 65 FR 55748.
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generated after titanium tetrachloride is produced as a saleable mineral product. See 65 FR
55750, quoting 54 FR 366211. Hence, as a titanium tetrachloride production waste,
vanadium-containing waste is Bevill-exempt.
While EPA has indicated that vanadium wastes are not Bevill-exempt in the Proposal and the
Background Document, that indication appears to be based on an erroneous process
description appearing in the Identification Document which has carried over into these two
documents. This error should be corrected,10 but it does not effect a narrowing of the Bevill
exemption, because EPA emphasized in the current rulemaking as in the Land Disposal
Restriction Phase IV rulemaking that it is not intending to modify the scope of the Bevill
exemption via these rulemakings or the support documents. See 65 FR 55688 ("We
emphasize that we are not reopening any Bevill decisions made in earlier actions regarding
the Bevill exemption.") and 63 FR 28584. Furthermore, EPA has noted that the Identification
Document provides guidance but is not legally binding. 63 FR 28593.
It was erroneous for EPA to have assessed vanadium-containing wastes for hazardous waste
listing purposes. As EPA notes in the preamble to the Proposal, the consent decree does not
require the agency to make listing determinations for Bevill exempt wastes, and EPA does not
intend to do so in this rulemaking. 65 FR 55689. Because EPA assessed vanadium wastes
from the chloride process, it should make clear in the preamble to the final rule that this was
an error so as to nullify an erroneous interpretation that these vanadium wastes are not
Bevill-exempt.
[see original comment for 2 flow diagrams.]
Response 8-4a: As described further in response to comments 8-2 and 22-3, we acknowledge our
erroneous description of the vanadium stream and are no longer extending the scope of the listing
to incorporate solids associated with this stream. The 1998 Identification Document will be
edited to reflect the change in technical understanding of the titanium tetrachloride process.
Comment 8-4b: Manganese Wastes
EPA incorrectly states that at the Hamilton plant wastes from manganese production are
commingled with wastes from sodium chlorate and titanium dioxide production. Sampling
and Analytical Data Report for Record Sampling and Characterization of Wastes from The
Inorganic Titanium Dioxide Manufacturing Sector, Kerr-McGee Corporation, Hamilton, Plant
page 5, At the Hamilton plant, separate waste treatment systems exist for manganese
production from those for sodium chlorate and titanium dioxide production. This confusion
10ln the Proposal EPA makes a helpful clarification as to Bevill exemption coverage of
solids in gases from the chlorinator in addition to solids removed by the cyclone. See 65 FR
55750-51.
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does not affect EPA's decision not to list these wastes. As EPA notes in the Proposal, the
constituents of these waste streams were addressed in the risk assessments conducted for
either titanium dioxide or for sodium chlorate. See 65 FR 55736 (noting that constituents in
commingled waste streams not assessed for the listing of sodium chlorate wastes were
assessed for titanium dioxide wastes).
Response 8-4b: EPA acknowledges the error we made in the Sampling and Analytical Data
Report for Record Sampling and Characterization of Wastes from the Inorganic Titanium Dioxide
Manufacturing Sector, Kerr-McGee Corporation, Hamilton, Plant page 5. As Kerr McGee
indicated, the error did not affect our decision not to list the wastes. We corrected the error and
placed a revised document in the docket for the rulemaking. Four other places, the preamble
sections III. F. 11. d. (1) and (5) (65 FR 55734 and 55738) and pages 16 and 33 of "the sodium
chlorate listing background document for the inorganic chemical listing determination," where we
describe Kerr McGee's sodium chlorate production and wastes were also examined and we found
no such error.
Comment 8-5: Kerr-McGee Chemical, LLC, ("Kerr-McGee") submits these comments on
EPA's proposed rule published at 65 FR 55683 (September 14, 2000) ("the Proposal").
These comments object to EPA's use of manganese in the risk assessments underlying the
proposed hazardous waste listings, the proposed K178 treatment standard and proposed
universal treatment standard for manganese and the proposed addition of manganese to
Appendices VII and VIII. Kerr-McGee is also submitting separate comments that address
other aspects of the Proposal. The Ferroalloy Association (TFA) also plans comments
regarding manganese and TFA's comments are hereby incorporated by reference.
Response 8-5: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 8-6: The IRIS Oral Reference Dose for Manganese Should Not Be Used in this
Rulemaking
The risk assessment performed by the EPA in the document titled Risk Assessment for the
Listing Determinations for Inorganic Chemical Manufacturing Wastes: Background Document
(USEPA, 2000), utilized the oral reference does (RfD) published for manganese in the
Integrated Risk Information System (IRIS) database. The IRIS RfD is 0.047 mg/kg-day, which
is reached by applying a modifying factor of three to a dose of 0.14 mg/kg-day is not
scientifically supportable, overly conservative and should not be used in this rulemaking.
The Oral RfD documentation was completed during the first half of 1995 and contains no
references subsequent to 1994. Some significant references published before 1994 that
address concerns expressed in the RfD documentation were omitted from that document.
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The Oral RfD value of 0.14 mg/kg-day for the intake of food is based on a reported no
observable adverse effects level (NOAEL) of 10 mg/day. The selection of 10 mg/day as the
NOAEL appears to be based on three studies of dietary intake for manganese. In a 1989
report, the Food and Nutrition Board of the National Research Council (NRC) determined an
"estimated safe and adequate daily dietary intake" (ESADDI) for manganese to be 2 to 5
mg/day. A 1987 study by nutritionists Freeland-Graves et al. suggested a range of 3.5 to 7
mg/day based on human health studies. The third study published by the World Health
Organization (WHO) in 1973 reported the average daily consumption of manganese to
range from 2 to 8.8 mg/day. In this report the WHO concluded that an intake of 8 to 9
mg/day is "perfectly safe".
In a 1996 document, the WHO reported updated dietary intakes for manganese. In that
report the intake range was given as 2 to 20 mg/day. The WHO concluded: "The intake of
manganese can be as high as 20 mg/day without apparent ill effects" (WHO, 1996). The
NRC is currently reviewing dietary reference intakes for various micronutrients including
manganese. As part of this review, the NRC plans to determine "tolerable upper intake
levels" for each nutrient.
The EPA's selection of 10 mg/day as a "NOAEL" appears to be based on the upper end of
dietary intake guidelines rather than being based on an intake that is actually safe for human
consumption with no observable adverse affects. Based on the more recent data published
in the WHO report and the ongoing review by NRC, a NOAEL of 20 mg/day is a more
reasonable intake rate on which to base the RfD.
Important studies subsequent to 1994 (also ignored in the 2000 risk assessment) have been
reported that mitigate the need for a modifying factor. Asjustification for this modifying
factor of 3, in the 5/1 /1996 Reference Dose for Chronic oral exposure to manganese, the
EPA cited four concerns:
1. "There is some evidence of increased uptake of manganese in water by fasted
individuals"
The oral reference dose for manganese is based on chronic human
consumption. This suggestive evidence cited by EPA is more indicative of the
lack of competing cations (Ca+2, Fe+2) in the fasting state than of a different
chemical form of manganese. At any rate, it is highly unlikely that a
significant portion of any individual's drinking water is consumed in the fasting
state (either adults or infants) and therefore this concern over increased uptake
of manganese by fasted individuals irrelevant for a lifetime oral exposure,
which is the basis of the risk assessment.
2. "The study by Kondakis et al 1989 raised the possibility of adverse health effects
associated with lifetime consumption of drinking water containing about 2 mg/L of
manganese."
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Vieregge et al, 199511 reported an ecological cross sectional study of 41
adults with chronic exposure to manganese in their drinking water at up to
2.16 mg/L compared with 74 control subjects with less than 0.05 mg/L
manganese. In addition to standard questionnaires, neurological
examinations and blood tests, Vieregge et al used instrumental testing
including tests for hand tremor and rapidity of motion. No clinical, sub-
clinical or subjective differences attributable to manganese were observed in
this important study. This study used more sensitive tests and did not confirm
the Kondakis et al 1989 study (which found subjective differences
(questionnaire) and hair manganese concentration differences attributed to
manganese but did not perform any sensitive instrumental testing for sub-
clinical movement disturbances). EPA failed to consider the Vieregge et al
study, which discounts this concern raised by EPA, in the 1995 RfD
documentation or the 2000 risk assessment.
3. "Although toxicity has not been demonstrated, there is concern for infants fed formula
that typically has a much higher concentration of manganese than does human milk.
If powdered formula is made with drinking water, the manganese in the water would
represent an additional source of intake."
Stastny et al 198412 demonstrated that, although infant formulas contained
significantly higher manganese levels that human milk, there were no
difference in blood levels manganese levels among infants fed formula
compared with breast fed infants. Lonnerdal 198513, 198914 reported that
relative manganese absorption from breast milk is much higher than from
infant formulas. This was explained by the presence of lactoferrin in human
milk which may facilitate iron and manganese uptake. High concentrations of
casein in cow's milk and cow's milk formulas limit trace element absorption
and the presence of phytate in soy formula limits absorption of trace elements.
11 Long term exposure to manganese in rural well water has no neurological effects. Vieregge P,
Heinzow B, Korf G, Teichert HM, Schleifenbaum P, Mosinger HU. Can J Neurol Sci 1995 Nov; 22(4):286-9.
12Manqanese intake and serum manganese concentration of human milk-fed and formula-fed infants.
Stastny D, Vogel RS, Picciano MF : Am J Clin Nutr 1984 Jun; 39(6):872-8.
"Dietary factors affecting trace element bioavailability from human milk, cow's milk
and infant formulas. Lonnerdal B. Prog Food Nutr Sci. 1985; 9(1-2):35-62.
14Trace element absorption in infants as a foundation to setting upper limits for trace
elements in infant formulas. Lonnerdal B J Nutr. 1989 Dec; 119(12 Suppl):1839-44.
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Cow-milk formulas currently contain 30-75 ug/L manganese and soy formulas
contain 100-300 ug/L down from the 300-1,400 ug/L concentrations a few
years ago (Lonnerdal 199715). Soy protein isolate formulas still contain 1.5%
phytates and all soy-based formulas and are now, iron-fortified (American
Academy of Pediatrics 199816). Both the phytate and iron in soy based
formulas inhibit manganese absorption. These studies and the absence of any
reports in the literature of neonatal manganese toxicity attributable to infant
formula or water demonstrate that this concern expressed by EPA is not
scientifically supported.
4. "There is some evidence that neonates absorb more manganese from the
gastrointestinal tract, that neonates are less able to excrete absorbed manganese,
and that in the neonate the absorbed manganese more easily passes the blood-brain
barrier"
Although EPA does not cite a reference for this statement, it appears to be
largely based on radioactive tracer studies conducted in the 1970's on
rodents. Fechter 199917 concludes that more recent "data show that the
neonatal rodent is significantly more effective in eliminating manganese than
previously believed based on tracer studies".
Manganese is known to be essential for normal skeletal development. Recent
studies indicate that significant physiological responses occur during
pregnancy and lactation to help assure adequate manganese for the infant.
Stastny et al 1984 demonstrated that mean human milk concentrations
decreased with progression of lactation from 6.6 ug/L during the first month to
3.5 ug/L by the third month.
Wilson et al 199218 studied 40 very low birth weight infants. Plasma
manganese levels were determined at birth and then serially to 3 months of
15Effects of milk and milk components on calcium magnesium, and trace element
absorption during infancy. Lonnerdal B : Physiol Rev 1997 Jul; 77(3):643-69.
16Soy Protein-based Formulas: Recommendations for Use in Infant Feeding American
Academy of Pediatrics- Committee on Nutrition. Pediatrics Vol. 101 No. 1 January 1998,
pp. 148-153.
^Distribution of Manganese in Development. Fechter LD, NeuroToxicology. 1999
20(2-3): 197-202
18Plasma manganese levels in the very low birth weight infant are high in earlv life.
Wilson DC, Tubman TR. Halliday HL, McMaster D. Biol Neonate 1992; 61(1):42-6.
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age. Mean plasma manganese concentration was 3.6 ug/L at birth and 3.0
ug/L at 3 months of age. These levels were approximately 3-fold greater than
those of a group of 9 adults analyzed using the same methods (mean 1.1
ug/l Manganese was also measured in parenteral nutrition fluids, breast milk
and 3 pre-term formulas. There was no relationship between manganese
intake and plasma manganese concentration.
Spencer 199919 demonstrated that maternal whole blood manganese levels
increase throughout pregnancy and are approximately 3-fold higher in the
neonate. Krachler et al 199920 demonstrated that manganese was 150%
higher in cord blood than in maternal blood and that manganese
concentrations in colostrum were twice that in maternal serum.
Kawamura et al in 1941 reported the only epidemiological study describing
toxicological responses in humans consuming large amounts of manganese
dissolved in drinking water. Twenty five cases of classical manganese
poisoning were described with symptoms including lethargy, increased muscle
tonus, tremor and mental disturbances. The most severe symptoms were
observed in elderly people, while children appeared to be unaffected.
These findings confirm a physiological concentrating effect of manganese throughout
pregnancy and more dramatically so in the neonate indicating a vital role in fetal
development. There are no reports in the literature of neonatal manganese toxicity or of
pediatric manganese toxicity in the absence of total parenteral nutrition or biliary atresia.
