# Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Final Rule

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A94-29376

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** November 30, 1994

## Text

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[OPPTS-400082B; FRL-4922-2]
RIN 2070-AC47

Addition of Certain Chemicals; Toxic Chemical Release Reporting;
Community Right-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 et
seq.. 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--and 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 left to the EPA's 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 Ingredients,
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 those 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.
a. Toxicity screen. A toxicity screen is a limited review of
readily available toxicity data that 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
addition 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 there was sufficient evidence to
establish that the 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 adverse
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 313 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 determination on 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 expansion of the TRI program. EPA plans to issue a
proposed rule in 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.

III. 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 in
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
----------------------------------------------------------------------------------------------------------------
Section Section Section
Chemical Name CAS No. 313(d)(2)(A) 313(d)(2)(B) 313(d)(2)(C)
----------------------------------------------------------------------------------------------------------------
Abamectin (Avermectin B1) 071751-41-2 X X
Acephate (Acetylphosphoramidothioic 030560-19-1 X
acid O,S-dimethyl ester)
Acifluorfen sodium salt (5-(2-Chloro-4- 062476-59-9 X
(triflouromethyl)phenoxy)-2-nitro-
benzoic acid, sodium salt)
Alachlor 015972-60-8 X
Aldicarb 000116-06-3 X
d-trans-Allethrin [d-trans- 028057-48-9 X
Chrysanthemic acid of d-allethrone]
Allylamine 000107-11-9 X
Aluminum phosphide 020859-73-8 X
Ametryn (N-Ethyl-N'-(1-methylethyl)-6- 000834-12-8 X X
(methylthio)-1,3,5,-triazine- 2,4
diamine)
Amitraz 033089-61-1 X
Anilazine (4,6-Dichloro-N-(2- 000101-05-3 X X
chlorophenyl)-1,3,5-triazin-2-amine)
Atrazine (6-Chloro-N-ethyl-N'-(1- 001912-24-9 X
methylethyl)-1,3,5,-triazine-2,4-
diamine)
Bendiocarb (2,2-Dimethyl-1,3- 022781-23-3 X X
benzodioxol-4-ol methylcarbamate)
Benfluralin (N-Butyl-N-ethyl-2,6- 001861-40-1 X
dinitro-4-(trifluoromethyl)
benzenamine)
Benomyl 017804-35-2 X
Bifenthrin 082657-04-3 X X
Bis(tributyltin) oxide 000056-35-9 X X
Boron trichloride 010294-34-5 X
Boron trifluoride 007637-07-2 X
Bromacil (5-Bromo-6-methyl-3-(1- 000314-40-9 X
methylpropyl)-2,4(1H,3H)-
pyrimidinedione)
Bromacil lithium salt (2,4(1H,3H)- 053404-19-6 X
Pyrimidinedione, 5-bromo-6-methyl-3 (1-
methylpropyl), lithium salt)
Bromine 007726-95-6 X
1-Bromo-1-(bromomethyl)-1,3- 035691-65-7 X
propanedicarbonitrile
2-Bromo-2-nitropropane-1,3-diol 000052-51-7 X
(Bronopol)
Bromoxynil (3,5-Dibromo-4- 001689-84-5 X
hydroxybenzonitrile)
Bromoxynil octanoate (Octanoic acid, 001689-99-2 X
