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Federal Register: Addition of Dioxin and Dioxin-Like Compounds;
Modification of Polychlorinated Biphenyls (PCBs) Listing; Toxic
Chemical Release Reporting; Community Right-to-Know




[Federal Register: May 7, 1997 (Volume 62, Number 88)]
[Proposed Rules]               
[Page 24887-24896]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my97-36]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[OPPTS-400111; FRL-5590-1]
RIN 2070-AC00

 
Addition of Dioxin and Dioxin-Like Compounds; Modification of 
Polychlorinated Biphenyls (PCBs) Listing; Toxic Chemical Release 
Reporting; Community Right-to-Know

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: In response to a petition filed under section 313(e)(1) of the 
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), EPA 
is proposing to add a chemical category that includes dioxin and 27 
dioxin-like compounds to the list of toxic chemicals subject to the 
reporting requirements under EPCRA section 313 and section 6607 of the 
Pollution Prevention Act of 1990 (PPA). EPA believes that dioxin and 
the dioxin-like compounds that are included in the petition, meet the 
criteria for addition to the list of toxic substances as established in 
EPCRA section 313(d)(2)(B). EPA is also proposing to modify the 
existing EPCRA section 313 listing for polychlorinated biphenyls (PCBs) 
in order to exclude those PCBs that are included in the proposed dioxin 
and dioxin-like compounds category.

DATES: Written comments must be received by July 7, 1997.

ADDRESSES: Written comments should be submitted in triplicate to: OPPT 
Docket Clerk, TSCA Document Receipt Office (7407), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Rm. G-099, Washington, DC 20460, Attention: Docket Control Number 
OPPTS-400109. Comments containing information claimed as confidential 
must be clearly marked as confidential business information (CBI). If 
CBI is claimed, three additional sanitized copies must also be 
submitted. Nonconfidential versions of comments on this proposed rule 
will be placed in the rulemaking record and will be available for 
public inspection. Comments should include the docket control number 
for this proposal, OPPTS-400111, and the name of the EPA contact for 
this proposal. Unit VII. of this preamble contains additional 
information on submitting comments containing information claimed as 
CBI.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: oppt.ncic@epamail.epa.gov. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket control number OPPTS-400109. No CBI should be submitted through 
e-mail. Electronic comments on this proposed rule may be filed online 
at many Federal Depository Libraries. Additional information on 
electronic submissions can be found in Unit VII. of this preamble.

FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions 
Coordinator, 202-260-3882, e-mail: bushman.daniel@epamail.epa.gov, for 
specific information on this proposed rule, or for more information on 
EPCRA section 313, the Emergency Planning and Community Right-to-Know 
Hotline, Environmental Protection Agency, Mail Code 5101, 401 M St., 
SW., Washington, DC 20460, Toll free: 1-800-535-0202, in Virginia and 
Alaska: 703-412-9877 or Toll free TDD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:

I. Introduction

A. Regulated Entities

    Entities potentially regulated by this action are those which 
manufacture, process, or otherwise use any of the 28 chemicals included 
in the proposed category and which are subject to the

[[Page 24888]]

reporting requirements of section 313 of the Emergency Planning and 
Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11023 and 
section 6607 of the Pollution Prevention Act of 1990 (PPA), 42 U.S.C. 
13106. However, based on what EPA knows about the sources of the 
chemicals in the proposed category, EPA believes that, under current 
reporting thresholds, it is highly unlikely that any entities will be 
required to report for the proposed chemical category. If thresholds 
are lowered in the future, then some of the potentially regulated 
categories and entities would include:

                                                                        
------------------------------------------------------------------------
                                               Examples of regulated    
                 Category                             entities          
------------------------------------------------------------------------
Industry                                   Facilities that: incinerate  
                                            hazardous waste, municipal  
                                            solid waste, sewage sludge, 
                                            or other wastes that contain
                                            chlorine; manufacture       
                                            chlorinated organic         
                                            compounds; operate          
                                            metallurgical processes such
                                            as steel production,        
                                            smelting operations, and    
                                            scrap metal recovery        
                                            furnaces; burn coal, wood,  
                                            petroleum products, and used
                                            tires; treat or dispose of  
                                            polychlorinated biphenyls.  
------------------------------------------------------------------------
Federal Government                         Federal Agencies that are    
                                            engaged in the combustion of
                                            wastes.                     
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be regulated by this action. Other types of entities 
not listed in the table could also be regulated. To determine whether 
your facility would be regulated by this action, you should carefully 
examine the applicability criteria in part 372 subpart B of Title 40 of 
the Code of Federal Regulations. If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed in the preceding ``FOR FURTHER INFORMATION CONTACT'' section.

B. Statutory Authority

    This action is taken under section 313(d)(1) of EPCRA. EPCRA is 
also referred to as Title III of the Superfund Amendments and 
Reauthorization Act of 1986 (SARA) (Pub. L. 99-499).

C. Background

    Section 313 of EPCRA requires certain facilities manufacturing, 
processing, or otherwise using listed toxic chemicals in amounts above 
reporting threshold levels, to report their environmental releases of 
such chemicals annually. Beginning with the 1991 reporting year, such 
facilities must also report pollution prevention and recycling data for 
such chemicals, pursuant to section 6607 of PPA. When enacted, section 
313 established an initial list of toxic chemicals that was comprised 
of more than 300 chemicals and 20 chemical categories. Section 313(d) 
authorizes EPA to add chemicals to or delete chemicals from the list, 
and sets forth criteria for these actions. Under section 313(e)(1), any 
person may petition EPA to add chemicals to or delete chemicals from 
the list. EPA has added and deleted chemicals from the original 
statutory list. Pursuant to EPCRA section 313(e)(1), EPA must respond 
to petitions within 180 days either by initiating a rulemaking or by 
publishing an explanation of why the petition has been denied.
    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 a statement of policy and guidance 
regarding the recommended content of petitions to delete individual 
members of the section 313 metal compound categories. EPA has published 
a statement clarifying its interpretation of the section 313(d)(2) and 
(3) criteria for adding and deleting chemicals from the section 313 
toxic chemical list (59 FR 61432; November 30, 1994) (FRL-4922-2).

II. Description of Petition

    On August 28, 1996, EPA received a petition from Communities For A 
Better Environment to add dioxin and 27 dioxin-like compounds to the 
list of chemicals subject to the reporting requirements of EPCRA 
section 313 and PPA section 6607. The petitioner believes that because 
dioxin and dioxin-like compounds are highly toxic, persist and 
bioaccumulate in the environment, and may cause severe adverse health 
effects, they meet the listing criteria of EPCRA section 313(d)(2). The 
petitioner also requested that EPA lower the reporting thresholds for 
these chemicals because under current reporting thresholds no 
facilities would be required to file a report on these chemicals, and 
thus the public would not be able to obtain information on releases of 
these highly toxic and environmentally persistent chemicals. Although 
the petition to add these chemicals to the EPCRA section 313 list is 
subject to the 180-day statutory petition response deadline discussed 
in Unit I.C. of this preamble, the request to lower the reporting 
thresholds is not subject to this statutory deadline (see EPCRA section 
313(f)(2)).

