Wednesday
November 30, 1994
U.S. EPA
OPPTS Chemical Library
EPA West Room 337? MC7407T
1200 Pennsylvania Ave. NW
Washington DC 20460-0001
Part V
Environmental
Protection Agency
40 CFR Part 372
Addition of Certain Chemicals; Toxic
Chemical Release Reporting; Community
Right-to-Know; Final Rule
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61432 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[OPPTS-400082B; FRL-4922-2]
RIN2070^AC47 •
Addition of Certain Chemicals; Toxic
Chemical Release Reporting;
Community Rlght-to-Know
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule..
SUMMARY: EPA is adding 286 chemicals
and chemical categories, which include
39 chemicals as-part of two delineated
categories, to the list of toxic chemicals'
subject to reporting under section 313 of
the Emergency Planning and
Community Right-to-Know Act of 1986
(EPCRA) and section 6607 of the
Pollution Prevention Act of 1990 (PPA).
The additions of these chemicals and
chemical categories are based on their
acute human health effects,
carcinogenicity or other chronic human
health effects, and/or their adverse
effects on the environment. EPA is
taking this action pursuant to its
authority to add to the list those
chemicals and chemical categories that
meet the EPCRA section 313(d)(2)
criteria .for addition to the list of toxic
chemicals. EPCRA section 313 reporting
for the newly listed chemicals and
chemical categories will be required :
beginning with the 1995 calendar year.
As such, the first reports for the added
chemicals and chemical categories must
be submitted to EPA and States by July
1, 1996.
EFFECTIVE DATE: This rule is effective
November 22,1994.
FOR FURTHER INFORMATION CONTACT:
Maria J. Doa, Project Manager, 202-260-
9592, for specific information regarding
this final rule. For further information
on EPCRA section 313, contact the
Emergency Planning and Community
Right:to-Know Information Hotline,
• Environmental Protection Agency, Mail
Stop 5101, 401 M St., SW., Washington,
DC 20460, Toll free: 800-535-0202,
TDD: 800-553-7672.
SUPPLEMENTARY INFORMATION: .
I. Introduction
A. Statutory Authority
This rule is issued under section
313(d) of the Emergency Planning and
Community Right-to-Know Act of 1986
(EPCRA), 42 U.S.C. 11001 etseq..
EPCRA is also referred to as Title III of
the Superfund Amendments and
Reauthorization Act of 1986.
B. Background
Section 313 of EPCRA requires certain
facilities manufacturing, processing, or
otherwise using listed toxic chemicals
to report their environmental releases of
such chemicals annually. Beginning
with the 1991 reporting year, such
facilities also must report pollution
prevention and recycling data for such
chemicals, pursuant to section 6607 of
the Pollution Prevention Act, 42 U.S.C.
13106. Section 313 established an initial
•-list of toxic chemicals that was
composed of more than 300 chemicals
and 20 chemical categories. Section
313{d) authorizes EPA to add or delete
chemicals from the list, and sets forth
criteria for these actions. Under section
313(e), any person may petition EPA to
add chemicals to or delete chemicals
from the list. EPA issued a statement of
petition policy and guidance in the
Federal Register of February 4,1987 (52
FR 3479), to provide guidance regarding
the recommended content and format
for petitions. On May 23, 1991 (56 FR
23703), EPA issued guidance regarding
the recommended content of petitions to
delete individual members of the
section 313 metal compound categories.
II. Background
On January 12,1994 (59 FR 1788),
EPA issued a proposal in the Federal
Register to add 313 chemicals and
chemical categories to the list of toxic
chemicals under EPCRA section 313
based on their acute human health
effects, carcinogenicity or other chronic
human health effects, and/or their
environmental effects. EPA's decision to
add the chemicals and chemical
categories in today's rule to the section
313 list is based on a further assessment,
in light of public comments of both the
relative toxicity of the chemicals-the
potency of the chemical's inherent
toxicity-dnd a careful consideration of
the type of adverse effect the chemical
causes or can reasonably be anticipated
to cause. Under section 313(d)(2)(A)
(acute human toxicity), the effect must
be "significant." Under section
313(d)(2)(B) the effect must either be
cancer or teratogenicity, or some other
"serious or irreversible" chronic health
effect. Under section 313(d)(2)(C)
(environmental toxicity) the effect must
be "significant" and "of sufficient
seriousness in the judgment of'the
Administrator'' to warrant reporting.
The'statute does not specify, how .
serious or significant an effect must be
in order for a chemical to be listed
under any of the criteria. This •
determination is Jeft to the EIWs
discretion, and scientific judgment. The
Agency recognizes that not every
adverse .effect is sufficiently significant
or serious to satisfy the criteria. For
chemicals with effects that satisfy the
criteria, Congress made it clear in
section 313 that communities have a
right to know about releases of such
chemicals. The Agency's goal in
implementing section 313 is to ensure
that the communities are provided with
that release information to allow them
to further educate themselves and, if
appropriate, take or recommend action.
A brief description of the selection
process follows, however, a detailed
description of EPA's methodology and
rationale for the proposed addition of
these chemicals and chemical categories
can be found in the proposed rule.
1. Development of the chemical
addition list. As a starting point for
screening candidates for addition to the
toxic chemical list under EPCRA section
313, EPA chose to examine the lists of
chemicals regulated or identified, as of
concern, under various environmental
statutes including: Section 112(b) of the
Clean Air Act (CAA) as amended in
1990 (Hazardous Air Pollutants); (2)
section 602(b) of the CAA (Class II
ozone depleting substances); (3) section
307(a) of the Clean Water Act (CWA)
(Priority Pollutant List); (4) Federal
.Insecticide, Fungicide, and Rodenticide
Act (FIFRA) Active Ingredieiits,
including Special Review, Canceled/ ••-
Denied or Suspended, and Restricted
Use Pesticides; (5) section 302 of EPCRA
(Extremely Hazardous Substances); (6)
section 102 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA); (7) section 3001 of the
Resource Conservation and Recovery
Act (RCRA) and chemicals listed at 40
CFR 261.33(e) and Appendix VIII; (8)
section 1412 of the Safe Drinking Water
Act as amended; (9) certain chemicals
subject to the Toxics Substance Control
Act (Existing Chemicals); and (10) the
State of California Safe Drinking Water
and Toxic Enforcement Act of 1986
(Proposition 65) (List of Chemicals
Known to the State to Cause
Reproductive Toxicity); and/or tiiose
chemicals designated as possible,
probable, or known carcinogens in the
Monographs of the International Agency
for Research on.Cancer (IARC) and the '
6th Annual Report on Carcinogens of
the National Toxicology Program (NTP),
U.S. Department of Health and Human
. Services (DHHS).
2. Screening of chemicals. To
prioritize chemicals for possible
addition to EPCRA section 313, EPA
applied a human health and ecotoxicity
Screen and a production'volume screen,
which are described below.
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, Federal Register A, Vol. 59, No, 229 /-Wednesday, November 30, 1994 /Rules and: Regulations61433
. a. Toxicity screen. A toxicity screen is
a limited review of readily available
toxicity data dial is used for a
preliminary categorization of a chemical
during the process of selecting
candidates for .possible listing under
EPCRA section 313. The toxicity screen
is used to identify chemicals for further
consideration and does not reflect a :
final determination for listing a
chemical under EPCRA section 313.
Such a determination can only be made
after a hazard assessment is conducted
. (See Unit II.3. of this preamble). The
chemicals identified above were
screened for four general effect .
categories: Acute human health effects,
cancer, other chronic human health
effects, and ecological effects.
The screening criteria associated with
each of the effect areas used in the
toxicity screen are discussed in detail in
the Revised Draft Hazard Assessment
Guidelines for Listing Chemicals on the
Toxic Release Inventory (Draft Hazard >
Assessment Guidelines), (Ref. 11). Based
on the results of this screen, the
chemicals Were preliminarily .placed in
one of three screening categories
defined in the Draft Hazard Assessment
Guidelines: "high priority;" "medium
priority;" or "low priority."
Chemicals that were categorized as
"low priority" during the.screening .
process were not considered further as
candidates for a'ddition to the EPCRA
section 313 list in this rulemaking.
b. Production'volume screen. EPCRA
section 313(f) establishes reporting
thresholds of either 25,000 or 10,000
pounds per facility per year related to
the amount of a chemical that is
manufactured, processed, or otherwise
used. EPA anticipates that the addition
of chemicals manufactured, imported,
processed, or used in quantities less
than the EPCRA section 313 activity
thresholds would not result, in the
submission of Toxic Release Inventory
(TRI) reports. Thus, EPA elected to
focus its attention on chemicals likely to
yield reports and also screened potential
candidates for the likelihood of meeting
the EPCRA section 313 volume
thresholds. Chemicals for which there'
were no data to indicate that the -
chemical is likely to meet or exceed the
EPCRA section 313 volume thresholds
were not considered further as possible
candidates for addition to the section
313 list at this time.
3. Hazard evaluation. After
completing the screening phase, EPA
conducted a thorough hazard. '
assessment.'for each of the addition , : ;
candidates that resulted from the above <
analyses and-determined based on the •
weight-of-the evidence if ithere was ••...-,
sufficient evidence.to establish thaMhe •
candidate chemical met the statutory
criteria for addition to EPCRA section
313. To make this determination, EPA
senior.scientists reviewed readily
available toxicity information on each
chemical for each of the following effect
areas: acute human health effects;
cancer; other chronic human effects;
and environmental effects. In addition,
EPA reviewed, where appropriate,
information on the environmental fate
of the chemical.
The hazard assessment-was
conducted in accordance with relevant
EPA guidelines for each .adverse human
health or environmental effect (e.g., the
appropriate guidelines for hazard
evaluation of chemical carcinogens and
for the type of evidence required to
/substantiate a determination of
carcinogenicity are the .Assessment
Guidelines for Carcinogen Risk (Ref. 4)).
During this assessment the number,
severity, and significance of the effects
induced by the chemical, the dose level
causing the effect, and the quality and
quantity of the available data, including
the nature of the data (e.g., human
epidemiological, laboratory animal,
field or workplace studies) and
confidence level in the existing data
'base, were all considered. Where a
careful review of the scientific data for
a particular chemical results in a high •
level of confidence that the chemical
• causes an adverse effect at relatively low
dose levels, EPA believes that this
evidence is sufficient for listing the •
chemical under section 313. EPA also
believes that where a review of the
scientific data indicates that the
chemical will cause various adverse
effects at moderate dose levels, the total
weight-of-the-evidence indicates that
there is sufficient evidence for listing
the chemical under EPCRA section 313.
EPA believes that both types of
chemicals described above exhibit
moderately high to high toxicity based
on a hazard.assessment.
EPA also conducted an analysis of
exposure for each chemical or chemical
category proposed for listing under
EPCRA section 313(d)(2)(A) (i.e., based
on adverse acute human health effects),
and, where appropriate, under section
313(d)(2)(C) (i.e., based on adverse
ecological effects). For chemicals listed
under EPCRA section 313(d)(2)(A), this
analysis included estimated
concentrations of the chemical at or
beyond the facility site boundary
through the use of estimated releases
and modelling techniques. EPA did not
conduct-an analysis of exposure for the
chemicals proposed for listing Under •
section 313(d)(2)(B) because these • ! :
chemicals'exhibit moderately high to ; '
high toxicity based on a hazard ' :; '•
assessment (see Unit IV.B; for a .
discussion of the use of exposure). As
discussed more thoroughly in Unit IV.B.
of this preamble, EPA does not believe
that it is appropriate to factor exposure
into the listing decisions for the
chemicals being listed pursuant to
section 313(d)(2)(B) in.this rulemaking.
Following a review and analysis of
the information available about each
chemical in this final rule (including
information provided through public
comment) by senior Agency scientists,
the Agency concludes that for each of
the chemicals listed one or more of the
EPCRA section 313 listing criteria are- '.
met. Moreover, the ad verse: effects
associated with each of the chemicals
being listed today are serious and
significant. In some cases the effects are
extreme, such as cancer or death.-In'
others, the effects are serious and
lasting, including, for example, >-.
impairment of a fetus' or an offspring's
physical development, neurological
effects inhibiting motor abilities or
mental processes or impairing the
ability to reproduce, or the :
sustainability of a fragile ecosystem
such as an estuary. For a number of
chemicals in the final rule, there is more
than one adverse effect. .
It is important to understand that
although an adverse effect is known or
can-be reasonably, anticipated to be
caused by a chemical on the section 31-3
list, a release of a chemical into a
community does not necessarily mean
that the effect will occur. Exposure and
dose, are also important factors in
determining whether an adverse effect
occurs and how serious the
manifestation will be. The listing of a
chemical on the section 313 list does
not mean that a particular community
will experience these adverse effects.
Instead the purpose for listing a
chemical is to ensure that the public
gets information about releases of such
chemicals. Thus; EPA believes that for
chemicals that typically do not affect
solely one or two species but rather
affect changes across a whole ecosystem
and for which there is well-documented
evidence supporting the adverse effects,
that their addition to the EPCRA section
313 list is warranted even though the
severity of the adverse effects that they
induce will be.dependent upon site-
specific characteristics. Once EPA
makes release data available through
TRI, the community may then make its
own determinati.on-6'ri the importance of
these releases (and their'potential
adverse effects).
The expansion of the EPCRA section
313 toxic chemical list is the first phase
of the expansion1 bflhe TRI program. "'.
EPA plans to issue a proposed rule'in '-
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61434 Federal Register / Vol. 59. No. 229 / Wednesday. November 30. 1994 / Rules and Regulations
early 1995 expanding the scope of
industry sectors that would be subject to
EPCRA section 313. EPA's initial
analysis for this effort is focused on
industrial sectors which have activities
related to manufacturing that result in
significant releases of chemicals listed
on EPCRA section 313. EPA is also
considering further expanding right-to-
know by investigating the feasibility of
adding data on exposure to and use of
chemicals at TRI facilities. The Agency
believes-that the collection of this type
of data would provide a greater
understanding of risk reduction and
pollution prevention opportunities.
In conjunction with these expansion
activities, the Agency is also
considering situations where data of
lesser value can be removed from the
TRI system. Elsewhere in this issue of
the Federal Register, EPA is
promulgating a rule establishing an
alternate threshold for facilities with
low annual reportable amounts of listed
toxic chemicals. This alternate
threshold will provide considerable
relief for facilities which generate
"small" amounts of EPCRA section 313
chemicals in reportable amounts. This
relief will offset the increased burden
that this expansion rule may impose.
The alternate threshold for manufacture,
or process, or otherwise use for each of
the chemicals meeting the facility
category will be an 'amount greater than
one million pounds per year. If a facility
meets the alternate threshold criteria,
that facility will not be required to file
a complete TRI report (Form R), but will
be required to submit an annual
certification statement for each chemical
meeting these conditions for the
reporting year for which these
conditions were met and maintain
records supporting calculations made to
determine these conditions. EPA
estimates that this alternate threshold
provides the option to convert
approximately 20,100 Form R reports to
certification statements.
in. Summary of Final Rule
In this action, EPA is adding 286
chemicals and chemical categories,
which includes 39 chemicals as part of
two delineated categories, to the EPCRA
section 313 list. EPA finds that each of
these chemicals and chemical categories
meets one or more of the EPCRA section
313(d)(2) criteria. Additionally, EPA
believes that each of these chemicals
can reasonably be anticipated to .be
manufactured or imported in quantities
of at least 10,000 pounds (the EPCRA
section 313 otherwise use reporting
threshold) by at least one facility.
Therefore, the Agency believes that the
listing of these chemicals can
reasonably be anticipated to generate
EPCRA section 313 reports and that
adding these chemicals to the toxic
chemical list is appropriate.
The proposed rule and record
supporting the rulemaking contain
information on EPA's review of these
chemicals, including the toxicity
evaluation. This background
information will not be repeated here ill
the final rule. However, to the extent
that comments were received on these
issues, those comments are addressed in
this document. In addition to general
comment and comment addressing a
broad number of chemicals, EPA
received specific technical comments on
110 of the chemicals and chemical
categories. Detailed responses to
comments are contained in Response to
Comments Received on the January 12,
1994 Proposed Rule to Expand the .
EPCRA Section 313 List (Response to
Comment Document, Ref. 14).
Summaries of responses to comments
on selected chemicals appear in units
IV.F. and IV.G. of this preamble. Table
1 lists the chemicals that EPA has
determined meet the statutory criteria of
EPCRA section 313(d)(2) and are
therefore being added to the toxic
chemical list. Each of the chemicals and
chemical categories listed below were
found to meet the statutory criteria
described in EPCRA section
313(d)(2)(A)-(C). This means that the
'Agency has made a finding that the
chemical is known to cause an effect, or
is reasonably anticipated to do so. It
does not necessarily mean that the
chemical is known to cause a given
effect. The specific criterion or criteria •
that the chemical meets are also listed
in Table 1 below.
TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST
Chemical Name
Abamectln (Avermectin B1)
Acephate (Acetylphosphoramidothioic acid O,S-dimethyl ester)
Acifluorfen sodium salt (5-<2-Chloro-4-
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Federal Register / VoL 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61435
TABLE f.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued
Chemical Name
Brucine
C.I. Adid Red 114
C.I. Direct Hue 21 8
Carbofuran
Carboxin (5,6-Dihydro-2-methyl-N-phenyl-1 ,4-oxathiin-3-cartx>xamide)
Chinomethionat (6-MethyM ,3-dithiolo[4,5-b]quinoxaIin-2-«ne)
Chlorendic acid
Chlorimuron ethyl (Ethyl-2-[[t(4-chloro-6-fnethoxyprimidin-2-yl)-cartx)nyl]-
amino]sulfonyl]benzoate)
1 -(3-Chloroallyl)-3,5,7-triaza-1 -azoniaadamantane chloride
p-Chloroaniline
3-Chloro-2-methyl-1 -propene
p-Chlorophenyl isocyanate
Chloropicrin
3-Chloropropionitrile
p-Chloro-c-toluidine
2-Chloro-1,1.1-trifluoroethane(HCFC-133a)
Chlorotrifluoromethane (CFC-13)
3-Chloro-1,1,1-trifluoropropane(HCFC-253fb)
Chlorpyrifos methyl (O,O-Dimethyl-O-(3,5,6-trichlon>-2- pyridyOphosphorothloate)
Chlorsulfuron (2-Chloro44-Q(4-melhoxy-J6-niethyl-1 ,3,5-triazin-2-yl)
amino]cartx)nyl]benzenesulfonamide)
Crotonaldehyde
Cyanazine
Cycloate
Cyclohexanol
Cyfluthrin (3-(2,2-Dichloroethenyl)-2,2-dimethyk^ctopropanecarboxylic acid,
cyano(4-fluorc-3-phenoxyphenyl)methylester)
Cyhalothrin (3-(2-CNort»-3,3>3-friftuoro-1-propenyl)-2>2-
Dimethylcyclopropanecarboxylic acid cyano(3-pt)enoxyphenyl)methyl ester)
Dazomet (TetrahydrD-3,5-diTnethyl-2H-1,3^-thiadiazme-2-tNone)
Dazomet sodium salt (2H-1 ,3,5-Thiadiazine-2-thione, tetrahydrc-3,5-dimethyl-.
ion(1-), sodium)
2,4-DB
2,4-D butoxyethyl ester
2,4-D butyl ester
2,4-D chlorocrotyl ester
Desmedipham
2,4-D 2-ethytiexyl ester
2,4-D 2-ethyW-methylpentyl ester
Diazinon
2,2-Dibromo-3-nitrilopropionamide
Dicamba (3,6-DichlofO-2-methyoxybenzoic acid)
Dichloran (2,6-Dichtorc-4-nitroaniline)
3,3'-Dfchlorobenzidine dihydrochloride
3,3'-Dichlorobenzidine sulfate
trans-1 ,4-Dichloro-2-toutene
1,2-Dichloro-1,1-difluoroethane (HCFC-132b)
Dichtorofluoromethane (HCFC-21)
Dichtoropentafluoropropane
1 ,3-Dlchloro-l ,1,2,3,3-pentafluoropropane (HCFC-225ea)
2,2-Dichlorol ,1 ,1 ,3,3-pentafluoropropane (HCFC-225aa)
1 ,1-Dichlorc-1 ,2,3,3,3-pentafluoropropane (HCFC-225eb)
1 ,1-Dichloro-1 ,2,2,3,3-pentafluoropropane (HCFC-225cc)
1 ,3-Dichloro-1 ,1 ,2,2,3-pentafluoropropane (HCFC-225cb)
1 ,2-Dichloro-1 ,1 ,3,3,3-pentafluoropropane (HCFC-225da)
3,3-Dichloro-1 ,1 ,1 ,2^-pentafluoropropane (HCFC-225ca)
2,3-Dichlorc-t ,1 ,1 ,2,3-pentafIuoropropane (HCFC-225ba)
1 ,2-Dichloro-1 ,1 ,2,3,3-pentafluoropropane (HCFC-225bb)
Dichlorophene (2,2'-Methylenebis(4-chlorophenol)
trans-1 ,3-Dichloropropene
Diclofop methyl (2-[4-(2,4-Dfchlorophenoxy) phenoxy]propanoicacid, methyl ester)
Dicyclopentadiene
Diethatyl ethyl
Diflubenzuron
Diglycidyl resorcinol ether
Diisocyanates, consisting of:
1 ,3-Bis(methylisocyanate) cyclohexane
t.4-Bis(methylisocyanate) cyclohexane
1 ,4-Cyclohexane diisocyanate
Diethyldiisocyanatobenzene
.CAS No,
000357-57-3
006459-94-5
028407-37-6
001563-66-2
005234-68-4
002439-01-2
000115-28-6
090982-32-4
004080-31-3
000106-47-8
000563-47-3
000104-12-1
000076-06-2
000542-76-7
000095-69-2
000075-88-7
000075-72-9
000460-35-5
005598-13-0
064902-72-3
004170-30-3
021725-46-2
001134-23-2
000108-93-0
068359-37-5
068085-85-8
000533-74-*
053404-60-7
000094-82-6
001929-73-3
000094-8CM
002971-38-2
013684-56-5
001928-43^1
053404-37-8
000333-41-5
010222-01-2
001918-00-9
000099-30-9
000612-83-9
064969-34-2
000110-57-6
001649-08-7
000075-43-4
127564-92-5
136013-79-1
128903-21-9
111512-56-2
013474-88-9
000507-55-1
000431-86-7
000422-56-0
000422-48-0
000422-44-6
000097-23-4
010061-02-6
051338-27-3
000077-73-6
038727-55-8
035367-38-5
000101-90-6
NA
038661-72-2
010347-54-3 -
002556-36-7 »
134190-37-7
Section
313{d)(2)(A)
X
X
X
"
X
Section
313(d)(2)(B)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
•
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
^x
X
X
X
X
X
Section
313(d)(2)(C)
X
X
X
X
X
X
,
X
*
-V.
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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61436 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued
Chemical Name
4,4'-Diisocyanatodiphenyl ether
2,4-Diisocyanatodiphenyl sulfide
3,3'-Dimethoxybenzidine-4,4'-diisocyanate
S.S'-DimethyM^'-diphenylene diisocyanate
3,3'-Dimethyi diphenylmethane^4,4'-diisocyanate
Hexamethytene-1 ,6-diisocyanate '
Isophorone diisocyanate
Methytenebis(phenyl teocyanate)
4-Methyldiphenylmethane-3,4-diisocyanate
1,1-Methylene bJs(4-isocyanatocyc)ohexane)
1,5-Naphthalene diisocyanate
1.3-Phenylene diisocyanate
1,4-Phenylene diisocyanate
Polymeric diphenylmetnane diisocyanate
2,2,4-Trimethylhexamethylene diisocyanate
2,4,4-Trimethylhexamethylene diisocyanate 015646-96-5
Dimethipln (2,3,-Dihydro-5,6-dimethy»-1.4-
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Federal Register / Vol. 59j No. 229 / Wednesday, November 30. 1994 / Rules and Regulations 61437
TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued
Chemical Name
Hydramethylnon (Tetrahydro-5,5-di-methyJ-2(1H)- pyrimidinone[3-[4-
(trifluoromflthyl)pr»nylj-1-p-[4-(trifluorornethy1) phenyl]ethenyl]-
2pcopenylidene]hydrazone)
Imazalil (1-[?-(2,4-Dichlorophenyl)-2-(2-propenyk)»(y)ethyJ}-1H-lmidazole)
3-lodo-2-propynyl butylcarbamate
Iron pentacaibonyl
Isodrin
Isofenphos (2-[[Ethoxyl[(1-methylethyl)amino]phosphirwthioyI]oxy] benzole acid 1-
methylethyl ester)
Lactofen (5-(2-Chk>ro-4-(trifluoromethyl)phen<»(y)-2-nil«>5-ethoxy-1 -methyl-2-
oxoetnyl ester)
Linuron
Lithium carbonate
Malathipn
Mecoprop
2-Mercaptobenzothiazole (MBT)
Merphos - V
Metham sodium (Sodium methyldithiocarbamate)
Methazole (2-(3,4-Oichlorophenyl)-4-methyl-1 ,2,4-oxadiazofidine-3,5-dione)
Methlocarb
Methoxone ((4-Chlorp-2-metnylphenoxy) acetic acid) (MCPA)
Methoxone sodium salt ((4-Chloro-2-methytphenoxyj acetate sodium salt)
Methyl isothiocyanate
2-MethyHactonitrile
N-Methylolacrylamide
Methyl parathion
N-Methyl-2-pyrrolidone
Methyftrichlorosilane
Metiram
Metribuzin
Mevlnphos
Molinate (1H?Azepine-1 carbothioic acid, hexahydro-S-ethyl ester)
Monuron
Myclobutanil (.alpha.-Butykalpha.-(4-chlorophenyl)-1H-1 .2,4-triazole-1-
propanenitrile)
Nabam
Naled
Nicotine and salts
Nitrapyrin <2-Chloro-6-(trichtofomethyl)pyridine)
Nitrate compounds (water cSssociable)
p-Nitroaniline
Norflurazon ; (4-Chloro-5-(methylamino)-2-p-(trifluoromethyl)phenyl]-3(2H)-
pyridazinone)
OryzaSn (4-(Oipropylamino)-3,5-dinitrobenzenesulfonamide)
Oxyctemeton methyl (S-(2-(Ethylsulfinyl)ethyl) O.O-dtmethyJ ester phosphorothioic
acid)
Oxydiazon (3-[2,4-Dichloro-5-(1 -rnethy!6ihpxy)pheny]]-5-0 ,1 -dimethylethyl)-1 ,3,4-
oxadiazol-2(3H)-one) f
Oxyfloorfen
Ozone
Paraquat dichloride
Pebulate (Butylethylcarbamothioic acid S-propyl ester)
Pendimethalin (N-(1-Ethylpropyl)-3,4-dimethyl-2,6-
-------
61438 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued
Chemical Name
Polycyclic aromatic compounds (PACs) consisting of:
Benz(a)anthracene
Benzo(a)phenanthrene
Benzo(a)pyrene
Benzo(b)fluorantnene
Benzo(j)fluoranthene
Benzo(k)fluoranthene
Benzo(rst)pentaphene
Dibenz(a,h)acridine
Dibenz(a,j)acridine
Dibenzo(a,h)anthracene
Dibenzo(a,e)fluoranthene
Dibenzo(a,e)pyrene
Dibenzo(a,h)pyrene
Dibenzo(a,l)pyrene
7H-Dibenzo(c,g)carbazole
7,12-Dirnethy) benz(a)anthracene
IndenoJI ,2,3-cdjpyrene
5-Methytehrysene
1-Nitropyrene
Potassium bromate
Potassium dimethyldithiocarbamate
Potassium N-methyldithiocarbamate
Profenofos (O-(4-Bromo-2-chlorophenyO-O-ethyt-S-propyl phosphorothioate)
Prometryn (N,N -Bis(1 -methylethyl)-6-methylthio-T ,3,5-triszine-2,4-diamine)
Propachlor (2-Chlorc-N-(1 -methylethyl)-N-phenylacetamide)
Propanil (N-(3,4-Dichlorophenyl)propanamide)
Propargite
Propargyl alcohol
Propetamphos (3-[{Ethylamino)methoxyphosphinothioyl]oxy]-2-butenoic acid, 1-
methylethyl ester)
Propiconazole (1 -[2-(2,4-Dichlorophenyl)-4-propyM ,3-dioxolan-2-yl]-methyl-1 H-
1,2,4,-triazole)
Quizalofop-ethyl (2-[4-[(6-Chloro-2-quinoxalinyl)oxy]phenoxy] propanoic acid ethyl
ester)
Resmethrin U5-(Phenylmethyl)-3-furanyqrnethyl 2,2-dimethyl-3-(2-methyt-1 -pro-
penyl)cyclopropanecarboxylate])
Sethoxydim (2-[1 -(Ethoxyimino)buty l]-5-[2-(etriylthio)propy l]-3-hydroxyl-2-
cyclohexen-1 -one)
Simazine
Sodium azide
Sodium dicamba (3,6-DicNoro-2-methoxybenzoic acid, sodium salt)
Sodium dimethyldithiocarbamate
Sodium fluoroacetate
Sodium nitrite
Sodium pentachlorophenate
Sodium o-phenylphenoxide
Strychnine and salts
Sulfuryt fluoride (Vlkane) *
Sulprofos (O-Ethyl O-{4-(methytthio)phenyl]phosphorodithioic acid S propyl ester)
Tebuthiuron (N-(5-(1 ,1 -Dimethylethyl)-1 ,3,4-thiadiazol-2-yl)- N,N'-dimethylurea)
Temephos
Terbacil (5-Chloro-3-{1,1-dimethylethyl)-6-methyf-2,4 (1 H,3H)-pyrimidinedione)
1 ,1 ,1 ^-Tetrachtorc-2-fluoroethane (HCF(M21a)
1,1,2,2-Tetraehloro-1-fluoroethane (HCFC-121)
Tetracycline hydrochloride
Tetramethrin (2,2-Dime1hyl-3-(2-methyl-1-propenyl) cyclopropanecarboxylic acid
(1 ,3,4,5,6,7-rtexahydro-1 ,3-dioxo-2H-isoindol-2-yl)methy) ester)
Thiabendazole (2-(4-Thiazolyl)-1H-benzimidazole)
Thiobencarb (Carbamic acid, diethyfthio-, S-(p-chlorobenzyl))
Tniodicarb
Thtophanate ethyl ([1,2-Phenylenebis(iminocart)onothioyl)] biscarbamic acid
diethyl ester)
Thiophanate-methyl
Thiosemtcarbazide
Triadimefon (1-(4-Chlorophenoxy)-3,3-dimethyl-1-{1H-1,2,4-triazol-1-yl)-2-
butanone)
Triallate
Tribenuron methyl (2-(4-Methoxy-6-methyl-1,3,5-triazin-2-yf)-
methylamino)carbonyl)amino)suHbnyl)-, methyl ester)
Trlbutyttin fluoride
CAS No.