Available human evidence suggests that the very young are the least susceptible population
for manganese neurotoxicity and that this concern by EPA is not well-founded.
In adopting these modifying factors, EPA failed to take into account the fact that manganese
is essential for normal physiological functioning and that disease states are associated with
both deficiencies and toxicity. Applying conservative modifying factors to prevent any
possibility of toxicity magnifies the risk of deficiency. Conflicting standards of this sort lead to
either alarm and/or cynicism among the public and scientists.21 Obviously, there should not
be overlap between public policy decisions for toxic clean up efforts and food fortification.
19Whole Blood Manganese Levels in Pregnancy and the Neonate. Spencer A.
Nutrition 1999 Oct; 15(10):731-4
20Trace Element Transfer from the mother to the newborn-investigations on triplets of
colostrum, maternal and umbilical cord sera. Krachler M, Rossipal E, Micetic-Turk D Eur J
Clin Nutr 1999 Jun; 53(6):486-94.
21Dietarv Standards for Manganese: Overlap between Nutritional and Toxicological
Studies. GregerJL. J. Nutrition 1998; 128(2): 368S-371S.
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An additional reason for not using the RfD based on the modification factor applied by EPA
in 1995 is that this modification factor and RfD have not been peer-reviewed. In 1996, EPA
instituted a Pilot Program to adopt or update IRIS databases, which was originally applied to
11 chemicals, 64 FR 14570 (April 12, 1996). This Pilot Program added external peer
review to the IRIS database development process. The process also consisted of internal
peer review and limited public involvement.
A recent EPA report has confirmed that the quality of information was improved in the IRIS
assessments done during and after the 1996 Pilot Program as compared to those done
before.22 This report was required by HR 106-379 directing EPA to study the extent to which
IRIS assessments "document the range of uncertainty and variability of data" because
Congress was "concerned about the accuracy of information" contained in IRIS. This report
also emphasized the need to update older assessments with more recent scientific data and
risk assessment methods.
Response 8-6: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 8-7: Comments on Sodium Chlorate Manufacturing Waste Descriptions and
Listing Proposals
Kerr-McGee Chemical, LLC, ("Kerr-McGee") submits these comments on EPA's proposed rule
published at 65 FR 55683 (September 14, 2000) ("the Proposal"). Kerr McGee supports
EPA's proposal not to list wastes from the sodium chlorate production process as hazardous
wastes. EPA incorrectly states that at the Hamilton plant wastes from manganese production
are commingled with wastes from sodium chlorate and titanium dioxide production.
Sampling and Analytical Data Report for Record Sampling and Characterization of Wastes
from The Inorganic Titanium Dioxide Manufacturing Sector, Kerr-McGee Corporation,
Hamilton, Plant page 5, At the Hamilton plant, separate waste treatment systems exist for
manganese production from those for sodium chlorate and titanium dioxide production.
This confusion does not effect EPA's decision not to list these wastes. As EPA notes in the
Proposal, the constituents of these waste streams were addressed in the risk assessments
conducted for either titanium dioxide or for sodium chlorate. See 65 FR 55736 (noting that
constituents in commingled waste streams not assessed by the listing of sodium chlorate
wastes were assessed for titanium dioxide wastes). Kerr-McGee is submitting separate
comments addressing other aspects of the Proposal.
22Characterization of Data Uncertainty and Variability in IRIS Assessments: Pre-Pilot
vs. Pilot/Post-Pilot, July 28, 2000 NCEA - U.S. EPA Contract No. 68-C-99-238 Task Order
No.2.
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Response 8-7: See our response to comment 8-4b.
Comment 8-8: Comments on Detection of CDDs and CDFs and Possible Re-assessment of
Bevill Exemption Status
Introduction: Kerr-McGee Chemical, LLC, ("Kerr-McGee") submits these comments on EPA's
proposed rule published at 65 FR 55683 (September 14, 2000). These comments object
to EPA's use of sampling data for CDDs and CDFs in its assessment of hazardous waste
listings and as a basis for a possible reconsideration of the Bevill status for chloride process
waste solids from titanium tetrachloride production, 40 CFR 261.4(b)(7)(ii)(S).
Comment 8-8a: There Is No Basis for EPA to Reconsider the Bevill Exemption for Chloride
Waste Solids from Titanium Tetrachloride Production
EPA states in the Proposal that it is considering whether to re-assess the Bevill-exempt status
of chloride waste solids from titanium tetrachloride production because the Agency found
measurable levels of dibenzo-p-dioxins (CDDs) and dibenzo-p-furans (CDFs) in chloride
process wastes and because these compounds were not assessed as part of the rulemakings
which established the mineral processing exemptions. 65 FR 55751. Although EPA states
that it is only "considering" such a re-assessment and although EPA has promised that any
reassessment would involve a separate analysis and opportunity for notice and comment,
Kerr McGee believes that it is improper for data to suggest that any such reassessment might
be warranted based on the data collected and its theories of CDD and CDF formation in
chlorinators.
Response 8-8a: The Agency's final Bevill rule (56 FR 27312) promulgated on July 13, 1991
stated that, "If EPA finds that this exemption is not protective of human health and the environment
and if an examination of titanium tetrachloride waste management shows any continuing or new
problems, the Agency will reconsider this subtitle D determination for chloride process waste
solids from titanium tetrachloride production." The Agency has uncovered new information
regarding CDDs and CDFs in these waste solids. The Agency will not take any further action as
part of this rule regarding a reevaluation of the Bevill status of chloride process waste solids from
titanium tetrachloride. EPA will provide notice and opportunity to comment prior to taking any
action that would affect the current exemption for these titanium tetrachloride wastes.
Comment 8-8b: The data which EPA refers to are summarized in the Titanium Dioxide
Listing Background Document for the Inorganic Chemical Listing Determination ("the
Background Document"). Chloride process waste sampling data are reported in the
Sampling and Analytical Data Report for Record Sampling and Characterization of Wastes
from the Inorganic Sodium Chlorate and Titanium Dioxide Manufacturing Sectors; Kerr-
McGee Corporation, Hamilton, Mississippi - USEPA, August 10, 1999 ("Hamilton Data
Report') and in Sampling and Analytical Data Report for Record Sampling and
Characterization of Wastes from the Inorganic Sodium Chlorate and Titanium Dioxide
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Manufacturing Sectors; Kemira Pigments, Inc., Savannah, Georgia -USEPA, September 9,
1999 ("Savannah Data Report"). The CDD and CDF data in these reports are not valid and
cannot be relied upon by EPA.
The Hamilton Data Report indicates that the purpose of the sampling visit was to sample
sodium chlorate wastes and that the sampling team discovered the opportunity to sample
titanium dioxide wastes only after their arrival. See page 5. CDD/CDF analysis on the
Hamilton samples was conducted three months after the sampling event, on "left over"
samples, at a laboratory approximately 2,000 miles from the original lab. Samples were
initially sent to APPL, Inc. in Fresno, California. The samples were then forwarded to Pace
Labs in Minneapolis. Page 60. In contrast, Savannah Dioxin samples arrived at Pace Labs
the day after being taken at the plant.
The dioxin samples were analyzed outside of the holding time interval specified in the
Quality Assurance Project Plan and the results were classified as not "Compliant" by Pace
Labs. Hamilton Sampling Report, page 38.
The solid samples for the Savannah plant were analyzed for leachable CDD/CDF three
months after sampling. This period is outside of the sampling plan's time interval. See
Savannah Data Report, page 47.
Response 8-8b: EPA is not taking any action today based on these analytical results and does not
need to establish their validity at this time. Nonetheless, EPA has concluded that the holding time
has not adversely affected the analysis. The holding times specified in our Quality Assurance
Project Plan (QAPP) for extraction and analysis of PCDD and PCDF were based on the required
holding times listed in Table 2-34 of December 1996 Version of the Third Edition of SW-846, as
updated by Updates I, II, IIA, IIB, III and IIIA. SW-846 is the EPA methods manual, "Test
Methods for Evaluating Solid Waste, Physical/Chemical Methods," which contains EPA-approved
sampling and analysis methods for use under the RCRA Program.
PCDD and PCDF are very stable in a variety of matrices and will not degrade easily in the
environment. EPA has recently removed the holding times for extraction (or leaching) and
analysis of PCDD and PCDF. We no longer have a holding time requirement for the analysis of
PCDD and PCDF. See Table 2-40 of Draft Update IVB to the Third Edition of SW-846 for the
revision. A recent Federal Register notice (65 FR 70678, November 27, 2000) announced the
availability of Draft Update IVB.
Dioxin samples collected from Kerr-McGee's Hamilton and Savannah facilities were extracted
(or leached) and analyzed for PCDD/PCDF outside the holding times stipulated in the QAPP.
Results of that sample were, therefore, classified as not "Compliant" by Pace Labs. As explained
earlier, we no longer have a holding time requirement of the analysis because PCDD and PCDF
are quite stable and will not degrade easily in the environment. We believe the PCDD and PCDF
data in the Hamilton Data Report and in the Savannah Data Report are valid and can be relied
upon by EPA. Even if PCDD/PCDF were degraded because the analysis was performed outside
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the holding time, we would have under-estimated, not over-estimated, the PCDD/PCDF levels in
Kerr McGee samples.
Furthermore, analysis of waste samples collected from other titanium dioxide producers also
confirms the presence of PCDD/PCDF in wastes generated from manufacturing of titanium
dioxide.
Comment 8-8c: Reconsideration of the Bevill status for an industry is a major policy decision,
one that should certainly not be made in reliance upon invalid sampling data, as EPA has
done here. Moreover, significance of any valid CDD/CDF sampling data must be carefully
evaluated in light of other factors. Surely one such factor is the relationship of any reported
values to background levels caused by their sources. For example, the Hamilton plant is in
the center of what has been a vast cotton growing area in Mississippi for scores of years.
Given the widespread use of CDD/CDF in pesticides for crops, especially cotton, this factor
must be assessed in any interpretation of CDD/CDF sampling data for waste solids or other
media.
It would also be improper for EPA to initiate reconsideration of the Bevill exemption based
upon the rather facile and alarmingly misleading theory of CDD/CDF formation in
chlorinators that is expressed in the Background Document on pages 79 to 82. Citing a
patent description, EPA states that the chloride-ilmenite process involves carbon, chlorine
and heat, which it alternately refers to as "a number of conditions" and "critical conditions" for
CDD/CDF formation that EPA has found in other processes. Uncritical readers of these
statements may incorrectly assume that these conditions are all that is necessary for
CDD/CDF formation and that if present, formation of these chemicals is inevitable. These
assumptions, of course, are not true. Also, since EPA states that "the vast majority" but
apparently not all of these processes involve these three conditions, one wonders how these
conditions can be considered "critical" if CDD/CDF can be formed in their absence. This
theory produced what EPA describes as its "expectation that dioxins and furans were likely to
be formed during the chlorination process" which in turn may have produced, as the above
comments point out, an overly eager willingness to accept the sampling data as confirmation
of the this theory. Background Document at 80. In any event, a much more critical approach
should have be taken by EPA in analyzing these data and in reaching conclusions based on
these data.
Response 8-8c: The commenter provided no data demonstrating that dioxins and furans are not, in
fact, present in their wastes, and no theory as to why dioxins would not form in their process,
despite the known presence of chlorine, carbon (i.e., coke), and elevated temperatures. Further,
the commenter did not discount the presence of CDDs and CDFs in other titanium dioxide
manufacturers' wastes or explain why these compounds would not also be present in its wastes.
Irrespective, we are not re-opening the Bevill determination for the currently exempt solids in this
final rule, but simply are providing notice that we may in the future give notice that we are
contemplating such an action.
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Comment ICMP-00009, American Chemistry Council - Titanium Dioxide Panel
EXECUTIVE SUMMARY
The Titanium Dioxide Panel ("the Panel") of the American Chemistry Council submits these
comments in response to the Environmental Protection Agency's (EPA's) proposed rule under
the Resource Conservation and Recovery Act (RCRA) to list as hazardous certain wastes
generated from inorganic chemical manufacturing processes. EPA also proposes not to list
as hazardous various other process wastes (Federal Register: September 14, 2000, volume
65, Number 179, page 55683). Members of the Titanium Dioxide Panel include the
following U.S. producers of titanium dioxide (TiO2): DuPont; Kerr-McGee Chemical LLC;
Kronos Inc.; Millennium Chemicals Inc.; and, Huntsman-Tioxide Inc.
The Titanium Dioxide Panel makes the following points in its comments:
The Panel supports comments of the American Chemistry Council, which have been
provided to EPA in a separate submission.
The Panel generally supports the tiered risk assessment methodology used for EPA's
listing determinations, other than the assessment as it applies to manganese.
The Panel supports the decision by EPA not to list the screened-out wastes.
The Panel supports the full consideration of site-specific factors in risk assessment for
either on-site or off-site management of materials that did not screen out in earlier
evaluations.
The Panel supports consideration of actual management practices by EPA in the final
rule.
The Panel supports EPA's recognition that many practices involving use or re-use
materials from manufacturing operations would not present any significant risk of
exposure and thus could appropriately be screened out of further consideration.
The Panel supports EPA's conclusion that dioxins and furans should not be used as
the basis for listings in this rulemaking.
The Panel believes that EPA's discussion of the "Bevill" status of waste streams requires
revision. The Panel recommends that for the final rule. EPA acknowledge that Bevill
determinations often involve a detailed review of facility-specific practices and
processes.