III. Technical Review of the Petition

    The technical review of the petition to add dioxin and dioxin-like 
compounds to the EPCRA section 313 list of toxic chemicals included an 
analysis of the chemistry (Ref. 1), environmental fate (Ref. 2), and 
health effects (Ref. 3) data available for dioxin and the 27 dioxin-
like compounds identified in the petition. A summary of the review of 
the available data is provided below and a more detailed discussion can 
be found in the EPA technical reports (Refs. 1, 2, and 3) and other 
cited references.

A. Chemistry, Use and Sources

    The petitioner requested the addition of dioxin and dioxin-like 
compounds to the EPCRA section 313 list of toxic chemicals. Dioxin and 
dioxin-like compounds refers to a group of 28 environmentally stable 
compounds which includes 7 polychlorinated dibenzo-p-dioxins (CDDs), 10 
polychlorinated dibenzofurans (CDFs), and 11 co-planar polychlorinated 
biphenyls (PCBs). The chemical structures and nomenclature for these 
compounds are discussed below.
    The structure of dibenzo-p-dioxin and the conventional numbering 
system for substituent positions are shown below:
[GRAPHIC] [TIFF OMITTED] TP07MY97.005

Chlorine can be substituted at the 8 possible positions marked on the 
two benzene rings to give 75 different congeners of chlorinated 
dibenzo-p-dioxins. Only the seven CDDs, having chlorine substitution at 
the 2, 3, 7, and 8 positions, are thought to have dioxin-like toxicity 
(i.e, toxicity similar to 2,3,7,8-tetrachlorodibenzo-p-dioxin which is 
referred to simply as ``dioxin'' or 2,3,7,8-TCDD). The seven CDDs 
included in the petition contain four to eight chlorines. The chemical 
names for the seven CDDs are listed below with their corresponding 
Chemical Abstract Service Registry Numbers (CAS No.) in parenthesis:

[[Page 24889]]

    1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin, (35822-46-9)
    1,2,3,4,7,8-hexachlorodibenzo-p-dioxin, (39227-28-6)
    1,2,3,6,7,8-hexachlorodibenzo-p-dioxin, (57653-85-7)
    1,2,3,7,8,9-hexachlorodibenzo-p-dioxin, (19408-74-3)
    1,2,3,4,6,7,8,9-octachlorodibenzo-p-dioxin, (3268-87-9)
    1,2,3,7,8-pentachlorodibenzo-p-dioxin, (40321-76-4)
    2,3,7,8-tetrachlorodibenzo-p-dioxin, (1746-01-6)
    The structure of dibenzofuran and the conventional numbering system 
for substituent positions are shown below.
[GRAPHIC] [TIFF OMITTED] TP07MY97.006

Chlorine can be substituted at the 8 possible positions marked on the 2 
benzene rings to give 135 different congeners of chlorinated 
dibenzofurans. Only 10 CDFs, having chlorine substitution at the 2, 3, 
7, and 8 positions, are thought to have dioxin-like toxicity. The 10 
CDFs included in the petition have 4 to 8 chlorines. The chemical names 
for the 10 CDFs are listed below with their corresponding CAS Nos. in 
parenthesis:
    1,2,3,4,6,7,8-heptachlorodibenzofuran, (67562-39-4)
    1,2,3,4,7,8,9-heptachlorodibenzofuran, (55673-89-7)
    1,2,3,4,7,8-hexachlorodibenzofuran, (70648-26-9)
    1,2,3,6,7,8-hexachlorodibenzofuran, (57117-44-9)
    1,2,3,7,8,9-hexachlorodibenzofuran, (72918-21-9)
    2,3,4,6,7,8-hexachlorodibenzofuran, (60851-34-5)
    1,2,3,4,6,7,8,9-octachlorodibenzofuran, (39001-02-0)
    1,2,3,7,8-pentachlorodibenzofuran, (57117-41-6)
    2,3,4,7,8-pentachlorodibenzofuran, (57117-31-4)
    2,3,7,8-tetrachlorodibenzofuran, (51207-31-9)
    The structure of biphenyl and the conventional numbering system are 
shown below.
[GRAPHIC] [TIFF OMITTED] TP07MY97.007

    The 10 positions marked on the 2 benzene rings (i.e., 2', 3, 3', 4, 
4', 5, 5', 6, and 6') can be chlorinated to give 209 different 
congeners of chlorinated biphenyls. Eleven PCBs believed to have 
dioxin-like toxicity are included in the petition. These 11 PCBs have 4 
to 7 chlorine atoms, but contain no more than 1 chlorine at the 4 ortho 
positions (i.e., 2, 2', 6 or 6') and all have 2 chlorines at the para 
positions (i.e., 4 and 4') and at least 2 chlorines at the meta 
positions (i.e., 3, 3', 5, or 5'). All 11 are regarded as coplanar 
PCBs. Coplanar PCBs are those in which the two benzene rings can rotate 
into the same plane. The two benzene rings can rotate into the same 
plane since chlorine substitution in only one of the ortho positions 
does not block the rotation of the two benzene rings over the bond 
connecting positions 1 and 1'. The chemical names for the 11 PCBs 
included in the petition are listed below with their corresponding CAS 
Nos. in parenthesis:
    2,3,3',4,4',5,5'-heptachlorobiphenyl, (39635-31-9)
    2,3,3',4,4',5-hexachlorobiphenyl, (38380-08-4)
    2,3,3',4,4',5'-hexachlorobiphenyl, (69782-90-7)
    2,3',4,4',5,5'-hexachlorobiphenyl, (52663-72-6)
    3,3',4,4',5,5'-hexachlorobiphenyl, (32774-16-6)
    2,3,3',4,4'-pentachlorobiphenyl, (32598-14-4)
    2,3,4,4',5-pentachlorobiphenyl, (74472-37-0)
    2,3',4,4',5-pentachlorobiphenyl, (31508-00-6)
    2',3,4,4',5-pentachlorobiphenyl, (65510-44-3)
    3,3',4,4',5-pentachlorobiphenyl, (57465-28-8)
    3,3',4,4'-tetrachlorobiphenyl, (32598-13-3)
    Except for laboratory scale preparation for chemical analysis and 
testing, CDDs and CDFs have never been produced intentionally for any 
commercial use; rather, they occur as trace contaminants in many 
chemical-industrial and thermal processes, and may be present in the 
chemical products and waste streams from such processes. PCBs, however, 
were commercially produced in large quantities and, as discussed below, 
were used in the U.S. mainly as nonflammable and heat resistant fluids 
for transformers and as dielectric media for capacitors. Except for 
small quantities of PCBs that are inadvertently generated during an 
excluded manufacturing process and exemptions that have been granted by 
EPA under section 6(e)(3) of the Toxic Substances Control Act (TSCA) 
for the manufacture of PCBs for research and development purposes, the 
manufacturing of PCBs was banned in the U.S. in 1979 and their use and 
disposal regulated. However, PCBs continue to be released to the 
environment through the use and disposal of products manufactured years 
ago.
    CDDs and CDFs are classified as chlorinated tricyclic aromatic 
hydrocarbons and they are structurally very similar and have similar 
physical and chemical properties. CDDs and CDFs normally exist as 
complex mixtures of congeners. One of the congeners, 2,3,7,8-TCDD, has 
been extensively studied due to its high toxicity (Ref. 4). The 7 CDDs 
and 10 CDFs included in the petition are high melting solids. They have 
extremely low vapor pressures, are highly insoluble in water, are quite 
lipophilic, and tend to persist and bioaccumulate in the environment 
(see Unit III.B. of this preamble for a more complete discussion of 
environmental fate including persistence and bioaccumulation). They are 
classified as lipophilic since 2,3,7,8-TCDD is more soluble in many 
organic solvents, fats, and oils than in water, although the overall 
solubility of 2,3,7,8-TCDD in organic solvents is quite low. The water 
solubility of 2,3,7,8-TCDD is about 19 parts per trillion (ppt), while 
that of 2,3,7,8-tetrachlorodibenzofuran is about 420 ppt. Generally, 
water solubility decreases as the chlorine substitution increases. The 
CDDs and CDFs are stable toward heat, oxidation, acids, and alkalies. 
CDDs and CDFs can be photolyzed by sunlight or ultraviolet radiation 
(Refs. 5 and 6). The melting point, water solubility, vapor pressure, 
and log Kow of the 17 CDDs and CDFs included in the petition 
have all been measured or calculated (Ref. 1).
    PCBs differ structurally from CDDs and CDFs, yet some have similar 
physical and chemical properties. They are chemically stable, have low 
vapor pressure, have low water solubility (1 part per billion (ppb)), 
and they are very lipophilic. Due to their high thermal stability, low 
flammability, high heat capacity, and low electrical conductivity, 
PCBs, under the U.S. trade name Aroclor series, were highly favored as 
cooling liquids in electrical equipment from 1929 to 1979. The Aroclor 
series vary greatly in congener numbers and compositions. Although most 
of the individual congeners are solids, Aroclors, since they are 
complex mixtures, exist as oils, viscous liquids, or sticky resins 
(Ref. 7). PCBs are unchanged in the presence of oxygen and active 
metals at temperatures up to 170  deg.C (Ref. 7). Pyrolysis of 
technical grade PCBs produces CDFs (Ref. 8). In