2,6-dibromo-4-cyanophenyl ester)
Brucine 000357-57-3 X
C.I. Acid Red 114 006459-94-5 X
C.I. Direct Blue 218 028407-37-6 X
Carbofuran 001563-66-2 X
Carboxin (5,6-Dihydro-2-methyl-N-phenyl- 005234-68-4 X
1,4-oxathiin-3-carboxamide)
Chinomethionat (6-Methyl-1,3- 002439-01-2 X
dithiolo[4,5-b]quinoxalin-2-one)
Chlorendic acid 000115-28-6 X
Chlorimuron ethyl (Ethyl-2-[[[(4-chloro- 090982-32-4 X
6-methoxyprimidin-2-yl)-carbonyl]-
amino]sulfonyl]benzoate)
1-(3-Chloroallyl)-3,5,7-triaza-1- 004080-31-3 X
azoniaadamantane chloride
p-Chloroaniline 000106-47-8 X
3-Chloro-2-methyl-1-propene 000563-47-3 X
p-Chlorophenyl isocyanate 000104-12-1 X
Chloropicrin 000076-06-2 X
3-Chloropropionitrile 000542-76-7 X
p-Chloro-o-toluidine 000095-69-2 X
2-Chloro-1,1,1-trifluoroethane (HCFC- 000075-88-7 X X
133a)
Chlorotrifluoromethane (CFC-13) 000075-72-9 X X
3-Chloro-1,1,1-trifluoropropane(HCFC- 000460-35-5 X X
253fb)
Chlorpyrifos methyl (O,O-Dimethyl-O- 005598-13-0 X X
(3,5,6-trichloro-2-
pyridyl)phosphorothioate)
Chlorsulfuron (2-Chloro-N-[[(4-methoxy- 064902-72-3 X
6-methyl-1,3,5-triazin-2-yl)
amino]carbonyl]benzenesulfonamide)
Crotonaldehyde 004170-30-3 X
Cyanazine 021725-46-2 X
Cycloate 001134-23-2 X
Cyclohexanol 000108-93-0 X
Cyfluthrin (3-(2,2-Dichloroethenyl)-2,2- 068359-37-5 X X
dimethylcyclopropanecarboxylic acid,
cyano(4-fluoro-3-
phenoxyphenyl)methylester)
Cyhalothrin (3-(2-Chloro-3,3,3- 068085-85-8 X
trifluoro-1-propenyl)-2,2-
Dimethylcyclopropanecarboxylic acid
cyano(3-phenoxyphenyl)methyl ester)
Dazomet (Tetrahydro-3,5-dimethyl-2H- 000533-74-4 X
1,3,5-thiadiazine-2-thione)
Dazomet sodium salt (2H-1,3,5- 053404-60-7 X
Thiadiazine-2-thione, tetrahydro-3,5-
dimethyl-, ion(1-), sodium)
2,4-DB 000094-82-6 X
2,4-D butoxyethyl ester 001929-73-3 X
2,4-D butyl ester 000094-80-4 X
2,4-D chlorocrotyl ester 002971-38-2 X
Desmedipham 013684-56-5 X
2,4-D 2-ethylhexyl ester 001928-43-4 X
2,4-D 2-ethyl-4-methylpentyl ester 053404-37-8 X
Diazinon 000333-41-5 X X
2,2-Dibromo-3-nitrilopropionamide 010222-01-2 X
Dicamba (3,6-Dichloro-2-methyoxybenzoic 001918-00-9 X
acid)
Dichloran (2,6-Dichloro-4-nitroaniline) 000099-30-9 X
3,3'-Dichlorobenzidine dihydrochloride 000612-83-9 X
3,3'-Dichlorobenzidine sulfate 064969-34-2 X
trans-1,4-Dichloro-2-butene 000110-57-6 X
1,2-Dichloro-1,1-difluoroethane (HCFC- 001649-08-7 X X
132b)
Dichlorofluoromethane (HCFC-21) 000075-43-4 X X
Dichloropentafluoropropane 127564-92-5 X X
1,3-Dichloro-1,1,2,3,3- 136013-79-1 X X
pentafluoropropane (HCFC-225ea)
2,2-Dichloro-1,1,1,3,3- 128903-21-9 X X
pentafluoropropane (HCFC-225aa)
1,1-Dichloro-1,2,3,3,3- 111512-56-2 X X
pentafluoropropane (HCFC-225eb)
1,1-Dichloro-1,2,2,3,3- 013474-88-9 X X
pentafluoropropane (HCFC-225cc)
1,3-Dichloro-1,1,2,2,3- 000507-55-1 X X
pentafluoropropane (HCFC-225cb)
1,2-Dichloro-1,1,3,3,3- 000431-86-7 X X
pentafluoropropane (HCFC-225da)
3,3-Dichloro-1,1,1,2,2- 000422-56-0 X X
pentafluoropropane (HCFC-225ca)
2,3-Dichloro-1,1,1,2,3- 000422-48-0 X X
pentafluoropropane (HCFC-225ba)
1,2-Dichloro-1,1,2,3,3- 000422-44-6 X X
pentafluoropropane (HCFC-225bb)
Dichlorophene (2,2'-Methylenebis(4- 000097-23-4 X X
chlorophenol)
trans-1,3-Dichloropropene 010061-02-6 X
Diclofop methyl (2-[4-(2,4- 051338-27-3 X
Dichlorophenoxy)
phenoxy]propanoicacid, methyl ester)
Dicyclopentadiene 000077-73-6 X