NA
000056-55-3
000218-01-9
000050-32-8
000205-99-2
000205-82-3
000207-08-9
000189-55-9
000226-36-8
000224-42-0
000053-70-3
005385-75-1
000192-65-4
000189-64-0
000191-30-0
00194-59-2
000057-97-6
000193-39-5
003697-24-3
005522-43-0
007758-01-2
000128-03-0
000137-41-7
041198-08-7
007287-19-6
001918-16-7
000709-98-8
002312-35-8
000107-19-7
031218-83-4
060207-90-1
076578-14-8
010453-86-8
074051-80-2
000122-34-9
026628-22-8
001982-69-0
000128-04-1
000062-74-8
007632-00-0
000131-52-2
000132-27^1
NA
002699-79-8
035400-43-2
034014-18-1
003383-96-8
005902-51-2
000354-11-0
000354-14-3
000064-75-5
007696-12-0
000148-79-8
028249-77-6
059669-26-0
023564-06-9
023564-05-8
000079-19-6
043121-43-3
002303-17-5
101200-48-0.
. : »
001983-10-4
Section
313(d)(2)(A)
'
X
•
».
X
Section
313(d)(2)(B)
X
.
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
sitSSh-
X
V
X
X
X
X
X
X
X
X
X
X
X
-------
federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61439
TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued
Chemical Name
Tributyltin methacrylate
S,S,S-Tributyltrithiophosphate (DEF)
Trichloroacetyl chloride
1 ,2,3-Trichloropropane
Triclopyr triethylammonium salt
Triethylamine
Triforine (N,N'-[1 ,4-Piperazinediylbis-2,2,2-trichloroethylidene)] bisformamide)
Trimethylchlorosilane
2,3,5-Trimethylphenyl methylcarbamate
Triphenyltin chloride
Triphenyltin hydroxide
Vinclozolin (3-(3,5-Dichlorophenyl)-5-ethenyl-5-methyl-2,4-oxa2olidinedione)
CAS No.
002155-70-6
000078-48-8
000076-02-8
000096-18-4
057213-69-1
000121-44-8
026644-46-2
000075-77-4
002655-15-4
000639-58-7
000076-87-9
050471-44-8
Section
313(d)(2)(A)
X
X
X
Section
313(d)(2)(B)
X
X
X
X
X
X
X
X
X
Section
313{d)(2)(C)
X
X
X
EPA is deferring final action on 40
chemicals and one chemical category
until a later date. These chemicals and
the comments received on them raised
particularly difficult technical or policy
issues which will require additional
time to address. The Agency does not
believe that it would be in the spirit of
community right-to-know to delay final
action on the remaining 286 chemicals
and chemical categories, pending
completion of work on the more limited
group. In a future rulemaking, EPA will
make a final determination as to
whether these chemicals should be
added to EPCRA section 313. The public
comment that has been received specific
to these deferred chemicals will be
addressed as part of the future
rulemaking discussed above. These
chemicals follow:
•o-benzyl-p-chlorophenol
butylate
butylated hydroxyanisole (BHA)
calcium hypochlorite
caprolactam
carbon monoxide
cyromazine
dichloromethylphenylsilane
dithiopyr
2,4-D 2-octyl ester
flumetralin
iprodione
isophorone
man made mineral fibers
methylene bis(thiocyanate)
nitric oxide
nitrogen dioxide
nine polycyclic aromatic compounds,
specifically:
carbazole
cyclopenta(cd)pyrene
dibenz(a ,c)anthracene
dibenz(a,j)anthracene
2-methylchrysene
3-methylchrysene
4-methylchrysene
6-methylchrysene !
2-methylfluoranthene
phosphorus oxychloride
phosphdrus pentachlbride
phosphorus pentasulfide
phosphorus pentoxide
primsulfuron
sodium chlorite
sodium hypochlorite • •
sodium 2-pyridinethiol-l-oxide
sulfur dioxide
sulfur trioxide
tefluthrin
thiabendazole, hypophosphite salt
trichloroethylsilane
trichlorophenylsilane
vanadium pentoxide
Based on an evaluation of the public
comments received and a reanalysis of
the available data cited in the proposed
rule, EPA has determined that three
chemicals, clomazone, 5-chloro-2-(2,4-
dichlorophenoxy)phenol, and
tetrasodium
ethylenediaminetetraacetate, that were
proposed for listing do not have
sufficient evidence of toxicity at this
time to meet the statutory criteria of
EPCRA section313(d)(2) and thus are
not listed in this final rule. Summaries
of responses to chemical-specific
comments for these chemicals appear in
unit IV.G. of this preamble.
IV. Surapiary of Public Comment
The public comment period for the
proposed rule closed April 12,1994. On
March 9,1994, EPA held a public
meeting on the proposed addition of
chemicals and chemical categories. Two
hundred and sixty-six comments were
received, including 136 from industry,
60 from trade associations, 32 from
environmental groups, 15 from private
citizens, 3 from Federal agencies, 7 from
State agencies and 13 from other public
interest groups, labor groups,
universities, and associations. In
addition to general comment and
comment addressing a broad number of
chemicals, EPA received specific
technical comments on 110 of the
chemicals arid chemical categories.
Detailed responses to all comments,'
except those comments specific to
chemicals for which final action is being
deferred, are contained in the Response
to Comment Document (Ref. 14).
hi addition to a number of comments
supporting the concept of chemical
expansion, EPA received comments in
the following major areas: EPA's
screening process used to identify
potential candidates and the Agency's
use of the Draft Hazard Assessment
Guidelines (Ref. 11); the use of exposure
in determining if a chemical meets the
statutory criteria of EPCRA section 313;
listing of categories; the addition of
chemicals that are regulated by the Food
and Drug Administration (FDA); the
addition of chemicals that are regulated
under FIFRA; duplicative reporting; ^
general technical comments; and
chemical-specific comments.
A. Comments on EPA's Screening
Process Used to Identify Potential
Candidates for Addition to EPCRA
Section 313 and on EPA's Use of the
Draft Hazard Assessment Guidelines
1. Screening based on toxicity.
Monsanto, Zeneca Incorporated, and the
National Oilseed Processors Association
contend that the use of minimum
effective doses (MEDs) to screen
chemicals as potential candidates for
addition to the EPCRA section 313 list
was unrealistic and overly broad as a
screening tool. One of these commenters
also contended that EPA based its
proposed addition on toxicity screening
only.
EPA believes that the commenter may
have misunderstood the use of the MED
screening criteria. The MED screen is
not intended, and is not used by EPA,
as a surrogate for the actual statutory
listing criteria. The MED was used as a
screening tool during the preliminary
review of several thousand candidate
chemicals, because MED values were
available and they are based on
experimental values. MEDs are n6t
"equivalent to lowest-obseryed-adVerse-
effect levels (LOAELs). MEDs are
-------
, 61440 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
generally derived from LOAELs from
chronic toxicity studies using a log
transformation and as such a MED is a
single value based upon the best
available study. Satisfying the MED
screening criteria, however, does not
mean that a chemical will necessarily be
added to the list. In every case, the
Agency determines that at least one of
the.section 313(d)(2) criteria is met
before a chemical is listed. For example,
isoprene, 1,3-dichloropropane, and
dichlorodimethylmethane passed the
toxicity screen, but upon a more
detailed review, were determined not to
meet the criteria of EPCRA section
313(d)(2) and thus were not proposed
for addition. -
EPA believes that MEDs are useful as
a screening tool and that the
methodology has been adequately
reviewed both internal and external to
the Agency. The MED system was first
presented in a peer reviewed article by
DeRpsa, et. al (Ref. 2). The MED
methodology has been used by EPA in
programs other than EPCRA section 313.
For example, the MED methodology is
integral to the reportable quantity (RQ)
scoring system as utilized by EPA in
CERCLA section 102! The RQ scoring
system scheme is described in several
Federal Register documents (April 4,
1985, 50 FR13456; September 29,1986,
51 FR 34535; and March 16,1987, 52 FR
8140). Further, the Superfund
Amendments and Reauthorization Act
of 1986 (SARA) required EPA and the
Agency for Toxic Substances and
Disease Registry (ATSDR) to develop a
list of 275 hazardous substances most
commonly found at facilities on the
National Priorities List (NPL) and
considered to present the most
significant threat to human health at
those sites or at other facilities where
releases may occur. During development
of criteria to select the first list of 100,
the RQ methodology (as discussed in
the Draft Hazard Assessment
Guidelines, Ref. 11) was selected as one
of the evaluation tools used to develop
the initial list, and the annual updates.
When the initial list was published
(April 17,1987, 52 FR 12866) a
summary of the methodology used to
develop the list was provided.
Monsanto believes that the use of an
MED of 500 mg/kg/day as the upper
limit of the "may be sufficient" category
of the screening criteria required an
unrealistically high dose to have been
used for toxicity testing.
EPA agrees that the upper bound for
the medium priority category may
.warrant reconsideration. EPA will
address this issue and other comments
received on the Draft Hazard
Assessment Guidelines (Ref. 11), when
the Agency finalizes that document.
However, none of the chemicals
proposed for listing in the proposed rule
had MEDs that approached this upper
bound. Of the chemicals proposed for
addition pursuant to EPCRA section
313(d)(2)(B), greater than 93 percent had
MED values that were in the range for
the high priority category; the remaining
chemicals (less than 7 percent) had
MEDs in the lowest fifth of the medium
priority category range, i.e., MEDs only
slightly greater, than the high priority
category range. EPA reiterates that the
MED screen is not intended, and is not
used by EPA, as a surrogate for the
actual statutory listing criteria.
Additions to EPCRA section 313 are
based on a hazard assessment, and,
where appropriate, an analysis of
exposure, to,determine whether the
chemical meets one or more of the
' EPCRA section 313(d)(2) listing criteria.
The Natural Resources Defense
Council supports the health and
environmental effects screening criteria
used by EPA as a reasonable basis to
screen chemicals as candidates for
possible addition to EPCRA section 313.
The Agency agrees with this
commenter in its support of the use of
the screening criteria and believes that
the screening criteria provide a
reasonable basis to make a preliminary
evaluation of chemicals for possible
addition to the EPCRA section 313 list.
EPA also agrees with the commenter's
statement that the specific screening
values are consistent with established
risk assessment procedures applied in
other EPA programs.
2. Screening based on production
volume. Eastman Chemical Company
states that, in addition to the use of a
production volume screen, the Agency
should consider the number of TRI
Form Rs that would likely be submitted
subsequent to listing. If the number is
considered to be minimal (perhaps 5,
10,15 or more reports), then EPA
should balance the public's right-to-
know with the economic burden placed
on an industry.
EPA adopted a production volume
screen for the development of the
proposed rule to screen out those
chemicals for which no reports are
expected to be submitted. The Agency
believes that it has the discretion to not
include such chemicals at this time. If
chemicals that did not meet the
production,volume screen were listed,
there would be an economic burden for
firms that would have to determine that
they did not exceed the reporting
threshold, without providing any
information to the public.
While the Agency has determined to
not list chemicals for which no reports
would be submitted, EPA believes that
it is appropriate to add chemicals to
EPCRA section 313 for which even a
small number of reports are likely to be
submitted nationally. In such cases, the
reporting facilities will still provide
important information to the
surrounding communities. Even though
a particular chemical may only be
manufactured, processed, or otherwise
used at a relatively small number of
facilities, the data provided in the TRI
Form R reports by these facilities could
represent significant information in the
communities in which the facilities are
located. The Agency believes that it
would be inconsistent with the public's
right-to-know not to list chemicals even
if only a low number of reports is
expected.
3. Use of the Draft Hazard Assessment
Guidelines. Six industry trade
organizations and three companies
contend that EPA's use of the Draft
Hazard Assessment Guidelines (Ref. 11)
was inappropriate. The commenters
state that the use of the term "draft
guidelines" indicates that the document
requires additional review. Therefore,
they believe that EPA should refrain
from using the document to support this
rulemaking.
It is appropriate for EPA to use the
Draft Hazard Assessment Guidelines
(Ref. 11), as it did in this rule, in
considering whether to list a chemical
on the section 313 list. The Draft
Hazard Assessment Guidelines are an
embodiment of internal EPA practices
that have been used in listing
determinations that have evolved since
the inception of the TRI program. The
Draft Hazard Assessment Guidelines do
not constitute a set of rules for adding
or deleting chemicals to or from the list:
the Draft Hazard Assessment Guidelines
are an explanation of the process and
general standards for evaluating
chemicals against the EPCRA section
313 listing criteria. These Draft Hazard
Assessment Guidelines
notwithstanding, EPA has evaluated
every chemical proposed for addition
directly against the EPCRA section 313
statutory criteria, and has taken into
consideration comments submitted by
the public specific to those chemicals
(responses to those chemical-specific
comments are found in the Response to
Comment Document, (Ref. 14);
summaries of most significant chemical-
specific comments are found in units
IV.F. and IV.G. of this preamble).
B. Use of Exposure Assessments
One of the most significant issues
raised by commenters relates to the
Agency's consideration of hazard,
exposure, and'risk in interpreting the
-------
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61441
section 313(d)(2) criteria. Specifically, a
number of commenters believe that
EPA's interpretation of the EPCRA
section 313(d)(2)(B) criterion, chronic
human health effects, and the section
313(d)(2)(C) criterion, ecological effects,
has been overly restrictive. The
commenters contend that. EPA should
conduct risk assessments and make a
formal determination that a chemical
poses a risk (i.e., a combination of -
exposure and hazard) before adding it to
the EPCRA section 313 list. The
commenters argue that the following
factors support their contention: (1) The
statutory criteria include an implicit
exposure and thus risk component; (2)
the legislative history illustrates
Congress" intent that exposure
considerations were to be an integral
part of determining whether a chemical
should be listed on the EPCRA section'
313 list; and (3) EPA should consider
exposure in conjunction with section
313(d)(2)(B), chronic human health
effects, and for all listings pursuant to
section 313(d)(2)(C), ecological effects,
because there is precedent for the use of
exposure in previous listing and
delisting actions.
In light of the many comments
received on this issue, EPA has
reviewed its positions in this area, and
agrees with many of the commenters
that there are limited circumstances
under which it is appropriate for EPA to
consider exposure factors for listing
decisions under section 313{d)(2). The
Agency believes that exposure
considerations are appropriate in
making determinations (1) under section
313(d)(2)(A), (2) under section
313(d)(2)(B) for chemicals that exhibit
low to moderately low toxicity based on
a hazard assessment (i.e., those
chemicals for which the value of listing
on the EPCRA section 313 list on hazard
alone is marginal), and (3) under section
313(d)(2)(C) for chemicals that are low
or moderately ecotoxic but do not
induce well-documented serious
adverse effects as described below. The
Agency believes that exposure
considerations are not appropriate in
making determinations (1) under section
313(d)(2)(B) for chemicals that exhibit
moderately high to high human toxicity
(These terms, which do not directly
correlate to the numerical screening
values reflected in the Draft Hazard
Assessment Guidelines, are defined in
unit II.) based on a hazard assessment, -
and (2) under section 313(d)(2)(C) for
chemicals that are highly ecotoxic or
induce well-established adverse
environmental effects. For chemicals
which induce well-established serious
adverse effects, e.g.,' '
chlorofluorocarbons, which cause
stratospheric ozone depletion, EPA
believes that an exposure assessment is
unnecessary. EPA believes that these
chemicals typically do not affect solely
one or two species but-rather cause
changes across a whole ecosystem. EPA
believes that these effects are
sufficiently serious because of the scope
of their impact and the well-
documented evidence supporting the
adverse effects.
EPA, however, disagrees with those
commenters who suggest that EPA must
include a risk assessment component to
EPCRA section 313 determinations.
Specifically, EPA does not agree with -
the commenters about the extent to
which exposure must be considered in
making determinations under sections
313(d)(2)(B) and (C). This is primarily
because EPA does not agree with the
commenters' understanding of EPCRA
section 313. Risk assessment'may be
pertinent and appropriate for use under
statutes that control the manufacture,
use, and/or disposal of a chemical, such
as the Clean Air Act or the Toxic
Substances Control Act. However,
EPCRA section 313 is an information
collection provision that is
fundamentally different from other
environmental statutes that control or
restrict chemical activities.
EPCRA section 313 charges EPA with
collecting and disseminating
information on releases, among other
waste management data, so that
communities can estimate local
exposure and local risks; risks which
can be significantly different than those
which would be assessed using generic
exposure considerations. The intent of
EPCRA section 313 is to move the
determination of what risks are
acceptable from EPA to the
communities in which the releases
occur. This basic local empowerment is
a cornerstone of the right-to-know
program.
EPCRA section 313 establishes an
information collection and
dissemination program, the burden it
imposes is significantly less than the
burden imposed by a statute which
controls the manufacture, use, and/or
disposal of a chemical. EPCRA section
313 requires that a facility use the best
available information to prepare each
chemical-specific TRI report. However,
the statute does not require that the
facility conduct monitoring or emissions
measurements to determine these
quantities. A facility must only estimate,
to the best of its ability, the quantitative.
information it reports. This is in
contrast to other environmental statutes
that may require a facility to monitor
releases, change its manufacturing
process, install specific waste treatment
technology, or dispose of wastes in a
certain manner. As such, the Agency
believes that the standard that must be
met to require information submission
under EPCRA section 313 is less than
that to regulate a chemical under a
statute such as the Clean Air Act.
EPA believes that its position
regarding the use of hazard, exposure,
and risk in listing decisions is
consistent with the purpose and
legislative history of EPCRA section
313, as illustrated in the following
passage from the Conference report:
The Administrator, in determining to list a
cheniical under any of the above criteria,
may, but is not required to conduct new
studies or risk assessments or perform site-
specific analyses to establish actual ambient
concentrations or to document adverse
effects at any particular location. (H. Rep. 99- .
962, 99th Cong., 2nd Sess., p. 295 (Oct. 3,
1986)).
This passage indicates Congress did not
intend to require EPA to conduct new
'studies, such as exposure studies, or
perform risk assessments, and therefore
did not consider these activities to be
mandatory components of all section
313 decisions. EPA believes that this
statement combined with the plain
language of the statutory criteria clearly
indicate that Congress intended that the
decision of whether and how to
consider exposure under EPCRA section-^
313(d)(2)(B) and (C) should be left to the"
Agency's discretion. EPA has carefully
considered when and how to use
exposure iff fully implement the righl-
. to-know provisions of EPCRA. The
Agency believes that in this final rule,
EPA has appropriately used the '
discretion provided to it to assure the
addition of chemicals that meet the
right-to-know objectives of EPCRA
section 313 while not unduly burdening
the regulated community.
EPCRA section 313 specifically
requires that exposure be considered for
listing a chemical pursuant to section
313(d)(2)(A). The statute mandates that
EPA consider whether "a chemical is
known to cause or can reasonably be
anticipated to cause significant adverse
acute human health effects at
concentration levels that are reasonably
likely to exist beyond facility site
boundaries." EPA has, and will
continue to look at exposures
reasonably likely to exist beyond facility
site boundaries when making a listing
determination pursuant to'EPCRA
section 313(d)(2)(A).
The statute is silent on the issue of
exposure considerations for the section
313(d)(2)(B) and (C) criteria. The
language of section 313 does not
prohibit EPA from considering exposure
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61442 Federal Register / Vol. 59, No. 229 / Wednesday, Ntivember 30,: 1994 / Rules and Regulations
.factors when making a finding under
either section 313(d)(2)(B) or section
313{d)(2)(C). However, the language of
sections 313(d)(2)(B) and (C) does not
require the type of exposure assessment
and/or risk assessment argued by the
commenters. EPA believes that it has
the discretion under both section
313(d)(2)(B) and section 313(d){2)(C) to
consider, where appropriate, those
exposure factors that may call into
question the validity of listing of any
specific chemical on TRI. In exercising
this discretion, EPA considers it
appropriate to employ exposure
considerations to a limited extent in
making determinations under EPCRA
section 313(d)(2)(C) because this
criterion requires the Agency to find a '
"significant adverse effect on the
environment of sufficient seriousness,
in the judgment of the Administrator to
warrant reporting" under EPCRA
section 313. This language recognizes
the possibility that under certain
circumstances, a chemical that could
theoretically cause an adverse effect on
the environment is unlikely to cause
one of a magnitude sufficient to warrant
listing. Moreover, because of the
limitation on the number of chemicals
listed pursuant to only section
313(d)(2)(C) that may be listed, EPA
believes that it is appropriate to use
both hazard and exposure factors as
prioritizing considerations in these
listing decisions. Therefore, to meet its
obligation under section 313(d)(2)(C). in
cases where a chemical is low or
moderately'ecotcixic, EPA may look at
certain exposure factors (including
pollution controls, the volume and
pattern of production, use, and release,
environmental fate, as well as other
chemical specific factors, and the use of
estimated releases and modeling
techniques) to determine if listing is
reasonable, i.e., could the chemical ever
be present at high enough
concentrations to cause a significant
adverse effect upon the environment to
warrant listing under section
313(d)(2)(C). Of the chemicals being
added in today's action pursuant to
section 313(d)(2)(C), all but one are
highly ecotoxic. These highly ecotoxic
chemicals are being added to the EPCRA
section 313 list pursuant to section
313(d)(2)(C) based on their hazard. The
other chemical, which is moderately
ecotoxic, is being added to the EPCRA
section 313 list pursuant to section
313(d)(2)(C) based on both its hazard
and an exposure assessment for this
chemical.
For listing determinations made .
pursuant to EPGRA section/313(d)(2)(B),
in instances where the-hazard .
assessment indicates that the value of
listing on EPCRA section 313 on hazard
alone is marginal (i.e:, a chemical is of
low toxicity and unrealistic exposures
would be necessary for it to pose a risk
to communities), EPA may use exposure
considerations in its listing decisions. .
Only chemicals for which the hazard
assessments indicate moderately high to
high toxicity are being added in today's
action to the EPCRA section 313 list
pursuant to section 313(d)(2)(B). None
of these chemicals are chemicals for
which the consideration of exposure >
factors would be appropriate.
Through this rulemaking, EPA is
clarifying its position regarding the use
of hazard, exposure, and risk in listing
decisions under EPCRA section 313.
EPA will consider exposure factors
when making determinations under
section 313(d)(2)(A) (acute human
toxicity). In addition, EPA has
discretion to consider exposure factors
where appropriate for determinations
under sections 313(d)(2)(B) (chronic
human toxicity) and (C) (environmental
toxicity), and that there is a broader
range of circumstances in which
exposure will be considered under
section 313(d)(2)(C) than under (B).
EPA has reviewed its past listing
decisions in light of this clarification,
and believes that its prior listing
determinations have been consistent in
the consideration of exposure in 31 of
the 32 listing/delisting determinations
previous to this action, including a
number of deletions of low toxicity
chemicals that Congress placed on the
initial EPCRA section 313 list. EPA is
currently reviewing the one exception,
inorganic fluorides, to determine if
additional action is warranted. EPA will
continue to evaluate petitions according
to this clarification and will delete
chemicals that do not meet the statutory
criteria. *
C. Addition of Categories
Six industry trade organizations, 7
companies, and the Department of
Energy contend that section 313 does
not provide EPA the statutory authority
to list chemical categories. Some of the
commenters contend that the intent of
Congress was for EPA to review
individual chemicals'. Therefore, the
commenters believe that EPA should list
all chemicals individually. General
Electric, American Iron and Steel
Institute, and Eastman Chemical
Company further contend that, based on
legal precedent (citing AFL-CIO vs.
OSHA, 965 F.2d 9262 (llth Cir. 1992)),
EPA does not have the authority to list
chemica.1 categories or specific groups of
chemicals. .••••..
EPA believes that the statutory
authority to add "a chemical" to the lig
may be reasonably interpreted to •
include the authority to list'groups or
categories of chemicals. Indeed, this
interpretation is supported by the initial
list of chemicals and chemical
categories adopted by Congress in
section 313(c). In that initial list,
Congress included 20 chemical
categories, mainly metal compounds,
but also categories of organic chemicals
such as chlorophenols. Nothing in
section 313 or its legislative history
indicates or even suggests that Congress
intended to preclude EPA from adding
chemical categories to the list where the
appropriate findings can be made.
Where, as with the categories being
added in this final rule, EPA determines
that the primary purpose of TRI--
providing information to 'the community
about the release of chemicals-is most
appropriately served by listing a
category of chemicals, EPA has the
discretion to list a category rather than
individual chemicals. Of course, in
adding a category to the list, EPA must
comply with the statutory criteria. The
Agency believes it satisfies the statutory
criteria to add a category to the list by
identifying the toxic effect of concern
for at least one member of the category
and then showing why that effect may
reasonably be expected to be caused by
all other members of the category. A -,
specific justification for each of the
categories included in the final rule ha.s
been provided in the preamble of the
January 12,1994 proposed rule, in the
docket supporting this rulemaking, and
in the Response to Comment Document
(Ref. 14).
Several commenters raised policy
concerns and suggested that there
would be regulatory difficulties
associated with adding chemical
categories. These are addressed below.
One commehter suggested that the
regulated community would face
uncertainty in deciding which
chemicals belong in the category. In this
final rule, EPA has described the
categories in sufficient detail to alleviate
uncertainty regarding their membership.
Of course, the Agency will work with
the public and the regulated community
to develop, as appropriate, any
interpretations and guidance the Agency
determines are necessary to facilitate
accurate reporting for these categories.
One commenter questions how to
properly report a chemical which could
be considered' pah of a category and
which is also specifically, individually
listed. Threshold determinations should
be made for the individually-listed
chemical rather than for the category.
The current EPCRA section 313 list
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Federal Register, / Vol. 59, No, 2297 Wednesday,-November 30, :1994 / Rules and (Regulations 61443
contains some individually-listed
chemicals that also meet the definition
of an EPCRA section 313 listed category.
For example, pentachlorophenol is
listed individually on EPCRA section
313 but also meets.the definition of the
chlorophenol category. In these
situations, threshold determinations
should be made for the chemical as an
individual entity father than as a
member of the category. A facility
would not count the quantities
manufactured, processed, or otherwise
• used toward threshold determinations
for both the individual listing and the
category listing, but rather only toward
the individual chemical threshold.
•° One commenter contends that
categories will lead to inadvertent non-
compliance with reporting
requirements. EPA does not believe that
this is a significant concern. Because the
categories being added to the EPCRA
section 313 list today each consist of
chemicals that are similar chemically
and, in effect, EPA believes that these
categories will not be difficult for the
public or industry to understand or for
the Agency to administer. In addition,
there are already categories on the
current list, and EPA has not
experienced a significant problem of the
sort suggested by the commenter. The
Congressional objective of providing
information is .outweighed by any
possible problems that some facilities
might have with inadvertent
noncompliance.
One commenter states that the use of
categories will artificially lower the
thresholds for reporting chemicals
within the category. The Agency
believes that calculating the thresholds
based on the category (i.e., a sum of the
activities for each individual category
member) is appropriate and not
"artificially lower." As described above,
categories are placed on the EPCRA
section 313 b'st where each of the
members can be expected to cause
similar effects because all members of
the category have a similar functional
group or. exhibit a similar, characteristic.
For each of the categories added in
today's rule, EPA believes that because
each member of the category has this
similar functional group or exhibits a
similar characteristic, each member of
the category can be reasonably
anticipated to cause similar adverse
effects. The members of the category are
not randomly selected,'but are closely
related and warrant being reported as a
category. These chemicals in aggregate
can reasonably.be anticipated to cause
an aggregate impact of the adverse effect
associated with each member of the
category. Thus, it is appropriate to apply
the reporting thresholds (6 the category
regardless of whether the threshold
amount is attributable to one member of
the category or to individual members
in aggregate.
One commenter believes that listing
broad categories where the individual .
members have diverse properties and
cause diverse effects does not constitute
"good science." The Agency agrees that
a category must be rationally
constructed both in terms of similarity
in the properties of the individual
members and in terms of their effects.
There is, of course, no requirement that
the properties across category members
be absolutely identical. EPA agrees that
the members of a category be reasonably
expected to elicit the same type of effect
or related effects in order for a category
to satisfy the statutory listing criteria.
Furthermore, EPA agrees that
determinations to list a category, as with
listing an individual chemical are to be
based on "good science." EPA has
applied these principles to the
categories being added in the final rule.
D. Policy Issues
There are several policy issues which
were consistently raised in comments
on specific chemicals and general
comment on the entire proposed rule.
For purposes of this final rule, EPA
addresses these issues in this unit of the
preamble and not in unit IV.F. of the .
preamble in the responses to chemical-
specific comments. Detailed responses
to comments on specific individual
chemicals are available in the Response
to Comments Document (Ref. 14).
1: The addition of chemicals that may
be released in small quantities. Many
commenters object to the addition of
many of the chemicals to the EPCRA
section 313 list because they do not
. believe that there will be significant
releases.of these chemicals. Therefore,
they contend there will not be
significant exposure to these chemicals
and the associated risks will be low.
EPA believes that the chemicals
added today meet the EPCRA section
313(d)(2) criteria and should be , ' '
included on the EPCRA section 313 list.
The quantity of a chemical released is
not part of the statutory criteria. .The
purpose of EPCRA section 313 is to
collect data on the quantity released so
that local communities can make their
own determinations about exposure.
Congress intended EPCRA section 313
to address the lack of information on
toxic chemicals in communities by
providing information on releases of
toxic chemicals. The public can then
use this release information with site-
specific information and the appropriate
attributes of a chemical to evaluate
exposure. EPA considered
inappropriate under the right-to-know
program to supplant the public's power
to make risk determinations on a
community level by the Agency's use of
specified levels of potential releases,
exposure, or risk as screening criteria to
exclude chemicals from the-EPCRA
section 313 list. By listing chemicals
that present a hazard and providing TRI
data on these chemicals to the public,
EPA allows the public to make the
determination as to whether there is a
risk in their community. Furthermore,
any exposure assessment conducted by
EPA would be conducted from a
national perspective and may not truly
represent the risks to a specific
community. (For a more detailed
discussion on the Agency's use of
exposure see Unit IV.B. of this
preamble).
2. The addition of chemicals that are
regulated by FDA. Eli Lily and
Company, National Agricultural
Chemical Association, Pharmeceutical
Manufacturers Association, and
Hoffman-La Roche state that chemicals
which are regulated by the FDA should
not be added to EPCRA section 313. The
commenters argue that the FDA
approves a drug only after extensive
testing and a determination that the
benefits to the patients outweigh the
risks. The commenters further state that
access to these drugs is controlled
because they can only be obtained
through a medical doctor:
EPA agrees that the drug testing and
approval process conducted by the FDA
is extensive and necessary to protect the
public health and well-being. However,
as discussed above, the purpose of
listing these chemicals under EPCRA
section 313 is to provide information on
the release.-transfer, and waste
management activities occurring in the
community. This is a different function
that addresses different issues than
those addressed by FDA. Furthermore,
while the main, use of these chemicals
is pharmaceutical in nature, that does
not mean that they are not a hazard in
other contexts. EPA agrees that in
controlled situations (e.g., a doctor's
prescription) ingestion of a drug is
likely to .have certain intended benefits.