[[Page 24890]]

the presence of a hydrogen donor, PCBs undergo photodechlorination when 
exposed to sunlight or ultraviolet radiation. With the exception of the 
vapor pressure for 1 PCB, EPA has identified measured or calculated 
melting points, vapor pressures, and log Kows for each of 
the 11 PCBs (Ref. 1).
    From 1929 to 1977, PCBs were produced commercially in the U.S. in 
large quantities by catalytic partial chlorination of biphenyl under 
heated conditions to produce complex mixtures, each containing 60 to 90 
different congeners and a specific percent of chlorine (Refs. 7 and 9). 
Because of their excellent thermal resistance and dielectric 
properties, PCBs were used mainly as insulators for transformers and as 
a dielectric medium for capacitors. PCBs were also used as 
plasticizers; ingredients in lacquers, printing inks, paints and 
varnishes, and adhesives; waterproofing compounds in various types of 
coatings; dye carriers for pressure-sensitive copying paper; lubricants 
or lubricant additives under extreme conditions; heat transfer fluids; 
fire resistant hydraulic fluids; and as vacuum pump fluids (Refs. 10 
and 11). The production of PCBs peaked at 33,000 tons in 1970 (Ref. 7). 
Although PCBs are no longer produced in the U.S. (except as discussed 
earlier in this Unit) and other industrialized countries, PCBs continue 
to be released into the environment through the use and disposal of 
products containing or contaminated with PCBs, and by the 
reintroduction of PCBs into the air and water from previously 
contaminated soil and sediment. Disposal and use of PCBs and PCB-
containing materials have been regulated by EPA under TSCA since 1978 
(Ref. 12). Some uses of PCBs are allowed, but the uses are very 
restrictive (Ref. 13).
    CDDs and CDFs are not produced commercially and there are no known 
commercial uses. CDDs and CDFs are produced in small amounts in 
laboratories for use in chemical analysis, and they are generated in 
trace amounts as byproducts from various chemical and combustion 
processes (Refs. 14 and 15). CDDs and CDFs can be produced from 
aromatic or potentially aromatic forming compounds in the presence of a 
chlorine source. The formation is enhanced under alkali conditions at 
elevated temperatures or in the presence of air upon heating. 
Industrial products, most likely to be contaminated with CDDs and CDFs, 
are polychlorinated phenols, polychlorinated diphenyl ethers, and other 
polychlorinated aromatic compounds (Ref. 15). CDDs and CDFs share most 
of the same precursor compounds, but chlorinated biphenyls form only 
corresponding furans and chlorinated 2-hydroxy phenyl ethers form only 
dioxins.
    The largest identified source for CDDs and CDFs is the combustion 
of waste (municipal, medical, and hazardous) (Refs. 4, 14, 15, and 16). 
Other sources include pulp and paper mills (from chlorine bleaching 
processes); oil refineries (catalyst regeneration processes); 
manufacture of chlorinated organic chemicals (chlorinated phenols and 
other aromatics, chlorinated aliphatic solvents and monomers, 
herbicides, etc.); combustion and incineration of wastes; steel 
production and smelting operations; and energy generation (combustion 
of coal, wood, petroleum products, tires etc.). The dioxin-like 
compounds have been found in all environmental media (air, water, soil, 
sediments) and foods.

B. Environmental Fate

    There is a good general understanding of the environmental fate and 
transport of CDDs, CDFs, and PCBs. CDDs and CDFs are primarily 
associated with particulate and organic matter in air, water, soil, and 
sediment, although vapor phase transport and deposition of lower 
chlorinated CDDs and CDFs does occur and is important to human exposure 
(Ref. 17). CDDs and CDFs with four or more chlorines are extremely 
stable in most environmental media and thus may be classified as 
persistent organic pollutants (POPs).
    CDDs and CDFs entering the atmosphere are removed by either 
photodegradation or wet/dry deposition (Refs. 18 and 19). For CDDs and 
CDFs sorbed to soil, burial in place or movement to water bodies by 
erosion of the soil are the predominant fate. CDDs and CDFs entering 
the aquatic environment primarily undergo sedimentation and burial. 
Resuspension of sediments can be an important route of exposure to fish 
and other aquatic organisms. Benthic sediments are believed to be the 
ultimate environmental sink (Ref. 20).
    Coplanar PCBs, like CDDs and CDFs, have very low water solubilities 
and tend to sorb strongly to organic matter in soils and sediments. 
However, they have somewhat higher vapor pressures than the CDDs and 
CDFs. Atmospheric transport and deposition are thought to be the 
principal mechanisms that account for the widespread environmental 
distribution of CDDs, CDFs, and PCBs (Ref. 21).
    Like CDDs and CDFs, PCBs are quite stable and may be classified as 
POPs. Soil erosion and sediment transport in water bodies and 
volatilization from soil and water with subsequent atmospheric 
transport and deposition are believed to be the dominant transport 
mechanisms, and account for the widespread environmental occurrence of 
PCBs (Ref. 22). Photodegradation of the more highly chlorinated 
congeners to less chlorinated products can be a significant 
transformation process for PCBs exposed to light (Ref. 23). There is 
now a substantial body of evidence indicating that microbial 
dehalogenation resulting in less chlorinated PCBs also occurs and may 
be a significant fate process under anaerobic conditions, principally 
in sediments (Refs. 22, 24, and 25). However, dehalogenation is a slow 
process that occurs over a time frame of years.
    CDDs, CDFs, and PCBs are very hydrophobic compounds, and this is 
reflected by their high estimated or measured octanol/water partition 
coefficients. Because of their high lipophilic nature, these compounds 
accumulate to a significant level in the fatty tissues of biota. This 
potential has been amply documented in both experimental and monitoring 
studies for many of the compounds. Measured bioconcentration factors 
(BCFs) for all the CDDs, CDFs, and PCBs included in the petition 
consistently exceed 1,000 (and may be much higher), indicating that 
they are all bioaccumulative (Refs. 26 and 27).
    CDDs, CDFs, and PCBs are found in measurable levels in human 
tissues across the general population. Typical levels for U.S. adults 
determined from literature data (Ref. 28) are 30 ppt toxic equivalents 
(TEQ) for CDDs and CDFs and 20 ppt TEQ for PCBs. TEQs are determined by 
summing the products of multiplying concentrations of individual 
dioxin-like compounds times the corresponding toxicity equivalence 
factor (TEF) for that compound (TEFs are discussed in Unit III.C. of 
this preamble). The principal route of human exposure is thought to be 
consumption of animal fats (e.g., beef, pork, poultry, milk, dairy 
products, and fish) (Ref. 29). For meat and dairy products, the 
mechanism by which these foods become contaminated is thought to be air 
deposition onto plants which are then eaten by livestock (Refs. 21 and 
30). Fish absorb these compounds directly from water or contact with 
sediments (Ref. 27).