Diethatyl ethyl 038727-55-8 X
Diflubenzuron 035367-38-5 X X
Diglycidyl resorcinol ether 000101-90-6 X
Diisocyanates, consisting of: NA X
1,3-Bis(methylisocyanate) cyclohexane 038661-72-2
1,4-Bis(methylisocyanate) cyclohexane 010347-54-3
1,4-Cyclohexane diisocyanate 002556-36-7
Diethyldiisocyanatobenzene 134190-37-7
4,4'-Diisocyanatodiphenyl ether 004128-73-8
2,4'-Diisocyanatodiphenyl sulfide 075790-87-3
3,3'-Dimethoxybenzidine-4,4'- 000091-93-0
diisocyanate
3,3'-Dimethyl-4,4'-diphenylene 000091-97-4
diisocyanate
3,3'-Dimethyl diphenylmethane-4,4'- 000139-25-3
diisocyanate
Hexamethylene-1,6-diisocyanate 000822-06-0
Isophorone diisocyanate 004098-71-0
Methylenebis(phenyl isocyanate) 000101-68-8
4-Methyldiphenylmethane-3,4- 075790-84-0
diisocyanate
1,1-Methylene bis(4- 005124-30-1
isocyanatocyclohexane)
1,5-Naphthalene diisocyanate 003173-72-6
1,3-Phenylene diisocyanate 000123-61-5
1,4-Phenylene diisocyanate 000104-49-4
Polymeric diphenylmethane 009016-87-9
diisocyanate
2,2,4-Trimethylhexamethylene 016938-22-0
diisocyanate
2,4,4-Trimethylhexamethylene
diisocyanate 015646-96-5
Dimethipin (2,3,-Dihydro-5,6-dimethyl- 055290-64-7 X
1,4-dithiin 1,1,4,4-tetraoxide)
Dimethoate 000060-51-5 X
3,3'-Dimethoxybenzidine dihydrochloride 020325-40-0 X
(o-Dianisidine dihydrochloride)
3,3'-Dimethoxybenzidine hydrochloride 111984-09-9 X
(o-Dianisidine hydrochloride)
Dimethylamine 000124-40-3 X
Dimethylamine dicamba 002300-66-5 X
3,3'-Dimethylbenzidine dihydrochloride 000612-82-8 X
(o-Tolidine dihydrochloride)
3,3'-Dimethylbenzidine dihydrofluoride 041766-75-0 X
(o-Tolidine dihydrofluoride)
Dimethyl chlorothiophosphate 002524-03-0 X
Dimethyldichlorosilane 000075-78-5 X
N,N-Dimethylformamide 000068-12-2 X
2,6-Dimethylphenol 000576-26-1 X
Dinitrobutyl phenol (Dinoseb) 000088-85-7 X X
Dinocap 039300-45-3 X X
Diphenamid 000957-51-7 X
Diphenylamine 000122-39-4 X
Dipotassium endothall (7- 002164-07-0 X
Oxabicyclo(2.2.1)heptane-2,3-
dicarboxylic acid, dipotassium salt)
Dipropyl isocinchomeronate 000136-45-8 X
Disodium cyanodithioimidocarbonate 000138-93-2 X
2,4-D isopropyl ester 000094-11-1 X
2,4-Dithiobiuret 000541-53-7 X
Diuron 000330-54-1 X X
Dodine (Dodecylguanidine monoacetate) 002439-10-3 X
2,4-DP (Dichlorprop) 000120-36-5 X
2,4-D propylene glycol butyl ether 001320-18-9 X
ester
2,4-D sodium salt 002702-72-9 X
Ethoprop (Phosphorodithioic acid O- 013194-48-4 X X
ethyl S,S-dipropyl ester)
Ethyl dipropylthiocarbamate (EPTC) 000759-94-4 X X
Famphur 000052-85-7 X X
Fenarimol (.alpha.-(2-Chlorophenyl)- 060168-88-9 X
.alpha.-4-chlorophenyl)-5-
pyrimidinemethanol)
Fenbutatin oxide (hexakis(2-methyl-2- 013356-08-6 X X
phenylpropyl)distannoxane)
Fenoxaprop ethyl (2-(4-((6-Chloro-2- 066441-23-4 X X
benzoxazolylen)oxy)phenoxy)propanoic
acid,ethyl ester)
Fenoxycarb (2-(4- 072490-01-8 X
Phenoxyphenoxy)ethyl]carbamic acid
ethyl ester)
Fenpropathrin (2,2,3,3- 039515-41-8 X X
Tetramethylcyclopropane carboxylic
acid cyano(3-phenoxyphenyl)methyl
ester)
Fenthion (O,O-Dimethyl O-[3-methyl-4- 000055-38-9 X X
(methylthio) phenyl] ester,
phosphorothioic acid)
Fenvalerate (4-Chloro-alpha-(1- 051630-58-1 X X
methylethyl)benzeneacetic acid cyano(3-
phenoxyphenyl)methyl ester)
Ferbam (Tris(dimethylcarbamodithioato- 014484-64-1 X X
S,S')iron)
Fluazifop butyl (2-[4-[[5- 069806-50-4 X