However, outside of this controlled
situation, any adverse effects are not
balanced by the benefits received from
the use of the drug. Further, EPCRA
section 313 will collect information on
the release and disposal of these
chemicals, which is not covered by the
regulation of the'use of a chemical as a
drug.
3. Chemicals regulated under FIFRA.
Several commenters do no.t suppprt the
addition of chemicals regulated under
FIFRA to the.ERGRA section 313 list of
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61444 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
toxic chemicals because* they contend,
the major route of exposure, agricultural
field use, has been..addressed through
FIFRA regulation which establishes
safety factors and use directions
allowing for safe use. They further
contend that the use of these chemicals
has been determined not to present an
unreasonable risk and therefore, listing
pesticides under EPCRA section 313 is
unnecessary.
FIFRA regulations require that the
Agency determine that pesticidal uses of
a chemical do .not cause "unreasonable
adverse effects on the environment"
which is defined in FIFRA section 2(bb)
- as "any unreasonable risk to man or the
environment taking into account the
economic, social, and environmental
costs and benefits of the use of .
pesticides" (7 U.S.C. section 136(bb)).
FIFRA is a regulatory statute, and the
impacts of regulation,can be immediate
and direct (e.g., banning of a chemical),
and as such EPA examines not only the
hazards presented by the chemical, but
also the specific exposure scenarios, and
weighs the risks against the benefits of
the chemical. The "unreasonable
adverse effects" determination under
FIFRA is specific to the intentional use
of the chemical as a pesticide and does
not address other uses or releases of the
chemical that may result from
manufacture, processing, or other use.
Furthermore, a determination under .
FIFRA that the use of a chemical will
not result in an "unreasonable adverse
effect" is not a determination that the
chemical is not hazardous or that the
use of the chemical is without risk.
Finally. EPCRA section 313 was not
enacted to serve the same purpose as
FIFRA. Listing on EPCRA section 313
provides communities with some of the
information'required to determine what
risks may result from the manufacture,-
processing and non-pesticidal use of a
chemical, information not generally
provided through FIFRA.
4. Duplicative reporting. Many
commenters believe that listing some of
the chemicals proposed will result in
duplicative regulation that will be
unduly burdensome and of little benefit.
One other commenter, Westinghouse
Electric Corporation, states that EPA
should utilize existing sources of
information to avoid duplicative
reporting.
Congress did not intend that the
chemicals listed under EPCRA section
313 be limited to those that are not
regulated under other environmental
statutes and for'which no information is
collected pursuant to other
requirements. The initial list of •
chemicals that Congress included in
section 313 consisted of substances
regulated under RCRA, CWA, SDWA,
CERCLA, FIFRA, and CAA. Further, as
Representative Edgar stated in the
House of Representatives debate on the
Conference bill:
With respect to the contents of the toxic
release form, estimates of releases into each
environmental medium must be provided.
This shall include any releases into the air,
water, and land, as well as releases from
waste treatment and storage facilities. This
shall include all releases of toxic chemicals
into surface waters whether or not such
releases are pursuant to the Clean Water Act
permits. (132 Cong. Rec. H9561, October 8,
1986) -
EPA believes that the chemicals being
added today meet the toxicity criteria of
EPCRA section 313(d)(2) and, therefore,
should be, added to the EPCRA section
313 list. EPA further believes that the.
EPCRA section 313 requirements do not
duplicate-other regulatory program
requirements. EPCRA was not enacted
to serve the same purpose as other
regulatory programs but to collect and
disseminate information to the public.
Nor is EPCRA section 313 intended to
regulate how a chemical may be used,
the amount of chemical a facility
manufactures, processes, otherwise
uses, and releases, what media the
chemical is released to, or how the
chemical is disposed. Therefore, TRI, as
an information collection and
dissemination program, is not designed
to directly impose controls for the
protection of human, health or the
environment in the same manner as
other regulatory programs. The benefit
of TRI .is that it empowers the public,
through access to release, transfer, and
waste management data on toxic
chemicals, to make determinations
about risks in their communities based
on TRJ data, site-specific information,
and the properties of the chemicals.
E. General Technical Comments
1. Maternal toxicity. A number of
commenters argued that for certain
chemicals in animal tests, the only
evidence for developmental toxicity
occurred at maternally toxic doses (that
is, doses that were high enough to
induce toxicity in the mother), and,
therefore, developmental toxicity cannot
be used as a basis for listing these
chemicals under EPCRA section 313.
EPA disagrees that fetal effects only in
the presence of maternal toxicity
demonstrate that a given substance does
not present a developmental hazard.
Although the developmental effects may
have been seen in the presence of
reversible maternal effects, the
developmental effects may be more
permanent and cannot be treated as only
secondary to reversible maternal
toxicity. With regard to adverse effects
in the presence of maternal toxicity,
EPA believes that developmental effect.
at maternal toxicity are 'V. .toxic
manifestations and as such are generally
considered a reasonable basis for
Agency regulation and/or risk
assessment" (Ref 6). This approach has
particular relevance in situations where
reversible maternal toxicity may occur
in the presence of irreversible adverse
fetal effects. The Agency does not
distinguish between fetal effects
observed in the presence of maternal
.toxicity or those observed without
concomitant maternal toxicity. Both
maternal and fetal toxicity are of
concern to the Agency, and are within
the criteria of EPCRA section 313(d)(2).
Thus, EPA will use the effect, maternal
or fetal, which is most sensitive to set
LOAELs and no-observed-adverse-effect
levels (NOAELs). If both occur at the
same level, the LOAELs and NOAELs
for both are the same. When the LOAEL
is the same for the adult and developing
organisms, it may simply indicate that
both are sensitive to that dose level;
rather than that the developmental
effects result only from maternal
toxicity. Moreover, whether
developmental effects are secondary to
maternal toxicity or not, the maternal
effects may be reversible while effects
on offspring may be permanent. There^
are several agents known to produce,~~
adverse developmental effects at
minimally toxic doses in adult humans
(e.g., tobacco smoking, alcohol,
isotretiaoin).
2. Use of IRIS and other secondary
sources. Several commenters object to
EPA's use of the Agency's Integrated
Risk Information System (IRIS) data
base, the Agency's Office of Pesticide
Programs' 1988 TOX-One-Liners data
base, Registry of Toxic Effects of
Chemical Substances (RTECS) data base.
and the Aquatic Information Retrieval
(AQUIRE) data base. The commenters
contend that in relying on these sources
the Agency ignores other pertinent data
that may be in its possession. They
contend that EPA should have
examined the primary sources, rather
than relying on data bases which are
summaries of studies. Specifically, some
commenters claim that there are many
studies in EPA's possession, but not
included in the 1988 TOX-One-Liner
data base, that appear not to have been
considered in the review process,
because they have not yet been
reviewed by EPA's Office of Pesticide
Programs. The commenters contend that
reliance on IRIS or the 1988 TOX-One-
Liner data base does not constitute a
detailed analysis and careful
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Federal Register / Vol. 59, No. 229 /Wednesday, November 30, 1994 / Rules and Regulations 61445
examination of the available data on a
chemical. .
EPA disagrees with the commenters.'
EPA's use of the Agency's IRIS data base
for EPCRA section 313 purposes does
constitute a hazard evaluation. That
data base generally provides
information against which EPA can
evaluate the section 313(d)(2) criteria.
The information contained in the IRIS
data base represents the Agency's
weight-of-evidence hazard assessment
for chemicals contained in the data
base. The information was developed
after the Agency's thorough scientific
review of the available.data. Therefore,
by relying on information in the IRIS
data base in the review of chemicals for
listing on EPCRA section 313, EPA
made statutory determinations based on
hazard assessments conducted by the
Agency.
Although the 1988" TOX-One-Liners
were used as part of the Agency's
evaluation of the toxicity of a candidate
chemical, a number of other sources
were also used. These include decision
documents from a number of Agency
and EPA internal peer review groups,
deliberations of the FIFRA Scientific
Advisory Panel, and reference to data
evaluation records for studies used in
support of listing. Therefore,
evaluations of the toxicity of individual
chemicals has been made on the entire
data base and did not rely only on the
1988 TOX-One-Liners data base.
Furthermore, inclusion of all of the
detailed studies in the docket was not
possible, because of the proprietary
nature of some of the information.
However, in cases where relevant
information was used in support of the
listing decision, but was not included in
the 1988 TOX One-Liners data base
(which is the most recent sanitized
version of the data base), sanitized
versions of the additional sources were
included in the docket. In those cases
where only the 1988 TOX-One-Liners
data base or other similar sources were
cited, no additional data not described
in the 1988 TOX-One-Liners, RTECS, or
the AQUIRE data bases was considered
to be relevant to this listing. For a few
chemicals it has become apparent based
on comments received that EPA's
analysis did not include studies which
are in EPA's possession but which EPA
has not reviewed. The Agency is
deferring the final action on these
chemicals until such studies can be
reviewed.
3. Testing at toxic doses. A number of
commenters stated that pesticides
which are registered under FIFRA
should not be listed under EPCRA
section 313 because the testing
conducted to obtain a pesticide
registration under the FIFRA review
process requires testing at dose levels
"virtually guaranteed to produce a
lexicological effect."
It is not EPA's position that chemicals
registered as pesticides under FIFRA
should be precluded from listing simply
because these chemicals were tested at
doses' which are designed to produce
toxic effects. The commenters are
correct that the FIFRA standard study
design attempts to set the doses at levels
which bracket the minimal toxic dose,
and, therefore, the high dose(s) by
design produces an effect. The purpose
of this study design under FIFRA is to
determine the potential for toxicity of
the chemical, whether the responses are
dose-rqlated and, depending on the
effects produced, the degree of toxicity.
Because virtually any chemical
substance can elicit a lexicological
response at some dose level, the mere
presence of the toxic response is not
used in isolation in listing decisions
under EPCRA section 313. Rather, il is
Ihe relative severily of the effecl, Ihe
presence of a dose/response
relalionship, and whether tfie effect is
manifested at relatively low doses
which are considered in determining
the hazard of the chemical, and in
making listing determinations under
EPCRA section 313.
4. Precursor chemicals. CRF AG
Producls Company, Monsanlo, FMC
Corporation, Eastman Chemical
Company, and the Chemical
Manufacturers Association question
EPA's authority to list precursor
chemicals (i.e., a chemical that reacts in
vivo or in the environment to generate
another chemical that produces the
toxic effect supporting the listing) on
the EPCRA section 313 list. The
commenters believe that a chemical
should only be added to the list based
on the toxicity of the chemical itself.
Further they contend that nowhere in
the legislative history is there any
indication that post-release
transformation products, degradation
products, or products of chemical
reactions are legitimate bases for adding
chemicals to the EPCRA section 313 list.
The EPCRA section 313(d)(2) listing
criteria each state that EPA may list a
chemical that it determines "causes or
may reasonably be anticipated to cause"
the relevant adverse human health or
environmental effects. EPA believes that
this language allows EPA to consider
the effects caused by the degradation
products of a listed chemical. Where it
may reasonably be anticipated, based on
available data, that the listed chemical
would readily degrade into another
chemical that would cause the adverse
effect, EPA is acting reasonably and
within its grant of authority in listing
the precursor to the toxic degradation
product.
Furthermore, one could also view the
effects caused by the degradation
product as effects indirectly caused by
the listed chemical. EPA believes it is
within its authority to consider both the
direct and indirect adverse human
health and environmental effects of a
chemical in making a listing
determination. Based on the statutory
language and legislative history, EPA
interprets EPCRA section 313(d)(2) to
include toxic effects indirectly caused
by a listed chemical. The statute and,the
legislative history do not specifically
preclude EPA from considering indirect
effects in deciding whether a chemical
meets the toxicity criteria under'section
313. In the absence of specific
congressional intent on the issue, it is
reasonable for EPA to consider indirect
effects in light of the broad statutory
purpose to inform the public about
releases of toxic chemicals to the
environment. Were EPA to exclude
indirect effects from consideration it
would ill-serve the purpose of the
statute by precluding public access to
information about chemicals that, albeit,
indirectly cause a wide range of adverse
health and environmental effects^
There is precedent for the Agency to
consider the "indirect" toxicity of a
chemical being considered for listing^
Indirect toxicity was the basis for the
granting of two petitions, one to add
seven chlorofiuorocarbons and halons"
(August 30,1990, 55 FR 31594) and a
second to add hydrochlorofluorocarbons
to the EPCRA section 313 list (December
1, 1993, 58 FR 64936). EPA also used
indirect toxicity in support of its denial
of petitions to delete certain volatile
organic chemicals from the section 313
list, specifically, the ethylene and
propylene petition (January 27,1989, 54
FR 4072) and the cyclohexane petition
(March 15,1989, 54 FR 10668).
5. Use of studies conducted by routes
other than oral, inhalation, or dermal.
Several commenters maintain that
intraperitoneal, intravenous, or
subcutaneous injection (injection into
the abdomen, a vein, or under the skin.
respectively) has minimal relevance for
evaluating potential human exposure
from industrial situations and should
not be used to support an EPCRA
section 313 listing decision. One
commenter contends that, if considered
at all, intraperitoneal injection is a form
of exposure that should be considered
in establishing a section 313(d)(2)(A)
finding of acute effects, not a section
313(d)(2)(B) finding of chronic effects.
* EPA disagrees with the commenters.
In making section 313 listing decisions.
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61446 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
the Agency cannot ignore the possible
significance of any existing data,
including data from intraperitoneal,
intravenous, or subcutaneous injection
studies. Although it is .preferable to have
toxicity data from the common routes of
human exposure, EPA believes that for
hazard assessment under EPCRA section
313, the Agency should use all available
information to identify the hazard
associated wit'h a chemical. This
comment relates to five chemicals
(bromacil lithium salt, fluorouracil,
pentobarbital sodium, tetracycline
hydrochloride, and sodium nitrite) that
are being added to the section 313 list
today. For three of these chemicals,
bromacil lithium salt, fluorouracil, and
sodium nitrite, any data from
intraperitoneal or other injection routes
of exposure are supplemented by data.
from other, non-injection exposure
routes. For example, in addition to
chronic dog and rat injection studies to
support the chronic hematological
concerns of sodium nitrite, there are
human oral data. For bromacil lithium
salt, intraperitoneal injection studies in
rats are supplemented by gavage studies
in mice to support the developmental
concerns for this chemical. In addition
to the developmental effects observed in
the offspring of women receiving
fluorouracil intravenously,
developmental abnormalities in mice,
rats and hamsters receiving fluorouracil
orally were used to support the
developmental toxicity finding. For both
pentobarbital sodium and tetracycline
hydrochloride, the studies cited in the
proposed rule in support of the
developmental effects of these
chemicals are either studies in which
the chemical was administered via
injection or studies in which the
chemical was administered via another
route. However, because both of these
chemicals are commonly administered
orally, and are efficacious by this route
(orally), there is reason to extrapolate
the effects observed in injection studies
to effects by other routes. The proposed
rule and the Response to Comment
Document (Ref. 14) contain information
on EPA's review of these chemicals,
including the toxicity evaluation. This
background information will not be
repeated here in the final rule. Based on
EPA's reanalysis of the available
information in the proposed rule for
these five chemicals, EPA has sufficient
evidence to determine that bromacil
lithium salt, fluorouracil, pentobarbital
sodium, tetracycline hydrochloride, and
sodium nitrite have sufficient evidence
to meet the statutory listing criteria
under .EPCRA section 3\3{d)(2)(B).
6. Use of acute studies to support a
chronic finding. Several commenters
object to the use of data from acute
studies to support a rinding of chronic
toxicity. The comrnenters contend that
there is no correlation between transient
acute impact and chronic toxicity that is
appropriate to industrial chemicals as a
-whole. The commenters contend that, if
a chemical exhibits transient acute but
not chronic effects, it should not be
listed based on chronic toxicity, unless
additional data on chronic effects are
also used in the determination to list the
chemical.
EPA agrees with the commenter that
if a chemical exhibits acute toxic effects,
it should be listed based on acute effects
unless additional data on adverse effects
after long'term exposure are available.
This comment relates to three of the
chemicals (bromine, 2-bromo-2-
nitropropane-l,3-diol, and sodium
nitrite) that are being added to the
section 313 list today. For these
chemicals, any data from acute studies
are supplemented by chronic toxicity
information. In chronic toxicity studies,
bromine produced upper respiratory
irritation and neurological symptoms. In
chronic toxicity studies, 2-bromo-2-
nitropropane-l,3-diol produced various
effects including lesions of the stomach
mucosa, ulceration, raised areas and
excrescences, inflammation, epithelial
hyperplasia and hyperkeratosis, and
congested vessels of the mucosa of the
gastrointestinal (G.I.) tract. Sodium
nitrite induced, in a chronic study in
mice, reduced motor activity and major
electroencephalogram (EEC) changes in
treated animals. The proposed rule and
the Response to Comment Document
(Ref. 14) contain information on EPA's
review of these chemicals, including the
toxicity evaluation. This background
information will not be repeated here in
the final rule. A summary of the
response tojcomments for these
chemicals is provided in Unit IV.F. of
this preamble.
7. Use ofcholinestera.se inhibition as
a measure of neurotoxicity. Several
commenters expressed concern that the
Agency has used a chemical's effect of
inhibiting plasma, red blood cell (RBC)
or brain cholinesterase activity as a
basis for listing chemicals on the EPCRA
section 313 list. These commenters feel
that this effect is not an adequate
indicator of neurotoxicity.
The. Agency believes that inhibition of
plasma; RBC, or brain cholinesterase
activity is an appropriate indicator to
assess the toxicity of potential
neurotoxicants (Ref. 7). In order for the
normal activity of the nervous, system to
be altered by a toxic chemical, the
chemical must enter the body, reach the
tissue target site(s), and be maintained
at a sufficient concentration for a period
of time in order for an adverse effect to
occur. Biochemical changes precede the
more overt, physiological changes
associated with neurotoxicity, and are
more easily detectable.
Acetylcholinesterase (AChE) is the
enzyme .that inactivates or terminates
the effect of the neurotransmitter
(acetylcholine) on its target. When this
enzyme is inhibited, acetylcholine is
built up in the body, and may result in
loss of appetite, anxiety, muscle
twitching, paralysis, or other neurotoxic
effects. Thus, one can assess the signs
and symptoms of systemic poisoning by
many neurotoxins from their
biochemical mechanism of action, such
as the inhibition of AChE. Because of
the severity of these effects, EPA takes
a cautious approach by using a measure
of cholinesterase activity as an indicator
of neurotoxicity.
The comments concerning
cholinesterase inhibition relate to six of
the chemicals that are being added to
the section 313 list today. The proposed
rule and the Response to Comment
Document (Ref. 14) contain information
on EPA's review of these chemicals,
including the toxicity evaluation. This
background information will not be
repeated here. Based on comments
received and EPA's reanalysis of the
available information in the proposed
rule for these six chemicals. EPA has
sufficient evidence to determine that
acephate, cycloate. diazinon, ethyl
dipropylthiocarbamate, pirimphos
methyl, and profenofos meet the
statutory listing criteria under EPCRA
section 313(d)(2)(B) based on available
neurotoxicity data for these chemicals.
8. Use of certain studies for hazard
assessment. Several commenters argue
that EPA should not use studies in
support of listing a chemical on the
EPCRA section 313 list, if these studies
have been determined to be insufficient
for use in risk assessments under FIFRA
orTSCA. For example, the commenters
point to studies EPA considered in this
rulemaking in conducting hazard
assessments even though the studies
when submitted for use under FIFRA or
TSCA were determined by EPA to be of
"low confidence." EPA believes its use
of these studies for section 313 purposes
is appropriate. The "low confidence"
determination under FIFRA or TSCA
applies to the use of the studies for
purposes of risk assessment associated
with regulations that impose controls.
The data base for a chemical may be
rated low confidence because of
shortcomings such as lack of
experimental detail. Although these
studies may be of limited value for
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61447
purposes of risk assessment in support
of regulatory controls, when considered
together, they present a sufficient •
weight-of-evidence as to the hazard
associated with the chemical. As
additions to EPCRA section 313 made
pursuant to EPCRA section 313(d)(2)(B)
are not based on the kind of risk
assessment needed for regulatory
controls, EPA believes that such studies
can be used to support listing.
9. Docket was incomplete for certain
chemicals. Several commenters contend
• that the docket information supporting
the listing of certain chemicals is
incomplete. Other commenters contend
that, overall, the docket is too general
and limited., Responses to comments
about the evidence provided in the
docket for specific chemicals ore
provided in the Response to Comment
Document (Ref. 14).
hi the public docket supporting this
rulemaking, EPA included copies of
EPA's support documents (Refs. 9,12,
and 13) for the proposed rule and copies
of the main references cited in those
documents. The primary references that
are cited in these main reference
documents were not themselves
included. However, these reference
documents are published material,
readily, accessible, and are in the public
domain. EPA believes that the. docket
material for both the proposed and final
rules contains the appropriate
information to support the addition of
these chemicals to the EPCRA section
313 list and to have provided the public
an adequate basis on which to comment
on the proposed rule.
F. Chemical-Specific Comments for
Chemicals that Are Being Finalized in
Today's Action
The Agency received comments on
110 of the 313 specific chemicals
included in the proposed rule. This unit
of the preamble summarizes the most
significant of those comments and the
" Agency's responses. More detailed
responses are included-in the Response
to Comment Document (Ref. 14).
Neither this unit of the preamble nor the
Response to Comment Document
addresses comments specific to
chemicals that have been deferred for
final action. These comments will be
addressed in a separate rulemaking
specific to those chemicals.
1. Abamectin. One commenter,
Merck, states that primates are less
sensitive to the acute effects of
abamectin and its analog, ivermectin,
than rodents. The commenter implies
that because humans are primates,
abamectin should be less toxic in
humans than in rodents. The
commenter further contends that
ivermectin and abamectin have been
used safely in animals and humans.
Abamectin interferes with gamma-
aminobutyric acid (GABA) transmission
and, as such, produces neurotoxic
clinical signs such as tremors, ataxia,
convulsions, or coma that are more
severe in rodents and dogs than
primates. EPA agrees that the available
studies indicate that the sensitivity as
well as doses required to produce
neurotoxic effects vary from rodents to
primates by a 20-fold factor. However,
abamectin was proposed for addition to
the EPCRA section 313 list based on
developmental effects rather than
neurotoxicrty. There are no
developmental studies with abamectin
in primates. Therefore, EPA believes
that the rodent studies cited in the
proposed rule provide sufficient
evidence that abamectin can reasonably
be anticipated to cause developmental
toxicity in humans.
When administered in therapeutic
doses, the Agency does not dispute the
animal and human safety and efficacy of
ivermectin and abamectin, but the safety-
of a 0.2 to 0.3 mg/kg single therapeutic
dose does not diminish the findings of
the developmental, reproductive,
neurotoxic, chronic, and carcinogenic
animal studies with abamectin which in
some cases demonstrate serious
compound-related effects at higher than
therapeutic doses in all species tested.
The same commenter states that
although the aquatic toxicity data cited
for the proposed listing of abamectin .
under EPCRA section 313 are accurate
and valid, it may be inappropriate to list
abamectin under EPCRA section 313
based on the environmental fate of this
chemical, because of environmental fate
factors which were not presented by
EPA in the proposed rule.
EPA agrees with the commenter that
the aquatic toxicity values presented in
the proposed rule are accurate and
valid. EPA disagrees that the
environmental fate of abamectin will
negate the chemical's ecological
toxicity. EPA believes that the
environmental fate factors presented by
- the commenter may reduce, but do not
eliminate, the potential for adverse
effects on aquatic organisms because the
chemical is extremely acutely toxic to
aquatic organisms.
EPA reaffirms that there is sufficient
evidence for listing abamectin on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental toxicity
data and pursuant to EPCRA section
313(d)(2)(C) based on the available
ecotoxicity data. Therefore, EPA is
finalizing the addition of abamectin on
the EPCRA section 313 list.
2. Alachlor. Monsanto states that at
the highest dose tested in the chronic
mouse study cited in the proposed rule,
EPA concluded there was an increase in
lung tumors in females. Monsanto •
believes that other regulatory agencies
have disagreed with this conclusion.
The commenter contends that these
tumors occur spontaneously in mice
with a fairly high and variable
frequency and a possible slight increase
in a common rodent tumor at the
highest dose tested does not represent a
risk to humans receiving, at most, trace
level exposure.
The Agency has concluded that there
was statistically significant increase (the
increase was greater than that which
would be expected to occur
spontaneously) in lung tumors in female
CD-I mice at 2 dose levels which were
relevant to potential carcinogenicity to
humans. The commenter provides no
specifics to support its contention that
"other regulatory agencies have
disagreed with this conclusion" nor is
the Agency aware of any.
The commenter further states that the
Support Document for the Health and
Ecological Toxicity Review of TR1
Expansion Chemicals (Ref. 13) also
incorrectly listed the dose levels
("[greater than] 42 mg/kg/day")
producing tumors in rats in the 2-year
rat feeding study cited in the proposed
rule. The-commenter argues that •-.
significant increases in thyroid and
stomach tumors were observed only at
126 mg/kg/day, .the highest dose tested;
this dose level also produced severe,
excessive toxicity. Thus, the commenter
concludes that the dose-response curves
for the stomach and thyroid tumors are
exceptionally steep, with increased
incidences observed only at a dose
which exceeded the Maximum
Tolerated Dose (MTD).
EPA believes that the Support
Document for the Health and Ecological
Toxicity Review of TRI Expansion
Chemicals (Ref. 13) correctly states the
toxic dose levels in the 2-year rat
feeding study as being greater than or
equal to 42 mg/kg/day. In this study,
nasal tumors were significantly
increased at 42 mg/kg/day and above
and the stomach and thyroid follicular
cell tumors at 126 mg/kg/day. The
Agency agrees that the 126 mg/kg/day
dose level probably exceeded the MTD;
however, upon reconsideration of the
carcinogenicity data, the Agency
determined that the MTD is between .42
mg/kg/day and 126 mg/kg/day.
Although the MTD was exceeded by the
highest dose (126 mg/kg/day),
significant effects were seen at 42 mg/
leg/day, which, does not exceed the
MTD. Therefore, EPA believes that the
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61448 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
2-year.chrbnic dog study cited in the
proposed rule is a valid measure of the
oncogenic potential of alachlor.
The commenter cites a chronic rat
feeding study, not cited by EPA in the
proposed rule, in which 5 to 6 months
of alachlor administration followed by
19 months on control diet did not
produce a significant increase in
stomach or thyroid tumors in rats. The
commenter believes that this
information is consistent with the
results of a study, not cited by EPA in
the proposed rule, in which a close
structural chloroacetanilide analog of
alachlor has been shown to be a
promoter but not an initiator of stomach
tumors- The commenter did not further
identify this study.
Although in the chronic rat feeding
study referred to by Monsanto, the
specific group which received alachlor
in the diet for 5 to 6 months in this
study, and then control diet as a
recovery period did not develop
stomach or thyroid tumors, the other •
groups on study which continued to
receive alachlor in the diet developed
both stomach and thyroid tumors as
well as nasal turbinate tumors.
Therefore, the failure to develop
stomach tumors after 5 to 6 months
treatment reflects the time frame
required for tumor development rather
than indicating a lack of carcinogenic
response.
The commenter also discusses the
mechanism of carcinogenicity for
alachlon The commenter states that the
mechanism is nongenotoxic and
hormonally mediated. The commenter
argues .that the mechanism exhibits a
threshold and that nasal turbinate
tumors, in particular are not relevant to
humans.
The Agency acknowledges the
mechanism of carcinogenicity may be
hormonally mediated. However, the
mechanism does not alter the fact that
the tumors are relevant to potential
carcinogenesis in man. Mechanism of
tumor development relates to the
appropriate model by which cancer risk
is calculated. However, mechanism has
no impact on the determination of
carcinogenicity hazard. In determining
cancer classification, EPA does not
assume that the specific types of tumors
seen in animals will develop in humans.
However, EPA believes that the
development of tumors, such as nasal
turbinates, in animals demonstrates the
potential for tumor development in
humans.
The same commenter states that two
epidemiology studies, not cited by EPA
in the proposed rule, have been
conducted on alachlor manufacturing' •
workers. The commenter contends that
neither study indicates an increase in
tumors in humans due to exposure to
alachlor. The commenter believes that
these studies provide important
additional evidence indicating that the
tumors produced in rats by alachlor are
not produced in humans and should
have been considered by the Agency.
Epidemiological studies are used oy
the Agency in the overall evaluation of
the carcinogenic potential of a chemical,'
along with other evidence. However, the
studies cited by the commenter are
based on a small sample size. Studies of
this type cannot verify the levels and
duration of exposure and represent
results from a heterogeneous
population: In addition, one of the two
studies apparently only focused on
tumors resulting in death of the study
subjects and may reflect an under
estimation of tumor incidence.
Therefore, in the face of evidence of
carcinogenicity in two adequately
performed bioassays in two species, the
epidemiology data, although pertinent,
do not negate the importance of the
animal data in the studies relied upon
in the proposed rule.
EPA reaffirms that there is sufficient
evidence for listing alachlor on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2MB) based on
the available carcinogenicity data for
this chemical. Therefore, EPA is
finalizing the addition of alachlor on the
EPCRA section 313 list.
3. Ametryn. Ciba-Geigy Corporation
objects to listing ametryn under EPCRA
section 313 on the basis of liver effects,
stating that hepatbtoxicity was observed
only at high dose levels (100 and 500
mg/kg/day) in subchronic studies.
The Agency believes that the LOEL of
100 mg/kg/day is sufficiently low given
the seriousness of the effect (hepatic
toxicity) to justify listing on the EPCRA
section 313 list. Thus, EPA reaffirms
that there is sufficient evidence for
listing ametryn on the EPCRA section
313 list pursuant to EPCRA section
313(d)(2)(B) based on the available '
hepatotoxicity data for this chemical, -
and pursuant to EPCRA section
313(d)(2)(C) based on the available
environmental toxicity data. Therefore,
EPA is finalizing the addition of
ametryn on the EPCRA section 313 list.
4. Amitraz. Nor-Am Chemical
Company states that in the 2-year beagle
dog feeding study cited in the proposed
rule, contrary to EPA's conclusions, the
only effects seen in the high dose (1.0
mg/kg/day) group were a small but
insignificant increase in blood glucose
and in one animal slight hypothermia
during weeks 52 and 79.
EPA disagrees with the commenter.
EPA has Devaluated this study, arid
determined that in this study amitraz
induced significant changes in blood
chemistry (increased blood glucose).