C. Toxicity Evaluation

    EPA has done extensive risk and hazard assessments over the years 
for dioxin and dioxin-like compounds and is in the final stages of 
reassessment of these compounds based on up-to-date

[[Page 24891]]

data. The reassessment is looking at many things including the sources 
of these chemicals and potential exposures. While not yet final, 
nothing in the current reassessment indicates less than high hazard 
levels for these compounds. Therefore, the reassessment will not change 
the toxicity determination as it relates to the EPCRA section 313 
listing criteria.
    An extensive data base exists showing that 2,3,7,8-TCDD is a potent 
toxicant in animals and has the potential to produce a wide spectrum of 
toxic effects in humans. There is sufficient evidence to conclude that 
2,3,7,8-TCDD is carcinogenic in experimental animals (Refs. 4, 31, 32, 
and 33).
    Long-term studies in rats, mice, hamsters and Medaka (a small fish) 
using various routes of administration all produced positive results at 
dose levels well below the maximum tolerated dose (MTD), leading to the 
conclusion that 2,3,7,8-TCDD is a potent carcinogen. Depending on the 
species of the animal, the principal target organs are the liver, lung, 
thyroid gland, and nasal-oral cavities by oral administration. When 
administered topically, 2,3,7,8-TCDD induced skin tumors in mice. 
Available human data cannot clearly demonstrate whether a cause and 
effect relationship exists between 2,3,7,8-TCDD exposure and increased 
incidence of cancer. However, there are a number of epidemiological 
studies associating exposure to 2,3,7,8-TCDD with increased cancer 
mortality (Refs. 4 and 32). Based on the EPA weight-of-evidence 
classification criteria, there is sufficient evidence to conclude that 
2,3,7,8-TCDD is a probable human carcinogen. It has been listed by the 
National Institute of Environmental Health Sciences/National Toxicology 
Program (NIEHS/NTP) as a substance which may reasonably be anticipated 
to be a human carcinogen (Ref. 31). Based on the 1985 slope factor 
(Ref. 4) 2,3,7,8-TCDD is the most potent chemical carcinogen that EPA 
has regulated.
    Similarly, there is sufficient evidence for the carcinogenicity of 
PCBs in experimental animals (Refs. 34 and 35). Based on the evidence 
from animal studies and inadequate/limited evidence for carcinogenicity 
to humans, PCBs are classified as group B2, probable human carcinogens 
by EPA (Ref. 36) and are listed as substances which may reasonably be 
anticipated to be human carcinogens in the NIEHS/NTP Annual Report on 
Carcinogens (Ref. 31).
    In addition to carcinogenic effects, 2,3,7,8-TCDD and PCBs have 
been shown to cause a variety of adverse effects in laboratory animals 
(Refs. 32, 33, and 35). Humans exposed to 2,3,7,8-TCDD or PCBs in a 
number of incidents have been reported to develop chloracne, liver 
disorders, porphyria, and neurological changes (Refs. 4, 33, and 35). 
In a number of animal species tested, including fish, birds, and 
mammals, 2,3,7,8-TCDD has been shown to induce various reproductive, 
fetotoxic and teratogenic responses. With a No Observed Effect Level 
(NOEL) of about 0.001 micrograms per kilogram (g/kg) in 
reproductive toxicity studies in rats, and a Minimum Effective Dose 
(MED) of about 0.1 g/kg/day in teratogenicity studies in rats 
and mice, 2,3,7,8-TCDD is one of the most, if not the most, potent 
reproductive/developmental toxicant known. Studies in various animal 
species have also demonstrated that the immune system is a target for 
toxicity of 2,3,7,8-TCDD. 2,3,7,8-TCDD has been shown to cause 
decreases in thymic and splenic weights, and alter serum immunoglobin 
levels in mice at oral doses as low as 0.01 ug/kg/week (Refs. 4 and 
33).
    The 11 dioxin-like PCBs are believed to have toxicities similar to 
CDDs and CDFs. In addition, PCBs as a class display a variety of 
adverse human health effects. Reproductive dysfunction due to exposure 
to PCBs has been documented in a wide variety of animal species 
including the rat, mouse, rabbit, monkey, and mink. Irregular menstrual 
cycle, decreased mating performance, early abortion, as well as 
resorption are the most commonly observed effects. Teratogenic effects 
have been noted in mice, dogs, and chickens which showed various 
skeletal deformities. Data from animal studies suggest that the immune 
system is also a sensitive target for toxicity of PCBs. Thymic atrophy, 
cellular alterations in the spleen and lymph nodes accompanied by 
reduced antibody production have been observed in rats, rabbits, and 
monkeys exposed to PCBs by various routes (Refs. 8 and 35).
    There are more limited data for other dioxin-like compounds. 
However, many of these compounds, especially those with chlorine or 
bromine substitution at the 2,3,7,8-positions, are generally recognized 
to exhibit toxicity and carcinogenicity similar to 2,3,7,8-TCDD. 
Indeed, carcinogenesis bioassays of a mixture of 1,2,3,6,7,8- and 
1,2,3,7,8,9-hexachlorodibenzo-p-dioxin have shown that these compounds 
are carcinogenic, inducing liver tumors in both sexes of rats and mice 
(Ref. 37).
    Presently, there is considerable evidence showing that the initial 
event involved in carcinogenesis and toxicity of dioxin and dioxin-like 
compounds is their stereospecific interaction with a cytosolic receptor 
(Ah receptor) (Ref. 38). Because of their common mechanism of action, 
Toxicity Equivalence Factors (TEFs) have been established for dioxin-
like compounds. TEFs represent order of magnitude estimates of the 
relative potency of dioxin-like compounds compared to 2,3,7,8-TCDD, and 
have been considered by EPA and the international scientific community 
to be a valid and scientifically sound approach for assessing the 
likely health hazard of dioxin-like compounds (Ref. 39). Structure-
activity relationship analysis of halogenated dibenzo-p-dioxin, 
dibenzofuran, and related compounds indicates that the degree of 
toxicity of these dioxin-like compounds is dependent on the number and 
positions of chlorine substitutions; all the lateral positions (2, 3, 
7, and 8) must be chlorinated to achieve the greatest degree of 
toxicity. Examination of all the dioxin and dioxin-like compounds (7 
CDDs and 10 CDFs) specified in the petition revealed that they all 
contain chlorine at the 2, 3, 7, and 8 positions. The range of the TEFs 
for CDDs and CDFs is between 0.5 and 0.001, indicating that they are 
estimated to be about half to three orders of magnitude less toxic than 
2,3,7,8-TCDD. The PCBs included in this proposal also have proposed TEF 
values which range from 0.1 to 0.00001 (Ref. 40). Nonetheless, all of 
these dioxin-like compounds are potent carcinogens and highly toxic 
compounds given the level of toxicity of 2,3,7,8-TCDD (Refs. 32, 33, 
and 35).
    Therefore, based on the available toxicity data, it is concluded 
that the 7 CDDs, 10 CDFs, and 11 PCBs specified in this petition are 
highly toxic and are reasonably anticipated to cause serious adverse 
health effects, including cancer, in humans.