(Trifluoromethyl)-2-pyridinyl]oxy]-
phenoxy]propanoic acid, butyl ester)
Fluorine 007782-41-4 X
Fluorouracil (5-Fluorouracil) 000051-21-8 X
Fluvalinate (N-[2-Chloro-4- 069409-94-5 X X
(trifluoromethyl)phenyl]-DL-valine(+)-
cyano (3-phenoxyphenyl)methyl ester)
Folpet 000133-07-3 X X
Fomesafen (5-(2-Chloro-4- 072178-02-0 X
(trifluoromethyl)phenoxy)-N
methylsulfonyl)-2-nitrobenzamide)
alpha-Hexachlorocyclohexane 000319-84-6 X X
n-Hexane 000110-54-3 X
Hexazinone 051235-04-2 X X
Hydramethylnon (Tetrahydro-5,5-di- 067485-29-4 X X
methyl-2(1H)- pyrimidinone[3-[4-
(trifluoromethyl)phenyl]-1-[2-[4-
(trifluoromethyl) phenyl]ethenyl]-
2propenylidene]hydrazone)
Imazalil (1-[2-(2,4-Dichlorophenyl)-2- 035554-44-0 X
(2-propenyloxy)ethyl]-1H-imidazole)
3-Iodo-2-propynyl butylcarbamate 055406-53-6 X
Iron pentacarbonyl 013463-40-6 X
Isodrin 000465-73-6 X
Isofenphos (2-[[Ethoxyl[(1- 025311-71-1 X X
methylethyl)amino]phosphinothioyl]oxy]
benzoic acid 1-methylethyl ester)
Lactofen (5-(2-Chloro-4- 077501-63-4 X
(trifluoromethyl)phenoxy)-2-nitro-2-
ethoxy-1-methyl-2-oxoethyl ester)
Linuron 000330-55-2 X
Lithium carbonate 000554-13-2 X
Malathion 000121-75-5 X X
Mecoprop 000093-65-2 X
2-Mercaptobenzothiazole (MBT) 000149-30-4 X
Merphos 000150-50-5 X
Metham sodium (Sodium 000137-42-8 X
methyldithiocarbamate)
Methazole (2-(3,4-Dichlorophenyl)-4- 020354-26-1 X
methyl-1,2,4-oxadiazolidine-3,5-dione)
Methiocarb 002032-65-7 X
Methoxone ((4-Chloro-2-methylphenoxy) 000094-74-6 X
acetic acid) (MCPA)
Methoxone sodium salt ((4-Chloro-2- 003653-48-3 X
methylphenoxy) acetate sodium salt)
Methyl isothiocyanate 00556-61-6 X
2-Methyllactonitrile 000075-86-5 X
N-Methylolacrylamide 000924-42-5 X
Methyl parathion 000298-00-0 X X
N-Methyl-2-pyrrolidone 000872-50-4 X
Methyltrichlorosilane 000075-79-6 X
Metiram 009006-42-2 X
Metribuzin 021087-64-5 X
Mevinphos 007786-34-7 X
Molinate (1H-Azepine-1 carbothioic 002212-67-1 X
acid, hexahydro-S-ethyl ester)
Monuron 000150-68-5 X
Myclobutanil (.alpha.-Butyl-.alpha.-(4- 088671-89-0 X
chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile)
Nabam 000142-59-6 X
Naled 000300-76-5 X X
Nicotine and salts NA X
Nitrapyrin (2-Chloro-6- 001929-82-4 X
(trichloromethyl)pyridine)
Nitrate compounds (water dissociable) NA X
p-Nitroaniline 000100-01-6 X
Norflurazon (4-Chloro-5-(methylamino)-2- 027314-13-2 X
[3-(trifluoromethyl)phenyl]-3(2H)-
pyridazinone)
Oryzalin (4-(Dipropylamino)-3,5- 019044-88-3 X
dinitrobenzenesulfonamide)
Oxydemeton methyl (S-(2- 000301-12-2 X
(Ethylsulfinyl)ethyl) O,O-dimethyl
ester phosphorothioic acid)
Oxydiazon (3-[2,4-Dichloro-5-(1- 019666-30-9 X
methylethoxy)phenyl]-5-(1,1-
dimethylethyl)-1,3,4-oxadiazol-2(3H)-
one)
Oxyfluorfen 042874-03-3 X X
Ozone 010028-15-6 X X
Paraquat dichloride 001910-42-5 X
Pebulate (Butylethylcarbamothioic acid 001114-71-2 X
S-propyl ester)
Pendimethalin (N-(1-Ethylpropyl)-3,4- 040487-42-1 X
dimethyl-2,6-dinitrobenzenamine)
Pentobarbital sodium 000057-33-0 X
Perchloromethyl mercaptan 000594-42-3 X
Permethrin (3-(2,2-Dichloroethenyl)-2,2- 052645-53-1 X X
dimethylcyclopropanecarboxylic acid,
(3-phenoxyphenyl)methyl ester)
Phenanthrene 000085-01-8 X
Phenothrin (2,2-Dimethyl-3-(2-methyl-1- 026002-80-2 X X
propenyl) cyclopropanecarboxylic acid
(3-phenoxyphenyl)methyl ester)
1,2-Phenylenediamine 000095-54-5 X
1,3-Phenylenediamine 000108-45-2 X