Hypothermia occurred not only at the
times noted by the commenter, but also
on days 1 and 2, and in one dog 3 hours
after dosing, which returned to normal
within 24 hours, at the 1.0 mg/kg/day
level, the LOEL. As noted in the
proposed rule, these findings were
supported by similar results obtained in
a 90-day feeding study in dogs cited in
the proposed rule. ,
Nor-Am disagrees with the Agency's
conclusion that the NOAEL for
fetotoxicity was 5 mg/kg/day in the 3-
generation,rat reproduction study cited
in the proposed rule. The commenter
believes that while there was a slight
decrease in the mean litter size at birth
in the 20 mg/kg/day dose group and
decreased pup viability in the 5 and 20
mg/kg/day dose groups post partum,
there was no direct evidence of
fetotoxicity. Nor-Am states that the
effect on litter size was only significant
in the third generation animals at 5 mg/
kg/day, and may have been due to an
effect on lactation.
EPA's reanalysis of this data indicates
that there was a decrease in litter size
and pup survival at 5 mg/kg/day in all
3 generations and a slight reduction in
pup weight in the FI and F2 generations.
Thus, there was direct evidence of v
fetotoxicity. "*•
The commenter contends that the
rabbit teratology study reported by the
Agency in the proposed rule was
considered by EPA to be invalid (i.e..
significantly flawed) due to high
abortion rates in all groups,
inadequately small group sizes, and lack
of assessment of fetuses. The commenter
argues that the low incidence of
anomalies upon which the NOAEL of 1
mg/kg/day was based were within
historical control ranges and failed to
show any clear dose-related effect. The
. commenter claims that a subsequent
study, not cited by EPA in the proposed
rule, revealed no effects on fetal
morphology at doses up to 12 mg/kg/
day while maternal toxicity was found
at 3 mg/kg/day and above; no NOEL
could be established. The commenter
claims that this subsequent study, not
cited by EPA in the proposed rule,
should have been considered by EPA.
EPA disagrees. The rabbit teratology
study cited by EPA in the proposed rule
was never declared by EPA to be invalid
(i.e., seriously flawed). Upon reanalysis
of the rabbit teratology study, EPA
determined that although this study
does not fully satisfy the guidelines for
^study conduct under FIFRA. it is
sufficient for'thei purposes of hazard
assessment, with a NOEL arid LOEL for
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61449
maternal and developmental toxicity of
5 and 25 mg/kg/day, respectively. As
described in the proposed rule, at 25
mg/kg/day, the following effects were
seen: Decreased litter size and increased
pre and post-implantation losses,
decreased maternal body weight gain,
and increased abortions. The high
abortion rate is indicative of maternal
toxicity. Although the abortion rates
were higher than the control, enough
animals remained at sacrifice to
evaluate the toxicity potential of this
chemical, and to support the finding
that amitraz can reasonably be
anticipated to cause developmental
toxicity.
The subsequent study cited by the
commenter was also considered by EPA.
This study also does not fully satisfy the
guidelines for study conduct under
FIFRA. Although the fetotoxic effects
observed in the initial study (cited in
the proposed rule) were not reproduced
in the subsequent study referred to by
the commenter and not cited in the
proposed rule, this does not invalidate
the results obtained in the initial study.
Both studies were considered by EPA in
determining the developmental toxicity
of amitraz.
EPA reaffirms that there is sufficient
evidence for listing amitraz on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the chronic toxicity and developmental
toxicity data for this chemical.
Therefore, EPA is finalizing the addition
of amitraz on the EPCRA section 313
list.
5. Atrazine. Ciba-Geigy Corporation
objects to the listing of atrazine under
EPCRA section 313 based on increased
incidence of mammary tumors in female
Sprague-Dawley rats because the
commenter contends that this tumor
type is not indicative of potential
carcinogenicity in humans. The
commenter states that the effect is
species (rat) and strain (Sprague-
Dawley) specific. Further, the
commenter states epidemiology data
from Ciba-Geigy manufacturing and use
indicate no evidence of carcinogenicity
in a human population exposed for up
to 30 years. Ciba-Geigy did not provide
EPA with a copy of this study but did
discuss the results in their comments.
While epidemiology data are
considered in the weight of the evidence
for carcinogenicity, the current
classification is. based uppn a positive
finding in a well conducted animal
study as described in the Risk
Assessment Guidelines of 1986 (Ref. 5).
Atrazine has been classified as a
category C chemical by EPA's OPP
Carcinogenicity Peer Review Committee
; and (|ie Scientific Advisory .Panel (EPA,
1988). The use of mammary tumor data
for hazard assessment purposes, even
when only one strain of test animal has
been demonstrated to be positive, is
consistent with current Agency policy.
The Agency considers the cancer
classification to be sufficient basis for
listing of atrazine.
EPA reaffirms that there is sufficient
evidence for listing atrazine on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available carcinogenicity data.
Therefore, EPA is finalizing the addition
of atrazine on the EPCRA section 313
list.
6. Bendiocarb. Nor-Am Chemical
Company states that bendiocarb does
not meet the criteria of EPCRA section
313(d)(2)(C) due to its environmental
fate. The commenter alleges that it has
been shown not to accumulate in soil,
water, or plants and has a relatively
short half-life (a few days). Nor-Am
Chemical Company also contends that
bendiocarb is rapidly broken down by
hydrolysis to a biologically inactive
product. As a result, the commenter
states that there is no clear evidence of
adverse effects on the environment
associated with bendiocarb.
EPA disagrees that the environmental
fate of bendiocarb will negate the •
chemical's ecological toxicity. EPA
believes that the environmental fate
factors presented by the commenter may
reduce but do not eliminate the
potential for adverse effects on aquatic
organisms and birds because the
chemical induces environmental
toxicity at low dose levels. Thus, EPA
believes that the chemical can
reasonably be anticipated to cause a
significant adverse effect on the
environment.
EPA reaffirms that there is sufficient
evidence for listing bendiocarb on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
neurological toxicity data for this
chemical, and pursuant to EPCRA
section 313(d)(2)(C) based on the
available environmental toxicity data.
Therefore, EPA is finalizing the addition
of bendiocarb on the EPCRA section 313
list.
7. Bifenthrin. FMC Corporation docs
not support the addition of bifcnthrin
under EPCRA section 313 because "EPA
overstates the neurological and
[developmental effects] of bifenthrin.
The neurological effects to which EPA
referred were tremors or twitching,
neurological signs that did not persist
for the entire duration of the studios."
EPA agrees with the commenter
regarding the developmental toxicity • ,
potential or lack thereof, but disagrees *
with the commenter regarding'the, :
neurological hazards. In addition to the
tremors or twitching effects cited by the
commenter, more severe symptoms,
including clonic convulsions and death,
occur in the studies referred to by the
commenters that are cited in the
proposed rule, at dose levels only
slightly higher than those causing slight
or occasional tremors and/or twitching.
In a rat developmental toxicity study by
gavage, cited in the proposed rule, the
maternal LOEL based on tremors was 2
mg/kg/day; the NOEL was 1 mg/kg/day.
The MTD of 2 mg/kg/day was
established on the basis of findings in a
rat pilot study (included as part of the
chronic rat study cited in the proposed
rule) in which there were 3 deaths out
of 10 animals at 2.5 mg/kg/day. With
regard to the comment concerning the
transitory nature of the effects, although
they may be transitory in nature, this
does not diminish the significance of
the adverse effects. In particular,
neurotoxic effects leading to convulsion
may result in more permanent,
underlying damage which is not
reversible upon cessation of immediate
signs and symptoms. Therefore, the
Agency concludes that the neurological
effects due to bifenthrin are of sufficient
seriousness to warrant listing.
EPA reaffirms that there is sufficient
evidence for listing bifenthrin on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based rfn
the available neurological toxicity data.
and pursuant to EPCRA section
313(d)(2)(C) based on the available "
environmental toxicity data. Therefore,
EPA is finalizing the addition of
bifenthrin on the EPCRA section 313
list.
8. Bromine. Great Lakes Chemical
Corporation and Albemarle Corporation
believe that bromine does not meet the
listing criteria of EPCRA section 313.
They contend that the Agency has failed
to show that chronic exposure to
bromine causes serious or irreversible
effects. They also contend that the time-
weighted average (TWA) of 0.1 part per
million (ppm) established by the
National Institute of Occupational
Safety and Health (NIOSH) will protect
against the acute effects of exposure.
They believe, therefore, that the
addition of bromine to the EPCRA
section 313 list should not be finalized.
NIOSH established the TWA for
bromine for acute effects. However, the
Agency is not listing bromine on the
EPCRA section 313 list on the basis of
its acute effects but on the basis of the
adverse effects it induces after chronic
exposure. These effects include
functional neurblogic effects and
abnormalities in respiratory and
endocrine systems. In humans, chronic
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61450 Federal Register / Vol. 59, No: 229 / Wednesday, November 30, 1994 / Rules and Regulations
exposure to bromine can cause severe
irritation of the skin, mucous
membranes and respiratory tract,
gastroenteritis, and death. This severe
irritation which can lead to death
through either, or both, respiratory or
gastroenteric irritation is the primary
endpoint of concern although.
neurologic signs and symptoms which
include dizziness, headache, and
"feelings of oppression" along with
other functional disturbances of the ..
central nervous system (CNS} may also.
occur after exposure to bromine.
EPA reaffirms that there is sufficient
evidence for. listing bromine on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available chronic toxicity data for
this chemical. Therefore, EPA is
finalizing the addition of bromine on
the EPCRA section 313 list.
9. 2-Bromo-2-nitropropane-l,3-diol
(Bronopol). Boots Microcheck contends
that 2-bromo-2-nitropropane-l,3-diol
presents only a moderate acute hazard, .
but does not present a chronic hazard.
Therefore, the commenter concludes
that the compound should not be listed
under EPCRA section 313 pursuant to
EPCRA section 313(d)(2)(B).
Although the Agency agrees with the
commenter that 2-bromo-2-
nitropropane-l,3-diol presents a
• moderate acute hazard, EPA does not
agree that the chemical is not a chronic
toxicant. The effects noted in both acute
and chronic studies, cited in the
proposed rule,, indicate irritation due to
exposure to the compound. However,
differing expressions of irritation are
obtained depending upon the level of
material to which the test animals were
exposed and the duration of exposure.
In the acute studies cited in the
proposed rule, the acute gastric effects
were seen at relatively high doses. In the
chronic studies, cited in the proposed
rule, the effects, described below, were
noted following repeated oral exposure
to lower doses of 2-bromo-2-
nitropropane-l,3-diol. The NOEL for
chronic oral exposure in rats was 10 mg/
kg/day, with effects including lesions of
the stomach mucosa, ulceration, raised
areas and excrescences. In a 13-week
study in rats cited in the proposed rule,
effects included inflammation,
epithelial hyperplasia and
hyperkeratosis, and congested vessels of
the mucosa of the G.I. tract. The chronic
studies cited in the proposed rule show
. that irritation was caused by a repeated
number of low doses. In these chronic
studies multiple doses were required
before irritation occurred. Further, the
type of irritation caused by acute and
chronic exposure are different.
Therefore, the irritation due to chronic
exposure to 2-bromo-2-nitropropane-
1,3-diol is distinguishable from that
caused by acute exposure. EPA believes
that the effects observed in the longer
term studies are serious and potentially
irreversible.
EPA reaffirms that there is sufficient
evidence for listing 2-bromo-2^
nitropropane-l,3-diol on the EPCRA
section 313 list pursuant to EPCRA
section 313(d)(2)(B) based on the
available chronic toxicity data for this
chemical. Therefore, EPA is finalizing
the listing of 2-bromo-2-nitropropane-
1,3-diol on the EPCRA section 313 list.
10. Carboxin. Zeneca Incorporated
and Uniroyal Chemical oppose the
listing of carboxin. The commenters
claim that the effect of renal toxicity
noted by EPA in the proposed rule was
seen only in rat feeding studies and not
in a chronic dog feeding study. Thus,
they claim it appears to be a species-
specific effect that.may not be relevant
to man.
EPA disagrees with the conclusions of
the commenters. Because direct human
testing is generally unavailable, animals
are commonly accepted as surrogates for
toxicity testing to predict potential
hazard(s) to humans. Exceptions occur
only in a few rare cases where effects
have been determined to be species-
specific te.g., a2n-globulin). It should be
noted that the actual number of species
tested with carboxin is limited and,
therefore, it is premature to state that
the renal toxicity of carboxin is species-
specific. Significantly, the commenters-
did not provide any additional evidence
to support their contention that the
renal toxicity is species-specific. EPA
uses information from the most
sensitive species, to evaluate potential
human hazard(s), as a conservative
assumption.
EPA reaffirms that there is sufficient
evidence for adding carboxin on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available renal toxicity data for this
chemical. Therefore, EPA is finalizing
the listing of carboxin on the EPCRA
section 313 list.
11.1 -(3-Chloroallyl)-3.5,7-triaza-1 -
azoniaadamantane chloride. Dow
Chemical Company notes that, in the
dog study cited in the proposed rule, the
test material was administered in gelatin
capsules due to problems with
palatability. They argue that this mode
of administration is unusual and
introduces the confounding factor of
what is in essence a bolus
administration (given all at one time) of
the chemical, and results in an
artificially lowered NOEL.
The Agency does not agree that this
mode of administration is unusual. EPA
frequently reviews dog studies in which
the test material is administered by
capsule. In addition, dog studies rarely
permit ad libitum feeding as used in rat
studies, even when dietary
incorporation is the means of dose
administration. Dogs generally receive a
measured amount of food that they
rapidly consume. Therefore, bolus
administration closely approximates
actual behavior in dogs. The concern
that capsule administration produces an
apparently altered response is not a
confounding factor in the study cited in
the proposed rule, and therefore the
reported NOEL does not need to be
raised as suggested by the commenter.
The same commenter contends that
the effects used as a basis for listing
occurred only in dogs and only in a
single study, and, therefore, are not
relevant to humans.
Because direct human testing is
generally unavailable, animals are
commonly accepted in the scientific and
regulatory communities as surrogates for
toxicity testing to predict potential
hazard to humans, except in a few rare
cases where-effects have been
determined to be species-specific (e.g.,
a2ji-globulin). In the interest of being
protective, EPA uses information from
the most sensitive species to evaluate
potential human hazard. In addition,
results demonstrated in a single well-
conducted study are sufficient and can--
serve as a basis for listing on the section
313 list.
The same commenter states that the
LOEL in the study was based upon a
slight, reversible effect in the liver of a
single animal. The study, the
commenter argues, should have been
considered in toto rather than relying on
a single effect. The commenter implies
that EPA should have set the LOEL at
a higher dose.
The commenter is incorrect. The
LOEL of 15 mg/kg/day is correct. This
LOEL was based upon obliterative
vasculitis and perivasculitis in one
animal. However, these effects are not
commonly seen in dogs, yet in the study
cited in the proposed rule, they
occurred in seven of eight dogs at 30
mg/kg/day, the dose next highest to the
LOEL. EPA considers the effects seen in
this study to be serious effects.
EPA reaffirms that there is sufficient
evidence for listing l-(3-chloroallyl)-
3,5,7-triaza-l-azoniaadamantane
chloride on the EPCRA section 313 list
pursuant to EPCRA section 313(d)(2)(B)
based on the available chronic toxicity
data for this chemical. Therefore, EPA is
finalizing the addition of l-(3-
chloroallyl)-3,5,7-triaza-l-
£zoniaadamantane chloride on the
EPCRA section 313 list.
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Federal Register / Vol. 59, No. 2297 Wednesday, November 30, 1994 / Rules and Regulations 61451
12. Chlorosilanes. Silicones
Environmental Health and Safety
Council and General Electric oppose the
listing of the six chlorosilanes that were
proposed for addition
(dichloromethylphenylsilane,
dimethyldichlorosilane,
methyltrichlorosilane,
trichloroethylsilane;
trichlorophenylsilane, and
trimethylchlorosilane) arguing that they
undergo rapid hydrolysis and are not
expected to be found in the atmosphere
in appreciable concentrations. The
commenters further state that EPA
estimated conditions in its exposure
assessment that greatly exceed actual
conditions.
Based on these comments, EPA
conducted revised exposure
assessments for each of the
chlorosilanes. These revisions support
EPA's initial finding that
dimethyldichlorosilane, -
methyltrichlorosilane, and
trimethylchlorosilane can reasonably be
anticipated to be present at facility
boundaries in concentration levels that
would cause a significant adverse effect.
EPA believes that the exposure
assessments were based on reasonable
release estimates and reasonable worst-
case concentration modeling. Details of
this analysis are provided in the
Response to Comment Document (Ref.
14). Thus EPA reaffirms that there is
sufficient evidence to list
dimethyldichlorosilane',
methyltrichlorosilane; and
trimethylchlorosilane on the EPCRA
section 313 list pursuant to
EPCRAsection 313(d)(2)(A). Therefore,
EPA is finalizing the listings for
dimethyldichlorosilane,
methyltrichlorosilane; and
trimethylchlorosilane on the EPCRA
section 313 list.
The revised exposure assessments for
dichloromethylphenylsilane,
trichloroethylsilane, and
trichlorophenylsilane, however,
indicate that these chemicals are not
individually present at facility
boundaries in concentration levels that
would cause a significant adverse effect.
However, two or more of these
chemicals are usually produced together
and as a category are reasonably
anticipated to be present at facility
boundaries in concentration levels that .
would cause a significant adverse effect.
Therefore, EPA is deferring the
individual listings of these three
chemicals for consideration as a
category possibly to be added at a later
date.
13. Crotonaldehyde. Eastman
Chemical and Monsanto believe that
crotonaldehyde should not be added to
the EPCRA section 313 list because of
inadequate data on human health.
Furthermore, they contend that
crotonaldehyde does not meet the
criteria for listing as a carcinogen as put
forth in the Risk Assessment Guidelines
for Carcinogen Risk (Ref. 4) because it
was tested in a single sex, single species
experiment. The commenters further
believe that EPA's statement that
crotonaldehyde did not induce tumors
at the high dose, because at that high
dose crotonaldehyde is cytotoxic, is a
contention which is not supported by
scientific evidence. They believe that
overall the weight of evidence for
carcinogenicity, including reactivity and
mutagenicity, is insufficient to support
listing. •
EPA agrees that the human
carcinogenicity data are inadequate but
feels that the available animal data are
adequate to support a concern for
carcinogenicity. The Agency accepts the
single-sex, single species testing of
crotonaldehyde as being sufficient for
listing because these data are supported
by strong evidence of mutagenicity in
Salmonella typhimurium; a statistically
significant increase in the number of
both benign and malignant tumors in •
low dose animals and induced altered
liver foci but not tumor formation in the
high dose group. Crotonaldehyde is
known to be severely cytotoxic with the
capacity'to induce cell death and alter
cellular macromolecules. It caused gross
degeneration, chromosome breakage and
reciprocal translocations in Drosophila
melanogaster and gross degeneration
and polyploidy in all stages of
spermatogenesis in mouse seminiferous
tubules thus showing that is has ample
ability to interact with cellular DNA and
cause severe disruption'in chromosome
structure and cellular integrity. It is
logical to assume that if crotonaldehyde
is capable'of such damage in the
..mammalian testis which is protected by
the blood/testis barrier, it can also cause
severe toxicity and cell death in the
liver which has no such protection from
toxic agents. Absent evidence to the
contrary, which the commenter did not
provide, EPA continues to believe that
failure to observe tumor formation is
due to cell death before tumors could
develop. Based on these findings, the
Agency believes that the weight of
evidence for crotonaldehyde is
sufficient for listing. EPA reaffirms that
there is sufficient evidence for listing
crotonaldehyde on the EPCRA section
313 list pursuant to EPCRA section
313{d)(2)(B) based on available
carcinogenicity and mutagenicity data
for this chemical. Therefore, EPA is
finalizing the .addition of
crotonaldehyde on the EPCRA section
313 list.
14. Cycloate. Zeneca Incorporated
contends that in the 3-generation rat
feeding study, cited in the proposed rule
as being of unknown duration, the
distended myelin sheath demyelination
and nerve fiber loss at the LOEL of 3.0
mg/kg/day occurred only after extensive
exposure and as such would not be
relevant to a toxic release type of short
exposure.
The effects described in this study are
considered to be both serious and
irreversible. Adverse effects that are
induced by a chemical after repeated
long-term exposures and are a valid
basis for listing under EPCRA section
313.
The same commenter states that the 3-
generation rat reproduction study cited
in the proposed rule was replaced by a
more recent (1990) 2-generation rat
reproduction study, also cited in the
proposed rule, in which the toxic effects
on pup survival (LOEL of 50 mg/kg/day)
and pup body weight (LOEL of 20 mg/
kg/day) occurred at doses which were
maternally toxic as well.
EPA considered both studies in its
evaluation of cycloate. As described in
unit IV.E. of this preamble,
developmental effects seen in
developing organisms are considered to
be adverse whether or not they occur als
doses that are also maternally toxic.
EPA reaffirms that there is sufficient
evidence for listing cycloate on the "
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available neurological and
developmental toxicity data. Therefore,
EPA is finalizing the addition of
cycloate on the EPCRA section 313 list.
15. Cyclohexanol. Monsanto opposes
the listing of cyclohexanol because
concentrations that led to tremors,
central nervous system depression,
lethargy, or hypothermia in rabbits, as
cited in the proposed rule, are above the
level of MED that EPA identified in the
Draft Hazard Assessment Guidelines
(Ref. 11) as high priority or moderate
priority. Furthermore, the
concentrations that led to reproductive
impacts in rats were above the MED
level of high priority. In addition,
Monsanto states that the Industrial
Health Foundation submitted to EPA's
TSCA office the results of a 2-generation
reproduction study demonstrating a
NOEL of 500 ppm in air which should
have been considered. The commenter
claims that EPA has also not
demonstrated that the effects
mentioned,.or concentrations at which
tfiey occurred, were serious or
. irreversible.
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61452 Federal Register / Vol. 59. No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
EPA agrees that the concentrations
that led to tremors, central nervous
system depression, lethargy, or
hypothermia in rabbits are above the
level of MED that EPA identifies in the
Draft Hazard Assessment Guidelines
(Ref. 11) as high priority for listing.
However, while the 2,500 mg/kg/day
dermal exposure is above the moderate
priority MED guideline, the 997 ppm
(438 mg/kg/day) is within this category.
In addition to the neurotoxicity effects,
as cited in the proposed rule,
cyclohexanol also induces renal,
hepatic, and myocardial effects at
moderate dose levels (for example,
inhalation of 0.59 mg/L of cyclohexanol
induced degenerative changes in the
livers and kidneys of rabbits); EPA
considers these effects to be serious. In
this case, based on' a weight-of-evidence
approach, EPA believes that • •
cyclohexanol presents a sufficient
hazard to warrant listing under EPCRA
section 313 even though the reported
values for neurotoxicity effects are in
excess of the MEDs placing a chemical
in the high priority grouping.
EPA disagrees that the concentrations
that led to reproductive impacts in rats
and gerbils (15 mg/kg) as described in
the proposed rule are above the MED
range for high priority listing. EPA
reiterates the overall reproductive
toxicity of this chemical, based on a
weight-of-evidence, supports the
addition of cyclohexanol to the EPCRA
section 313 list.
The chemical tested in the 2-
generation reproduction study
submitted to the Agency by the
Industrial Health Foundation, cited by
the commenter, was cyclohexanone not
cyclohexanol as claimed by the
commenter. •
EPA reaffirms that there is sufficient
evidence for listing cyclohexanol
pursuant to EPCRA section 313
pursuant to EPCRA section 313(d)(2)(B)
based on the available chronic
neurological, hepatic, renal, myocardial,
and reproductive toxicity data for'this
chemical. Therefore, EPA is finalizing
the addition of cyclohexanol on the
EPCRA section 313 list.
16. Cyhalothrin. Zeneca Incorporated
contends that the neurotoxicity signs
observed in the 6-month and 1-year dog
studies cited in the proposed rule
occurred at doses that were "otherwise
toxic as well" and do not provide any
evidence of a specific neurotoxicity.
Zeneca Incorporated implies that the
presence of "otherwise toxic" signs
reduces the significance of the
neurotoxicity observed in the cited
study. . '- •
The phrase "otherwise toxic as well"
was not defined by-the commenter. The
clinical signs of neurotoxicity observed
in the dogs at 3.5 mg/kg/day (ataxia,
muscle tremors, and convulsions in the
1-year study cited in the proposed rule)
and at 10 mg/kg/day (unsteadiness and
trembling in the 6—month study cited in
the proposed rule) are considered by
EPA to be evidence of physiological
neurotoxicity. Although there were no
pathologic changes in the nervous
tissue, EPA considers these effects to be
serious because they often precede
pathologic neurotoxicity. With the
exception of liquid feces, there were no
reported toxic findings other than those
related to neurotoxicity.
EPA reaffirms that there is sufficient
evidence for listing cyhalothrin on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available neurological toxicity data.
Therefore, EPA is finalizing the addition
of cyhalothrin on the EPCRA section
313 list.
17. Desmedipham. Nor-Am Chemical
states that methemoglobin formation,
which is cited by EPA as the basis for
listing, is an entirely reversible effect
which occurs only after prolonged and
consistent exposure. Therefore, the
commenter concludes that this finding,
by itself, should not be used.
Based on the 90-day dog study, cited
in the proposed rule, EPA considers 150
ppm to be a NOAEL. Methemoglobin
values were only minimally higher than
control levels and were not associated
with an increase in Heinz bodies. In the
1-year dog feeding study, after 13 weeks
treatment at 300 ppm, methemoglobin
was seen associated with
histopathological changes (hemosiderin
and hemopoiesis). While
methemoglobinemia may be a reversible
effect, it is nevertheless a-serious effect,
and in some cases irreversible damage
may occur as a result of
methemoglobinemia.
Methemgglobinemia interfers with the
oxygenating capacity of blood resulting
in an undersupply of oxygen to the
tissues. Therefore, methemoglobinemia
is a toxic effect and not simply an
indicator of exposure to desmedipham
as concluded by the commenter.
Therefore; EPA reaffirms that there is
sufficient evidence for listing
desmedipham on the EPCRA section
313 list pursuant to EPCRA section
313(d)(2)(B) based on the available
hematological toxicity data. Therefore,
EPA is finalizing the addition of -
desmedipham on the EPCRA section
313 list.
18. 2,2*Dibromo-3-
nitrilopropionamide. Dow Chemical
Company and Rohm Haas state that the
corrosivity and irritancy of the 2,2-
dibromo-3-nitrilopropionamide
(DBNPA) solutions to the esophagus.
pharynx, trachea, and lungs led to
• development 'of dyspnea in rats. The
commenters imply that the dyspnea in.
rats should be discounted because it
was caused by the method of
administration rather than the toxicity
of the chemical.
The Agency agrees that the dyspnea
observed in the 4-week and 13-week rat
gavage studies cited in the proposed
rule may have been due to severe
irritation of the trachea and lungs from
accidental or incidental delivery of
small amounts of the.DBNPA dosing
solutions into the larynx, pharynx,
trachea, and/or lungs during the
procedure. However, this suggestion of
possible cause can be neither refuted
nor confirmed based upon the available
data. Dyspnea is the basis for the LOEL
in the study. One of the commemers
agrees that DBNPA is corrosive,
particularly to the eyes and, at the least,
is severely irritating to the respiratory
tract. This is consistent with the effects
observed in the two subject studies. The
Agency considers the finding of
dyspnea in the 4- and 13-week studies
to be of sufficient seriousness to warrant
listing on the EPCRA section 313 list.
EPA reaffirms that there is sufficient
evidence for listing 2,2-dibromo-3-
nitrilopropionamide on the EPCRA
section 313 list pursuant to EPCRA
section 313(d)(2)(B) based on the
available chronic respiratory toxicity '
data. Therefore. EPA is finalizing the
addition of 2,2-dibromo-3-
nitriloproprionamide on the EPCRA
section 313 list.
19. Diclofop-methyl. Nor-Am
Chemical and Hoechst-Celanese
contend that EPA interpreted the doses
administered by gavage as diet
concentrations (ppm) in the rat
teratology study cited in the proposed
rule. One commenter states the Agency
should provide clarifications concerning
"mortality" of the pups and the
calculation of the actual test substance
intake at different stages during the in-
life phases during development in the 3-
generation rat reproduction study.
The commenter is correct in stating
that the Agency erred in interpreting
gavage doses as ppm in the rat
teratology study. However, EPA still
believes that the doses at which adverse
effects occur are sufficiently low and the
adverse effects reported are of sufficient
seriousness to warrant listing. The
developmental NOEL is 10 mg/kg/day
and the LOEL is 32 rrig/kg/day based on
an increased incidence of a number of
variations and malformations, as
described in the proposed rule. While
the maternal effects on body weight and
food consumption at 32 mg/kg/day are
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61453
transient and reversible, some of the
developmental effects at this dose are
irreversible. In the 3-generation rat
reproduction study cited in the
proposed rule, a decrease in pups born
alive in the-Fu, reduced pup weights
(Fla and 2a) and general retardation of
•physical development (Fia and 2a) was
noted in offspring at 100 ppm (5 mg/kg/
day). The commenter considers the
LOEL for this study to be 6.7 mg/kg/day.
. This dose resulted in decreased parental
food consumption and body weight and
there were no post partum pup
mortalities. Additionally, there were no
effects on fertility at the LOEL at any
time during the three generations.
The commenters further stated that
EPA should "consider the validity" of
the 30-day rat study cited in the
proposed rule because heart, kidney,
and adrenal weights were increased
only at doses with no histopathological
correlates and were due to the
pharmacodynamic lipid metabolism of
the test material by the liver.
The increased relative heart, liver,
and kidney weights at 80 ppm (4 mg/kg/
day) in the 30-day rat feeding study is
further substantiated by a recent 9fr-day
rat feeding study cited in the proposed
rule with a LOEL of 80 ppm and a NOEL
of 20 ppm (1 mg/kg/day). In the recent
90-day study cited in the proposed rule,
absolute and relative liver and kidney
weight was increased in males and',
relative liver and kidney weight was
increased in females at 80 ppm. These
increased organ weights are evidence of
a compound-related effect. The Agency
interprets Hoechst-Celanese's own
statements regarding {he 30-day rat
feeding study that "increased liver
weights and centrilobular enlargement
of hepatic cells at dietary concentrations
of 80 ppm and higher" as evidence of
toxicity.
Hoechst-Celanese also contends that
the effects in the renal cortex observed
in the 90-day dog study cited in the
proposed rule at 250 ppm (15 and 13.4
mg/kg/day in males and females,
respectively) did not occur at the
highest concentration tested in the 1-
year dog study (80 ppm, 4-5mg/kg/day)
indicating that the finding in the 90-day
study was not test substance related:
EPA believes that the effects occurring
in the-renal cortex in the 90-day dog
study at 13 to 15 mg/kg/day may not
have appeared in the 1-year dog study,
since the highest dose tested was 4r5
mg/kg/day. If higher doses were'
employed in the 1-yearstudy, then
renal effects could possibly have
occurred. However, the results of the 1—
year study do not negate the 90-day
results, since the dose levels'used.in the.
90-day. study .were 'so much higher. .. •
Hoechst-Celanese also states that the
Agency used an invalid (flawed)
reproductive toxicity study to support
the listing. The commenter indicates
that the study was compromised by
infection of the rat colony with RCV7
SDA virus. They further state that
another reproductive toxicity study,
which EPA did not cite in the proposed
rule, should have been evaluated in
which the fetotoxic NOEL was 30 mg/
kg/day instead of greater than 5 mg/kg/
day as in the original study. .