IV. Technical Summary

    EPA's technical review revealed that dioxin and dioxin-like 
compounds are known to cause chloracne, immunotoxicity, reproductive/
developmental effects, and cancer in experimental animals, and that it 
is reasonable to anticipate that these chemicals will also cause cancer 
and other serious adverse chronic health effects in humans. The review 
also shows that dioxin and dioxin-like compounds are chemically stable 
compounds that persist and bioaccumulate in the environment.

V. Petition Response and Rationale

    EPA is proposing to grant the petition to add dioxin and dioxin-
like compounds to the EPCRA section 313

[[Page 24892]]

list of toxic chemicals. However, as discussed in Unit V.C. of this 
preamble, EPA is not proposing to lower reporting thresholds for these 
compounds at this time.

A. Proposed Addition of a Chemical Category

    EPA is proposing to add a delimited chemical category entitled 
``Dioxin and Dioxin-like Compounds'' to the EPCRA section 313 list of 
toxic chemicals. This delimited category will include the 28 individual 
chemicals identified by name and CAS number under Unit III.A. of this 
preamble. The technical review of dioxin and dioxin-like compounds 
indicates that these chemicals are highly toxic and persist and 
bioaccumulate in the environment. EPA believes that the toxicity data 
for these chemicals clearly indicate that these chemicals are known to 
cause or can reasonably be anticipated to cause cancer and other 
serious chronic health effects in humans. Therefore, EPA believes that 
dioxin and dioxin-like compounds meet the EPCRA section 313(d)(2)(B) 
criteria for listing. In addition, because dioxin and dioxin-like 
compounds can reasonably be anticipated to cause high chronic toxicity 
and cancer, EPA does not believe that an exposure assessment is 
necessary to conclude that these compounds meet the toxicity criterion 
of EPCRA section 313(d)(2)(B). For a discussion of the use of exposure 
in EPCRA section 313 listing/delisting decisions, see 59 FR 61432, 
November 30, 1994.
    As EPA has explained in the past (59 FR 61432, November 30, 1994), 
the Agency believes that EPCRA allows a chemical category to be added 
to the list, where EPA identifies the toxic effect of concern for at 
least one member of the category and then shows why that effect can 
reasonably be expected to be caused by all other members of the 
category. Here, individual toxicity data do not exist for each member 
of the proposed category; however, as discussed in Unit III.C. of this 
preamble, there is sufficient information to conclude that all of these 
chemicals are highly toxic based on structural and physical/chemical 
property similarities to those members of the category for which data 
are available.
    For purposes of EPCRA section 313, threshold determinations for 
chemical categories must be based on the total of all chemicals in the 
category (see 40 CFR 372.25(d)). 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. When filing reports for chemical 
categories, the releases are determined in the same manner as the 
thresholds. One report is filed for the category and all releases are 
reported on one Form R (the form for filing reports under EPCRA section 
313 and PPA section 6607).

B. Modification of Current Listing for PCBs

    The current EPCRA section 313 list of toxic chemicals includes a 
listing for polychlorinated biphenyls (PCBs) under the CAS No. 1336-36-
3. This is a broad listing that includes all chlorinated 1,1'-
biphenyls, not just the ones that are proposed to be included in the 
dioxin and dioxin-like compounds category. The non-dioxin-like PCBs are 
also toxic and EPA is not proposing to remove them from the EPCRA 
section 313 list. However, EPA is proposing to modify the current PCBs 
listing to exclude those PCBs that are listed as part of the new 
category in order to avoid having some PCBs reportable under two 
listings, which might lead to double reporting. EPA is proposing to 
modify the current PCB listing to read ``polychlorinated biphenyls 
(PCBs) (excluding those PCBs listed under the dioxin and dioxin-like 
compounds category).''

C. Deferral of Lower Reporting Thresholds

    The petitioner also requested that EPA lower the reporting 
thresholds for dioxin and dioxin-like compounds. This request is not 
subject to the statutory 180-day petition response deadline in EPCRA 
section 313(e)(1) and EPA intends to address this request as part of 
the Agency's ongoing project to assess the utility and impacts of 
lowering reporting thresholds for EPCRA section 313 listed toxic 
chemicals that persist and bioaccumulate in the environment. EPA has 
initiated this project in response to concerns that chemicals that 
persist and bioaccumulate in the environment can have a cumulative 
effect and therefore it is important for the public to be able to track 
even low releases of such chemicals. The current reporting thresholds 
of 25,000 pounds for manufacturing or processing and 10,000 pounds for 
otherwise use are high enough that many biologically significant 
releases of persistent bioaccumulative chemicals are usually not 
reported.
    EPA believes that rather than proposing lower reporting thresholds 
for dioxin and dioxin-like compounds at this time, this issue should be 
considered within the context of lower reporting thresholds for all 
EPCRA section 313 listed toxic chemicals that persist and bioaccumulate 
in the environment. Taking this approach will provide adequate time for 
EPA to evaluate and address issues pertaining to the use of lower 
reporting thresholds for these chemicals. Therefore, EPA is not 
proposing to lower the reporting thresholds for the dioxin and dioxin-
like compounds category proposed as part of today's petition response. 
However, EPA is requesting comment on the issue of lower reporting 
thresholds for these compounds.

D. Schedule for Final Rule

    Based on what EPA knows about the sources of the chemicals in the 
proposed dioxin and dioxin-like compounds category, EPA believes that, 
under current reporting thresholds, it is highly unlikely that any 
reports would be filed for the category if it were added to the EPCRA 
section 313 list. EPA believes that delaying final action to add this 
category to the EPCRA section 313 list will not result in a loss of 
significant information. Therefore, if after consideration of comments 
received on this proposed rule, EPA decides to finalize the addition of 
the category, EPA will postpone that action until a rule lowering the 
reporting thresholds for the category is ready to be finalized. EPA 
intends to address the issue of lower reporting thresholds for the 
dioxin and dioxin-like compounds category within the next year.