1,2-Phenylenediamine dihydrochloride 000615-28-1 X
1,4-Phenylenediamine dihydrochloride 000624-18-0 X
Phenytoin 000057-41-0 X
Phosphine 007803-51-2 X
Picloram 001918-02-1 X
Piperonyl butoxide 000051-03-6 X
Pirimiphos methyl (O-(2-(Diethylamino)- 029232-93-7 X
6-methyl-4- pyrimidinyl)-O,O-dimethyl
phosphorothioate)
Polychlorinated alkanes NA X X
Polycyclic aromatic compounds (PACs) NA X
consisting of:
Benz(a)anthracene 000056-55-3
Benzo(a)phenanthrene 000218-01-9
Benzo(a)pyrene 000050-32-8
Benzo(b)fluoranthene 000205-99-2
Benzo(j)fluoranthene 000205-82-3
Benzo(k)fluoranthene 000207-08-9
Benzo(rst)pentaphene 000189-55-9
Dibenz(a,h)acridine 000226-36-8
Dibenz(a,j)acridine 000224-42-0
Dibenzo(a,h)anthracene 000053-70-3
Dibenzo(a,e)fluoranthene 005385-75-1
Dibenzo(a,e)pyrene 000192-65-4
Dibenzo(a,h)pyrene 000189-64-0
Dibenzo(a,l)pyrene 000191-30-0
7H-Dibenzo(c,g)carbazole 00194-59-2
7,12-Dimethyl benz(a)anthracene 000057-97-6
Indeno[1,2,3-cd]pyrene 000193-39-5
5-Methylchrysene 003697-24-3
1-Nitropyrene 005522-43-0
Potassium bromate 007758-01-2 X
Potassium dimethyldithiocarbamate 000128-03-0 X
Potassium N-methyldithiocarbamate 000137-41-7 X
Profenofos (O-(4-Bromo-2-chlorophenyl)- 041198-08-7 X
O-ethyl-S-propyl phosphorothioate)
Prometryn (N,N'-Bis(1-methylethyl)-6- 007287-19-6 X
methylthio-1,3,5-triazine-2,4-diamine)
Propachlor (2-Chloro-N-(1-methylethyl)- 001918-16-7 X
N-phenylacetamide)
Propanil (N-(3,4- 000709-98-8 X
Dichlorophenyl)propanamide)
Propargite 002312-35-8 X X
Propargyl alcohol 000107-19-7 X
Propetamphos (3- 031218-83-4 X
[(Ethylamino)methoxyphosphinothioyl]ox
y]-2-butenoic acid, 1-methylethyl
ester)
Propiconazole (1-[2-(2,4- 060207-90-1 X
Dichlorophenyl)-4-propyl-1,3-dioxolan-
2-yl]-methyl-1H-1,2,4,-triazole)
Quizalofop-ethyl (2-[4-[(6-Chloro-2- 076578-14-8 X
quinoxalinyl)oxy]phenoxy] propanoic
acid ethyl ester)
Resmethrin ([5-(Phenylmethyl)-3- 010453-86-8 X X
furanyl]methyl 2,2-dimethyl-3-(2-
methyl-1-
propenyl)cyclopropanecarboxylate])
Sethoxydim (2-[1-(Ethoxyimino)butyl]-5- 074051-80-2 X
[2-(ethylthio)propyl]-3-hydroxyl-2-
cyclohexen-1-one)
Simazine 000122-34-9 X
Sodium azide 026628-22-8 X
Sodium dicamba (3,6-Dichloro-2- 001982-69-0 X
methoxybenzoic acid, sodium salt)
Sodium dimethyldithiocarbamate 000128-04-1 X
Sodium fluoroacetate 000062-74-8 X X
Sodium nitrite 007632-00-0 X
Sodium pentachlorophenate 000131-52-2 X X
Sodium o-phenylphenoxide 000132-27-4 X
Strychnine and salts NA X
Sulfuryl fluoride (Vikane) 002699-79-8 X
Sulprofos (O-Ethyl O-[4- 035400-43-2 X X
(methylthio)phenyl]phosphorodithioic
acid S propyl ester)
Tebuthiuron (N-[5-(1,1-Dimethylethyl)- 034014-18-1 X
1,3,4-thiadiazol-2-yl)- N,N'-
dimethylurea)
Temephos 003383-96-8 X
Terbacil (5-Chloro-3-(1,1- 005902-51-2 X
dimethylethyl)-6-methyl- 2,4 (1H,3H)-
pyrimidinedione)
1,1,1,2-Tetrachloro-2-fluoroethane 000354-11-0 X X
(HCFC-121a)
1,1,2,2-Tetrachloro-1-fluoroethane 000354-14-3 X X
(HCFC-121)
Tetracycline hydrochloride 000064-75-5 X
Tetramethrin (2,2-Dimethyl-3-(2-methyl- 007696-12-0 X X
1-propenyl) cyclopropanecarboxylic
acid (1,3,4,5,6,7-hexahydro-1,3-dioxo-
2H-isoindol-2-yl)methyl ester)
Thiabendazole (2-(4-Thiazolyl)-1H- 000148-79-8 X X
benzimidazole)
Thiobencarb (Carbamic acid, diethylthio- 028249-77-6 X
, S-(p-chlorobenzyl))
Thiodicarb 059669-26-0 X X
