[Federal Register Volume 69, Number 227 (Friday, November 26, 2004)]
[Rules and Regulations]
[Pages 68809-68815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26162]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 355

[SFUND-2003-0007; FRL-7842-1]
RIN 2050-AE42


Emergency Planning and Community Right-to-Know Act; Extremely 
Hazardous Substances List; Deletion of Phosmet

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On November 12, 2003, the Environmental Protection Agency 
proposed to delete phosmet from the list of extremely hazardous 
substances (EHS) issued under the Emergency Planning and Community 
Right-to-Know Act (EPCRA). Today, EPA is taking final action to delete 
phosmet from the EHS list. Facilities with phosmet on-site will no 
longer be required to comply with emergency planning and emergency 
release notification requirements. In addition, facilities handling 
phosmet will no longer have to file an emergency and hazardous chemical 
inventory form and Material Safety Data Sheet (MSDS) for phosmet with 
their State Emergency Response Commission (SERC), Local Emergency 
Planning Committee (LEPC), and local fire department, for amounts less 
than 10,000 pounds.

DATES: This rule is effective December 27, 2004.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. SFUND-2003-0007. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., 
Washington, DC. The Public Reading Room 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.

FOR FURTHER INFORMATION CONTACT: For general information, contact the 
Emergency Planning and Community Right-to-Know Hotline at (800) 424-
9346; in the Washington, DC metropolitan area, contact (703) 412-9810. 
The Telecommunications Device for the Deaf (TDD) Hotline number is 
(800) 535-7672. You may also access general information online at the 
Hotline Internet site, http://www.epa.gov/epaoswer/hotline/. For 
questions on the contents of this document, contact Kathy Franklin, 
Office of Emergency Management (formerly Chemical Emergency Prevention 
and Preparedness Office), Office of Solid Waste and Emergency Response, 
(5104A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460, Telephone (202)564-7987; Fax (202) 564-8444 e-
mail: [email protected]

SUPPLEMENTARY INFORMATION:

I. General Information

    A. Does this Action Apply to Me? 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 produce phosmet formulations, distribute phosmet as a 
pesticide for commercial use, and farms that store, handle and apply 
phosmet. 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.
    B. 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

[[Page 68810]]

at http://www.epa.gov/edocket/ to 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: SFUND-2003-0007.
    The information in this final rule is organized as follows:

I. Background
    A. Statutory Authority
    B. Extremely Hazardous Substances under EPCRA
II. Basis for Final Rule
III. The EHS Listing Criteria
    A. Primary Listing Criteria
    B. Secondary Listing Criteria
    C. Development of Listing Criteria
    D. Toxicity Data Sources
IV. Response to Comments on the November 12, 2003 Proposed Rule
V. Regulatory Impacts of This Rule
VI. 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
    J. Congressional Review Act

I. Background

A. Statutory Authority

    This final rule is issued under sections 302 and 328 of the 
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

B. Extremely Hazardous Substances Under EPCRA

    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 
certain hazardous materials 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. Under section 304 
of EPCRA, the facility must also report accidental releases in excess 
of the Reportable Quantity (RQ) to the National Response Center, the 
LEPC and SERC. However, releases from the application of a registered 
pesticide are exempted from the EPCRA section 304 emergency release 
notification according to 40 CFR 355.40(a)(2)(iv).
    As provided under 40 CFR 370.20, EHSs are subject to EPCRA section 
311 and 312 reporting requirements. Facilities with an EHS present on-
site in excess of 500 pounds or its TPQ, whichever is lower, are 
required to submit an emergency and hazardous chemical inventory form 
and Material Safety Data Sheet (MSDS) to their SERC, LEPC and local 
fire department. Facilities must also submit chemical inventory forms 
and MSDS for other hazardous chemicals present on-site in quantities of 
10,000 pounds or more. However, under sections 311 and 312 of EPCRA, 
facilities that apply chemicals to crops as a pesticide, do not have to 
file the inventory form or MSDS for those chemicals, 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.
    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. See Section III of this notice 
for the criteria used for determining whether a substance qualifies as 
an extremely hazardous substance.
    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.

II. Basis for Final Rule

    On November 12, 2003 (68 FR 64041), EPA proposed to delete the 
chemical phosmet from the EHS list under Section 302 of EPCRA, in 
response to a petition from Gowan Company. Gowan believed that the 
listing of phosmet was based on an invalid toxicity study and argued 
that phosmet should be removed from the EHS list because there were no 
valid data to indicate that the chemical meets the listing criteria.
    Phosmet was originally listed on the EHS list because a four-hour 
rat inhalation LC50, reported in the 1985 Registry of Toxic 
Effect of Chemical Substances (RTECS) database, met the EHS primary 
toxicity inhalation criteria of LC50 <= 0.5 mg/L. See 
Section III of this notice for discussion of the EHS listing criteria. 
The secondary toxicity criteria for EHSs did not apply to phosmet 
because it does not have a high production volume. Approximately 
1,125,000 pounds of phosmet as an active ingredient (a.i.) in pesticide 
formulations are used annually. The LC50 result of 0.054 mg/
L was from in a 1969 Russian study, unavailable to EPA. However, a 
translation of a 1969 Russian journal article about the study

