[Federal Register: November 12, 2003 (Volume 68, Number 218)]
[Proposed Rules]
[Page 64041-64050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no03-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 355
[FRL-7585-4]
RIN 2050-AE42
Emergency Planning and Community Right-to-Know Act; Extremely
Hazardous Substances List; Proposed Deletion of Phosmet
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
delete phosmet from the list of extremely hazardous substances (EHS)
under the Emergency Planning and Community Right to Know Act (EPCRA).
EPA is proposing this change in response to a petition submitted by the
registrant of the pesticide in which they argue that phosmet should be
removed from the EHS list because there are no valid data that indicate
the chemical meets the listing criteria. Facilities with phosmet on-
site would no longer be required to comply with State Emergency
Response Commission (SERC) and Local Emergency Planning Committee
(LEPC) requirements for the chemical phosmet. In addition, facilities
with phosmet would no longer have to file an emergency and hazardous
chemical inventory form and Material Safety Data Sheet (MSDS) under
EPCRA for phosmet with their SERC, LEPC and local fire department for
amounts less than 10,000 pounds.
DATES: Comments: Comments must be submitted on or before January 12,
2004.
ADDRESSES: Comments may be submitted electronically, or through hand
delivery/courier or by mail. Send an original and two copies of your
comments to: SUPERFUND Docket Information Center, Environmental
Protection Agency, Mailcode: 5305T, 1200 Pennsylvania Ave., NW.,
Washington, DC, 20460, Attention Docket ID No. SFUND-2003-0007. Follow
the detailed instructions as provided in the SUPPLEMENTARY INFORMATION
section.
FOR FURTHER INFORMATION CONTACT: For general information, contact the
[[Page 64042]]
Emergency Planning and Community Right-to-Know Hotline at 800-424-9346
or TDD 800-553-7672 (hearing impaired). In the Washington, DC,
metropolitan area, call 703-412-9810 or TDD 703-412-3323. For more
detailed information on specific aspects of this rulemaking, contact Kathy Franklin, phone 202-564-7987; email: franklin.kathy@epa.gov
SUPPLEMENTARY INFORMATION:
I. Does This Notice Apply to Me?
A. Affected Entities: Entities that would be affected by this
section are those organizations and facilities subject to 40 CFR part
355--Emergency Planning and Emergency Release Notification Requirements
and 40 CFR part 370--Hazardous Chemical Reporting. To determine whether
your facility is affected by this action, you should carefully examine
the applicability provisions at 40 CFR part 355 and 40 CFR part 370.
Entities potentially affected by this action are facilities that
distribute phosmet as a pesticide for commercial use and farms that
store, handle and apply phosmet to variety of fruit, nut, and field
crops. If you have any questions regarding the applicability of this
action to a particular entity, consult the person(s) listed in the FOR
FURTHER INFORMATION CONTACT section.
II. How Can I Get Copies of This Document and Other Related
Information?
Docket. EPA has established an official docket for this action
under Docket ID No. SFUND-2003-0007. The official docket consists of
the documents specifically referenced in this action, any public
comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The public docket is the
collection of materials that is available for public viewing at
SUPERFUND Docket in the EPA Docket Center, (EPA/DC) EPA West, Room
B102, 1301 Constitution Avenue, NW., Washington, DC. This Docket
Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the SUPERFUND
Docket is (202) 566-0270. You may copy up to 100 pages from any
regulatory document at no cost. Additional copies are $0.15 per page.
Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the public
docket, and access those documents in the public docket that are
available electronically. Once in the system, select ``search,'' then
key in the appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the docket
facility. EPA intends to work toward providing electronic access to all
of the publicly available docket materials through EPA's electronic
public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
For additional information about EPA's electronic public docket
visit EPA Dockets online or see 67 FR 38102, May 31, 2002.
III. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification number in the subject line on the
first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments.
Electronically. If you submit an electronic comment as prescribed
below, EPA recommends that you include your name, mailing address, and
an e-mail address or other contact information in the body of your
comment. Also include this contact information on the outside of any
disk or CD ROM you submit, and in any cover letter accompanying the
disk or CD ROM. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. EPA's policy is that EPA
will not edit your comment, and any identifying or contact information
provided in the body of a comment will be included as part of the
comment that is placed in the official public docket, and made
available in EPA's electronic public docket. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
Your use of EPA's electronic public docket to submit comments to
EPA electronically is EPA's preferred method for receiving comments. Go
directly to EPA Dockets at http://www.epa.gov/edocket, and follow the
online instructions for submitting comments. To access EPA's electronic
public docket from the EPA Internet Home Page, select ``Information
Sources,'' ``Dockets,'' and ``EPA Dockets.'' Once in the system, select
``search,'' and then key in Docket ID No. SFUND-2003-0007. The system
is an ``anonymous access'' system, which means EPA will not know your
identity, e-mail address, or other contact information unless you
provide it in the body of your comment.
