Wednesday 

November 30, 1994 

Part V 

Environmental 

Protection Agency 

40 CFR Part 372 

Addition of Certain Chemicals; Toxic 

Chemical Release Reporting; Community 

Right-to-Know; Final Rule 
61432 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 372 

[OPPTS-400082B; FRL-4922-2] 

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 categoi'ies, 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 

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 exarnine the lists of 

chemicals regulated or identified, as of 

concern, under various environinental 

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. 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / R ulesandRegulations 61433 

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 

Toaric 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 ineeting 

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 sitespecific 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 
61434 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

early 1995 expanding the scope of 

industry sectors that would be subject to 

EPCRA section 313. EPA's initial 

analysis for this effort is focused on 

industrial sectors which have activities 

related to manufacturing that result in 

significant releases of chemicals listed 

on EPCRA section 313. EPA is also 

considering further expanding right-toknow 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 conirnents are addressed in 

this document. In addition to general 

comment and comment addressing a 

broad number of chemicals, EPA 

received specific technical comments on 

110 of the chemicals and chemical 

categories. Detailed responses to 

comments are contained in Response to 

Comments Received on the January 12, 

1994 Proposed Rule to Expand the 

EPCRA Section 313 List (Response to 

Comment Document, Ref. 14). 

Summaries of responses to comments 

on selected chemicals appear in units 

IV.F. and IV.G. of this preamble. Table 

1 lists the chemicals that EPA has 

determined meet the statutory criteria of 

EPCRA section 313(d)(2) and are 

therefore being added to the toxic 

chemical list. Each of the chemicals and 

chemical categories listed below were 

found to meet the statutory criteria 

described in EPCRA section 

313(d)(2)(A)-(C). This means that the 

Agency has made a finding that the 

chemical is known to cause an effect, or 

is reasonably anticipated to do so. It 

does not necessarily mean that the 

chemical is known to cause a given 

effect. The specific criterion or criteria 

that the chemical meets are also listed 

in Table 1 below. 

TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

Abamectin (Avermectin 131) 071751-41-2 X X 

Acephate (Acetylphosphoramidothioic acid O,S-dimethyl ester) 030560-19-1 X 

Ac'rfluorten sodium salt (5-(2-Chloro-4-(triflouromethyl)phenoxy)-2-nitro-benzoic 062476-59-9 X 

acid, sodium salt) 

Alachlor 015972-60-8 X 

Aldicarb 000116-06-3 X 

d-trans-Allethrin [d-trans-Chrysanthemic acid of d-allethrone] 028057-48-9 X 

Allylamine 000107-11-9 X 

Aluminum phosphide 020859-73-8 X 

Ametryn (N-Ethyl-N'-(1-methylethyl)-6-(methylthio)-1,3,5,-triazine- 2,4 diamine) 000834-12-8 X X 

Amitraz 033089-61-1 X 

Anilazine (4,6-Dichloro-N-(2-chlorophenyl)-1,3,5-triazin-2-amine) 000101-05•3 X X 

Atrazine (6-Chloro-N-ethyl-N'-(1-methylethyl)-1,3,5,-triazine-2,4-diamine) 001912-24-9 X 

Bendiocarb (2,2-Dimethyl-1,3-benzodioxol-4-ol methylcarbamate) 022781-23-3 X X 

Benfluralin (N-Butyl-N-ethyl-2,6-dinitro-4-(trifluoromethyl) benzenamine) 001861-40-1 X 

Benomyl 017804-35-2 X 

Bifenthrin 082657-04-3 X X 

Bis(tributyftin) 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-methylpropyl)-2,4(1H,3H)-pyrimidinedione) 000314-40-9 X 

Bromacil lithium salt (2,4(11-1,31-1)-Pyrimidinedione, 5-bromo-6-methyl-3 (1- 053404-19-6 X 

methylpropyl), lithium sait) 

Bromine 007726-95-6 X 

1-Bromo- t -(bromomethyl)-1,3-propanedicarbonitrile 035691-65-7 X 

2-Bromo-2-nitropropane-1,3-diol (Bronopol) 000052-51-7 X 

Bromoxynil (3,5-Dibromo-4-hydroxybenzonitrile) 001689-84-5 X 

Bromoxvnil octanoate (Octanoic acid. 2.6-dibromo-4-cvanooherrvl ester) 001689-99-2 X 
Federal Register / Vol. .59, No. 229 / Wednesday, November 30, 1994 / Rules and Regu lations 61 435 

TABLE 1.—CHEMICALS BEING ADDED TO THE EPCFiA SECTION 313 LIST—Cotltinued 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

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-1,4-0xathiin-3-carboxamide) 005234-68-4 X 

Chinomethionat (6-Methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one) 002439-01-2 X 

Chlorendic acid 000115-28-6 X 

Chlorimuron ethyl (Ethyl-2-[[[(4-chloro-6-methoxyprimidin-2-yl)-carbonyl]- 090982-32-4 X 

amino]sulfonyl] benzoate) 

1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride 004080-31-3 X 

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-133a) 000075-88-7 X X 

Chlorotrifluoromethane (CFG13) 000075-72-9 X X 

3-Chloro-1,1,1-trifluoropropane(HCFG253fb) 000460-35-5 X X 

Chlorpyrifos methyl (O,O-Dimethyl-0-(3,5,6-trichloro-2- pyridyl)phosphorothioate) 005598-13-0 X X 

Chlorsulfuron (2-Chloro-N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl) 064902-72-3 X 

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-dimethylcyclopropanecarboxylic acid, 068359-37-5 X X 

cyano(4-fluoro-3-phenoxyphenyl)methylester) 

Cyhalothrin (3-(2-Chloro-3,3,3-trifluoro-1-propenyl)-2,2- 068085-85-8 X 

Dimethylcyclopropanecarboxylic acid cyano(3-phenoxyphenyl)methyl ester) 

Dazomet (Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione) 000533-74-4 X 

Dazomet sodium salt (2H-1,3,5-Thiadiazine-2-thione, tetrahydro-3,5-dimethyl-, 053404-60-7 X 

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 acid) 001918-00-9 X 

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-132b) 001649-08-7 X X 

Dichlorofluoromethane (HCFC-21) 000075-43-4 X X 

Dichloropentafluoropropane 127564-92-5 X X 

1,3-Dichloro-1,1,2,3,3-pentafluoropropane (HCFC-225ea) 136013-79-1 X X 

2,2-Dichloro-1,1,1,3,3-pentafluoropropane (HCFC-225aa) 128903-21-9 X X 

1,1-Dichloro-1,2,3,3,3-pentafluoropropane (HCFC-225eb) 111512-56-2 X X 

1,1-Dichloro-1,2,2,3,3-pentafluoropropane (HCFC-225cc) 013474-88-9 X X 

1,3-Dichloro-1,1,2,2,3-pentafluoropropane (HCFC-225cb) 000507-55-1 X X 

1,2-Dichloro-1,1,3,3,3-pentafluoropropane (HCFC-225da) 000431-86-7 X X 

3,3-Dichloro-1,1,1,2,2-pentafluoropropane (HCFC-225ca) 000422-56-0 X X 

2,3-Dichloro-1,1,1,2,3-pentafluoropropane (HCFC-225ba) 000422-48-0 X X 

1,2-Dichloro-1,1,2,3,3-pentafluoropropane (HCFC-225bb) 000422-44-6 X X 

Dichlorophene (2,2'-Methylenebis(4-chlorophenol) 000097-23-4 X X 

trans-1,3-Dichloropropene 010061-02-6 X 

Diclofop methyl (2-[4-(2,4-Dichlorophenoxy) phenoxy]propanoicacid, methyl ester) 051338-27-3 X 

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 

Diethvldiisocvanatobenzene 134190-37-7 
61436 Federal Register / Vol. 59, No. 229 / Wednesday, Novernber 30, 1994 / Rules and Regulations 

TABLE 1.--CHEMICALS BEING ADDED TO THE EPCFiA SECTION 313 LIST--Contlnued 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

4,4'-Diisocyanatodiphenyl ether 004128-73-8 

2,4'-Diisocyanatodiphenyl sulfide 075790-87-3 

3,3'-Dimethoxybenzidine4,4'-diisocyanate 000091-93-0 

3,3'-Dimethyl4,4'-diphenylene diisocyanate 000091-974 

3,3'-Dimethyl diphenylmethane-4,4'-diisocyanate 000139-25-3 

Hexamethylene-1,6{liisocyanate 000822-06-0 

Isophorone diisocyanate 004098-71-0 

Methylenebis(phenyl isocyanate) 000101-68-8 

4-Methyldiphenylmethane-3,4-diisocyanate 075790-84-0 

1, 1 -Methylene bis(4-isocyanatocyclohexane) 005124-30-1 

1,5-Naphthalene diisocyanate 003173-72-6 

1,3-Phenylene diisocyanate 000123-61-5 

1,4-Phenylene diisocyanate 000104•494 

Polymeric diphenylmethane diisocyanate 009016-87-9 

2,2,4-Trimethylhexamethylene diisocyanate 016938-22-0 

2,4,4-Trimethylhexamethylene diisocyanate 015646-96-5 

Dimethipin (2,3,-Dihydro-5,6-dimethyl-1,4-dithiin 1,1,4,4-tetraoxide) 055290-64-7 X 

Dimethoate 000060-51-5 X 

3,3'-Dimethoxybenzidine dihydrochloride (o-Dianisidine dihydrochloride) 020325-40-0 X 

3,3'-Dimethoxybenzidine hydrochloride (o-Dianisidine hydrochloride) 111984-09-9 X 

Dimethylamine 00012440-3 X 

Dimethylamine dicamba 002300-66-5 X 

3,3'-Dirnethylbenzidine dihydrochloride (o-Tolidine dihydrochloride) 000612-82-8 X 

3,3'-Dimethylbenzidine dihydrofluoride (o-Tolidine dihydrofluoride) 041766-75-0 X 

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 000122-394 X 

Dipotassium endothall (7-Oxabicyclo(2.2.1)heptane-2,3-dicarboxylic acid, 002164-07-0 X 

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 ester 001320-18-9 X 

2,4-D sodium salt 002702-72-9 X 

Ethoprop (Phosphorodithioic acid O-ethyl S,S-dipropyl ester) 013194-48-4 X X 

Ethyl dipropylthiocarbamate (EPTC) 000759-944 X X 

Famphur 000052-85-7 X X 

Fenarimol (.alpha.-(2-Chlorophenyl)-.alpha. 4-chlorophenyl)-5-pyrimidinemethanol) 060168-88-9 X 

Fenbutatin oxide (hexakis(2-methyl-2-phenylpropyl)distannoxane) 013356-08-6 X X 

Fenoxaprop ethyl (2-(4-((6-Chloro-2-benzoxazolylen)oxy)phenoxy)propanoic 066441-23-4 X X 

acid,ethyl ester) 

Fenoxycarb (2-(4-Phenoxyphenoxy)ethyl]carbamic acid ethyl ester) 072490-01-8 X 

Fenpropathrin (2,2,3,3-Tetramethylcyclopropane carboxylic acid cyano(3- 039515-41-8 X X 

phenoxyphenyl)methyl ester) 

Fenthion (O,O-Dimethyl 0-[3-methyl4-(methylthio) phenyl] ester, phosphorothioic 000055-38-9 X X 

acid) 

Fenvalerate (4-Chloro-alpha-(1-methylethyl)benzeneacetic acid cyano(3- 051630-58-1 X X 

phenoxyphenyl)methyl ester) 

Ferbam (Tris(dimethylcarbamodithioato-S,S')iron) 014484-64-1 X X 

Fluazifop butyl (2-[4-[(5-(Trifluoromethyl)-2-pyridinyl]oxy]-phenoxy]propanoic acid, 069806-504 X 

butyl ester) 

Fluorine 007782-414 X 

Fluorouracil (5-Fluorouracil) 000051-21-8 X 

Fluvalinate (N-[2-Chloro-4-(trifluoromethyl)phenyl]-DL-valine(+)-cyano (3- 069409-94-5 X X 

phenoxyphenyl)methyl ester) 

Folpet 000133-07-3 X X 

Fomesafen (5-(2-Chloro4-(trifluoromethyl)phenoxy)-N methylsulfonyl)-2- 072178-02-0 X 

nitrobenzamide) 

alpha-Hexachlorocyclohexane 000319-84-6 X X 

n-Hexane 000110-54-3 X 

Hexazinnne 051235-04-2 X X 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61437 

TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—COntinued 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

Hydramethylnon (Tetrahydro-5,5-di-methyl-2(1 H)- pyrimidinone[3-[4- 067485-29-4 X X 

(trifluoromethyl)phenyl]-1-[2-[4-(trifluoromethyl) phenyl]ethenyl]- 

2propenylidene]hydrazone) 

Imazalil (1-[2-(2,4-Dichlorophenyl)-2-(2-propenyloxy)ethyl]-1H-imidazole) 035554-44-0 X 

3-lodo-2-propynyl butylcarbamate 055406-53-6 X 

Iron pentacarbonyl 013463-40-6 X 

Isodrin 000465-73-6 X 

Isofenphos (2-[[Ethoxyl[(1-methylethyl)amino]phosphinothioyl]oxy] benzoic acid 1- 025311-71-1 X X 

methylethyl ester) 

Lactofen (5-(2-Chloro-4-(trifluoromethyl)phenoxy)-2-nitro-2-ethoxy-l-methyl-2- 077501-63-4 X 

oxoethyl ester) 

Linuron 000330-55-2 X 

L'ithium 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 meihykiithiocarbamate) 000137-42-8 X 

Methazole (2-(3,4-Dichlorophenyl)-4-methyl-1,2,4-oxadiazolidine-3,5-dione) 020354-26-1 X 

Methiocarb 002032-65-7 X 

Methoxone ((4-Chloro-2-methylphenoxy) acetic acid) (MCPA) 000094-74-6 X 

Methoxone sodium salt ((4-Chloro-2-methylphenoxy) acetate sodium salt) 003653-48-3 X 

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 

Methyhrichlorosilane 000075-79-6 X 

Metiram 009006-42-2 X 

Metribuzin 021087-64-5 X 

Mevinphos 007786-34-7 X 

Molinate (1H-Azepine-1 carbothioic acid, hexahydro-S-ethyl ester) 002212-67-1 X 

Monuron 000150-68-5 X 

Myclobutanil (.alpha: Butyl-.alpha.-(4-chlorophenyl)-1H-1,2,4-triazole-l- 088671-89-0 X 

propanenitrile) 

Nabam 000142-59-6 X 

Naled 000300-76-5 X X 

Nicotine and saRs NA X 

Nitrapyrin (2-Chloro-6-(trichloromethyl)pyridine) 001929-82-4 X 

Nitrate compounds (water dissociable) NA X 

p-Nitroaniline 000100-01 -6 X 

Norflurazon (4-Chloro-5-(methylamino)-2-[3-(trifluoromethyl)phenyl]-3(2H)- 027314-13-2 X 

pyridazinone) 

Oryzalin (4-(Dipropylamino)-3,5-dinitrobenzenesulfonamide) 019044-88-3 X 

Oxydemeton methyl (S-(2-(Ethylsulfiny1)ethyt) O,O-dimethyl ester phosphorothioic 000301-12-2 X 

acid) 

Oxydiazon (3-[2,4-Dichloro-5-(1-methylethoxy)phenyq-5-(1,1-dimethylethyl)-1,3,4- 019666-30-9 X 

oxadiazo I-2 (3 H )-one) 

Oxyfluorfen 042874-03-3 X X 

Ozone 010028-15-6 X X 

Paraquat dichloride 001910-42-5 X 

Pebulate (Burylethylcarbamothioic acid S-propyl ester) 001114-71-2 X 

Pendimethalin (N-(1-Ethylpropyl)-3,4-dimethyl-2,6-dinRrobenzenamine) 040487-42-1 X 

Pentobarbital sodium 000057-33-0 X 

Perchloromethyl mercaptan 000594-42-3 X 

Permethrin (3-(2,2-Dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3- 052645-53-1 X X 

phenoxyphenyl)methyl ester) 

Phenanthrene 000085-01-8 X 

Phenothrin (2,2-Dimethyl-3-(2-methyl-l-propenyl) cyclopropanecarboxylic acid (3- 026002-80-2 X X 

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 (0-(2-(Diethylamino)-6-methyl-4- pyrimidinyl)-O,O-dimethyl 029232-93-7 X 

phosphorothioate) 

Polychlorinated alkanes NA X X 
61438 FederalRegister / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

TABLE 1.--CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—Continued 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

Polycyclic aromatic compounds (PACs) consisting of: NA X 

Benz(a)anthracene 000056-55-3 

Benzo(a)phenanthrene 000218-01-9 

Benzo(a)pyrene 000050-32-8 

Benzo(b)fluoranthene 000205-99-2 

BenzoQ)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 dimethykiithiocarbarnate 000128-03-0 X 

Potassium N-methyldithiocarbamate 00013741-7 X 

Profenofos (0-(4-Bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate) 041198-08-7 X 

Prometryn (N,N'-Bis(1-methylethyl)-6-methylthio-1,3,5-triazine-2,4-iiamine) 007287-19-6 X 

Propachlor (2-Chloro-N-(1-methylethyl)-N-phenylacetamide) 001918-16-7 X 

Propanil (N-(3,4-Dichlorophenyl)propanamide) 000709-98-8 X 

Propargite 002312-35-8 X X 

Propargyl alcohol 000107-19-7 X 

Propetamphos (3-[(Ethylamino)methoxyphosphinothioyl]oxy]-2-butenoic acid, 1- 031218-83-4 X 

methylethyl ester) 

Propiconazole (1-[2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]-methyl-1H- 060207-90-1 X 

1,2,4,-triazole) 

Quizalofop-ethyl (2-[4-[(6-Chloro-2-quinoxalinyl)oxy]phenoxy] propanoic acid ethyl 076578-14-8 X 

ester) 

Resmethrin ([5-(Phenylmethyl)-3-furanyl]methyl 2,2-dimethyl-3-(2-methyl-l-pro- 010453-86-8 X X 

penyl)cyclopropanecarboxylate]) 

Sethoxydim (2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxyl-2- 074051-80-2 X 

cyclohexen-l-one) 

Simazine 000122-34-9 X 

Sodium azide 026628-22-8 X 

Sodium dicamba (3,6-Dichloro-2-methoxybenzoic acid, sodium salt) 001982-69-0 X 

Sodium dimethyldithiooarbamate 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 fiuoride (Vikane) 002699-79-8 X 

Sulprofos (O-Ethyl 0-[4-(methylthio)phenyl]phosphorodithioic acid S propyl ester) 035400-43-2 X X 

Tebuthiuron (N-[5-(1,1-Dimethylethyl)-1,3,4-thiadiazol-2-yl)- N,N'-dimethylurea) 034014-18-1 X 

Temephos 003383-96-8 X 

Terbacil (5-Chloro-3-(1,1-dimethylethyl)-6-methyl- 2,4 (1H,3H)-pyrimidinedione) 005902-51-2 X 

1,1,1,2-Tetrachloro-2-fluoroethane (HCFC-121a) 000354-11-0 X X 

1,1,2,2-Tetrachloro-l-fluoroethane (HCFC-121) 000354-14-3 X X 

Tetracycline hydrochloride 000064-75-5 X 

Tetramethrin (2,2-Dimethyl-3-(2-methyl-l-propenyl) cyclopropanecarboxylic acid 007696-12-0 X X 

(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl ester) 

Thiabendazole (2-(4-Thiazolyl)-1 H-benzimidazole) 000148-79-8 X X 

Thiobencarb (Carbamic acid, diethylthio-, S-(p-chlorobenzyl)) 028249-77-6 X 

Thiodicarb 059669-26-0 X X 

Thiophanate ethyl ([1,2-Phenylenebis(iminocarbonothioyl)] biscarbamic acid 023564-06-9 X 

diethyl ester) 

Thiophanate-methyl 023564-05-8 X 

Thiosemicarbazide 000079-19-6 X 

Triadimefon (1-(4-Chlorophenoxy)-3,3-dimethyl-l-(1H-1,2,4-triazol-1-yl)-2- 043121-43-3 X 

butanone) 

Triallate 002303-17-5 X 

Tribenuron methyl (2-(4-Methoxy-6-methyl-1,3,5-triazin-2-yl)- 101200-48-0 X 

methylamino)carbonyl)amino)sulfonyl)-, methyl ester) 

Tributvltin fluoride 001983-10-4 X 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61439 

TABLE 1.—CHEMICALS BEING ADDED TO THE EPCRA SECTION 313 LIST—COfltiflued 

Chemical Name CAS No. Section 

313(d)(2)(A) 

Section 

313(d)(2)(B) 

Section 

313(d)(2)(C) 

TributyRin methacrylate 002155-70-6 X 

S,S,S-Tributyftrithiophosphate (DEF) 000078-48-8 X X 

Trichloroacetyl chloride 000076-02-8 X 

1,2,3-Trichloropropane 000096-1 &4 X 

Triclopyr triethylammonium salt 057213-69-1 X 

Triethylamine 000121-44-8 X 

Triforine (N,N'-[1,4-Piperazinediylbis-2,2,2-trichloroethylidene)] bisformamide) 026644-46-2 X 

Trimethylchlorosilane 000075-77-4 X 

2,3,5-Trimethylphenyl methylcarbamate 002655-15-4 X 

TriphenyRin chloride 000639-58-7 X X 

Triphenyftin hydroxide 000076-87-9 X X 

Vinclozolin (3-(3,5-Dichlorophenyl)-5-ethenyl-5-methyl-2,4-oxazolidinedione) 050471-44-8 X 

~ EPA is deferring final action on 40 

chemicals and one chemical category 

until a later date. These chemicals and 

the comments received on them raised 

particularly difficult technical or policy 

issues which will require additional 

time to address. The Agency does not 

believe that it would be in the spirit of 

community right-to-know to delay final 

action on the remaining 286 chemicals 

and chemical categories, pending 

completion of work on the more limited 

group. In a future rulemaking, EPA will 

make a final determination as to 

whether these chemicals should be 

added to EPCRA section 313. The public 

comment that has been received specific 

to these deferred chemicals will be 

addressed as part of the future 

rulemaking discussed above. These 

chemicals follow: 

o-benzyl-p-chlorophenol 

butylate 

butylated hydroxyanisole (BHA) 

calcium hypochlorite 

caprolactam 

carbon monoxide 

cyromazine 

dichloromethylphenylsilane 

dithiopyr 

2,4-D 2-octyl ester 

flumetralin 

iprodione 

isophorone 

man made mineral fibers 

methylene bis(thiocyanate) 

nitric oxide 

nitrogen dioxide 

nine polycyclic aromatic compounds, 

specifically: 

carbazole 

cyclopenta (cd)pyrene 

dibenz(a,c)anthracene 

dibenz(a,j ) anthracene 

2-methylchrysene 

3-methylchrysene 

4-methylchrysene 

6-methylchrysene 

2-methylfluoranthene 

phosphorus oxychloride 

phosphorus pentachloride 

phosphorus pentasulfide 

phosphorus pentoxide 

primsulfuron 

sodium chlorite 

sodium hypochlorite 

sodium 2-pyridinethiol-l-oxide 

sulfur dioxide 

sulfur trioxide 

tefluthrin 

thiabendazole, hypophosphite salt 

trichloroethylsilane 

trichlorophenylsilane 

vanadium pentoxide 

Based on an evaluation of the public 

comments received and a reanalysis of 

the available data cited in the proposed 

rule, EPA has determined that three 

chemicals, clomazone, 5-chloro-2-(2,4- 

dichlorophenoxy)phenol, and 

tetrasodium 

ethylenediaminetetraacetate, that were 

proposed for listing do not have 

sufficient evidence of toxicity at this 

time to meet the statutory criteria of 

EPCRA section313(d)(2) and thus are 

not listed in this final rule. Summaries 

of responses to chemical-specific 

comments for these chemicals appear in 

unit IV.G. of this preamble. 

IV. 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 IdentifyPotential 

Candidates forAddition toEPCRA 

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-adverseeffect levels (LOAELs). MEDs are 
61440 FederalRegister / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

generally derived from LOAELs from 

chronic toxicity studies using a log 

transformation and as such a MED is a 

single value based upon the best 

available study. Satisfying the MED 

screening criteria, however, does not 

mean that a chemical will necessarily be 

added to the list. In every case, the 

Agency determines that at least one of 

the section 313(d)(2) criteria is met 

before a chemical is listed. For example, 

isoprene, 1,3-dichloropropane, and 

dichlorodimethylmethane passed the 

toxicity screen, but upon a more 

detailed review, were determined not to 

meet the criteria of EPCRA section 

313(d)(2) and thus were not proposed 

for addition. 

EPA believes that MEDs are useful as 

a screening tool and that the 

methodology has been adequately 

reviewed both internal and external to 

the Agency. The MED system was first 

presented in a peer reviewed article by 

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. il) 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 Draff 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 Chernical 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-toknow 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 chemicalspecific comments are found in units 

IV.F. and IV.G. of this preamble). 

B. Use of Exposure Assessments 

One of the most significant issues 

raised by commenters relates to the 

Agency's consideration of hazard, 

exposure, and risk in interpreting the 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulati ons 61441 

section 313(d)(2) criteria. Specifically, a 

number of commenters believe that 

EPA's interpretation of the EPCRA 

section 313(d)(2)(B) criterion, chronic 

human health effects, and the section 

313(d)(2)(C) criterion, ecological effects, 

has been overly restrictive. The 

commenters contend that EPA should 

conduct risk assessments and make a 

formal determination that a chemical 

poses a risk (i.e., a combination of 

exposure and hazard) before adding it to 

the EPCRA section 313 list. The 

commenters argue that the following 

factors support their contention: (1) The 

statutory criteria include an implicit 

exposure and thus risk component; (2) 

the legislative history illustrates 

Congress' intent that exposure 

considerations were to be an integral 

part of determining whether a chemical 

should be listed on the EPCRA section 

313 list; and (3) EPA should consider 

exposure in conjunction with section 

313(d)(2)(B), chronic human health 

effects, and for all listings pursuant to 

section 313(d)(2)(C), ecological effects, 

because there is precedent for the use of 

exposure in previous listing and 

delisting actions. 

In light of the many comments 

received on this issue, EPA has 

reviewed its positions in this area, and 

agrees with many of the commenters 

that there are limited circumstances 

under which it is appropriate for EPA to 

consider exposure factors for listing 

decisions under section 313(d)(2). The 

Agency believes that exposure 

considerations are appropriate in 

making determinations (1) under section 

313(d)(2)(A), (2) under section 

313(d)(2)(B) for chemicals that exhibit 

low to moderately low toxicity based on 

a hazard assessment (i.e., those 

chemicals for which the value of listing 

on the EPCRA section 313 list on hazard 

alone is marginal), and (3) under section 

313(d)(2)(C) for chemicals that are low 

or moderately ecotoxic but do not 

induce well-documented serious 

adverse effects as described below. The 

Agency believes that exposure 

considerations are not appropriate in 

making determinations (1) under section 

313(d)(2)(B) for chemicals that exhibit 

moderately high to high human toxicity 

(These terms, which do not directly 

correlate to the numerical screening 

values reflected in the Draft Hazard 

Assessment Guidelines, are defined in 

unit II.) based on a hazard assessment, 

and (2) under section 313(d)(2)(C) for 

che2nicals 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 welldocumented 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 sitespecific 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, 

i9s6) ). 

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 rightto-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 
61442 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

factors when making a finding under 

either section 313(d)(2)(B) or section 

313(d)(2)(C). However, the language of 

sections 313(d)(2)(B) and (C) does not 

require the type of exposure assessment 

and/or risk assessment argued by the 

commenters. EPA believes that it has 

the discretion under both section 

313(d)(2)(B) and section 313(d)(2)(C) to 

consider, where appropriate, those 

exposure factors that may call into 

question the validity of listing of any 

specific chemical on TRI. In exercising 

this discretion, EPA considers it 

appropriate to employ exposure 

considerations to a limited extent in 

making determinations under EPCRA 

section 313(d)(2)(C) because this 

criterion requires the Agency to find a 

"significant adverse effect on the 

environment of sufficient seriousness, 

in the judgment of the Administrator to 

warrant reporting" under EPCRA 

section 313. This language recognizes 

the possibility that under certain 

circumstances, a chemical that could 

theoretically cause an adverse effect on 

the environment is unlikely to cause 

one of a magnitude sufficient to warrant 

listing. Moreover, because of the 

limitation on the number of chemicals 

listed pursuant to only section 

313(d)(2)(C) that may be listed, EPA 

believes that it is appropriate to use 

both hazard and exposure factors as 

prioritizing considerations in these 

listing decisions. Therefore, to meet its 

obligation under section 313(d)(2)(C), in 

cases where a chemical is low or 

moderately 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 (llth 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 in dividually- listed 

chemical rather than for the category. 

The current EPCRA section 313 list 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 /Rulesand Regulations 61443 

contains some individually-listed 

chemicals that also meet the definition 

of an EPCRA section 313 listed category. 

For example, pentachlorophenol is 

listed individually on EPCRA section 

313 but also meets the definition of the 

chlorophenol category. In these 

situations, threshold determinations 

should be made for the chemical as an 

individual entity 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 noncompliance 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. Policylssues 

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 chemicalspecific 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 sitespecific 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 3131ist. 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 byFDA. 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 underFIFRA. 

Several commenters do not support the 

addition of chemicals regulated under 

FIFRA to the EPCRA section 313 list of 
61444 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

toxic chemicals because, they contend, 

the major route of exposure, agricultural 

field use, has been addressed through 

FIFRA regulation which establishes 

safety factors and use directions 

allowing for safe use. They further 

contend that the use of these chemicals 

has been determined not to present an 

unreasonable risk and therefore, listing 

pesticides under EPCRA section 313 is 

unnecessary. 

FIFRA regulations require that the 

Agency determine that pesticidal uses of 

a chemical do not cause "unreasonable 

adverse effects on the environment" 

which is defined in FIFRA section 2(bb) 

as "any unreasonable risk to man or the 

environment taking into account the 

economic, social, and environmental 

costs and benefits of the use of 

pesticides" (7 U.S.C. section 136(bb)). 

FIFRA is a regulatory statute, and the 

impacts of regulation can be immediate 

and direct (e.g., banning of a chemical), 

and as such EPA examines not only the 

hazards presented by the chemical, but 

also the specific exposure scenarios, and 

weighs the risks against the benefits of 

the chemical. The "unreasonable 

adverse effects" determination under 

FIFRA is specific to the intentional use 

of the chemical as a pesticide and does 

not address other uses or releases of the 

chemical that may result from 

manufacture, processing, or other use. 