VI. Request for Public Comment

    EPA requests general comments on this proposal to add the delimited 
dioxin and dioxin-like compounds category to the list of toxic 
chemicals subject to the reporting requirements under EPCRA section 313 
and PPA section 6607. Further, EPA requests comment on the issue of 
lowering the EPCRA section 313 reporting thresholds for the proposed 
dioxin and dioxin-like compounds category. Comments should be submitted 
to the address listed under the ADDRESSES unit at the front of this 
document. All comments must be received by July 7, 1997.

VII. Rulemaking Record

    A record, that includes the references in Unit VIII. of this 
preamble, has been established for this rulemaking under docket control 
number OPPTS-400111 (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from noon to 4 p.m., Monday through Friday, excluding legal holidays. 
The public

[[Page 24893]]

record is located in the TSCA Nonconfidential Information Center, Rm. 
NE-B607, 401 M St., SW., Washington, DC 20460.
    Electronic comments can be sent directly to EPA at: 
oppt.ncic@epamail.epa.gov Electronic comments must be submitted as an 
ASCII file avoiding the use of any special characters and any form of 
encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted in writing. The official rulemaking record is the paper 
record maintained at the address in ``ADDRESSES'' at the beginning of 
this document.

VIII. References

    1. USEPA, OPPT. Tou, Jenny; ``Chemistry Report for EPCRA 313 
Petition for the Addition of Dioxin-Like Compounds.'' (December 9, 
1996).
    2. USEPA, OPPT. Boethling, Robert S.; ``Environmental Fate and 
Bioaccumulation Potential of Dioxin-Like Compounds.'' (January 14, 
1997).
    3. USEPA, OPPT. Memorandum from Dr. David Lai, Toxicologist, Health 
and Environmental Review Division. Subject: Health Effects Review of 
the Petition to Add Dioxin and Dioxin-Like Compounds to the TRI List. 
(October 21, 1996).
    4. USEPA, OHEA. Health Assessment Document for Polychlorinated 
Dibenzo-p-dioxins. Prepared by the Office of Health and Environmental 
Assessment, U.S. Environmental Protection Agency, Washington, DC, 
(1985): EPA/600/8-84/014F.
    5. Buser, H. R., ``Rapid Photolytic Decomposition of Brominated and 
Brominated/Chlorinated Dibenzodioxins and Dibenzofurans.'' Chemosphere 
v. 17(5), (1988), pp. 889-903.
    6. USEPA, OTS. Exposure Assessment for Polychlorinated Biphenyls 
(PCBs), Polychlorinated Dibenzofurans (PCDFs), and Polychlorinated 
Dibenzodioxins (PCDDs) Released During Transformer Fires. Prepared by 
the Exposure Evaluation Division, Office of Toxic Substances, U.S. 
Environmental Protection Agency, Washington, DC and Versar Inc. EPA 
Contract No. 68-02-3986, Task No. 48. (June 1985): EPA 560/1985.4
    7. International Programme on Chemical Safety (IPCS). 1993. 
Environmental Health Criteria 140, Polychlorinated Biphenyls and 
Terphenyls (Second Edition), World Health Organization, Geneva.
    8. ATSDR. 1993. Toxicological Profile for Selected PCBs (Aroclor -
1260, -1254, -1248, -1242, -1232, -1221, and -1016). U.S. Department of 
Health and Human Services, Public Health Service, Agency for Toxic 
Substances and Disease Registry (ATSDR), Atlanta, GA, Report No. ATSDR/
TP-92/16.
    9. Frame, G.M. et al., ``Comprehensive, Quantitative, Congener-
Specific Analysis of Eight Aroclors and Complete PCB Congener 
Assignments on DB-1 Capillary GC Columns.'' Chemosphere v. 33(4), 
(1996), pp. 603-623.
    10. Hatton, R.E., ``Chlorinated Biphenyls and Related Compounds.'' 
In: Kirk-Othmer, Encyclopedia of Chemical Technology, Vol. 5, 3rd 
Edition, John Wiley Sons, New York, NY (1979), pp. 844-848.
    11. Beck, U, ``Chlorinated Biphenyls.'' In: Ullmanns Encyclopedia 
of Industrial Chemistry, 5th Edition, Vol. A6, VCH Publishers, New York 
(1986), Chapter 8, section 8.3, pp. 347-350.
    12. ATSDR. 1995. Toxicological Profile for Polychlorinated 
Biphenyls (Draft). U.S. Department of Health and Human Services, Public 
Health Service, Agency for Toxic Substances and Disease Registry 
(ATSDR), Atlanta, GA, Report No. ATSDR/TP-93/04.
    13. USEPA. 1996. Code of Federal Regulations. 40 CFR 761.30.
    14. Fiedler, H., ``Sources of PCDD/PCDF and Impact on the 
Environment.'' Chemosphere v. 32(1), (1996), pp. 55-64.
    15. International Programme on Chemical Safety (IPCS). 1989. 
Environmental Health Criteria 88, Polychlorinated Dibenzo-paradioxins 
and Dibenzofurans, World Health Organization, Geneva.
    16. Canadian Environmental Protection Act. 1990. Priority 
Substances List Assessment Report No. 1: Polychlorinated Dibenzodioxins 
and Polychlorinated Dibenzofurans.
    17. Welsch-Paulsch, K., McLachlan, M., Umlauf, G. ``Determination 
of the Principal Pathways of Polychlorinated Dibenzo-p-dioxins and 
Dibenzofurans to Lolium Multiflorum (Welsh Ray Grass).'' Envion. Sci. 
Technol. v. 29, (1995), pp. 189-194.
    18. Choudhry, G.C. and Hutzinger, O. ``Photochemical Formation and 
Degradation of PCDDs and PCDFs.'' Residue Reviews, v. 84, (1982), pp. 
112-161.
    19. Koester, C.J. and Hites, R.A. ``Wet and Dry Deposition of CDD/
Fs.'' Envion. Sci. Technol., v. 26, (1992), pp. 1375-1382.
    20. Fletcher, C.L. and McKay, W.A. ``PCDDs and PCDFs in the Aquatic 
Environment - a Literature Review.'' Chemosphere, v. 26, (1993), pp. 
1041-1069.
    21. Lorber, M. et al., ``Development and Validation of Airto-Beef 
Food Chain, Model for Dioxin-Like Compounds.'' Sci. Total Envion. v. 
156, (1994), pp. 39-65.
    22. USEPA, OTS. Leifer, A. et al., ``Environmental Transport and 
Transformation of Polychlorinated Biphenyls.'' Office of Toxic 
Substances, U.S. Environmental Protection Agency, Washington, DC, 
(December 1983): EPA-560/5-83-025.
    23. Lepine, R., Milot, S., Vincent, N. ``Formation of Toxic PCB 
Congeners and PCB-Solvent Adducts in a Sunlight Irradiated Cyclohexane 
Solution of Aroclor 1254.'' Bulletin of Environmental Contamination and 
Toxicology v. 48, (1992), pp. 152-156.
    24. Abramowitz, D. ``Aerobic and Anaerobic Biodegradation of 
PCBs.'' Critical Reviews in Biotechnologies v. 10(3), (1990), pp. 241-
251.
    25. Brown, J.F. and Wagner, R.E. ``PCB Movement, Dechlorination and 
Detoxication in the Acushnet Estuary.'' Environ. Toxicol. Chem. v. 9, 
(1990), pp. 1215-1233.
    26. USEPA, ORD. Interim Report on Data and Methods for Assessment 
of 2,3,7,8-Tetra Chlorodibenzo-p-dioxin Risks to Aquatic Life and 
Associated Wildlife. Office of Research and Development, U.S. 
Environmental Protection Agency, Washington, DC, (1993): EPA/600/R-93/
055.
    27. USEPA, OW. Great Lakes Water Quality Initiative Technical 
Support Document for the Procedure to Determine Bioaccumulation 
Factors. Office of Water, U.S. Environmental Protection Agency, 
Washington, DC, (March 1995): EPA-820-B-95005.
    28. USEPA, OTS. Chlorinated Dioxins and Furans in the General U.S. 
Population: NHATS FY87 Results. Office of Toxic Substances, U.S. 
Environmental Protection Agency, Washington, DC, (December 1991): EPA-
560/5-91-003.
    29. Travis, C.C. and Hattemer-Frey, H.A. ``Human Exposure to 
Dioxin.'' Sci. Total Environ. v. 104, (1991), pp. 97-127.
    30. Fries, G.F. and Paustenbach, D.J. ``Evaluation of Potential 
Transmission of 2,3,7,8-Tetrachlorodibenzo-p-dioxin-Contaminated 
Incinerator Emmissions to Humans Via Foods.'' Journal of Toxicological 
and Environmental Health v. 29, (1990), pp. 143.
    31. NIEHS. 1994. Seventh Annual Report on Carcinogens. U.S. 
Department of Health and Human Services, Public