[[Page 64043]]
Comments may be sent by electronic mail (e-mail) to superfund.docket@epa.gov, Attention Docket ID No. SFUND-2003-0007. In
contrast to EPA's electronic public docket, EPA's e-mail system is not
an ``anonymous access'' system. If you send an e-mail comment directly
to the Docket without going through EPA's electronic public docket,
EPA's e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
You may submit comments on a disk or CD ROM that you mail to the
mailing address identified in the following paragraph. These electronic
submissions will be accepted in WordPerfect or ASCII file format. Avoid
the use of special characters and any form of encryption.
By Mail. Send an original and two copies of your comments to:
SUPERFUND Docket Information Center, U.S. Environmental Protection
Agency, Mailcode: 5305T, 1200 Pennsylvania Ave., NW., Washington, DC,
20460, Attention Docket ID No. SFUND-2003-0007.
By Hand Delivery or Courier. Deliver your comments to: SUPERFUND
Docket Information Center (EPA/DC) EPA West, Room B102, 1301
Constitution Avenue, NW., Washington, DC. Attention Docket ID No.
SFUND-2003-0007. Such deliveries are only accepted during the Docket's
normal hours of operation as identified in the ``How Can I Get Copies
of This Document and Other Related Information?'' section.
IV. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be confidential
business information (CBI) electronically through EPA's electronic
public docket or by e-mail. Send or deliver information identified as
CBI only to the following address: SUPERFUND CBI Document Control
Officer (5305T), U.S. EPA, 1200 Pennsylvania Avenue, NW., Washington,
D.C. 20460, Attention Docket ID No. SFUND-2003-0007. You may claim
information that you submit to EPA as CBI by marking any part or all of
that information as CBI (if you submit CBI on disk or CD ROM, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is CBI).
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR, Part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the FOR FURTHER INFORMATION CONTACT section.
V. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
identification number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.
I. Introduction and Background
A. Statutory Authority
B. Background
1. Regulatory Background
2. Gowan's Petition to Delist Phosmet
II. The EHS Listing Criteria
A. Primary Listing Criteria
B. Secondary Listing Criteria
C. Toxicity Data Sources
III. Proposed Modification of EHS List
A. Basis of Phosmet Listing
B. Gowan's Phosmet Petition
C. Review of Phosmet Acute Toxicity Data
1. Phosmet Acute Inhalation Toxicity
2. Phosmet Acute Dermal Toxicity
3. Phosmet Acute Oral Toxicity
4. Phosmet Oral Mouse Study (Haley et al., 1975)
5. Phosmet Oral Mouse Study (Gowan 2002)
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act of 1995
I. Introduction and Background
A. Statutory Authority
This proposed rule is issued under sections 302 and 328 of the
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).
B. Background
On October 17, 1986, the President signed into law the Superfund
Amendments and Reauthorization Act of 1986 (SARA), Pub. L. 99-499
(1986). Title III of SARA established a program designed to require
state and local planning and preparedness for spills or releases of
hazardous substances and to provide the public and local governments
with information concerning potential chemical hazards in their
communities. This program is codified as the Emergency Planning and
Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11001-11050.
Subtitle A of EPCRA establishes the framework for local emergency
planning. The statute requires that EPA publish a list of ``extremely
hazardous substances'' (EHSs). The EHS list was established by EPA to
identify chemical substances which could cause serious irreversible
health effects from accidental releases (51 FR 13378). EPA had
previously published this list as the list of acutely toxic chemicals
in November 1985, in Appendix A of the Chemical Emergency Preparedness
Program Interim Guidance (CEPP Guidance). The Agency was also directed
to establish ``threshold planning quantities'' (TPQs) for each
extremely hazardous substance.
Under EPCRA section 302, a facility which has on-site an EHS in
excess of its TPQ must notify the State Emergency Response Commission
(SERC) and Local Emergency Planning Committee (LEPC) as well as
participate in local emergency planning activities. The facility must
also report accidental releases in excess of the Reportable Quantity
(RQ) to the LEPC and SERC. Under EPCRA section 311 and 312, some
facilities with phosmet on-site in excess of its TPQ are required to
submit an emergency and
[[Page 64044]]
hazardous chemical inventory form and Material Safety Data Sheet (MSDS)
required for phosmet with their SERC, LEPC and local fire department.
However, facilities that apply phosmet to crops as a pesticide, do not
have to file the inventory form or MSDS because chemicals that are used
at facilities in routine agricultural operations are not included as
hazardous chemicals subject to the reporting requirements.
The purpose of the extremely hazardous substance list is to focus
initial efforts in the development of State and local contingency
plans. Inclusion of a chemical on the EHS list does not mean state or
local communities should ban or otherwise restrict use of a listed
chemical. Rather, such identification indicates a need for the
community to undertake a program to investigate and evaluate the
potential for accidental exposure associated with the production,
storage or handling of the chemical at a particular site.
1. Regulatory Background
The list of extremely hazardous substances and their threshold
planning quantities are codified in 40 CFR part 355, Appendices A & B.