Furthermore, a determination under 

FIFRA that the use of a chemical will 

not result in an "unreasonable adverse 

effect" is not a determination that the 

chemical is not hazardous or that the 

use of the chemical is without risk. 

Finally, EPCRA section 313 was not 

enacted to serve the same purpose as 

FIFRA. Listing on EPCRA section 313 

provides communities with some of the 

information required to determine what 

risks may result from the manufacture, 

processing and non-pesticidal use of a 

chemical, information not generally 

provided through F)FRA. 

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 chernical 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 

dissernination 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 Comrnents 

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-OneLiner data base does not constitute a 

detailed analysis and careful 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61445 

examination of the available data on a 

chemical. 

EPA disagrees with the commenters. 

EPA's use of the Agency's IRIS data base 

for EPCRA section 313 purposes does 

constitute a hazard evaluation. That 

data base generally provides 

information against which EPA can 

evaluate the section 313(d)(2) criteria. 

The information contained in the IRIS 

data base represents the Agency's 

weight-of-evidence hazard assessment 

for chemicals contained in the data 

base. The information was developed 

after the Agency's thorough scientific 

review of the available data. Therefore, 

by relying on information in the IRIS 

data base in the review of chemicals for 

listing on EPCRA section 313, EPA 

made statutory determinations based on 

hazard assessments conducted by the 

Agency. 

Although the 1988 TOX-One-Liners 

were used as part of the Agency's 

evaluation of the toxicity of a candidate 

chemical, a number of other sources 

were also used. These include decision 

documents from a number of Agency 

and EPA internal peer review groups, 

deliberations of the FIFRA Scientific 

Advisory Panel, and reference to data 

evaluation records for studies used in 

support of listing. Therefore, 

evaluations of the toxicity of individual 

chemicals has been made on the entire 

data base and did not rely only on the 

1988 TOX-One-Liners data base. 

Furthermore, inclusion of all of the 

detailed studies in the docket was not 

possible, because of the proprietary 

nature of some of the information. 

However, in cases where relevant 

information was used in support of the 

listing decision, but was not included in 

the 1988 TOX One-Liners data base 

(which is the most recent sanitized 

version of the data base), sanitized 

versions of the additional sources were 

included in the docket. In those cases 

where only the 1988 TOX-One-Liners 

data base or other similar sources were 

cited, no additional data not described 

in the 1988 TOX-One-Liners, RTECS, or 

the AQUIRE data bases was considered 

to be relevant to this listing. For a few 

chemicals it has become apparent based 

on comments received that EPA's 

analysis did not include studies which 

are in EPA's possession but which EPA 

has not reviewed. The Agency is 

deferring the final action on these 

chemicals until such studies can be 

reviewed. 

3. Testing at toxic doses. A number of 

commenters stated that pesticides 

which are registered under FIFRA 

should not be listed under EPCRA 

section 313 because the testing 

conducted to obtain a pesticide 

registration under the FIFRA review 

process requires testing at dose levels 

"virtually guaranteed to produce a 

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 chAmical 

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 byroutes 

otherthan oral, inhalation, ordermal. 

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, 
61446 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

the Agency cannot ignore the possible 

significance of any existing data, 

including data from intraperitoneal, 

intravenous, or subcutaneous injection 

studies. Although it is preferable to have 

toxicity data from the common routes of 

human exposure, EPA believes that for 

hazard assessment under EPCRA section 

313, the Agency should use all available 

information to identify the hazard 

associated 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 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61447 

purposes of risk assessment in support 

of regulatory controls, when considered 

together, they present a sufficient 

weight-of-evidence as to the hazard 

associated with the chemical. As 

additions to EPCRA section 313 made 

pursuant to EPCRA section 313(d)(2)(B) 

are not based on the kind of risk 

assessment needed for regulatory 

controls, EPA believes that such studies 

can be used to support listin . 

9. Docket was incomplete ~or 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 (Re£ 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 comrnent 

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 gammaaminobutyric 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 3131ist 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 ToxicityReviewof 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 
61448 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

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 

estirnation 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 

10o mg/kg/day is sufficiently low given 

the seriousness of the effect (hepatic 

toxicity) to justify listing on the EPCRA 

section 3131ist. 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 F, 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 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61449 

maternal and developmental toxicity of 

5 and 25 mg/kg/day, respectively. As 

described in the proposed rule, at 25 

mg/kg/day, the following effects were 

seen: Decreased litter size and increased 

pre and post-implantation losses, 

decreased maternal body weight gain, 

and increased abortions. The high 

abortion rate is indicative of maternal 

toxicity. Although the abortion rates 

were higher than the control, enough 

animals remained at sacrifice to 

evaluate the toxicity potential of this 

chemical, and to support the finding 

that amitraz can reasonably be 

anticipated to cause developmental 

toxicity. 

The subsequent study cited by the 

commenter was also considered by EPA. 

This study also does not fully satisfy the 

guidelines for study conduct under 

FIFRA. Although the fetotoxic effects 

observed in the initial study (cited in 

the proposed rule) were not reproduced 

in the subsequent study referred to by 

the commenter and not cited in the 

proposed rule, this does not invalidate 

the results obtained in the initial study. 

Both studies were considered by EPA in 

determining the developmental toxicity 

of amitraz. 

EPA reaffirms that there is sufficient 

evidence for listing amitraz on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the chronic toxicity and developmental 

toxicity data for this chemical. 

Therefore, EPA is finalizing the addition 

of amitraz on the EPCRA section 313 

list. 

5. Atrazine. Ciba-Geigy Corporation 

objects to the listing of atrazine under 

EPCRA section 313 based on increased 

incidence of mammary tumors in female 

Sprague-Dawley rats because the 

commenter contends that this tumor 

type is not indicative of potential 

carcinogenicity in humans. The 

commenter states that the effect is 

species (rat) and strain (SpragueDawley) 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 coniunenter 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 timeweighted 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 
61450 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / RulesandRegulations 

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-Brom o-2-ni tropropane-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 

befors 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-nitropropane1,3-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-nitropropane1,3-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 speciesspecific 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 speciesspecific (e.g., a2μ-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 speciesspecific. 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. Therefare, EPA is finalizing 

the listing of carboxin on the EPCRA 

section 313 list. 

11. 1-(3-Chloroallyl)-3,5, 7-triaza-lazoniaadamantane 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 adniinistration is unusual. EPA 

frequently reviews dog studies in which 

the test material is administered by 

capsule. In addition, dog studies rarely 

permit ad libitum feeding as used in rat 

studies, even when dietary 

incorporation is the means of dose 

administration. Dogs generally receive a 

measured amount of food that they 

rapidly consume. Therefore, bolus 

administration closely approximates 

actual behavior in dogs. The concern 

that capsule administration produces an 

apparently altered response is not a 

confounding factor in the study cited in 

the proposed rule; and therefore the 

reported NOEL does not need to be 

raised as suggested by the commenter. 

The same commenter contends that 

the effects used as a basis for listing 

occurred only in dogs and only in a 

single study, and, therefore, are not 

relevant to humans. 

Because direct human testing is 

generally unavailable, animals are 

commonly accepted in the scientific and 

regulatory communities as surrogates for 

toxicity testing to predict potential 

hazard to humans, except in a few rare 

cases where effects have been 

determined to be species-specific (e.g., 

a2μ-globulin). In the i.nterest of being 

protective, EPA uses information from 

the most sensitive species to evaluate 

potential human hazard. In addition, 

results demonstrated in a single wellconducted study are sufficient and can 

serve as a basis for listing on the section 

313 list. 

The same commenter states that the 

LOEL in the study was based upon a 

slight, reversible effect in the liver of a 

single animal. The study, the 

commenter argues, should have been 

considered in toto rather than relying on 

a single effect. The commenter implies 

that EPA should have set the LOEL at 

a higher dose. 

The commenter is incorrect. The 

LOEL of 15 mg/kg/day is correct. This 

LOEL was based upon obliterative 

vasculitis and perivasculitis in one 

animal. However, these effects are not 

commonly seen in dogs, yet in the study 

cited in the proposed rule, they 

occurred in seven of eight dogs at 30 

mg/kg/day, the dose next highest to the 

LOEL. EPA considers the effects seen in 

this study to be serious effects. 

EPA reaffirms that there is sufficient 

evidence for listing 1-(3-chloroallyl)- 

3,5,7-triaza-l-azoniaaciamantane 

chloride on the EPCRA section 313 list 

pursuant to EPCRA section 313(d)(2)(B) 

based on the available chronic toxicity 

data for this chemical. Therefore, EPA is 

finalizing the addition of 1-(3- 

chloroallyl)-3,5, 7-triaza-lazoniaadamantane chloride on the 

EPCRA section 313 list. 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61451 

12. Chlorosilanes. Silicones 

Environmental Health and Safety 

Council and General Electric oppose the 

listing of the six chlorosilanes that were 

proposed for addition 

(dichloromethylphenylsilane, 

dimethyldichlorosilane, 

methyltrichlorosilane, 

trichloroethylsilane, 

trichlorophenylsilane, and 

trimethylchlorosilane) arguing that they 

undergo rapid hydrolysis and are not 

expected to be found in the atmosphere 

in appreciable concentrations. The 

commenters further state that EPA 

estimated conditions in its exposure 

assessment that greatly exceed actual 

conditions. 

Based on these comments, EPA 

conducted revised exposure 

assessments for each of the 

chlorosilanes. These revisions support 

EPA's initial finding that 

dimethyldichlorosilane, 

methyltrichlorosilane, and 

trimethylchlorosilane can reasonably be 

anticipated to be present at facility 

boundaries in concentration levels that 

would cause a significant adverse effect. 

EPA believes that the exposure 

assessments were based on reasonable 

release estimates and reasonable worstcase concentration modeling. Details of 

this analysis are provided in the 

Response to Comment Document (Ref. 

14). Thus EPA reaffirms that there is 

sufficient evidence to list 

dimethyldichlorosilane, 

methyltrichlorosilane, and 

trimethylchlorosilane on the EPCRA 

section 313 list pursuant to 

EPCRAsection 313(d)(2)(A). Therefore, 

EPA is finalizing the listings for 

dimethyldichlorosilane, 

methyltrichlorosilane, and 

trimethylchlorosilane on the EPCRA 

section 313 list. 

The revised exposure assessments for 

dichl oromethylphenylsilane, 

trichloroethylsilane, and 

trichlorophenylsilane, however, 

indicate that these chemicals are not 

individually present at facility 

boundaries in concentration levels that 

would cause a significant adverse effect. 

However, two or more of these 

chemicals are usually produced together 

and as a category are reasonably 

anticipated to be present at facility 

boundaries in concentration levels that 

would cause a significant adverse effect. 

Therefore, EPA is deferring the 

individual listings of these three 

chemicals for consideration as a 

category possibly to be added at a later 

date. 

13. Crotonaldehyde. Eastman 

Chemical and Monsanto believe that 

crotonaldehyde should not be added to 

the EPCRA section 313 list because of 

inadequate data on human health. 

Furthermore, they contend that 

crotonaldehyde does not meet the 

criteria for listing as a carcinogen as put 

forth in the Risk Assessment Gufdelines 

for Carcinogen Risk (Ref. 4) because it 

was tested in a single sex, single species 

experiment. The commenters further 

believe that EPA's statement that 

crotonaldehyde did not induce tumors 

at the high dose, because at that high 

dose crotonaldehyde is cytotoxic, is a 

contention which is not supported by 

scientific evidence. They believe that 

overall the weight of evidence for 

carcinogenicity, including reactivity and 

mutagenicity, is insufficient to support 

listing. 

EPA agrees that the human 

carcinogenicity data are inadequate but 

feels that the available animal data are 

adequate to support a concern for 

carcinogenicity. The Agency accepts the 

single-sex, single species testing of 

crotonaldehyde as being sufficient for 

lieting because these data are supported 

by strong evidence of mutagenicity in 

Salmonella typhimurium; a statistically 

significant increase in the number of 

both benign and malignant tumors in 

low dose animals and induced altered 

liver foci but not tumor formation in the 

high dose group. Crotonaldehyde is 

known to be severely cytotoxic with the 

capacity to induce cell death and alter 

cellular macromolecules. It caused gross 

degeneration, chromosome breakage and 

reciprocal translocations in Drosophila 

melanogaster and gross degeneration 

and polyploidy in all stages of 

spermatogenesis in mouse seminiferous 

tubules thus showing that is has ample 

ability to interact with cellular DNA and 

cause severe disruption in chromosome 

structure and cellular integrity. It is 

logical to assume that if crotonaldehyde 

is capable of such damage in the 

mammalian testis which is protected by 

the blood/testis barrier, it can also cause 

severe toxicity and cell death in the 

liver which has no such protection from 

toxic agents. Absent evidence to the 

contrary, which the commenter did not 

provide, EPA continues to believe that 

failure to observe tumor formation is 

due to cell death before tumors could 

develop. Based on these findings, the 

Agency believes that the weight of 

evidence for crotonaldehyde is 

sufficient for listing. EPA reaffirms that 

there is sufficient evidence for listing 

crotonaldehyde on the EPCRA section 

313 list pursuant to EPCRA section 

313(d)(2)(B) based on available 

carcinogenicity and mutagenicity data 

for this chemical, Therefore, EPA is 

finalizing the addition of 

crotonaldehyde on the EPCRA section 

313 list. 

14. Cycloate. Zeneca Incorporated 

contends that in the 3—generation rat 

feeding study, cited in the proposed rule 

as being of unknown duration, the 

distended myelin sheath demyelination 

and nerve fiber loss at the LOEL of 3.0 

mg/kg/day occurred only after extensive 

exposure and as such would not be 

relevant to a toxic release type of short 

exposure. 

The effects described in this study are 

considered to be both serious and 

irreversible. Adverse effects that are 

induced by a chemical after repeated 

long-term exposures and are a valid 

basis for listing under EPCRA section 

313. 

The same commenter states that the 3- 

generation rat reproduction study cited 

in the proposed rule was replaced by a 

more recent (1990) 2-generation rat 

reproduction study, also cited in the 

proposed rule, in which the toxic effects 

on pup survival (LOEL of 50 mg/kg/day) 

and pup body weight (LOEL of 20 mg/ 

kg/day) occurred at doses which were 

maternally toxic as well. 

EPA considered both studies in its 

evaluation of cycloate. As described in 

unit W.E. of this preamble, 

developmental effects seen in 

developing organisms are considered to 

be adverse whether or not they occur at 

doses that are also maternally toxic. 

EPA reaffirms that there is sufficient 

evidence for listing cycloate on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available neurological and 

developmental toxicity data. Therefore, 

EPA is finalizing the addition of 

cycloate on the EPCRA section 313 list. 

15. Cyclohexanol. Monsanto opposes 

the listing of cyclohexanol because 

concentrations that led to tremors, 

central nervous system depression, 

lethargy, or hypothermia in rabbits, as 

cited in the proposed rule, are above the 

level of MED that EPA identified in the 

Draft Hazard Assessment Guidelines 

(Ref. 11) as high priority or moderate 

priority. Furthermore, the 

concentrations that led to reproductive 

impacts in rats were above the MED 

level of high priority. In addition, 

Monsanto states that the Industrial 

Health Foundation submitted to EPA's 

TSCA office the results of a 2-generation 

reproduction study demonstrating a 

NOEL of 500 ppm in air which should 

have been considered. The commenter 

claims that EPA has also not 

demonstrated that the effects 

mentioned, or concentrations at which 

they occurred, were serious or 

irreversible. 
61452 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

EPA agrees that the concentrations 

that led to tremors, central nervous 

system depression, lethargy, or 

hypothermia in rabbits are above the 

level of MED that EPA identifies in the 

Draft Hazard Assessment Guidelines 

(Ref. 11) as high priority for listing. 

However, while the 2,500 mg/kg/day 

dermal exposure is above the moderate 

priority MED guideline, the 997 ppm 

(438 mg/kg/day) is within this category. 

In addition to the neurotoxicity effects, 

as cited in the proposed rule, 

cyclohexanol also induces renal, 

hepatic, and myocardial effects at 

moderate dose levels (for example, 

inhalation of 0.59 mg/L of cyclohexanol 

induced degenerative changes in the 

livers and kidneys of rabbits). EPA 

considers these effects to be serious. In 

this case, based on a weight-of-evidence 

approach, EPA believes that 

cyclohexanol presents a sufficient 

hazard to warrant listing under EPCRA 

section 313 even though the reported 

values for neurotoxicity effects are in 

excess of the MEDs placing a chemical 

in the high priority grouping. 

EPA disagrees that the concentrations 

that led to reproductive impacts in rats 

and gerbils (15 mg/kg) as described in 

the pfoposed rule are above the MED 

range for high priority listing. EPA 

reiterates the overall reproductive 

toxicity of this chemical, based on a 

weight-of-evidence, supports the 

addition of cyclohexanol to the EPCRA 

section 313 list. 

The chemical tested in the 2- 

generation reproduction study 

submitted to the Agency by the 

Industrial Health Foundation, cited by 

the commenter, was cyclohexanone not 

cyclohexanol as claimed by the 

commenter. 

EPA reaffirms that there is sufficient 

evidence for listing cyclohexanol 

pursuant to EPCRA section 313 

pursuant to EPCRA section 313(d)(2)(B) 

based on the available chronic 

neurological, hepatic, renal, myocardial, 

and reproductive toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of cyclohexanol on the 

EPCRA section 313 list. 

16. Cyhalothrin. Zeneca Incorporated 

contends that the neurotoxicity signs 

observed in the 6-month and 1-year dog 

studies cited in the proposed rule 

occurred at doses that were "otherwise 

toxic as well" and do not provide any 

evidence of a specific neurotoxicity. 

Zeneca Incorporated implies that the 

presence of "otherwise toxic" signs 

reduces the significance of the 

neurotoxicity observed in the cited 

study. 

The phrase "otherwise toxic as well" 

was not defined by the commenter. The 

clinical signs of neurotoxicity observed 

in the dogs at 3.5 mg/kg/day (ataxia, 

muscle tremors, and convulsions in the 

1—year study cited in the proposed rule) 

and at 10 mg/kg/day (unsteadiness and 

trembling in the 6—month study cited in 

the proposed rule) are considered by 

EPA to be evidence of physiological 

neurotoxicity. Althaugh there were no 

pathologic changes in the nervous 

tissue, EPA considers these effects to be 

serious because they often precede 

pathologic neurotoxicity. With the 

exception of liquid feces, there were no 

reported toxic findings other than those 

related to neurotoxicity. 

EPA reaffirms that there is sufficient 

evidence for listing cyhalothrin on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available neurological toxicity data. 

Therefore, EPA is finalizing the addition 

of cyhalothrin on the EPCRA section 

313 list. 

17. Desmedipham. Nor-Am Chemical 

states that methemoglobin formation, 

which is cited by EPA as the basis for 

listing, is an entirely reversible effect 

which occurs only after prolonged and 

consistent exposure. Therefore, the 

commenter concludes that this finding, 

by itself, should not be used. 

Based on the 90—day dog study, cited 

in the proposed rule, EPA considers 150 

ppm to be a NOAEL. Methemoglobin 

values were only minimally higher than 

control levels and were not associated 

with an increase in Heinz bodies. In the 

1-year dog feeding study, after 13 weeks 

treatment at 300 ppm, methemoglobin 

was seen associated with 

histopathological changes (hemosiderin 

and hemopoiesis). While 

methemoglobinemia may be a reversible 

effect, it is nevertheless a serious effect, 

and in some cases irreversible damage 

may occur as a result of 

methemoglobinemia. 

Methemoglobinemia interfers with the 

oxygenating capacity of blood resulting 

in an undersupply of oxygen to the 

tissues. Therefore, methemoglobinemia 

is a toxic effect and not simply an 

indicator of exposure to desmedipham 

as concluded by the commenter. 

Therefore, EPA reaffirms that there is 

sufficient evidence for listing 

desmedipham on the EPCRA section 

313 list pursuant to EPCRA section 

313(d)(2)(B) based on the available 

hematological toxicity data. Therefore, 

EPA is finalizing the addition of 

desmedipham on the EPCRA section 

313 list. 

18. 2,2-Dibromo-3- 

nitrilopropionamide. Dow Chemical 

Company and Rohm Haas state that the 

corrosivity and irritancy of the 2,2- 

dibromo-3-nitrilopropionamide 

(DBNPA) solutions to the esophagus, 

pharynx, trachea, and lungs led to 

development of dyspnea in rats. The 

commenters imply that the dyspnea in 

rats should be discounted because it 

was caused by the method of 

administration rather than the toxicity 

of the chemical. 

The Agency agrees that the dyspnea 

observed in the 4—week and 13—week rat 

gavage studies cited in the proposed 

rule may have been due to severe 

irritation of the trachea and lungs from 

accidental or incidental delivery of 

small amounts of the DBNPA dosing 

solutions into the larynx, pharynx, 

trachea, and/or lungs during the 

procedure. However, this suggestion of 

possible cause can be neither refuted 

nor confirmed based upon the available 

data. Dyspnea is the basis for the LOEL 

in the study. One of the commenters 

agrees that DBNPA is corrosive, 

particularly to the eyes and, at the least, 

is severely irritating to the respiratory 

tract. This is consistent with the effects 

observed in the two subject studies. The 

Agency considers the finding of 

dyspnea in the 4- and 13—week studies 

to be of sufficient seriousness to warrant 

listing on the EPCRA section 313 list. 

EPA reaffirms that there is sufficient 

evidence for listing 2,2-dibromo-3- 

nitrilopropionamide on the EPCRA 

section 313 list pursuant to EPCRA 

section 313(d)(2)(B) based on the 

available chronic respiratory toxicity 

data. Therefore, EPA is finalizing the 

addition of 2,2-dibromo-3- 

nitriloproprionamide on the EPCRA 

section 313 list. 

19. Dfclofop-methyl. Nor-Am 

Chemical and Hoechst-Celanese 

contend that EPA interpreted the doses 

administered by gavage as diet 

concentrations (ppm) in the rat 

teratology study cited in the proposed 

rule. One commenter states the Agency 

should provide clarifications concerning 

"mortality" of the pups and the 

calculation of the actual test substance 

intake at different stages during the inlife phases during development in the 3- 

generation rat reproduction study. 

The commenter is correct in stating 

that the Agency erred in interpreting 

gavage doses as ppm in the rat 

teratology study. However, EPA still 

believes that the doses at which adverse 

effects occur are sufficiently low and the 

adverse effects reported are of sufficient 

seriousness to warrant listing. The 

developmental NOEL is 10 mg/kg/day 

and the LOEL is 32 mg/kg/day based on 

an increased incidence of a number of 

variations and malformations, as 

described in the proposed rule. While 

the maternal effects on body weight and 

food consumption at 32 mg/kg/day are 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61453 

transient and reversible, some of the 

developmental effects at this dose are 

irreversible. In the 3—generation rat 

reproduction study cited in the 

proposed rule, a decrease in pups born 

alive in the F ia, reduced pup weights 

(F, eand Za) and general retardation of 

physical development (F, aand 2a) was 

noted in offspring at 100 ppm (5 mg/kg/ 

day). The commenter considers the 

LOEL for this study to be 6.7 mg/kg/day. 

This dose resulted in decreased parental 

food consumption and body weight and 

there were no post partum pup 

mortalities. Additionally, there were no 

effects on fertility at the LOEL at any 

time during the three generations. 

The commenters further stated that 

EPA should "consider the validity" of 

the 30—day rat study cited in the 

proposed rule because heart, kidney, 

and adrenal weights were increased 

only at doses with no histopathological 

correlates and were due to the 

pharmacodynamic lipid metabolism of 

the test material by the liver. 

The increased relative heart, liver, 

and kidney weights at 80 ppm (4 mg/kg/ 

day) in the 30—day rat feeding study is 

further substantiated by a recent 90—day 

rat feeding study cited in the proposed 

rule with a LOEL of 80 ppm and a NOEL 

of 20 ppm (1 mg/kg/day). In the recent 

90—day study cited in the proposed rule, 

absolute and relative liver and kidney 

weight was increased in males and 

relative liver and kidney weight was 

increased in females at 80 ppm. These 

increased organ weights are evidence of 

a compound-related effect. The Agency 

interprets Hoechst-Celanese's own 

statements regarding the 30—day rat 

feeding study that "increased liver 

weights and centrilobular enlargement 

of hepatic cells at dietary concentrations 

of 80 ppm and higher" as evidence of 

toxicity. 

Hoechst-Celanese also contends that 

the effects in the renal cortex observed 

in the 90—day dog study cited in the 

proposed rule at 250 ppm (15 and 13.4 

mg/kg/day in males and females, 

respectively) did not occur at the 

highest concentration tested in the 1- 

year dog study (80 ppm, 4-5mg/kg/day) 

indicating that the finding in the 90—day 

study was not test substance related. 

EPA believes that the effects occurring 

in the renal cortex in the 90—day dog 

study at 13 to 15 mg/kg/day may not 

have appeared in the 1—year dog study, 

since the highest dose tested was 4-5 

mg/kg/day. If higher doses were 

employed in the 1—year study, then 

renal effects could possibly have 

occurred. However, the results of the 1— 

year study do not negate the 90—day 

results, since the dose levels used in the 

90—day study were so much higher. 

Hoechst-Celanese also states that the 

Agency used an invalid (flawed) 

reproductive toxicity study to support 

the listing. The commenter indicates 

that the study was compromised by 

infection of the rat colony with RCV/ 

SDA virus. They further state that 

another reproductive toxicity study, 

which EPA did not cite in the proposed 

rule, should have been evaluated in 

which the fetotoxic NOEL was 30 mg/ 

kg/day instead of greater than 5 mg/kg/ 

day as in the original study. 

The Agency does not find the original 

study to be invalid. The data were 

considered to be valid for regulatory 

purposes. In addition, the Agency found 

the fetotoxic NOEL in the study referred 

to by the commenter, not cited by EPA 

in the proposed rule, to be 5 mg/kg/day, 

not 30 mg/kg/day as stated by the 

commenter. 

EPA reaffirms that there is sufficient 

evidence for listing diclofop-methyl on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available developmental, hepatic, 

and renal toxicity data. Therefore, EPA 

is finalizing the addition of diclofopmethyl on the EPCRA section 313 list. 

20. Diisocyanates. EPA originally 

proposed to list three diisocyanates 

(hexamethylene-1,6-dii socyanate, 

isophorone diisocyanate, and 1,1- 

methylene bis(4-isocyanatocyclohexane) 

on the basis of acute toxicity pursuant 

to EPCRA section 313(d)(2)(A). As an 

alternative, EPA proposed to create a 

delimited diisocyanates category 

containing these 3 diisocyanates and 17 

other diisocyanates based on chronic 

pulmonary irritation pursuant to EPCRA 

section 313(d)(2)(B). EPA is finalizing 

addition of the delimited diisocyanate 

category based on chronic pulmonary 

toxicity and therefore has not addressed 

comments concerning the acute toxicity 

of any of the diisocyanates. EPA 

believes that diisocyanates are best 

added as a category because the 

members of this category are 

structurally similar (i.e., each contains 

the diisocyanate functionality), they 

induce a similar toxic effect (chronic 

pulmonary irritation), and their toxicity 

is due to the diisocyanate portion of the 

molecule common to all members. 

Chemical Manufacturers Association 

Hexamethylene-1,6-Diisocyanate Panel, 

Dow Chemical Company, Monsanto, 

Olin Chemicals, Sealed Air Corporation, 

Huls America Incorporated, and the 

Diisocyanates Panel of the Chemical 

Manufacturers Association oppose 

EPA's alternative proposal to create a 

diisocyanate category and believe that 

individual diisocyanates should be 

evaluated and included on the EPCRA 

section 313 list only if the diisocyanate 

independently satisfies the statutory 

listing criteria. The commenters state 

that in adding a broad category of 

diisocyanates, EPA ignores its statutory 

mandate to evaluate the individual 

toxicity of each chemical and to 

evaluate the exposure potential to the 

EPCRA community by each individual 

chemical. The commenters contend that 

the category would mislead the public 

as to the amount and type of toxic 

chemicals to which communities may 

be exposed. The commenters contend 

that data collected in aggregate is 

confusing and difficult to use or 

interpret. Commenters state that adding 

a category of diisocyanates based upon 

the isocyanate functionality is based on 

the chronic effects associated with 

exposures to a limited number of 

diisocyanates and that this method 

unjustifiably equates toxicity across an 

entire class of chemicals that have 

different properties and effects. 

Commenters state that diisocyanates 

encompass a diverse group of chemicals 

which vary significantly in physical and 

chemical properties and in potential 

toxicity. Commenters state that the 

available evidence on the pulmonary 

effects or toxicity of individual 

diisocyanates (toluene diisocyanate, 

methylenebis(phenylisocyanate), and 

isophorone diisocyanate) does not 

support the addition of a diisocyanates 

category. The commenters also state that 

EPA has not cited any data to support 

the assertions that diisocyanates cause 

these effects. Commenters state that 

individual diisocyanates have been 

shown to respond differently in 

mutagenicity studies and that other 

toxicological differences would be 

expected among individual 

diisocyanates, because of differences in 

their ability to penetrate membranes, the 

capacity of organisms to metabolize 

them, the specific reactivity of the 

diisocyanate groups, etc. Commenters 

state that in the proposed rule EPA 

recognized these differences by stating 

that some diisocyanates are classiPied as 

probable carcinogens and others are not. 

The Wisconsin Department of Natural 

Resources supports EPA's alternative 

proposal to create a diisocyanate 

category and would prefer this manner 

of listing to listing each diisocyanate 

separately. 

As discussed in unit IV.C. of the 

preamble, EPA believes that it is acting 

reasonably within its discretion in 

listing a category of chemicals by 

showing that at least one member of the 

category meets the listing criteria of 

EPCRA section 313 and that the other 

members can reasonably be expected to 

exhibit the same or similar toxic effect, 
61454 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

EPA believes that the available data on 

the chronic pulmonary toxicity for 

several members of the diisocyanates 

category are sufficient for listing under 

EPCRA section 313(d)(2)(B). EPA also 

believes that the diisocyanate moiety, 

common to all members of the category, 

is responsible for the observed chronic 

pulmonary toxicity. Therefore, EPA 

believes that it is reasonable to 

anticipate that all members of the 

diisocyanate category will exhibit 

chronic pulmonary toxicity and that 

creating a category of diisocyanates is 

the most appropriate way to list this 

class of chemicals. As stated in Unit 

IV.B. of the preamble, EPA does not 

believe that it is required to consider 

exposure for chemicals that are 

moderately high to highly toxic based 

on a hazard assessment when 

determining if a chemical can be added 

for chronic effects pursuant to EPCRA 

section 313(d)(2)(B); therefore, EPA is 

not required to evaluate the exposure 

potential for the members of the 

diisocyanates category. EPA believes 

that, because each member of the 

diisocyanates category has the same 

functional groups and can reasonably be 

anticipated to cause similar toxic 

effects, the diisocyanates category will 

not mislead the public as to the amounts 

and type of chemicals released and will 

not be confusing to use or interpret. 