The Agency does not find the original
study to be invalid. The data were
considered to be valid for regulatory
purposes: In addition, the Agency found
the. fetotoxic NOEL in the study referred
to by the commenter, not cited by-EPA
in the proposed rule, to be 5 mg/kg/day.
not 30 mg/kg/day as stated by the
commenter.
EPA reaffirms'that there is sufficient
evidence for listing diclofop-methyl on
the EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental, hepatic,
and renal toxicity data.'Therefore, EPA
is finalizing the addition of diclofop-
methyl on the EPCRA section 313 list.
20. Diisocyanates. EPA originally
proposed to list three diisocyanates
(hexamethylene-l,6-diisocyanate,
isophorone diisocyanate, and 1,1-
methylene bis(4-isocyanatocyclohexane)
on the basis of acute toxicity pursuant
to EPCRA section 313(d)(2)(A). As an
alternative, EPA proposed to create a
delimited diisocyanates category
containing these 3 diisocyanates and 17
other diisocyanates based on chronic
pulmonary irritation pursuant to EPCRA
section 313(d)(2)(B). EPA is finalizing
addition of the delimited diisocyanate
category based on chronic pulmonary
toxicity and therefore has not addressed
comments concerning the acute toxicity
of any of the diisocyanates. EPA
believes that diisocyanates are best
added as a category because the
members of this category are
structurally similar (i.e., each contains
the diisocyanate functionality), they
induce a similar toxic effect (chronic
pulmonary irritation), and their toxicity
is due to the diisocyanate portion of the
molecule common to all members.
Chemical Manufacturers Association
Hexamethylene-l,6-Diisocyanate Panel.
Dow Chemical Company, Monsanto,
Olin Chemicals, Sealed Air Corporation.
Huls America Incorporated, and the .
Diisocyanates Panel of the Chemical
Manufacturers Association oppose
EPA's alternative proposal to create a
diisocyanate category and believe that-
individual diisocyanates should be
evaluated and included on the EPCRA-
section 313 list only if the diisocyanate
independently satisfies the statutory
listing criteria. The commenters state
that in adding a broad category of
diisocyanates, EPA ignores its statutory
mandate to evaluate the individual
toxicity of each chemical and to
evaluate the exposure potential to the
EPCRA community by each individual
chemical. The commenters contend that
the category would mislead the public
as to the amount and type of toxic
chemicals to which communities may
be exposed. The commenters contend
that data collected in aggregate is
confusing and difficult to use or
interpret. Commenters state that adding
a category of diisocyanates based upon
the isocyanate functionality is based on
the chronic effects associated, with
exposures to a limited number of
diisocyanates and that this method
unjustifiably equates toxicity across an -
entire class of chemicals that have
different properties and effects.
Commenters state that diisocyanates
encompass a diverse group of chemicals
which vary significantly in physical and
chemical properties and in potential
toxicity. Commenters state that the
available evidence on the pulmonary
effects or toxicity of individual
diisocyanates (toluene diisocyanate.
methylenebis(phenylisocyanate), and '
isophorone diisocyanate) does not
support the addition of a diisocyanates
category. The cpmmenters also state that
EPA has not cited any data' to support
the assertions that diisocyanates cause-
tliese effects. Commenters state that
individual diisocyanates have been
shown to respond differently in
mutagenicity studies and that other
lexicological differences would be
expected among individual
diisocyanates, because, of differences in
their ability to penetrate membranes, the
capacity of organisms to metabolize
them, the specific reactivity of the.
diisocyanate groups, etc. Commenters
state that in the proposed rule EPA
recognized these differences by stating
that some diisocyanates are classified as
probable carcinogens and others are not.
The Wisconsin Department of Natural
Resources supports EPA's alternative
proposal to create a diisocyanate
category and would 'prefer this manner
of listing to listing each diisocyanate
separately.
As discussed in unit IV.C. of the
preamble, EPA believes that it is acting
reasonably within its discretion in
listing a category of chemicals by
showing that at least one member of the
category meets the listing criteria of
EPCRA section 313 and that the other
members can reasonably be expected to
•exhibit the same-or similar toxic-effect.
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61454 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
EPA believes that the available data on
the chronic pulmonary toxicity for
several members of the diisocyanates
category are sufficient for listing under
EPCRA section 313(d)(2)(B). EPA also
believes that .the diisocyanate moiety,
common to all members of the category,
is responsible for the observed chronic
pulmonary toxicity. Therefore, EPA
believes that it is reasonable to
anticipate that all members of the
diisocyanate category will exhibit
chronic pulmonary toxicity and that
creating a category of diisocyanates is
the most appropriate way to list this
class of chemicals.-As stated in Unit
IV.B. of the preamble, EPA does not
believe that it is required to consider
exposure for chemicals that are
moderately high to highly toxic based
on a hazard assessment when
determining if a chemical can be added
for chronic effects pursuant to EPCRA
section 313(d)(2)(B); therefore, EPA is
not required to evaluate the exposure
potential for the members of the
diisocyanates category. EPA believes
that, because each member of the
diisocyanates category has. the same
functional groups and can'reasonably be
anticipated to cause similar toxic
effects, the diisocyanates category will
not mislead the public as to the, amounts
and type of chemicals released and will
not be confusing to use or interpret.
. EPA agrees that the diisocyanates are
a diverse group of chemicals which vary
in physical and chemical properties.
However, EPA also believes that the
reactive portion of diisocyanate
chemicals is the diisocyanate moiety
itself and that the rest of the molecule
does not affect the reactivity of this
portion of the molecule. EPA stands by
its'interpretation of the literature, as
cited in the proposed rule and
background material, on the adverse
pulmonary effects of diisocyanates and
believes that this information supports
the addition of a diisocyanates category.
The Agency agrees that structural .
differences among individual
diisocyanates may indeed affect their
absorption and metabolism. However,
since absorption and metabolism are not
necessary for chronic pulmonary
irritation to occur, the effect of
structural differences upon either
absorption or metabolism is not an issue
in this case. The Agency agrees with the
commenter that there are differences in
the carcinogenicity/mutagenicity of
toluene diisocyanate, ,
methylenebis(phenylisocyanate), and
isophorone diisocyanate and that these
differences are most likely the result of
the differences in absorption and
metabolism.. However, since neither of
these endppints is the basis for listing
diisocyanates as a category and since
chronic pulmonary irritation can occur
without absorption and metabolism
taking place, these issues do not affect
the Agency's overall concern for
diisocyanates or its decision to list them
as a category on the EPCRA section 313.
As EPA discussed in the proposed
rule, there currently are four other
diisocyanates listed on the EPCRA
section 313 list, these are:
Toluene-2,4-diisocyanate (000584-84-
9)
Toluene-2,6-diisocyanate (000091-08-
7)
Toluene diisocyanate (mixed isomers)
(026471-62-5)
Methylenebis(phenylisocyanate)
(000101-68-8)
EPA is leaving the toluene •
diisocyanate compounds listed
individually. In addition to the effects
discussed above, these compounds have
been shown to be carcinogenic. EPA
believes it is appropriate to continue to
individually list carcinogenic
diisocyanates because they exhibit a
different toxic endpoint than other
members of the category.
Methylenebis(phenylisocyanate) has not
been shown to be a carcinogen and as
EPA discussed in the proposed rule it is -
being moved into the diisocyanate
category.
EPA reaffirms its determination that
diisocyanates meet the criteria of
EPCRA section 313(d)(2)(B). Therefore,
EPA is finalizing the addition of the
diisocyanates category that consists of
the following chemicals:
l,3-Bis(methylisocyanate)cyclohexane
(CAS No. 038661-72-2)
l,4-Bis(methylisocyanate)cyclohexane
(CAS No. 010347-54-3)
1,4-Cyclohexane diisocyanate (CAS
No. 002556-36-7)
Diethyldiisocyanatobenzene (CAS No.
134190-37-7)
4,4'-Dn'socyanatodiphenyl ether (CAS
No. 004128-73-8)
2,4'-Diisocyanatodiphenyl sulfide
(CAS No. 075790-87-3)
3,3'-Dimethoxybenzidine-4,4'-
diisocyanate (CAS No. 000091-93-0)
3,3 '-Dimethyl-4,4 '-diphenylene
diisocyanate (CAS No. 000091-97-4)
3,3'-Dimethyldiphenylmethane-4,4'-
diisocyanate (CAS No. 000139-25-3)
. Hexamethylene-l,6-diisocyanate (CAS
No. 000822-06-0)
Isophorone. diisocyanate (CAS No.
004098-71-0) '
' Methylenebis(phenylisocyanate) (CAS
No. 000101-68-8)
4-Methyldiphenylmethane-3,4-
diisocyanate (CAS No. 075790-84-0)
1,1-Methylene bis(4-
isocyanatocyclohexane) (CAS No.
005124-30-1)
1,5-Naphthalene diisocyanate (CAS
No. 003173-72-6)
1,3-Phenylene diisocyanate (CAS Nl
000123-61-5)
1,4-Phenylene'diisocyanate (CAS No.
000104-49-4)
Polymeric diphenylmethane
diisocyanate (CAS No. 009016-87-9)
2,2,4 -Trimethy Ihexamethy lene
diisocyanate (CAS No. 016938-22-0)
2,4,4-Trimethy Ihexamethy lene
diisocyanate (CAS No. 015646-96-5)
In reassessing the Agency's proposal
in light of comments received and other
information, it has become clear to EPA
that the effect of concern (chronic
pulmonary toxicity) is related to the
diisocyanate moiety and therefore
common to all diisocyanate compounds
not just those included in the delimited
category finalized in this rule. EPA
believes that many other diisocyanates
not covered by the category may meet
the EPCRA section 313 criteria.
Therefore, EPA believes that it may be
more appropriate to create a
•diisocyanates category based on a
molecular formula description rather
than a more limited category comprised
of certain named diisocyanates.
However, EPA did not include a
molecular formula category option in its
proposal and therefore has not given the
public an opportunity to comment on
such a category. Accordingly, in thiss
action EPA is finalizing the addition of
a delimited category consisting of the 20
diisocyanates on which the Agency Ifts
received comment and for which the
Agency has made a final determination
that the chemicals
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Federal Register / Vol. 59, No, 229 / Wednesday, November 30, 1994 / Rules and Regulations 61455
human health effects at concentration
levels that are reasonably likely to exist
beyond facility site boundaries...."
EPA disagrees that the data cited are
insufficient to prove that dimethylamine
is likely to cause significant human
health effects. As articulated in the
proposed rule, dimethylamine is
corrosive to mucous membranes, the
eyes and respiratory tract. Chronic
exposure results in dose-related lesions
in the respiratory and olfactory
epithelium and is associated with
centrilobular fatty degeneration and
necrosis of parenchymal cells after
inhalation exposure for 18 to 20 weeks.
Rats exposed to oral doses as low as
0.035 mg/kg for 8 months showed ' •
neurological effects including'changes
in conditioned reflexes while single
doses of 240 to 260 mg/kg caused
excitement and muscle weakness in
mice,.rats, guinea pigs, and rabbits.
Dimethylamine is corrosive to the
respiratory tract, exhibits hepatotoxicity
and is neurotoxic. EPA reaffirms that
there is sufficient evidence to list
dimethylamine on the EPCRA section
313 list pursuant to EPCRA section
313(d)(2)(B) based on the available
chronic respiratory, hepatic, and
neurological toxicity data for this
chemical Therefore, EPA is finalizing
the addition of dimethylamine on the
EPCRA section 313 list.
22. 2,6-Dimethylphenol. One
commenter, General Electric, states that •
the proposed addition of 2,6-
dimethylphenol to EPCRA section 313 •
is based upon a "low confidence" study
and a 10-week subchronic study which
the ITC found insufficient to evaluate.
The commenter is concerned that EPA
is using the same data set in two rule .
makings'; TSCA section 4 and the
decision to list on the EPCRA section
313 list. The commenter quotes the ITC
finding that the studies are of "low
confidence." The Agency used these
data to derive an oral RfD of 0.0006 mg/
kg/day. IRIS confidence in the studies is
low because of lack of experimental
detail. EPA also concedes that the ITC
had low confidence in these studies for
its purposes which are risk assessment.
However, EPA believes that these data
are sufficient for the purposes of hazard
assessment and concludes that these
studies when considered together
present a sufficient weight of the .
evidence determination for listing 2,6-
dimethylphenol on EPCRA section 313
because 2,6-dimethylphenol causes
hepatotoxicity and nephrptoxicity at
relatively low dose levels. EPA reaffirms
that there is sufficient evidence to list
2,6-dimethylphenol on the EPCRA
section 313 list pursuant to EPCRA
section 313(d)(2)(B) based on the
available hepatotoxicity and
nephrotoxicity data for this chemical.
Therefore, EPA is finalizing the addition
of 2,6-dimethylphenol on the EPCRA
section 313 list.
23. Dinoseb. Uniroyal Chemical
Company objects to the listing of
dinoseb (dinoseb is the trade name for
dinitrobutyl phenol) because the sale of
dinoseb as a herbicide or insecticide is
prohibited and remaining inventories
have been used up or disposed.
However, the commenter notes that
dinitrobutyl phenol continues to be
produced and sold for uses not subject
to FIFRA (e.g. as an inhibitor in the
polymer industry).
EPA believes that the chemical is'
more properly listed by its common
chemical name, dinitrobutyl phenol,
rather than its trade name. However,
EPA also recognizes that this chemical
is well known as dinoseb. Therefore,
EPA is finalizing the addition of this
chemical as dinitrobutyl phenol
(dinoseb).
24. Disodium
cyanodithiomidocarbamate. Buckman
Laboratories International, Incorporated
contends that the compound was not
teratogenic in either the rat or rabbit
studies cited in the proposed rule.
Specifically, they contend that skeletal
variations and increased resorptions
should be considered an artifact (i.e.,
occurring by chance rather than as a
result of treatment), and should not be
considered as evidence of
developmental toxicity.
. EPA disagrees with the commenter. In
both the rabbit and rat teratology studies
cited in the proposed rule,
developmental effects were observed at
levels that were above the maternally
toxic level (greater than 3 mg/kg for
rabbits and greater than 6 mg/kg for
rats). Furthermore, the effects observed
cannot £e considered an artifact,
because in rabbits receiving 30 mg/kg,
there is a continuation of the effects
observed at 10 mg/kg, with an
accompanying increase in the severity
of the developmental findings. This
shows that the effects are related to the
dose received and do not occur by
chance.
EPA reaffirms that there is sufficient
evidence for listing disodium
cyanodithioimidocarbonate on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental toxicity
data. Therefore, EPA is finalizing the
listing of disodium
cyanodithiomidocarbamate on the
EPCRA section 313 list.
25. Ethyl dipropylthiocarbamate
(EPTC). Zeneca Incorporated states that *
in the study cited by EPA in the
proposed rule in which rats were orally
administered the test compound for 2
years, brain cholinesterase reductions
were slight and only occurred at 120
mg/kg/day, not 15 mg/kg/day. The
commenter claims that neuromuscular
changes occurred only after extended
exposure, and are not relevant to listing
on the EPCRA section 313 list.
The commenter is referring to two
studies cited in the proposed rule. A 2-
year rat feeding study established a
NOEL of 5 mg/kg/day and a systemic
LOEL of 25 mg/kg/day with
neuromuscular atrophy/degeneration
and decreased body weight gains as the
findings. At 125 mg/kg/day, the effects
included chronic myocarditis, cataracts,
increased SCOT and decreased RBC
cholinesterase (ChE) activity. The
neuromuscular and cardiac changes are
serious and potentially irreversible
effects. The second study is a 3-month
feeding study in Sprague-Dawley rats.
Although this study was hot identified
in the proposed rule, the results of the
study were described. The systemic
NOEL in this study was 3 mg/kg/day,
and the LOEL was 15 mg/kg/day. The
effects seen included increase in
cardiomyopathy and decreased weight
gain and food consumption. As noted by
the commenter, brain ChE depression in
this study in females was slight and
occurred at 120 mg/kg/day and, takea,
by itself, is not sufficient for listing, "^
however, when considered with other
effects in a weight-of-evidence »
approach, this endpoint is supportive of
listing. The commenter further states
that the 2-year dietary rat study is old
and has been superseded by another
study (Ref. 8), in which the NOEL was
25 mg/kg/day.
The Agency agrees with the
commenter's comment regarding the
replacement of the older study with a
newer-study, but disagrees with the
commenter's NOEL. The Agency's
NOEL for this study is 5 mg/kg/day and
not 25 mg/kg/day. However, the results
of the older study demonstrate that
heart effects of EPTC are seen in more
than one study.
The commenter. further states that in
the 2-generation rat reproduction study,
cardiomyopathy was observed only in
the F1A females and was incidental to
treatment. EPA disagrees with this
contention. The investigators did not
look for this effect in other generations.
Thus, there is no reason to conclude
that this effect was not manifested in
other generations. In addition, this type
of adverse effect has been seen in other
studies, such as the 2-year rat study and
the 3-month rat study discussed above
and cited in the proposed rule.
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61456Federal Register7 Vol. 59, No. 229 / Wednesday/November 30, 1994 / Rules 'and Regulations
The Agency believes that the
cardiopathic finding at 10 mg/kg/day,
degenerative cardiomyopathy, is the
pivotal finding of lexicological
significance for EPTC. EPA believes that
this is a serious effect. Therefore, this
effect cannot be considered incidental to
treatment. , . '-
The conunenter further states that the
..neurological effects seen in the study
are not relevant to the EPCRA section
313 due to prolonged exposure and the
cardiovascular observations occurred at
the highest dose tested in the studies
cited. . •' ' • - .
The cardiovascular effects occur after
relatively short ;exposures at doses of 9
mg/kg/day in male rats and 18 mg/kg/
day in female rats. These dose levels are
sufficiently low and the adverse effects
are serious and potentially irreversible.
The Agency considers the neurotoxicity
due to prolonged exposure to be
relevant for purposes of listing on the
EPCRA section 313 list. Releases of
chemicals that induce adverse effects
after prolonged exposure is among the
type of information that Congress
intended TRI to include.
EPA reaffirms that there is sufficient
evidence for listing EPTC on the EPCRA
section 313 list pursuant to EPCRA
section 313(d)(2)(B) based on the
available neurological, cardiovascular,
and reproductive toxicity data for this
chemical. Therefore, EPA is finalizing
the addition of EPTC on the EPCRA
section 313 list.
26. -Fenoxaprop-ethyl. Hoechst-
Celanese and Nor-Am Chemical indicate
that the chronic interstitial nephritis
reported at 80 ppm in the 3-month dog
study cited in the proposed rule "was
[a] non substance-related, incidental
rinding since'12/24-months chronic
treatment produced no comparable
pathogenesis" and that "liver and
kidney were not the target organs in
dogs; effects were confined to reduced
body weight gains at the highest '
concentration (75 ppm)."' •• . •
EPA disagrees with the commenters.
The dietary levels of fenoxaprop-ethyl
in the studies compared by the
commenter were 0,16, 80, and 400 ppm
and o; 3,15,:and 75 ppm for the 3-
month and 24—month studies,
respectively; both studies are cited in
the proposed rule. The microscopic
findings in the 3-month study indicated
that there was a dose response for
chronic interstitial nephritis with
inflammatory-changes in the medulla
and inner cortex. One half of the dogs
were affected at 400 ppm, which is
much higher than'the highest dietary
levelah the 24^raonth.stody (75 ppm).
• Thejrefojrei theihflanuriatbry .changes in
!the kidney* of treatetfdogs.attao and
400 ppm in the 3-morith study appear
to be related to the ingestion of
fenoxaprop-ethyl and, therefore, the
kidney appears to be a target organ. The
Agency did not cite liver effects in dogs
as a basis for Listing.
EPA reaffirms that there is sufficient
evidence for listing fenoxaprop-ethyl on
the EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available renal and developmental
toxicity data for this: chemical, and
pursuant to EPCRA section 313(d)(2)(C)
based on the available environmental
toxicity data. Therefore, EPA is
finalizing the addition of fenoxaprop-
ethyl on the EPCRA section 313 list.
27. Fenoxycarb. Ciba-Geigy
Corporation and Miles Incorporated
disagree with the listing of fenoxycarb
on the EPCRA section 313 list because
they believe that the adverse hepatic
effects observed in mice and rats (3-
month dietary study and 2-year <
oncogenicity study, both cited in the
proposed rule) are not sufficiently
. serious to support listing. They note that
no evidence of neoplastic lesions was
reported in the chronic studies. They
further state that delayed pinna
unfolding in the reproductive toxicity
study in rats cited in the proposed rule
is a reflection of slower growth only,
and therefore should not be used to
support listing. '
The Agency disagrees that the
evidence, does not support a finding that
section 313(d)(2)(B) are satisfied. The
effects in the chronic studies include
focal necrosis, changes which are
considered by the Agency to be serious
and potentially irreversible in nature.
The liver effects in the subchronic study
demonstrate the progression of changes
leading to necrosis in the chronic study.
The Agency considers these to be
serious adverse effects.
The developmental effects (slight
delays in pinna unfolding) were said by
the commenter not to reflect
developmental effects since' •
development was complete and
function apparently unaffected, and that
these effects'Were considered a
reflection of slower growth (reduced
body weights) as were the differences in
relative organ weights. The Agency
considers reduced rat pup body weight
and slower growth with resulting
differences in organ weight to be effects
that are indicators of potential hazard.
The Agency's Developmental Risk
Assessment Guidelines (Ref. 6);state "A
change in offspring body weight is a
sensitive indicator of developmental
toxicity, in part because it is' a: " '.
. continuous variable, fa some: cases,'
'. offspring weight reductidffriiaiy be the
• only indicator of developmental" : " r '
toxicity. While there is always a
question as to whether weight reductfl
is a permanent or transitory effect, little
is known about the long-term
consequences of short-term fetal or
neonatal weight changes. Therefore,
when significant weight'reduction
effects are noted, they are used as a
basis to establish the NOAEL." EPA,
therefore, considers evidence of delayed'
development, including delayed pinna
unfolding and reduced body weight
gain, to be significant signs of
developmental toxicity. :
EPA reaffirms that there is sufficient
evidence for Listing fenoxycarb on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available hepatic and developmental
toxicity data for this chemical.
Therefore, EPA is finalizing the addition
of fenoxycarb on the EPCRA section 313
list. -
28. Fomesafen. Zeneca Incorporated
states that clear species differences are
evident which would suggest that
peroxisome proliferation and
consequential liver toxicity is not
relevant to man.
Zeneca Incorporated did not provide
any new evidence which supports the
lack of relevance of these effects to man.
In the absence of evidence to the
contrary, the Agency believes diat liver
toxicity, which is associated with ^3,
peroxisome proliferation is relevant to
the assessment of potential human
health effects. As there is evidence of
hepatic toxicity in three different rat
studies at varying dosages and durations
and one dog study, EPA reaffirms that
there is sufficient.evidence for listing •
fomesafen on the EPCRA section 313 list
pursuant to EPCRA section 313(cl}(2)(B)
based on the available hepatic toxicity
data for this chemical. Therefore, EPA is
finalizing the addition of fomesafen on
the EPCRA section 313 list.
29. n-Hexane. The National Oilseed
Processors Association and The
National Cotton Council of America
contend that EPA failed to perform a
detailed hazard evaluation that
culminated in a weight-of-evideiice
determination regarding the toxicity of
n-hexane as required under the
Agency's Draft Hazard Assessment
Guidelines (Ref. 11). Commenters state
that portions of EPA's support
document were taken almost verbatim
from the Agency's IRIS data^se and
that the Agency appears to. have relied'
extensively on trie IRIS stirhmary '
previously prepared for h-hexane.
Commeiiters state that EPA should have
evaluated the merits and cohclusjiOhs.of
'eVJi study Separately. . . "'
'- TM IftlSfdata'^ase;that EPA cited in
support of the listing of h-hexane
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Federal Register / Vol. 59,-No. 229 /Wednesday, November 30, 1994 / Rules arid'Regulations 61457
represents the"Agency's weight-6f-
evidence hazard determination for
chemicals contained in the data base.
The information contained in the IRIS
data base was developed after the
Agency's thorough review of the
available data on n-hexane. Therefore,
by relying on the IRIS data base EPA did
not fail to perform a detailed hazard
evaluation of n-hexane as required by
the Draft Hazard Assessment Guidelines
(Ref. 11).
The same commenters state that based
on EPA's screening criteria included in
the Draft Hazard Assessment Guidelines
(Ref. 11) if a substance produces
neurotoxic effects at doses that are
greater than" 500 mg/kg/day (i.e., if the
lowest observable adverse" effect level is
500 mg/kg/day), then the substance
would be placed in the "insufficient for
listing" category. Commenters went on
to state that most of the studies that
EPA-cited in support of the listing of n-
hexane indicated that n-hexane "
produces neurotoxic effects only at very
high dose levels and in many cases
significant effects are only seen at doses
that exceed 500 mg/kg/day.
EPA believes that the commenters
have misinterpreted the screening
criteria contained in the Draft Hazard
Assessment Guidelines (Ref. 11). The
criteria are based on the MED levels
which are not LOAELs. These MED
values are derived from the LOAELs
and, therefore, the direct comparison of
the screening criteria with LOAELs is
inappropriate. However, EPA notes that
significant effects from n-hexane are
seen in quantities significantly less than
500 nig/kg/day, for example, a LQAEL
of 204 mg/m3 (58 ppm, LOAEL(ADJ) of
73 mg/m3) was established for certain
electrophysiological alterations in-
hurnans.
These commeuters-made numerous
specific comments concerning the
adequacy of the studies summarized in
IRIS used to support a chrtmic
neurotoxicity finding for n-hexane.
Coiiimenters state that n-hexane is only
toxic at veryhigh levels if at all and that
the data are not sufficient to support
listing under EPCRA section 313. The
commenters state that EPA failed to
show how the data contained in the
Support Document for the Addition of
Ch em icals from Section 112(b) of the .
Clean
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61458 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
chemical. Therefore, EPA is finalizing
the addition of iron pentacarbonyl on
the EPCRA section 313 list:
32. Lithium carbonate. FMC
Corporatiort*contends that although
lithium is toxic at therapeutic levels,
naturally occurring levels are below the
toxic range and therefore, lithium
carbonate poses no threat to the general
population. The commenter also
contends that there is no evidence that
lithium carbonate is "known to cause or
can reasonably be anticipated to cause
significant adverse acute human health
effects at concentration levels that are
reasonably likely to exist beyond facility
site boundaries as a result of
continuous, or frequently recurring,
releases." Thus, the commenter feels
that there is no basis for the listing of
lithium carbonate on the EPCRA section
313 list.
The Agency is not proposing to list
lithium carbonate on the basis of acute
effects but on the basis of
developmental effects. Therefore, the
Agency does not need to determine that
lithium carbonate is "known to cause or
can reasonably be anticipated to cause
significant adverse acute human health
effects at concentration levels that are
reasonably likely to exist beyond facility
site .boundaries as a result of
continuous, or frequently recurring,
releases," but rather must satisfy the
section 313(d)(2)(B) criteria.
As the commenter noted, lithium
carbonate is a well-known
developmental toxicant in both animals
and humans at therapeutic levels and
can cause life-threatening cardiac
abnormalities in the developing human
fetus. The commenter argues that
lithium is toxic at therapeutic levels but
not at naturally "occurring levels." The
Agency agrees that lithium may be toxic
at therapeutic levels but also recognizes
that use of lithium in a therapeutic
setting is carefully controlled. Levels
observed in a therapeutic setting may
have little or no relationship to levels
seen in an uncontrolled release setting.
Furthermore, both the efficacy of
lithium and its associated toxicity in
humans is dependent upon individual
sensitivity and can vary widely from
individual to individual making
uncontrolled release even more
problematic. EPA reaffirms that there is
sufficient evidence to list lithium
carbonate under EPCRA section 313
pursuant to EPCRA section 313(d)(2HB)
based on the available developmental
toxicity data for this chemical.
Therefore, EPA is finalizing the addition
of lithium carbonate on the EPCRA ..
section 313 list.
33. Metam sodium. Buckman
Laboratories International, incorporated
and Zeneca Incorporated state that the
developmental toxicity studies cited in
support of listing for metam sodium
were rejected by the Agency to support
the registration of a pesticide under
FIFRA, and therefore should not be
used. Further, they state that these data
have been superseded by two new
studies that have been accepted by the
Agency, and that only the new studies
should be considered for listing of
metam sodium.
The two earlier studies referred to by
the commenters and cited in the
proposed rule were submitted to the
Agency under FIFRA. EPA's evaluation
of those studies for purposes of FIFRA
indicated that they did not fully satisfy
the guidelines for developmental
toxicity studies (Ref. 6); however, EPA
did not reject these studies. EPA
considers them sufficient as part of a
weight-of-evidence evaluation, in
determining the developmental toxicity
of this chemical. The two new studies
cited by the commenter have been
reviewed by the Agency. The Agency
found these studies to fully satisfy the
guidelines (Ref. 6). However, these new
studies do not supersede the previous
studies nor did the Agency ignore them.
Rather, all four studies were used
together as part of the Agency's weight-
of-evidence to evaluate the chemical.
EPA does not ignore indications of
potential toxicity simply because of
study design flaws. A full discussion of
these studies is contained in the
Response to Comment Document (Ref.
14)..
Zeneca Incorporated further stated
that the rat teratology study was a
gavage study and not a dietary study.
The commenter claims that this is an
unrealistic route of human exposure.
The commenter is correct in stating
that the rat teratology study was a
gavage study and not a dietary study.
This does not diminish its
appropriateness for consideration in the
hazard assessment for listing. In fact,
EPA requests that developmental
toxicity studies be conducted by gavage,
because this route allows for a more
accurate assessment of the dose the
animal actually receives.
EPA reaffirms that there is sufficient
evidence for listing metam sodium on
the EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental toxicity
data for this chemical and its
metabolite, carbon disulfide. Therefore,
EPA is finalizing the addition of metam
sodium on the EPCRA section 313 list.
34. N-Methyl-2-pyrrolidone. IBM,
American Automobile Manufacturers
Association, and N-Methylpyrrolidone
Producers Group object to, the listing of
N-methyl-2-pyrrolidone (NMP) on the
EPCRA section 313 list. NMP Producers
Group contends that the 2-generation
reproductive study and the rabbit
gavage developmental study cited in the
proposed rule are flawed. NMP
Producers Group further contends that
the author of the 2-generation rat
reproductive study and an independent
reviewer have reached similar
conclusions.
In reviewing the material submitted
by the commenter, EPA failed to find a
statement from the author that the study
was-flawed. The review of the 2-
generation rat reproductive study by an
independent reviewer did not find fault
with the entire study but stated that it
should not be used for risk assessment
purposes. EPA agrees with this
judgement but is not using this study for
risk assessment purposes but rather as
an indication of human health hazard.