Thiophanate ethyl ([1,2- 023564-06-9 X
Phenylenebis(iminocarbonothioyl)]
biscarbamic acid diethyl ester)
Thiophanate-methyl 023564-05-8 X
Thiosemicarbazide 000079-19-6 X
Triadimefon (1-(4-Chlorophenoxy)-3,3- 043121-43-3 X
dimethyl-1-(1H-1,2,4-triazol-1-yl)-2-
butanone)
Triallate 002303-17-5 X
Tribenuron methyl (2-(4-Methoxy-6- 101200-48-0 X
methyl-1,3,5-triazin-2-yl)-
methylamino)carbonyl)amino)sulfonyl)-,
methyl ester)
Tributyltin fluoride 001983-10-4 X
Tributyltin methacrylate 002155-70-6 X
S,S,S-Tributyltrithiophosphate (DEF) 000078-48-8 X X
Trichloroacetyl chloride 000076-02-8 X
1,2,3-Trichloropropane 000096-18-4 X
Triclopyr triethylammonium salt 057213-69-1 X
Triethylamine 000121-44-8 X
Triforine (N,N'-[1,4-Piperazinediylbis- 026644-46-2 X
2,2,2-trichloroethylidene)]
bisformamide)
Trimethylchlorosilane 000075-77-4 X
2,3,5-Trimethylphenyl methylcarbamate 002655-15-4 X
Triphenyltin chloride 000639-58-7 X X
Triphenyltin hydroxide 000076-87-9 X X
Vinclozolin (3-(3,5-Dichlorophenyl)-5- 050471-44-8 X
ethenyl-5-methyl-2,4-oxazolidinedione)
----------------------------------------------------------------------------------------------------------------

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
phosphorus pentachloride
phosphorus pentasulfide
phosphorus pentoxide
primsulfuron
sodium chlorite
sodium hypochlorite
sodium 2-pyridinethiol-1-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. Summary 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 and 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).
In 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 not equivalent to
lowest-observed-adverse-effect levels (LOAELs). MEDs are 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 DeRosa, 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
FR 13456; 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 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 chemical 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 to fully implement the right-
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 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 ecotoxic, 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 EPCRA 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 (11th Cir. 1992)), EPA does not
have the authority to list chemical categories or specific groups of
chemicals.
EPA believes that the statutory authority to add ``a chemical'' to
the list 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 has 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 commenter 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 part 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 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 rather 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 list 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
to 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 considers it
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 not
support the addition of chemicals regulated under FIFRA to the EPCRA
section 313 list of 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 TRI 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 effects at maternal toxicity are ``. .
.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,
isotretinoin).