EPA agrees that the diisocyanates are 

a diverse group of chemicals which vary 

in physical and chemical properties. 

However, EPA also believes that the 

reactive portion of diisocyanate 

chemicals is the diisocyanate moiety 

itself and that the rest of the molecule 

does not affect the reactivity of this 

portion of the molecule. EPA stands by 

its interpretation of the literature, as 

cited in the proposed rule and 

background material, on the adverse 

pulmonary effects of diisocyanates and 

believes that this information supports 

the addition of a diisocyanates category. 

The Agency agrees that structural 

differences among individual 

diisocyanates may indeed affect their 

absorption and metabolism. However, 

since absorption and metabolism are not 

necessary for chronic pulmonary 

irritation to occur, the effect of 

structural differences upon either 

absorption or metabolism is not an issue 

in this case. The Agency agrees with the 

commenter that there are differences in 

the carcinogenicity/mutagenicity of 

toluene diisocyanate, 

methylenebis(phenylisocyanate), and 

isophorone diisocyanate and that these 

differences are most likely the result of 

the differences in absorption and 

metabolism. However, since neither of 

these endpoints is the basis for listing 

diisocyanates as a category and since 

chronic pulmonary irritation can occur 

without absorption and metabolism 

taking place, these issues do not affect 

the Agency's overall concern for 

diisocyanates or its decision to list them 

as a category on the EPCRA section 313. 

As EPA discussed in the proposed 

rule, there currently are four other 

diisocyanates listed on the EPCRA 

section 313 list, these are: 

Toluene-2,4-diisocyanate (000584-84- 

9) 

Toluene-2,6-diisocyanate (000091-08- 

7) 

Toluene diisocyanate (mixed isomers) 

(026471-82-5) 

Methylenebis (phenylisocyanate) 

(000101-68-8) 

EPA is leaving the toluene 

diisocyanate compounds listed 

individually. In addition to the effects 

discussed above, these compounds have 

been shown to be carcinogenic. EPA 

believes it is appropriate to continue to 

individually list carcinogenic 

diisocyanates because they exhibit a 

different toxic endpoint than other 

members of the category. 

Methylenebis(phenylisocyanate) has not 

been shown to be a carcinogen and as 

EPA discussed in the proposed rule it is 

being moved into the diisocyanate 

category. 

EPA reaffirms its determination that 

diisocyanates meet the criteria of 

EPCRA section 313(d)(2)(B). Therefore, 

EPA is finalizing the addition of the 

diisocyanates category that consists of 

the following chemicals: 

1,3-Bis(methylisocyanate)cyclohexane 

(CAS No. 038661-72-2) 

1,4-Bis(methylisocyanate)cyclohexane 

(CAS No. 010347-54-3) 

1,4-Cyclohexane diisocyanate (CAS 

No. 002556-36-7) 

Diethyldiisocyanatobenzene (CAS No. 

134190-37-7) 

4,4'-Diisocyanatodiphenyl ether (CAS 

No. 004128-73-8) 

2,4'-Diisocyanatodiphenyl sulfide 

(CAS No. 075790-87-3) 

3 , 3'-Dimethoxybenzi dine-4,4'- 

diisocyanate (CAS No. 000091-93-0) 

3 , 3'-Dimethyl-4, 4'-diphenylene 

diisocyanate (CAS No. 000091-97-4) 

3 , 3'-Dimethyldiphenylmethane-4,4'- 

diisocyanate (CAS No. 000139-25-3) 

Hexamethylene-1,6-diisocyanate (CAS 

No. 000822-06-0) 

Isophorone diisocyanate (CAS No. 

004098-71-0) 

Methylenebis(phenylisocyanate) (CAS 

No. 000101-88-8) 

4 -Methyldiphenylmethane-3 ,4- 

diisocyanate (CAS No. 075790-84-0) 

1,1-Methylene bis(4- 

isocyanatocyclohexane) (CAS No. 

005124-30-1) 

1,5-Naphthalene diisocyanate (CAS 

No. 003173-72-6) 

1,3-Phenylene diisocyanate (CAS No. 

000123-61-5) 

1,4-Phenylene diisocyanate (CAS No. 

000104-49-4) 

Polymeric diphenylmethane 

diisocyanate (CAS No. 009016-87-9) 

2, 2,4-Trimethylhexamethylene 

diisocyanate (CAS No. 016938-22-0) 

2, 4,4-Trimethylhexamethylene 

diisocyanate (CAS No. 015646-96-5) 

In reassessing the Agency's proposal 

in light of comments received and other 

information, it has become clear to EPA 

that the effect of concern (chronic 

pulmonary toxicity) is related to the 

diisocyanate moiety and therefore 

common to all diisocyanate compounds 

not just those included in the delimited 

category finalized in this rule. EPA 

believes that many other diisocyanates 

not covered by the category may meet 

the EPCRA section 313 criteria. 

Therefore, EPA believes that it may be 

more appropriate to create a 

diisocyanates category based on a 

molecular formula description rather 

than a more limited category comprised 

of certain named diisocyanates. 

However, EPA did not include a 

molecular formula category option in its 

proposal and therefore has not given the 

public an opportunity to comment on 

such a category. Accordingly, in this 

action EPA is finalizing the addition of 

a delimited category consisting of the 20 

diisocyanates on which the Agency has 

received comment and for which the 

Agency has made a final determination 

that the chemicals meet the EPCRA 

section 313 criteria for listing. EPA 

believes that the chemicals covered by 

this category represent the majority of 

diisocyanates in production and that 

listing the delimited category will 

provide meaningful data to the public. 

At a later date, EPA will consider 

whether a more broad diisocyanates 

category is warranted and appropriate. 

21. Dimethylamine. Olin Chemicals 

does not believe that the data cited by 

EPA are sufficient to prove that 

dimethylamine causes ". . . significant 

adverse acute human health effects at 

concentration levels that are reasonably 

likely to exist beyond facility site 

boundaries. . . ." The commenter did 

not substantiate this contention. The 

commenter requests a more rigorous 

review of the available data before 

adding dimethylamine to the EPCRA 

section 313 list. 

The Agency is not proposing to list 

dimethylamine pursuant to section 

313(d)(2)(A), therefore the Agency does 

not have to show that the chemical 

causes ". . .significant adverse acute 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61455 

human health effects at concentration 

levels that are reasonably likely to exist 

beyond facility site boundaries...... 

EPA disagrees that the data cited are 

insufficient to prove that dimethylamine 

is likely to cause significant human 

health effects. As articulated in the 

proposed rule, dimethylamine is 

corrosive to mucous membranes, the 

eyes and respiratory tract. Chronic 

exposure results in dose-related lesions 

in the respiratory and olfactory 

epithelium and is associated with 

centrilobular fatty degeneration and 

necrosis of parenchymal cells after 

inhalation exposure for 18 to 20 weeks. 

Rats exposed to oral doses as low as 

0.035 mg/kg for 8 months showed 

neurological effects including changes 

in conditioned reflexes while single 

doses of 240 to 260 mg/kg caused 

excitement and muscle weakness in 

mice, rats, guinea pigs, and rabbits. 

Dimethylamine is corrosive to the 

respiratory tract, exhibits hepatotoxicity 

and is neurotoxic. EPA reaffirms that 

there is sufficient evidence to list 

dimethylamine on the EPCRA section 

313 list pursuant to EPCRA section 

313(d)(2)(B) based on the available 

chronic respiratory, hepatic, and 

neurological toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of dimethylamine on the 

EPCRA section 313 list. 

22. 2, 6-Dimethylphenol. One 

commenter, General Electric, states that 

the proposed addition of 2,6- 

dimethylphenol to EPCRA section 313 

is based upon a"low confidence" study 

and a 10-week subchronic study which 

the ITC found insufficient to evaluate. 

The commenter is concerned that EPA 

is using the same data set in two rule 

makings; TSCA section 4 and the 

decision to list on the EPCRA section 

313 list. The commenter quotes the ITC 

finding that the studies are of "low 

confidence." The Agency used these 

data to derive an oral RfD of 0.0006 mg/ 

kg/day. IRIS confidence in the studies is 

low because of lack of experimental 

detail. EPA also concedes that the ITC 

had low confidence in these studies for 

its purposes which are risk assessment. 

However, EPA believes that these data 

are sufficient for the purposes of hazard 

assessment and concludes that these 

studies when considered together 

present a sufficient weight of the 

evidence determination for listing 2,6- 

dimethylphenol on EPCRA section 313 

because 2,6-dimethylphenol causes 

hepatotoxicity and nephrotoxicity at 

relatively low dose levels. EPA reaffirms 

that there is sufficient evidence to list 

2,6-dimethylphenol on the EPCRA 

section 313 list pursuant to EPCRA 

section 313(d)(2)(B) based on the 

available hepatotoxicity and 

nephrotoxicity data for this chemical. 

Therefore, EPA is finalizing the addition 

of 2,6-dimethylphenol on the EPCRA 

section 313 list. 

23. Dinoseb. Uniroyal Chemical 

Company objects to the listing of 

dinoseb (dinoseb is the trade name for 

dinitrobutyl phenol) because the sale of 

dinoseb as a herbicide or insecticide is 

prohibited and remaining inventories 

have been used up or disposed. 

However, the commenter notes that 

dinitrobutyl phenol continues to be 

produced and sold for uses not subject 

to FIFRA (e.g. as an inhibitor in the 

polymer industry). 

EPA believes that the chemical is 

more properly listed by its common 

chemical name, dinitrobutyl phenol, 

rather than its trade name. However, 

EPA also recognizes that this chemical 

is well known as dinoseb. Therefore, 

EPA is finalizing the addition of this 

chemical as dinitrobutyl phenol 

(dinoseb). 

24. Disodium 

cyanodithiomidocarbamate. Buckman 

Laboratories International, Incorporated 

contends that the compound was not 

teratogenic in either the rat or rabbit 

studies cited in the proposed rule. 

Specifically, they contend that skeletal 

variations and increased resorptions 

should be considered an artifact (i.e., 

occurring by chance rather than as a 

result of treatment), and should not be 

considered as evidence of 

developmental toxicity. 

EPA disagrees with the commenter. In 

both the rabbit and rat teratology studies 

cited in the proposed rule, 

developmental effects were observed at 

levels that were above the maternally 

toxic level (greater than 3 mg/kg for 

rabbits and greater than 6 mg/kg for 

rats). Furthermore, the effects observed 

cannot be considered an artifact, 

because in rabbits receiving 30 mg/kg, 

there is a continuation of the effects 

observed at 10 mg/kg, with an 

accompanying increase in the severity 

of the developmental findings. This 

shows that the effects are related to the 

dose received and do not occur by 

chance. 

EPA reaffirms that there is sufficient 

evidence for listing disodium 

cyanodithioimidocarbonate on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available developmental toxicity 

data. Therefore, EPA is finalizing the 

listing of disodium 

cyanodithiomidocarbamate on the 

EPCRA section 313 list. 

25. Ethyl dipropylthiocarbamate 

(EPTC). Zeneca Incorporated states that 

in the study cited by EPA in the 

proposed rule in which rats were orally 

administered the test compound for 2 

years, brain cholinesterase reductions 

were slight and only occurred at 120 

mg/kg/day, not 15 mg/kg/day. The 

commenter claims that neuromuscular 

changes occurred only after extended 

exposure, and are not relevant to listing 

on the EPCRA section 313 list. 

The commenter is referring to two 

studies cited in the proposed rule. A 2- 

year rat feeding study established a 

NOEL of 5 mg/kg/day and a systemic 

LOEL of 25 mg/kg/day with 

neuromuscular atrophy/degeneration 

and decreased body weight gains as the 

findings. At 125 mg/kg/day, the effects 

included chronic myocarditis, cataracts, 

increased SGOT and decreased RBC 

cholinesterase (ChE) activity. The 

neuromuscular and cardiac changes are 

serious and potentially irreversible 

effects. The second study is a 3—month 

feeding study in Sprague-Dawley rats. 

Although this study was not identified 

in the proposed rule, the results of the 

study were described. The systemic 

NOEL in this study was 3 mg/kg/day, 

and the LOEL was 15 mg/kg/day. The 

effects seen included increase in 

cardiomyopathy and decreased weight 

gain and food consumption. As noted by 

the commenter, brain ChE depression in 

this study in females was slight and 

occurred at 120 mg/kg/day and, taken 

by itself, is not sufficient for listing, 

however, when considered with other 

effects in a weight-of-evidence 

approach, this endpoint is supportive of 

listing. The commenter further states 

that the 2—year dietary rat study is old 

and has been superseded by another 

study (Ref. 8), in which the NOEL was 

25 mg/kg/day. 

The Agency agrees with the 

commenter's comment regarding the 

replacement of the older study with a 

newer study, but disagrees with the 

commenter's NOEL. The Agency's 

NOEL for this study is 5 mg/kg/day and 

not 25 mg/kg/day. However, the results 

of the older study demonstrate that 

heart effects of EPTC are seen in more 

than one study. 

The commenter further states that in 

the 2-generation rat reproduction study, 

cardiomyopathy was observed only in 

the FIA females and was incidental to 

treatment. EPA disagrees with this 

contention. The investigators did not 

look for this effect in other generations. 

Thus, there is no reason to conclude 

that this effect was not manifested in 

other generations. In addition, this type 

of adverse effect has been seen in other 

studies, such as the 2—year rat study and 

the 3-month rat study discussed above 

and cited in the proposed rule. 
61456 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

The Agency believes that the 

cardiopathic finding at 10 mg/kg/day, 

degenerative cardiomyopathy, is the 

pivotal finding of toxicological 

significance for EPTC. EPA believes that 

this is a serious effect. Therefore, this 

effect cannot be considered incidental to 

treatment. 

The commenter further states that the 

neurological effects seen in the study 

are not relevant to the EPCRA section 

313 due to prolonged exposure and the 

cardiovascular observations occurred at 

the highest dose tested in the studies 

cited. 

The cardiovascular effects occur after 

relatively short exposures at doses of 9 

mg/kg/day in male rats and 18 mg/kg/ 

day in female rats. These dose levels are 

sufficiently low and the adverse effects 

are serious and potentially irreversible. 

The Agency considers the neurotoxicity 

due to prolonged exposure to be 

relevant for purposes of listing on the 

EPCRA section 313 list. Releases of 

chemicals that induce adverse effects 

after prolonged exposure is among the 

type of information that Congress 

intended TRI to include. 

EPA reaffirms that there is sufficient 

evidence for listing EPTC on the EPCRA 

section 313 list pursuant to EPCRA 

section 313(d)(2)(B) based on the 

available neurological, cardiovascular, 

and reproductive toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of EPTC on the EPCRA 

section 313 list. 

26. Fenoxaprop-ethyl. HoechstCelanese and Nor-Am Chemical indicate 

that the chronic interstitial nephritis 

reported at 80 ppm in the 3—month dog 

study cited in the proposed rule "was 

[a] non substance-related, incidental 

finding since 12/24—months chronic 

treatment produced no comparable 

pathogenesis" and that "liver and 

kidney were not the target organs in 

dogs; effects were confined to reduced 

body weight gains at the highest 

concentration (75 ppm)." 

EPA disagrees with the commenters. 

The dietary levels of fenoxaprop-ethyl 

in the studies compared by the 

commenter were 0, 16, 80, and 400 ppm 

and 0, 3, 15, and 75 ppm for the 3— 

month and 24—month studies, 

respectively; both studies are cited in 

the proposed rule. The microscopic 

findings in the 3—month study indicated 

that there was a dose response for 

chronic interstitial nephritis with 

inflammatory changes in the medulla 

and inner cortex. One half of the dogs 

were affected at 400 ppm, which is 

much higher than the highest dietary 

level in the 24—month study (75 ppm). 

Therefore, the inflammatory changes in 

the kidneys of treated dogs at 80 and 

400 ppm in the 3—month study appear 

to be related to the ingestion of 

fenoxaprop-ethyl and, therefore, the 

kidney appears to be a target organ. The 

Agency did not cite liver effects in dogs 

as a basis for listing. 

EPA reaffirms that there is sufficient 

evidence for listing fenoxaprop-ethyl on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available renal and developmental 

toxicity data for this chemical, and 

pursuant to EPCRA section 313(d)(2)(C) 

based on the available environmental 

toxicity data. Therefore, EPA is 

finalizing the addition of fenoxapropethyl on the EPCRA section 313 list. 

27. Fenoxycarb. Ciba-Geigy 

Corporat.ion and Miles Incorporated 

disagree with the listing of fenoxycarb 

on the EPCRA section 313 list because 

they believe that the adverse hepatic 

effects observed in mice and rats (3- 

month dietary study and 2-year 

oncogenicity study, both cited in the 

proposed rule) are not sufficiently 

serious to support listing. They note that 

no evidence of neoplastic lesions was 

reported in the chronic studies. They 

further state that delayed pinna 

unfolding in the reproductive toxicity 

study in rats cited in the proposed rule 

is a reflection of slower growth only, 

and therefore should not be used to 

support listing. 

The Agency disagrees that the 

evidence does not support a finding that 

section 313(d)(2)(B) are satisfied. The 

effects in the chronic studies include 

focal necrosis, changes which are 

considered by the Agency to be serious 

and potentially irreversible in nature. 

The liver effects in the subchronic study 

demonstrate the progression of changes 

leading to necrosis in the chronic study. 

The Agency considers these to be 

serious adverse effects. 

The developmental effects (slight 

delays in pinna unfolding) were said by 

the commenter not to reflect 

developmental effects since 

development was complete and 

function apparently unaffected, and that 

these effects were considered a 

reflection of slower growth (reduced 

body weights) as were the differences in 

relative organ weights. The Agency 

considers reduced rat pup body weight 

and slower growth with resulting 

differences in organ weight to be effects 

that are indicators of potential hazard. 

The Agency's Developmental Risk 

Assessment Guidelines (Ref. 6) state "A 

change in offspring body weight is a 

sensitive indicator of developmental 

toxicity, in part because it is a 

continuous variable. In some cases, 

offspring weight reduction may be the 

only indicator of developmental 

toxicity. While there is always a 

question as to whether weight reduction 

is a permanent or transitory effect, little 

is known about the long-term 

consequences of short-term fetal or 

neonatal weight changes. Therefore, 

when significant weight reduction 

effects are noted, they are used as a 

basis to establish the NOAEL." EPA, 

therefore, considers evidence of delayed 

development, including delayed pinna 

unfolding and reduced body weight 

gain, to be significant signs of 

developmental toxicity. 

EPA reaffirms that there is sufficient 

evidence for listing fenoxycarb on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available hepatic and developmental 

toxicity data for this chemical. 

Therefore, EPA is finalizing the addition 

of fenoxycarb on the EPCRA section 313 

list. 

28. Fomesafen. Zeneca Incorporated 

states that clear species differences are 

evident which would suggest that 

peroxisome proliferation and 

consequential liver toxicity is not 

relevant to man. 

ZenecaIncorporated did not provide 

any new evidence which supports the 

lack of relevance of these effects to man. 

In the absence of evidence to the 

contrary, the Agency believes that liver 

toxicity, which is associated with 

peroxisome proliferation is relevant to 

the assessment of potential human 

health effects. As there is evidence of 

hepatic toxicity in three different rat 

studies at varying dosages and durations 

and one dog study, EPA reaffirms that 

there is sufficient evidence for listing 

fomesafen on the EPCRA section 313 list 

pursuant to EPCRA section 313(d)(2)(B) 

based on the available hepatic toxicity 

data for this chemical. Therefore, EPA is 

finalizing the addition of fomesafen on 

the EPCRA section 313 list. 

29. n-Hexane. The National Oilseed 

Processors Association and The 

National Cotton Council of America 

contend that EPA failed to perform a 

detailed hazard evaluation that 

culminated in a weight-of-evidence 

determination regarding the toxicity of 

n-hexane as required under the 

Agency's Draft Hazard Assessment 

Guidelines (Ref. 11). Commenters state 

that portions of EPA's support 

document were taken almost verbatim 

from the Agency's IRIS data base and 

that the Agency appears to have relied 

extensively on the IRIS summary 

previously prepared for n-hexane. 

Commenters state that EPA should have 

evaluated the merits and conclusions of 

each study separately. 

The IRIS data base that EPA cited in 

support of the listing of n-hexane 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61457 

represents the Agency's weight-ofevidence hazard determination for 

chemicals contained in the data base. 

The information contained in the IRIS 

data base was developed after the 

Agency's thorough review of the 

available data on n-hexane. Therefore, 

by relying on the IRIS data base EPA did 

not fail to perform a detailed hazard 

evaluation of n-hexane as required by 

the Draft Hazard Assessment Guidelines 

(Ref. 11). 

The same commenters state that based 

on EPA's screening criteria included in 

the Draft Hazard Assessment Guidelines 

(Ref. 11) if a substance produces 

neurotoxic effects at doses that are 

greater than 500 mg/kg/day (i.e., if the 

lowest observable adverse effect level is 

500 mg/kg/day), then the substance 

would be placed in the "insufficient for 

listing" category. Commenters went on 

to state that most of the studies that 

EPA-cited in support of the listing of nhexane indicated that n-hexane 

produces neurotoxic effects only at very 

high dose levels and in many cases 

significant effects are only seen at doses 

that exceed 500 mg/kg/day. 

EPA believes that the commenters 

have misinterpreted the screening 

criteria contained in the Draft Hazard 

Assessment Guidelfnes (Ref. 11). The 

criteria are based on the MED levels 

which are not LOAELs. These MED 

values are derived from the LOAELs 

and, therefore, the direct comparison of 

the screening criteria with LOAELs is 

inappropriate. However, EPA notes that 

significant effects from n-hexane are 

seen in quantities significantly less than 

500 mg/kg/day, for example, a LOAEL 

of 204 mg/m3(58 ppm, LOAEL(ADJ) of 

73 mg/m3 ) was established for certain 

electrophysiological alterations in 

humans. 

These commenters made numerous 

specific comments conceming the 

adequacy of the studies summarized in 

IRIS used to support a chronic 

neurotoxicity finding for n-hexane. 

Commenters state that n-hexane is only 

toxic at very high levels if at all and that 

the data are not sufficient to support 

listing under EPCRA section 313. The 

commenters state that EPA failed to 

show how the data contained in the 

Support Document for the Addition of 

Chemicals from Section 112(b) of the 

Clean AirAct Amendments and 

Chlorinated Paraffins to EPCRA Section 

313 (Ref. 12) and the IRIS data base 

compare with the criteria for adding 

substances to the EPCRA section 313 list 

and how the Agency evaluated these 

studies in light of such criteria. 

In the Response to Comment 

Document (Ref. 14), EPA has addressed 

the specific comments concerning the 

adequacy of the studies used to support 

a chronic neurotoxicity finding for nhexane. EPA agrees with the 

commenters that some of the studies 

included in the data base for n-hexane 

have limitations. However, the review of 

the comments and data have not 

changed EPA's position that the weightof-evidence supports a finding of 

chronic neurotoxicity for n-hexane. The 

weight-of-evidence determination 

contained in the Agency's IRIS data base 

is the basis for determining that nhexane can reasonably be anticipated to 

cause neurotoxicity in humans. EPA 

reaffirms that there is sufficient 

evidence for listing n-hexane on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available neurotoxicity data for this 

chemical. Therefore, EPA reaffirms its 

determination that n-hexane meets the 

listing requirements of EPCRA section 

313. 

DuPont states that if EPA adds nhexane (CAS No. 110-54-3) to the 

EPCRA section 313 list the Agency 

should clarify that isomers of n-hexane 

are not included in the addition of nhexane. 

EPA notes that the listing of n-hexane 

is for the straight chain (i.e., "n") isomer 

of hexane only as the chemical name 

and CAS number indicate. EPA does not 

believe that any special qualifier is 

needed to make the distinction between 

n-hexane and other isomers of hexane 

that are not included in this listing. 

30. 3-I o d o- 2- pro p yn yl 

butylcarbamate. Troy Corporation 

disagrees with the Agency's conclusion 

that no NOEL was achieved in the rat 

chronic toxicity/carcinogenicity study 

cited in the proposed rule. The 

commenter states that the nonneoplastic changes observed at the 40 

mg/kg/day and 80 mg/kg/day dose 

levels, while also present at the 20 mg/ 

kg/day dose level (lowest dose tested), 

were not statistically significant and 

therefore a NOEL was clearly 

established at this dose. The commenter 

also contends that non-neoplastic 

lesions of the stomach in rats are not 

relevant to humans. 

The Agency agrees with the 

commenter that the increases in 

nonneoplastic changes reported at 20 

mg/kg/day were not statistically 

significant. However, the lack of a study 

NOEL was based upon decreased bodyweight gain in males at 20 mg/kg/day 

(the lowest dose tested), not the 

nonneoplastic lesions. The nonneoplastic lesions reported at 40 and 80 

mg/kg/day are still considered serious 

enough to support a listing on the 

EPCRA section 313 list. 

The same commenter states that the 

simple findings of increased liver-tobody weight ratio found in the 

subchronic oral toxicity study in rats 

cited in the proposed rule as well as the 

incidence of non-neoplastic stomach 

irritation found in the chronic toxicity/ 

carcinogenicity study cited in the 

proposed rule in rats is not of sufficient 

seriousness to warrant EPCRA section 

313 listing. The commenter claims that 

neither study cited demonstrates a 

sufficiently known or reasonably 

anticipated adverse health effect in 

humans to warrant section 313 listing. 

EPA disagrees. The commenter 

provides no basis for the contention that 

the nonneoplastic lesions of the 

stomach in rats are not relevant to 

humans. The incidence of these lesions 

was dose dependent, and was apparent 

at both sacrifices. Moreover, incidence 

increased with duration of treatment. 

The Agency considers this effect to be 

serious in nature and not readily 

reversible, and therefore the chemical 

warrants listing. The liver-to-body 

weight ratio from the subchronic study 

is not in itself sufficient to warrant 

listing on the EPCRA section 313 list but 

is provided as corroborating 

information. 

EPA reaffirms that there is sufficient 

evidence for listing 3-iodo-2-propynyl 

butylcarbamate 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 3-iodo-2-propynyl butylcarbamate on 

the EPCRA section 313 list. 

31. Iron pentacarbonyl. International 

Specialty Products contends that iron 

pentacarbonyl cannot reasonably be 

anticipated to cause significant adverse 

human health effects at concentration 

levels that are likely to exist beyond 

facility site boundaries because it 

rapidly decomposes. 

EPA disagrees. The Agency 

considered the instability of iron 

pentacarbonyl under certain conditions, 

such as high temparature and/or 

prolonged exposure to direct sunlight, 

in its original modeling of exposure to 

iron pentacarbonyl cited in the 

proposed rule. EPA believes that its 

modeling was based on reasonable 

reactivity data. EPA reiterates that its 

exposure assessment indicates that iron 

pentacarbonyl can reasonably be 

anticipated to be present at facility 

boundaries at concentration levels that 

would cause an adverse effect. EPA 

reaffirms that iron pentacarbonyl is 

sufficient for listing on the EPCRA 

section 313 list pursuant to EPCRA 

section 313(d)(2)(A) based on available 

acute toxicity and exposure data for this 
61458 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

chemical. Therefore, EPA is finalizing 

the addition of iron pentacarbonyl on 

the EPCRA section 313 list. 

32. Lithium carbonate. FMC 

Corporation contends that although 

lithium is toxic at therapeutic levels, 

naturally occurring levels are below the 

toxic range and therefore, lithium 

carbonate poses no threat to the general 

population. The commenter also 

contends that there is no evidence that 

lithium carbonate is "known to cause or 

can reasonably be anticipated to cause 

significant adverse acute human health 

effects at concentration levels that are 

reasonably likely to exist beyond facility 

site boundaries as a result of 

continuous, or frequently recurring, 

releases." Thus, the commenter feels 

that there is no basis for the listing of 

lithium carbonate on the EPCRA section 

313 list. 

The Agency is not proposing to list 

lithium carbonate on the basis of acute 

effects but on the basis of 

developmental effects. Therefore, the 

Agency does not need to determine that 

lithium carbonate is "known to cause or 

can reasonably be anticipated to cause 

significant adverse acute human health 

effects at concentration levels that are 

reasonably likely to exist beyond facility 

site boundaries as a result of 

continuous, or frequently recurring, 

releases," but rather must satisfy the 

section 313(d)(2)(B) criteria. 

As the commenter noted, lithium 

carbonate is a well-known 

developmental toxicant in both animals 

and humans at therapeutic levels and 

can cause life-threatening cardiac 

abnormalities in the developing human 

fetus. The commenter argues that 

lithium is toxic at therapeutic levels but 

not at naturally "occurring levels." The 

Agency agrees that lithium may be toxic 

at therapeutic levels but also recognizes 

that use of lithium in a therapeutic 

setting is carefully controlled. Levels 

observed in a therapeutic setting may 

have little or no relationship to levels 

seen in an uncontrolled release setting. 

Furthermore, both the efficacy of 

lithium and its associated toxicity in 

humans is dependent upon individual 

sensitivity and can vary widely from 

individual to individual making 

uncontrolled release even more 

problematic. EPA reaffirms that there is 

sufficient evidence to list lithium 

carbonate under EPCRA section 313 

pursuant to EPCRA section 313(d)(2)(B) 

based on the available developmental 

toxicity data for this chemical. 

Therefore, EPA is finalizing the addition 

of lithium carbonate on the EPCRA 

section 313 list. 

33. Metam sodium. Buckman 

Laboratories International, Incorporated 

and Zeneca Incorporated state that the 

developmental toxicity studies cited in 

support of listing for metam sodium 

were rejected by the Agency to support 

the registration of a pesticide under 

FIFRA, and therefore should not be 

used. Further, they state that these data 

have been superseded by two new 

studies that have been accepted by the 

Agency, and that only the new studies 

should be considered for listing of 

metam sodium. 