The Agency believes that the adverse
effects seen in these studies are of
sufficient seriousness to warrant listing
under EPCRA section 313(d)(2)(B).
NMP Producers Group also states that
when the 2-generation reproductive
study is evaluated taking into account
the genetic fertility problem in the strain
of male rats, the study establishes a
NOAEL of 160 mg/kg rather than the
NOAEL of 50 mg/kg cited in the
proposed rule. The commenters also v
believe the study should not be "*'
considered because die variability in
male fertility was not dose-dependent. *
EPA does not agree that the NOAEL
should be adjusted for the fertility
problem of the strain of male rats used
in the study. During the first mating on
which EPA based its concern level (Fja)
the high-dose male group exhibited a 24
percent reduction in the mating index.
In addition, there was a statistically
significant, dose-related reduction in the
male fertility index; thus, the index was
93.1, 72.4, 72.4, and 46.7 in the control,
low-, mid-, and bigh-dose groups,
respectively. The control value in this
study is 93.1 percent, well within
acceptable limits for any reproductive
effects study and as seen the reduction
in mating index is dose-related being
72.4 percent in the low- and mid-dose
groups and 46.7 percent in the high-
dose group. With a control value of 93.1
percent and using the concurrent
controls as an index of mating
performance for the males in this study,
the Agency feels that there is no reason
to adjust the NOAEL of 50 mg/kg to
account for reduced fertility in the test
animals. During the second mating (Fzb),
the male high-dose group exhibited a 31
pe/cent reduction in the mating index,
and again, there was a statistically
significant, dose-related reduction in the
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61459
male fertility index (83.3, 69.0, 60.0. and
34.5 in the control, low-, mid-, and
high-dose groups, respectively). The
female high-dose group exhibited a 28
percent reduction in the fertility index,
and again, there was a statistically
significant, dose-related reduction in the
fecundity index (92.6,74.1,64,3, and
50.0 in the control, low-, mid-, and
high-dose groups, respectively). Again,
the Agency does not feel that a control
value of 83.3 percent fertility index in
the control animals is abnormal and is
more concerned with the dose-related
decrease in fertility as an indication that
NMP is a reproductive toxicant. EPA is
also concerned with the decrease in
fecundity index in the females and does
not feel that the control value of 92.6
percent warrants any adjustment of
NOAEL for reduced.fertility or mating
ability among males in the study.
The Agency also disagrees with NMP
Producers Group's contention that
decreases in male fertility observed are
not dose dependent. The data presented
above clearly show a-correlation
between dose and 'decreased fertility.
NMP Producers Group claims that the
effects of NMP administration
manifested only in the second
generation'of animals.
EPA disagrees and believes that
effects were manifested in the first
generation.-There was a reduction in
fertility in the Fl generation,
histolpgical evidence of reproductive
effects including hypospermia and
significant systemic toxicity in the Fl
generation. In addition, EPA does not
believe that it is unusual to see
increased severity in the second
generation since animals have either
been treated for 2 generations or are the
offspring of treated animals and
cumulative effects or effects on the
reproductive system of the first
generation animals may manifest in the
. second generation.
NMP Producers Group further
believes that NMP is not a
developmental hazard because EPA's
conclusion is based on observations
from what the commenter claims is a
flawed reproductive study. The
'commenter adds that a considerable
body of evidence supports the
conclusion that NMP is not uniquely
toxic to a developing fetus.
EPA's conclusions about the
developmental toxicity of NMP are .
based upr.n a rabbit gavage study and
the developmental portion of the 2-
generation reproductive study referred
to above and cited in the proposed rule.
The rabbit gavage study showed a
significant increase in resorptions and
malformations (misshapen skull bone
and cardiovascular malformations). The
LOAEL for developmental toxicity in
this study was 540 mg/kg and the
NOAEL was 175 mg/kg. The
developmental portion of the 2-
generation reproductive effects study
showed evidence of developmental
toxicity in both generations after
exposure to 500 mg/kg as demonstrated
by reduced litter size, reduced postnatal
survival, and reduced pup body weight.
The Agency believes that despite the
flaws in the study, the data described
above clearly show' evidence of
developmental toxicity. In addition,
EPA believes that, the body of evidence
supports the finding that NMP is
uniquely toxic to the developing fetus
and the information available to the
Agency both from the rat developmental
study and rabbit gavage study is
sufficient to list NMP on the EPCRA
section 313 list.
EPA reaffirms that there is sufficient'
evidence to list N-methyl-2-pyrrolidone
under EPCRA section 313 pursuant to
EPCRA section 313(d)(2)(B) based on
available developmental and
reproductive toxicity data for this
chemical. Therefore, EPA is finalizing
the addition of N-methyl-2-pyrrolidone
on the EPCRA section 313 list.
35. Molinate. Zeneca Incorporated
contends that the observations
attributed to the 35 mg/kg/day dose
level in the rat developmental toxicity
study "in fact occurred at 140 mg/kg/
day, the highest dose tested and were
thus a consequence of maternal
toxicity." The commenter states that the
NOEL for that study was 35 me/kg/day.
The Agency does not agree that the
NOEL for this study was 35 mg/kg/day.
The NOEL for developmental toxicity
was 2.2 mg/kg/day based on an increase
in runting at the next highest doses, 35 .
and 140 mg/kg/day. The other adverse
effects listed in the comments for this
study occurred only at the highest dose
tested (14ftriig/kg/day). The NOEL for
maternal toxicity was 35 mg/kg/day and
that the effects on the pups (runting)
occurred at a dose level lower than the
dose level found to be'materoally toxic.
The same commenter stated that the
issue of whether mblinate is a
reproductive toxin on the basis of its
adverse effect on fertility in rodents has
been very extensively investigated with
studies in rabbits, dogs, monkeys, and
man, and these studies have shown
"conclusively that the effects seen in
rodents is [sic] not relevant to man."
While EPA agrees that there has been
extensive testing of molinate with
respect to fertility, the data on the rabbit
and dog do not support the commenter's
contention that the effects seen in
rodents are specific only to rodents. For
example, in each.of the fertility studies -
in rabbits, both an increase in pre-
implantation loss and abnormal sperm
were observed. These two consistent.
[reproducible] observations are
suggestive of fertility'effects, are two of
the same observations found in rats and,
although not as dramatic as observed in
rats! cannot be negated. In the chronic
dog study, lesions in male reproduction
organs and effects on sperm .were
observed, which demonstrate that, at
least in the males, the gonads are target
organs for molinate. The lack of any
effect on the limited parameters
assessed in the male monkey studies
lends little credence to the argument
since only male monkeys were exposed
to-molinate, and no reproduction
studies have been performed to assess
reproductive performance. Since
molinate is reaching the gonads in all
species, not only in rodents as the .
commenter claims, molinate can
reasonably be anticipated to cause
fertility/reprocfuctive effects in humans.
Further, animals are accepted as
surrogates for toxicity testing to predict
potential hazard-to humans, except in a
few rare cases where effects have been
determined to be species-specific [e.g..
a2u-globulin).
The same commenter further
contends that a NOEL of 2 mg/kg/day
was established in the rat 2-year study,
and that this study should not be used
to evaluate the neurotoxicity of molinat^
because the study was not designed to
evaluate that effect. Rather, the
commenter contends that the "definitive
position on neurotoxicity has been
determined by specific [neurotoxicity) .
studies." Zeneca Incorporated did not
provide a reference for these "specific
studies."
EPA agrees that the NOEL for effects
other than neurotoxic effects is 2 mg/kg/
day in the chronic rat study. No NOEL
for neurotoxic effects was established in
that study. The LOEL for neurotoxicity
in this study is 0.35 mg/kg/day.
Although this study was not specifically
designed to evaluate the neurotoxic
effects of molinate, adverse neurological
effects were reported. Further, they were
substantiated by the findings from a 1-
year study in dogs.
The same commenter stated that thf>
effects observed in the dog study were
found at the highest dose administered
for 1-year and were "largely a
consequence of extended exposure" and
as such should not form a part of the
EPCRA listing. The commenter implies
that because this is a chronic adverse
effect, the effect is not relevant to the
EPCRA section 313 criteria.
»As specified in section 313(d)(2)(B). a
chemical may be listed if it causes
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61460 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
chronic toxicity. Thus, the comment is
not relevant.
EPA reaffirms that there is sufficient
evidence for listing molinate on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental,
reproductive, and neurological toxicity
data for this chemical. Therefore, EPA is
finalizing the addition of molinate oh
the EPCRA section 313 list.
36. Nitrate compounds (proposed as
nitrate ion). American Automobile
Manufacturers Association, Merck, and
the Department of Energy disagree with
EPA's proposal to list nitrate ion
because an ion is not a chemical. Merck
further states that nitrate ion "exists
only in aqueous media." The Chevron
Companies, the Department of Energy,
Chemical Manufacturers Association,
and Air Products and Chemicals,
Incorporated .contend that in proposing
to add nitrate ion to EPCRA section 313
the Agency actually proposed to add a
category of chemicals' that dissociate to
generate nitrate ion. EPA agrees with the
commenters that an ion does not meet
the definition of a chemical for purposes
of listing on the EPCRA section 313 list
and that by proposing nitrate ion the
Agency had, in effect, proposed the
addition of a category of nitrate
compounds that dissociate in water that
are reportable only when in aqueous
solution. Thus based'on the comments
provided by the commenters, the
Agency is finalizing the addition of the
following category: water dissociable
nitrate compounds (reportable only
when in aqueous solution). Qualifiers of
this sort have been used to define the
form of a chemical for which reports
should be.submitted, e.g., zinc (fume or
dust),_The qualifier following this listing
indicates that only water dissociable
nitrate compounds that are
manufactured, processed, or otherwise
used as an aqueous solution at a facility
are subject to reporting. As with all
other aspects of EPCRA section 313
reporting, only the weight of the listed
chemical is subject to threshold
determinations. That determination
does not include, for example the
weight of the water or any other
constituent in the solution other than
the nitrate compound. Beyond the
threshold determination, the amounts
reportable on Form R should only
include the mass of the nitrate portion
of the compound in solution. This
approach is consistent with guidance
given for determining threshold and
release amounts for metal compounds.
EPA recognizes that most monitoring
data available measure only the
dissociated nitrate ion released arid not
the amount of total nitrate compounds
from which the nitrate ion dissociated.
Reporting of the amount of the total
water dissociable nitrate' compound in
wastes would be complicated when
more than one substance contributes to
the nitrate ion content of the waste and
when the nitrate compound is converted
to a different substance due to waste
treatment or other processes. It is
therefore reasonable to require reporting
of only, the nitrate ion'released in order
to avoid confusion over the meaning of
total compound released.
EPCRA section 313 requires threshold
determinations for chemical categories
to be based on the total of all chemicals
in the category manufactured,
processed, or otherwise used. For .
.example, a facility that manufactures
three members of a chemical category
would count the total amount of all'
three chemicals manufactured towards
the manufacturing threshold for that
category. One report is filed for the
category and all releases are reported on
this form.
In the proposed rule, EPA discussed
both the human health and
environmental adverse effects
attributable to nitrates. EPA continues to
be concerned about the potential
environmental impacts of nitrates. In
today's action, EPA is adding nitrate
compounds based on the adverse
human health effects' that the nitrate
moiety causes. Nitrate causes
methemoglobinemia.
Methemoglobinemia, like carbon
monoxide, interferes with the
oxygenating capacity of the blood
resulting in an under supply of oxygen
to the tissues^ In adults, cyanosis to lips
and mucous membranes occurs at a
level of 1.5 g/dL (10 percent saturation
in an adult with normal hemoglobin
levels). Levels between 30 percent and
50 percent saturation in adults produce
depression of the cardiovascular and
central nervous systems; levels between
50 percent and 70 percent cause stupor,
convulsions and respiratory depression
and levels above 70 percent are usually
fatal. Because of increased requirement
for oxygen in growing tissue and
because of decreased blood volume in
infants, they are much more sensitive to
nitrate ion toxicity than adults. Infants
have a lower activity of methemoglobin
reductase and thus are more susceptible.
Consequently adverse effects are seen at
much lower levels in infants than in
adults. Irreversible damage to organs
such as the heart or brain, and the
development of coronary artery disease
or pulmonary disease are more likely to
develop in infants because the anoxia
caused by methemoglobinemia can
occur more rapidly and have more
devastating effects in growing tissue
than in the "static" tissue of the adult
body. EPA believes that these are
serious adverse effects that satisfy the/
criteria of EPCRA section 313(d)(2)(B'jl
37. Ozone. Many commenters
opposed the addition of the CAA
criteria pollutants (sulfur dioxide, sulfur
trioxide (SOX), nitric oxide and nitrogen
dioxide (NOX), carbon monoxide (CO),
and ozone) to the EPCRA section 31'3
list since extensive data on these
chemicals is already collected under the
CAA.
EPA agrees with the commenters that
there are many complex issues
associated with the extensive collection
of data on these chemicals under the
Clean Air Act. Therefore, EPA is
deferring the listing of these chemicals
for possible addition at a later time to
address some of the issues involving the
availability of data collected under the
CAA. The Agency does not believe,
however, that the listing of ozone
should also be deferred. Emissions of
ozone, also a criteria pollutant, are not
captured under the CAA. The CAA
mandates the collection of data on the
releases of VOCs (VOCs react in the
troposphere to generate ozone and other
air pollutants), which are regulated to
maintain the ambient 'air quality
standard for ozone. EPA believes there
are many other significant uses of ozone
(e.g., waste water treatment, bottled
water purification, arid chemical •
intermediate) that would be captureefcby
EPCRA section 313 reporting.
Accordingly, EPA does not believe that
the finalization of ozone should be
deferred. EPA reaffirms that ozone
meets the EPCRA section 313(d)(2)
criteria pursuant to EPCRA section
313(d)(2)(B) and 313(d)(2)(C) based on
the available toxicity data for this
chemical. Therefore, EPA is finalizing •
the addition of ozone on the EPCRA
section 313 list.
38. Pebulate. Zeneca Incorporated
comments that the neurological effects
noted in the 1-year feeding study in
dogs cited in the proposed rule occurred
at the highest dose level (100 mg/kg/
day), which w.as, by design, a toxic
dose. Thus, the commenter claims that
there is no reasonable hazard.
The Agency disagrees. Although the
highest dose tested is designed to elicit
toxicity in the dogs, the presence of
Wallerian'type degeneration of the
white matter of the spinal cord at the
100 mg/kg/day dose level in dogs of
both sexes is of considerable seriousness
and cannot be dismissed only because it
occurred at the' highest dose tested.
Although the dose eliciting
degeneration of the spinal cord was thnrf
-highest dose tested, 100 mg/kg/day,
* these adverse effects are of sufficient
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61461
seriousness,to warrant listing based
upon the potential for similar effects in
humans.: > •; • •. .: .
In this study, the NOEL for the
Wallerian type neurological lesions is
50 mg/kg/day. However, the NOEL in
males is less than 5 mg/kg/day (LOEL
based oh Findings of abnormal behavior,
ataxia, severe convulsions, and
congestion in both kidneys in one dog).
In females, the NOEL was 5 mg/kg/day
and the LOEL was 25 mg/kg/day with
occurrence of blood in feces, increased
absolute and relative liver weight,
increase in severity of lipofuscin
deposition in kidneys, and hemosiderin
deposition in liver and spleen.,
EPA reaffirms that there is sufficient
evidence for listing pebulate on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available neurological toxicity data
for this chemical. Therefore, EPA is
finalizing the addition of pebulate on
the EPCRA section 313 list.
39. Permethrin. Zeneca Incorporated
states that the hepatic effects noted in
the liver of rats and dogs are adaptive
rather than toxic responses to the
pyrethroid. The commenter further „
claims that there were no changes in
liver weight relative to body weight.
EPA does not agree that the incidence
of li ver weight increase is not a
significant effect, or that there were no
changes in liver weight relative to body
weight. The liver weights, relative to
bodyweight, were increased in all
treated groups in the 2-year rat study.
EPA believes that the hepatic changes
noted in these studies represent a
significant adverse effect.
The same commenter contends that in
the 2-year rat study cited in the
proposed rule, "the NOEL is also
incorrectly stated as 5 mg/kg/day, where
EPA states a LOEL of 100 mg/kg/day."
The Agency disagrees with the
commenter. The NOEL and LOEL
should be 5 and 100 mg/kg/day,
respectively. At 100 mg/kg/day there
was an increase in alkaline phosphatase,
liver weight arid cellular swelling of the
liver (indicative of typical smooth
endoplasmic reticulum proliferation),
and one male in the low dose group was
affected, focal inflammation with
degenerative change in the zona
fasciculate and swelling and
vacuolation ofcells in the zona
reticularis of the adrenals and reduced
body weight in females. EPA considers
these to be serious adverse effects..
EPA reaffirms that there is sufficient
evidence for listing permethrin on the
EPCRA section 313 list pursuant tq
EPCRA section 313(d)(2)(B) based on
the available hepatic toxicity data for-
this chemical, and pursuant to EPCRA
section 313(d)(2)(C) based on the -
available environmental toxicity data.
Therefore, EPA is finalizing the addition
of permethrin on the EPCRA section 313
list.
40. Phosphine. COOTS Brewing
Company states that only liquid
phosphine can cause the health effects
necessary to support a listing on the
EPCRA section 313 list.
Phosphine is a gas (the boiling point
is negative 87.4 °C); it only occurs as a
liquid when placed under reduced
temperature and/or pressure. The acute
toxicity data used to support the listing
of phosphine is based on exposure to
phosphine in the air (i.e., phosphine
gas). Thus, EPA does not agree that only
liquid phosphine could cause the health
effects necessary to support listing
under EPCRA section 313. EPA
reaffirms that there is sufficient
evidence for listing phosphine on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(A). Therefore,
EPA is finalizing the addition of
phosphine on the EPCRA section 313
list.
41. Polychlorinated alkanes (proposed
as chlorinated paraffins). EPA proposed
the addition of clorinated paraffins that
consisted of polychlorinated alkanes.
Occidental Chemical Corporation and
the Chlorinated Paraffins Industry
Association state that the proposed
chlorinated paraffins category is really a
category of chlorinated hydrocarbons
since it covers a broad range of
chlorinated hydrocarbons including
chlorinated paraffins and chlorinated
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61462Federal Register!/ Vol. 59, No. 229 / Wednesday-, November '30, 1994 / Rules arid Regulations
cancer in treated animals. The NTP
found no evidence of cancer in male rats
treated with 1,875 or 3,750 mg/kg/day
for 24 months with long-chain
chlorinated paraffins. Female rats
treated with 900 mg/kg/day showed
marginal increases in adrenal gland
tumors; female rats treated with 5,000
mg/kg/day had marginal increases in
liver tumors. The only significant
increase in tumor formation occurred in
male mice which had a significant
increase in malignant lymphomas. After
further evaluation of the available data
and considering the available statistics,
the high background rate of lymphoma
in the strain of mice used in the NTP
bioassay and the statements made by the
NTP Working Group and the Quality
Assessment Narrative, which was
submitted by the commenters, EPA
agrees that there is insufficient evidence
to conclude that the malignant
lymphomas observed in male mice were
treatment related and that long-chain
chlorinated paraffins should not be
classified as potential carcinogens.
Therefore, the Agency concludes that
there is insufficient evidence to list
long-chain chlorinated paraffins on the
EPCRA section 313 list/
b. Short^chain chlorinated paraffins.
1ARC has classified the short-chain
chlorinated paraffins as Group 2B, i.e.,
sufficient evidence for carcinogenicity :
in animals and probably carcinogenic in
humans. Detailed responses to all of the
comments concerning the toxicity of the
short-chain species are contained in the
Response to Comment Document (Ref.
14). Summaries of the responses to the
most significant comments concerning
flaws in the studies used to support the
listing of the short-chain-species are
provided below.
• (!) The Agency agrees that the kidney
tumors observed in rats are most likely
not relevant to tumor formation in man
because the male rat kidney possess a
unique protein, fx2(i-globulin which has
been shown to be responsible for the
development of rat liver kidney tumors,
not only after administration pf short-
chain chlorinated paraffins but after
• administration of many'other chemicals
also. However j to state that chlorinated
paraffins bind to a protein which is
similar to o2ji-globulin and that this
binding is not seen in guinea pigs as
evidence-that kidney tumor formation is
not relevant to human tumor formation
in this instance is not a convincing
argument. •
.; . (2) The Agency agrees that forced
gavage feeding may not be a relevant
route of administration when- one is
using the: data for human risk- .--:. ;;•••-.
assessment. In this instance-, the'data are
being Used as an indication of potential
human hazard and EPA accepts the data
as being indicative of such potential.
(3) EPA believes that corn oil is an
accepted vehicle of administration for
many in vivo studies because it is
relatively inert and has not been shown
to interact with test agents.
(4) The B6C3F1 mouse is the accepted
test species of the NTP and EPA has ho
reason to question the NTPs choice of
test species nor to discount results of
cancer bioassays using this species.
(5) EPA does not believe that non-
genptoxicity is a sufficient reason to
dismiss the relevance to man of tumor
formation by the short-chain chlorinated
paraffins. Non-genotoxicity may be a
factor-in selecting a model to use for
dose response estimation, once tumor
formation has been established, but it is
not a reason to disregard the
significance of tumors which are formed
by agents which are non-genotoxic in
short-term tests.
(6) The Agency is not convinced that
failure to observe liver growth,
peroxisome proliferation in hepatocytes
and stimulation of replicative DN A in
guinea pigs is proof that these effects are
specific to rats and mice and have no
bearing oh tumor formation in humans.
(7) The Agency agrees that there was
a perturbation of thyroxine levels in .
treated animals but does not agree that
the observed tumors are therefore
irrelevant.
Therefore, the Agency finds that there
is sufficient evidence for listing short-
chain chlorinated paraffins on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available carcinogenicity data for
these chemicals.
i. Ecotoxicity data. Courtaulds
Aerospace, Occidental Chemical
Corporation, and the American
Automobile Manufactures Association
contend th/st ecotoxicity data are only
available for the short-chain .(10 to .13 • .
carbons, 59 percent chlorine) ;
chlorinated paraffins.,The commenters
object to EPA assuming the same .
ecotoxicity for all-members of the
chlorinated 'paraffin category because of
the potential difference in effects related
to chain length and chlorine content..
Altiiough it was stated as such in the
proposed rule, EPA did not intend to
equate the ecotoxicity of the short-chain
chlorinated paraffins with the
ecotoxicity of other members of the
category. The ecotoxicity. data on the
short-chain chemicals was provided as
further support for the listing of the, :
short-chain chemicals. Howeverj;as:EPA
is hot finalizing the addition of the long-.
chained species, this issue is ho longer •
- relevant. C' ••• • .••-•!•. -...'-.. •;;--: >?' .=
ii. Chlorinated paraffins versus
chlorinated a-olefins. OxyGhem, the
American Automobile Manufacturers
Association, the Association of
International Automobile
Manufacturers, the Independent"
Lubricant Manufacturers Association,
and the Chlorinated Paraffins Industry
Association correctly state that EPA's
proposed definition of chlorinated
paraffins does not exclude chlorinated
a-olefins. The commenters further
contend that chlorinated paraffins and
chlorinated a-olefins are distinctly
'different chemicals with different
physical, chemical, and biological
properties.
The information provided by die
commenters does not substantiate their
claim that chlorinated paraffins and
chlorinated o-olefins are distinctly
different chemicals with different
physical/chemical properties. The main
difference between chlorinated paraffins
and chlorinated a-olefins that EPA is
aware of is that chlorinated paraffins,
typically manufactured from paraffin
mixtures, are also mixtures whereas
individual chlorinated a-olefins can be
manufactured in moderate to high
purity. The issue is whether a pure
chlorinated a-olefin falls within the
range of structural characteristics that
vary in a chlorinated paraffin mixture.
In this case, EPA believes that there are^
no significant structural differences •*
between chlorinated paraffins and
chlorinated a-olefins. Both are primarily
linear hydrochlorocarbons, and the
degree of chlorination of both groups of
substances can be controlled. Sixty
percent chlorination of 1-dodecene, for
example, would yield a product with
the formula CuHi^l? and a molecular
weight of approximately 411. Sixty
percent chlorination of the short-chain
grade paraffin mixture would yield a
mixture of products with an average
formula of C'uHigCl? and an average
molecular weight of approximately 411.
The commenters claim that the
chlorine positions in chlorinated a-
olefins differ significantly compared to
the chlorine positions in- chlorinated
paraffins. EPA does not believe that
chlorination at carbons 1 and 2 of the
a-olefins makes a significant difference
in the majority of the isomers formed by.
both reactions and even if it did, there
are no data that indicate that having two
of the chlorines at carbons 1 and 2 is
significant from a toxicity standpoint.
The commenters do hot substantiate
their claim (mass spectral data
submitted by one commenter is
inconclusive and cannot be used in
-.-support; for or against, the commenter 's:
position); EPA is not aware of ; '
experimental evidence that suggests that
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Federal Register / VpL ,59, No.-. 229 7, Wednesday, November .30, 1994 / Rules and Regulations 61463
the possible variations in chlorine, .
positions between the chlorinated
paraffins and the chlorinated a-olefins
differ significantly from the variations
possible within these two groups of
substances. Since for the a-olefins the
first two chlorines are'added at carbons
1 and 2, the relative amounts rather than
type of each isdmer formed may differ
between the chlorination of paraffins.
and a-olefins, especially as die degree of
chlorination decreases.
The coinmenters' claim that
chlorinated arplefins are distinctly
different from chlorinated paraffins
because their physical properties are .
very different is unjustifiable. As
discussed in detail in the Response to
Comment Document (Ref. 14), the
physical properties of discreet
chemicals cannot be compared to those
of chemical mixtures. The coinmenters
do not discuss specific differences
between chlorinated paraffins and
chlorinated a-olefins and therefore do
not substantiate their claim. They do,
however, elaborate on the differences
between structures within the
chlorinated paraffins group, particularly
those structures that represent the
extremes in the Cio to Cao range. This
discussion is therefore more relevant to
the issue bf listing categories versus
individual chemicals discussed • -
subsequently and does hot address the
issue of differences in the physical
properties between chlorinated paraffins
and chlorinated a-olefins, discussed
previously ^ Furthermore, EPA believes
that the. specific differences between
structural extremes within the
chlorinated paraffins group that the .
commenters elaborate on are trends that
are also observed between structural
extremes within the chlorinated a-
olefins group.
A valid comparison of physical
property data can only be made between
two discreet substances of known purity
or, in'some cases, between two mixtures
of chemicals with well defined
compositions. EPA believes that an a-
olefin and a paraffin.-both with the same
chain length and. both with the sanie
degree of chlorination, are essentially
identical structurally (especially if the
degree of chlorination is high); the same
isomers can be predicted for the
chlorination ;of an a-olefin and a
paraffin of the same chain length. The
physical properties of chlorinated a-
olefiris and'the corresponding
chlorinated, paraffins are therefore
expected to |»e very similar. The
differences in the chemical .and physical
properties that the commenters refer to
are largely or completely due to the fact
that the chlorinated paraffins are ...' . •
mixjure.s..ot.different chain lengths ,
while the chlorinated a-olefins typically
are composed of a single chain length. ..
iii. Category definition. Since EPA has
determined .that .only the short-chain
species meet the listing requirements of
EPCRA section 313, the polychlorinated
alkaries category will be defined by the,;
following formula and description:
CxHzx.yCly; where x = 10 to 13 and y =
3 to 12 and where the average chlorine
content ranges from 40 to 70 percent
with the limiting molecular formulas set
at CioH^Cla and C^HieCli^.
EPCRA section 313 requires threshold
determinations for chemical categories
to be based on the total of all chemicals
in the category manufactured,
processed, or otherwise.used. For
example, a facility that manufactures
three members of a chemical category
would count the total amount of all
three chemicals manufactured towards
the manufacturing threshold for that
category. One report is filed for the
category and all releases are reported on
this form.
42. Polycyclic aromatic compounds.
In the proposed rule, EPA proposed the
addition of a delineated polycyclic
aromatic compounds (PAC) category
that consisted of 28 polycyclic aromatic
compounds. Alternatively, EPA
proposed the addition of a PAC category
based on the following broad definition:
"includes all chemical species from the
polycyclic aromatic hydrocarbon, aza-
polycyclic, thio-polycyclic, or
nitroarene families where polycyclic
means three or more fused rings. More
specifically, it means any combination
of three or more fused six or five
membered hydrocarbon rings with at
least two or more rings being aromatic.
The structure may contain-fused non-
aromatic 5-membered rings, a ring
nitrogen, a ring sulfur, one or more
attached nitro groups, or one or more
attached alkyl groups" (January 12,
1994, 59 F* 1832).
Monsanto', The Chevron Companies.
Amoco Corporation, Armco Steel
Company, Mobil Oil Corporation,
UNOCAL, Pennzoil, Phillips Petroleum
Company, American Petroleum
Institute, and the Department of Energy
object to listing polycyclic aromatic
compounds as a category and
recommend that EPA list them
separately as individual chemicals.
American Coke and Coal Chemicals
Institute and Mobil Oil Corporation
state that if the chemicals are not
individually listed then the proposed
delineated category should be used.
Koch Industries Incorporated, Texaco .
Incorporated, and the Wisconsin
Department of Natural Resources object.
to the alternative proppsaLfor a PAC • <
category with the broad definition and
recommend that EPA implement the • •
delineated category approach. The
Natural Resources Defense Council
recommends that EPA use the broad
category definition.
EPA 'believes that polycyclic aromatic
compounds should be listed as a •
delineated category rather than listed
individually or defined under the broad
category definition. Most if not all of the
polycyclic aromatic compounds
included in the category are not
intentionally manufactured, they are
byproducts and impurities from various
industrial processes. As-such, they
occur as complex mixtures that are
typically released or transferred
together! EPA believes that for this class
of compounds a category listing is the
most appropriate way to track releases
and transfers under EPCRA section 313
because members of this category are
structurally similar and induce a similar
toxic effect.
The American Petroleum Institute,
Mobil Oil Corporation, American Coke
and Coal Chemicals Institute, Koch
Industries Incorporated, Monsanto, The
Chevron Companies, and Amoco
Corporation state that analytical
methodologies do exist to identify
s'pecific chemicals such as those
proposed for the delimited PAC
category; however, these analytical
methodologies require a chemical-by-
chemical analysis. They add that since ^S,
a chemical-by-chemical analysis is
required, there would be no reduction
in the reporting burden for either a
category based on the broad definition
or for the proposed delimited category.
EPA proposed the broad category
definition approach as a possible way to
reduce the reporting burden for a PAC
category. However, the majority of the
industries that would have to report do
not agree that this will result in a
reduction of their reporting burden, they
believe that it will cause confusion over
what chemicals are covered by this
category, and do not believe that
analytical methodologies exist to
identify all of the thousands of
chemicals that would be covered by a
PAC category based on the alternative
broad definition. EPA is therefore not
finalizing the alternative proposal to
create a PAC category based on the
broad definition but is finalizing the
proposed delimited PAC category as
explained above.