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The Panel supports EPA's decision to assess the potential need for listing of mixtures
based solely on the non-exempt portion of the waste mixture.
The Panel believes that materials that are not solid wastes are also not wastes for the
purposes of evaluating the Bevill exempt status.
The Panel believes that metal chlorides separated from the in-process titanium
tetrachloride purification stream are mineral processing wastes, not chemical
processing wastes.
EPA mischaracterized vanadium-containing material from the chloride process. EPA
needs to correct this and in the final rule acknowledge the "solid" status of the
vanadium stream.
EPA needs to correct another error and in the final rule acknowledge that the titanium
tetra-chloride purification stream is an in-process stream, not a solid waste. Because
the in-process titanium tetrachloride purification stream is used within an on-going
and continuous process and never "disposed of," the stream is not within EPA's
regulatoryjurisdiction under Subtitle C of RCRA.
The Panel supports the position that manganese should not be added to EPA's list of
RCRA Appendix VIII Hazardous Constituents.
COMMENTS OF THE TITANIUM DIOXIDE PANEL
ON THE PROPOSED INORGANIC CHEMICALS LISTING RULE
INTRODUCTION
The Titanium Dioxide Panel ("the Panel") of the American Chemistry Council submits these
comments in response to the Environmental Protection Agency's (EPA's) proposed rule under
the Resource Conservation and Recovery Act (RCRA) to list as hazardous certain wastes
generated from inorganic chemical manufacturing processes. EPA also proposes not to list
as hazardous various other process wastes (Federal Register, September 14, 2000, volume
65, Number 179). Members of the Titanium Dioxide Panel include the following U.S.
producers of titanium dioxide (Ti02): DuPont; Kerr-McGee Chemical LLC; Kronos Inc.;
Millennium Chemicals Inc.; and, Huntsman-Ti oxide Inc. In addition to their own specific
comments, the Titanium Dioxide Panel supports the comments of the American Chemistry
Council, which have been provided to EPA in a separate submission (letter dated November
13, 2000 to David Bussard of EPA from the American Chemistry Council).
Comment 9-1: THE PANEL GENERALLY SUPPORTS THE RISK ASSESSMENT
METHODOLOGY USED FOR THE LISTING DETERMINATIONS, OTHER THAN
THE ASSESSMENT AS IT APPLIES TO MANGANESE.
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A. EPA Properly Used Screening as Part of its Risk Assessment Methodology.
As part of its risk assessment methodology, EPA used a tiered approach, by initially
using a variety of screening methodologies rather than conduct full scale risk
assessment modeling for all the waste streams under consideration. In so doing, EPA
appropriately conserved its own resources and those of industry by using a set of
conservative assumptions that adequately demonstrated that the wastes screened out
would not pose any significant risk to human health and the environment. The Panel
supports this tiered approach since it conserves time and resources while still
establishing a sufficiently sound scientific basis for concluding that no further
evaluation is warranted with respect to the screened-out wastes from the production
of titanium dioxide. The Panel further supports the decision by the Agency not to list
these screened-out wastes.
B. EPA Generally Considered Site-Specific Factors in Assessing Risk Posed.
EPA collected extensive data and supporting information from titanium dioxide (TiO2)
producers in preparation for the proposal. For on-site practices, EPA generally made
use of this information on current waste management practices and representative
site-specific factors in assessing the risk of these practices where fuller assessment
beyond screening was indicated. The Panel supports the full consideration of such
site-specific factors in risk assessment for either on-site or off-site management of
materials that did not screen out in earlier evaluations.
C. The Panel Supports the Consideration of Actual Practices.
EPA appropriately considered the use of specific current waste management units,
LfL,_tanks or on-site landfills, at facilities. The Agency appropriately recognized that
these facilities with these units are likely to continue use of these units rather than
pursue use of less cost-effective alternatives (i.e., off-site disposal at a third-party or
municipal landfill). Hence, the Panel supports consideration of actual management
practices by the Agency in the final rule.
Furthermore, the Panel supports the Agency's recognition that many practices
involving use or re-use of materials from manufacturing operations would not present
any significant risk of exposure and thus could appropriately be screened out of
further consideration.
D. EPA Properly Decided Not To Use Dioxins and Furans as Appendix VII
Constituents in this Rulemaking
The Panel supports EPA's conclusion that dioxins and furans should not be used as
the basis for listing in this rulemaking. As EPA indicated, it has not undertaken a
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sufficient evaluation of potential risk to support action on this issue in this rulemaking.
Furthermore, in many instances, such action would have been outside the scope of
the listing decisions required to be addressed under the consent decree.
Response 9-1: EPA acknowledges ACC's support of the rule.
Comment 9-2: ERA'S DISCUSSION OF THE "BEVILL" STATUS OF WASTE STREAMS
REQUIRES REVISION
Comment 9-2a: Bevill Determinations Involve Detailed Review of Facility Practices.
The Panel concurs with EPA's statement in the preamble that the process of determining
whether specific waste streams are Bevill-exempt is "not always simple." The Panel
underscores the view that EPA should proceed cautiously in making generic statements on
the Bevill status of waste streams based upon only a general assessment of the
manufacturing and processing steps that generate a waste. The Panel recommends that EPA
acknowledge in the final rule that these types of assessments often involve detailed review of
facility-specific processes and operations and may be more appropriately made on that
basis.
Response 9-2a: EPA agrees that Bevill opinions must take relevant site-specific information into
account. Where appropriate, EPA has issued, and will continue to issue, opinions for categories
of similar processes using site specific information to support this type of determination. In this
rulemaking, the Agency evaluated site specific information as input into reaching Bevill opinions
about a group of facilities using the same processes. For this rule, EPA has considered site-
specific information submitted by affected facilities to ensure that its understanding of their
processes and wastes was correct and to make warranted exceptions to categorical opinions.
Comment 9-2b: The Panel Supports EPA's Decision to Assess Potential Need for Listing of
Mixtures Based Solely on the Non-Exempt Portion of the Mixture.
EPA appropriately fulfilled its obligations under consent decree with respect to mixtures of
exempt and non-exempt wastes. The Panel supports the Agency's decision to assess risks
and potential need for listing based only upon the nonexempt portion of such waste mixtures.
Response 9-2b: EPA acknowledges ACC's support of the rule.
Comment 9-2c: Materials that are Not "Solid Wastes" are also Not Wastes for the Purposes
of Evaluating Bevill Exempt Status.
The Panel notes that EPA's decision not to evaluate its jurisdiction with respect to materials
that are re-used or recycled in some way in light of the D.C. Circuit decision in Association
of Battery Recyclers v. EPA necessarily has a negative impact on the accuracy of the Agency's
assessment of the Bevill status of certain waste streams. Those manufacturing streams that
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are outside the Agency'sjurisdiction under the Battery Recyclers decision and hence not "solid
wastes" also are not "solid wastes" for purposes of evaluating their status under the Bevill
exemption.
Response 9-2c: The Bevill exclusion only applies to solid wastes. This position was originally
stated in the first Bevill rule at 54 FR 36614 (September 1, 1989). The Agency has never changed
this position. If we had determined that any materials were not "solid wastes" for listing purposes
in this rulemaking, we also would have concluded that they were not "solid wastes" for Bevill
exemption purposes. We received both supportive and critical comments on our approach to
evaluating secondary materials that may be reused or recycled. As discussed in the proposed rule,
these determinations are complex, time consuming and best made on a site-specific basis. We
continue to believe that this is the appropriate approach and thus, have not made site-specific
determinations on whether secondary materials are or are not solid wastes if we could more
quickly determine that they did not pose a listable risk. The decision not to move forward with
further evaluation of a specific secondary material because we expect no listable risk does not
imply that the material is or is not a solid waste, but rather, represents an efficient way for EPA to
make a list/no-list decision and ensure we meet the requirements of the Consent Decree.
Comment 9-2d: Metal Chlorides Separated from the In-Process Titanium Tetrachloride
Purification Stream are Mineral Processing Wastes, Not Chemical Processing Wastes.
The Agency has long maintained "that Congress did not intend the Bevill exclusion to extend
to processing operations that are performed after (emphasis added) the production of a
saleable mineral product." 54 FR 36620/1, September 1, 1989 (emphasis added).
Similarly, the Agency has also maintained that it "considers titanium tetrachloride, produced
during the titanium chloride process, to be a saleable [mineral] product; any processing
subsequent (emphasis added) to its production is considered to be chemical processing." 54
FR 36620/1, September 1, 1989 (emphasis added).
The Agency reaffirms that it still maintains this position in its sector specific discussion of
titanium dioxide in the proposed rule. "Mineral processing ends when titanium dioxide is
produced in the oxidation unit. Further steps are chemical manufacturing. The Agency
defines the beginning of oxidation as the beginning of chemical manufacturing because the
facility is using a saleable mineral product, titanium tetrachloride, to produce titanium
dioxide." 65 FR 55750, September 14, 2000.
The practice of introducing a treating, agentjust prior to distillation of crude liquid titanium
tetrachloride, which is not yet a saleable mineral product, is to facilitate the most economical
extraction of the intermediate product, titanium tetrachloride. For this reason, metal
chlorides separated from the in-process titanium tetrachloride purification stream are clearly
mineral processing wastes, NOT chemical processing wastes.
Response 9-2d: Chemical manufacturing, as defined in the September 1, 1989 Bevill rulemaking
(54 FR 36592) does not necessarily begin with the introduction of a treating agent at the
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distillation step. Solid wastes from the distillation step would be viewed by the Agency as
mineral processing wastes if they are disposed. See also our response to comment 22-3a-6
(DuPont).
Comment 9-2e: EPA Mischaracterized Vanadium-Containing Material from the Chloride
Process.
Comment 9-2e(1): The Vanadium Material is Physically Solid.
The vanadium material generated during distillation is a "solid" material. EPA errs factually
with its statement that the vanadium waste stream is not "solid" and therefore cannot be Bevill
exempt. EPA needs to correct this error in the final rule by acknowledging the "solid" status of
the vanadium stream.
Response 9-2e(l): See response to Comment 22-3a-2.
Comment 9-2e(2): The Titanium Tetrachloride Purification Stream is an In-Process Stream,
Not a Solid Waste.
The proposed rule incorrectly identifies the in-process titanium tetrachloride purification
stream as a liquid "non-exempt vanadium waste." 65 FR 55760/5 (September 14, 2000).
Rather, this stream is a valuable in-process material that is being further processed to
maximize yield of the intermediate product, titanium tetrachloride. This is performed by
continuously processing the stream within the same process that generates it. In fact, the in-
process titanium tetrachloride purification stream is even more valuable than the crude
gaseous titanium tetrachloride with which it is co-processed, as it contains significantly
higher concentrations of titanium tetrachloride. This stream is not a solid waste, because it
is never discarded.
Under RCRA, in order for a material to be considered a "solid waste," that material must first
be a "discarded material." RCRA § 1004(27). Congress clearly and unambiguously used
the term "discarded" in its ordinary sense to mean "disposed of," "thrown away" or
"abandoned." Congress thus intended "to regulate under RCRA only materials that have truly
been discarded." Consequently, materials are not "discarded" and are not "solid wastes" if
they are "in-process materials employed in an ongoing manufacturing process" because they
are not being "disposed of "thrown away" or "abandoned." American Mining Congress v.
EPA, ,824 F.2d. 1177,1 184, 1192 (D.C. Cir. 1987) (AMC I). The validity of this
standard for determining when a material becomes a "solid waste" has again been recently
confirmed by the D. C. Circuit in Association of Battery Recyclers, Inc. v. EPA, 208 F. 3d
1047, 1056 (D.C. Cir. 2000).
Accordingly, the in-process titanium tetrachloride purification stream is not a "solid waste" as
defined for purposes of the hazardous waste regulations. Rather, this material is
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immediately used within an on-going and continuous process of manufacturing an
intermediate product, purified titanium tetrachloride. It is never "disposed of," "thrown away,"
or "abandoned." In contrast, it is continuously processed in order to maximize the yield of
titanium tetrachloride. Therefore, the in-process titanium tetrachloride purification stream is
not within the EPA's regulatoryjurisdiction under Subtitle C of RCRA.
Response 9-2e(2): See our response to comments 9-2d and 22-3a-2 (DuPont). We agree that
vanadium solids when separated from ferric chloride waste acids are Bevill exempt solid wastes.
Comment 9-3: Manganese Should Not Be Added to EPA's List of RCRA Appendix VIII
Hazardous Constituents.
Introduction
EPA is proposing (65 FR 55687, September 14, 2000) to add manganese to the list of
hazardous constituents in Appendix VIII to 40 CFR 261.
Regarding criteria for addition to Appendix VIII, EPA at existing 40 CFR 261.11 states,
"Substances will be listed on Appendix VIII only if they have been shown in scientific studies
to have toxic, carcinogenic, mutagenic, or teratogenic effects on humans or other life forms."
Comment 9-3a: Manganese is an Essential Mineral.
Greger (NeuroToxicology, 1999) quotes other references stating that manganese is an
essential element.