The two earlier studies referred to by 

the commenters and cited in the 

proposed rule were submitted to the 

Agency under FIFRA. EPA's evaluation 

of those studies for purposes of FIFRA 

indicated that they did not fully satisfy 

the guidelines for developmental 

toxicity studies (Ref. 6); however, EPA 

did not reject these studies. EPA 

considers them sufficient as part of a 

weight-of-evidence evaluation, in 

determining the developmental toxicity 

of this chemical. The two new studies 

cited by the commenter have been 

reviewed by the Agency. The Agency 

found these studies to fully satisfy the 

guidelines (Ref. 6). However, these new 

studies do not supersede the previous 

studies nor did the Agency ignore them. 

Rather, all four studies were used 

together as part of the Agency's weightof-evidence to evaluate the chemical. 

EPA does not ignore indications of 

potential toxicity simply because of 

study design flaws. A full discussion of 

these studies is contained in the 

Response to Comment Document ( Ref. 

14). 

Zeneca Incorporated further stated 

that the rat teratology study was a 

gavage study and not a dietary study. 

The commenter claims that this is an 

unrealistic route of human exposure. 

The comrnenter is correct in stating 

that the rat teratology study was a 

gavage study and not a dietary study. 

This does not diminish its 

appropriateness for consideration in the 

hazard assessment for listing. In fact, 

EPA requests that developmental 

toxicity studies be conducted by gavage, 

because this route allows for a more 

accurate assessment of the dose the 

animal actually receives. 

EPA reaffirms that there is sufficient 

evidence for listing metam sodium on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available developmental toxicity 

data for this chemical and its 

metabolite, carbon disulfide. Therefore, 

EPA is finalizing the addition of inetam 

sodium on the EPCRA section 313 list. 

34. N-Methyl-2-pyrrolidone. IBM, 

American Automobile Manufacturers 

Association, and N-Methylpyrrolidone 

Producers Group object to the listing of 

N-methyl-2-pyrrolidone (NMP) on the 

EPCRA section 3131ist. NMP Producers 

Group contends that the 2-generation 

reproductive study and the rabbit 

gavage developmental study cited in the 

proposed rule are flawed. NMP 

Producers Group further contends that 

the author of the 2-generation rat 

reproductive study and an independent 

reviewer have reached similar 

conclusions. 

In reviewing the material submitted 

by the commenter, EPA failed to find a 

statement from the author that the study 

was flawed. The review of the 2- 

generation rat reproductive study by an 

independent reviewer did not find fault 

with the entire study but stated that it 

should not be used for risk assessment 

purposes. EPA agrees with this 

judgement but is not using this study for 

risk assessment purposes but rather as 

an indication of human health hazard. 

The Agency believes that the adverse 

effects seen in these studies are of 

sufficient seriousness to warrant listing 

under EPCRA section 313(d)(2)(B). 

NMP Producers Group also states that 

when the 2-generation reproductive 

study is evaluated taking into account 

the genetic fertility problem in the strain 

of male rats, the study establishes a 

NOAEL of 160 mg/kg rather than the 

NOAEL of 50 mg/kg cited in the 

proposed rule. The commenters also 

believe the study should not be 

considered because the variability in 

male fertility was not dose-dependent. 

EPA does not agree that the NOAEL 

should be adjusted for the fertility 

problem of the strain of male rats used 

in the study. During the first mating on 

which EPA based its concern level (F2a) 

the high-dose male group exhibited a 24 

percent reduction in the mating index. 

In addition, there was a statistically 

significant, dose-related reduction in the 

male fertility index; thus, the index was 

93.1, 72.4, 72.4, and 46.7 in the control, 

low-, mid-, and high-dose groups, 

respectively. The control value in this 

study is 93.1 percent, well within 

acceptable limits for any reproductive 

effects study and as seen the reduction 

in mating index is dose-related being 

72.4 percent in the low- and mid-dose 

groups and 46.7 percent in the highdose group. With a control value of 93.1 

percent and using the concurrent 

controls as an index of mating 

performance for the males in this study, 

the Agency feels that there is no reason 

to adjust the NOAEL of 50 mg/kg to 

account for reduced fertility in the test 

animals. During the second mating (Fzb), 

the male high-dose group exhibited a 31 

percent reduction in the mating index, 

and again, there was a statistically 

significant, dose-related reduction in the 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61459 

male fertility index (83.3, 69.0, 60.0, and 

34.5 in the control, low-, mid-, and 

high-dose groups, respectively). The 

female high-dose group exhibited a 28 

percent reduction in the fertility index, 

and again, there was a statistically 

significant, dose-related reduction in the 

fecundity index (92.6, 74.1, 64.3, and 

50.0 in the control, low-, mid-, and 

high-dose groups, respectively). Again, 

the Agency does not feel that a control 

value of 83.3 percent fertility index in 

the control animals is abnormal and is 

more concemed with the dose-related 

decrease in fertility as an indication that 

NMP is a reproductive toxicant. EPA is 

also concerned with the decrease in 

fecundity index in the females and does 

not feel that the control value of 92.6 

percent warrants any adjustment of 

NOAEL for reduced fertility or mating 

ability among males in the study. 

The Agency also disagrees with NMP 

Producers Group's contention that 

decreases in male fertility observed are 

not dose dependent. The data presented 

above clearly show a correlation 

between dose and decreased fertility. 

NMP Producers Group claims that the 

effects of NMP administration 

manifested only in the second 

generation of animals. 

EPA disagrees and believes that 

effects were manifested in the first 

generation. There was a reduction in 

fertility in the Fl generation, 

histological evidence of reproductive 

effects including hypospermia and 

significant systemic toxicity in the F1 

generation. In addition, EPA does not 

believe that it is unusual to see 

increased severity in the second 

generation since animals have either 

been treated for 2 generations or are the 

offspring of treated animals and 

cumulative effects or effects on the 

reproductive system of the first 

generation animals may manifest in the 

second generation. 

NMP Producers Group further 

believes that NMP is not a 

developmental hazard because EPA's 

conclusion is based on observations 

from what the commenter claims is a 

flawed reproductive study. The 

commenter adds that a considerable 

body of evidence supports the 

conc?usion that NMP is not uniquely 

toxic to a developing fetus. 

EPA's conclusions about the 

developmental toxicity of NMP are 

based upon a rabbit gavage study and 

the developmental portion of the 2- 

generation reproductive study referred 

to above and cited in the proposed rule. 

The rabbit gavage study showed a 

significant increase in resorptions and 

malformations (misshapen skull bone 

and cardiovascular malformations). The 

LOAEL for developmental toxicity in 

this study was 540 mg/kg and the 

NOAEL was 175 mg/kg. The 

developmental portion of the 2- 

generation reproductive effects study 

showed evidence of developmental 

toxicity in both generations after 

exposure to 500 mg/kg as demonstrated 

by reduced litter size, reduced postnatal 

survival, and reduced pup body weight. 

The Agency believes that despite the 

flaws in the study, the data described 

above clearly show evidence of 

developmental toxicity. In addition, 

EPA believes that the body of evidence 

supports the finding that NMP is 

uniquely toxic to the developing fetus 

and the information available to the 

Agency both from the rat developmental 

study and rabbit gavage study is 

sufficient to list NMP on the EPCRA 

section 313 list. 

EPA reaffirms that there is sufficient 

evidence to list N-methyl-2-pyrrolidone 

under EPCRA section 313 pursuant to 

EPCRA section 313(d)(2)(B) based on 

available developmental and 

reproductive toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of N-methyl-2-pyrrolidone 

on the EPCRA section 313 list. 

35. Molinate. Zeneca Incorporated 

contends that the observations 

attributed to the 35 mg/kg/day dose 

level in the rat developmental toxicity 

study "in fact occurred at 140 mg/kg/ 

day, the highest dose tested and were 

thus a consequence of maternal 

toxicity." The commenter states that the 

NOEL for that study was 35 mg/kg/day. 

The Agency does not agree that the 

NOEL for this study was 35 mg/kg/day. 

The NOEL for developmental toxicity 

was 2.2 mg/kg/day based on an increase 

in runting at the next highest doses, 35 

and 140 mg/kg/day. The other adverse 

effects listed in the comments for this 

study occurred only at the highest dose 

tested (140 mg/kg/day). The NOEL for 

maternal toxicity was 35 mg/kg/day and 

that the effects on the pups (runting) 

occurred at a dose level lower than the 

dose level found to be maternally toxic. 

The same commenter stated that the 

issue of whether molinate is a 

reproductive toxin on the basis of its 

adverse effect on fertility in rodents has 

been very extensively investigated with 

studies in rabbits, dogs, monkeys, and 

man, and these studies have shown 

"conclusively that the effects seen in 

rodents is [sic] not relevant to man." 

While EPA agrees that there has been 

extensive testing of molinate with 

respect to fertility, the data on the rabbit 

and dog do not support the commenter's 

contention that the effects seen in 

rodents are specific only to rodents. For 

example, in each of the fertility studies 

in rabbits, both an increase in preimplantation loss and abnormal sperm 

were observed. These two consistent 

[reproducible] observations are 

suggestive of fertility effects, are two of 

the same observations found in rats and, 

although not as dramatic as observed in 

rats, cannot be negated. In the chronic 

dog study, lesions in male reproduction 

organs and effects on sperm were 

observed, which demonstrate that, at 

least in the males, the gonads are target 

organs for molinate. The lack of any 

effect on the limited parameters 

assessed in the male monkey studies 

lends little credence to the argument 

since only male monkeys were exposed 

to molinate, and no reproduction 

studies have been performed to assess 

reproductive performance. Since 

molinate is reaching the gonads in all 

species, not only in rodents as the 

commenter claims, molinate can 

reasonably be anticipated to cause 

fertility/reproductive effects in humans. 

Further, animals are accepted as 

surrogates for toxicity testing to predict 

potential hazard to humans, except in a 

few rare cases where effects have been 

determined to be species-specific [e.g., 

a2g-globulin]. 

The same commenter further 

contends that a NOEL of 2 mg/kg/day 

was established in the rat 2—year study, 

and that this study should not be used 

to evaluate the neurotoxicity of molinate 

because the study was not designed to 

evaluate that effect. Rather, the 

commenter contends that the "definitive 

position on neurotoxicity has been 

determined by specific [neurotoxicity] 

studies." Zeneca Incorporated did not 

provide a reference for these "specific 

studies." 

EPA agrees that the NOEL for effects 

other than neurotoxic effects is 2 mg/kg/ 

day in the chronic rat study. No NOEL 

for neurotoxic effects was established in 

that study. The LOEL for neurotoxicity 

in this study is 0.35 mg/kg/day. 

Although this study was not specifically 

designed to evaluate the neurotoxic 

effects of molinate, adverse neurological 

effects were reported. Further, they were 

substantiated by the findings from a 1— 

year study in dogs. 

The same commenter stated that the 

effects observed in the dog study were 

found at the highest dose administered 

for 1—year and were "largely a 

consequence of extended exposure" and 

as such should not form a part of the 

EPCRA listing. The commenter implies 

that because this is a chronic adverse 

effect, the effect is not relevant to the 

EPCRA section 313 criteria. 

As specified in section 313(d)(2)(B), a 

chemical may be listed if it causes 
61460 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

chronic toxicity. Thus, the comment is 

not relevant. 

EPA reaffirms that there is sufficient 

evidence for listing molinate on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available developmental, 

reproductive, and neurological toxicity 

data for this chemical. Therefore, EPA is 

finalizing the addition of molinate on 

the EPCRA section 313 list. 

36. Nitrate compounds (proposed as 

nitrate ion). American Automobile 

Manufacturers Association, Merck, and 

the Department of Energy disagree with 

EPA's proposal to list nitrate ion 

because an ion is not a chemical. Merck 

further states that nitrate ion "exists 

only in aqueous media." The Chevron 

Companies, the Department of Energy, 

Chemical Manufacturers Association, 

and Air Products and Chemicals, 

Incorporated contend that in proposing 

to add nitrate ion to EPCRA section 313 

the Agency actually proposed to add a 

category of chemicals that dissociate to 

generate nitrate ion. EPA agrees with the 

commenters that an ion does not meet 

the definition of a chemical for purposes 

of listing on the EPCRA section 313 list 

and that by proposing nitrate ion the 

Agency had, in effect, proposed the 

addition of a category of nitrate 

compounds that dissociate in water that 

are reportable only when in aqueous 

solution. Thus based on the comments 

provided by the commenters, the 

Agency is finalizing the addition of the 

following category: water dissociable 

nitrate compounds (reportable only 

when in aqueous solution). Qualifiers of 

this sort have been used to define the 

form of a chemical for which reports 

should be submitted, e.g., zinc (fume or 

dust). The qualifier following this listing 

indicates that only water dissociable 

nitrate compounds that are 

manufactured, processed, or otherwise 

used as an aqueous solution at a facility 

are subject to reporting. As with all 

other aspects of EPCRA section 313 

reporting, only the weight of the listed 

chemical is subject to threshold 

determinations. That determination 

does not include, for example the 

weight of the water or any other 

constituent in the solution other than 

the nitrate compound. Beyond the 

threshold determination, the amounts 

reportable on Form R should only 

include the mass of the nitrate portion 

of the compound in solution. This 

approach is consistent with guidance 

given for determining threshold and 

release amounts for metal compounds. 

EPA recognizes that most monitoring 

data available measure only the 

dissociated nitrate ion released and not 

the amount of total nitrate compounds 

from which the nitrate ion dissociated. 

Reporting of the amount of the total 

water dissociable nitrate compound in 

wastes would be complicated when 

more than one substance contributes to 

the nitrate ion content of the waste and 

when the nitrate compound is converted 

to a different substance due to waste 

treatment or other processes. It is 

therefore reasonable to require reporting 

of only the nitrate ion released in order 

to avoid confusion over the meaning of 

total compound released. 

EPCRA section 313 requires threshold 

determinations for chemical categories 

to be based on the total of all chemicals 

in the category manufactured, 

processed, or otherwise used. For 

example, a facility that manufactures 

three members of a chemical category 

would count the total amount of all 

three chemicals manufactured towards 

the manufacturing threshold for that 

category. One report is filed for the 

category and all releases are reported on 

this form. 

In the proposed rule, EPA discussed 

both the human health and 

environmental adverse effects 

attributable to nitrates. EPA continues to 

be concerned about the potential 

environmental impacts of nitrates. In 

today's action, EPA is adding nitrate 

compounds based on the adverse 

human health effects that the nitrate 

moiety causes. Nitrate causes 

methemoglobinemia. 

Methemoglobinemia, like carbon 

monoxide, interferes with the 

oxygenating capacity of the blood 

resulting in an under supply of oxygen 

to the tissues. In adults, cyanosis to lips 

and mucous membranes bccurs at a 

level of 1.5 g/dL (10 percent saturation 

in an adult with normal hemoglobin 

levels). Levels between 30 percent and 

50 percent saturation in adults produce 

depression of the cardiovascular and 

central nervous systems; levels between 

50 percent and 70 percent cause stupor, 

convulsions and respiratory depression 

and levels above 70 percent are usually 

fatal. Because of increased requirement 

for oxygen in growing tissue and 

because of decreased blood volume in 

infants, they are much more sensitive to 

nitrate ion toxicity than adults. Infants 

have a lower activity of inethemoglobin 

reductase and thus are more susceptible. 

Consequently adverse effects are seen at 

much lower levels in infants than in 

adults. Irreversible damage to organs 

such as the heart or brain, and the 

development of coronary artery disease 

or pulmonary disease are more likely to 

develop in infants because the anoxia 

caused by methemoglobinemia can 

occur mmore rapidly and have more 

devastating effects in growing tissue 

than in the "static" tissue of the adult 

body. EPA believes that these are 

serious adverse effects that satisfy the 

criteria of EPCRA section 313(d)(2)(B). 

37. Ozone. Many commenters 

opposed the addition of the CAA 

criteria pollutants (sulfur dioxide, sulfur 

trioxide (SOx ), nitric oxide and nitrogen 

dioxide (NOx), carbon monoxide (CO), 

and ozone) to the EPCRA section 313 

list since extensive data on these 

chemicals is already collected under the 

CAA. 

EPA agrees with the commenters that 

there are many complex issues 

associated with the extensive collection 

of data on these chemicals under the 

Clean Air Act. Therefore, EPA is 

deferring the listing of these chemicals 

for possible addition at a later time to 

address some of the issues involving the 

availability of data collected under the 

CAA. The Agency does not believe, 

however, that the listing of ozone 

should also be deferred. Emissions of 

ozone, also a criteria pollutant, are not 

captured under the CAA. The CAA 

mandates the collection of data on the 

releases of VOCs (VOCs react in the 

troposphere to generate ozone and other 

air pollutants), which are regulated to 

maintain the ambient air quality 

standard for ozone. EPA believes there 

are many other significant uses of ozone 

(e.g., wastewater treatment, bottled 

water purification, and chemical 

intermediate) that would be captured by 

EPCRA section 313 reporting. 

Accordingly, EPA does not believe that 

the finalization of ozone should be 

deferred. EPA reaffirms that ozone 

meets the EPCRA section 313(d)(2) 

criteria pursuant to EPCRA section 

313(d)(2)(B) and 313(d)(2)(C) based on 

the available toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of ozone on the EPCRA 

section 313 list. 

38. Pebulate. Zeneca Incorporated 

comments that the neurological effects 

noted in the 1—year feeding study in 

dogs cited in the proposed rule occurred 

at thp highest dose level (100 mg/kg/ 

day), which was, by design, a toxic 

dose. Thus, the commenter claims that 

there is no reasonable hazard. 

The Agency disagrees. Although the 

highest dose tested is designed to elicit 

toxicity in the dogs, the presence of 

Wallerian type degeneration of the 

white matter of the spinal cord at the 

100 mg/kg/day dose level in dogs of 

both sexes is of considerable seriousness 

and cannot be dismissed only because it 

occurred at the highest dose tested. 

Although the dose eliciting 

degeneration of the spinal cord was the 

highest dose tested, 100 mg/kg/day, 

these adverse effects are of sufficient 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regu)ations 61461 

seriousness to warrant listing based 

upon the potential for similar effects in 

humans. 

In this study, the NOEL for the 

Wallerian type neurological lesions is 

50 mg/kg/day. However, the NOEL in 

males is less than 5 mg/kg/day (LOEL 

based on findings of abnormal behavior, 

ataxia, severe convulsions, and 

congestion in both kidneys in one dog). 

In females, the NOEL was 5 mg/kg/day 

and the LOEL was 25 mg/kg/day with 

occurrence of blood in feces, increased 

absolute and relative liver weight, 

increase in severity.of lipofuscin 

deposition in kidneys, and hemosiderin 

deposition in liver and spleen. 

EPA reaffirms that there is sufficient 

evidence for listing pebulate on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available neurological toxicity data 

for this chemical. Therefore, EPA is 

finalizing the addition of pebulate on 

the EPCRA section 313 list. 

39. Permethrin. Zeneca Incorporated 

states that the hepatic effects noted in 

the liver of rats and dogs are adaptive 

rather than toxic responses to the 

pyrethroid. The commenter further 

claims that there were no changes in 

liver weight relative to body weight. 

EPA does not agree that the incidence 

of liver weight increase is not a 

significant effect, or that there were no 

changes in liver weight relative to body 

weight. The liver weights, relative to 

bodyweight, were increased in all 

treated groups in the 2—year rat study. 

EPA believes that the hepatic changes 

noted in these studies represent a 

significant adverse effect. 

The same commenter contends that in 

the 2-year rat study cited in the 

proposed rule, "the NOEL is also 

incorrectly stated as 5 mg/kg/day, where 

EPA states a LOEL of 100 mg/kg/day." 

The Agency disagrees with the 

commenter. The NOEL and LOEL 

should be 5 and 100 mg/kg/day, 

respectively. At 100 mg/kg/day there 

was an increase in alkaline phosphatase, 

liver weight and cellular swelling of the 

liver (indicative of typical smooth 

endoplasmic reticulum proliferation), 

and one male in the low dose group was 

affected, focal inflammation with 

degenerative change in the zona 

fasciculate and swelling and 

vacuolation ofcells in the zona 

reticularis of the adrenals and reduced 

body weight in females. EPA considers 

these to be serious adverse effects. 

EPA reaffirms that there is sufficient 

evidence for listing permethrin on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available hepatic toxicity data for 

this chemical, and pursuant to EPCRA 

section 313(d)(2)(C) based on the 

available environmental toxicity data. 

Therefore, EPA is finalizing the addition 

of permethrin on the EPCRA section 313 

list. 

40. Phosphine. Coors Brewing 

Company states that only liqufd 

phosphine can cause the health effects 

necessary to support a listing on the 

EPCRA section 313 list. 

Phosphine is a gas (the boiling point 

is negative 87.4 °C); it only occurs as a 

liquid when placed under reduced 

temperature and/or pressure. The acute 

toxicity data used to support the listing 

of phosphine is based on exposure to 

phosphine in the air (i.e., phosphine 

gas). Thus, EPA does not agree that only 

liquid phosphine could cause the health 

effects necessary to support listing 

under EPCRA section 313. EPA 

reaffirms that there is sufficient 

evidence for listing phosphine on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(A). Therefore, 

EPA is finalizing the addition of 

phosphine on the EPCRA section 313 

list. 

41. Polychlorinated alkanes (proposed 

as chlorinated paraffins). EPA proposed 

the addition of clorinated paraffins that 

consisted of polychlorinated alkanes. 

Occidental Chemical Corporation and 

the Chlorinated Paraffins Industry 

Association state that the proposed 

chlorinated paraffins category is really a 

category of chlorinated hydrocarbons 

since it covers a broad range of 

chlorinated hydrocarbons including 

chlorinated paraffins and chlorinated aolefins. 

EPA believes that there may be 

confusion over what is covered by the 

chlorinated paraffins category, as 

named, because the name chlorinated 

paraffins identifies a particular 

feedstock used to make this class of 

compounds. However, as discussed 

below, EPA believes that the 

chlorination of paraffins and a-olefins 

results in products that do not differ 

significantly structurally, physically, or 

toxicologically. EPA believes that, rather 

than name the category based on one of 

the feedstocks used to make these 

compounds, a more appropriate name 

for the category is one that describes the 

actual members of the category. 

Therefore, because the members of this 

category are alkanes containing three or 

more chlorines, EPA is renaming this 

category polychlorinated alkanes. The 

new category name will not expand the 

scope of the category. EPA believes that 

the toxicity data for chlorinated 

paraffins is sufficient for all 

polychlorinated alkanes that fall within 

the same carbon number and chlorine 

content regardless of what materials 

where used to manufacture them. 

Courtlands Aerospace, ELF Lubricants 

North America, Incorporated, Tower Oil 

& Technology Company, National Oil 

Products, Incorporated, OxyChem, the 

American Automobile Manufacturers 

Association, the Association of 

International Automobile 

Manufacturers, Incorporated, the 

Specialty Steel Industry of the United 

States, the Independent Lubricant 

Manufacturers Association, Engineered 

Lubricants, Sealed Air Corporation, 

American Federation of Labor and 

Congress of Industrial Organizations, 

Chlorinated Paraffins Industry 

Association, and Far West Oil Company, 

Incorporated contend that the available 

toxicity data is insufficient to support 

the addition of chlorinated paraffins to 

EPCRA section 313. Some of these 

commenters state that they do not 

believe that EPA should create chemical 

categories such as that proposed for 

chlorinated paraffins on the EPCRA 

section 313 list. Some of these 

commenters state that the long-chain 

chlorinated paraffins have not been 

classified as "probable human 

carcinogens" by NTP or IARC. Some of 

these commenters made numerous 

specific comments concerning the 

adequacy of the studies used to support 

EPA's listing of chlorinated paraffins 

and pointed out flaws in the data for 

both long and short-chain chlorinated 

paraffins. Some of the flaws that the 

commenters allege concern the studies 

used to support the listing of the shortchain species and included: (1) Kidney 

tumors in male rats may be due to 

binding to a2μ-globin, a male ratspecific protein; (2) route of 

administration (forced gavage feeding); 

(3) corn oil as a vehicle; (4) use of the 

B6C3F1 mouse; (5) short-chain 

chlorinated paraffins are non-genotoxic 

in a variety of short-term assays; (6) 

peroxisome proliferation, liver growth 

in male and female rats and mice and 

stimulation of replicative DNA in 

rodents have not been shown to occur 

in guinea pigs indicating that they are 

mouse and rat specific and have no 

relation to tumor formation in humans; 

and (7) thyroid tumors may be a 

consequence of a perturbation in the 

metabolism of thyroxine. Some of the 

commenters contend that only the data 

on short-chain chlorinated paraffins are 

sufficient to justify a listing on the 

EPCRA section 313 list and that EPA 

should limit the category to just the 

short-chain species. 

a. Long-chain chlorinated paraffins. 

IARC has not classified the long-chain 

chlorinated paraffins because there is 

insufficient evidence that they cause 
61462 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

cancer in treated animals. The NTP 

found no evidence of cancer in male rats 

treated with 1,875 or 3,750 mg/kg/day 

for 24 months with long-chain 

chlorinated paraffins. Female rats 

treated with 900 mg/kg/day showed 

marginal increases in adrenal gland 

tumors; female rats treated with 5,000 

mg/kg/day had marginal increases in 

liver tumors. The only significant 

increase in tumor formation occurred in 

male mice which had a significant 

increase in malignant lymphomas. After 

further evaluation of the available data 

and considering the available statistics, 

the high background rate of lymphoma 

in the strain of mice used in the NTP 

bioassay and the statements made by the 

NTP Working Group and the Quality 

Assessment Narrative, which was 

submitted by the commenters, EPA 

agrees that there is insufficient evidence 

to conclude that the malignant 

lymphomas observed in male mice were 

treatment related and that long-chain 

chlorinated paraffins should not be 

classified as potential carcinogens. 

Therefore, the Agency concludes that 

there is insufficient evidence to list 

long-chain chlorinated paraffins on the 

EPCRA section 313 list. 

b. Short-chain chlorinated paraffins. 

IARC has classified the short-chain 

chlorinated paraffins as Group 2B, i.e., 

sufficient evidence for carcinogenicity 

in animals and p.obably carcinogenic in 

humans. Detailed responses to all of the 

comments conceming the toxicity of the 

short-chain species are contained in the 

Response to Comment Document (Ref. 

14). Summaries of the responses to the 

most significant comments concerning 

flaws in the studies used to support the 

listing of the short-chain species are 

provided below. 

(1) The Agency agrees that the kidney 

tumors observed in rats are most likely 

not relevant to tumor formation in man 

because the male rat kidney possess a 

unique protein, a2μ-globulin which has 

been shown to be responsible for the 

development of rat liver kidney tumors, 

not only after administration of shortchain chlorinated paraffins but after 

administration of many other chemicals 

also. However, to state that chlorinated 

paraffins bind to a protein which is 

similar to a2μ-globulin and that this 

binding is not seen in guinea pigs as 

evidence that kidney tumor formation is 

not relevant to human tumor formation 

in this instance is not a convincing 

ar ument. 

~2) The Agency agrees that forced 

gavage feeding may not be a relevant 

route of administration when one is 

using the data for human risk 

assessment. In this instance, the data are 

being used as an indication of potential 

human hazard and EPA accepts the data 

as being indicative of such potential. 

(3) EPA believes that corn oil is an 

accepted vehicle of administration for 

many in vivo studies because it is 

relatively inert and has not been shown 

to interact with test agents. 

(4) The B6C3F1 mouse is the accepted 

test species of the NTP and EPA has no 

reason to question the NTPs choice of 

test species nor to discount results of 

cancer bioassays using this species. 

(5) EPA does not believe that nongenotoxicity is a sufficient reason to 

dismiss the relevance to man of tumor 

formation by the short-chain chlorinated 

paraffins. Non-genotoxicity may be a 

factor in selecting a model to use for 

dose response estimation, once tumor 

formation has been established, but it is 

not a reason to disregard the 

significance of tumors which are formed 

by agents which are non-genotoxic in 

short-term tests. 

(6) The Agency is not convinced that 

failure to observe liver growth, 

peroxisome proliferation in hepatocytes 

and stimulation of replicative DNA in 

guinea pigs is proof that these effects are 

specific to rats and mice and have no 

bearing on tumor formation in humans. 

(7) The Agency agrees that there was 

a perturbation of thyroxine levels in 

treated animals but does not agree that 

the observed tumors are therefore 

irrelevant. 

Therefore, the Agency finds that there 

is sufficient evidence for listing shortchain chlorinated paraffins on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available carcinogenicity data for 

these chemicals. 

i. Ecotoxicity data. Courtaulds 

Aerospace, Occidental Chemical 

Corporation, and the American 

Automobile Manufactures Association 

contend that ecotoxicity data are only 

available for the short-chain (10 to 13 

carbons, 59 percent chlorine) 

chlorinated paraffins. The commenters 

object to EPA assuming the same 

ecotoxicity for all members of the 

chlorinated paraffin category because of 

the potential difference in effects related 

to chain length and chlorine content. 

Although it was stated as such in the 

proposed rule, EPA did not intend to 

equate the ecotoxicity of the short-chain 

chlorinated paraffins with the 

ecotoxicity of other members of the 

category. The ecotoxicity data on the 

sho.-t-chain chemicals was provided as 

further support for the listing of the 

short-chain chemicals. However, as EPA 

is not finalizing the addition of the longchained species, this issue is no longer 

relevant. 

ii. Chlorinated paraffins versus 

chlorinated a-olefins. OxyChem, the 

American Automobile Manufacturers 

Association, the Association of 

International Automobile 

Manufacturers, the Independent 

Lubricant Manufacturers Association, 

and the Chlorinated Paraffins Industry 

Association correctly state that EPA's 

proposed definition of chlorinated 

paraffins does not exclude chlorinated 

a-olefins. The commenters further 

contend that chlorinated paraffins and 

chlorinated a-olefins are distinctly 

different chemicals with different 

physical, chemical, and biological 

properties. 

The information provided by the 

commenters does not substantiate their 

claim that chlorinated paraffins and 

chlorinated a-olefins are distinctly 

different chemicals with different 

physical/chemical properties. The main 

difference between chlorinated paraffins 

and chlorinated a-olefins that EPA is 

aware of is that chlorinated paraffins, 

typically manufactured from paraffin 

mixtures, are also mixtures whereas 

individual chlorinated a-olefins can be 

manufactured in moderate to high 

purity. The issue is whether a pure 

chlorinated a-olefin falls within the 

range of structural characteristics that 

vary in a chlorinated paraffin mixture. 

In this case, EPA believes that there are 

no significant structural differences 

between chlorinated paraffins and 

chlorinated a-olefins. Both are primarily 

linear hydrochlorocarbons, and the 

degree of chlorination of both groups of 

substances can be controlled. Sixty 

percent chlorination of 1—dodecene, for 

example, would yield a product with 

the formula C12H19C17 and a molecular 

weight of approximately 411. Sixty 

percent chlorination of the short-chain 

grade paraffin mixture would yield a 

mixture of products with an average 

formula of Cl2H19C17 and an average 

molecular weight of approximately 411. 