EPA believes that, although it may be
necessary to perform a chemical- by-.
chemical-analysis for members of this
delimited category, the most appropriate
way to track releases and transfers :
upder EPCRA;section 313 is by creating.
this category as explained above... •'•'•• *.•
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61464 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations
The Chevron Companies, Amoco
Corporation. Mobil Oil, UNOCAL,
Pennzoil, and the American Petroleum
Institute state that polycyclic aromatic
compounds share some physical and
chemical properties but that this does
not necessarily imply similar toxicities.
These commenters state that the toxicity
potentials vary widely among the
polycyclic aromatic compounds but that
the public tends to associate all
members of a category with the most
toxic chemical in the category.
EPA recognizes that similarities in
physical and chemical properties do not
necessarily indicate that the ability to
induce carcinogenic effect among the
members of the polycyclic aromatic
compounds category are identical.
However, these compounds are
chemically similar, induce the same
lexicological effect (carcinogenic!ty),
and typically are produced, released,
and transferred as complex mixtures
rather than individual chemicals. EPA
therefore believes that it is appropriate
to consider these compounds as a
category.
Mobil Oil Corporation contends that
11 of the PACs proposed for listing have
been reviewed by IARC and found to
have insufficient data in animals and no
data in humans making the overall
evaluation IARC-3 or.inadequate
evidence of carcinogenicity.
The 11 chemicals the commenter cites
as being classified by IARC as a group
3 chemical, i.e., the chemical is not
classifiable as to its carcinogenicity, are:
carbazole (CAS No. 86-74-8);
.cyclopenta(cd)pyrene (CAS No. 27208-
. 37-3); dibenz(a,c)anthracene (CAS No.
215-58-7); dibenz(a,j)anthracene (CAS
No. 224^-41-9);
dibenzo(a,e)fluoranthene (CAS No.
5385-75-1); 2-methylchryserie (CAS No.
3351-32-4); 3-methylchrysene (CAS No.
3351-31-3); 4-methylchrysene (CAS No.
3351-30-2); 6-methylchrysene (CAS No.
1705-85-7); 2-methylfluoranthene (CAS
No. 33543-31-6); and 1-nitropyrene
(CAS No. 5522-43-0). The commenter
is correct in that 10 of these 11
compounds have been classified as
IARC group 3 chemicals. The llth
compound, 1-nitropyrene (CAS No.
5522-43-0), was classified by IARC as
a Group 2B chemical, i.e., a possible
human carcinogen. The IARC
classification and a review of the data
indicate that the data is sufficient to
support the listing of this chemical on
the EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B). A second
compound, dibenzo(a,e)fluoranthene
(CAS No. 5385-75-1) was classified by
EPA as a B2 category chemical, the
chemical is a probable human
carcinogen, which justifies its.addition
to EPCRA section 313 pursuant to
EPCRA section 313(d)(2)(B). Upon
further review of the other 9 IARC group
C chemicals, the Agency believes that a
more detailed review of their
relationship to the 19 PACs for which
cancer data is available and is sufficient
is necessary before they can be placed
on the list on the basis of structure
alone. Therefore, EPA will not add these
9 chemicals to the EPCRA section 313
list at this time and the delineated
category will consist of the other,19
chemicals proposed for this category.
EPCRA section 313 requires threshold
determinations for chemical categories
to be based on the total of all chemicals
in the category manufactured,
processed, or otherwise used. For
example, a facility that manufactures
three members of a chemical category
would count the total amount of all
three chemicals manufactured towards
the manufacturing threshold for that
category. One report is filed for the
category and all releases are reported on
this form.
43.-Potassium
dimethyldithiocarbamate. Buckman
Laboratories International, Incorporated
states that the proposed listing of the
chemical was based on the results of the
rat and rabbit teratology studies, cited in
the proposed rule, although neither
study demonstrates evidence of
developmental toxicity. They contend
that the findings in the developmental
studies should be considered an artifact.
The findings in rabbits cannot be
considered artifacts because there is a
dose-related increase in the severity of
developmental effects at 38 and 77 mg/
kg. At 38 mg/kg, developmental toxicity
was characterized by increased post
implantation loss, malformations, and
sternebral malalignments. At 77 mg/kg,
there were reports of severe fetal 'and
embryo lethality. EPA did not cite a rat
study irtthe proposed rule as the
commenter claims.
EPA reaffirms that there is sufficient
evidence for listing potassium
dimethyldithiocarbamate on the EPCRA
section 313 list pursuant to EPCRA
section 313(d)(2)(B) based on the
available neurological toxicity data for
this chemical. Therefore, EPA is
finalizing the'addition of potassium
dimethyldithiocarbamate on the EPCRA
section 313 list.
44. Promefryn_Ciba-Geigy
Corporation states that marked renal
and hepatic degenerative changes were
noted in the high-dose dogs only in the
2-year dog study cited in the proposed
rule. The commenter further claims that
although minor liver effects were seen
in rats in the 28-day study cited in the
proposed rule, there were no liver
effects in rats after 90 days at dose levels
up to 5,000 ppm. This 90-day study that
the commenter cited was not cited by
EPA in the proposed rule. Thus, the
commenter does not believe that the
data support the addition of this
chemical to the EPCRA section 313 list.
EPA disagrees with the cbmmenter. In
the 2-year dog feeding study, prometryn
induced degenerative changes in liver
and kidney and bone marrow atrophy at
37.5 mg/kg/day (LOEL, the NOEL is 3.75
mg/kg/day). Although the dose eliciting
degenerative changes in liver and
kidney and bone marrow atrophy was
the highest dose tested, these adverse
effects are of sufficient seriousness to
warrant listing based upon the potential
for similar effects in humans. Further,
the findings of the 2-year dog study and
the 28—day rat study, cannot be
discounted based solely on of the results
of the 90—day study referred to by the
commenter. Rather EPA has considered
all of the data in concluding that
prometryn meets the criteria for
addition to the EPCRA section 313 list.
The commenter questions the use of
the rabbit developmental toxicity study
because only a slight effect (if real) was
noted at the highest dose tested, and
was not statistically significant.
Although the use of the rabbit
developmental toxicity study may not
be justified, and the potential for
developmental effects therefore not V
supported, EPA reaffirms that there is •
sufficient evidence for listing prometryn
on the EPCRA section 313 list pursuant
to EPCRA section 313(d)(2)(B) based on
available hepatic, renal, and bone
marrow toxicity data. Therefore, EPA is
finalizing the addition of prometryn on
the EPCRA section 313 list.
45. Propachlor. Monsanto contends
that the developmental toxicity study in
rabbits cited in the proposed rule was a
study that was rejected by the Agency.
Monsanto further stated that in this
study "a slight decrease in viable
fetuses, slight increase in post-
implantation loss, and slight decrease in
mean fetal weight was noted at the
highest dose tested (116.7 mg/kg/day)
which caused severe treatment-related
maternal toxicity including death. An
equivocal increase in post-implantation
loss on a percent basis was noted in the
mid-dose (58.3 mg/kg/day) level.
Marginal developmental effects that
were seen were not statistically .
significant and were within the
historical control limits. Propachlor
does not produce any observable
maternal or fetal toxicity at 5.8 or 58.3
mg/kg/day. In addition, propachlor does
• not cause developmental toxicity in
^rats." Monsanto concluded that, based
on the "weight of evidence from the rat
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Federal Register / Vol. 59» No, 229 /Wednesday, November 30, 1994 / Rules and Regulations 61465
and rabbit studies, there does not appear
to be any developmental risk to
humans."
The Agency does not concur with the
commenter's statement that "propachlor
does not produce any observable
maternal or fetal toxicity at 5.8 or 58.3
mg/kg/day dose levels," nor with the
statement that "the marginal
developmental effects that were seen
were .... within the historical control
limits." The Agency's rationale for the
disagreements are as follows:
In a developmental toxicity study in
rabbits, oral administration of.
propachlor at 116.7 mg/kg/day caused
maternal toxicity as evidenced by death,
clinical signs [salivation and reduced
defecation], decreased body weight gain
and food cons'umption, and gross
pathological lesions of the stomach.
Developmental toxicity at 58.3 and
116.7 mg/kg/day included dose-related
increases in the total number of
resorptions/litter and post-implantation
losses compared to concurrent and/or
historical controls.
Based on these findings, it is apparent
that the developmental effects seen at
58.3 and 116.7 mg/kg/day levels are
attributable to propachlor; the NOEL
was 5.8 mg/kg/day.
EPA reaffirms mat there is sufficient
evidence for listing propachlor on the
EPCRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available developmental toxicity
data for this chemical. Therefore, EPA is
finalizing the addition of propachlor on
the EPCRA section 313 list.
46. Propargyl alcohol. International
Specialty Products.is opposed to the
listing of propargyl alcohol apparently
because an uncertainty factor of 3,000
was used by EPA in setting the RfD. The
commenter feels that an uncertainty
factor of 100 would have been more
appropriate and cites instances where
such an uncertainty factor has been
used by IRIS in setting reference doses.
The commenter.does not question the ,.
renal or hepatotoxicity cited in IRIS as
a basis of its concern. •
The commenter is correct in stating
that EPA has used uncertainty factors of
100 for other chemicals. However, that
was not deemed appropriate in this
instance for reasons which are set out by
EPA in the IRIS data base. EPA
continues to support the listing of
propargyl alcohol under EPGRA section
313 on the basis- of chronic toxicity
which may pose a significant health
hazard as manifested by .renal and
hepatic effects. The uncertainty factor
plays no part in this decision. EPA
reaffirms that there is sufficient -
evidence for listing propargyl alcohol on
the EPCRA section 3.13- list 'pursuant to
EPCRA section 313(d)(2)(B) based on
the available hepatotoxicity and
nephrotoxicity data for this chemical.
Therefore, EPA is finalizing the addition
of propargyl alcohol on the EPCRA
section 313 list.
47. Propiconazole. Ciba-Geigy
Corporation states that the increased
incidence of liver tumors in the
oncogenicity study on propiconazole
was noted only in male mice in the high
dose (2,500 ppm), which exceeded the
MTD, based on decreased survival and
body weight gain.
EPA believes that the study high dose
(2,500 ppm, equivalent to 325 mg/kg/
day) was excessively toxic; however", the
Agency also determined that the mid
dose (500 ppm, equivalent.to 65 mg/kg/
day) was not considered sufficiently
high to evaluate the carcinogenic
potential of propiconazole! The Agency
believes that a supplementary study
should be conducted in male mice at
doses selected to sufficiently evaluate
carcinogenic potential without
excessive toxicity. At this time however,
based on the currently available
evidence, propiconazole remains
classified as a Group C, possible human
carcinogen, widi the RfD approach
recommended for quantification of
human risk.
The commenter further states that
relatively minor gastrointestinal effects
were noted in dogs at the high dose only
(250 ppm).
EPA believes that the data in both the
3-month and 1—year dog studies
demonstrate gastrointestinal effects at
the high-dose (250 ppm, equivalent to
6.25 mg/kg/day). These effects are
considered severe, and, therefore, are of
sufficient seriousness to warrant listing
propiconazole on the EPCRA section
313 list.
EPA reaffirms that there is sufficient
evidence for listing propiconazole on
the EPQRA section 313 list pursuant to
EPCRA section 313(d)(2)(B) based on
the available hepatic and
gastrointestinal.toxicity data for this
chemical. Therefore, EPA is finalizing
the addition of propiconazole on the
EPCRA section 313 list.
48. Simazine. Ciba-Geigy Corporation
objects to the listing of simazine undej
EPCRA section 313 based on reports of
liver, kidney, testicular and neural
pathology in sheep and increases in
liver enzymes in a dog 2-year .study. The
commenter maintains that the.sheep
study was conducted to investigate the
possible effects that would result if large
amounts of simazine were ingested by .
this species. The commenter also states
that in a 1-year study there were some
indications of effects on the
hematopoietic system but not the
hepatic system at the high dose of 1,500
ppm.
In a 1-year study, NOEL and LOELa
of 0.68 and 3.41 mg/kg/day,
respectively, were established based on
decreased body weight gain, and
decreased RBC, HGB, HCT in females.
Although the sheep study was
conducted for a purpose other than to
investigate the overall toxicity of
simazine, this does not negate the
relevance of its results. EPA reaffirms
that there is sufficient evidence for
listing simazine on the EPCRA section
313 list pursuant to EECRA 'section
313(d)(2)(B) based on the available
hepatic, renal, neurological, and
reproductive toxicity data for this
chemical. Therefore, EPA is finalizing
the addition of simazine on the EPCRA
section 313 list.
49. Sodium nitrite. American
Automobile Manufacturers Association
contends that EPA has proposed listing
on the basis of "chronic toxicity but the
support document cites studies based
on high dose, acute exposures. High
dose gestational"studies in rats and mice
were also cited as the basis for
developmental (fetal) toxicity.
EPA agrees that the human studies
cited in the proposed rule are acute
studies. However, these studies in
conjunction with the chronic study in
mice, which showed reduced motor
activity and major EEC changes in s
*Mreated animals, support the basis for
concern for chronic neurological effects.
EPA thus considers sufficient indication
of a'potential chronic neurologic hazard
to list this chemical on the EPCRA
section 313.
There were two developmental
studies in mice and one reproductive
study in rats cited in the proposed rule
which showed effects on the ietal
development whether sodium nitrite
was administered during gestation or
lactation. The doses used in the studies
with mice, 30 and 80 mg/kg/day,
.respectively, are not abnormally high for
this type of study; the dose range
reported for therat reproductive study,
26 to 256 mg/kg/day is also not
abnormally high. The results from all
three studies indicate that sodium
nitrite induces developmental effects in
animals and are sufficient to make a
determination that the chemical is a
potential health hazard in man.
EPA reaffirms that there is sufficient
evidence for listing sodium nitrite on
the EPCRA section 313 list pursuant to
section 313(d)(2)(B>based on the
chronic hernatological and
developmental toxicity data for this
chemical. Therefore, EPA is finalizing
the addition of sodium nitrite on the
EPCRA section-313"lrst.
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50. Triallate. Monsanto contends that
the hepatic health effects listed in the
proposed rule for triallate are trivial
effects that do not provide sufficient
evidence that triallate causes hepatic
toxicity. In addition, Monsanto claims
that pregnant rats exhibited abnormal
behavioral signs at 90 but not at 30 mg/
kg/day.
Although the Agency agrees that there
is not sufficient evidence for
hepatotoxic potential of triallate, the
Agency does not concur with the
commenter that "pregnant rats exhibited
abnormal behavioral signs at 90 but not
at 30 mg/kg/day." Head bobbing and
circling, clear signs of neurotoxicity,
were observed in pregnant females at 30
mg/kg/day. Males and non-pregnant
females did not exhibit these clinical
signs. These data suggest that pregnant
rats are more susceptible to the
neurologic potential of triallate than the
general population.
The commenter noted the existence of
a subchronic neurotoxicity study in rats
and indicated that this study provides a
better estimation of the neurotoxic
potential of triallate than the 2-
generation reproduction study.
The Agency agrees that the
subchronic neurotoxicity study in rats
(Ref. 10) provides a clearer picture of
the neurotoxic potential of triallate. The
Agency has reviewed this study and
concludes that the results indicate the
neurotoxic potential of triallate and
further corroborates the findings cited
by EPA in the proposed rule.
Thus, the Agency reaffirms that there
is sufficient evidence for listing triallate
on the EPCRA section 313 list pursuant
to EPCRA section 313(d)(2)(B) based on
the available chronic neurotoxicity data
for this chemical. Therefore, EPA is
finalizing the addition of triallate'on the
EPCRA section 313 list.
G. Chemicals Not Being Added to
EPCRA Section 313
\. 5-Chhro-2-(2,4-
dichlorophenoxy)phenol.Ciba-Geigy
Corporation and The Dial Corporation
contend that insufficient evidence is
. available to support the conclusion that
5-chloro-2-(2,4-dichlorophenoxy)phenol
poses a risk of hematological toxicity to
humans based on handling and uses of
the product.
Based on these comments and EPA's
reanalysis of the data, the Agency has
concluded that the information'
presented in the proposed rule is not
sufficient to justify adding 5-chloro-2-
(2,4-dichlorophenoxy)phenol to the
EPCRA section 313 list based upon
potential human hazard. Therefore, EPA
is not finalizing the addition of this
chemical on the EPCRA section 313 list.
2. Clomazone. FMC Corporation
claims that clomazone induces adverse
effects only at .high dose levels.
The Agency agrees with the
commenter: Based on these comments
and EPA's reanalysis of the data, the
Agency has concluded that the
information presented in the proposed
rule is not sufficient to justify adding
clomazone to the EPCRA section 313 list
based upon potential human hazard.
Therefore, EPA is not finalizing the
addition of this chemical to EPCRA
section'313.
3. Tetrasodium
eihylenediaminetetraacetate. Eight
commenters contend that-the proposed
listing for this chemical was based
solely on a single, unreliable
developmental toxicity study which
used a mixture that contained
tetrasodium
ethylenediaminetetraacetate along with
several other chemicals.
EPA concedes that the effects cannot
be attributed solely to tetrasodium
ethylenediaminetetraacetate. Therefore,
the Agency is not finalizing the addition
of tetrasodium
ethylenediaminetetraacetate on the
EPCRA section 313 list.
H. Miscellaneous Comments
I. Year-to-year comparisons of the
TRI data. BP America, Texaco, and
American Automobile Manufacturers
Association contend that the proposed^
expansion of the EPCRA section 3.13 list
will eliminate any consistency with .
earlier TRI data and make tracking
environmental progress impossible.
American Automobile Manufacturers
Association further states that EPA
needs to ensure that the "total TRI
releases and transfers" measurement
system allows accurate interpretation of
the data, allowing the public to
realistically assess progress in pollution
prevent^oh. Also, the commenters add
that considerable confusion results in
trying to explain the different data sets
to the public. Mobil Oil Corporation
states that EPA should divide the list
into three sub-groups so that a facility's
history can be tracked on a more
common basis.
EPA recognizes that changes in the
EPCRA section 313 list and in the
reporting requirements have an effect on
the characterization of the TRI data. In
fact, some change has occurred for every
reporting year. In an attempt to provide
useful year-to-year comparisons, EPA
has presented the TRI data annually on
a normalized list of chemicals, i.e., the
list of chemicals used for year-to-year
comparisons is the same.for .every year
in the comparison. EPA further
recognizes the effect that expansion of
the EPCRA section 313 list will have on
the TRI data and will continue to work
to find ways to make the data usea
for cross-year comparisons. EPA will
use the 1995 reporting year' as the base
year for comparisons that include the
chemicals added today. Facilities
should still be able to track pollution
prevention progress for those chemicals
previously listed (using 1988 as the base
year) and have a newbase year for the
additional chemicals which can be used
to track future pollution prevention
progress.
2. Public perceptions. Roussell Uclaf
Corporation, National Paint and -
Coatings Association, Association of
International Automobile
Manufacturers, and American Frozen
Food Institute oppose the listing of
these chemicals under EPCRA section
313 because of the public's
misperception of the associated dangers.
American Automobile Manufacturers
Association (AAMA) states that, since
the public considers all chemicals on
the EPCRA section 313 list to be toxic,
any chemical on the list is subject to
adverse scrutiny, regardless of the actual
risks associated with the chemical.
While recognizing past efforts by EPA
towards public education, AAMA
believes that misunderstanding and
misinterpretation of the data still exists
which makes it more critical that EPA
not expand the list with low risk ^2, •
chemicals. Texaco and AAMA believe'
that before the Agency expands the x
EPCRA section 313 list, resources
should be committed to provide public
education on actual risks portrayed by
the data and educate the public on
viable means of chemical risk reduction
and chemical management.
The chemicals that are listed under
EPCRA section 313 exhibit a wide range
of effects at various dose levels. While
EPA attempts to communicate the TRI
data in the most accurate manner, the
Agency recognizes that there exists the
perception that the TRI data may
so'metimes be mischaracterized, but that
does not justify not adding a chemical
for which the statutory criteria are
clearly met. EPA agrees that the better
approach to such a problem is
improving public information on the
chemioal, which, combined with the
release, transfer, and waste management
data will enable the public to participate'
in informed environmental decision-
making. EPA continues to attempt to
provide the public with means for
interpreting the TRI data.
3. Persistent bioaccumulative
chemicals. In the proposed rule, EPA
requested comment on whether
chemicals that are manufactured in
trace amounts in waste streams, are
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61467
highly toxic at very low dose levels and
have physical, chemical, or biological
properties that make the chemicals
persist for extended periods in the
environment, and bioaccumulate
through the food chain should be listed
on the EPCRA section 313 list (January
12,1994, 59 FR1791). EPA noted that
persistent bioaccumulative toxic
chemicals, such as dioxins, are of
particular concern in ecosystems such
as the Great Lakes Basin due to the long
retention time of the individual lakes
and the cycling of the chemical from
one component of the ecosystem to
another. EPA also requested comment
on the following: If EPA were to add
this type of chemical to EPCRA section
313, what modifications to EPCRA
section 313, such as lowering the
.reporting thresholds and modifying the
de minimis in mixture exemption (40
CFR 372.38), would be required to
ensure that release and transfer
information would be collected? In
addition to two comments opposed to
the addition of this type of chemical,
EPA received 35 comments supporting
the addition of toxic persistent
bioaccumulative chemicals. Trie
majority of these commenters also-
supported lowering the reporting
thresholds for this type of chemical.
Monsanto and Dow Chemical
Company object to the addition of
persistent bioaccumulative chemicals
that are produced in quantities less than
the EPCRA section 313 reporting
thresholds. The commenters state that
many of the persistent, bioaccumulative
toxic compounds which are of concern
are no longer manufactured in the
United States, and are merely present in
the environment due to historical
activities and not'current activities.
EPA disagrees with this contention.
EPA's request for comment focused on
chemicals that are generated in small
quantities. This is not limited to
chemicals produced as a product, but
includes chemicals that are generated in
waste streams. Many persistent,
bioaccumulative toxic chemicals are
produced in waste streams. Further,
EPCRA section 313 requires the
reporting of chemicals manufactured in
waste streams if the quantity produced
exceeds the appropriate reporting
threshold.
Monsanto further claims that "the
amounts of these particularly dangerous
substances coming from industrial
facilities are so small that they can have
no measurable impact on health or the
environment."
EPA disagrees that releases of these
chemicals are so low that they wilt not
have an adverse effect upon human
healthrorthe environment The
persistent bioaccumulative aspects of
these toxic chemicals are such that even
very small quantities released can
reasonably be anticipated to cause
adverse effects upon human health and
the environment.
Monsanto also states that the concept
of different reporting thresholds
suggests that this threshold would be
proportional to the relative hazard.
Thresholds for practically non-toxic
chemicals may be very high using this
concept.
EPA requested comment on lowering
the thresholds for these chemicals not
so that the reporting thresholds for
chemicals .listed on the EPGRA section
313 list would be proportional to the
relative hazard of the chemicals. Rather,
EPA requested comment on lowering
the threshold for persistent
bioaccumulative chemicals because
even minimal releases of these
chemicals may result in elevated
concentrations in the environment or in
an organism that can reasonably be
,anticipated to result in significant
adverse effects. This reflects the
increased likelihood that there will be
exposure to a chemical that persists due
to its longer residence time in the
environment. Repeated minimal
releases of a persistent chemical may
result iil elevated concentrations in the
environment. For a chemical that
bioaccumulates, even low levels of the
chemical in the environment may result
in increased concentrations in an
organism. Thus, lower thresholds for
these substances would be considered
due to the persistent and
bioaccumulative nature of the
substances, rather than the direct
hazard.
In its next action to add chemicals to
the EPCRA section 313 list, the Agency
intends to consider the addition of
chemicals that are persistent and
bioaccuaiulate. EPA also intends to
consider lowering the reporting
thresholds for these additional
chemicals and those chemicals that are
persistent and bioaccumulate that are
now on the EPCRA section 313 list.
Accordingly, comments received in
response to EPA's request for comment
on the potential addition of persistent
bioaccumulators will be addressed in
the future rulemaking if these chemicals
are proposed for addition.
4. Additional chemicals. The
Wisconsin Department of Natural
Resources states that the EPCRA section
.313 chemical list should be expanded to
include the six chemicals listed in
section 112(b) of the CAA not currently
included on the EPCRA section 313 list
or as part of the January 12,1994
proposal.
. EPA has reviewed all of the chemicals
listed under section 112(b) of the CAA
not currently on the EPCRA section 313
list and has determined that the
remaining chemicals" either do not meet
the Current listing criteria or no reports
would be received since their
production volumes are below reporting
thresholds.
5. Hormone mimics. The National
Wildlife Federation recommends that
EPA add to the section 313 list all
chemicals with estrogenic or other
hormone-mimicking qualities, and the
reporting thresholds aixd de minimis
exemption for mixtures eliminated for
these chemicals.
EPA agrees that the deleterious effects
of hormone mimicking chemicals may
warrant their future review for listing on
the EPCRA section 313 list. Although
the effects of these chemicals are
difficult to predict, and it is often
impossible to establish a clear cause/
effect relationship, still it is clear from
the available evidence that these
chemicals warrant consideration. Wide
scale changes in wildlife and human
populations have been noted by some
researchers. Population decreases and
reproductive effects have been linked to
these chemicals in a number of wildlife
species, including but not limited to
bears, Florida panthers, songbirds, and
bald eagles, to list just a few. Possibly
of greater concern are the effects of th^se
chemicals in humans. In addition to tfie
carcinogenic potential of many of these
chemicals, effects on fertility, immune
system damages, arid many childhood
problems have been attributed to
hormone-mimics. A number of the
chemicals with widespread distribution
in the environment reported to have
reproductive aind endocrine-disrupting
effects (Ref. .1) are either already on the
EPCRA section 313 list, or are being
added as a result of this action. EPA
may consider reviewing the remaining
chemicals on this list as part of a future
action.
As to removing the reporting
thresholds and de minimis exempli on
for the hormone-mimicking chemicals
already on the section 313 list, these
possibilities will be examined at the
time that modifying the reporting
thresholds and de minimis exemption
for persistent and bioaccumulative
chemicals is addressed. As many of the
hormone mimicking chemicals are also
either persistent or bioaccumulative
they could be included as part of such
a review. • '
/. Comment on EPA's Regulatory Impact
Assessment
»v Comments that are specific to
individual chemicals or chemical
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61468 Federal Register / Vol. 59, No. 229 / Wednesday. November 30. 1994 / Rules and Regulations
categories are addressed in the Response
to Comments Document (Ref. 14).
Many commenters state that EPA's
Regulatory Impact Analysis (RIA) failed
to meet the requirements of Executive
Order 12866, which mandates
regulatory planning and review. The
commenters state that: (1) The RIA for
the proposed rule did not analyze any
alternatives other than adding the 313
chemicals and chemical categories to
the EPCRA section 313 list, (2) that it .
excluded the economic effects due to
complying with state, local and other
federal requirements that are triggered.
when a chemical is listed under EPCRA
section 313, and (3) that it did not
analyze the benefits of the rule. Many
commenters also contend that small
• business impacts were understated in
the RIA, and that the time required for
compliance is higher than estimated in
the RIA. These comments and the
Agency's responses are discussed
below. •
1. Alternatives. The commenters
believe that the RIA should have
included alternatives to adding all of the
proposed chemicals and chemical
categories to the EPCRA section 313 list.
In response to these comments, EPA has
revised the RIA to include a variety of
alternatives, such as adding the CAA
criteria air pollutants,, not adding
chemicals regulated under FIFRA, not
adding the water dissociable nitrate
compounds category, and adding the
proposed chemicals in conjunction with
an. alternate reporting threshold for
facilities with low-levels of TRI
chemicals in wastes. The commenters
requested that EPA present the costs for
adding each individual chemical. EPA
cannot provide the costs on an
individual chemical basis because the
. estimates for most of the chemicals were
derived from confidential business
information. Displaying the costs for
each chemical could disclose this
confidential information.
2. Linked requirements. Numerous
commenters state that the RIA excludes
the costs of compliance with state, local
. and other federal requirements that are •
triggered when a chemical is listed
under EPCRA section 313. The linked
requirements that the commenters raise ,
include state taxes and fees, state
pollution prevention planning
requirements, special requirements for
certain National Pollutant Discharge
Elimination System (NPDES) storm .
water permits* and requirements for
federal facilities under Executive Order
12856. EPA has revised the RIA to
discuss state and federal requirements
that are linked to reporting under -
EPCRA section 313. However, EPA has
not quantifiedlhe costs of such
requirements. In some cases, this is
because there is insufficient data to
make a reasonable estimate. In other
cases, EPA does not believe that the
requirements represent a social cost.
The requirements that may be linked to
listing under EPCRA section 313 are
discussed below.
a. State fees. Thirteen states place a
tax or fee on facilities filing TRI Form
R reports. These states are Colorado,
Florida, Iowa, Kansas, Maine,
Massachusetts, Minnesota, Mississippi,
Nevada, Ohio, Pennsylvania, South
Dakota, and Texas. Many commenters
estimate that the costs resulting from
state fees and taxes linked to EPCRA
section 313 reporting are up to 50
percent of the direct cost of filing the
forms, and state that any tax is likely to
induce a reduction in economic welfare.
EPA has revised the RIA to discuss state
fees and taxes that are linked to
reporting under EPCRA section 313.
However, the taxes and fees are not
direct social costs, and EPA does not
believe that there is sufficient
information to estimate the net social
costs or benefits of these requirements.
The commenters treat state taxes and
fees on the EPCRA section 313 reports
as costs, but these are transfer payments
and not economic costs to society.
Specifically, the standard definition of a
cost in economics is the consumption of
a resource (e.g., labor, equipment,
natural resources, etc.). A tax or fee is
a transfer payment from one party to
another. While the fee is a cost to the
firm (and/or its customers), it is income
to the state. No resources are consumed,
except for transaction costs, so the
amount of the fee is not a cost to society.
EPA disagrees with the commenters'
contention that any tax or fee is likely
to induce a reduction in economic
welfare. EPA believes that taxes or fees
on toxic chemicals may resolve a market
failure and increase'social welfare. The
use of toxic chemicals often creates a
negative externality. For instance,
releases of a chemical may cause health
and environmental-effects in the
surrounding community. In such cases,
it is likely that private costs are below
true social costs, because private
markets do not provide an adequate '
incentive for firms to internalize these
externalities. In such cases, taxes may
be the optimal method to correct the
market failure. EPA believes that if the
commenters feel that the fees are not set
at the level that optimizes social
welfare, their remedy lies with the
appropriate state agency, and not EPA.
EPA does not feel that it is feasible to
estimate the size of the transfer payment
resulting from state fees and taxes
linked to EPCRA section 313, or the net
social costs or benefits of these
payments. The commenters made their
estimates by applying the maximum
state fees to all facilities nation-wide.