According to the 1999 edition of the most widely used basic nutrition college text in the
United States, Understanding Nutrition by Whitney and Rolfes:
The human body contains a tiny 20 milligrams of manganese, mostly in bones and
metabolically active organs such as the liver, kidneys, and pancreas. Manganese
acts as a cofactor for many enzymes that facilitates dozens of different metabolic
processes. For example, manganese metalloenzymes assist in urea synthesis, the
conversion of pyruvate to a TCA cycle compound, and the prevention of lipid
peroxidation by free radicals.
The Food and Nutrition Board of the National Research Council (Recommended Daily
Allowances, 10th edition, 1989) has established an estimated safe and adequate daily
dietary intake for manganese to foster adequate dietary consumption of this essential trace
element.
Response 9-3a: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
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final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 9-3b: EPA Has Not Demonstrated via Scientific Studies that Manganese has
Toxic, Carcinogenic, Mutagenic, or Teratogenic Effects on Humans When Ingested in
Drinking Water and Therefore Has Not Shown that Manganese Warrants Addition to
Appendix VIII.
EPA has compiled an extensive health assessment in support of inhalation hazard in the
1996 Integrated Risk Information System (IRIS) substance file for manganese used as the
basis for the addition to Appendix VIII in the proposed rulemaking. The inhalation hazard
described by EPA and Agency of Toxic Substances and Disease Registry (ATSDR) is already
addressed via the inclusion of manganese as a Hazardous Air Pollutant under the Clean Air
Act.
However, neither the IRIS substance profile nor the ATSDR draft Toxicological Profile for
Manganese (September 1997) establishes a conclusive link between manganese in drinking
water ingestion and toxicity to humans.
One reason for the apparent lack of manganese toxicity to humans via oral ingestion is that
iron and calcium in the diet or in dietary supplements limit manganese absorption (Whitney
and Rolfes, 1999). Greger (NeuroToxicology, 1999) elaborates,"... the body is protected
against manganese toxicity by low absorption and/or rapid presystemic elimination of
manganese by the liver but not the kidneys."
The IRIS substance file (page 6 of 37) refers to a 1941 report by Kawamura et al. (Kitasato
Arch. Exxon. Med 1 S: 145-169) as "the only epidemiologic study describing toxicologic
responses in humans consuming large amounts of manganese dissolved in drinking water."
Velazquez and Ru (in Risk Assessment of Essential Elements, Mertz, 1994) review the
Kawamura paper and note that the "concentration of manganese at the time of exposure was
probably at least 28 mg Mn/L" and further that "the total intake was at least 58 mg Mn/day."
Referring to the study by Kawamura, ATSDR states, "Thus, while there is no doubt these
people were exposed to manganese, there is considerable doubt that all of the features of
this outbreak (particularly the deaths) were due to manganese alone." (p. 45)
The IRIS substance file also discusses neurological effects suggested to be related to chronic
intake of drinking water containing 1.8 to 2. 3 mg/L of manganese in northwest Greece (p.
4 of 37). ATSDR (p. 47) reviews the same study by Kondakis et al (Arch. Environ. Health,
1959) and concludes, "Thus, this study supports but does not prove that chronic oral intake
of manganese can lead to neurological changes in humans."
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Furthermore, Vieregge et al. (Cart. .1. Neurol. Sci., 1995) directly contradict the Kondakis
study by demonstrating that long term exposure to rural well water containing 0.3 to 2.16
mg/L has no neurological effects.
The International Programme on Chemical Safety of the World Health Organization (Concise
International Chemical Assessment document on Manganese and its Compounds, 1999)
sums up the overall situation stating, "The available evidence for adverse effects associated
with chronic ingestion of excess manganese is suggestive but inconclusive."
Response 9-3b: We are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
CONCLUSION
The Titanium Dioxide Panel of the American Chemistry Council is pleased to submit these
comments to EPA regarding the inorganic chemicals listing rule. Should the Agency have
any questions regarding these comments, please contact Jonathon T. Busch, Manager of the
Titanium Dioxide Panel (703/741-5633).
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Comment ICMP-00010, Association of Battery Recyclers
Introduction
The Association of Battery Recyclers ("ABR") appreciates the opportunity to provide comments
on the U.S. Environmental Protection Agency's ("EPA's") Proposed Rule titled "Hazardous
Waste Management System; Identification and Listing of Hazardous Waste: Inorganic
Chemical Manufacturing Wastes; Land Disposal Restrictions for Newly Identified Wastes;
and CERCLA Hazardous Substances Designation and Reportable Quantities," which was
published at 65 FR 55684 (Sept. 14, 2000) (the "Proposed Rule").
ABR is a national trade association that has represented the lead recycling industry for more
than twenty-five years. Members of the ABR include battery manufacturers, lead chemical
manufacturers, secondary lead smelters, and consultants and vendors to the lead recycling
industry. The battery recycling industry members of the ABR collectively represent
approximately 85% of the lead recycling capacity currently available in the United States.
ABR's comments on the Proposed Rule are limited to two issues: 1) the inadequate and
misleading notice concerning the potentially far-reaching aspects of the Proposed Rule; and
2) the addition of manganese to the list of hazardous constituents in 40 CFR Part 261
Appendix VIII, the addition of manganese to the table of underlying hazardous constituents in
40 CFR § 268.48, and the addition of a universal treatment standard for manganese in the
Table UTS in 40 CFR § 268.48.
Comment 10-1: Notice Issues
The title of the Proposed Rule reflects its focus on the potential identification and listing of
hazardous wastes from the inorganic chemical manufacturing industry. The title also notes
that the proposal pertains to Land Disposal Restrictions for such "newly identified wastes."
Likewise, in the summary section of the Proposed Rule, the preamble states, "Section IV of
today's proposal describes the proposed changes to the land disposal restrictions, which
would establish treatment standards for specific constituents in the wastes proposed for
listing." 65 FR 55687 (emphasis added).
The narrow title and summary of the Proposed Rule are misleading. In fact, the potential
effects of the Proposed Rule are much broader with respect to land disposal restrictions for
wastes containing manganese, which heretofore has not been a regulated constituent under
subtitle C of RCRA. In background documents for the Proposed Rule, EPA acknowledges
that manganese is an essential element, and is ubiquitous in the environment and found in
low levels in water, air, soil, and food. See "Risk Assessment for the Listing Determinations
for Inorganic Chemical Manufacturing Wastes: Background Document" ("Background Risk
Assessment") (August 28, 2000) at J-25. By proposing to add manganese to 40 CFR
Appendix VIII and Table UTS in 40 CFR § 268.48, however, the Proposed Rule affects any
listed or characteristic hazardous waste that contains manganese. Prior to land disposal,
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these wastes would now have to be treated and tested to demonstrate compliance with the
proposed manganese UTS of 17.1 mg/l for wastewaters or 3.6 mg/L TCLP for
nonwastewaters.
ABR believes the notice provided for the Proposed Rule is inadequate in light of the
potentially far-reaching effects of the rule. It is clear from the preamble and background
documents relating to the Proposed Rule that there is very little information concerning the
presence of manganese in hazardous wastes and possible treatment technologies for
manganese. To date, manganese has not been regulated under RCRA subtitle C.
Consequently, there has been no need for regulated parties to determine 1) the presence of
manganese in their wastes, 2) whether manganese in such wastes are amenable to
treatment, and 3) potentially appropriate treatment technologies and the capabilities of such
treatment technologies. All of this information is relevant to the issues on which EPA requests
comment; however, because manganese is currently unregulated, it is unlikely that industry
would have the necessary data available within the time frame established by EPA to provide
meaningful comments. In light of this inadequate notice, ABR requests a reasonable
extension so that it may have an opportunity to develop data relevant to the issues raised in
the Proposed Rule and, if necessary, submit further comments on the proposed changes to
the subtitle C regulations.
Response 10-1: EPA denied ABR's request for extension. However, we are deferring final action
on all elements of our proposal that are specifically related to the waste constituent manganese.
Please see section IV.B of the preamble to today's final rule for a further discussion of our
decision to defer final action on manganese-related elements of the proposed rule.
Comment 10-2: Regulation of Manganese
Comment 10-2a: In its proposal, EPA seeks to 1) add manganese to the list of hazardous
constituents in 40 CFR Part 261 Appendix VIII, 2) add manganese to the table of underlying
hazardous constituents in 40 CFR § 268.48, and 3) establish universal treatment standards
for manganese under 40 CFR §268.48. According to the preamble to the Proposed Rule,
manganese is a constituent of concern in nine of the waste streams for the inorganic
chemical manufacturing industry that EPA considered for listing. Of those nine waste
streams containing manganese, however, EPA only found a significant risk in one of the
waste streams, which it chose to list as a hazardous waste: nonexempt nonwastewaters from
chloride ilmenite process. See 55 FR at 55760-63. This was the only process where the
Background Risk Assessment supporting the proposed rule indicates a Hazard Quotient of
greater than 1 for manganese. The other two newly listed waste streams did not contain
manganese as a constituent of concern.
Notwithstanding this limited information in the record for this rulemaking, EPA is proposing
for the first time to add manganese to the list of hazardous constituents and the table of
underlying hazardous constituents, and is proposing universal treatment standards for
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manganese. EPA is undertaking this action because it "believe[s] the available studies
clearly show that manganese has toxic effects on humans and other life forms." 65 FR
55763. There is no information in the preamble supporting this statement, however. The
only support for this position is a reference is to the Background Risk Assessment, which itself
is not very clear on this issue. The Background Risk Assessment notes that manganese is an
essential element in humans, and that the World Health Organization has determined that
an average daily consumption of manganese in the range of 8 to 9 mg/day for adults is
"perfectly safe." Background Risk Assessment at J-26. Notwithstanding, without any specific
explanation, EPA establishes an oral reference dose ("RfD") for purposes of the Proposed Rule
at 10 mg/day. EPA claims in the Background Risk Assessment that it has "medium
confidence" in the RfD and the studies upon which the RfD is based; however, a separate
document from the Office of Air Quality Planning and Standards states: "EPA has low to
medium confidence in the studies on which the RfDs for manganese were based, due to the
lack of data on dietary manganese in the three populations studied; low to medium
confidence in the database due to varying reports of manganese toxicity in the literature;
and, consequently, low to medium confidence in the RfDs." See "Manganese and
Compounds Hazard Summary, Unified Air Toxics Website, Office of Air Quality Planning
and Standards" at p. 3 (attached). It is not evident from the record what changes in the
studies upon which EPA relies would cause the agency to alter its position concerning its
confidence in the RfD for manganese.
The preamble also references EPA's IRIS database for support for regulating manganese.
The IRIS Substance File for Manganese notes that manganese "is a ubiquitous element that is
essential for normal physiologic functioning in all animal species," that "manganese is
ubiquitous in foodstuffs," that the normal daily intake of dietary manganese may exceed
EPA's RfD of 10 mg/day, particularly for a vegetarian diet, that "[i]n contrast to inhaled
manganese, ingested manganese has rarely been associated with toxicity," and that "because
of the homeostatic control humans maintain over manganese, it is generally not considered
to be very toxic when ingested in the diet." See IRIS Substance File - Manganese: CASRN
7439-96-5 (attached). This record cannot fairly be characterized as "clearly showing" the
toxic effects of manganese at the levels established for regulation by EPA.
Response 10-2a: We are deferring final action on all elements of our proposal that are
specifically related to the waste constituent manganese. Please see section IV.B of the preamble to
today's final rule for a further discussion of our decision to defer final action on manganese-
related elements of the proposed rule.
Comment 10-2b: Based on the severely limited record in this rulemaking, ABR has similar
concerns with respect to establishing the universal treatment standard for nonwastewaters
containing manganese, which would be applicable to all hazardous wastes sent for land
disposal. EPA appears to rely on a single sample from one waste stream to arrive at the
proposed manganese UTS for nonwastewaters of 3.6 mg/L TCLP. Moreover, by its own
admission EPA notes that it lacks any studies demonstrating treatment effectiveness for highly
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concentrated manganese nonwastewaters. 55 FR 55768. This record is insufficient to
support the establishment of the proposed universal treatment standard for all hazardous
wastes, and is insufficient to establish that the treatment standard is achievable for the broad
range of wastes for which it will apply. ABR believes additional data is needed to support
any such standard.23
Response 10-2b: We are deferring final action on all elements of our proposal that are
specifically related to the waste constituent manganese. Please see section IV.B of the preamble to
today's final rule for a further discussion of our decision to defer final action on manganese-
related elements of the proposed rule.
Summary
ABR believes that the notice provided by EPA for the Proposed Rule, in which EPA attempts to
add manganese to the list of hazardous constituents in 40 CFR Part 261 Appendix VIII, to
add manganese to the table of underlying hazardous constituents in 40 CFR 5 268.48, and
to establish a universal treatment standard for manganese in 40 CFR §268.48, is
inadequate. Also, ABR believes the existing record for the proposed rule does not establish
that manganese warrants listing as a hazardous constituent, and EPA has not demonstrated
that the proposed UTS is appropriate and achievable for all wastes subject to it.
These are the extent of ABRs comments. However, they did provide a significant number of
attachments on manganese. See the original ABR submission in the docket for the proposed
rule for these attachments.
Response to Summary Comments: See our response to comment 6-1 and 10-1.
