[Federal Register Volume 68, Number 218 (Wednesday, November 12, 2003)]
[Proposed Rules]
[Pages 64041-64050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28308]


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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: [email protected]

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 
[email protected], 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 
[email protected], 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