EPA first published the EHS list and TPQs along with the methodology
for determining threshold planning quantities as an interim final rule
on November 17, 1986 (51 FR 41573-41579 and 41580 ). In the final rule,
EPA made a number of revisions to the interim final rule (52 FR 13387,
April 22, 1987). Among other things, the final rule republished the EHS
list, with the addition of four new chemicals and revised the
methodology for determining some TPQs. Details of the methodology used
to determine whether to list a substance as an extremely hazardous
substance and for deriving the threshold planning quantities are found
in the November 1986 and April 1987 Federal Register notices and in
technical support documents in the rulemaking records. These records
are found in Superfund Docket No. 300PQ.
EPA has since received a number of petitions to amend the EHS list.
To date, 46 chemicals have been delisted from the EHS list in previous
rulemakings because they did not meet the toxicity criteria for the
list and were originally listed under section 302 in error.
2. Gowan's Petition to Delist Phosmet
EPA received a petition dated August 8, 1996 from Gowan Company to
delete the chemical phosmet from the EHS list under Section 302 of
EPCRA. Gowan believes that listing of phosmet was based on an
inappropriate toxicity study and argues that phosmet should be removed
from the EHS list because there are no valid data that indicate the
chemical meets the listing criteria.
Phosmet (O,O-dimethyl-S-phthalimidomethylphosphorodithioate, CAS
No. 732-11-6) is a pink to white crystalline solid with chemical
formula C11H12NO4PS2. It is
slightly soluble in water and has a relatively low vapor pressure. It
is a non-systemic organophosphate insecticide used for agricultural
crop protection in fruit, nut and certain field crops. It is also used
on trees and ornamental plants. According to EPA's Office of Pesticide
Programs (OPP), approximately 1,250,000 pounds active ingredient (a.i.)
of phosmet are used annually. Technical grade phosmet contains
approximately 94% phosmet. Products containing phosmet can be in the
form of dusts, emulsifiable concentrates, soluble concentrates, and
wettable powders and can contain varying amounts of the active
ingredient phosmet. More information on phosmet can be found in the
February 2003 Technical Background Document: Proposed Rule to Delist
Phosmet from the EHS List, available in the docket.
II. The EHS Listing Criteria
As previously described, in November 1985, EPA published a list of
substances in Appendix A of the ``Chemical Emergency Preparedness
Program Interim Guidance.'' Under section 302(a) of EPCRA, Congress
required EPA to adopt that same list as the EHS list. Appendix A
defines the list of chemicals as those ``for which an acute toxicity
measure has a value meeting the criteria stated in Chapter 6'' of the
November 1985 Interim Guidance. The listing criteria discussed in
Chapter 6 are the same criteria referenced and discussed in EPA's
interim final and final rules establishing the EHS list. Those criteria
contain two sets of numerical acute toxicity measures. For purposes of
clarification in today's rulemaking, EPA will refer to the two sets of
numerical acute toxicity criteria as the primary listing criteria and
the secondary listing criteria. In developing these criteria, the
Agency presumed that humans may be as sensitive as the most sensitive
mammalian species tested.
A. Primary Listing Criteria
The primary acute toxicity criteria are, based on data from
mammalian testing:
Inhalation LC50 <= 0.5 milligrams per liter of air (mg/L)
(for exposure time <= 8 hours), or
Dermal LD50 <= 50 milligrams per kilogram of body weight
(mg/kg), or
Oral LD50 <= 25 milligrams per kilogram of body weight (mg/
kg)
LC50 is the median lethal concentration, defined as the
concentration level at which 50 percent of the test animals died when
exposed by inhalation for a specified time period.
LD50 is the median lethal dose, defined as the dose at
which 50 percent of the test animals died during exposure.
B. Secondary Listing Criteria
EPA included on the EHS list other chemicals that did not meet the
primary acute toxicity criteria. These were added based on the
secondary acute toxicity criteria below as well as the following
factors: Large volume production and known risk, as indicated by the
fact that some of the chemicals have caused death and injury in
accidents.
The secondary acute toxicity criteria are, based on data from
mammalian testing:
Inhalation LC50 <= 2 mg/L for exposure time of <= 8 hours,
or
Dermal LD50 <= 400 mg/kg or
Oral LD50 <= 200 mg/kg
The chemical with the lowest production volume that was included as
an EHS based on the secondary criteria and high production volume, had
an annual production volume of 30 million pounds. In addition to high
production chemicals meeting these criteria, several other chemicals
slightly less toxic than the secondary criteria, were listed because of
their recognized toxicity as a chemical of concern or known hazard; for
example several of them have caused death or injury in accidents.
The selection criteria were designed as screening tools to identify
highly acute toxic chemicals. The specific values chosen are recognized
by the scientific community as indicating a high potential for acute
toxicity, and chemicals meeting the toxicity criteria are considered
potentially hazardous. Even with the amount of animal data that are
available, some chemicals have no standard acute toxicity test data.