23EPA further complicates the notice problem with respect to this Proposed Rule by cryptically stating
that it "may use the list of commenters on this topic as the only individuals notified of potential changes to this
proposed treatment standard." 65 FR 55768
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Comment ICMP-00011, OxyChem
Comment 11-1: OxyChem actively participates in several trade associations such as the
American Chemistry Council (ACC), the American Industrial Health Council (AIHC), Synthetic
Organic Chemical Manufacturers Association (SOCMA), American Petroleum Institute (API),
Chlorine Institute (Cl) and the Chlorine Chemical Council (CCC). OxyChem is fully
supportive of the comments submitted by these organizations as part of this docket.
Response 11-1: ACC was the only group of those listed above to respond to the proposed rule.
See our response to the ACC comment sets (9 and 15).
Comment 11-2: OxyChem concurs with the decision to list baghouse filters from the
production of antimony oxide as hazardous wastes when they are disposed. However, if the
baghouse filters can be recycled through the production process to enable a more complete
usage of the antimony raw material, we understand the proposed listing does not apply. We
applaud the agency's consideration of this direct recycling through the production process to
not represent waste management. OxyChem believes that the Agency's approach is
consistent with the rulings of the U.S. Circuit Court of Appeals for the District of Columbia
regarding the definition of 'solid waste.'
Response 11-2: EPA meant only that, to the extent that existing rules exclude such filters from
regulation, the listing would not apply. EPA is taking no action to expand or narrow existing rules
regarding the regulation of recycling.
Comment 11-3: OxyChem concurs with the decision to list slag from the production of
antimony oxide only when it is disposed or speculatively accumulated. We applaud the
agency's understanding that the direct recycling of this material through the production
process does not constitute waste management, but is further processing to gain additional
raw material value.
Response 11-3: EPA based its decision on the lack of risks associated with management of the
slag up to the point it was used in a different non-consent decree industry. EPA did not limit the
scope of the listing because it determined that management of the slag up to the point it was used in
a different non-consent decree industry did not present a risk that would warrant listing the waste
as hazardous.
Comment 11-4: OxyChem concurs with the decision not to list any of the residual streams
from the sodium dichromate manufacturing process. The constituents in sodium dichromate
manufacturing residuals do not pose a human health or environmental risk and are already
being managed in a manner protective of human health and the environment.
Response 11-4: EPA acknowledges the commenter's support.
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Comment ICMP-00012, National Mining Association
Introduction
The National Mining Association (NMA) hereby submits its written comments on the
Environmental Protection Agency's (EPA's or agency's) September 14, 2000, proposed rule
referenced above (65 FR 55684), also known as the "Inorganics Listing Proposal".
Among other things, the proposed rule would list three inorganic chemical waste streams as
hazardous wastes pursuant to Subtitle C of the Resource Conservation and Recovery Act
(RCRA). These three streams are: (1) baghouse filters from the production of antimony oxide;
(2) slag from the production of antimony oxide that is disposed of or speculatively
accumulated; (3) nonwastewaters from the production of titanium dioxide by the chloride-
ilmenite process. In reaching the decision to propose these three listings, EPA examined
fourteen different inorganic chemical sectors. That examination included considerations of
the scope of the Bevill Amendment and its coverage or non-coverage of processing waste
streams in specific mineral sectors including, but not necessarily limited to, antimony oxide,
titanium dioxide, barium carbonate, and kernite ore boric acid production. The proposed
rule also involves considerations of whether particular materials are or are not solid wastes
under RCRA.
NMA comprises the producers of most of the nation's coal, metals, industrial and
agricultural minerals; the manufacturers of mining and mineral processing machinery,
equipment and supplies; and the engineering and consulting firms, financial institutions and
other firms serving the mining industry. NMA and its members have, since the inception of
RCRA Subtitle C and the enactment of the Bevill Amendment, been deeply involved in EPA's
efforts to implement the mandates of the Bevill Amendment as it pertains to the mining and
mineral processing industry's wastes. Moreover, NMA in its own right and through its
predecessor organization the American Mining Congress has been intimately involved in
regulatory and judicial developments affecting the agency's definition of solid waste. Thus,
the interests of NMA and its members in the proposed rule are more than clear.
Overview of NMA's Comments
Accordingly, NMA's comments focus on the Inorganics Listing Proposal's relationship to the
scope of the Bevill Amendment as it affects this industry, particularly the mineral processing
sector. It is clear that EPA in this proposed rule has made significant errors in its evaluation
of the Bevill Amendment status of various materials.
Our comments also focus on the Inorganics Listing Proposal's consistency, or lack thereof,
with the RCRA statutory and case law defining the scope of EPA's jurisdiction under RCRA.
Here, again, the agency has made numerous significant errors in evaluating the status of
materials under the statutory definition of solid waste; indeed, it appears that the agency
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has, for the most part, ignored relevant case law or, when acknowledging such case law, has
totally mischaracterized it.
NMA comments also touch on several issues related to the agency's risk assessment. NMA
supports the approach taken in this proposed rule to the use of the Toxicity Characteristics
Leaching Procedure (TCLP) and Synthetic Precipitation Leaching Procedure (SPLP) tests.
Nonetheless, the NPRM takes an inefficient and counterproductive approach by conducting
risk assessments on materials before determining whether or not those materials are wastes
subject to agency RCRAjurisdiction. Furthermore, EPA alludes to but fails to identify so-
called recently raised technical issues that allegedly have caused the agency to forego use of
a basic risk assessment model, the MINTEQA2 model. Finally, NMA comments note that
the agency's risk assessment, particularly for manganese, is very seriously flawed.
Comment 12-1: Procedural Failings of the Proposed Rule
This proposed rule contains some fundamentally unfair procedural shortfalls. We have
noted above the agency's failure to provide any identification, much less explanation, of the
so-called technical issues leading EPA to forego use of the MINTEQA2. Such a failure
substantially deprives interested parties of the ability to comment meaningfully on a key
component of EPA's risk assessment in this proposed rule.
In addition, there is an over-riding issue of procedural fairness: the agency's failure to
provide an adequate period for comment on this proposed rule. The agency has been
working on the substance of this proposed rule, in one form or another, for several years.
The Docket Index for this proposal lists well over 300 documents24, totaling several
thousands of pages, many of them highly technical in nature. Yet the agency allotted only
60 days for interested parties to examine the rulemaking record, determine which issues and
documents were critical to their interests, obtain and analyze those relevant record materials
(only some of which were available on the Internet), and then prepare and submit written
comments on the proposed rule. Even for just one element alone, e.g., the manganese risk
assessment, 60 days is not an adequate period within which to prepare and submit
comments that reasonably address all the critical factors therein.25 In rejecting requests to
24 By August 30, 2000, two weeks prior to the proposal's publication in the Federal Register, there
already were 327 documents in the docket for this proposed rule.
25 NMA endorses the comments submitted by the Lead Industries Association (LIA) on the adequacy of
the comment period and the agency's manganese risk assessment.
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extend the comment period,26 EPA took refuge behind the terms of a consent decree27 and
thus allowed that decree to result in a clearly unreasonable comment period.
Response 12-1: Although the proposal covered many industry sectors, EPA proposed to list only
three wastestreams from two sectors. This limited the number of issues that industry commenters
needed to address. Moreover, some commenters succeeded in submitting very detailed comments.
Finally, although EPA decided not to extend the comment period, it considered numerous late
comments. EPA provided adequate opportunity to comment on this proposal. See response to
comment 12-8 regarding the MINTEQA2 model.
Comment 12-2: EPA HAS INCORRECTLY EVALUATED THE STATUS OF VARIOUS
MATERIALS UNDER THE BEVILL AMENDMENT
Comment 12-2a: EPA Cannot And Should Not Re-evaluate The Bevill Status Of Chloride
Waste Solids From Titanium Tetrachloride Production, And If It Does EPA Must Perform A
Bevill Study and Regulatory Determination.
"Chloride waste solids from titanium tetrachloride production" ("chloride solids") are excluded
pursuant to the Bevill Amendment process from regulation under Subtitle C of the Resource
Conservation and Recovery Act ("RCRA"). 40 CFR § 261.4(b)(7). In the Inorganics Listing
Proposal, EPA states that:
These compounds [chlorinated dibenzo-p-dioxins ("CDPs") and dibenzo-p-furans
("CDFs")] were not assessed, however, as part of the rulemakings which established
the mineral processing exemptions, and so these results could present new issues for
these wastes if such compounds were found to pose unacceptable risks. During the
development of the mineral processing exemption, EPA anticipated certain conditions
might suggest the appropriateness of re-opening these exemptions [footnote omitted].
We are considering whether we should re-assess the status of these wastes as exempt
mineral processing wastes.28
Under the terms of the Bevill amendment and its regulations, EPA is precluded from such "re-
assessment." Moreover, even if EPA had the authority to engage in a re-assessment, the
record does not justify such action. Finally, any such action by EPA would require a Bevill
26 There have been numerous requests made to EPA to extend the comment period on this rule. Such
requests have been submitted by, among others, the American Chemistry Council, LIA, and NMA.
27 The consent decree in question is that reached between EPA and the Environmental Defense Fund
(EOF) as a result of the litigation brought by EOF in EDF v. Browner, D.D.C. Civ.No.89-0598)
28 65 FR 55751
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study and regulatory determination, and must involve industry and other stakeholders in a
meaningful way.
Response 12-2a: As stated in the proposal and as implemented in the final rule, we are not re-
opening the Bevill status of the chloride process solids. These solids remain exempt under
261.4(b)(7).
We disagree with the commenter regarding the premise that EPA is precluded from future re-
assessment of existing Bevill exemptions. Section 3001(b)(3)(A) in no way precludes further
assessments of these materials. The Agency's final Bevill rule (56 FR 27312) promulgated on July
13, 1991 stated that, "If EPA finds that this exemption is not protective of human health and the
environment and if an examination of titanium tetrachloride waste management shows any
continuing or new problems, the Agency will reconsider this subtitle D determination for chloride
process waste solids from titanium tetrachloride production."
While we have limited the scope of the final rule to those activities mandated by consent decree,
we believe the data developed as part of this investigation revealed new information that may
warrant re-assessment with respect to the appropriateness of the 261(b)(7) exemption. In
particular, our study documented the presence of chlorinated dioxins and furans in the solids, for
which the Agency had not previously tested. The proposal also described risks for thallium and
manganese that exceed the Agency's listing thresholds in commingled exempt and non-exempt
solids for the chloride ilmenite sector, in a material that was largely composed of exempt solids.
At some point in the future, apart from this final rule, EPA may conduct additional analyses
regarding this new information as it pertains to the 261.4(b)(7) exemption. Any regulatory
determination stemming from those additional analyses would be compliant with the requirements
of section 3001 and would be subject to all applicable opportunities for notice and comment.
We note that we are deferring final action on all elements of our proposal that are specifically
related to the waste constituent manganese. Please see section IV.B of the preamble to today's
final rule for a further discussion of our decision to defer final action on manganese-related
elements of the proposed rule.
Comment 12-2a(1): EPA lacks the authority to revisit its Bevill Determination for chloride
waste solids from titanium tetrachloride production.
EPA submitted its Second Report to Congress on Mineral Processing Wastes on July 31,
1990. 55 FR 32135 (1990). EPA published its regulatory determination for mineral
processing wastes, including chloride solids, in June 1991. 56 FR 27300 (June 13, 1991).
The Agency has explicitly recognized that its regulatory determinations are "one-time"
decisions that can not be revisited. In EPA's April 1989 proposed rule for the management
of mineral processing wastes, the Agency firmly rejected the idea that additional studies and
regulatory determinations would be done in the future for mining and mineral processing
wastes, emphasizing that the Agency's obligation under RCRA to undertake studies and
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make regulatory determinations were one-time responsibilities. EPA explained that after
"examining the history of the Bevill exclusion in depth," the Agency had determined that the
obligations imposed by Section 8002 were "one-time" obligations even though
"technological advances and changing market conditions may lead to the genesis of new
waste streams . . ." 54 FR 15316, 15337 (Apr, 17, 1989). EPA explained that "a one-time
decision will serve to encourage rather than discourage environmentally sound mineral
production and waste treatment process innovations" and will give industry "substantial
knowledge of the regulatory regime that it will face." 54 FR at 15338. EPA came to its
conclusion that the Report to Congress and the regulatory determination are one-time
obligations because "Congress directed EPA to conduct a single study of wastes generated
by mineral mining . . . and the statutory language includes explicit time limits on the Bevill
exclusion, which apply to the submission of the required Report to Congress and subsequent
regulatory determination." id.29
In promulgating the final rule on mineral processing wastes, EPA once again emphasized
that its duty to report to Congress and make a regulatory determination were one-time
obligations. After the proposed rule, commenters had specifically argued that EPA's
regulatory determinations should not be one-time decisions, and should be revisited in the
future. 54 FR at 36595-56. In response, EPA reiterated its position that after preparing a
report to Congress and a regulatory determination, the Agency had satisfied its obligation
under Section 8002 of RCRA and would not undertake these obligations again, id. at
36596.
EPA also explained that "the 1985 Report, and the subsequent regulatory determination [for]
extraction and beneficiation wastes, discharged its statutory duty with respect to all extraction
and beneficiation wastes." |d. EPA "disagree[d] that it [wa]s necessary for the Agency to
commit to further studies of extraction and beneficiation wastes under section 8002(p)." jd.