The commenters claini that the 

chlorine positions in chlorinated aolefins differ significantly compared to 

the chlorine positions in chlorinated 

paraffins. EPA does not believe that 

chlorination at carbons 1 and 2 of the 

a-olefins makes a significant difference 

in the majority of the isomers formed by 

both reactions and even if it did, there 

are no data that indicate that having two 

of the chlorines at carbons 1 and 2 is 

significant from a toxicity standpoint. 

The commenters do not substantiate 

their claim (mass spectral data 

submitted by one commenter is 

inconclusive and cannot be used in 

support, for or against, the commenter's 

position); EPA is not aware of 

experimental evidence that suggests that 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61463 

the possible variations in chlorine 

positions between the chlorinated 

paraffins and the chlorinated a-olefins 

differ significantly from the variations 

possible within these two groups of 

substances. Since for the a-olefins the 

first two chlorines are added at carbons 

1 and 2, the relative amounts rather than 

type of each isomer formed may differ 

between the chlorination of paraffins 

and a-olefins, especially as the degree of 

chlorination decreases. 

The commenters' claim that 

chlorinated a-olefins are distinctly 

different from chlorinated paraffins 

because their physical properties are 

very different is unjustifiable. As 

discussed in detail in the Response to 

Comment Document ( Ref. 14), the 

physical properties of discreet 

chemicals cannot be compared to those 

of chemical mixtures. The commenters 

do not discuss specific differences 

between chlorinated paraffins and 

chlorinated a-olefins and therefore do 

not substantiate their claim. They do, 

however, elaborate on the differences 

between structures within the 

chlorinated paraffins group, particularly 

those structures that represent the 

extremes in the C ioto C30range. This 

discussion is therefore more relevant to 

the issue of listing categories versus 

individual chemicals discussed 

subsequently and does not address the 

issue of differences in the physical 

properties between chlorinated paraffins 

and chlorinated a-olefins, discussed 

previously. Furthermore, EPA believes 

that the specific differences between 

structural extremes within the 

chlorinated paraffins group that the 

commenters elaborate on are trends that 

are also observed between structural 

extremes within the chlorinated aolefins group. 

A valid comparison of physical 

property data can only be made between 

two discreet substances of known purity 

or, in some cases, between two mixtures 

of chemicals with well defined 

compositions. EPA believes that an aolefin and a paraffin, both with the same 

chain length and both with the same 

degree of chlorination, are essentially 

identical structurally (especially if the 

degree of chlorination is high); the same 

isomers can be predicted for the 

chlorination of an a-olefin and a 

paraffin of the same chain length. The 

physical properties of chlorinated aolefins and the corresponding 

chlorinated paraffins are therefore 

expected to be very similar. The 

differences in the chemical and physical 

properties that the commenters refer to 

are largely or completely due to the fact 

that the chlorinated paraffins are 

mixtures of different chain lengths 

while the chlorinated a-olefins typically 

are composed of a single chain length. 

iii. Category definition. Since EPA has 

determined that only the short-chain 

species meet the listing requirements of 

EPCRA section 313, the polychlorinated 

alkanes category will be defined by the 

following formula and description: 

CxI-i2x -yCIY ; where x= 10 to 13 and y= 

3 to 12 and where the average chlorine 

content ranges from 40 to 70 percent 

with the limiting molecular formulas set 

at CI Oa1yC13 and C13H16C112. 

EPCRA section 313 requires threshold 

determinations for chemical categories 

to be based on the total of all chemicals 

in the category manufactured, 

processed, or otherwise used. For 

example, a facility that manufactures 

three members of a chemical category 

would count the total amount of all 

three chemicals manufactured towards 

the manufacturing threshold for that 

category. One report is filed for the 

category and all releases are reported on 

this form. 

42. Polycyclic aromatic compounds. 

In the proposed rule, EPA proposed the 

addition of a delineated polycyclic 

aromatic compounds (PAC) category 

that consisted of 28 polycyclic aromatic 

compounds. Alternatively, EPA 

proposed the addition of a PAC category 

based on the following broad definition: 

"includes all chemical species from the 

polycyclic aromatic hydrocarbon, azapolycyclic, thio-polycyclic, or 

nitroarene families where polycyclic 

means three or more fused rings. More 

specifically, it means any combination 

of three or more fused six or five 

membered hydrocarbon rings with at 

least two or more rings being aromatic. 

The structure may contain fused nonaromatic 5-membered rings, a ring 

nitrogen, a ring sulfur, one or more 

attached nitro groups, or one or more 

attached alkyl groups" (January 12, 

1994, 59 FR 1832). 

Monsanto, The Chevron Companies, 

Amoco Corporation, Armco Steel 

Company, Mobil Oil Corporation, 

UNOCAL, Pennzoil, Phillips Petroleum 

Company, American Petroleum 

Institute, and the Department of Energy 

object to listing polycyclic aromatic 

compounds as a category and 

recommend that EPA list them 

separately as individual chemicals. 

American Coke and Coal Chemicals 

Institute and Mobil Oil Corporation 

state that if the chemicals are not 

individually listed then the proposed 

delineated category should be used. 

Koch Industries Incorporated, Texaco 

Incorporated, and the Wisconsin 

Department of Natural Resources object 

to the alternative proposal for a PAC 

category with the broad definition and 

recommend that EPA implement the 

delineated category approach. The 

Natural Resources Defense Council 

recommends that EPA use the broad 

category definition. 

EPA believes that polycyclic aromatic 

compounds should be listed as a 

delineated category rather than listed 

individually or defined under the broad 

category definition. Most if not all of the 

polycyclic aromatic compounds 

included in the category are not 

intentionally manufactured, they are 

byproducts and impurities from various 

industrial processes. As such, they 

occur as complex mixtures that are 

typically released or transferred 

together. EPA believes that for this class 

of compounds a category listing is the 

most appropriate way to track releases 

and transfers under EPCRA section 313 

because members of this category are 

structurally similar and induce a similar 

toxic effect. 

The American Petroleum Institute, 

Mobil Oil Corporation, American Coke 

and Coal Chemicals Institute, Koch 

Industries Incorporated, Monsanto, The 

Chevron Companies, and Amoco 

Corporation state that analytical 

methodologies do exist to identify 

specific chemicals such as those 

proposed for the delimited PAC 

category; however, these analytical 

methodologies require a chemical-bychemical analysis. They add that since 

a chemical-by-chemical analysis is 

required, there would be no reduction 

in the reporting burden for either a 

category based on the broad definition 

or for the proposed delimited category. 

EPA proposed the broad category 

definition approach as a possible way to 

reduce the reporting burden for a PAC 

category. However, the majority of the 

industries that would have to report do 

not agree that this will result in a 

reduction of their reporting burden, they 

believe that it will cause confusion over 

what chemicals are covered by this 

category, and do not believe that 

analytical methodologies exist to 

identify all of the thousends of 

chemicals that would be covered by a 

PAC category based on the alternative 

broad definition. EPA is therefore not 

finalizing the alternative proposal to 

create a PAC category based on the 

broad definition but is finalizing the 

proposed delimited PAC category as 

explained above. 

EPA believes that although it may be 

necessary to perform a chemical- bychemical analysis for members of this 

delimited category, the most appropriate 

way to track releases and transfers 

under EPCRA section 313 is by creating 

this category as explained above. 
61464 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

The Chevron Companies, Amoco 

Corporation, Mobil Oil, UNOCAL, 

Pennzoil, and the American Petroleum 

Institute state that polycyclic aromatic 

compounds share some physical and 

chemical properties but that this does 

not necessarily imply similar toxicities. 

These commenters state that the toxicity 

potentials vary widely among the 

polycyclic aromatic compounds but that 

the public tends to associate all 

members of a category with the most 

toxic chemical in the category. 

EPA recognizes that similarities in 

physical and chemical properties do not 

necessarily indicate that the ability to 

induce carcinogenic effect among the 

members of the polycyclic aromatic 

cotnpounds category are identical. 

However, these compounds are 

chemically similar, induce the same 

toxicological effect (carcinogenicity), 

and typically are produced, released, 

and transferred as complex mixtures 

rather than individual chemicals. EPA 

therefore believes that it is appropriate 

to consider these compounds as a 

category. 

Mobil Oil Corporation contends that 

11 of the PACs proposed for listing have 

been reviewed by IARC and found to 

have insufficient data in animals and no 

data in humans making the overall 

evaluation IARC-3 or inadequate 

evidence of carcinogenicity. 

The 11 chemicals the commenter cites 

as being classified by IARC as a group 

3 chemical, i.e., the chemical is not 

classifiable as to its carcinogenicity, are: 

carbazole (CAS No. 86-74-8); 

cyclopenta(cd)pyrene (CAS No. 27208— 

37-3); dibenz(a,c)anthracene (CAS No. 

215-58-7); dibenz(a,j)anthracene (CAS 

No. 224-41-9); 

dibenzo(a,e)fluoranthene (CAS No. 

5385-75-1); 2-methylchrysene (CAS No. 

3351-32-4); 3-methylchrysene (CAS No. 

3351-31-3); 4-methylchrysene (CAS No. 

3351-30-2); 6-r}Zethylchrysene (CAS No. 

1705-85-7); 2-methylfluoranthene (CAS 

No. 33543-31-6); and 1-nitropyrene 

(CAS No. 5522-43-0). The commenter 

is correct in that 10 of these 11 

compounds have been classified as 

IARC group 3 chemicals. The 11th 

compound, 1-nitropyrene (CAS No. 

5522-43-0), was classified by IARC as 

a Group 2B chemical, i.e., a possible 

human carcinogen. The IARC 

classification and a review of the data 

indicate that the data is sufficient to 

support the listing of this chemical on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B). A second 

compound, dibenzo(a,e)fluoranthene 

(CAS No. 5385-75-1) was classified by 

EPA as a B2 category chemical, the 

chemical is a probable human 

carcinogen, which justifies its addition 

to EPCRA section 313 pursuant to 

EPCRA section 313(d)(2)(B). Upon 

further review of the other 9 IARC group 

C chemicals, the Agency believes that a 

more detailed review of their 

relationship to the 19 PACs for which 

cancer data is available and is sufficient 

is necessary before they can be placed 

on the list on the basis of structure 

alone. Therefore, EPA will not add these 

9 chemicals to the EPCRA section 313 

list at this time and the delineated 

category will consist of the other 19 

chemicals proposed for this category. 

EPCRA section 313 requires threshold 

determinations for chemical categories 

to be based on the total of all chemicals 

in the category manufactured, 

processed, or otherwise used. For 

example, a facility that manufactures 

three members of a chemical category 

would count the total amount of all 

three chemicals manufactured towards 

the manufacturing threshold for that 

category. One report is filed for the 

category and all releases are reported on 

this form. 

43. Potassium 

dimethyldithiocarbamate. Buckman 

Laboratories International, Incorporated 

states that the proposed listing of the 

chemical was based on the results of the 

rat and rabbit teratology studies, cited in 

the proposed rule, although neither 

study demonstrates evidence of 

developmental toxicity. They contend 

that the findings in the developmental 

studies should be considered an artifact. 

The findings in rabbits cannot be 

considered artifacts because there is a 

dose-related increase in the severity of 

developmental effects at 38 and 77 mg/ 

kg. At 38 mg/kg, developmental toxicity 

was characterized by increased post 

implantation loss, malformations, and 

sternebral malalignments. At 77 mg/kg, 

there were reports of severe fetal and 

embryo lethality. EPA did not cite a rat 

study in the proposed rule as the 

commenter claims. 

EPA reaffirms that there is sufficient 

evidence for listing potassium 

dimethyldithiocarbamate on the EPCRA 

section 3131ist pursuant to EPCRA 

section 313(d)(2)(B) based on the 

available neurological toxicity data for 

this chemical. Therefore, EPA is 

finalizing the addition of potassium 

dimethyldithiocarbamate on the EPCRA 

section 313 list. 

44. Prometryn. Ciba-Geigy 

Corporation states that marked renal 

and hepatic degenerative changes were 

noted in the high-dose dogs only in the 

2-year dog study cited in the proposed 

rule. The commenter further claims that 

although minor liver effects were seen 

in rats in the 28—day study cited in the 

proposed rule, there were no liver 

effects in rats after 90 days at dose levels 

up to 5,000 ppm. This 90—day study that 

the commenter cited was not cited by 

EPA in the proposed rule. Thus, the 

commenter does not believe that the 

data support the addition of this 

chemical to the EPCRA section 313 list. 

EPA disagrees with the commenter. In 

the 2—year dog feeding study, prometryn 

induced degenerative changes in liver 

and kidney and bone marrow atrophy at 

37.5 mg/kg/day (LOEL, the NOEL is 3.75 

mg/kg/day). Although the dose eliciting 

degenerative changes in liver and 

kidney and bone marrow atrophy was 

the highest dose tested, these adverse 

effects are of sufficient seriousness to 

warrant listing based upon the potential 

for similar effects in humans. Further, 

the findings of the 2—year dog study and 

the 28—day rat study, cannot be 

discounted based solely on of the results 

of the 90—day study referred to by the 

commenter. Rather EPA has considered 

all of the data in concluding that 

prometryn meets the criteria for 

addition to the EPCRA section 313 list. 

The comrnenter questions the use of 

the rabbit developmental toxicity study 

because only a slight effect (if real) was 

noted at the highest dose tested, and 

was not statistically significant. 

Although the use of the rabbit 

developmental toxicity study may not 

be justified, and the potential for 

developmental effects therefore not 

supported, EPA reaffirms that there is 

sufficient evidence for listing prometryn 

on the EPCRA section 313 list pursuant 

to EPCRA section 313(d)(2)(B) based on 

available hepatic, renal, and bone 

marrow toxicity data. Therefore, EPA is 

finalizing the addition of prometryn on 

the EPCRA section 313 list. 

45. Propachlor. Monsanto contends 

that the developmental toxicity study in 

rabbits cited in the proposed rule was a 

study that was rejected by the Agency. 

Monsanto further stated that in this 

study "a slight decrease in viable 

fetuses, slight increase in postimplantation loss, and slight decrease in 

mean fetal weight was noted at the 

highest dose tested (116.7 mg/kg/day) 

which caused severe treatment-related 

maternal toxicity including death. An 

equivocal increase in post-implantation 

loss on a percent basis was noted in the 

mid-dose (58.3 mg/kg/day) level. 

Marginal developmental effects that 

were seen were not statistically 

significant and were within the 

historical control limits. Propachlor 

does not produce any observable 

maternal or fetal toxicity at 5.8 or 58.3 

mg/kg/day. In addition, propachlor does 

not cause developmental toxicity in 

rats." Monsanto concluded that, based 

on the "weight of evidence from the rat 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61465 

and rabbit studies, there does not appear 

to be any developmental risk to 

humans." 

The Agency does not concur with the 

commenter's statement that "propachlor 

does not produce any observable 

maternal or fetal toxicity at 5.8 or 58.3 

mg/kg/day dose levels," nor with the 

statement that "the marginal 

developmental effects that were seen 

were .... within the historical control 

limits." The Agency's rationale for the 

disagreements are as follows: 

In a developmental toxicity study in 

rabbits, oral administration of 

propachlor at 116.7 mg/kg/day caused 

maternal toxicity as evidenced by death, 

clinical signs [salivation and reduced 

defecation], decreased body weight gain 

and food consumption, and gross 

pathological lesions of the stomach. 

Developmental toxicity at 58.3 and 

116.7 mg/kg/day included dose-related 

increases in the total number of 

resorptions/litter and post-implantation 

losses compared to concurrent and/or 

historical controls. 

Based on these findings, it is apparent 

that the developmental effects seen at 

58.3 and 116.7 mg/kg/day levels are 

attributable to propachlor; the NOEL 

was 5.8 mg/kg/day. 

EPA reaffirms that there is sufficient 

evidence for listing propachlor on the 

EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available developmental toxicity 

data for this chemical. Therefore, EPA is 

finalizing the addition of propachlor on 

the EPCRA section 313 list. 

46. Propargyl alcohol. International 

Specialty Products is opposed to the 

listing of propargyl alcohol apparently 

because an uncertainty factor of 3,000 

was used by EPA in setting the RfD. The 

commenter feels that an uncertainty 

factor of 100 would have been more 

appropriate and cites instances where 

such an uncertainty factor has been 

used by IRIS in setting reference doses. 

The commenter does not question the 

renal or hepatotoxicity cited in IRIS as 

a basis of its concern. 

The commenter is correct in stating 

that EPA has used uncertainty factors of 

100 for other chemicals. However, that 

was not deemed appropriate in this 

instance for reasons which are set out by 

EPA in the IRIS data base. EPA 

continues to support the listing of 

propargyl alcohol under EPCRA section 

313 on the basis of chronic toxicity 

which may pose a significant health 

hazard as manifested by renal and 

hepatic effects. The uncertainty factor 

plays no part in this decision. EPA 

reaffirms that there is sufficient 

evidence for listing propargyl alcohol on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available hepatotoxicity and 

nephrotoxicity data for this chemical. 

Therefore, EPA is finalizing the addition 

of propargyl alcohol on the EPCRA 

section 313 list. 

47. Propiconazole. Ciba-Geigy 

Corporation states that the increased 

incidence of liver tumors in the 

oncogenicity study on propiconazole 

was noted only in male mice in the high 

dose (2,500 ppm), which exceeded the 

MTD, based on decreased survival and 

body weight gain. 

EPA believes that the study high dose 

(2,500 ppm, equivalent to 325 mg/kg/ 

day) was excessively toxic; however, the 

Agency also determined that the mid 

dose (500 ppm, equivalent to 65 mg/kg/ 

day) was not considered sufficiently 

high to evaluate the carcinogenic 

potential of propiconazole. The Agency 

believes that a supplementary study 

should be conducted in male mice at 

doses selected to sufficiently evaluate 

carcinogenic potential without 

excessive toxicity. At this time however, 

based on the currently available 

evidence, propiconazole remains 

classified as a Group C, possible human 

carcinogen, with the RfD approach 

recommended for quantification of 

human risk. 

The commenter further states that 

relatively minor gastrointestinal effects 

were noted in dogs at the high dose only 

(250 ppm). 

EPA believes that the data in both the 

3-month and 1—year dog studies 

demonstrate gastrointestinal effects at 

the high-dose (250 ppm, equivalent to 

6.25 mg/kg/day). These effects are 

considered severe, and, therefore, are of 

sufficient seriousness to warrant listing 

propiconazole on the EPCRA section 

313 list. 

EPA reaffirms that there is sufficient 

evidence for listing propiconazole on 

the EPCRA section 313 list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available hepatic and 

gastrointestinal toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of propiconazole on the 

EPCRA section 313 list. 

48. Simazine. Ciba-Geigy Corporation 

objects to the listing of simazine under 

EPCRA section 313 based on reports of 

liver, kidney, testicular and neural 

pathology in sheep and increases in 

liver enzymes in a dog 2-year study. The 

commenter maintains that the sheep 

study was conducted to investigate the 

possible effects that would result if large 

amounts of simazine were ingested by 

this species. The commenter also states 

that in a 1—year study there were some 

indications of effects on the 

hematopoietic system but not the 

hepatic system at the high dose of 1,500 

ppm. 

In a 1—year study, NOEL and LOELs 

of 0.68 and 3.41 mg/kg/day, 

respectively, were established based on 

decreased body weight gain, and 

decreased RBC, HGB, HCT in females. 

Although the sheep study was 

conducted for a purpose other than to 

investigate the overall toxicity of 

simazine, this does not negate the 

relevance of its results. EPA reaffirms 

that there is sufficient evidence for 

listing simazine on the EPCRA section 

313 list pursuant to EPCRA section 

313(d)(2)(B) based on the available 

hepatic, renal, neurological, and 

reproductive toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of simazine on the EPCRA 

section 313 list. 

49. Sodium nitrite. American 

Automobile Manufacturers Association 

contends that EPA has proposed listing 

on the basis of chronic toxicity but the 

support document cites studies based 

on high dose, acute exposures. High 

dose gestational studies in rats and mice 

were also cited as the basis for 

developmental (fetal) toxicity. 

EPA agrees that the human studies 

cited in the proposed rule are acute 

studies. However, these studies in 

conjunction with the chronic study in 

mice, which showed reduced motor 

activity and major EEG changes in 

treated animals, support the basis for 

concern for chronic neurological effects. 

EPA thus considers sufficient indication 

of a potential chronic neurologic hazard 

to list this chemical on the EPCRA 

section 313. 

There were two developmental 

studies in mice and one reproductive 

study in rats cited in the proposed rule 

which showed effects on the fetal 

development whether sodium nitrite 

was administered during gestation or 

lactation. The doses used in the studies 

with mice, 30 and 80 mg/kg/day, 

respectively, are not abnormally high for 

this type of study; the dose range 

reported for the rat reproductive study, 

26 to 256 mg/kg/day is also not 

abnormally high. The results from all 

three studies indicate that sodium 

nitrite induces developmental effects in 

animals and are sufficient to make a 

determination that the chemical is a 

potential health hazard in man. 

EPA reaffirms that there is sufficient 

evidence for listing sodium nitrite on 

the EPCRA section 313 list pursuant to 

section 313(d)(2)(B) based on the 

chronic hematological and 

developmental toxicity data for this 

chemical. Therefore, EPA is finalizing 

the addition of sodium nitrite on the 

EPCRA section 313 list. 
61466 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

50. Triallate. Monsanto contends that 

the hepatic health effects listed in the 

proposed rule for triallate are trivial 

effects that do not provide sufficient 

evidence that triallate causes hepatic 

toxicity. In addition, Monsanto claims 

that pregnant rats exhibited abnormal 

behavioral signs at 90 but not at 30 mg/ 

kg/day. 

Although the Agency agrees that there 

is not sufficient evidence for 

hepatotoxic potential of triallate, the 

Agency does not concur with the 

commenter that "pregnant rats exhibited 

abnormal behavioral signs at 90 but not 

at 30 mg/kg/day." Head bobbing and 

circling, clear signs of neurotoxicity, 

were observed in pregnant females at 30 

mg/kg/day. Males and non-pregnant 

females did not exhibit these clinical 

signs. These data suggest that pregnant 

rats are more susceptible to the 

neurologic potential of triallate than the 

general population. 

The commenter noted the existence of 

a subchronic neurotoxicity study in rats 

and indicated that this study provides a 

better estimation of the neurotoxic 

potential of triallate than the 2- 

generation reproduction study. 

The Agency agrees that the 

subchronic neurotoxicity study in rats 

(Ref. 10) provides a clearer picture of 

the neurotoxic potential of triallate. The 

Agency has reviewed this study and 

concludes that the results indicate the 

neurotoxic potential of triallate and 

further corroborates the findings cited 

by EPA in the proposed rule. 

Thus, the Agency reaffirms that there 

is sufficient evidence for listing triallate 

on the EPCRA section 313 list pursuant 

to EPCRA section 313(d)(2)(B) based on 

the available chronic neurotoxicity data 

for this chemical. Therefore, EPA is 

finalizing the addition of triallate on the 

EPCRA section 313 list. 

G. Chemicals Not Being Added to 

EPCHA Section 313 

1. 5-Chl oro-2-(2, 4- 

dichlorophenoxy)phenol. Ciba-Geigy 

Corporation and The Dial Corporation 

contend that insufficient evidence is 

available to support the conclusion that 

5 -chloro-2-(2,4-dichlorophenoxy)phenol 

poses a risk of hematological toxicity to 

humans based on handling and uses of 

the product. 

Based on these comments and EPA's 

reanalysis of the data, the Agency has 

concluded that the information 

presented in the proposed rule is not 

sufficient to justify adding 5-chloro-2- 

(2,4-dichlorophenoxy)phenol to the 

EPCRA section 313 list based upon 

potential human hazard. Therefore, EPA 

is not finalizing the addition of this 

chemical on the EPCRA section 313 list. 

2. Clomazone. FMC Corporation 

claims that clomazone induces adverse 

effects only at high dose levels. 

The Agency agrees with the 

commenter. Based on these comments 

and EPA's reanalysis of the data, the 

Agency has concluded that the 

information presented in the proposed 

rule is not sufficient to justify adding 

clomazone to the EPCRA section 3131ist 

based upon potential human hazard. 

Therefore, EPA is not finalizing the 

addition of this chemical to EPCRA 

section 313. 

3. Tetrasodium 

ethylenediaminetetraacetate. Eight 

commenters contend that the proposed 

listing for this chemical was based 

solely on a single, unreliable 

developmental toxicity study which 

used a mixture that contained 

tetrasodium 

ethylenediaminetetraacetate along with 

several other chemicals. 

EPA concedes that the effects cannot 

be attributed solely to tetrasodium 

ethylenediaminetetraacetate. Therefore, 

the Agency is not finalizing the addition 

of tetrasodium 

ethylene di aminetetraacetate on the 

EPCRA section 313 list. 

H. Miscellaneous Comments 

1. Year-to-year comparisons of the 

TRI data. BP America, Texaco, and 

American Automobile Manufacturers 

Association contend that the proposed 

expansion of the EPCRA section 313 list 

will eliminate any consistency with 

earlier TRI data and make tracking 

environmental progress impossible. 

American Automobile Manufacturers 

Association further states that EPA 

needs to ensure that the "total TRI 

releases and transfers" measurement 

system allows accurate interpretation of 

the data, allowing the public to 

realistically assess progress in pollution 

prevention. Also, the commenters add 

that considerable confusion results in 

trying to explain the different data sets 

to the public. Mobil Oil Corporation 

states that EPA should divide the list 

into three sub-groups so that a facility's 

history can be tracked on a more 

common basis. 

EPA recognizes that changes in the 

EPCRA section 313 list and in the 

reporting requirements have an effect on 

the characterization of the TRI data. In 

fact, some change has occurred for every 

reporting year. In an attempt to provide 

useful year-to-year comparisons, EPA 

has presented the TRI data annually on 

a normalized list of chemicals, i.e., the 

list of chemicals used for year-to-year 

comparisons is the same for every year 

in the comparison. EPA further 

recognizes the effect that expansion of 

the EPCRA section 313 list will have on 

the TRI data and will continue to work 

to find ways to make the data useable 

for cross-year comparisons. EPA will 

use the 1995 reporting year as the base 

year for comparisons that include the 

chemicals added today. Facilities 

should still be able to track pollution 

prevention progress for those chemicals 

previously listed (using 1988 as the base 

year) and have a new base year for the 

additional chemicals which can be used 

to track future pollution prevention 

progress. 

2. Public perceptions. Roussell Uclaf 

Corporation, National Paint and 

Coatings Association, Association of 

International Automobile 

Manufacturers, and American Frozen 

Food Institute oppose the listing of 

these chemicals under EPCRA section 

313 because of the public's 

misperception of the associated dangers. 

American Automobile Manufacturers 

Association (AAMA) states that since 

the public considers all chemicals on 

the EPCRA section 313 list to be toxic, 

any chemical on the list is subject to 

adverse scrutiny, regardless of the actual 

risks associated with the chemical. 

While recognizing past efforts by EPA 

towards public education, AAMA 

believes that misunderstanding and 

misinterpretation of the data still exists 

which makes it more critical that EPA 

not expand the list with low risk 

chemicals. Texaco and AAMA believe 

that before the Agency expands the 

EPCRA section 313 list, resources 

should be committed to provide public 

education on actual risks portrayed by 

the data and educate the public on 

viable means of chemical risk reduction 

and chemical management. 

The chemicals that are listed under 

EPCRA section 313 exhibit a wide range 

of effects at various dose levels. While 

EPA attempts to communicate the TRI 

data in the most accurate manner, the 

Agency recognizes that there exists the 

perception that the TRI data may 

sometimes be mischaracterized, but that 

does not justify not adding a chemical 

for which the statutory criteria are 

clearly met. EPA agrees that the better 

approach to such a problem is 

improving public information on the 

chemical, which, combined with the 

release, transfer, and waste management 

data will enable the public to participate 

in informed environmental decisionmaking. EPA continues to attempt to 

provide the public with means for 

interpreting the TRI data. 

3. Persistent bioaccumulative 

chemicals. In the proposed rule, EPA 

requested comment on whether 

chemicals that are manufactured in 

trace amounts in waste streams, are 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61467 

highly toxic at very low dose levels and 

have physical, chemical, or biological 

properties that make the chemicals 

persist for extended periods in the 

environment, and bioaccumulate 

through the food chain should be listed 

on the EPCRA section 313 list (January 

12, 1994, 59 FR 1791). EPA noted that 

persistent bioaccumulative toxic 

chemicals, such as dioxins, are of 

particular concern in ecosystems such 

as the Great Lakes Basin due to the long 

retention time of the individual lakes 

and the cycling of the chemical from 

one component of the ecosystem to 

another. EPA also requested comment 

on the following: If EPA were to add 

this type of chemical to EPCRA section 

313, what modifications to EPCRA 

section 313, such as lowering the 

reporting thresholds and modifying the 

de minimis in mixture exemption (40 

CFR 372.38), would be required to 

ensure that release and transfer 

information would be collected? In 

addition to two comments opposed to 

the addition of this type of chemical, 

EPA received 35 comments supporting 

the addition of toxic persistent 

bioaccumulative chemicals. The 

majority of these commenters also 

supported lowering the reporting 

thresholds for this type of chemical. 

Monsanto and Dow Chemical 

Company object to the addition of 

persistent bioaccumulative chemicals 

that are produced in quantities less than 

the EPCRA section 313 reporting 

thresholds. The commenters state that 

many of the persistent, bioaccumulative 

toxic compounds which are of concern 

are no longer manufactured in the 

United States, and are merely present in 

the environment due to historical 

activities and not current activities. 

EPA disagrees with this contention. 

EPA's request for comment focused on 

chemicals that are generated in small 

quantities. This is not limited to 

chemicals produced as a product, but 

includes chemicals that are generated in 

waste streams. Many persistent, 

bioaccumulative toxic chemicals are 

produced in waste streams. Further, 

EPCRA section 313 requires the 

reporting of chemicals manufactured in 

waste streams if the quantity produced 

exceeds the appropriate reporting 

threshold. 

Monsanto further claims that "the 

amounts of these particularly dangerous 

substances coming from industrial 

facilities are so small that they can have 

no measurable impact on health or the 

environment." 

EPA disagrees that releases of these 

chemicals are so low that they will not 

have an adverse effect upon human 

health or the environment. The 

persistent bioaccumulative aspects of 

these toxic chemicals are such that even 

very small quantities released can 

reasonably be anticipated to cause 

adverse effects upon human health and 

the environment. 