In choosing chemicals for the EHS list, EPA matched the criteria
against all mammalian test data for all chemicals. A chemical was
identified as acutely toxic according to these criteria if mammalian
acute toxicity data for any one of the three routes of administration
was equal to or less than the numerical criteria specified for that
route. The Agency used LCLO or LDLO data for a
chemical in cases where median lethal concentration or dose
(LC50 or LD50 ) were not available. The lethal
concentration low (LCLO) and the lethal dose low
(LDLO) are the lowest concentration in air or the lowest
dose
[[Page 64045]]
in milligrams of chemical per kilogram of body weight, respectively, at
which any test animals died. These values may be more variable than
those provided from median lethality tests, but for the purposes of
screening large numbers of chemicals, it was deemed necessary to
provide a second level screening tool in preference to missing
potentially toxic chemicals because they were not adequately tested.
For inhalation data, the Agency chose to use LC50 and
LCLO values with exposure periods up to eight hours or even
with no reported exposure period. EPA recognized that this was a
conservative approach, but did not want to miss any acutely toxic
chemical of concern.
The Agency also used lethality data from the most sensitive
mammalian species and not only those from rats because it was not
possible to predict which species is the appropriate surrogate for
humans for a given chemical. In addition, because populations are
heterogeneous and individuals are expected to vary considerably in
their sensitivity to chemical substances, the Agency assumed that
humans may be as sensitive as the most sensitive mammalian species
tested.
C. Toxicity Data Sources
When the initial list was developed, the Agency used acute toxicity
data from the Registry of Toxic Effects of Chemical Substances (RTECS),
maintained by the National Institute of Occupational Safety and Health
(NIOSH). The RTECS data was compared with the EHS listing toxicity
criteria (both primary and secondary). The RTECS data base was used as
the principal source of toxicity data for identifying acutely toxic
chemicals because it represents the most comprehensive repository of
acute toxicity information available with basic toxicity information
and other data on more than 79,000 chemicals. Although RTECS is not
formally peer-reviewed, data from RTECS is widely accepted and used as
a toxicity data source by industry and regulatory agencies alike. The
data presented are from scientific literature which has been edited by
the scientific community before publication.
III. Proposed Modification of EHS List
A. Basis of Phosmet Listing
Phosmet was originally listed on the EHS list because a four-hour
rat inhalation LC50 of 0.054 mg/L, reported in the 1985
RTECS database, met the EHS primary toxicity inhalation criteria of
LC50 <= 0.5 mg/L. The value in RTECS was cited from a 1982
Russian publication, which was a compilation of toxicity data for many
chemicals.
The TPQ for phosmet depends on its physical state. As a solid,
phosmet has a TPQ of 10 pounds if it: (1) Is a powder with particle
size less than 100 microns, (2) is in molten form, (3) is in solution,
or (4) has a National Fire Protection Association (NFPA) reactivity
rating of 2, 3, or 4. Otherwise, the TPQ for phosmet is 10,000 pounds.
B. Gowan's Phosmet Petition
Gowan Company of Yuma, Arizona submitted to EPA a petition dated
August 8, 1996 requesting that EPA remove phosmet from the EHS list
because it does not meet the toxicity criteria. During EPA's review of
the petition, Gowan submitted additional toxicity data and other
information. EPA also reviewed acute toxicity data for phosmet
previously submitted to EPA's Office of Pesticide Programs (OPP) for
the registration of phosmet as a pesticide. Gowan argued that the
inhalation LC50 (rat) value of 0.054 mg/liter/4 hours, as
cited in RTECS, is unverifiable because the experimental details, study
protocol, and quality control procedures are unavailable. Without these
experimental details, Gowan maintained that it is impossible to
reconstruct and validate the original experiment. In addition, Gowan
asserted that this LC50 value is inconsistent with all other
available inhalation toxicity data for technical grade (95% purity or
higher) phosmet. Gowan also asserted that the phosmet technical grade
does not meet the toxicity criteria for listing as an EHS following
exposure by the oral or dermal routes, as indicated by a number of
experimental studies. Gowan submitted with their petition data from a
number of acute inhalation toxicity tests which they believe show that
phosmet technical poses a low risk of acute toxicity by inhalation, as
indicated by the absence of mortality when test animals were exposed to
phosmet vapor or dust. Gowan also claimed that the toxicity studies on
phosmet formulations, including wettable powders and liquid
formulations, indicate that these phosmet products do not meet the
criteria for the EHS list.
Because phosmet is not a high production chemical (less than 2
million pounds annually), EPA focused its efforts on evaluating whether
the existing toxicity data meets the primary listing criteria. In
addition to the phosmet toxicity data submitted by Gowan and available
data from OPP, EPA found data from acute mouse oral toxicity studies
identified from a search of toxicity databases and literature. In July
2001, Gowan supplied EPA with data from five acute oral mouse studies
and EPA obtained a journal article on an acute mouse oral toxicity
study conducted by the National Center for Toxicological Research
(NCTR) of the Food and Drug Administration (FDA). More details of the
phosmet toxicity studies and their evaluation can be found in the
February 2003 Technical Background Document: Proposed Rule to Delist
Phosmet from the EHS List available in the public docket.