In Solite v. EPA, 942 F.2d 473 (D.C. Cir. 1991), NMA and other petitioners challenged
EPA's decision that the Bevill Amendment required only a "one-time" determination. The
D.C. Circuit rejected NMA's challenge, citing Environmental Defense Fund v. EPA, 852 F.2d
1316, 1329 (D.C. Cir. 1988) ("EOF II") for the proposition that "we clearly enough rejected
the theory that Congress intended the coverage of the Bevill exclusion to evolve with time."
Solite, 952 F.2d at 491. The Solite Court upheld EPA's position that the Bevill process was
a one-time event.
Since 1985, industry has been bound by EPA's position, upheld by the D.C. Circuit, that EPA
will not reexamine the status of extraction, beneficiation and mineral processing waste
streams. This position has provided industry and the states with a stable regulatory
29 In an earlier proposed rule on mineral processing wastes, EPA had also stated that "there [would] be
no further studies or regulatory determinations." 53 FR 41288 (Oct. 20, 1988).
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environment that has contributed to a growth in State environmental regulation. The
statement in the Inorganics Listings Proposal cited by EPA from the 1991 preamble where
EPA said it might reconsider its Bevill Determination for chloride waste solids is inconsistent
with, and contradicted by, EPA's long standing statements on the "one time" nature of Bevill
determinations, as well as the Solite decision. Thus, EPA cannot "reassess" the status of
chloride solids.
Response 12-2a(l): We do not read the statute or the Bevill exemption rules to imply that wastes
exempted under the Bevill provisions would forever be shielded from regulation or further re-
assessment. EPA believes that this comment misunderstands both the nature of EPA's and the D.C.
Circuit's statements about the "one-time" nature of EPA's Bevill determinations, as well as the
nature of our decisions here.
In 1989, when EPA was deciding which mineral processing wastes were exempt under the Bevill
Amendment, mining interests argued that the door should be left open to allow additional wastes to
be excluded in the future. EPA refused, reasoning that the Congressionally-mandated process of
excluding wastes under Bevill need only occur once. As EPA explained at the time, the Agency
had previously
proposed to make a one-time determination of Bevill status. Wastes not yet in existence and
wastes not meeting the high volume/low hazard criteria during any of the past five years
would
therefore not be eligible for Bevill exclusion status in the future...
54 Fed. Reg. at 36,595-96 (JA 2138-2139). On review, the D.C. Circuit agreed with the Agency,
ruling that "EPA's position is surely reasonable and we must uphold it." Solite, 952 F.2d at 491.
This comment misunderstands the above-quoted passages, and the Court's holding in Solite
affirming
EPA's position that the Bevill Amendment requires only a "one time determination" that "would
not be
allowed to evolve over time." The cited portion of Solite only addresses whether EPA has an
obligation under the Bevill Amendment to revise its regulatory determinations over time, by
considering whether newly generated waste streams fall within the exemption. The Solite court
held that the statute did not require EPA to continually revise its regulatory determination over
time whenever industry identified waste streams that did not exist at the time EPA made the
determination. 952 F.2d at 491. The Court did not hold that EPA has no discretionary authority to
revise existing Bevill exemptions. Nor did the Court find that EPA could not interpret the scope of
the 1989 regulation as to particular wastes. Since EPA demarcated the scope of the Bevill
exemption for mining and mineral processing wastes, the Agency has on several occasions
determined whether particular wastestreams in fact fall within the original exemption.
In this rulemaking EPA is simply applying the existing exemption for chloride process waste
solids to the wastestreams before it. EPA interpreted the scope of the existing exemption, finding
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that some subcomponents of this waste produced at chloride-ilmenite facilities were included in
the scope of the original exemption, while others were not.
Comment 12-2a (2): The Data Cited By EPA Do Not Justify Any Reassessment of the Bevill
Status of Chloride Solids.
EPA suggests that it is considering a reassessment based on the alleged presence of CDDs
and CDFs in chloride solids. The data which EPA relies on are summarized in the Titanium
Dioxide Listing Background Document for the Inorganic Chemical Listing Determination ("the
Background Document"). Chloride process waste sampling data are reported in the
sampling and Analytical Data Report for Record Sampling and Characterization of Wastes
from the Inorganic Sodium Chlorate and Titanium Dioxide Manufacturing Sectors; Kerr-
McGee Corporation, Hamilton, Mississippi - USEPA, August 10, 1999 ("Hamilton Data
Report" and in Sampling and Analytical Data Report for Record Sampling and
Characterization of Wastes from the Inorganic Sodium chlorate and Titanium Dioxide
Manufacturing Sectors; Kemira Pigments, Inc., Savannah, Georgia - USEPA, September 9,
1999 ("Savannah Data Report"). For the reasons described in detail in the comments of Kerr-
McGee Chemical, LLC, that have been submitted to this docket, CDD and CDF data in
these reports are not valid and cannot be relied upon by EPA to justify any "reassessment" of
chloride solids.
Response 12-2a(2): See our response to comment 8-8b (Kerr McGee).
Comment 12-2a(3): Even If EPA Had the Authority to Reassess the Bevill Status of Chloride
Solids, EPA Would Be Required to Perform a Bevill Study and Regulatory Determination, and
Involve Industry in a Meaningful Way
Even assuming that EPA had the authority to reexamine the Bevill status of chloride solids,
the Agency would first have to undertake a study in compliance with Sections 8002 (f) and
(p) of RCRA. 42 U.S.C. § 6982(0, (p); see also Environmental Defense Fund y. EPA, 852 F.
2d. 1309, 1310 ("EOF II"). Congress stipulated that the following factors were to be
considered in the study:
1. source and volumes of the waste generated per year;
2. present disposal and use of the waste;
3. potential danger to human health and the environment from the disposal and reuse of
the waste;
4. proof of actual danger (through documented cases) to human health and the
environment;
5. alternatives to current disposal methods;
6. the costs of such alternatives;
7. the impacts of those alternatives on other natural resources; and
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8. current and potential use of the wastes.
42 U.S.C. §§ 6982(0, (p); 51 FR at 24,497. The Agency would also have to evaluate
existing federal and state regulatory controls. 42 U.S.C. § 6982(p). Data collection
activities would include, among other things, soliciting public comments, obtaining updated
data on waste characteristics and waste management and conducting an in-depth
examination (far beyond what is currently in the record) of the extent to which any of the
wastes have been implicated in environmental contamination incidents. Industry and the
states would have to be included as integral and meaningful parts of the study process.
When the study was completed, the Agency would then have to publish a report detailing the
results of the study and submit that report to Congress. 42 U.S.C. § 6982(p).
Within six months after the Agency reports to Congress, EPA would have to make a
"regulatory determination" based upon the findings of the study, |d. § 6921(b)(3)(C). As the
D.C. Circuit held in EOF I, "it is appropriate for the regulatory determination to be based on
consideration of all the factors enumerated in section 8002(p)." EOF I, 852 F.2d at 1314-
1315." EPA would have to hold hearings and provide an opportunity for public comment on
the regulatory proposal before finalizing any regulations, |d. § 6921(b)(3)(C).
It is clear, therefore, that to "reassess" the Bevill status of chloride solids, EPA would have to
complete a Report to Congress and make a regulatory determination, both to be based on
the factors set forth in RCRA. Failure to do so would doom any such "re-assessment" by EPA.
Response 12-2a(3): While the Agency disagrees with the commenter that it does not have the
authority to conduct such reevaluations, in today's rule the Agency is not changing the Bevill status
of any of the 20 Bevill exempt mineral processing waste streams noted at 40 CFR 261.4(b)(7).
EPA takes no position today on the procedural requirements for such a re-evaluation.
Comment 12-3: EPA Has Unlawfully Concluded That Waste Streams Generated From The
Production Of Barium Carbonate from Primary Barite Ore Are Not Bevill Exempt
When evaluating barium carbonate production, EPA identifies a "Georgia facility" that "uses
locally mined barite ore, containing barium in the form of barium sulfate, as the primary
feedstock." EPA states that "[t]he ore is crushed and milled, thermally reduced in a roasting
kiln, and leached with water to dissolve the barium." Subsequent production steps follow.
EPA alleges that wastes produced from these crushing and milling operations, as well as
wastes generated from the roasting and leaching operations, are not beneficiation wastes.
65 FR 55706. EPA apparentlyjustifies this conclusion based on footnote 29, which asserts
that "primary barite ore has widespread use in drilling muds for the petroleum and numerous
other uses, including use as feedstock for barium chemicals." id. EPA's contention is that
because this primary barite ore can be so used, it is what EPA describes as "a saleable
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mineral product," and that any processes using saleable mineral products are chemical
manufacturing, and not beneficiation or mineral processing operations, |d.
EPA's position is contradicted by both the Bevill Amendment and its own regulations.
Congress included the following within the scope of the Bevill Amendment: "solid waste from
the extraction, beneficiation and processing of ores and minerals." 42 U.S. C. sec.
6921(b)(3)(A)(ii). EPA's own regulations identify the industry production operations
performed at the Georgia facility as beneficiation. 40 CFR §261.4(b)(7)(i). "Crushing" and
"grinding" operations fall within the beneficiation definition, id. "Roasting" before leaching,
and the leaching operation itself, are included as "beneficiation" activities, |d. Because all of
these beneficiation operations use primary barite ore, or materials containing minerals from
primary barite ore, as feedstock, the wastes generated from these operations are Bevill
exempt. Moreover, wastes generated from any other operations that qualify as Bevill wastes
under the statutory language and the regulatory definition of beneficiation are beneficiation
wastes and are Bevill exempt, regardless of any EPA analysis that such an operation might
be preceded by a processing or manufacturing step.
Response 12-3: EPA evaluated all of the waste streams associated with the production of barium
carbonate and concluded that none of them meet the criteria for hazardous waste listings under 40
CFR 261.II. Consequently, the Agency does not need to reach a final position on the applicability
of the Bevill exemption to any of these wastes. The statement in the September, 2001 preamble to
the proposed final rule is not a final Agency position on the Bevill exemption for barium carbonate
wastes. The statement in the September, 2001 preamble to the proposed final rule was a tentative
conclusion; the Agency is not taking in this rulemaking any final action on this issue. The issue
concerning the applicability of the Bevill exemption to barium carbonate wastes remains open, and
the commenter may raise its views again in any appropriate regulatory or judicial proceeding.
Comment 12-4: Tailings And Gangue From Kernite Ore Boric Acid Production Are Bevill-
Exempt Wastes
Comment 12-4a: One method by which boric acid is produced is from sodium borate
kernite ore. As EPA describes, it, the boric acid is produced "through a process of
dissolution, classification, thickening, filtration, arid crystallization." With regard to the Bevill
status of these materials, EPA states that "because we propose not to list these wastes, we
did not review the facility's Bevill exemption claims." 65 FR 55712.
While NMA supports EPA's decision not to list these wastes, EPA should find that the tailings
and gangue from kernite ore boric acid production are Bevill exempt. These wastes are
generated from processes that fall within the definition of beneficiation at 40 CFR §
261.4(b)(7)(i). Accordingly, these wastes are Bevill-exempt.
Response 12-4a: Today's rule does not require that the Agency complete a Bevill opinion for
wastes from the production of boric acid. Should NMA or the company wish to secure a Bevill
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opinion on wastes from the production of boric acid, they may make a request for such an opinion
to the authorized state or the EPA region.
Comment 12-5: EPA HAS INCORRECTLY EVALUATED THE STATUS OF VARIOUS
MATERIALS UNDER THE RCRA REGULATORY DEFINITION OF SOLID WASTE
Comment 12-5(a): The Proposed Rule Fails to Recognize The Clear Requirements of the
Statute and of the Relevant Case Law
The preamble to the proposed rule contains a section entitled "Evaluation of Secondary
Materials" (65 FR 55693-94). That section discusses the agency's perception of its RCRA
jurisdiction over secondary materials that are recycled, i.e., whether or not recyclable
secondary materials are "solid wastes" subject to EPA's RCRAjurisdiction. This discussion
provides a general EPA overview of the provisions of 40 CFR 261.2(e), "Materials that are
not solid waste when recycled".
The agency then briefly discusses a line of court cases that, as EPA acknowledges, "hold that
EPA lacks authority to regulate materials that are immediately reused in an ongoing
manufacturing or industrial process." |d. at 55694. This line of cases began in 1987 with
America Mining Congress v. EPA (824 F.2d 1177 (D.C.Cir.)C'AMC I"), includes the D.C.
Circuit's 1990 decision in American Mining Congress v. EPA (907 F.2d 1179)("AMC II"),
and reaches into 2000 with the two most recent D.C. Circuit decisions, Association of
Battery Recyclers, Inc. v. EPA (208 F.3d 1047) ("ABR") and American Petroleum Institute v.
EPAJ216 F.3d50).30
In the ABR case, NMA had challenged EPA's authority to impose RCRA Subtitle C waste
management regulations on the storage of mineral processing secondary materials that were
not discarded. These materials were reused in the industry's on-going production processes.
The ABR Court emphasized that "Congress clearly and unambiguously expressed its intent
that 'solid waste' (and therefore EPA's regulatory authority) be limited to materials that are
'discarded' by virtue of being disposed of, abandoned, or thrown away."31
In the Inorganics Listing Proposal, EPA describes the ABR decision as having "remanded a
rule regulating the reuse of some closely related materials. EPA declares: "We are still
evaluating the impacts of this decision. However, the remand does not affect this [inorganics
listing] rule because we are not relying on the exemptions in the remanded rule." |d. This is
a blatantly disingenuous statement.