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 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 toxicological 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-related and, depending on the effects produced, the degree of
toxicity. Because virtually any chemical substance can elicit a
toxicological 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, it is the relative severity of the effect,
the presence of a dose/response relationship, and whether the 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 Products Company, Monsanto, 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
chlorofluorocarbons 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, 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 with 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 313(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
finding of chronic toxicity. The commenters 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-1,3-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-1,3-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 (EEG) 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 to comments for these
chemicals is provided in Unit IV.F. of this preamble.
7. Use of cholinesterase 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 or TSCA. 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 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 are provided in
the Response to Comment Document (Ref. 14).
In 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 neurotoxicity. 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-1 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 TRI 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/kg/day, which does not exceed
the MTD. Therefore, EPA believes that the 2-year chronic 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
alachlor. 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 by 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)(2)(B) 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
hepatotoxicity 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 re-evaluated this study,
and 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 F1 and F2
generations. Thus, there was direct evidence of 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 the purposes of hazard
assessment, with a NOEL and LOEL for 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 upon
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 the 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 does not support the addition of
bifenthrin 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
studies.'' 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 on 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
neurologic effects and abnormalities in respiratory and endocrine
systems. In humans, chronic 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-1,3-diol (Bronopol). Boots Microcheck
contends that 2-bromo-2-nitropropane-1,3-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-1,3-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-1,3-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-1,3-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 (e.g.,
2-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 incorporat

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-29376. Public record. Not legal advice.