C. Review of Phosmet Acute Toxicity Data
1. Phosmet Acute Inhalation Toxicity
The four-hour rat inhalation LC50 of 0.054 mg/L,
reported in 1985 RTECS was cited from a Russian publication (Izmerov et
al. 1982. Toxicometric Parameters of Industrial Toxic Chemical Under
Single Exposure) which contained compiled toxicity values for many
chemicals, but no study details. In both the Russian and English
translation version of this document, the chemical structure given for
phosmet is incorrect, which led Gowan to assert that there was some
uncertainty as to whether the chemical being tested was indeed phosmet.
EPA was not able to obtain the actual phosmet toxicity study conducted
by a Russian researcher L.P. Danilenko, but was able to obtain a
translation of a Russian 1969 journal article by Danilenko that
discussed the rat inhalation study and the results. Based on the
chemical name and chemical synonyms (O,O-dimethyl-phthalimidio-methyl-
dithiophosphate or phthalophos) used in (Danilenko 1969), EPA believes
the chemical being tested was indeed phosmet. No chemical structure was
given in the article.
In Danilenko (1969), the following acute toxicity results were
reported for phthalophos, also known as Imidan or phosmet: a four-hour
rat inhalation LC50 of 54 mg/m\3\ (0.054 mg/L); a four-hour
rat inhalation LCLO of 31 mg/m\3\ (0.031 mg/L); and a four-
hour cat inhalation LCLO of 65 mg/m\3\ (0.065 mg/L). The
tests were performed using an aqueous emulsion of phthalophos (phosmet)
on albino rats and cats. The animals were exposed to a liquid aerosol
produced by atomization of the preparation with a special sprayer
(Boitenko). The concentration of phthalophos (phosmet) in the chamber
air was determined by a thin-layer chromatographic method.
However, the Danilenko (1969) article severely lacks key details of
the experimental methods, such as the purity of phosmet, extent of
animal
[[Page 64046]]
body exposure, possibility of other routes of exposure, specific
emulsion components and their toxicity. The phosmet used in the
experiment was manufactured in the Union of Soviet Socialist Republics
(USSR) by a research institute using an unknown method. With the number
of unanswered key questions regarding the experimental protocol, EPA
has determined that the results in this paper are insufficient to
provide the basis for the continued listing of phosmet on the EHS list.
EPA evaluated more than 20 other inhalation studies of technical
grade phosmet (=94% phosmet) and other phosmet formulations,
such as wettable powders and emulsions. The testing exposure routes
included vapor, particulates and aerosols. Only three of these
inhalation studies produced any mortality. The LC50 data
from these three studies were not in the range of the LC50
value in the Russian study and did not meet the primary toxicity
listing criteria of <=0.5 mg/L. Of these three studies, results of one
study with mortality were not considered appropriate to use because the
phosmet formulation contained methylene chloride, a toxic component.
Another study conducted in 1994, exposed rats to aerosols from an
emulsion containing 27.5% phosmet and 8.4% naphthalenes. The aerosols
were respirable-sized having a mass median aerodynamic diameter (MMAD)
of 1.5-2.2 microns ([mu]m). This study resulted in a LC50 of
1.19 mg/L for male rats and 0.845 mg/L for females. A third study
conducted in 1995 reported a LC50 of 1.6 mg/L for rats and
exposed the animals to a 70% phosmet particulates having a MMAD of 1.61
to 2.38 microns ([mu]m).
Given the uncertainties with the inhalation toxicity data from
(Danilenko, 1969) and based on the Agency's review of all the acute
inhalation toxicity data for phosmet, EPA believes that there are no
inhalation data meeting the primary listing criteria for phosmet of
sufficient reliability or quality to support the listing of phosmet as
an EHS chemical. As a result, EPA has decided to remove this inhalation
value from consideration for the purpose of listing phosmet as an EHS.
EPA solicits comments on the validity of the available inhalation
toxicity studies to support listing of phosmet as an EHS based on the
listing criteria for inhalation toxicity. EPA invites submission of any
valid acute inhalation toxicity studies not already made available to
EPA. EPA's review of all currently available acute inhalation toxicity
studies can be found in the February 2003 Technical Background
Document: Proposed Rule to Delist Phosmet from the EHS List available
in the public docket.
2. Phosmet Acute Dermal Toxicity
EPA undertook review of existing acute dermal toxicity data for
phosmet. EPA could find no dermal toxicity data that met the primary
dermal listing criteria of LD50 <= 50 mg/kg. The lowest test
results for technical phosmet indicated that the dermal LD50
is greater than 3160 mg/kg.
3. Phosmet Acute Oral Toxicity
Gowan submitted several acute rat oral studies in 1996, for
technical grade phosmet and phosmet powder and emulsion formulations.
None of the rat LD50 values from these studies met the EHS
listing criteria, even when the percentage of inert ingredients in the
formulation was taken into account. The lowest reported rat oral
LD50 for technical grade phosmet (96.1%) is 113 mg/kg, which
does not exceed the primary oral listing criteria of 25 mg/kg. The
lowest reported rat oral LD50 for a phosmet formulation of
70% dust is 147 mg/kg (73.5 mg/kg based on active ingredient). Even
when adjusted for the percentage active ingredient, this dose still
does not exceed the criteria of 25 mg/kg.