[[Page 24894]]

Health Service, National Institute of Environmental Health Sciences, 
Research Triangle Park, NC.
    32. USEPA. Interim Procedures for Estimating Risks Associated with 
Exposures to Mixtures of Chlorinated Dibenzo-p-dioxins and 
Dibenzofurans (CDDs and CDFs) and 1989 Update. Risk Assessment Forum, 
U.S. Environmental Protection Agency, Washington, DC, (1989): EPA/625/
3-89/016.
    33. Woo, Y.-t., Lai, D.Y., Arcos, J.C. and Argus, M.F.; 
``Halogenated Phenoxy Acids, Aromatic Ethers, Dibenzofurans, and 
Dibenzo-p-dioxins.'' In: Chemical Induction of Cancer, Academic Press, 
New York, Vol. IIIB, (1985), pp. 237-274.
    34. IARC 1987. IARC Monographs on the Evaluation of Carcinogenic 
Risks to Humans. Suppl. 7. ``Polychlorinated Biphenyls,'' International 
Agency for Research on Cancer, Lyon, France, (1987), pp. 322-326.
    35. Lai, D.Y.; ``Halogenated Benzenes, Naphthalenes, Biphenyls and 
Terphenyls in the Environment: Their Carcinogenic, Mutagenic and 
Teratogenic Potential and Toxic Effects.'' J. Environ. Sci. Health v. 
C2(2), (1984), pp. 135-184.
    36. IRIS. 1996. U.S. Environmental Protection Agency's Integrated 
Risk Information System file pertaining to polychlorinated biphenyls.
    37. NTP, 1980. ``Bioassay of a mixture of 1,2,3,6,7,8-
Hexachlorodibenzo-p-dioxin and 1,2,3,7,8,9-Hexachlorodibenzo-p-dioxin 
(Gavage) for Possible Carcinogenicity,'' National Toxicology Program, 
Research Triangle Park, North Carolina. NTP80-12, NIH Publ. No. 80-
1754, 1980.
    38. Poland, A. and Knutson, J.C.; ``2,3,7,8-Tetrachlorodibenzo-p-
dioxin and Related Halogenated Aromatic Hydrocarbons: Examination of 
the Mechanism of Toxicity.'' Ann. Rev. Pharmacol. Toxicol. v. 22, 
(1982), p. 517.
    39. Safe, S.; ``Polychlorinated Biphenyls, Dibenzo-p-dioxin and 
Dibenzofurans and Related Compounds: Environmental and Mechanistic 
Considerations Which Support the Development of Toxic Equivalency 
Factors.'' CRC Crit. Rev. Toxicol. v. 21, (1990), pp. 51-88.
    40. Ahlborg, U.G. et al., ``Toxic Equivalency Factors for Dioxin-
Like PCBs: Report on a WHO-ECEH and IPCS Consultation December 1993.'' 
Chemosphere v. 28, (1994), pp. 1049-1067.

IX. 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 subject to 
review by the Office of Management and Budget (OMB). Pursuant to the 
terms of this Executive Order, this action was submitted to OMB for 
review, and any comments or changes made in response to OMB suggestions 
or recommendations have been documented in the public record.

B. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act 5 
U.S.C. 601 et seq., the Agency hereby certifies that this proposed 
action does not have a significant adverse economic impact on a 
substantial number of small entities. Based on what EPA currently knows 
about the sources of the chemicals in the proposed category, EPA 
believes that, under the current EPCRA section 313 reporting 
thresholds, it appears unlikely that any reports would be filed for the 
proposed category. Nevertheless, it is possible that 1 or more of the 
13 facilities that currently report under the existing PCBs listing 
might process enough of the specific PCB members of the proposed 
category to exceed current reporting thresholds. Since, as discussed 
elsewhere in this proposed rule, the chemicals in the proposed category 
clearly meet the listing criteria of EPCRA section 313(d)(2), EPA is 
proposing to add them even though current projected reports are few. 
EPA estimates that the cost of reporting for any facility that exceeds 
reporting thresholds would be $3,023 and the cost to EPA of processing 
and reporting any filed report would be $77. EPA believes that under 
current reporting thresholds the proposed rule would not have a 
significant impact on facilities, including small entities.

C. Paperwork Reduction Act

    This proposed rule does not contain any new information collection 
requirements that require additional approval by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq. Currently, facilities subject to the reporting 
requirements under EPCRA 313 and PPA 6607 may either use the EPA Toxic 
Chemical Release Inventory Form R (EPA Form #9350-1), or the EPA Toxic 
Chemical Release Inventory Form A (EPA Form #9350-2). The Form R must 
be completed if a facility manufactures, processes, or otherwise uses 
any listed chemical above threshold quantities and meets certain other 
criteria. For the Form A, EPA established an alternate threshold for 
those facilities with low annual reportable amounts of a listed toxic 
chemical. A facility that meets the appropriate reporting thresholds, 
but estimates that the total annual reportable amount of the chemical 
does not exceed 500 pounds per year, can take advantage of an alternate 
manufacture, process, or otherwise use threshold of 1 million pounds 
per year for that chemical, provided that certain conditions are met, 
and submit the Form A instead of the Form R. In addition, respondents 
may designate the specific chemical identity of a substance as a trade 
secret pursuant to EPCRA section 322 (42 U.S.C. 11042; 40 CFR part 
350).
    OMB has approved the reporting and recordkeeping requirements 
related to Form R, supplier notification, and petitions under OMB 
Control #2070-0093 (EPA ICR #1363); those related to Form A under OMB 
Control #2070-0143 (EPA ICR #1704); and those related to trade secret 
designations under OMB Control #2050-0078 (EPA ICR #1428). As provided 
in 5 CFR 1320.5(b) and 1320.6(a), an Agency may not conduct or sponsor, 
and a person is not required to respond to a collection of information 
unless it displays a currently valid OMB control number. The OMB 
control numbers for EPA's regulations are listed in 40 CFR part 9, 48 
CFR Chapter 15, and displayed on the information collection instruments 
(e.g., forms, instructions, etc.).
    For Form R, EPA estimates the industry reporting and recordkeeping 
burden for collecting this information to average 74 hours per report 
in the first year, at an estimated cost of $4,587 per Form R. In 
subsequent years, the burden is estimated to average 52.1 hours per 
report, at an estimated cost of $3,023 per Form R. For Form A, EPA 
estimates the burden to average 49.4 hours per report in the first 
year, at an estimated cost of $3,101 per Form A. In subsequent years, 
the burden is estimated to average 34.6 hours per report, at an 
estimated cost of $2,160 per Form A. These estimates include the time 
needed to become familiar with the requirement (first year only); 
review instructions; search existing data sources; gather and maintain 
the data needed; complete and review the collection of information; and 
transmit or otherwise disclose the information. The actual burden to 
any specific facility may be different from this estimate depending on 
the complexity of the facility's operations and the profile of the 
releases at the facility. Upon promulgation of a final