EPA does not feel'that such a
calculation is appropriate. Most states
have no fees or taxes linked to EPCRA
section 313 reporting, and the level of
the fees or taxes (and how they are
assessed) is different in each of the rest
of the states, varying from $25 to.
$50,000. Many of the state requirements
are not flat fees, but are graduated
depending on the level of releases that
a facility reports. An accurate
representation of the" size of the transfer
payments would require estimating the
geographic distribution of new reports,
and the level of releases and transfers
for each report. EPA feels that it is not
possible to predict with a reasonable
degree of accuracy the location and
level of releases for facilities that will
report on the chemicals being'added to
the EPCRA section 313 list.
Nor is it feasible to accurately
estimate the net social costs or benefits
of the state fees and taxes. To do so
would require knowing not only the size
of the transfer payments, but the
damages caused by the use and release
of the chemicals, and the change in
behavior that would result from the fees
and taxes. EPA does not have adequate
information on the facilities that would
be affected by the rule to make such ^
estimates. As a result, the RIA has been
revised to qualitatively .discuss state fees
and taxes linked to EPCRA section 3l3
reporting, but does not estimate the size
of the resulting transfer payments, or the
net social costs or benefits.
b. State pollution prevention
programs. Seven states (Arizona, Maine,
Massachusetts, Minnesota, Mississippi,
New Jersey, and Texas) mandate
pollution prevention plans from
facilities reporting under EPCRA section
313. Facilities in these states that are
reporting to TRI for the first time
because of the additions to the chemical
list will have to prepare pollution'
prevention plans. Although the
development of pollution prevention
plans imposes a cost on facilities, the
RIA did not analyze the costs of these
requirements. Many commenters
contend that there are significant costs
for preparing such plans, and that the
RIA should have included these costs.
Quantifying the impacts of state
pollution prevention requirements
would require predicting which
facilities reporting for the additional
chemicals would be located in these
seven states. As stated above, it is not
possible to accurately predict the
geographic location of new reporters.
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Federal Register./ Vol. 59, No. 229 / Wednesday; November 30, 4994 / Rules and Regulations 61469
Thus, no costs are estimated for state
pollution prevention plans in the RIA.
Nor does the RIA quantify the benefits
derived from these pollution prevention
planning requirements. None of the
commenters submitted any evidence
comparing the social benefits of .such
requirements to the costs. Therefore,
EPA has no information from which to
conclude that the linked requirements
for state pollution prevention plans
would reduce the net social benefits of
adding chemicals to EPCRA section 313.
EPA has not quantitatively estimated .
either the costs of state pollution
prevention planning requirements.or the
benefits of such programs in the RIA.
However, the RIA has been revised to
qualitatively discuss requirement's that
are linked to EPCRA section 313
reporting, including pollution
prevention plan preparation.
c. NPDES storm water permits. EPA
issued National Pollutant Discharge
Elimination System {NPDES) "baseline"
general permits for storm water
discharges associated with industrial
activity on September 9,1992 (57 FR
41236). EPA subsequently proposed a
multi-sector storm water industrial
permit covering 29 industrial sectors
(November 19,1993, 58:FR 61147). The
"baseline" general and multi-sector
general permits have special pollution
prevention requirements for certain
EPCRA section 313 facilities, and the
"baseline" permits also contain special
monitoring requirements. Many
commenters assert that the RIA
underestimates the costs of the rule by
a factor of up to 5.6 by not including the
costs of NPDES storm water permit
requirements that are triggered by
adding chemicals to the EPCRA section
313 list.
j EPA believes that the commenters'
estimates are based on a cost scenario
that is not applicable to the typical-
facility affected by the proposal to add
chemicals under EPCRA section 313.
There are four reasons that the
commenters' estimates are not generally
appropriate. Any of these reasons alone
demonstrate that the commenters have
overestimated the number of facilities
; that are affected and the the size of the
impact. Because there may also be a
significant overlap among the four, the
i commenters' estimates are likely to
' apply to few, if any, facilities. The
• commenters' estimates wduldnot apply
> to all facilities affected by the rule, as
the commenters contend.
! First, only a fraction of the facilities
that would report under EPCRA section
313 for the additional chemicals.would
be affected by the NPD^S storm water
permits. A facility that submits TRI
Form R is only subject to storm water
permitting requirements if industrial
materials or activities are exposed to
storm water, arid if the facility-is
reporting to TRI for one of the section
313 water priority chemicals. Only
about two dozen of the chemicals being
added to the EPCRA section 313 list
qualify as section 313 water priority
chemicals, and thus would be covered
by the NPDES requirements. About half
of these are pesticides, which would not
be manufactured or processed.at many
facilities.
Second, EPA expects the majority of
facilities to have existing containment
systems that meet most of the
requirements of the NPDES permits.
Third, many of the costs for the storm
water .requirements are likely to apply at
the facility level. In such cases, facilities
that installed systems for the current
EPCRA section 313 chemicals will not
face incremental costs for the additional
chemicals. Fourth, the special
requirements of the NPDES storm water
permits are based oh the coverage of
EPCRA section 313 at the time the
permits were issued. The NPDES
requirements do not apply to chemicals
that are added to the EPCRA section 313
list until the time of permit renewal
(which occurs every 5 years), and may
not apply in subsequent permits,
depending on the Agency's decisions at
the time those permits are issued.
In addition, the commenters based
their estimates solely on the upper
bound of EPA's estimates for the NPDES
permits, and have ignored the mix of •
low-cost and high-cost facilities that is
likely to exist. EPA believes that the
commenters' estimate is a hypothetical
"worst-case" scenario that does not
apply to the typical facility and may not
apply to any facilities. EPA believes that
the costs of the storm water
requirements for the proposed
chemicals will be relatively minor.
Again, EPA has revised the RIA to
qualitatively discuss the linkage
between EPCRA section 313 reporting
and the NPDES storm water, but it has
not made any quantitative estimates of
these costs.
d. Executive order 12856. Executive
Order 12856, signed by the President in
August 1993, extends the coverage of
EPCRA to federal facilities. In addition,
section 3-303(a) of the Executive Order
states that "Each federal agency shall
establish a plan and goals for
eliminating or reducing the unnecessary
acquisition by that agency of products
containing extremely hazardous
substances or toxic chemicals"
(emphasis added). The Executive Order
defines "toxic chemical" as a substance
on the list described in section 313 of
EPCRA. Many commenters contend that
the cost to the federal government and
the private sector of complying with
Executive Order 12856 for the chemicals
being added to EPCRA section 313 will
be $1.5 billion per year.
, EPA does not believe that the effects
of Executive Order 12856 should have a
bearing on the decision-making
regarding the addition of toxic
chemicals to EPCRA section 313. EPA
believes that following the commenters
line of reasoning would discourage the
federal government from ever making
any changes in procurement, for
whatever reason, beca'iise doing so
might have an impact on a supplier.
Furthermore, EPA believes that there is
insufficient data to make any estimate of
the effects of the Executive Order, and
that the resources required to make such
an estimate would exceed the value of
the information.
EPA notes that section 3-303(a) of the
Executive Order does not require the
elimination of toxic chemicals in federal
procurement. If the performance
characteristics of a toxic chemical or
product containing a toxic chemical are
critical in the required tasks, federal
agencies may continue to purchase it.
Each federal agency must make its own
determination whether a particular toxic
chemical is necessary in a particular
use.
• The Executive Order requires that
federal agencies eliminate or reduce^he
unnecessary procurement of extremely
hazardous substances or toxic
chemicals. None of the commentersx
identify which toxic chemicals are being
unnecessarily purchased-by the federal
government, and which federal agencies
are making these unnecessary
purchases. Without such information,
/ EPA cannot verify the commenters'
claim that the addition of chemicals to
EPCRA section 313 will create
significant impacts as.a result of the
Executive Order. Jf these chemicals are
not being purchased by the federal
government, or are not being purchased
unnecessarily, there will not be an
impact.
The commenters' estimate of $1.5
billion in costs is based solely on a
series of assumptions, which are not
supported by data. EPA does not believe
that the commenter's analysis was based
on a careful analysis of any factual
information. EPA has no data with
which to replace these assumptions.
Given EPA's belief that effect of the
Executive Order should not have a
bearing on the'rulemaking (as well as
.the limitations of the Executive Order,
the small amount of procurement that
v would-be affected, and the ability of
producers to sell to private sector clients
or manufacture substitutes), EPA does
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61470 Federal Register / Vol. 59. No. 229 / Wednesday. November 30, 1994 7 Rules and Regulations
not believe that there is a need to
develop any data on these factors.
The Executive Order states that "the
environmental, energy and economic
benefits of energy and water use
reductions are very significant," and
that "the federal government has the
opportunity to realize significant
economic as Well as environmental
benefits of pollution prevention." The
Executive Order provided a mandate for
the federal government to reduce its
unnecessary use of toxic chemicals. EPA
believes that the proposal to add
chemicals to the section 313 list
complements this mandate.
Furthermore, EPA hopes that federal
agencies will comply with the spirit of
the Order, and reduce their unnecessary
use of toxic and hazardous chemicals,
whether or not these chemicals are
listed on the EPCRA section 313 list.
EPA believes that, by definition, the
social benefits cannot exceed .the social
costs for an unnecessary toxic chemical,
and social welfare can be improved by
switching to a substitute product.
Therefore, EPA;believes that any actions
federal agencies take to meet their
obligations under Executive Order
12856 will have a positive net benefit.
3. Benefits. Many commenters assert
that the RIA did not show any benefits
to adding chemicals to the EPCRA
section 313 list of chemicals. The
commenters appear to have made these
statements because EPA did not make a
quantitative estimate of the benefits
associated with.the rule.
There are two types of benefits
associated with EPCRA section 313. The
first type of benefit is due to .'
improvements in understanding,
awareness, and decision-making related
to the provision and distribution of
information.'The second type of benefits
derive from changes in behavior that
result from the information reported to
TRI. These benefits include reduced.
environmental and health risks, and
reduced treatment and disposal costs:
These changes in behavior come at some
cost to society. Because the current state
of knowledge about the economics of
information is not highly developed,
EPA has not attempted to quantify the
pure information benefits of adding
chemicals to the EPCRA section 313 list.
Because of the inherent uncertainty in
the chain of events, EPA has also not
attempted to-quantify the benefits or the
costs of the changes iri behavior that
result from the information. EPA does
not believe that there are adequate •
methodologies to make reasonable
quantitative estimates of either type of
benefits. However, EPA believes that its
. qualitative discussion of the effects of
the current TRI program show that such
benefits do exist. The information on
the additional chemicals is expected to
improve scientific understanding of the
environment and health risks, foster
greater community awareness of
industrial activities, and allow Federal,
state, and local authorities to make
better informed decisions on acceptable
levels of toxic chemicals in
communities.
Instead, EPA has drawn its
conclusions about the net benefits of
adding chemicals to EPCRA section 313
by inference. In enacting EPCRA and the
PPA, Congress implicitly determined
that the net benefits of reporting was
positive for the original list of 320
chemicals and categories. EPA's
interpretation of the statutory toxicity
criteria is more stringent than Congress'
original determination because EPA has
deleted 12 chemicals from the original
list of 320 chemicals and categories
developed by Congress. EPA believes
that all of the chemicals being finalized
meet the statutory toxicity criteria of
section 313, and are at least as toxic as
some of the chemicals for which
Congress believed there were net
benefits due to reporting. Thus, by
inference, the net benefits of reporting
for the chemicals added in this
rulemaking should be positive as well.
EPA believes that the experience of
the past 5 years shows that, reporting
under EPCRA section 313 has produced
real gains in understanding about
exposure to toxic chemicals. EPA sees
no reason why the information on the
additional chemicals will provide less .
understanding than the currently
reported-chemicals have provided.
4. Small business. Under the
Regulatory Flexibility Act (5 U.S.C.
sections 601 - 612), agencies must
prepare an analysis of small business
impacts for proposed rules. Many
commenters contend that small business
' impacts vfere understated in the RIA,
and they question EPA's conclusion that
the rule will not have a significant
impact on a substantial number of small
entities. EPA believes that the
commenters have significantly .
overestimated the costs of the rule, and
that the commenters' estimates of small
business impacts are not valid. EPA has
provided additional analysis in the RIA
for the final rule that demonstrates that
the rule will not have significant cost
impacts on small entities.
EPA believes that, whether or not the
proposed rule would have had
significant cost impacts on small
entities, the Agency has subsequently
met its obligations under the Regulatory
Flexibility Act. Where a proposed rule
would have significant impacts on small
entities, the Act requires EPA to identify
and consider (hut not necessarily adopt)
alternatives that minimize the impact on
these entities, while accomplishing the '
stated objectives of the applicable
statute.
Elsewhere in this issue of the Federal
Register, EPA is finalizing a rule
establishing an alternate threshold for
low-levels of TRI chemicals in waste
that would otherwise meet the reporting
requirements under EPCRA section 313.
Such facilities can submit an annual
certification statement in lieu of a TRI
Form R. EPA estimates that facilities
will require an average of 34 hours to
comply with the requirements for a
certification statement, compared to 53
hours for a TRI Form R. The alternate
reporting threshold will apply to the
chemicals being added under EPCRA
section 313 by this rule as well as
chemicals currently listed under EPCRA
section 313.
EPA's guidelines for implementing
the Regulatory Flexibility Act state that
"The alternatives considered for the
purpose of fulfilling the Act's
requirements need not be restricted in
applicability to small entities.
Regulatory alternatives that prove to be
more cost-effective for small entities
often will be more cost-effective for
larger entities as well. For example,
alternatives that place lesser burden on
facilities with lower emission levels,
lower production levels, etc., should b»
analyzed in conjunction with fulfilling
the Act's requirements even though x
such alternatives may not ease the
burden on all (or even most) small
entities and may benefit large entities as
well as small ones."
Because EPA has considered, and
adopted, an alternative that places lesser
burden on facilities with lower emission
levels, EPA believes that it has met the
requirements of the Regulatory
Flexibility Act. The alternate threshold
will provide significant relief for small
businesses that will report for the
proposed chemicals, which is the intent
of the Act.
5. Reporting burden. Many
commenters report that the time
required for compliance with EPCRA
section 313 is higher than that estimated
in the RIA. Commenters estimates of the
time required to prepare a TRI Form R
and perform the necessary
recordkeeping vary from 91 to 2,000
hours, compared with EPA's estimate of
53 hours.
The unit time estimates used by EPA
are average values. EPA recognizes that
large multi-divisional, multi-
departmental facilities may require
more than the average time to comply.
As with any average, some facilities will
be above the average and others will be
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Federal Register / Vol. 59, No. 229 / Wednesday t November 30, 1994 / Rules and Regulations 61471
below it. However, there are many other
facilities subject to the rule that are not
large, multi-divisional or multi-
departmental. These facilities will
typically have a simpler compliance
process;
The variability among facilities is ••
evident in comments on the rule
submitted by a large chemical . .
manufacturing company, that provided
estimates showing that it spends an
average of 28 hours for each TRI Form
R that is submitted to compile
information, perform calculations,
prepare the TRI Form R and maintain
records. This includes the.time spent on
compliance determination for chemicals
that are below threshold levels: This is
less than EPA's estimate of 53 hours for
the same activities.
While some of the commenters may
require more time than average to
comply with the rule, other companies
require less time than average. EPA
believes that its time estimates are a
reasonable average for the •
manufacturing sector as a whole.
V. Rulemaking Record
The record supporting this final rule
is contained in the docket number
OPPTS-400082B. All documents,
including an index of the docket, are •
available in the TSCA Nonconfidential
information Center (NQC), also known
as the TSCA Public Document Office,
from noon to 4 p.m., Monday through
Friday, excluding legal holidays. TSCA
NCIC is located at EPA Headquarters,
Rm; N&-B607,401 M St., SW.,
Washington, DC 20460.
VI. References
(1) Colborn, T., F.S. fom Saal A.M.
Soto. Developmental Effects of
Endocrine-Disrupting Chemicals in
Wildlife and Humans. Environmental
Health Perspectives 101:378-384.
(2) DeRosa, Stara and Durkin Ranking
Chemicals Based on Chronic Toxicity
Data, Tox. andlnd. Health, Vol. 1, No.4,
(1985)
(3) NAS/NRC. Risk Assessment in the
Federal Government: Managing the
Process. National Academy Press,
Washington, DC (1983)
(4) USEPA/OHEA. Rj'sJc Assessment
Guidelines for Carcinogen Risk. U.S.
Environmental Protection Agency,
Cincinnati, OH. (1987).
(5) USEPA/OHEA. The Risk
Assessment Guidelines of 1986. U.S.
Environmental Protection Agency,
Washington, DC (1987)
(6). USEPA/OHEA. Guidelines for
Developmental Toxicity Risk
Assessment. U.S. Environmental
Protection Agency, Washington, DC
(1991) [56 FR 63805]
(7) USEPA/OHEA. Draft Report:
Principles 'of Neurotoxicity Risk
Assessment; Notice. U.S. Environmental
Protection Agency, Washington, DC
(1993) (58 FR 41556]
(8) USEPA/OPP. EPTC-RS-DCl.
Evaluation of Two-Year Chronic Rat
Study (Accession Nos. 254335, 254336,
254337,254338, and Addendum to
Final Report (Accession Nos. 258076, .
260057). U. S. Environmental Protection
Agency, Washington, DC (1986)
(9) USEPA/OPP. Support Document
for the Addition of Chemicals from
Federal Insecticide, Fungicide,
Rodenticide Act (FIFRA) Active
Ingredients to EPCRA Section 313. U. S.
Environmental Protection Agency,
Washington, DC (1993).
(1.0) USEPA/OPP. Triallate:
Subchronic Neurotoxicity Study in Rats.
U.S. Environmental Protection Agency,
Washington, DC (1994).
(11) USEPA/OPPT. Revised Draft
Hazard Assessment Guidelines for .
, Listing Chemicals on the ToxfaRelease -
Inventory. U. S. Environmental
Protection Agency, Washington, DC
(1992).
(12) USEPA/OPPT. Support
Document for the Addition of Chemicals
from Section 112(b) of the Clean Air Act
Amendments and Chlorinated Paraffins
to EPCRA section 313. U. S.
Environmental Protection Agency,
Washington, DC (1993).
(13) USEPA/OPPT. Support
Document for the Health and Ecological
Toxicity Review of TRI Expansion
Chemicals. U. S. Environmental
Protection Agency, Washington, DC
(1993).
(14) USEPA/OPPT. Response to
Comments Received on the January 12,
1994 Proposed Rule to Expand the
EPCRA Section 313 List. U. S.
Environmental Protection Agency,
Washington, DC (1994).
VII. Regulatory Assessment
Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR
51735,.October 4,1993) the Agency
must determine whether the regulatory
action is "significant", and therefore
subject to review by tne Office of
Management and Budget (OMB) and the
requirements of the Executive Order.
Under section 3(f), the order defines as
"significant" those regulatory actions
likely to lead to a rule (1) Having an
annual effect on the economy of $100
million or more, or adversely and
materially affecting a sector of the
economy, productivity, competition, .
jobs, the environment, public health or
safety, or State, local or tribal
governments or communities (also
referred to as "economically
significant"); (2) creating serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlements,
grants, user fees, or-loan programs; or (4)
raising novel legal or policy issues N
arising out of legal mandates, the ^
President's priorities, or the principles
set forth in this Executive Order. *
EPA has prepared a Regulatory Impact
Analysis (RIA) in conjunction with this
rulemaking. A copy of this document
(titled "Regulatory Impact Analysis of
the Final Rule to Add Various
Chemicals and Chemical Categories to
the EPCRA Section 313 List of Toxic
Chemicals") is available in the TSCA
NCIC (See Unit V. of this preamble), for
review and copying.
EPA has estimated that the total costs
to industry of adding the new chemicals
to the EPCRA section 313 list is
approximately $99 million in the first
year and $49 million each year
thereafter. Costs to EPA are
approximately $1 million per year.
TABLE 2.-SUMMARY OF COST COMPARISON BETWEEN PROPOSED AND FINAL RULE
Number of chemicals and chemical
categories
Number of new facilities '
Total number of facilities
Number of TRI Form Rs submitted
Number of annual certifications submit-
ted. . .
First, year industry costs
Proposed Rule
313
2,404
7,049
28,196
0
S160.4 milBon
. Final Rule
286'
1,225
3,509
14,036
,0 .
* -
.899 million
Final Rule with Alternate
Threshold
286 -
1,225
$509
10,548
3,488
$92.8 million
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61472 Federal Register /Vol. 59, No. 229 / Wednesday, November 30,: 1994 /Rules and Regulations
TABLE 2.-SUMMARY OF COST COMPARISON BETWEEN PROPOSED AND FINAL RULE—Continued
t
Subsequent year industry costs
EPA Costs
Proposed Rule
.$88.5 million
$2.1 million
Final Rule
$48.8 million
$1.1 million
Final Rule with Alternate <
Threshold
$44.3 million
$0.9 million .
Source-RIA. The results for the alternate
threshold are based on a 500 pound level of
total waste.
'This Includes 39 chemicals as part of two
delineated categories.
The costs for the final rule are
different from the costs for the proposed
rule, as shown in Table 2. There are two
reasons for this change. First, the
number of chemicals and chemical
categories added has decreased from
313 to 286, which reduced the number
of reports that would be submitted.
Second, the number of reports estimated
for one chemical, water dissociable
nitrate compounds (reportable only
when in aqueous solution), was
increased from 2,146 to 3,066 to account
for facilities that create water
dissociable nitrate compounds in
aqueous solution through on-site
biological treatment of wastewater.
Elsewhere in this issue of the Federal
Register, EPA is finalizing a rule
establishing an alternate threshold for
facilities with low amounts of a listed
toxic chemical in waste (see Unit II. of
this preamble). Qualifying facilities
would be eligible to submit an annual
certification statement instead of a TRI
Form R. Because the time required for
the alternate threshold is less than the
time required for a TRI Form R, the cost
of compliance with this rule will be
lowered as a result. The effect of the
alternate threshold on the chemicals
being added by this rule is
demonstrated in Table 2. Further
information on the effect of the alternate
threshold is presented elsewhere in this
issue of the Federal Register.
The costs described in Table 1
represent only those actions that are
required by this rule. There are other
requirements that are linked to reporting
under EPCRA section 313, but which
are not required by this ruje. There are
13 states that place a fee or tax on
facilities that file a TRI Form R or report
to EPA under EPCRA section 313, and
7 states that mandate pollution
prevention plans from such facilities.
EPA has also created special . ••
requirements for certain facilities with
NPDES storm water permits that report
under EPCRA section 313.
Adding chemicals and chemical
categories to the EPCRA section 3X3 list
may cause some facilities to incur
additional costs through these linked
requirements. These costs have not been
monetized, but they should not be
significant. The linked fees and taxes
are transfers, and not social costs, and
many of the reporting facilities will not
be located in the 13 states with fees and
taxes. Also, the NPDES and pollution
prevention planning requirements are
most likely to create costs for facilities
that are new reporters.-There will be
approximately 1,225 new reporters.as a
result of this rule, although not all of
these will be subject to the NPDES
requirements, or be located in states
with pollution prevention planning
requirements. The linkage to the NPDES
requirements is limited to about two
dozen of the new chemicals, not all 286
chemicals and chemical categories being
added.
The market failure that this rule is
intended to correct is the externality
created by the lack of information
available to citizens about the releases
and transfers of toxic chemicals in their
communities. Taking no action would
allow this externality (and the resultant
social costs) to continue. It is expected
that this rulemaking will generate
benefits by providing citizens with
access to information that otherwise
would not be available to them. The
benefits of the rule itself are limited to
improvements in understanding,
awareness and decision-making related
to the provision and distribution of
information.
EPA b^Keves that the rulemaking can
reasonably be anticipated to indirectly
yield health and environmental benefits
by leading to reductions in the releases
and transfers of toxic chemicals. These
changes in behavior come at some cost
to industry. The net benefits of the
follow-on activities are the difference
between the benefits of decreased
chemical releases and transfers, and the
costs of the actions needed to achieve
them. As noted above, EPA has not
quantified the benefits of this rule or the
follow-on activities.
This action was submitted to OMB for
review, as required by Executive Order
12866, and any comments or changes
made in response to OMB suggestions or
recommendations have been
documented in the public record.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980
requires each Federal agency to perform
a Regulatory Flexibility Analysis for all
rules that are likely to have a
"significant impact on a substantial
number of small entities." EPA
investigated the potential impact of the
proposed rule-on small businesses, and
has prepared a Final Regulatory
Flexibility Analysis (FRFA). This
assessment has been included as part of
the RIA and.is summarized below.
In assessing small business impacts,
EPA calculated the costs incurred by
two hypothetical facilities that are
supplier notification facilities reporting
to the TRI for the first time. Facilities
were assumed to file only Form Rs,
instead of any annual certification
statements. Thus, the results are based
on conservative assumptions. The first
facility files a report for a single new
chemical, while the other files reports
for four new chemicals. For each
hypothetical facility, annual regulatory
costs were calculated and compared to
average annual sales.
The cost impact ratios were calculated
based on the average annual sales of x
those facilities currently reporting under
EPCRA section 313 for which annual
sales and employee figures could be
obtained from Dun Bradstreet. The Dun
Bradstreet data base was used instead of
Census data on the assumption that
facilities that report under EPCRA
section 313 are not uniformly
distributed throughout the entire
population of facilities in each size
category. EPA believes that it is
reasonable to assume that facilities
reporting under EPCRA section 313
have, on average, larger annual sales
than the typical facility in an industry.
Therefore, the annual sales of current
reporters should be a more appropriate
measure than the sales of all facilities in
anindustry.
A small business was defined as.
having fewer than 50 employees.
Although a more detailed break-down of
size categories would have allowed for
a closer examination of the potential
impact on even smaller facilities, the
total number'of observations in the
matched data base was too small to
, allow for additional categories.
„"•". EPA often uses a cost impact
percentage of one percent as a threshold
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Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 /Rules and Regulations 61473
measure feelow iwhiclrfacilitiesare.not •-„•
considered to be significantly .impacted
as a result of a regulation. Under the
scenario in which-facilities are assumed
to submit one TRI Form R, the cost
impact percentages are well below one
percent for all employee size classes in
all.SICs. The highest cost impact
percentageas 0.4 percent for small
facilities in Standard Industrial
Classification (SIC) codes 25 (Furniture)
and 31 (Leather) in the first year of
reporting.
. Under the scenario in which facilities
are assumed to submit four TRI Form
Rs, cost impact percentages in the first
year of reporting are above one percent
only forsmall facilities in SIC codes 25
(1.2 percent) and 31 (1.1 percent). Cost
impact percentages are below 0.8
percent for all industries in subsequent
years.
The higher impact rates for the
hypothetical facilities occur in industry
sectors where there have historically
been a relatively smaH number of
establishments reporting.
Approximately 8 percent of all facilities
in SIC code 25 (Furniture) and 10
percent of all facilities in SIC code 31
(Leather) currently report to EPCRA
section.313 (compared to 57 percent of
all facilities in the chemical industry). It
is reasonable that large and medium
businesses are more highly represented
in these percentages than small
businesses, because they would be more
likely to.exceed the EPCRA section 313
thresholds. In addition, facilities in SIC
25 and 31 have typically submitted
fewer than four reports each, and would
be less likely to submit four reports for
the new chemicals than facilities in
other industries.
Thus, cost impacts for facilities
potentially affected by the rule were not
found to-be of sufficient magnitude to
cause significant impacts. Although
EPA has foj.ind that the rule does not
result in significant impacts on small
facilities, EPA has separately developed
alternatives to meet the goals of the
Regulatory Flexibility Act (i.e., to
accomplish the objectives of EPCRA
section 313 while minimizing the
economic impact on small entities). EPA
proposed a rule establishing an
alternative reporting threshold for low-
level releases and transfers (July 28,
1994, 59 FR 38524). The proposal
requested comment on five different
levels for the alternate reporting
threshold. This rule is .being finalized
elsewhere in today's issue of the
Federal Register.
C. Paperwork Reduction Act
The collection of information and
other requirements under section 313 of
EPCRA and section 6607 of the PP A are
covered under OMB approval number
2070-0093, which was issued on May
14,1992. While this approval normally
would have expired on November 30,
1992, it remains in effect pursuant to the
1993 Department of Veteran Affairs and
Housing and Urban Development and
Independent Agencies Appropriations
Act, Pub. L. 102-389, signed October 6,
1992, which states that:
'Notwithstanding the Paperwork Reduction
Act of 1980 or any requirements thereunder
the Environmental Protection Agency Toxic
Chemical Release Inventory TRI Form R and
instructions, revised 1991 version issued
May 19,1992, and related requirements
(OMB No. 2070-0093), shall be effective for
reporting under section 6607 of the'Pollution
Prevention Act of 1990 (Public Law 101-508)
and section 313 of the Superfund
Amendments and Reauthorization Act of
1986 (Public Law 99-499) until such time as
revisions are promulgated pursuant to law.
This final rule adds chemicals to the
list of toxic chemicals subject to "
reporting under section 313 of EPCRA
and section 6607 of the PPA and does
not change the elements of. the TRI
reporting form, its instructions, or
related requirements. Accordingly, the
TRI Form R and instructions and related
requirements remain in effect, as
provided by Pub. L. 102-389,
The industry reporting burden for
collecting this information is estimated
to average 53 hours per respondent
annually, including time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing the collection of information.
The actual burden to a specific facility
may deviate from this estimate
depending on the complexity of the
facility's operations and the profile of
the release.
List of Subjects in 40 CFR Part 372 -
Environmental protection,
Community right-to-know, Reporting
and recordkeeping requirements, Toxic
chemicals.
Dated: November 22,1994.
Carol M. Browner,
Administrator.
Therefore, 40 CFR part 372 is
amended to read as follows:
Part 372—[AMENDED]
1. The authority citation for part 372
continues to read as follows:
Authority: 42 U.S.C. 11013 and 11028.
2. In § 372.65 by adding chemicals to
paragraph (a) alphabetically, to
paragraph (b) by CAS no. sequence, and
to paragraph (c) by alphabetically
adding six categories to read as follows:
§ 372.65 Chemicals and chemical
categories to which the part applies.
(a)
*
Chemical Name
Abamectin [Avermectin B1]
Acephate (Acetylphosphoramidothioic acid O,S-dimethyl ester)
*
******
Acifluorfen, sodium salt [5-{2-Chloro-4-(triflouromethy!)phenoxy)-2-nitro-benzoic acid, sodium salt] .
Alachlor
Aldicarb
*
.
**"**«*
#*•**,
d-trans-Allethrin (d-trans-Chrysanjhemic acid of d-allethrone]
•Allylamine
*
*»»•**
Aluminum phosphide
Ametryn (NrEthyl-N'-(1-melriytethyl)-6-(methylthio)-l ,3,5,-triazine-2,4-diamlne)
Amttraz
»
***»*•
CAS No.
71751-41-2
30560-19-1
62476-59-9
15972-60-8
116-06-3
28057-48-9
107-11-9
20859-73-8
834-12-8
33089-61-1
Eflective
Date
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
1/1/95
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