Subsequently, EPA retrieved LD50 values from six mouse
oral studies on technical grade phosmet from toxicity databases and the
literature. Gowan was able to supply five of the mouse studies, which
had been conducted by Stauffer Chemical Company. EPA also reviewed oral
acute toxicity data available from OPP. Review of the six acute mouse
oral studies indicates that mice are more sensitive than rats to
phosmet. One mouse study conducted by Stauffer Chemical Company in 1971
reported a phosmet technical LD50 of 23.3 mg/kg for mice for
technical grade phosmet, percentage unspecified . Another study
conducted by researchers at NCTR (Haley et al., 1975) reported
LD50 results of 23.1 and 24.9 mg/kg for males and female
mice, respectively for 99.5% phosmet. Other acute oral studies of
technical grade phosmet with mice had LD50 results varying
from 36.9 to 51 mg/kg. For a phosmet powder formulation, the lowest
reported oral LD50 was 79.4 mg/kg in mice for 50% phosmet
wettable powder. These studies are discussed in more detail in the
February 2003 Technical Background Document: Proposed Rule to Delist
Phosmet from the EHS List, available in the public docket.
The oral mouse LD50 of 23.3 mg/kg for phosmet technical
resulted from testing a material called Imidan-EDC. Phosmet is also
known by the name ``Imidan.'' Gowan stated that EDC (ethylene
dichloride or dichloroethane), was a solvent used in the initial
synthesis step of a discontinued process and that the impurity profile
is not known. Gowan was not sure whether this product was ever
registered for commercial use by Stauffer, who was the previous
pesticide registrant with EPA. Gowan never utilized the EDC process and
currently uses a benzene process to manufacture technical phosmet, the
product currently registered with EPA. According to Gowan, Stauffer
also licensed the phosmet-benzene process as a registrant with EPA. The
Stauffer researchers determined the mouse oral LD50 for
Imidan-Benzene to be 43 mg/kg. The greater toxicity observed for
technical phosmet synthesized via the EDC route presumably may have
been due to impurities resulting from the starting material, incomplete
synthesis, degradation or other syntheses method-specific factors.
Gowan believes that the ``Imidan-EDC'' phosmet is an inappropriate test
substance. Because of these uncertainties, EPA does not believe the
Imidan-EDC results are representative for the phosmet manufactured and
registered with EPA by either Stauffer Chemical (former pesticide
registrant) or Gowan Company (current pesticide registrant). Therefore,
EPA removed these values from consideration for EHS listing purposes.
4. Phosmet Oral Mouse Study (Haley et al., 1975)
Only one other study (Haley et al., 1975) reported results with an
LD50 <= 25 mg/kg. This study examined the acute oral
toxicity of five organophosphate pesticides (including Imidan or
phosmet) in a total of three experiments: a range finding experiment, a
pilot experiment, and a main experiment designed to estimate an
LD1 value and extrapolate an LD0.1 value.
LD50 values for phosmet were reported from the pilot study
as 25.2 and 23.1 mg/kg for males and females, respectively and from the
main study as 23.1 and 24.9 mg/kg for males and females, respectively.
The study was conducted by the National Center for Toxicological
Research (FDA), Arkansas. After reviewing this information, Gowan made
several arguments why the information in the Haley study was
insufficient to support the listing of phosmet as an EHS.
Haley et al. (1975) conducted two dose response experiments, a
pilot study (100 mice) and a main study (660 mice). A linear regression
was developed from the pilot results. The LD50 and its
confidence intervals, and the slope of the regression and its
[[Page 64047]]
confidence intervals are provided in the journal article. Using this
regression, doses for LD1, LD2, LD4,
LD8, LD16, LD32, and LD64
were taken from the regression and used in the main study. The goal of
the study was to estimate the LD1 and extrapolate the
LD0.1. For the pilot study the actual doses and number of
animals killed are not presented. The LD1, LD16,
and LD50 results only, by sex, were presented in a table in
Haley et al. (1975) as predicted doses from the pilot study and
calculated doses from the main study. The actual doses in the main
study were chosen based on the results from the pilot study. The log of
actual doses and percentage of animals killed are presented in a graph
for each sex, except the value of the LD2 for males which
gave an aberrant response.
One of Gowan's key criticisms of Haley et al. (1975) was that no
mortality data was presented from the pilot experiment and complete
data from the main experiment is presented only in graphical form.
Because the actual doses and animals killed at each dose are not cited,
Gowan stated that the LD50 results cannot be replicated or
confirmed. EPA agrees with Gowan that the lack of tabulated mortality
data is a serious flaw in this experiment. EPA attempted to recover the
actual mortality data from the National Center for Toxicological
Research, but the NCTR was not able to recover it. Gowan also raised
other issues regarding Haley et al. (1975) which included the
variations in main study mortality response, lack of information on the
use of control data, and other questions or potential problems with the
study methodology or design. The Agency addresses these issues in
detail in the technical background document supporting this rulemaking.