30 EPA's preamble discussion omitted another decision in this line of cases, American Petroleum Institute
v. EPA, 906 F.2d 729 (D.C.Cir. 1990)
31 Id. at 1051, citing AMC I, 824 F. 2d at 1190
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The ABR decision did not merely "remand" a rule regulating the reuse of some "closely
related" materials. It did far more. The ABR court vacated those parts of the agency's
mineral processing land disposal rule that impermissibly attempted to expand EPA's RCRA
jurisdiction over mineral processing secondary materials that were not discarded. In striking
down the agency's over-reaching conditional exemption, the ABR court confirmed the prior
regulatory exclusions from the definition of "solid waste" for characteristic sludges and
byproducts. The ABR court left in place the new exclusion (from the definition of solid waste)
for spent materials, since that new exclusion represented a lessening of EPA's regulatory
over-reach.
EPA's September 14 proposed inorganics listing rule deals in a number of instances with
materials that are secondary materials in the primary mineral processing industry (e.g.
baghouse filters and slags from antimony oxide; residues from barium carbonate). This is
precisely the category of materials at issue in the ABR decision, i.e., "mineral processing
secondary materials". To say that these are "closely related materials" is a considerable
understatement, and makes it very difficult to understand why the agency, would ignore the
ABR decision. Nonetheless, it would be as wrong to limit the holding of ABR to "closely
related" materials as it would be wrong to ignore that court decision.32
Thus, it is difficult to understand what EPA means when it says in the Inorganics Listing.
Proposal preamble that the ABR decision "does not affect this [Inorganics] rule because we
are not relying on the exemptions in the remanded rule". Since the ABR court spoke directly
to the issue of EPA's RCRA jurisdiction over the category of mineral processing secondary
materials, and rendered a clear decision limiting the agency's authority in that regard, the
ABR case is directly applicable to other EPA rulemakings that address the recycling of
secondary materials in the mineral processing sector.
Nonetheless, EPA dismisses ABR and its entire line of precedents stretching back to 1987.
The agency ignores the ABR court's declaration, in no uncertain language, that EPA's view of
that line of cases "misapprehends the law of the circuit"33, and that the agency's RCRA
authority is "limited to materials that are 'discarded' by virtue of being disposed of,
abandoned, or thrown away."34
Response 12-5(a): See our response to comment 8-4a and 22-3a-2.
32 EPA introduces a new regulatory concept in this proposal, Le., "closely related" materials. NMA
hopes that EPA is not pursuing yet another unlawful and ultimately futile attempt to elude the clear mandate of
the D.C. Circuit in ABR and in AMC 1: that all secondary materials are solid wastes only if they are discarded,
and that to be discarded those materials must be thrown away or abandoned.
33 ABR, 208 F.3d 1047, 1052.
34 Id. at 1051
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We acknowledge your comments regarding current case law involving the definition of solid
waste, including the Association of Battery Recyclers v. EPA decision. However, as discussed in
the proposed rule, in the context of this rulemaking, we did not make site-specific or waste-
specific determinations on whether or not secondary materials were solid wastes, since we
believed that we could more quickly determine whether they pose a listable risk. As a result of
our risk-based evaluation, in this rule, we are not listing specific wastes that are being recycled or
reclaimed. Therefore, we do not believe that it is necessary for the purposes of this rulemaking to
develop a final interpretation of the new case law, including the Association of Battery Recylers
decision. We do acknowledge that we erred when we said that the Court "remanded" the portions
of the mineral processing rule that expanded our jurisdiction. You correctly point out that the
Court "vacated" these portions of the rule.
Comment 12-5(b): EPA Again Mis-Apprehends the Law: Storage of a Product Prior to Sale Is
Not "Discard" of a Waste
In the preamble's discussion of wastes from the production of titanium dioxide, the agency
notes that one facility produces a product, ferric chloride. Ferric chloride is a product sold
for use as a water and wastewater treatment reagent. In this particular facility's case, the
ferric chloride is stored in a surface impoundment prior to sale. The preamble goes on to
state: "EPA has often considered land-based units, and impoundments in particular, to be
associated with the discard of wastes, rather than the storage of products, because of their
potential for releases to the environment. "65 FR 55759. In footnote 56, EPA continues,
stating that:
Material that is placed in a surface impoundment, where it is capable of posing a
substantial present or potential hazard to human health or the environment when
improperly treated, stored, transported or disposed of or otherwise managed, "by
leaching into the ground, is 'discarded material' and hence a solid waste." (AMC II,
907 F.2d) id.
Were they true, the import of these sweeping agency pronouncements would be to relegate
all surface impoundments, including those that are part of a legitimate production process
or are employed to store raw materials, intermediates, or finished products awaiting sale, to
the status of waste management units. As authority for such a draconian and distorted view,
the agency cites to the API and AMC II cases.
This EPA position was rejected in ABR. Had the agency not discarded the ABR opinion, it
would have realized that EPA has been wrong in its long-held view that the API and AMC 11
cases limited the AMC I holding that, to be subject to EPA's RCRA authority, a material must
be discarded.
In the ABR case, the agency advanced precisely the same view of API and AMC II that it
proclaims in footnote 56 to the Inorganics Listing Proposal. After reviewing the facts and
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holding in API, the ABR Court found that API did not limit AMC I. The ABR Court pointed out
that, in API, the materials at issue had already been discarded; regulation of such discarded
materials thus "is entirely consistent with AMC I."35 Nor was EPA any more successful in
arguing that AMC II had limited AMC I's holding on "discard". The ABR Court explicitly
stated that AMC II "did not disturb AMC I's interpretation of 'discarded'." In AMC II the
materials at issue were listed hazardous mineral processing wastes - sludges generated in
the treatment of wastewaters in surface impoundments. EPA had argued to the ABR court
that these AMC II sludges were entirely recycled, and were not stored in anticipation of
recycling.
The ABR Court looked at the facts and holding in AMC II, declaring that "EPA is flatly wrong
about this" [the quantities of recycled AMC II sludges].36 Noting that AMC II was not at odds
with AMC 1, the ABR Court then emphasized:
The point of AMC II, and for that matter API, is that once material qualifies as "solid
waste" something derived from it retains that designation even if it might be reclaimed
and reused at some future time. In contrast, the Phase IV rule [on mineral processing
secondary materials] seeks to regulate materials that are not a by-product of solid
waste, but a direct by-product of industrial processes.37
In relying on its mistaken views of API and AMC II, the agency continues to misapprehend
the law of the D.C. Circuit, which is particularly surprising in the face of that Circuit's clear
mandate in ABR. In ABR the materials at issue were being stored prior to beneficial reuse; in
the Inorganics Listing Proposal, ferric chloride is stored prior to sale. The ABR Court bluntly
rejected EPA's attempt to impose RCRA hazardous waste management requirements on the
storage of secondary materials held for reuse: "[T]o say that when something is saved it is
thrown away is an extraordinary distortion of the English language. Yet that is where EPA's
definition leads."38 It is a distortion of equal or greater magnitude to argue that storage of a
product prior to sale amounts to "discard" of that product and its management as a "waste".
Response 12-5(b): See comment responses 22-3a-2, 8-4a, and 22-3a-2. EPA is not listing the
ferric chloride sold as a product. Thus, EPA need not reach a conclusion about the storage issue
that the commenter raised. If EPA had needed to determine whether the ferric chloride was a
product rather than a waste, it might have considered storage in an unlined impoundment to be an
indicator that the producer did not value this material highly. This could be a factor in determining
35 ABR at 1054
36 Id. at 1055
37 Id. at 1056
38 ABR at 1053
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whether the material was a waste, especially if other manufacturers of this material used more
secure storage. EPA notes that it is listing solids that separate during ferric chloride storage onsite.
The ferric chloride manufacturer, however, does not claim that these solids are products. Rather,
it manages them as wastes.
Comment 12-5(c): The Proposed Rule Mistakenly Asserts RCRA Jurisdiction Over Off-site
Reuse of Secondary Materials
Since the AMC I decision in 1987, the D.C. Circuit has consistently maintained that
materials "destined for beneficial reuse or recycling in a continuous process by the generating
industry itself are not "solid wastes"subject to EPA's RCRA authority.39 EPA's view of this
case law, a view that is carried over to the Inorganics Listing Proposal, "misapprehends the
law of the circuit."40 Not only does the NPRM wrongly attempt to expand EPA's RCRA reach
to
materials that are not discarded, the NPRM also mistakenly tries to limit "recycling" to the
reinsertion of a mineral processing secondary material into the process that generated the
material originally.
In its discussion of "secondary materials" at 65 FR 55693-94, the preamble notes that the
agency has evaluated risks for materials that are recycled on-site, including materials
"inserted into separate manufacturing processes co-located on-site" with the process that
originally generated the material. EPA also considered "the risks of materials recycled off
site". 65 FR 55694. One specific example is that of antimony oxide residuals shipped off
site to another smelter:
In one case involving antimony oxide residuals, we found that the residuals were sent
off-site to another smelter producing antimony oxide. This smelter happens to be
located outside of the country. We did not evaluate risks from its residuals, as we
have no legal jurisdiction to regulate them. We have evaluated the production of
antimony oxide within the U.S. in this rulemaking, so we have evaluated the risks that
would be posed if this generator changed its practice and sent the materials to an
antimony oxide smelter located within the U.S. id.
Thinly disguised in the above agency approach is an attempt to expand EPA's regulatory
reach to materials that are reused off-site, even when the reuse occurs as part of an on-
going industrial process. Here, antimony oxide residuals are sent off-site to another
antimony oxide facility so that the antimony values may be recovered. These materials are
not wastes; they are precisely the kind of mineral processing secondary materials that the
39 Id., citing AMC I, 824 F. 2d 1186 (italics in original)
40 Id. at 1052
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ABR Court, following the line of cases beginning with AMC I, found were not "discarded" and
thus were not "part of the waste disposal problem".41
To narrow the world of legitimate reuse options not only is unlawful, it is environmentally
counter-productive. NMA endorses the comments submitted by the Doe Run Corporation on
this point, as those comments go directly to the very practical need to recycle materials in
units that can recover the sought-after values. Indeed, were the final Inorganics Listing
Proposal to limit reuse options to reinsertion into the original generating unit, such an ill-
founded rule would cause the loss of valuable, recoverable mineral resources by subjecting
mineral processing secondary materials to a RCRA Subtitle C hazardous waste management
regime, in direct contradiction of the statute's definition of "solid waste" and the AMC I -ABR
line of cases confirming the statutory limits to EPA's RCRA authority.
Response 12-5(c): See comment responses 12-5(a), 22-3a-2, 8-4a, and 22-3a-2.
Comment 12-6: NMA SUPPORTS THE PROPOSED RULE'S USE OF THE TCLP AND SPLP
TESTS
In the Inorganics Listing Proposal, EPA proposes to use results from either the Toxicity
Characteristics Leaching Procedure (TCLP) or the Synthetic Precipitation Leaching Procedure
(SPLP), depending on the disposition of the particular waste streams. Results of the TCLP will
be employed where the waste is disposed of in a municipal solid waste (MSW) landfill; SPLP
results will apply where disposal in an MSW landfill is not likely. EPA states in the preamble:
We believe the TCLP is the most appropriate leaching procedure to use for wastes in
municipal landfills, because the leaching solution is similar to the type of leachate
generated from the decomposition of municipal waste...The SPLP test uses a leach
solution which mimics acid rain, while the TCLP uses a leach solution which mimics
acids formed in municipal landfills ...For today's [Inorganics] rule ...we have specific
data showing that some wastes do not go to municipal landfills and are unlikely to be
disposed of in municipal landfills. We used the SPLP sampling results for wastes that
were not likely to go to municipal landfills, and we used the TCLP results for wastes
going to municipal landfills. 65 FR 55695
In its comments on EPA's 1997 proposed land disposal restrictions (LDR) rule,42 NMA offered
as an alternative approach to the blanket, indiscriminate use of the TCLP. In fact, NMA
suggested precisely the approach that EPA proposes to take in the Inorganics Listing
Proposal. Indeed, in that 1997 proposed LDR rule, the agency had not demonstrated that
mineral processing wastes were "likely" to be disposed of in MSW landfills, only that there
41 AMC I, 824 F.2d 1186, cited in ABR at 1053
42 62 FR 26041 (May 12, 1997)
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were some "possible" or "potential" cases of disposal in an MSW landfill. As NMA stated in
its comments:
At most, the TCLP should be used in those cases (if any) where mineral processing
wastes are actually co-disposed in MSW landfills. As discussed in detail in its
comments on the January 25, 1996 Supplemental Phased IV proposal, NMA would
support a contingent management approach in which the leaching test to be applied
to a mineral processing waste would depend upon the type of landfill in which the
waste is disposed.43
Although the agency has not heretofore responded to NMA's 1997 suggestion on the use of
the TCLP and SPLP tests, we believe that the approach EPA proposes in the Inorganics Listing
Proposal is well-founded and reasonable.
Response 12-6: EPA acknowledges NMA's support of the rule.