Monsanto also states that the concept 

of different reporting thresholds 

suggests that this threshold would be 

proportional to the relative hazard. 

Thresholds for practically non-toxic 

chemicals may be very high using this 

concept. 

EPA requested comment on lowering 

the thresholds for these chemicals not 

so that the reporting thresholds for 

chemicals listed on the EPCRA section 

313 list would be proportional to the 

relative hazard of the chemicals. Rather, 

EPA requested comment on lowering 

the threshold for persistent 

bioaccumulative chemicals because 

even minimal releases of these 

chemicals may result in elevated 

concentrations in the environment or in 

an organism that can reasonably be 

anticipated to result in significant 

adverse effects. This reflects the 

increased likelihood that there will be 

exposure to a chemical that persists due 

to its longer residence time in the 

environment. Repeated minimal 

releases of a persistent chemical may 

result in elevated concentrations in the 

environment. For a chemical that 

bioaccumulates, even low levels of the 

chemical in the environment may result 

in increased concentrations in an 

organism. Thus, lower thresholds for 

these substances would be considered 

due to the persistent and 

bioaccumulative nature of the 

substances, rather than the direct 

hazard. 

In its next action to add chemicals to 

the EPCRA section 313 list, the Agency 

intends to consider the addition of 

chemicals that are persistent and 

bioaccumulate. EPA also intends to 

consider lowering the reporting 

thresholds for these additional 

chemicals and those chemicals that are 

persistent and bioaccumulate that are 

now on the EPCRA section 313 list. 

Accordingly, comments received in 

response to EPA's request for comment 

on the potential addition of persistent 

bioaccumulators will be addressed in 

the future rulemaking if these chemicals 

are proposed for addition. 

4. Additional chemicals. The 

Wisconsin Department of Natural 

Resources states that the EPCRA section 

313 chemical list should be expanded to 

include the six chemicals listed in 

section 112(b) of the CAA not currently 

included on the EPCRA section 313 list 

or as part of the January 12, 1994 

proposal. 

EPA has reviewed all of the chemicals 

listed under section 112(b) of the CAA 

not currently on the EPCRA section 313 

list and has determined that the 

remaining chemicals either do not meet 

the current listing criteria or no reports 

would be received since their 

production volumes are below reporting 

thresholds. 

5. Hormone mimics. The National 

Wildlife Federation recommends that 

EPA add to the section 313 list all 

chemicals with estrogenic or other 

hormone-mimicking qualities, and the 

reporting thresholds and de minimis 

exemption for mixtures eliminated for 

these chemicals. 

EPA agrees that the deleterious effects 

of hormone mimicking chemicals may 

warrant their future review for listing on 

the EPCRA section 313 list. Although 

the effects of these chemicals are 

difficult to predict, and it is often 

impossible to establish a clear cause/ 

effect relationship, still it is clear from 

the available evidence that these 

chemicals warrant consideration. Wide 

scale changes in wildlife and human 

populations have been noted by some 

researchers. Population decreases and 

reproductive effects have been linked to 

these chemicals in a number of wildlife 

species, including but not limited to 

bears, Florida panthers, songbirds, and 

bald eagles, to list just a few. Possibly 

of greater concern are the effects of these 

chemicals in humans. In addition to the 

carcinogenic potential of many of these 

chemicals, effects on fertility, immune 

system damages, and many childhood 

problems have been attributed to 

hormone-mimics. A number of the 

chemicals with widespread distribution 

in the environment reported to have 

reproductive and endocrine-disrupting 

effects (Ref. 1) are either already on the 

EPCRA section 313 list, or are being 

added as a result of this action. EPA 

may consider reviewing the remaining 

chemicals on this list as part of a future 

action. 

As to removing the reporting 

thresholds and de minimis exemption 

for the hormone-mimicking chemicals 

already on the section 313 list, these 

possibilities will be examined at the 

time that modifying the reporting 

thresholds and de minimis exemption 

for persistent and bioaccumulative 

chemicals is addressed. As many of the 

hormone mimicking chemicals are also 

either persistent or bioaccumulative 

they could be included as part of such 

a review. 

I. Comment on EPA's Regulatory Impact 

Assessment 

Comments that are specific to 

individual chemicals or chemical 
61468 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

categories are addressed in the Response 

to Comments Document (Ref. 14). 

Many commenters state that EPA's 

Regulatory Impact Analysis (RIA) failed 

to meet the requirements of Executive 

Order 12866, which mandates 

regulatory planning and review. The 

commenters state that: (1) The RIA for 

the proposed rule did not analyze any 

alternatives other than adding the 313 

chemicals and chemical categories to 

the EPCRA section 313 list, (2) that it 

excluded the economic effects due to 

complying with state, local and other 

federal requirements that are triggered 

when a chemical is listed under EPCRA 

section 313, and (3) that it did not 

analyze the benefits of the rule. Many 

commenters also contend that small 

business impacts were understated in 

the RIA, and that the time required for 

compliance is higher than estimated in 

the RIA. These comments and the 

Agency's responses are discussed 

below. 

1. Alternatives. The commenters 

believe that the RIA should have 

included alternatives to adding all of the 

proposed chemicals and chemical 

categories to the EPCRA section 313 list. 

In response to these comments, EPA has 

revised the RIA to include a variety of 

alternatives, such as adding the CAA 

criteria air pollutants, not adding 

chemicals regulated under FIFRA, not 

adding the water dissociable nitrate 

compounds category, and adding the 

proposed chemicals in conjunction with 

an alternate reporting threshold for 

facilities with low-levels of TRI 

chemicals in wastes. The commenters 

requested that EPA present the costs for 

adding each individual chemical. EPA 

cannot provide the costs on an 

individual chemical basis because the 

estimates for most of the chemicals were 

derived from confidential business 

information. Displaying the costs for 

each chemical could disclose this 

confidential information. 

2. Linked requirements. Numerous 

commenters state that the RIA excludes 

the costs of compliance with state, local 

and other federal requirements that are 

triggered when a chemical is listed 

under EPCRA section 313. The linked 

requirements that the commenters raise 

include state taxes and fees, state 

pollution prevention planning 

requirements, special requirements for 

certain National Pollutant Discharge 

Elimination System (NPDES) storm 

water permits, and requirements for 

federal facilities under Executive Order 

12856. EPA has revised the RIA to 

discuss state and federal requirements 

that are linked to reporting under 

EPCRA section 313. However, EPA has 

not quantified the costs of such 

requirements. In some cases, this is 

because there is insuf$cient data to 

make a reasonable estimate. In other 

cases, EPA does not believe that the 

requirements represent a social cost. 

The requirements that may be linked to 

listing under EPCRA section 313 are 

discussed below. 

a. State fees. Thirteen states place a 

tax or fee on facilities filing TRI Form 

R reports. These states are Colorado, 

Florida, Iowa, Kansas, Maine, 

Massachusetts, Minnesota, Mississippi, 

Nevada, Ohio, Pennsylvania, South 

Dakota, and Texas. Many commenters 

estimate that the costs resulting from 

state fees and taxes linked to EPCRA 

section 313 reporting are up to 50 

percent of the direct cost of filing the 

forms, and state that any tax is likely to 

induce a reduction in economic welfare. 

EPA has revised the RIA to discuss state 

fees and taxes that are linked to 

reporting under EPCRA section 313. 

However, the taxes and fees are not 

direct social costs, and EPA does not 

believe that there is sufficient 

information to estimate the net social 

costs or benefits of these requirements. 

The commenters treat state taxes and 

fees on the EPCRA section 313 reports 

as costs, but these are transfer payments 

and not economic costs to society. 

Specifically, the standard definition of a 

cost in economics is the consumption of 

a resource (e.g., labor, equipment, 

natural resources, etc.). A tax or fee is 

a transfer payment from one party to 

another. While the fee is a cost to the 

firm (and/or its customers), it is income 

to the state. No resources are consumed, 

except for transaction costs, so the 

amount of the fee is not a cost to society. 

EPA disagrees with the commenters' 

contention that any tax or fee is likely 

to induce a reduction in economic 

welfare. EPA believes that taxes or fees 

on toxic chemicals may resolve a market 

failure and increase social welfare. The 

use of toxic chemicals often creates a 

negative externality. For instance, 

releases of a chemical may cause health 

and environmental effects in the 

surrounding community. In such cases, 

it is likely that private costs are below 

true social costs, because private 

markets do not provide an adequate 

incentive for firms to internalize these 

externalities. In such cases, taxes may 

be the optimal method to correct the 

market failure. EPA believes that if the 

commenters feel that the fees are not set 

at the level that optimizes social 

welfare, their remedy lies with the 

appropriate state agency, and not EPA. 

EPA does not feel that it is feasible to 

estimate the size of the transfer payment 

resulting from state fees and taxes 

linked to EPCRA section 313, or the net 

social costs or benefits of these 

payments. The commenters made their 

estimates by applying the maximum 

state fees to all facilities nation-wide. 

EPA does not feel that such a 

calculation is appropriate. Most states 

have no fees or taxes linked to EPCRA 

section 313 reporting, and the level of 

the fees or taxes (and how they are 

assessed) is different in each of the rest 

of the states, varying from $25 to 

$50,000. Many of the state requirements 

are not flat fees, but are graduated 

depending on the level of releases that 

a facility reports, An accurate 

representation of the size of the transfer 

payments would require estimating the 

geographic distribution of new reports, 

and the level of releases and transfers 

for each report. EI'A feels that it is not 

possible to predict with a reasonable 

degree of accuracy the location and 

level of releases for facilities that will 

report on the chemicals being added to 

the EPCRA section 313 list. 

Nor is it feasible to accurately 

estimate the net social costs or benefits 

of the state fees and taxes. To do so 

would require knowing not only the size 

of the transfer payments, but the 

damages caused by the use and release 

of the chemicals, and the change in 

behavior that would result from the fees 

and taxes. EPA does not have adequate 

information on the facilities that would 

be affected by the rule to make such 

estimates. As a result, the RIA has been 

revised to qualitatively discuss state fees 

and taxes linked to EPCRA section 313 

reporting, but does not estimate the size 

of the resulting transfer payments, or the 

net social costs or benefits. 

b. State pollution prevention 

programs. Seven states (Arizona, Maine, 

Massachusetts, Minnesota, Mississippi, 

New Jersey, and Texas) mandate 

pollution prevention plans from 

facilities reporting under EPCRA section 

313. Facilities in these states that are 

reporting to TRI for the first time 

because of the additions to the chemical 

list will have to prepare pollution 

prevention plans. Although the 

development of pollution prevention 

plans imposes a cost on facilities, the 

RIA did not analyze the costs of these 

requirements. Many comrnenters 

contend that there are significant costs 

for preparing such plans, and that the 

RIA should have included these costs. 

QuantifVing the impacts of state 

pollution prevention requirements 

would require predicting which 

facilities reporting for the additional 

chemicals would be located in these 

seven states. As stated above, it is not 

possible to accurately predict the 

geographic location of new reporters. 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61469 

Thus, no costs are estimated for state 

pollution prevention plans in the RIA. 

Nor does the RIA quantify the benefits 

derived from these pollution prevention 

planning requirements. None of the 

commenters submitted any evidence 

comparing the social benefits of such 

requirements to the costs. Therefore, 

EPA has no information from which to 

conclude that the linked requirements 

for state pollution prevention plans 

would reduce the net social benefits of 

adding chemicals to EPCRA section 313. 

EPA has not quantitatively estimated 

either the costs of state pollution 

prevention planning requirements or the 

benefits of such programs in the RIA. 

However, the RIA has been revised to 

qualitatively discuss requirements that 

are linked to EPCRA section 313 

reporting, including pollution 

prevention plan preparation. 

c. NPDES storm water permits. EPA 

issued National Pollutant Discharge 

Elimination System (NPDES) "baseline" 

general permits for storm water 

discharges associated with industrial 

activity on September 9, 1992 (57 FR 

41236). EPA subsequently proposed a 

multi-sector storm water industrial 

permit covering 29 industrial sectors 

(November 19, 1993, 58 FR 61147). The 

"baseline" general and multi-sector 

general permits have special pollution 

prevention requirements for certain 

EPCRA section 313 facilities, and the 

"baseline" permits also contain special 

monitoring requirements. Many 

commenters assert that the RIA 

underestimates the costs of the rule by 

a factor of up to 5.6 by not including the 

costs of NPDES storm water permit 

requirements that are triggered by 

adding chemicals to the EPCRA section 

313 list. 

EPA believes that the commenters' 

estimates are based on a cost scenario 

that is not applicable to the typical 

facility affected by the proposal to add 

chemicals under EPCRA section 313. 

There are four reasons that the 

commenters' estimates are not generally 

appropriate. Any of these reasons alone 

demonstrate that the commenters have 

overestimated the number of facilities 

that are affected and the the size of the 

impact. Because there may also be a 

significant overlap among the four, the 

commenters' estimates are likely to 

apply to few, if any, facilities. The 

commenters' estimates would not apply 

to all facilities affected by the rule, as 

the commenters contend. 

First, only a fraction of the facilities 

that would report under EPCRA section 

313 for the additional chemicals would 

be affected by the NPDES storm water 

permits. A facility that submits TRI 

Form R is only sub)ect to storm water 

permitting requirements if industrial 

materials or activities are exposed to 

storm water, and if the facility is 

reporting to TRI for one of the section 

313 water priority chemicals. Only 

about two dozen of the chemicals being 

added to the EPCRA section 313 list 

qualify as section 313 water priority 

chemicals, and thus would be covered 

by the NPDES requirements. About half 

of these are pesticides, which would not 

be manufactured or processed at many 

facilities. 

Second, EPA expects the majority of 

facilities to have existing containment 

systems that meet most of the 

requirements of the NPDES permits. 

Third, many of the costs for the storm 

water requirements are likely to apply at 

the facility level. In such cases, facilities 

that installed systems for the current 

EPCRA section 313 chemicals will not 

face incremental costs for the additional 

chemicals. Fourth, the special 

requirements of the NPDES storm water 

permits are based on the coverage of 

EPCRA section 313 at the time the 

permits were issued. The NPDES 

requirements do not apply to chemicals 

that are added to the EPCRA section 313 

list until the time of permit renewal 

(which occurs every 5 years), and may 

not apply in subsequent permits, 

depending on the Agency's decisions at 

the time those permits are issued. 

In addition, the commenters based 

their estimates solely on the upper 

bound of EPA's estimates for the NPDES 

permits, and have ignored the mix of 

low-cost and high-cost facilities that is 

likely to exist. EPA believes that the 

commenters' estimate is a hypothetical 

"worst-case" scenario that does not 

apply to the typical facility and may not 

apply to any facilities. EPA believes that 

the costs of the storm water 

requirements for the proposed 

chemicals will be relatively minor. 

Again, EPA has revised the RIA to 

qualitatively discuss the linkage 

between EPCRA section 313 reporting 

and the NPDES storm water, but it has 

not made any quantitative estimates of 

these costs. 

d. Executive order 12856. Executive 

Order 12856, signed by the President in 

August 1993, extends the coverage of 

EPCRA to federal facilities. In addition, 

section 3-303(a) of the Executive Order 

states that "Each federal agency shall 

establish a plan and goals for 

eliminating or reducing the unnecessary 

acquisition by that agency of products 

containing extremely hazardous 

substances or toxic chemicals" 

(emphasis added). The Executive Order 

defines "toxic chemical" as a substance 

on the list described in section 313 of 

EPCRA. Many commenters contend that 

the cost to the federal government and 

the private sector of complying with 

Executive Order 12856 for the chemicals 

being added to EPCRA section 313 will 

be $1.5 billion per year. 

EPA does not believe that the effects 

of Executive Order 12856 should have a 

bearing on the decision-making 

regarding the addition of toxic 

chemicals to EPCRA section 313. EPA 

believes that following the commenters 

line of reasoning would discourage the 

federal government from ever making 

any changes in procurement, for 

whatever reason, because doing so 

might have an impact on a supplier. 

Furthermore, EPA believes that there is 

insufficient data to make any estimate of 

the effects of the Executive Order, and 

that the resources required to make such 

an estimate would exceed the value of 

the information. 

EPA notes that section 3-303(a) of the 

Executive Order does not require the 

elimination of toxic cheinicals in federal 

procurement. If the performance 

characteristics of a toxic chemical or 

product containing a toxic chemical are 

critical in the required tasks, federal 

agencies may continue to purchase it. 

Each federal agency must make its own 

determination whether a particular toxic 

chemical is necessary in a particular 

use. 

The Executive Order requires that 

federal agencies eliminate or reduce the 

unnecessary procurement of extremely 

hazardous substances or toxic 

chemicals. None of the commenters 

identify which toxic chemicals are being 

unnecessarily purchased by the federal 

government, and which federal agencies 

are making these unnecessary 

purchases. Without such information, 

EPA cannot verify the commenters' 

claim that the addition of chemicals to 

EPCRA section 313 will create 

significant impacts as a result of the 

Executive Order. If these chemicals are 

not being purchased by the federal 

government, or are not being purchased 

unnecessarily, there will not be an 

impact. 

The commenters' estimate of $1.5 

billion in costs is based solely on a 

series of assumptions, which are not 

supported by data. EPA does not believe 

that the commenter's analysis was based 

on a careful analysis of any factual 

information. EPA has no data with 

which to replace these assumptions. 

Given EPA's belief that effect of the 

Executive Order should not have a 

bearing on the rulemaking (as well as 

the limitations of the Executive Order, 

the small amount of procurement that 

would be affected, and the ability of 

producers to sell to private sector clients 

or manufacture substitutes), EPA does 
61470 Federal Register / Vol: 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

not believe that there is a need to 

develop any data on these factors. 

The Executive Order states that "the 

environmental, energy and economic 

benefits of energy and water use 

reductions are very significant," and 

that "the federal governrnent has the 

opportunity to realize significant 

economic as well as environmental 

benefits of pollution prevention." The 

Executive Order provided a mandate for 

the federal government to reduce its 

unnecessary use of toxic chemicals. EPA 

believes that the proposal to add 

chemicals to the section 313 list 

complements this mandate. 

Furthermore, EPA hopes that federal 

agencies will comply with the spirit of 

the Order, and reduce their unnecessary 

use of toxic and hazardous chemicals, 

whether or not these chemicals are 

listed on the EPCRA section 313 list. 

EPA believes that, by definition, the 

social benefits cannot exceed the social 

costs for an unnecessary toxic chemical, 

and social welfare can be improved by 

switching to a substitute product. 

Therefore, EPA believes that any actions 

federal agencies take to meet their 

obligations under Executive Order 

12856 will have a positive net benefit. 

3. Benefits. Many commenters assert 

that the RIA did not show any benefits 

to adding chemicals to the EPCRA 

section 313 list of chemicals. The 

commenters appear to have made these 

statements because EPA did not make a 

quantitative estimate of the benefits 

associated with the rule. 

There are two types of benefits 

associated with EPCRA section 313. The 

first type of benefit is due to 

improvements in understanding, 

awareness, and decision-making related 

to the provision and distribution of 

information. The second type of benefits 

derive from changes in behavior that 

result from the information reported to 

TRI. These benefits include reduced 

environmental and health risks, and 

reduced treatment and disposal costs: 

These changes in behavior come at some 

cost to society. Because the current state 

of knowledge about the economics of 

information is not highly developed, 

EPA has not attempted to quantify the 

pure information benefits of adding 

chemicals to the EPCRA section 313 list. 

Because of the inherent uncertainty in 

the chain of events, EPA has also not 

attempted to quantify the benefits or the 

costs of the changes in behavior that 

result from the information. EPA does 

not believe that there are adequate 

methodologies to make reasonable 

quantitative estimates of either type of 

benefits. However, EPA believes that its 

qualitative discussion of the effects of 

the current TRI program show that such 

benefits do exist. The information o,i 

the additional chemicals is expected to 

improve scientific understanding of the 

environment and health risks, foster 

greater community awareness of 

industrial activities, and allow Federal, 

state, and local authorities to make 

better informed decisions on acceptable 

levels of toxic chemicals in 

communities. 

Instead, EPA has drawn its 

conclusions about the net benefits of 

adding chemicals to EPCRA section 313 

by inference. In enacting EPCRA and the 

PPA, Congress implicitly determined 

that the net benefits of reporting was 

positive for the original list of 320 

chemicals and categories. EPA's 

interpretation of the statutory toxicity 

criteria is more stringent than Congress' 

original determination because EPA has 

deleted 12 chemicals from the original 

list of 320 chemicals and categories 

developed by Congress. EPA believes 

that all of the chemicals being finalized 

meet the statutory toxicity criteria of 

section 313, and are at least as toxic as 

some of the chemicals for which 

Congress believed there were net 

benefits due to reporting. Thus, by 

inference, the net benefits of reporting 

for the chemicals added in this 

rulemaking should be positive as well. 

EPA believes that the experience of 

the past 5 years shows that reporting 

under EPCRA section 313 has produced 

real gains in understanding about 

exposure to toxic chemicals. EPA sees 

no reason why the information on the 

additional chemicals will provide less 

understanding than the currently 

reported chemicals have provided. 

4. Small business. Under the 

Regulatory Flexibility Act (5 U.S.C. 

sections 601 - 612), agencies must 

prepare an analysis of small business 

impacts for proposed rules. Many 

commenters contend that small business 

impacts were understated in the RIA, 

and they question EPA's conclusion that 

the rule will not have a significant 

impact on a substantial number of small 

entities. EPA believes that the 

commenters have.significantly 

overestimated the costs of the rule, and 

that the commenters' estimates of small 

business impacts are not valid. EPA has 

provided additional analysis in the RIA 

for the final rule that demonstrates that 

the rule will not have significant cost 

impacts on small entities. 

EPA believes that, whether or not the 

proposed rule would have had 

significant cost impacts on small 

entities, the Agency has subsequently 

met its obligations under the Regulatory 

Flexibility Act. Where a proposed rule 

would have significant impacts on small 

entities, the Act requires EPA to identify 

and consider (but not necessarily adopt) 

alternatives that minimize the impact on 

these entities, while accomplishing the 

stated objectives of the applicable 

statute. 

Elsewhere in this issue of the Federal 

Register, EPA is finalizing a rule 

establishing an alternate threshold for 

low-levels of TRI chemicals in waste 

that would otherwise meet the reporting 

requirements under EPCRA section 313. 

Such facilities can submit an annual 

certification statement in lieu of a TRI 

Form R. EPA estimates that facilities 

will require an average of 34 hours to 

comply with the requirements for a 

certification statement, compared to 53 

hours for a TRI Form R. The alternate 

reporting threshold will apply to the 

chemicals being added under EPCRA 

section 313 by this rule as well as 

chemicals currently listed under EPCRA 

section 313. 

EPA's guidelines for implementing 

the Regulatory Flexibility Act state that 

"The altematives considered for the 

purpose of fulfilling the Act's 

requirements need not be restricted in 

applicability to small entities. 

Regulatory alternatives that prove to be 

more cost-effective for small entities 

often will be more cost-effective for 

larger entities as well. For example, 

altematives that place lesser burden on 

facilities with lower emission levels, 

lower production levels, etc., should be 

analyzed in conjunction with fulfilling 

the Act's requirements even though 

such alternatives may not ease the 

burden on all (or even most) small 

entities and may benefit large entities as 

well as small ones," 

Because EPA has considered, and 

adopted, an alternative that places lesser 

burden on facilities with lower emission 

levels, EPA believes that it has met the 

requirements of the Regulatory 

Flexibility Act. The alternate threshold 

will provide significant relief for small 

businesses that will report for the 

proposed chemicals, which is the intent 

of the Act. 

5. Reporting burden. Many 

commenters report that the time 

required for compliance with EPCRA 

section 313 is higher than that estimated 

in the RIA. Commenters estimates of the 

time required to prepare a TRI Form R 

and perforrn the necessary 

recordkeeping vary from 91 to 2,000 

hours, compared with EPA's estimate of 

53 hours. 

The unit time estimates used bv EPA 

are average values. EPA recognizes that 

large multi-divisional, multidepartmental facilities may require 

more than the average time to comply. 

As with any average, some facilities will 

be above the average and others will be 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61471 

below it. However, there are many other 

facilities subject to the rule that are not 

large, multi-divisional or multidepartmental. These facilities will 

typically have a simpler compliance 

process. 

The variability among facilities is 

evident in comments on the rule 

submitted by a large chemical 

manufacturing company, that provided 

estimates showing that it spends an 

average of 28 hours for each TRI Form 

R that is submitted to compile 

information, perform calculations, 

prepare the TRI Form R and maintain 

records. This includes the time spent on 

compliance determination for chemicals 

that are below threshold levels. This is 

less than EPA's estimate of 53 hours for 

the same activities. 

While some of the commenters may 

require more time than average to 

comply with the rule, other companies 

require less time than average. EPA 

believes that its time estimates are a 

reasonable average for the 

manufacturing sector as a whole. 

V. Rulemaking Record 

The record supporting this final rule 

is contained in the docket number 

OPPTS-400082B. All documents, 

including an index of the docket, are 

available in the TSCA Nonconfidential 

Information Center (NCIC), also known 

as the TSCA Public Document Office, 

from noon to 4 p.m., Monday through 

Friday, excluding legal holidays. TSCA 

NCIC is located at EPA Headquarters, 

Rm. NE—B607, 401 M St., SW., 

Washington, DC 20460. 

VI. References 

(1) Colborn, T., F.S. fom Saal A.M. 

Soto. Developmental Effects of 

Endocrine-Disrupting Chemicals in 

Wildlife and Humans. Environmental 

Health Perspectives 101:378-384. 

(2) DeRosa, Stara and Durkin Ranking 

Chemicals Based on Chronic Toxicity 

Data, Tox. and Ind. Health, Vol. 1, No.4, 

(1985) 

(3) NAS/NRC. Risk Assessment in the 

Federal Government: Managing the 

Process. National Academy Press, 

Washington, DC (1983) 

(4) USEPA/OHEA. Risk Assessment 

Guidelines for Carcinogen Risk. U.S. 

Environmental Protection Agency, 

Cincinnati, OH. (1987). 

(5) USEPA/OHEA. The Risk 

Assessment Guidelines of 1986. U.S. 

Environmental Protection Agency, 

Washington, DC (1987) 

(6) USEPA/OHEA. Guidelines for 

Developmental Toxicity Risk 

Assessment. U.S. Environmental 

Protection Agency, Washington, DC 

(1991) [56 FR 63805] 

(7) USEPA/OHEA. Draft Report: 

Principles of Neurotoxicity Risk 

Assessment; Notice. U.S. Environmental 

Protection Agency, Washington, DC 

(1993) [58 FR 415561 

(8) USEPA/OPP. EPTC-RS-DCI. 

Evaluation of Two-Year Chronic Rat 

Study (Accession Nos. 254335, 254336, 

254337, 254338, and Addendum to 

Final Report (Accession Nos. 258076, 

260057). U. S. Environmental Protection 

Agency, Washington, DC (1986) 

(9) USEPA/OPP. Support Document 

for the Addition of Chemicals from 

Federal lnsecticide, Fungicide, 

Rodenticide Act (FIFRA) Active 

Ingredients to EPCRA Section 313. U. S. 

Environmental Protection Agency, 

Washington, DC (1993). 

(10) USEPA/OPP. Triallate: 

Subchronic Neurotoxicity Study in Rats. 

U.S. Environmental Protection Agency, 

Washington, DC (1994). 

(11) USEPA/OPPT. Revised Draft 

Hazard Assessment Guidelines for 

Listing Chemicals on the Toxic Release 

Inventory. U. S. Environmental 

Protection Agency, Washington, DC 

(1992). 

(12) USEPA/OPPT. Support 

Document for the Addition of Chemicals 

from Section 112(b) of the C/ean AirAct 

Amendments and Chlorinated Paraffins 

to EPCRA section 313. U. S. 

Environmental Protection Agency, 

Washington, DC (1993). 

(13) USEPA/OPPT. Support 

Document for the Health and Ecological 

Toxicity Review of TRI Expansion 

Chemicals. U. S. Environmental 

Protection Agency, Washington, DC 

(1993). 

(14) USEPA/OPPT. Response to 

Comments Received on the January 12, 

1994 Proposed Rule to Expand the 

EPCRA Section 313 List. U. S. 

Environmental Protection Agency, 

Washington, DC (1994). 

VII. Regulatory Assessment 

Requirements 

A. Executive Order 12866 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993) the Agency 

must determine whether the regulatory 

action is "significant" and therefore 

subject to review by the Office of 

Management and Budget (OMB) and the 

requirements of the Executive Order. 

Under section 3(f), the order defines as 

"significant" those regulatory actions 

likely to lead to a rule (1) Having an 

annual effect on the economy of $100 

million or more, or adversely and 

materially affecting a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local or tribal 

governments or communities (also 

referred to as "economically 

significant"); (2) creating serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlements, 

grants, user fees, or loan programs; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President's priorities, or the principles 

set forth in this Executive Order. 

EPA has prepared a Regulatory Impact 

Analysis (RIA) in conjunction with this 

rulemaking. A copy of this document 

(titled "Regulatory Impact Analysis of 

the Final Rule to Add Various 

Chemicals and Chemical Categories to 

the EPCRA Section 313 List of Toxic 

Chemicals") is available in the TSCA 

NCIC (See Unit V. of this preamble), for 

review and copying. 

EPA has estimated that the total costs 

to industry of adding the new chemicals 

to the EPCRA section 313 list is 

approximately $99 million in the first 

year and $49 million each year 

thereafter. Costs to EPA are 

approximately $1 million per year. 

TABLE 2.-SUMMARY OF COST COMPARISON BETWEEN PROPOSED AND FINAL RULE 

Proposed Rule Final Rule Final Rule with Alternate 

Threshold 

Number of chemicals and chemical 313 286 , 286 

categories 

Number of new facilities 2,404 1,225 1,225 

Total number of facilities 7,049 3,509 3,509 

Number of TRI Form Rs submifted 28,196 14,036 10,548 

Number of annual certifications submit- 0 0 3,488 

ted 

First vear industry costs $160.4 million S99 million 692.8 million 
61472 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

TABLE 2: SUMMARY OF COST COMPARISON BETWEEN PROPOSED AND FINAL RULE--Continued 

Proposed Rule Final Rule Final Rule with Alternate 

Threshold 

Subsequent year industry costs $88.5 million $48.8 million $44.3 million 

EPA Costs $2.1 million $1.1 million $0.9 million 

Source-RIA. The results for the alternate 

threshold are based on a 500 pound level of 

total waste. 