5. Phosmet Oral Mouse Study (Gowan 2002)
Because of the uncertainties surrounding verification of results of
the Haley study, EPA proposed conducting a new acute oral mouse
LD50 study using the Up-And-Down Method, as described in the
Office of Prevention, Pesticides and Toxic Substances (OPPTS) new
Harmonized Test Guideline 870.1100 for Acute Oral Toxicity. This
guideline has been adopted by the Federal Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM), the
Organization for Economic Coordination and Development (OECD) and EPA's
Science Advisory Panel (SAP). EPA's participation in ICCVAM is part of
the Agency's commitment to support testing that reduces the use of
animals.
Before EPA initiated the new test, Gowan decided to conduct its own
acute toxicity study in mice. Based on its review of the existing
toxicity data and the recommended test method, EPA provided Gowan with
the recommended test method and comments on Gowan's draft test
protocol. EPA recommended that Gowan test at multiple dose levels using
the Up and Down Procedure (UDP) for acute oral toxicity. (See Docket
for test method and comments provided to Gowan.)
Gowan completed its study of mouse responses to acute oral exposure
to phosmet in December 2002. Their study planned to dose 20 female mice
at 40 mg/kg, initially, with subsequent doses tested, if warranted.
Twenty female mice were administered 40 mg/kg by oral gavage. After 14
days observation, there were no mortalities. Because no mortality
occurred at 40 mg/kg, Gowan saw no need to conduct further tests. Thus,
Gowan conducted a single dose study rather than an LD50
test. Gowan believes the test results confirm that the oral
LD50 of phosmet exceeds 25 mg/kg listing criterion and that
there is no basis for continuing to list phosmet as an Extremely
Hazardous Substance.
The study results have been carefully reviewed by a cross-agency ad
hoc committee whose consensus was that the Gowan study seemed to
confirm the oral mouse LD50 results from most of the
previous literature studies, which showed LD50s greater than
EHS listing criterion of 25 mg/kg. EPA believes that the new test
results support the conclusion that the acute oral LD50 of
phosmet exceeds 25 mg/kg and that phosmet should be removed from the
EHS list. The Gowan study appears to be sound and conducted properly
according to Good Laboratory Practices, although it is only for a
single dose. The large number of mice (20) tested at a much higher
concentration than the EHS List criterion supports the probability that
the acute oral mouse LD50 is greater than 25 mg/kg . In
addition, Gowan had done a thorough chemical analysis of the phosmet
material that was administered to the animals.
Normally EPA would not accept a single dose study for drawing
conclusions about the LD50 for a chemical. However, the
Agency believes this study can be used in its analysis because of
existing data indicating the approximate range of probable
LD50 values and data showing that phosmet has a steep dose-
response curve. Although the new test did not follow new acute oral
toxicity testing guidelines, the test results are consistent with the
variability of individual animal dose response seen in existing oral
mouse LD50 studies.
Phosmet is an organophosphate pesticide, with known lethal and
toxic human health effects. However, after careful consideration of all
of the toxicity data, EPA proposes that phosmet should be delisted from
the EHS list for the following reasons: (1) The mouse oral
LD50 data that meet the criteria from the Haley et al.
(1975) study have a number of deficiencies that increase the
uncertainty around the results, such as lack of tabulated mortality
data for either the pilot or the main study, lack of information on
treatment of the control data, and considerable variability in the
results at the LD01-LD08 doses, (2) the Haley
LD50 results are right at the limit of the oral toxicity
listing criteria of 25 mg/kg, and (3) other acute mouse oral studies
(including Gowan's December 2002 study conducted using Good Laboratory
Practices) indicate the mouse oral LD50 exceeds the 25 mg/kg
listing criteria. EPA solicits comment on the proposed delisting
decision and its rationale, and invites the public to submit or
identify relevant peer-reviewed studies or data, of which the Agency
may not be aware. EPA invites submission of any valid oral toxicity
studies for phosmet that meet the listing criteria which are not
already been reviewed by EPA. EPA's review of all currently available
acute oral toxicity studies can be found in the February 2003 Technical
Background Document: Proposed Rule to Delist Phosmet from the EHS List
available in the public docket.
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735), the Agency must
determine whether this regulatory action is ``significant'' and
therefore subject to formal review by the Office of Management and
Budget (OMB) and to the requirements of the Executive Order, which
include assessing the costs and benefits anticipated as a result of the
proposed regulatory action. The Order defines ``significant regulatory
action'' as one that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by
[[Page 64048]]
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
B. Paperwork Reduction Act
The Office of Management and Budget (OMB) has previously approved
the information collection requirements contained in the existing
regulations 40 CFR Part 355 under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2050-0092, (EPA ICR No. 1395.04). Copies of the ICR document(s)
may be obtained from Susan Auby, by mail at U.S. Environmental
Protection Agency, Collection Strategies Division (Mail Code 2822),
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, by email at auby.susan@epa.gov, or by calling 202-566-1672. A copy may also be
downloaded off the internet at http://www.epa.gov/icr Include the ICR
and / or OMB number in any correspondence.
This action does not impose any new information collection burden.