[[Page 24895]]

rule, the Agency may determine that the existing burden estimates in 
both ICRs need to be amended in order to account for an increase in 
burden associated with the final action. If so, the Agency will submit 
an information collection worksheet (ICW) to OMB, requesting that the 
total burden in each ICR be amended, as appropriate.
    The Agency would appreciate any comments or information that could 
be used to: (i) Evaluate whether the proposed collection of information 
is necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility; (ii) 
evaluate the accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (iii) enhance the quality, utility, 
and clarity of the information to be collected; and (iv) minimize the 
burden of the collection of information on those who are to respond, 
including through the use of appropriate automated electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology, e.g., permitting electronic submission of 
responses. Please submit your comments within 60 days as specified at 
the beginning of this proposal. Copies of the existing ICRs may be 
obtained from Sandy Farmer, OPPE Regulatory Information Division, 
Environmental Protection Agency (2137), 401 M St., SW., Washington, DC 
20460, by calling (202) 260-2740, or electronically by sending an e-
mail message to ``farmer.sandy@epamail.epa.gov.''

D. Unfunded Mandates Reform Act and Executive Order 12875

    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4), or require prior 
consultation as specified by section 204 of the UMRA and Executive 
Order 12875 (58 FR 58093, October 28, 1993).

E. Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations,'' the Agency has determined 
that there are no environmental justice related issues with regard to 
this action since this action would add a reporting requirement for all 
covered facilities including those that may be located near minority or 
low-income populations.

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, Toxic chemicals.

    Dated: April 28, 1997.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
    Therefore, it is proposed that 40 CFR part 372 be amended as 
follows:
    1. The authority citation for part 372 would continue to read as 
follows:

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

    2. Section 372.65 is amended by revising the entry for 
polychlorinated biphenyls under paragraph (a), revising the CAS number 
entry for 1336-36-3 under paragraph (b), and by adding alphabetically 
one category to paragraph (c) to read as follows:


Sec. 372.65   Chemicals and chemical categories to which the part 
applies.

    *    *    *    *    *
    (a)  *  *  *

                                                                        
------------------------------------------------------------------------
            Chemical                    CAS No.         Effective date  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Polychlorinated biphenyls (PCBs)  1336-36-3           1/1/87            
 (excluding those PCBs listed                                           
 under the dioxin and dioxin-                                           
 like compounds category).                                              
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

    *    *    *    *    *
    (b)  *  *  *

                                                                        
------------------------------------------------------------------------
             CAS No.                 Chemical name      Effective date  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
1336-36-3                         Polychlorinated     1/1/87            
                                   biphenyls (PCBs)                     
                                   (excluding those                     
                                   PCBs listed under                    
                                   the dioxin and                       
                                   dioxin-like                          
                                   compounds                            
                                   category).                           
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

    *    *    *    *    *
    (c)  *  *  *

                                                                        
------------------------------------------------------------------------
               Category name                       Effective date       
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Dioxin and Dioxin-Like Compounds: (This     1/98                        
 category includes only those chemicals                                 
 listed below)                                                          
                                                                        
  39635-31-9     2,3,3,4,4,5,5-                                         
   Heptachlorobiphenyl                                                  
  67562-39-4     1,2,3,4,6,7,8-                                         
   Heptachlorodibenzofuran                                              
  55673-89-7     1,2,3,4,7,8,9-                                         
   Heptachlorodibenzofuran                                              
  38380-08-4     2,3,3,4,4,5-                                           
   Hexachlorobiphenyl                                                   
  69782-90-7     2,3,3,4,4,5-                                           
   Hexachlorobiphenyl                                                   
  52663-72-6     2,3,4,4,5,5-                                           
   Hexachlorobiphenyl                                                   
  32774-16-6     3,3,4,4,5,5-                                           
   Hexachlorobiphenyl                                                   
  70648-26-9     1,2,3,4,7,8-                                           
   Hexachlorodibenzofuran                                               
  57117-44-9     1,2,3,6,7,8-                                           
   Hexachlorodibenzofuran                                               
  72918-21-9     1,2,3,7,8,9-                                           
   Hexachlorodibenzofuran                                               
  60851-34-5     2,3,4,6,7,8-                                           
   Hexachlorodibenzofuran                                               
  39227-28-6     1,2,3,4,7,8-                                           
   Hexachlorodibenzo-p-dioxin                                           
  57653-85-7     1,2,3,6,7,8-                                           
   Hexachlorodibenzo-p-dioxin                                           
  19408-74-3     1,2,3,7,8,9-                                           
   Hexachlorodibenzo-p-dioxin                                           
  35822-46-9     1,2,3,4,6,7,8-                                         
   Heptachlorodibenzo-p-dioxin                                          
  39001-02-0     1,2,3,4,6,7,8,9-                                       
   Octachlorodibenzofuran                                               
  03268-87-9     1,2,3,4,6,7,8,9-                                       
   Octachlorodibenzo-p-dioxin                                           
  32598-14-4     2,3,3,4,4-                                             
   Pentachlorobiphenyl                                                  
  74472-37-0     2,3,4,4,5-                                             
   Pentachlorobiphenyl                                                  
  31508-00-6     2,3,4,4,5-                                             
   Pentachlorobiphenyl                                                  
  65510-44-3     2,3,4,4,5-                                             
   Pentachlorobiphenyl                                                  
  57465-28-8     3,3,4,4,5-                                             
   Pentachlorobiphenyl                                                  
  57117-41-6     1,2,3,7,8-                                             
   Pentachlorodibenzofuran                                              
  57117-31-4     2,3,4,7,8-                                             
   Pentachlorodibenzofuran                                              
  40321-76-4     1,2,3,7,8-                                             
   Pentachlorodibenzo-p-dioxin                                          
  32598-13-3     3,3,4,4-                                               
   Tetrachlorobiphenyl                                                  
  51207-31-9     2,3,7,8-                                               
   Tetrachlorodibenzofuran                                              
  01746-01-6     2,3,7,8-                                               
   Tetrachlorodibenzo-p-dioxin                                          

[[Page 24896]]

                                                                        
                                                                        
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[FR Doc. 97-11899 Filed 5-6-97; 8:45 am]
BILLING CODE 6560-50-F

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