'This includes 39 chemicals as part of two 

delineated categories. 

The costs for the final rule are 

different from the costs for the proposed 

rule, as shown in Table 2. There are two 

reasons for this change. First, the 

number of chemicals and chemical 

categories added has decreased from 

313 to 286, which reduced the number 

of reports that would be submitted. 

Second, the number of reports estimated 

for one chemical, water dissociable 

nitrate compounds (reportable only 

when in aqueous solution), was 

increased from 2,146 to 3,066 to account 

for facilities that create water 

dissociable nitrate compounds in 

aqueous solution through on-site 

biological treatment of wastewater. 

Elsewhere in this issue of the Federal 

Register, EPA is finalizing a rule 

establishing an alternate threshold for 

facilities with low amounts of a listed 

toxic chemical in waste (see Unit H. of 

this preamble). Qualifying facilities 

would be eligible to submit an annual 

certification statement instead of a TRI 

Form R. Because the time required for 

the alternate threshold is less than the 

time required for a TRI Form R, the cost 

of compliance with this rule will be 

lowered as a result. The effect of the 

alternate threshold on the chemicals 

being added by this rule is 

demonstrated in Table 2. Further 

information on the effect of the alternate 

threshold is presented elsewhere in this 

issue of the Federal Register. 

The costs described in Table 2 

represent only those actions that are 

required by this rule. There are other 

requirements that are linked to reporting 

under EPCRA section 313, but which 

are not required by this rule. There are 

13 states that place a fee or tax on 

facilities that file a TRI Form R or report 

to EPA under EPCRA section 313, and 

7 states that mandate pollution 

prevention plans from such facilities. 

EPA has also created special 

requirements for certain facilities with 

NPDES storm water permits that report 

under EPCRA section 313. 

Adding chemicals and chemical 

categories to the EPCRA section 313 list 

may cause some facilities to incur 

additional costs through these linked 

requirements. These costs have not been 

monetized, but they should not be 

significant. The linked fees and taxes 

are transfers, and not social costs, and 

many of the reporting facilities will not 

be located in the 13 states with fees and 

taxes. Also, the NPDES and pollution 

prevention planning requirements are 

most likely to create costs for facilities 

that are new reporters. There will be 

approximately 1,225 new reporters as a 

result of this rule, although not all of 

these will be subject to the NPDES 

requirements, or be located in states 

with pollution prevention planning 

requirements. The linkage to the NPDES 

requirements is limited to about two 

dozen of the new chemicals, not a11286 

chemicals and chemical categories being 

added. 

The market failure that this rule is 

intended to correct is the externality 

created by the lack of information 

available to citizens about the releases 

and transfers of toxic chemicals in their 

communities. Taking no action would 

allow this externality (and the resultant 

social costs) to continue. It is expected 

that this rulemaking will generate 

benefits by providing citizens with 

access to information that otherwise 

would not be available to them. The 

benefits of the rule itself are limited to 

improvements in understanding, 

awareness and decision-making related 

to the provision and distribution of 

information. 

EPA believes that the rulemaking can 

reasonably be anticipated to indirectly 

yield health and environmental benefits 

by leading to reductions in the releases 

and transfers of toxic chemicals. These 

changes in behavior come at some cost 

to industry. The net benefits of the 

follow-on activities are the difference 

between the benefits of decreased 

chemical releases and transfers, and the 

costs of the actions needed to achieve 

them. As noted above, EPA has not 

quantified the benefits of this rule or the 

follow-on activities. 

This action was submitted to OMB for 

review, as required by Executive Order 

12866, and any comments or changes 

made in response to OMB suggestions or 

recommendations have been 

documented in the public record. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act of 1980 

requires each Federal agency to perform 

a Regulatory Flexibility Analysis for all 

rules that are likely to have a 

"significant impact on a substantial 

number of small entities." EPA 

investigated the potential impact of the 

proposed rule on small businesses, and 

has prepared a Final Regulatory 

Flexibility Analysis (FRFA). This 

assessment has been included as part of 

the RIA and is summarized below. 

In assessing small business impacts, 

EPA calculated the costs incurred by 

two hypothetical facilities that are 

supplier notification facilities reporting 

to the TRI for the first time. Facilities 

were assumed to file only Form Rs, 

instead of any annual certification 

statements. Thus, the results are based 

on conservative assumptions. The first 

facility files a report for a single new 

chemical, while the other files reports 

for four new chemicals. For each 

hypothetical facility, annual regulatory 

costs were calculated and compared to 

average annual sales. 

The cost impact ratios were calculated 

based on the average annual sales of 

those facilities currently reporting under 

EPCRA section 313 for which annual 

sales and employee figures could be 

obtained from Dun Bradstreet. The Dun 

Bradstreet data base was used instead of 

Census data on the assumption that 

facilities that report under EPCRA 

section 313 are not uniformly 

distributed throughout the entire 

population of facilities in each size 

category. EPA believes that it is 

reasonable to assume that facilities 

reporting under EPCRA section 313 

have, on average, larger annual sales 

than the typical facility in an industry. 

Therefore, the annual sales of current 

reporters should be a more appropriate 

measure than the sales of all facilities in 

an industry 

A small business was defined as 

having fewer than 50 employees. 

Although a more detailed break-down of 

size categories would have allowed for 

a closer examination of the potential 

impact on even smaller facilities, the 

total number of observations in the 

matched data base was too small to 

allow for additional categories. 

EPA often uses a cost impact 

percentage of one percent as a threshold 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regul ations61473 

measure below which facilities are not 

considered to be significantly impacted 

as a result of a regulation. Under the 

scenario in which facilities are assumed 

to submit one TRI Form R, the cost 

impact percentages are well below one 

percent for all employee size classes in 

all SICs. The highest cost impact 

percentage is 0.4 percent for small 

facilities in Standard Industrial 

Classification (SIC) codes 25 (Furniture) 

and 31 (Leather) in the first year of 

reing. 

Mer the scenario in which facilities 

are assumed to submit four TRI Form 

Rs, cost impact percentages in the first 

year of reporting are above one percent 

only for small facilities in SIC codes 25 

(1.2 percent) and 31 (1.1 percent). Cost 

impact percentages are below 0.8 

percent for all industries in subsequent 

years. 

The higher impact rates for the 

hypothetical facilities occur in industry 

sectors where there have historically 

been a relatively small number of 

establishments reporting. 

Approximately 8 percent of all facilities 

in SIC code 25 (Furniture) and 10 

percent of all facilities in SIC code 31 

(Leather) currently report to EPCRA 

section 313 (compared to 57 percent of 

all facilities in the chemical industry). It 

is reasonable that large and medium 

businesses are more highly represented 

in these percentages than small 

businesses, because they would be more 

likely to exceed the EPCRA section 313 

thresholds. In addition, facilities in SIC 

25 and 31 have typically submitted 

fewer than four reports each, and would 

be less likely to submit four reports for 

the new chemicals than facilities in 

other industries. 

Thus, cost impacts for facilities 

potentially affected by the rule were not 

found to be of sufficient magnitude to 

cause significant impacts. Although 

EPA has found that the rule does not 

result in significant impacts on small 

facilities, EPA has separately developed 

alternatives to meet the goals of the 

Regulatory Flexibility Act (i.e., to 

accomplish the objectives of EPCRA 

section 313 while minimizing the 

economic impact on small entities). EPA 

proposed a rule establishing an 

alternative reporting threshold for lowlevel releases and transfers (July 28, 

1994, 59 FR 38524). The proposal 

requested comment on five different 

levels for the alternate reporting 

threshold. This rule is being finalized 

elsewhere in today's issue of the 

Federal Register. 

C. Paperwork Reduction Act 

The collection of information and 

other requirements under section 313 of 

EPCRA and section 6607 of the PPA are 

covered under OMB approval number 

2070-0093, which was issued on May 

14, 1992. While this approval normally 

would have expired on November 30, 

1992, it remains in effect pursuant to the 

1993 Department of Veteran Affairs and 

Housing and Urban Development and 

Independent Agencies Appropriations 

Act, Pub. L. 102-389, signed October 6, 

1992, which states that: 

Notwithstanding the Paperwork Reduction 

Act of 1980 or any requirements thereunder 

the Environmental Protection Agency Toxic 

Chemical Release Inventory TRI Form R and 

instructions, revised 1991 version issued 

May 19, 1992, and related requirements 

(OMB No. 2070-0093), shall be effective for 

reporting under section 6607 of the Pollution 

Prevention Act of 1990 (Public Law 301-508) 

and section 313 of the Superfund 

Amendments and Reauthorization Act of 

1986 (Public Law 99-499) until such time as 

revisions are promulgated pursuant to law. 

This final rule adds chemicals to the 

list of toxic chemicals subject to 

reporting under section 313 of EPCRA 

and section 6607 of the PPA and does 

not change the elements of the TRI 

reporting form, its instructions, or 

related requirements. Accordingly, the 

TRI Form R and instructions and related 

requirements remain in effect, as 

provided by Pub. L. 102-389. 

The industry reporting burden for 

collecting this information is estimated 

to average 53 hours per respondent 

annually, including time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

The actual burden to a specific facility 

may deviate from this estimate 

depending on the complexity of the 

facility's operations and the profile of 

the release. 

List of Subjects in 40 CFR Part 372 

Environmental protection, 

Community right-ta-know, Reporting 

and recordkeeping requirements, Toxic 

chemicals. 

Dated: November 22, 1994. 

Carol M. Browner, 

Administrator. 

Therefore, 40 CFR part 372 is 

amended to read as follows: 

Part 372—[AMENDED] 

1. The authority citation for part 372 

continues to read as follows: 

Authority: 42 U.S.C. 11013 and 11028. 

2. In § 372.65 by adding chemicals to 

paragraph (a) alphabetically, to 

paragraph (b) by CAS no. sequence, and 

to paragraph (c) by alphabetically 

adding six categories to read as follows: 

§ 372.65 Chemicals and chemical 

categories to which the part applies. 

( a) x .. * 

Chemical Name CAS No. Effective 

Date 

Abamectin [Avermectin 131] 71751-41-2 1/1/95 

Acephate (Acetylphosphoramidothioic acid O,S-dimethyl ester) 30560-19-1 1 1/1/95 

Acifluorfen, sodium salt [5-(2-Chloro-4-(trifiouromethyl)phenoxy)-2-nitro-benzoic acid, sodium salt] 

Alachlor 

Aldicarb 

d-trans-Allethrin [d-trans-Chrysanthemic acid of d-allethrone] 

Allylamine 

Aluminum phosphide 

Ametryn (N-Ethyl-N'-(1-methyiethyl)-6-(methyithio)-1,3,5,-triazine-2,4-diamine) 

62476-59-9 1 1 /1 /95 

15972-60-8 1 /1 /95 

116-06-3 1 /1 /95 

28057-48-9 1/1 /95 

107-11-9 1/1 /95 

20859-73-8 1/1/95 

834-12-8 1 /1 /95 

Amitraz 1 33089-61-1 1 1/1 /95 
61474 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

Chemical Name CAS No. Effective 

Date 

Anilazine [4,6-dichloro-N-(2-chlorophenyl)-1,3,5-triazin-2-amine] 101-05-3 1/1/95 

Atrazine (6-Chloro-N-ethyl-N'-(1-methylethyl)-1,3,5,-triazine-2,4-diamine) 1912-24-9 1/1195 

Bendiocarb [2,2-Dimethyl-1,3-benzodioxol-4-0I meth yIcarbamate] 

Benfluralin (N-Butyl-N-ethyl-2,6-dinitro-4-(trifluoromethyl)benzenamine) 

22781-23-3 

1861-40-1 

1/1/95 

1 /1 /95 

Benomyl 17804-35-2 1/1/95 

Bifenthrin 82657-04-3 1/1/95 

Bis(tributylin) oxide 56-35-9 1/1/95 

Boron trichloride 10294-34-5 1/1/95 

Boron trifluoride 7637-07-2 1/1/95 

Bromacil (5-Bromo-6-meth I-3-(1-methylprbpyl)-2,4- ( 1H,3H)-pyrimidinedione) 

Bromacll, lithium saft [2,4-~ H,3H)-Pyrimidinedione, 5-bromo-6-methyl-3-(1-methylpropyl), lithium saft] 

314-40-9 

53404-19-8 

1 1 1 195 

1/1/95 

Bromine 7726-95-6 1 /1 /95 

1-Bromo-l-(bromomethyl)-1,3-propanedicarbonitrile 35691-65-7 111 /95 

2-Bromo-2-nitropropane-1,3-diol (Bronopol) 52-51-7 1/1/95 

Bromoxynil (3,5-Dibromo-4-hydroxybenzonitrile) 1689-84-5 1/1/95 

Bromoxynil octanoate (Octanoic acid, 2,6-dibromo-4-cyanophenyl ester) 1689-99-2 1/1/95 

Brucine 357-57-3 1 /1 /95 

C.I. Acid Red 114 6459-94-5 1/1 /95 

C.I. Direct Blue 218 28407-37-6 1/1/95 

Carbofuran 1563-66-2 1 /1 /95 

Carboxin (5,6-Dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide) 5234-68-4 1/1/95 

Chinomethionat [6-Methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one) 2439-01-2 1/1/95 

Chlorendic acid 115-28-6 1l1/95 

Chlorimuron ethyl [Ethyl-2-[[[(4-chloro-6-methoxyprimidin-2-yl)-carbonyq-amino]sulfonyl]benzoate] 90982-32-4 1/1 /95 

1- (3-Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride 4080-31-3 1/1195 

p-Chloroaniline 106-47-8 111195 

3-Chloro-2-methyl-1-propene 563-47-3 1 /1/95 

p•Chlorophenyl isocyanate 104-12-1 1/1 /95 

Chloropicrin 76-06-2 1 /1 /95 

3-Chloropropionitrile 542-76-7 1/1/95 

p-Chloro-o-toluidine R 95-69-2 1 /1 /95 

2-Chloro-1,1,1-trifluoro-ethane (HCFC-133a) 75-88-7 111/95 

Chlorotrifluoromethane (CFC-13) 75-72-9 1/1/95 

3-Chloro-1,1,1-trifluoro-propane (HCFC-253fb) 460-35-5 1/1/95 

Chlorpyrifos methyl [0,0-dimethyl-O-(3,5,6-trichloro-2-pyridyl)phosphorothioate 5598-13-0 1/1/95 

Chlorsulfuron [2-chloro-N-[[4-methoxy-6-methyl-1,3,5-triazin-2-yl)ammo]oarbonyqbenzenesulfonamide] 64902-72-3 1/1/95 

Crotonaldehyde • 4170-30-3 1/1/95 

Cyanazine 21725-46-2 1 /1 /95 

Cycloate • 1134-23-2 1 / 1195 

Cyclohexanol • • • 108-93-0 1/1/95 

Cyfluthrin [3-(2,2-Dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, cyano(4-fluoro-3- 68359-37-5 1/1/95 

phenoxyphenyI)methyl ester] 

Cyhalothrin [3-(2-Chloro-3,3,3-trifluoro-l-propenyl)-2,2-dimethylcyclopropanecarbbxylic acid cyano(3- 68085-85-8 1/1/95 

phenoxyphenyl)methyl ester] 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61475 

Chemical Name CAS No. Effective 

Date 

Dazomet(Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione) 533-74-4 1 /1/95 

Dazomet, sodium saft [Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione, ion(1-), sodium] 53404-60-7 1/1/95 

2,4,-DB 94-82-6 1 /1 /95 

2,4-D butoxyethyl ester 1929-73-3 1/1/95 

2,4-D butyl ester 94-80-4 1/1195 

2,4-D chlorocrotyl ester 2971-38-2 1/1 /95 

Desmedipham 13684-56-5 1 /1 /95 

2,4-D 2-ethylhexyl ester 1928-43-4 1/1/95 

2,4-D 2-ethyl-4-methylpentyl ester 53404-37-8 1/1/95 

Diazinon 333-41-5 1/1 /95 

2,2-Dibromo-3-nitrilopropionamide 10222-01-2 1 /1 /95 

Dicamba (3,6-Dichloro-2-methyoxybenzoic acid) 1918-00-9 1/1/95 

Dichloran [2,6-Dichloro-4-nitroaniline] 99-30-9 1/1/95 

3,3'-Dichlorobenzidine dih ydrochtoride 612-83-9 1/1/95 

3,3'-Dichlorobenzidine sulfate 64969-34-2 1/1/95 

trans-1,4-Dichloro-2-butene 110-57-6 1 /1 /95 

1,2-Dichloro-1,1-difluoroethane (HCFC-132b) 1649-08-7 1/1/95 

Dichlorofluoromethane (HCFC-21) 75-43-4 1/1/95 

Dichloropentafluoropropane 

1,1-dichloro-1,2,2,3,3-pentafluoropropane (HCFC-225oc) 

127564-92-5 

13474-88-9 

1/1/95 

1/1/95 

1,1-dichloro-1,2,3,3,3-pentafluoropropaneHCFC-225eb 111512-56-2 1/1/95 

1,2- lichloro- 1,1,2,3,3-pentafluoropropane FC-225bb~ 422-44-6 1/1/95 

1,2-dichloro- 1,1,3,3,3-pentafluoropropane FC-225da) 

SFC-225cb) 

431-86-7 1/1/95 

1,3-dichloro-1,1,2,2,3-pentafluoropropane 507-55-1 1/1/95 

1,3-dichloro-1,1,2,3,3-pentafluoropropane (HCFC-225ea) 136013-79-1 1/1/95 

2,2-dichloro-1,1,1,3,3-pentafluoropropane (HCFC-225aa) 128903-21-9 1/1/95 

2,3-dichloro-1,1,1,2,3-perrtafluoropro3ane (HCFC-225ba) 422-48-0 1/1/95 

3,3-dichloro- 1,1,1,2,2-pentafluoropropane HCFC-225ca) 

( 

Dichlorophene [ 2,2'-Methylene-bis(4-chlorophenol)) 

422-56-0 

97-23-4 

1/1/95 

1/1/95 

trans-1,3-Dichloropropene 10061-02-6 1 /1 /95 

Diclofop methyl [2-[4-(2,4-Dichlorophenoxy)phenoxy]propanoic acid, methyl ester] 51338-27-3 1/1/95 

Dicyclopentadiene 77-73-6 1 /1 /95 

Diethatyl ethyl 38727-55-8 1/1/95 

Diflubenzuron 35367-38-5 1 /1 /95 

Diglycidyl resorcinol ether 101-90-6 1/1/95 

Dimethipin [2,3,-Dihydro-5,6-dimethyl-1,4-dithiin-1,1,4,4-tetraoxide] 55290-64-7 1/1/95 

Dimethoate 60-51-5 1 /1 /95 

3,3'-Dimethoxybenzidine dihydrochloride (o-Dianisidine dihydrochloride) 

3,3'-Dimethoxybenzidine hydrochloride (o-Dianisidine hydrochloride) 

20325-40-0 

111984-09-9 

1/1/95 

1/1/95 

Dimethylamine 124-40-3 1/1 /95 

Dimethylamine dicamba 2300-66-5 1/1/95 

3,3'-Dimethylbenzidine dihydrochloride ( o-Tolidine dihydrochloride) 612-82-8 1/1/95 

3,3'-Dimethylbenzidine dihydrofluoride (o-Tolidine dihydrofluoride) 41766-75-0 1/1 /95 

Dimethyl chlorothiophosphate 2524-03-0 1/1/95 

Dimethyldichlorosilane 75-78-5 1 /1 /95 

N,N-Dimethylformamide 68-12-2 1 /1 /95 

2,6-Dimethylphenol 1 576-26-1 1 1/1 /95 
1/1195 

1 /1 /95 

1/1195 

1 /1 /95 

111195 

1 /1 /95 

1 /1 /95 

1/1195 

111195 

1 /1 /95 

1 /1 /95 

1l1 /95 

1/1/95 

1/1/95 

1I1 /95 

1l1 /95 

1/1/95 

1 /1 /95 

1 /1 /95 

111/95 

111195 

1/1195 

1/1/95 

1 /1 /95 

1/1 /95 

1/1/95 

1/1/95 

1l1 /95 

111195 

1/1195 

1/1195 

111/95 

1 /1 /95 

1/1 /95 

111/95 

111195 

1l1 /95 

1 /1 /95 

1/1 /95 

1/1/95 

1 /1 /95 

1/1 /95 

1 /1 /95 

1/1/95 

1 /1 /95 

1 /1 /95 

1 /1 /95 

1 /1 /95 

1/1/95 

1/1/95 

1 /1195 

61476 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

Chemical Name I CAS No. I Effective 

Date 

Dinitrobutyl phenol (Dinoseb) 

Dinocap 

Diphenamid 

Diphenylamine 

Dipotassium endothall [7-Oxabicyclo(2.2.1)heptane-2,3-dicarboxyiic acid, dipotassium saft] 

Dipropyl isocinchomeronate 

Disodium cyanodithioimidocarbonate 

2,4-D isopropyl ester 

2,4-Dithiobiuret 

Diuron 

Dodine [Dodecyiguariidine monoacetate] 

2,4,-DP 

2,4-D propylene giycol butyl ether ester 

2,4-D sodium sait 

Ethoprop [Phosphorodithioic acid O-ethyl S,S-dipropyl ester] 

Ethyl dipropyithiocarbamate [EPTC] 

Famphur 

Fenarimol [.aipha.-(2-Chiorophenyl)-.alpha.-4-chioro henyl)-5-pyrimidinemethanol] 

Fenbutatin oxide (Hexakis(2-methyl-2-phenyl-propyldistannoxane) 

Fenoxaprop ethyl ~2 

Fenoxycarb [2-(4- henoxyphenoxy)ethyi]carbamic acid ethyl esterT 

Fenpropathrin [2,2,3,3-Tetramethylcyciopropane carboxyiic acidcy ano(3-phenoxy-phenyl)methyl ester] 

Fenthion [O,O-Dimethyl 0-[3-methyl-4-(methyfthio)phenyl]ester, phosphorothioic acid] 

Fenvalerate [4-Chloro-aipha-(1-methylethyI)benzeneacetic acid cyano(3-phenoxyphenyl)methyl ester] 

Ferbam [Tris(dimethy Icarbamo-dithioato-S,S')iron] 

Fluazifop-butyl [2-[4-[[5-(Trifiuoromethyl)-2-pyridinyl]oxy]-phenoxy)propanoic acid, butyl ester] 

Fluorine 

Fluorouracil (5-Fluorouracil) 

Fluvalinate [N-[2-Chioro-4-(trifluoromethyl)phenyq-DL-vaiine(+)-cyano (3-phenoxyphenyl)methyl ester] 

Folpet 

Fomesafen [5-(2-Chioro-4-(trifiuoromethyl)phenoxy)-N-methylsuifonyl)-2-nitrobenzamide] 

aipha-Hexachlorocyclohexane 

n-Hexane 

Hexazinone 

Hydramethylnon (fetrahydro-5,5-fimethyl-2(1H)-pyrimidinone[3-14- (trifiuoromethyl)phenyl]-1-[2-[4- 

(trifluoromethyqphenyl] ethenyl]-2-prope nyiidene]hydrazone] 

Imazalil [t-[2-(2,4-Dichiorophenyl)-2-(2-propenyioxy)ethyl]-1H-imidazoie] 

3-lodo-2-propynyl butylcarbamate 

Iron pentacarbonyl 

Isodrin 

Isofenphos [2-[[Ethoxyl[(1-methyiethyl)amino]phosphinothioyl]oxy]benzoic acid 1-methylethyl ester] 

Lactofen [5-(2-Chioro-4-(trifluoromethyl)phenoxy)-2-nitro-2-ethoxy-l- methyl-2-oxoethyl ester] 

Linuron 

Lithium carbonate 

Malathion 

Mecoprop 

2-Mercaptobenzothiazoie (MBT) 

Merphos 

Metham sodium (Sodium methyidithiocarbamate) 

Methazole [2-(3,4-Dichlorophenyl)-4-methyl-1,2,4-oxadiazolidine-3,5-dione] 

Methiocarb 

Methoxone (4-Chioro-2-methyiphenoxy) acetic acid (MCPA)) 

88$5-7 

39300-45-3 

957-51-7 

122-39-4 

2164-07-0 

136-45-8 

138-93-2 

94-11-1 

541-53-7 

330-54-1 

2439-10-3 

120-36-5 

1320-18-9 

2702-72-9 

13194-48-4 

759-94-4 

52-85-7 

60168-88-9 

13356-08-6 

66441-23-4 

72490-01-8 

39515-41-8 

55-38-9 

51630-58-1 

14484-64-1 

69806-50-4 

7782-41-4 

51-21-8 

69409-94-5 

133-07-3 

72178-02-0 

319-84-6 

110-54-3 

51235-04-2 

67485-29-4 

35554-44-0 

55406-53-6 

13463-40-6 

465-73-6 

25311-71-1 

77501-63-4 

330-55-2 

554-13-2 

121-75-5 

93-65-2 

149-30-4 

150-50-5 

137-42-8 

20354-26-1 

2032-65-7 

94-74-6 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61477 

Chemical Name CAS No. Effective 

Date 

Methoxone-sodium salt ((4-chloro-2-methylphenoxy) acetate sodium salt) 3653-48-3 1/1/95 

Methyl isothiocyanate [Isothiocyanatomethane] 556-61-6 1/1/95 

2-Methyllactonitrile 75-86-5 1 /1/95 

N-Methylolacrylamide 924-42-5 1 /1 /95 

Methyl parathion 298-00-0 1/1/95 

N-Methyl-2-pyrrolidone 872-50-4 1/1 /95 

Methyltrichlorosilane 75-79-6 1 /1 /95 

Metiram 9006-42-2 1 /1 /95 

Metribuzin 21087-64-5 1 /1 /95 

Mevinphos 7786-34-7 1 /1 /95 

Molinate (1H-Azepine-1-carbothioic acid, hexahydro-S-ethyl ester) 2212-67-1 1/1/95 

Monuron 150-68-5 1 /1 /95 

Myclobutanil [.alpha: Butyl-.alpha: (4-chlorophenyl)-1H-1,2,4-triazole-l-propanenitrile] 88671-89-0 1/1/95 

Nabam 142-59-6 1/1 /95 

Naled 300-76-5 1/1 /95 

Nitrapyrin (2-Chloro-6-(trichloromethyl) pyridine) 1929-82-4 1/1/95 

p-N itroaniline 100-01-6 1 /1 /95 

Norflurazon [4-Chloro-5-(methylamino)-2-[3-(trifluoromethyl)phenylj-3(2H)-pyridazinone] 27314-13-2 1/1/95 

Oryzalin [4-(Dipropylamino)-3,5-dinitrobenzenesulfonamide] 19044-88-3 1/1/95 

Oxydemeton methyI[S-(2-(ethylsulfinyl)ethyl) o,o-dimeth I ester phosphorothioic acid] 

Oxydiazon [3-[2,4-Dichloro-5-(1-methylethoxy)phenyl]-5-r1,1-dimethylethyl)-1,3,4-oxadiazol-2(3H)-one] 

301-12-2 

19666-30-9 

1/1/95 

1/1/95 

Oxyfluorfen 42874-03-3 1 /1 /95 

Ozone 10028-15-6 1 /1/95 

Paraquat dichloride 1910-42-5 1/1/95 

Pebulate [Butyleth Icarbamothioic acid S-pro pyl ester] 

Pendimethalin [N-~ -Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] 

1114-71-2 

40487-42-1 

1/1/95 

1/1/95 

Pentobarbital sodium 57-33-0 1/1 /95 

PerchloromethyI mercaptan 594-42-3 1/1/95 

Permethrin [3-(2,2-Dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl)methyl 52645-53-1 1/1195 

ester] 

Phenanthrene 85-01-8 1 /1 /95 

Phenothrin [2,2-Dimethyl-3-(2-methyl-l-propenyl)cyclopropanecarboxylic acid (3-phenoxyphenyl)methyl 26002-80-2 1/1/95 

ester] 

1,2-Phenylenediamine 95-54-5 1 /1/95 

1,3-Phenylenediamine 108-45-2 1/1/95 

1,2-Phenylenediamine dihydrochloride 615-28-1 1/1/95 

1,4-Phenylenediamine dihydrochloride 624-18-0 1/1/95 

Phenytoin 57-41-0 1 /1 /95 

Phosphine 7803-51-2 1 /1 /95 

Picloram 1918-02-1 1/1 /95 

Piperonyl butoxide • 51-03-6 1/1/95 

Pirimiphos methyl [0-(2-(Diethylamino)-6-methyl-4-pyrimidinyl)-O,O-dimethylphosphorothioate] 29232-93-7 1/1/95 

Potassium bromate 7758-01-2 1/1/95 

Potassium dimethyldithiocarbamate 128-03-0 1/1/95 
61478 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

Chemical Name CAS No. Effective 

Date 

Potassium N-methyldithiocarbamate 137-41-7 1/1/95 

Profenofos [O-(4-Bromo-2-chlorophenyl)-0-ethyl-S-propyl phos~orothioate] 41198-08-7 111/95 

Prometryn [N,N'-Bis(1-methylethyI)-6-methylthio-1,3,5-tnazme- ,4- diamine] 7287-19~ 1/1/95 

Propachlor [2-Chlor o-N-(1-methylethyl)-N-phenylacetamide] 1918-16-7 1/1/95 

Propanil [N-(3,4-Dichlorophenyl)propanamide] 709-98-8 1/1/95 

Propargite 2312-35-8 1 /1 /95 

Propargyl alcohol 107-19-7 1/1/95 

Propetamphos [3-[[(Ethvlamino)methoxyphosphinothioyl]oxy]-2-butenoic acid, 1-methylethyl ester] 

[1-[2-(2,d-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]- 

31218-83-4 

60207-90-1 

1/1 195 

Propiconazole methyl-11-1-1,2,4,-triazole] 1/1195 

Quizalotop-ethyl [2-[4-[(6-Chloro-2-quinoxalinyl)oxy]phenoxy)propanoic acid ethyl ester] 76578-14-8 111/95 

Resmethrin [[5-(Phenylmethyl)-3-furanyqmethyl 2,2-dimethyl-3-(2-methyl-1-pro- 10453-86-8 1/1195 

penyl)cyclopropanecarboxylate]] 

Sethoxydim [2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-l-one] 74051-80-2 1/1/95 

Simazine 122-34-9 111/95 

Sodium azide 26628-22-8 111/95 

Sodium dicamba [3,6-Dichloro-2-methoxybenzoic acid, sodium salt] 1982-69-0 1/1/95 