This proposed rule will relieve burden for facilities that have phosmet
on-site. Therefore, we conclude that this proposed action does not
impose any new information collection burden, rather, it would relieve
the regulatory burden for those facilities that handled phosmet. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
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 and 48 CFR Chapter 15.
Comments are requested on the changes included in this proposal.
Send comments on the ICR to the Director, Collection Strategies
Division; U.S. Environmental Protection Agency (2823); 1200
Pennsylvania Avenue, NW., Washington, DC 20460-0001; and to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th St., NW., Washington, DC 20503, marked ``Attention: Desk
Officer for EPA.'' Include the ICR number in any correspondence. Since
OMB is required to make a decision concerning the ICR between 30 and 60
days after November 12, 2003, a comment to OMB is best assured of
having its full effect if OMB receives it by December 12, 2003. The
final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C.
601 et. seq., generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute, unless the agency certifies that the rule will not have
a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business that has
fewer than 1000 or 100 employees per firm depending upon the SIC code
the firm primarily is classified; (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's proposed rule on
small entities, I hereby certify that this proposal will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities'' (5 U.S.C. 603
and 604). Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on small entities subject to the rule. This proposed
rule would remove requirements for reporting and emergency planning for
small entities with phosmet on site. We have therefore concluded that
today's proposed rule would relieve regulatory burden for small
entities.
We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal Agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
must prepare a written analysis, including a cost-benefit analysis, for
proposed and final rules with ``Federal mandates'' that may result in
expenditures to State, local, and tribal governments, in the aggregate,
or to the private sector, of $100 million or more in any one year.
Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA requires EPA to identify and consider a
reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials to have
meaningful
[[Page 64049]]
and timely input in the development of regulatory proposals, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
EPA has determined that this rule does not include a Federal
mandate that may result in expenditures of $100 million or more for
State, local, or tribal governments, in the aggregate, or the private
sector in any one year. This is because this proposed rule would
provide regulatory burden relief and does not impose any additional
costs to any State, local, or tribal governments. EPA also has
determined that this rule contains no regulatory requirements that
might significantly or uniquely affect small governments. In addition,
as discussed above, the private sector is not expected to incur costs
exceeding $100 million. Therefore, today's proposed rule is not subject
to the requirements of Sections 202 and 205 of UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This proposal does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed rule does not
impose any new requirements on states or other levels of government.
Instead it relieves LEPCs of the responsibility of developing and
maintaining emergency plans for facilities that handle and store
phosmet. SERCs and LEPCs will no longer be notified of releases of
phosmet under the requirements of EPCRA Section 304. Thus, the
requirements of section 6 of the Executive Order do not apply to this
proposal.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.''
This proposed rule does not have tribal implications, as specified
in Executive Order 13175. This proposed rule does not impose any new
requirements on tribal officials. Instead it relieves them of the
responsibility of developing emergency plans for facilities that handle
and store phosmet. EPA does not believe that tribes have any
significant number of facilities that handle, store or use phosmet.
Phosmet formulations are handled and stored by farm chemical
distributors and used mostly on fruit and nut crops. Today's rule does
not significantly or uniquely affect the communities of Indian tribal
governments, nor would it impose substantial direct compliance costs on
them. Thus, Executive Order 13175 does not apply to this rule.
EPA specifically solicits additional comment on this proposed rule
from tribal officials.
G. Executive Order 13045: Protection of Children From Environmental
Risks and Safety Risks
The Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) applies to any rule that EPA determines (1) is ``economically
significant'' as defined under Executive Order 12866, and (2) the
environmental health or safety risk addressed by the rule has a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
This proposal is not subject to the Executive Order because it is
not economically significant as defined in Executive Order 12866, and
because the Agency does not have reason to believe the environmental
health or safety risks addressed by this proposed rule present a
disproportionate risk to children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use
This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. This proposed
rule reduces regulatory burden. It thus should not adversely affect
energy supply, distribution or use.
I. National Technology Transfer and Advancement Act of 1995
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities, unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
proposed rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.
List of Subjects in 40 CFR Part 355
Environmental Protection, Air pollution control, Chemicals,
Chemical accident prevention, Chemical emergency preparedness,
Community emergency response plan, Community right-to-know, Extremely
hazardous substances, Hazardous substances, Reportable quantity,
Reporting and recordkeeping requirements, Superfund, Threshold planning
quantity.
Dated: November 4, 2003.
Marianne L. Horinko,
Acting Administrator.
For the reasons set out in the preamble, part 355 of title 40 of
the Code of Federal Regulations is proposed to be amended as follows:
PART 355--EMERGENCY PLANNING AND NOTIFICATION
1. The authority citation for part 355 continues to read as
follows:
Authority: 42 U.S.C. 11002, 11004, and 11048.
[[Page 64050]]
Appendices A and B--[Amended]
2. Appendices A and B are amended by removing the entry for CAS No.
732-11-6 for the chemical name Phosmet.
[FR Doc. 03-28308 Filed 11-10-03; 8:45 am]
BILLING CODE 6560-50-P