[Federal Register Volume 62, Number 88 (Wednesday, May 7, 1997)]
[Proposed Rules]
[Pages 24887-24896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11899]
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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:
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Examples of regulated
Category entities
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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.
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Federal Government Federal Agencies that are
engaged in the combustion of
wastes.
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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