Sodium dimethyldithiocarbamate 128-04-1 1/1/95 

Sodium fluoroacetate 62-74-8 111195 

Sodium nitrfte 7632-00-0 111/95 

Sodium pentachlorophenate 131-52-2 

Sodium o-phenylphenoxide 132-27-4 1l1/95 

Sulfuryl fluoride [Vikane] 2699-79-8 1/1/95 

Sulprofos [O-EthyI O-[4-(methylthio)phenyl]phosphorodithioic acid S-propyl ester] 

Tebuthiuron [N-[5 (1,1-Dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N'-dimethylurea] 

35400-43-2 

34014-18-1 

111/95 

111195 

Temephos 3383-96-8 1 /1 /95 

Terbacil [5-Chloro-3-(1,1-dimethylethyl)-6-methyl-2,4(1H,3H)-pyrimidinedione] 5902-51-2 1/1/95 

1,1,1,2-Tetrachloro-24luoroethane (HCFC-121a) 354-11-0 1/1195 

1,1,2,2-Tetrachloro-l-fluoroethane (HCFC-121) 354-14-3 1/1195 

Tetracycline h drochloride 

Tetramethrin ~2,2-Dimethyl-3-(2-methyl-l-propenyl)cyclopropanecarboxylic acid (1,3,4,5,6,7-hexahydro-1,3- 

64-75-5 

7696-12-0 

1/1/95 

1l1/95 

dioxo-2H-isoindol-2-yl)methyl ester] 

Thiabendazole 12-(4-Thiazolyl)-1 H-benzimidazole] 148-79-8 111/95 

Thiobencarb [Carbamic acid, diethylthio-, s-(p-chlorobenzyl)] 28249-77-6 111195 

Thiodicarb 59669-26-0 1 /1 /95 

Thiophanate ethyl [[1,2-Phenylenebis(iminocarbonothioyl)]biscarbamic acid diethyl ester] 23564-06-9 1/1195 

Thiophanate-methyl 23564-05-8 1 / 1195 

Thiosemicarbazide 79-19-6 1 /1 l95 

Triadimefon [i-(4-Chlorophen)xy)-3,3-dimethyl-l-(1H-1,2,4-triazol-l-yl)-2-butanone] 43121-43-3 111/95 

Triallate 2303-17-5 111195 

Tribenuron methyl [2-(((((4-Methoxy-6-methyl-1,3,5-triazin-2-yl)- methylamino)carbonyl)amino)sulfonyl)-, 101200-48-0 111195 

methyl ester] 

Tributyftin fluoride 1983-10-4 1/1195 

Tributyltin methacrylate 2155-70-6 1/1/95 

S,S,S-Tributyltrithiophosphate (DEF) 78-48-8 1/1/95 

Trichloroacetyl chloride 76-02-8 1/1 /95 

1,2,3-Trichloropropane 96-18-4 111/95 

Triclopyr, triethylammonium salt 57213-69-1 1/1195 

Triethylamine 121-44-8 1 /1/95 

Triforine [N,N'-[1,4-Piperazinediyl-bis(2,2,2-trichloroethylidene)] bisformamide] 26644-46-2 1/1195 

TrimethXlchlorosilane 75-77-4 1 11 /95 

2,3,5-Tnmethylphenyl methylcarbamate 2655-15-4 1/1/95 

Triphenyltin chloride 639-58-7 111/95 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61479 

Chemical Name CAS No. Effective 

Date 

Triphenyftin hydroxide 76-87-9 1/1/95 

Vinclozolin [3-(3,5-Dichlorophenyl)-5-ethenyl-5-methyl-2,4- oxazolidinedione] 50471-44-8 1/1/95 

(b) . x * 

CAS No. Chemical Name Effective 

Date 

51-03-6 Piperonyl butoxide 1/1/95 

51-21-8 Fluorouracil (5-Fluorouracil) 1/1/95 

52-51-7 2-Bromo-2-nitropropane-1,3-diol (Bronopol) 1/1/95 

52-85-7 Famphur 1/1/95 

55-38-9 Fenthion [O,O-Dimethyl O-[3-methy1-4-(methylthio)phenyl] ester, phosphorothioic acid] 1/1195 

56-35-9 Bis(tributyltin) oxide 1/1/95 

57-33-0 Pentobarbital sodium 1/1/95 

57-41-0 Phenytoin 1/1/95 

60-51-5 Dimethoate 1/1/95 

62-74-8 Sodium fluoroacetate 1/1/95 

64-75-5 Tetracycline hydrochloride 1/1/95 

68-12-2 N,N-Dimethylformamide 1/1/95 

75-43-4 Dichlorofluoromethane (HCFC-21) 1/1/95 

75-72-9 Chlorotrifluoromethane (CFC-13) 1/1/95 

75-77-4 Trimethylchlorosilane 1/1/95 

75-78-5 Dimethyldichlorosilane 1/1/95 

75-79-6 Methyltrichlorosilane 1/1/95 

75-86-5 2-Methyllactonitrile 1/1/95 

75-88-7 2-Chloro-1,1,14rifluoroethane (HCFC-133a) 1/1/95 

76-02-8 Trichloroacetyl chloride 1/1/95 

76-06-2 Chloropicrin 1/1/95 

76-87-9 Triphenyltin hydroxide 1/1/95 

77-73-6 Dicyclopentadiene 1/1/95 

7848-8 S,S,S-Tributyltrithiophosphate (DEF) 1/1/95 

79-19-6 Thiosemicarbazide 1/1/95 

85-01-8 Phenanthrene 1/1/95 

88-85-7 Dinitrobutyl phenol (Dinoseb) 1/1/95 

93-65-2 Mecoprop 1/1/95 

94-11-1 2,4-D isopropyl ester 1/1/95 
61480 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

CAS No. Chemical Name Effective 

Date 

94-74-6 Methoxone (4-Chloro-2-methy"noxy) acetic acid (MCPA) 1/1195 

94-80-4 2,4-D butyl ester 1/1/95 

94-82-6 2,4-DB 1/1195 

95-54-5 1,2-Phenylenediamine 1/1/95 

95-69-2 p-Chloro-o-toluidine 1/1/95 

96-18-4 1,2,3-Trichloropropane 1 /1 /95 

97-23-4 Dichlorophene [ 2,2'-Methylene-bis(4-chlorophenol)] 1/1/95 

99-30-9 Dichloran [2,6-Dichloro-4-nitroaniline] 1/1/95 

100-01-6 p-Nitroaniline 1/1/95 

101-05-3 Anilazine [4,6-dichloro-N-(2-chlorophenyl)-1,3,5-triazin-2-amine] 1/1/95 

101-90-6 Diglycidyl resorcinol ether 1/1195 

104-12-1 p-Chlorophenyl isocyanate 111/95 

106-47-8 p-Chloroardline 1/1/95 

107-11-9 Allylamine 1/1/95 

107-19-7 Propargyl alcohol 1/1/95 

108-45-2 1,3-Phenylenediamine 1/1/95 

108-93-0 Cyclohexanol 1/1/95 

110-54-3 n-Hexane 1l1 /95 

110-57-6 trans-1,4-Dichloro-2-butene 1/1/95 

115-28-6 Chlorendic acid 1/1195 

116-06-3 Aldicarb 1/1/95 

120-36-5 2,4-DP 1/1195 

121-44-8 Triethylamine 1/1/95 

121-75-5 Malathion 1/1/95 

122-34-9 Simazine 1/1/95 

122-39-4 Diphenylamine 1/1/95 

124-40-3 Dimethylamine 1/1/95 

128-03-0 Potassium dimethyldithiocarbamate 1/1/95 

128-04-1 Sodium dimethyldithiocarbamate 1/1/95 

131-52-2 Sodium pentachlorophenate 1/1/95 

132-27-4 Sodium o-phenylphenoxide 1/1/95 

133-07-3 Folpet • • ` • • • • 1/1/95 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61481 

CAS No. Chemical Name Effective 

Date 

136-45-8 DipropYl isocinchomeronate 1/1/95 

137-41-7 Potassium n-methyldithiocarbamate 1/1/95 

137-42-8 Metham Sodium 1/1/95 

138-93-2 Disodium cyanodithioimidocarbonate 1/1/95 

142-59-6 Nabam 1/1/95 

148-79-8 Thiabendazole [2-(4-Thiazolyl)-1H-benzimidazole] 1/1/95 

149-30-4 2-Mercaptobenzothiazole 1/1/95 

150-50-5 Merphos 1/1/95 

150-68-5 Monuron 1/1/95 

298-00-0 Methyl parathion 1/1/95 

300-76-5 Naled 1/1 /95 

301-12-2 Oxydemeton methyl [s-(2-(Ethylsulfinyl) ethyl) o,o-dimethyl ester phosphorothioic acid] 1/1/95 

314-40-9 Bromacil (5-Bromo-6-methyl-3-(1-methylpropyl)-2,4-(1H,3H)-pyrimidinedione) 1/1/95 

319-84-6 alPha-Hexachlorocyclohexane 1/1/95 

330-54-1 Diuron 1/1/95 

330-55-2 Linuron 1/1/95 

333-41-5 Diazinon 1/1/95 

354-11-0 1,1,1,2-Tetrachloro-2-fluoroethane (HCFC-121a) 1/1/95 

354-14-3 1,1,2,2-Tetrachloro-l-fluoroethane (HCFC-121) 1/1/95 

357-57-3 Brucine 1/1/95 

422-44-6 1,2-dichloro-1,1,2,3,3-pentafluoropropane (HCFG225bb) 1/1/95 

422-48-0 2,3-dichloro-1,1,1,2,3-pentafluoropropane (HCFG225ba) 1/1/95 

422-56-0 3,3-dichloro-1,1,1,2,2-pentafluoropropane (HCFC-225ca) 1/1/95 

431-86-7 

460 35-5 

1,2-dichloro-1,1,3,3,3-pentafluoropropane (HCFC-225da) 

3 chloro-1,1,1-trifluoropropane (HCFG253fb) 

1/1/95 

1/1/95 

465-73-6 Isodrin 1 /1 /95 

507-55-1 1,3-dichloro-1,1,2,2,3-pentafluoropropane (HCFC-225cb) 1/1/95 

533-74-4 Dazomet (Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione) 1/1/95 

541-53-7 2,4-Dithiobiuret 1/1/95 

542-76-7 3-Chloropropionitrile 1/1/95 

554-13-2 Lithium carbonate 1/1/95 

556-61-6 

563-47-3 

MethyI isothiocyanate [Isothiocyanatomethane] 1/1/95 

3-Chloro-2-methyl-l-propene 1/1/95 

576-26-1 2,6-Dimethylphenol 1 /1 /95 

594-42-3 Perchloromethyl mercaptan 1/1/95 

612-82-8 3,3'-Dimethylbenzidine dihydrochloride (o-Tolidine dihydrochloride) 1/1/95 

612-83-9 3,3'-Dichlorobenzidine dihydrochloride 1/1/95 

615-28•1 1,2-Phenylenediamine dihydrochloride 1/1/95 

624-18-0 1,4-Phenylenediamine dihydrochloride 1/1/95 

639-58-7 Triphenyltin chloride ~ 1/1/95 

709-98-8 Propanil [N-(3,4-Dichlorophenyl)propanamide] 1/1/95 

759-94-4 Ethyl dipropylthiocarbamate (EPTC) • 1/1/95 

834-12-8 Ametryn (N-Ethyl-N'-(1-methylethyl)-6-(methylthio)-1,3,5,-triazine-2,4-diamine) 1/1/95 

872-50-4 N-Methyl-2-pyrrolidone 1/1/95 
61482 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

CAS No. Chemical Name Effective 

Date 

924-42-5 N-Methylolacrylamide 1/1/95 

957-51-7 Diphenamid 111195 

1114-71-2 Pebulate [Butylethylcarbamo-thioic acid S-propyl ester] 1/1/95 

1134-23-2 Cycloate 111/95 

1320-18-9 2,4-D propylene glycol butyl ether ester 1/1/95 

1563-66-2 Carbofuran 111/95 

1649-08-7 1,2-dichloro-1,1-difluoroethane (HCFC-132b) 1/1/95 

1689-84-5 Bromoxynil (3,5-Dibromo-4-hydroxybenzonitrile) 1/1/95 

1689-99-2 Bromoxynil octanoate (Octanoic acid, 2,6-dibromo-4-cyanophenyl ester) 1/1195 

1861-40-1 Benfluralin(N-Butyl-N-ethyl-2,6-dinitro-4-(trifluoromethyl)benzenamine) 1/1/95 

1910-42-5 Paraquat dichloride 111/95 

1912-24-9 Atrazine (6-Chloro-N-ethyl-N'-(1-methylethyl)-1,3,5,-triazine-2,4-diamine) 111/95 

1918-00-9 Dicamba (3,6-Dichloro-2-methyoxybenzoic acid) 1/1/95 

1918-02-1 Picloram 1/1195 

1918-16-7 Propachlor [2-Chloro-N-(1-methylethyl)-N-phenylacetamide] 1/1/95 

1928-43-4 2,4-D 2-ethylhexyl ester 1/1/95 

1929-73-3 

1929-82-4 

2,4-D butoxyethyI ester 

(2-Chloro-6-(trichloromethyl)pyridine) 

1/1/95 

Nitrapyrin 111/95 

1982-69-0 Sodium dicamba [3,6-Dichloro-2-methoxybenzoic acid, sodium salt] 1/1/95 

1983-10-4 TributyRin fluoride 1/1/95 

2032-65-7 Methiocarb 111/95 

2155-70-6 

2164-07-0 

Tributyltin methacryIate 

Dipotassium endothall [7-0xabicyclo(2.2.1)heptane-2,3-dicarboxylic acid, dipotassium salt] 

111/95 

1/1/95 

2212-67-1 Molinate (11-1-Azepine-1-carbothioic acid, hexahydro-S-ethyl ester) 1/1/95 

2300-66-5 Dimethylamine dicamba 1/1 /95 

2303-17-5 Triallate 111195 

2312-35-8 Propargite 1/1/95 

2439-01-2 Chinomethionat [6-Methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one] 1/1/95 

2439-10-3 Dodine [Dodecylguanidine monoacetate] 1/1195 

2524-03-0 Dimethyl chlorothiophosphate 1/1195 

2655-15-4 2,3,5-Trimethylphenyl methylcarbamate 111 /95 

2699-79-8 Sulfuryl Fluoride [Vikane] 1/1195 

2702-72-9 2,4-D sodium salt 1/1195 

2971-38-2 2,4-D chlorocrotyl ester 111/95 

3383-96-8 Temephos 1l1 /95 

3653-48-3 Methoxone - sodium salt (4-Chloro-2-methylphenoxy acetate sodium salt) 1/1195 

4080-31-3 1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride 111/95 

4170-30-3 Crotonaldehyde 1/1 /95 

5234-68-4 Carboxin (5,6-Dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide) 1/1/95 

5598-13-0 

5902-51-2 

Chlorpyrifos methyl [O,O-dimethyl-O-(3,5,6-trichloro-2-pyridyl)phosphorothioate] 

Terbacil [5-Chloro-3-(1,1-dimethylethyl)-6-methyl-2,4-(1H,3H)-pyrimidinedione] 

1/1/95 

111195 

6459-94-5 C.I. Acid Red 114 1/1195 

7287-19-6 Prometryn [N,N'-Bis(1-methylethyl)-6-methylthio-1,3,5-triazine-2,4-diamine] 1/1/95 

7632-00-0 Sodium nitrite 1/1/95 

7637-07-2 Boron trifluoride 1/1/95 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61483 

CAS No. Chemical Name Effective 

Date 

7696-12-0 Tetramethrin [2,2-Dimethyl-3-(2-methyl-l-propenyl)cyclopropane-carboxylic acid (1,3,4,5,6,7-hexahydro-1,3- 1/1/95 

dioxo-21-1-isoindol-2-yl)methyl esterl 

7726-95-6 Bromine 111195 

7758-01-2 Potassium bromate 1 /1 /95 

7782-41-4 Fluorine 1/1/95 

7786-34-7 Mevinphos 1/1/95 

7803-51-2 Phosphine 1/1/95 

9006-42-2 Metiram 1/1/95 

10028-15-6 Ozone 1/1/95 

10061-02-6 trans-1,3-Dichloropropene 1/1/95 

10222-01-2 2,2-Dibromo-3-nitrilopropionamide 1/1/95 

10294-34-5 Boron trichloride 1/1/95 

10453-86-8 Resmethrin [[5-(Phenylmethyl)-3-furanyl]methyl 2,2-dimethyl-3-(2-methyl-l-pro- 111/95 

penyl) cyclopropanecarboxylate]] 

13194-48-4 Ethoprop [Phosphorodithioic acid O-ethyl S,S-dipropyl ester] 1/1 /95 

13356-08-6 Fenbutatin oxide (hexakis(2-methyl-2-phenylpropyl)distannoxane) 1/1/95 

13463-40-6 Iron pe ntacarbonyI 1/1/95 

13474-88-9 1,1-Dichloro-1,2,2,3,3-pentafluoropropane (HCFC-225cc) 1/1/95 

13684-56-5 Desmedi ham 1/1 /95 

14484-64-1 Ferbam ~Tris(dimethylcarbamo-dithioato-S,S')iron] 1/1/95 

15972-60-8 Alachlor 1/1/95 

17804-35-2 Benomyl 1/1/95 

19044-88-3 

19666-30-9 

Oryzalin [4-(Dipropylamino)-3,5-dinitrobenzene-suHonamide] 

Oxydiazon [3-[2,4-Dichloro-5-(1-methylethoxy)phenyl]-5-(1,1-iimethylethyl)-1,3,4-oxadiazol-2(3H)-one] 

1/1/95 

1/1/95 

20325-40-0 3,3'-Dimethox benzidine dihydrochloride (Dianisidine dihydrochloride) 1/1 /95 

20354-26-1 Methazole [2-~3,4-Dichlorophenyl)-4-methyl-1,2,4-oxadiazoiidine-3,5-dione] 1/1/95 

20859-73-8 Aluminum phosphide 1/1/95 

21087-64-5 Metribuzin 1/1/95 

21725-46-2 Cyanazine 1/1/95 

22781-23-3 Bendiocarb (2,2-Dimethyl-1,3-benzodioxol-4-ol methylcarbamate] 1/1/95 

23564-05-8 Thiophanate methyl 1/1/95 

23564-06-9 Thiophanate ethyl [[1,2-Phenylenebis(iminocarbonothioyl)]biscarbamic acid diethyl ester] 1/1 /95 

25311-71-1 Isofenphos [2-[[Ethoxyl[(1-methylethyl)amino]phiosphinothioyl]oxy]benzoic acid 1-methylethyl ester] 1/1/95 

26002-80-2 Phenothrin [2,2-Dimethyl-3-(2-methyl-l-propenyl)cyclopropanecarboxylic acid (3-phenoxyphenyl)methyl 1/1/95 

ester] 

26628-22-8 Sodium azide 1/1/95 

26644-46-2 Triforine [N,N'-[1,4-Piperazinediylbis(2,2,2-trichloroethylidene)] bisformamide] 1/1/95 

27314-13-2 Norflurazon [4-Chloro-5-(methylamino)-2-[3-(trifluoromethyl)phenyl]- 3(2H)-pyridazinone] 1/1 /95 

28057-48-9 d-trans-Allethrin [d-trans-Chrysanthemic acid of d-allethrone] 1/1/95 

28249-77-6 Thiobencarb [Carbamic acid, diethylthio-, s-(p-chlorobenzyl)] 1/1/95 

28407-37-6 C.I. Direct Blue 218 1/1 /95 

29232-93-7 Pirimiphos methyl [0-(2-(Diethylamino)-6-methyl-4-pyrimidinyl)-O,O-dimethyl phosphorothioate] 1/1/95 

30560-19-1 Acephate (Acetylphosphoramidothioic acid O,S-dimethyl ester) 1/1/95 

31218-83-4 Propetamphos (3-[[(Ethylamino)methoxyphosphino-thioyl]oxy]-2-butenoic acid, 1-methylethyl ester] 1/1/95 

33089-61-1 Amitraz 1/1/95 

34014-18-1 Terbuthiuron [N-[5-(1,1-Dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N'- dimethylurea] 1/1/95 

35367-38-5 Diflubenzuron 1/1/95 

35400-43-2 Sulprofos [O-Ethyl 0-[4-(methylthio)phenyl]phosphorodithioic acid S-propyl ester] 1/1/95 

35554-44-0 Imazalil [1-[2-(2,4-Dichlorophenyl)-2-(2-propenyloxy)ethyl]-1H-imidazole] 1/1/95 

35691-65-7 1-Bromo-l-(bromomethyl)-1,3-propanedicarbonitrile 1 /1/95 

38727-55-8 Diethatyl ethyl 1/1/95 

39300-45-3 Dinocap 1/1/95 

39515-41-8 Fenpropathrin [2,2,3,3-Tetramethylcyclopropane carboxylic acid cyano(3-phenoxyphenyl)methyl ester] 1/1/95 

40487-42-1 Pendimethalin [N-(1-Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzen-amine] 1/1/95 

41198-08-7 

41766-75-0 

Profenofos [0-(4-Bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate] 

3,3'-Dimethylbenzidine dihydrofluoride (ortho-Tolidine dihydrofluoride) 

1/1/95 

1/1/95 

42874-03-3 Oxyfluorfen 1/1/95 

43121-43-3 Triadimefon [1-(4-Chlorophenoxy)-3,3-dimethyl-l-(1H-1,2,4-triazol-l-yl)-2-butanone] 1/1/95 

50471-44-8 Vinclozolin [3-(3,5-Dichlorophenyl)-5-ethenyl-5-methyl-2,4- oxazolidinedione] 1/1/95 

51235-04-2 Hexazinone 1/1/95 

51338-27-3 Diclofop methyl [2-[4-(2,4-Dichlorophenoxy)phenoxy]propanoic acid, methyl ester] 1/1/95 
61484 Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 

CAS No. Chemical Name Effective 

Date 

51630-58-1 Fenvalerate 111195 

52645-53-1 Permethrin [3-(2,2-Dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl)methyl 1/1195 

ester] 

53404-19-6 Bromacil, lithium salt [2,4-(1H,3H)-Pyrimidinedione, 5-bromo-6-methyl-3- (1-methylpropyl), lithium salt] 111195 

53404-37-8 2,4-D 2-ethyl-4-methlpentyl ester 1/1/95 

53404-60-7 

55290-64-7 

Dazomet, sodium sat [Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione, ion(1-), sodium] 

Dimethipin [2,3,-Dihydro-5,6-dimethyl-1,4-dithiin 1,1,4,4-tetraoxide] 

1/1/95 

1/1/95 

55406-53-6 3-lodo-2- ropynyI bu Icarbamate 111/95 

57213-69-1 Triclopyr,Priethylammonium saft 111195 

59669-26-0 Thiodicarb 111195 

60168-88-9 

60207-90-1 

Fenarimol [.alpha: (2-Chlor ophenyl)-.alpha.-4-chlorophenyl)-5-p yrimidine- methanol] 1/1195 

1/1/95 

62476-59-9 

Propiconazole [1-[2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]-methyl-iH-1,2,4,-triazole] 

Acifluorien, sodium salt [5-(2-Chloro-4-(tnflouromethyl)phenox y)2-nitro-benzoic acid, sodium salt) 111/95 

62924-70-3 Flumetralin [2-Chloro-N-(2,6-dinitro-4-(trifluoromethyl)-phenyl)-N-ethyl-6-fluorobenzenemethanamme] 1l1/95 

64902-72-3 Chlorsulfuron [2-chloro-N-[[4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino] carbonyl]benzenesulfonamide] 1/1/95 

64969-34-2 3,3'-Dichlorobenzidine.sulfate 111195 

66441-23-4 Fenoxaprop ethyl [2-(4-((6-Chloro-2-benzoxazolylen)oxy)phenoxy) propanoic acid, ethyl ester] 111195 

67485-29-4 Hydramethylnon [Tetrahydro-5,5-dimethyl-2(1H)-pyrimidinone[3-[4- (trifluoromethyl)phenyl]-1-[2-[4- 1/1195 

68085-85-8 

(trifluoromethyl)phenyl]ethen yI]-2- propenylidene)hydrazone] 

Cyhalothrin [3-(2-Chloro-3,3,3-trifluoro-l-propeny[)-2,2- dimethylcyclopropanecarboxylic acid cyano(3- 111/95 

phenoxyphenyI)methyl ester] 

68359-37-5 Cyfluthrin [3-(2,2-Dichloro-ethenyl)-2,2-dimethylcyclo-propanecarboxylic acid, cyano(4-fluoro-3- 111195 

phenoxyphenyl)methyl ester) 

69409-94-5 

69806-50-4 

Fluvalinate [N-[2-Chloro-4-(trifluoromethyl)phen yI]-DL-valine(+)-cyano(3-phenoxyphenyl)methylester] 

Fluazifop-butyl [2-[4-[[5-(Trifluoromethyl)-2-pyridinyfjoxy]-phenoxy]propanoic acid, butyl ester] 

1/1/95 

111 /95 

71 751-41-2 Abamectin [Avermectin 811 111/95 

72178-02-0 Fomesafen [5-(2-Chloro-4-(trifluoromethyI)phenoxy)-N-methylsulfonyl)-2- nitrobenzamide] 1/1/95 

72490-01-8 Fenoxycarb 2-(4-Phenoxyphenoxy)ethyl]carbamic acid ethyl ester] 1/1 195 

74051-80-2 Sethoxydim €2-[1-(Ethoxyimino)butyl]-5-[2-(eth yIthio)propyl]-3-hydroxy-2-cyclohexen-l-one] 1/1/95 

76578-14-8 Quizalofo thyl [2-[4-[(6-Chloro-2-quinoxalmyl)ox y]phenoxy] propanoic acid ethyl ester] 

~(2-Chloro-4-(trifluoromethyl)phenoxy)-2-rntro-2-ethoxy-l-methyl-2-oxoethyl 

1/1/95 

77501-63-4 Lactofen ester] 111/95 

82657-04-3 Bifenthrin 1/1/95 

88671-89-0 Myclobutanil [.alpha.-Butyl-.alpha: (4-chlorophenyl)-1H-1,2,4-triazole- 1-propanenitrile] 1/1/95 

90982-32-4 Chlorimuron ethyl [Ethyl-2-[[[(4-chloro-6-methox yprimidin-2-yl)-carbonyq-aminoIsulfonyI]benzoate] 111/95 

101200-48-0 Tribenuron methyl [2-(((((4-Methoxy-6-methyl-1,3,5-triazin-2-yl)- methylamino)carbonyl)amino)sulfonyl)-, 1/1/95 

methyl ester] 

111512-56-2 1,1-dichloro-1,2,3,3,3-pentafluoropropane (HCFC-225eb) 1/1/95 

111984-09-9 3,3'-Dimethox ybenzidine hydrochloride (Dianisidine dihydrochloride) 1/1/95 

127564-92-5 Dichloropentatluoropropane 1/1/95 

128903-21-9 2,2-Dichloro-1,1,1,3,3-pentafluoropropane (HCFC-225aa) 1/1/95 

136013-79-1 1,3-Dichloro-1,1,2,3,3-pentafluoropropane (HCFC-225ea) 111/95 

( c) * x * 

Category Name Effective 

Date 

Diisocyanates (This category includes only those chemicals listed below) 

038661-72-2 1,3-Bis(methylisocyanate)cyclohexane 

010347-54-3 1,4-Bis(methylisocyanate)cyclohexane 

002556-36-7 1,4-Cyclohexane diisocyanate 

134190-37-7 Diethyldiisocyanatobenzene 

004128-73-8 4,4' Diisocyanatodiphenyl ether 

075790-87-3 2,4'-Diisocyanatodiphenyl sulfide 

000091-93-0 3,3'-Dimethoxybenzidine-4,4'-diisocyanate 

000091-97-4 3,3'-Dimethyl-4,4'-diphenylene diisocyanate 

000139-25-3 3,3'-Dimethyldiphenyimethane-4,4'-diisocyanate 

000822-06-0 Hexamethylene-1,6-diisocyanate 

004098-71-0 Isophorone diisocyanate 

075790-84-0 4-Methyldiphenylmethane-3,4-diisocyante 

005124-30-1 1,1-Methylene bis(4-isocyanatocyclohexane) 

000101-68-8 Methylenebis(phenylisocyanate) (MDI) 

003173-72-6 1,5-Naphthalene diisocyanate 

000123-61-5 1,3-Phenylene diisocyanate 

000104-494 1,4-Phenylene diisocyanate 

009016-87-9 Polymeric diphenylmethane diisocyanate 

016938-22-0 2,2,4-Trimethylhexamethylene diisocyanate 

015646-96-5 2,4,4-Trimeihylhexamethylene diisocyanate 

Nicotine and salts 

Nitrate compounds (water dissociable; reportable only when in aqueous solution) 

111/95 

1 /1 /95 

1 /1 /95 
Federal Register / Vol. 59, No. 229 / Wednesday, November 30, 1994 / Rules and Regulations 61485 

Category Name Effective 

Date 

Polychlorinated alkanes: Includes those chemicals defined by the following formula: 1/1/95 

CxH2x _yCl 

where x= 10 to 19; 

y= 3 to 12; and 

where the average chlorine content ranges from 40-70% with the limiting molecular formulas C,oH19Cl3 and C,sH,6Cl,z. 

Polycyclic aromatic compounds (PACs): (This category includes only those chemicals listed below) 1/1/95 

00056-55-3 Benz(a)anthracene 

00218-01-9 Benzo(a)phenanthrene 

00050-32-8 Benzo(a)pyrene 

00205-99-2 Benzo(b)fluoranthene 

00205-82-3 Benzo ')fluoranthene 

00207-08-9 Benzo( )fluoranthene 

00189-55-9 Benzo(rst)pentaphene 

00226-36-8 Dibenz(a,h)acridine 

00224-42-0 Dibenz(a,j)acridine 

00053-70-3 Dibenzo(a,h)anthracene 

05385-75-1 Dibenzo(a,e)fluoranthene 

00192-65-4 Dibenzo(a,e)pyrene 

00189-64-0 Dibenzo(a,h)pyrene 

00191-00-0 Dibenzo(a,l)pyrene 

00194-59-2 7H-Dibenzo(c,g)carbazole 

00057-97-6 7,12-Dimethylbenz(a)anthracene 

00193-39-5 Indeno[ 1,2,3-cd]pyrene 

03697-24-3 5-Methylchrysene 

05522-43-0 1-Nitropyrene 

Strychnine and salts 1/1/95 

[FR Doc. 94-29376 Filed 11-23-94; 4:03 pm] 

BILLING CODE 8580-60-F