Comment 12-7: THE PROPOSED RULE TAKES AN INEFFICIENT AND
COUNTERPRODUCTIVE APPROACH TO CONDUCTING RISK ASSESSMENTS
EPA announces in the September 14 preamble that, for almost all of the proposed rule's
recycled inorganic chemical residuals, the agency has
decided not to attempt to determine whether the recycling practice is not subject to
regulation under the court decisions [AMC I, AMC 11, API, ABR1 and regulations
described above. Such determinations can be very time-consuming ....Consequently,
we decided that it would be more efficient to examine first the potential risks posed by
the reported recycling practices ...If ..we found risks, we evaluate the recycling
practice prior to making a listing decision. 65 FR 55694
In other words, instead of limiting its inquiry to materials that were truly discarded and thus
within the agency's legitimate RCRA authority, EPA began by looking for risks in recycling
practices. Then, if EPA found risks in the recycling practices, it would move on to consider
whether or not the material in question was to be a listed hazardous waste.
It is unclear when, or how, the agency ever made clear determinations in this proposed rule
as to the limits of its legitimate RCRA authority over various secondary materials.
Nonetheless, the agency appears to have made such decisions at some point because, a
few paragraphs after declaring that it would not make determinations on whether or not a
43 NMA incorporates herein by reference its comments of August 11,1997, on EPA's May 12,1997,
Land Disposal Restrictions Phase IV Second Supplemental Proposal (62 FR 26041, Docket No. F-97-2P4P-
FFFFF). NMA also incorporates by reference its April 24, 1996, comments on EPA's Land Disposal Restrictions
Supplemental Proposal to Phase IV (61 FR 2338, January 25, 1996).
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recycling practice was subject to agency RCRAjurisdiction, EPA then declared "[W]e felt we
were evaluating all of the potential risks within our jurisdiction associated with the recycling
of these materials." |d.
On the one hand, the agency has conducted numerous risk assessments on multiple
materials without considering whether or not those materials were subject to legitimate RCRA
jurisdiction. While the agency pleads that such determinations "can be very time-
consuming", the agency chose to ignore the statute itself and relevant case law, both of
which would have rendered such determinations considerably less time-consuming. On the
other hand, the agency contradicts itself in the space of a few paragraphs when it declares
that it believes it has evaluated all the "potential risks within our jurisdiction associated with
the recycling of these materials."
Clearly the agency cannot have it both ways. It cannot ignore the mandate of ABR and AMC
1 on the limits of agency RCRAjurisdiction, yet declare that it has examined all the risks from
practices within itsjurisdiction. Until such time as the agency acknowledges the mandate of
the statute and this line of cases, the Inorganics Listing Proposal will remain critically flawed.
Response 12-7: The parenthetical statement "within our jurisdiction" in column 2 on page 55694
that the commenter points out gives the wrong impression of EPA's approach to solid waste issues
for this rule. As stated earlier in the preamble, EPA did not determine whether any particular
recycling practice fell within its Subtitle C jurisdiction. Rather, EPA assumed, for purposes of
evaluation, that all of the recycling practices might fall within itsjurisdiction, and evaluated the
risks presented. The phrase probably should have read "within the scope of the consent decree."
See also comment responses 12-5(a), 22-3a-2, 8-4a, and 22-3a-2. See comment responses 12-
5(a), 22-3a-2, 8-4a, and 22-3a-2.
Comment 12-8: EPA FAILS TO EXPLAIN ITS RELUCTANCE TO EMPLOY THE MINTEQA2
MODEL
In its discussion of the risk assessment and, in particular, for the groundwater pathway risk
assessment, EPA announces that it is foregoing the use of a mathematical model that it had
in the past employed when seeking to model contaminant concentrations in groundwater.
The agency states that it has
used the MINTEQA2 equilibrium speciation model to estimate Kd's for a variety of
metals rather than relying solely on field measurements. However, recently a number
of technical issues have been raised concerning the model and its application. EPA is
in the process of evaluating the model to address those issues. Therefore, we have
decided not to use the MINTEQA2 for today's proposed rule. 65 FR 55698
The agency offers no further explanation of its decision to abandon the MINTEQA2 in this
instance. Nor does EPA identify even one of the "number of technical issues that have been
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raised concerning the model and its application." This is hardly a fair way to inform the
public of the basis for a very important and fundamental decision on groundwater risk
assessment. The Agency's behavior does not afford the public any opportunity to assess the
soundness of the reasons behind the agency's decision. This failure to provide a basis for
reasonable public comment on a crucial aspect of the proposed rule constitutes a significant
procedural deficiency in the Inorganics Listing Proposal, rendering at least this aspect of the
Proposal arbitrary and capricious.
NMA notes that a paper critical of the MINTEQA2 model has appeared in several RCRA
regulatory proceedings over the last 18 months. Prepared by Charles H. Norris and
Christina E. Hubbard on behalf of the Environmental Defense Fund, Friends of the Earth,
Hoosier Environmental Council, and the Mineral Policy Center, the paper is entitled "Use of
MINTEQA2 and EPACMTP to Estimate Groundwater Pathway Risks from the Land Disposal
of Metal-Bearing Wastes" (Final Report, June 1999)44. The Norris & Hubbard paper alleges
that EPA has made a number of errors and faulty assumptions in using the MINTEQA2, and
that these errors and faulty assumptions have caused the agency to underestimate metals
mobility.
Because of EPA's failure to identify, much less explain, its reasons for not using the
MINTEQA2 model, NMA can only assume that the Norris & Hubbard paper may be playing
a role in that agency decision. Nevertheless, NMA points out that the Norris & Hubbard
paper has itself been carefully analyzed and found seriously lacking in some very crucial
respects. Gradient Corporation has conducted a very thoughtful evaluation of the Norris &
Hubbard critique of the MINTEQA2 model.45
Entitled "Evaluation of the Norris and Hubbard Critique of the MINTEQA2 and EPACMTP
Models", the Gradient Report concluded that Norris and Hubbard's claims:
adopt a hydrous ferric oxide surface area, a key determinant of metal binding
sites to soil or porous media, that is orders of magnitude lower than values
supported by scientifically proven data;
44 Hereafter the "Norris & Hubbard paper". This paper has been submitted to EPA by the above groups
in comments on the agency's then-pending Bevill Amendment regulatory determination on fossil fuel combustion
by-products (Docket No. F-1999-FF2P-FFFFF). It also has appeared in the administrative record for the
agency's efforts to develop a "Guide to Industrial Waste Management" (Docket No. F-1999-1DWA-FFFFF).
45 A copy of the Gradient report is included with these comments. The Gradient Report was prepared at
the request of the American Coal Ash Association, the American Forest & Paper Association, the Edison Electric
Institute, the Lead Industries Association, and the National Mining Association.
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rely upon colloid transport mechanisms that are based on theoretical
considerations and limited laboratory data, but remain inconclusive and lack
field testing;
yield elevated estimates of metal concentrations in groundwater that are
contradicted by tens of thousands of actual field measurements; overstating
their mobility and threat to human health and the environment.46
As a result of these errors in its revised assumptions, the Norris & Hubbard paper yielded "a
very restrictive set of extreme conditions"47 when the MINTEQA2 was run using those
assumptions. The changes advocated by Norris & Hubbard paper "yield isotherm results
that are implausible".48 That paper adopted an unsupported value for iron chemistry, which
then was used as a basis for the paper's colloid analysis, in itself a factor "does not appear
to substantially affect metal mobility with the possible exception under conditions where
metal concentrations are low, precisely those conditions where the threat to human health
and the environment is low."49 Gradient further concluded that the Norris & Hubbard paper
had miscalculated the lead isotherm value by a factor of at least 100, and perhaps
10,000.50
Thus, to the extent that EPA has relied on factors identified in the Norris & Hubbard paper as
reasons for deciding not to employ the MINTEQA2 model, that decision is not well founded.
Response 12-8: As noted by the commenter, EPA has received public comments on our use of
MINTEQA2 equilibrium metals speciation model in previous rulemakings to estimate partition
coefficients. These comments included the Norris and Hubbard paper referred to by the
commenter51, as well as other comments. EPA is in the process of evaluating all of the comments
received on MINTEQA2, including the Norris and Hubbard paper and has not reached any final
conclusions. (EPA notes that the overall effect of the Norris and Hubbard suggestions would
generally be to estimate lower partition coefficients.) However, as indicated in the preamble to
the proposed rule, EPA is concerned enough about the comments received to warrant not using the
model in the current rulemaking. The approach taken in the proposed rule that relies on empirical
46 Gradient Report at 2 (footnotes omitted)
47 Jd, at 3
48 Id. at 18.
49 Id. at 1 9
51Norris, C.H. and C.E. Hubbard, "Use of MINTEQA2 and EPACMTP to Estimate
Groundwater Pathway Risks from the Land Disposal of Metal -Bearing Wastes".
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data for specifying soil-water distribution coefficients (IQ's) is well accepted in the field of
ground water transport modeling. Furthermore, all Kd values used for the proposed rule were fully
documented in the risk assessment background document (see "Risk Assessment for the Listing
Determinations for Inorganic Chemical Manufacturing Wastes, " August, 2000). Therefore,
EPA believes the information available to the public on the modeling approach that EPA chose
was adequate for notice and comment purposes. EPA notes that the commenter did not submit any
comments challenging any of the Kd values derived from empirical data. Nor did the commenter
criticize the empirical data approach. Finally, EPA notes that the commenter has not explained
how it was harmed-or could potentially be harmed by the decision to use Kd's derived from
empirical data rather than the MINTEAQA2 model.
Comment 12-9: EPA's Risk Assessment for Manganese Is Very Seriously Flawed
Kerr-McGee Chemical, LLC, ("Kerr-McGee") has submitted to EPA very thoughtful and
thorough comments concerning aspects of the Inorganics Listing Proposal dealing with
manganese.52 NMA endorses, and incorporates by reference, the Kerr-McGee comments.
Response 12-9: EPA refers the commenter to its responses to the Kerr-McGee comments
(specifically, to response 8-6).
Conclusion
The Inorganics Listing Proposal has made fundamental errors regarding the Bevill
Amendment. For instance, EPA should not, indeed, cannot, re-evaluate the Bevill
Amendment status of chloride waste solids from titanium tetrachloride production; were it to
do so, the agency is under a statutory obligation to conduct a study and regulatory
determination pursuant to the Bevill Amendment.
Moreover, EPA's conclusion that waste streams from production of barium carbonate from
barite ore are not Bevill-exempt wastes is unlawful. In addition, the Inorganics Listing
Proposal fails to recognize that tailings and wastes from kernite ore production of boric acid
are also Bevill-exempt wastes.
Despite the agency's claims that it is still evaluating the implications of the court's decision in
Association of Battery Recyclers v. EPA, it appears from the Inorganics Listing Proposal that
the agency is ignoring, not evaluating, that decision. The proposed rule ignores the statutory
mandate, as confirmed in ABR and AMC I, that materials are solid wastes subject to EPA's
RCRAjurisdiction only if those materials are discarded, i.e., thrown away or abandoned. To
the extent that the Inorganics Listing Proposal pays any attention to the ABR decision, the
52See "Comments on Proposals With Respect To Manganese" (November 10, 2000) submitted by Kerr-
McGee Chemical, LLC, as part of Kerr-McGee's overall comments on the Inorganics Listing Proposal.
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Proposal attempts to limit the court's holding to materials that are "closely related" to the
materials at issue in the Inorganics Listing Proposal.
In addition, the agency continues to misapprehend the law by asserting in this proposed rule
that surface impoundment storage of a product prior to sale equates to waste management
subject to Subtitle C. Furthermore, the Inorganics Listing Proposal mistakenly asserts RCRA
jurisdiction over off-site reuse of secondary materials.
NMA reiterates its support for the proposed uses of the TCLP and SPLP tests, as set forth in
the Inorganics Listing Proposal.
The Inorganics Listing Proposal takes a wasteful and counterproductive approach when it
insists on conducting risk assessments on recycling practices instead of first determining
whether materials in question had been discarded by being abandoned or thrown away, and
thus were truly within EPA's legitimate RCRA authority.
EPA's failure to identify, much less explain, its reasons for failing to employ the MINTEQA2
model have substantially deprived the public of any meaningful opportunity to comment on
a crucial aspect of the proposed rule's groundwater risk assessment. To the extent that EPA,
in making the decision to forego use of MINTEQA2, relied on factors set forth in the Norris &
Hubbard paper, it must be remembered that the Norris & Hubbard paper has been shown
(in the attached Gradient Corporation report) to be critically flawed. Thus, any decision
based on the Norris & Hubbard paper also lacks a sound foundation.
The Inorganics Listing Proposal's risk assessment for manganese is very seriously flawed, as
demonstrated in the comments filed by Kerr-McGee Chemical, LLC.
Finally, NMA regrets that EPA refused to extend the comment period on the Inorganics Listing
Proposal. The lack of an adequate comment period, together with the agency's failure to
identify or explain its rationale for not using the MINTEQA2 model, are two decisions that
render this rulemaking arbitrary and capricious.
Response to Conclusion: See the responses to the individual issues raised in comments and
responses 12- 1 through 12-8. Also note that we are deferring final action on all elements of our
proposal that are specifically related to the waste constituent manganese. Please see section IV.B
of the preamble to today's final rule for a further discussion of our decision to defer final action on
manganese-related elements of the proposed rule.
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