[[Page 68811]]

was available for review. The phosmet used in the experiment was 
manufactured in a Russian research institute using an unknown method. 
The journal article severely lacked key details of the experimental 
methods, such as the purity of phosmet, extent of animal body exposure, 
possibility of other routes of exposure, specific emulsion components 
and their toxicity. With the number of unanswered key questions 
regarding the experimental protocol, EPA agrees that the Russian study 
results were not a sufficient basis for keeping phosmet on the EHS 
list.
    However, before EPA took any regulatory action, a comprehensive 
review was undertaken of available acute toxicity studies by 
inhalation, dermal and oral routes; this review found no other 
inhalation or dermal study results for phosmet that met the EHS primary 
listing criteria of inhalation LC50 <= 0.5 mg/L or dermal 
LD50 of <=50 mg/kg. A review of acute oral toxicity studies 
indicated that mice were more sensitive than rats to phosmet. The 
lowest reported rat oral LD50 for technical grade phosmet 
(96.1%) is 113 mg/kg, which did not meet the primary oral listing 
criteria of <= 25 mg/kg. Technical grade phosmet is generally 94% or 
higher phosmet content. Reported acute oral toxicity LD50s 
of technical grade phosmet in mice varied from of 23.1 to 51 mg/kg, 
based on eight studies.
    Stauffer Chemical Company in 1971 reported an oral LD50 
of 23.3 mg/kg for mice for technical grade phosmet, purity unspecified. 
The phosmet used in the study was manufactured by a different synthesis 
method (using ethylene chloride (EDC) as solvent) than used by the 
current and previous pesticide registrants (Gowan and Stauffer) and 
thus the phosmet tested may not be representative of the phosmet used 
in commerce. 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. Because of 
these uncertainties, EPA does not believe the phosmet-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 did not consider these 
values in its review of phosmet for EHS listing purposes.
    Another study conducted by researchers at the National Center for 
Toxicological Research (NCTR) reported oral LD50 results of 
23.1 and 24.9 mg/kg for male and female mice, respectively, using 99.5% 
phosmet. The results from this study were presented in a journal 
article (Haley et al., 1975), but the actual study data could not be 
found. Because the actual doses and number of animals killed at each 
dose are not cited, the LD50 results could not be replicated 
or confirmed. Other concerns regarding the Haley study included the 
variations in mortality response, lack of information on the use of 
control data, and other questions or potential problems with the study 
methodology and design. The Agency discussed these issues in detail in 
the technical background document supporting this rulemaking.
    Because of the uncertainties surrounding result verification and 
the design details of the Haley study, EPA proposed conducting a new 
acute oral mouse LD50 study. Gowan then offered to conduct a 
new study in acute oral toxicity in mice, which they completed in 
December 2002. In Gowan's study, twenty female mice were administered 
40 mg/kg of 98% pure phosmet, by oral gavage. No mortalities occurred. 
Because the tested dose produced no deaths in the twenty mice, testing 
at lower doses was considered unnecessary. EPA believes the Gowan study 
confirms the oral mouse LD50 results from the majority of 
the previous reported studies, which show LD50s greater than 
the EHS listing criterion of <= 25 mg/kg. Therefore, EPA believes that 
phosmet does not meet the acute oral toxicity listing criterion and it 
should be removed from the EHS list. Because phosmet does not have a 
high production volume (about 1.25 million pounds are applied 
annually), only the primary listing criteria (discussed below) were 
used to evaluate whether phosmet should be retained on the EHS list.

III. 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.

C. Development of Listing Criteria

    The selection criteria were designed as screening tools to identify 
chemicals with high acute toxicity. The specific values chosen are 
recognized by the scientific community as indicating a high potential 
for acute toxicity, and

[[Page 68812]]

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 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 wanted to ensure that acutely toxic 
chemicals of concern were identified.
    For purposes of this assessment, 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 for this 
assessment, the Agency assumed that humans may be as sensitive as the 
most sensitive mammalian species tested.

D. 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.

IV. Response to Comments on the November 12, 2003 Proposed Rule

    EPA received eight comments during the comment period.\1\ Four were 
from growers or agricultural trade associations, one was from a 
horticultural agent, one was from a certified professional agronomist, 
one was from an pesticide/fertilizer retailer and one was from the 
petitioner seeking delisting of phosmet. All commenters supported the 
removal of phosmet from the EHS list. Most commenters stated that 
phosmet has been an essential pest control tool. Some commented that 
EPA used good science to eliminate unnecessary regulation and would 
provide regulatory relief. Additionally, several of these commenters 
stated that the delisting would allow public and private resources to 
be focused on more critical issues.
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    \1\ In addition, the Agency also received toxicity information 
on phosmet from the Working Group of Community Right-To-Know in July 
2002, which requested that these documents be placed in the official 
docket if the Agency proposed to change phosmet's listing as an 
Extremely Hazardous Substance under EPCRA.
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    Gowan Company, the petitioner requesting the removal of phosmet 
from the EHS list and the one of the pesticide registrants, had already 
submitted many toxicity studies and other information to EPA before the 
proposal was published. Their comments on the proposed rule noted that 
in addition to no valid data being available that indicate phosmet 
meets the listing criteria, a robust set of valid data is available 
that unequivocally shows that phosmet does not meet any of the toxicity 
(or other) listing criteria. Gowan also believes that the proposed 
rulemaking will appropriately rectify the mischaracterization of risk.
    EPA agrees that there are many acute toxicity studies available for 
phosmet with results that do not meet the listing criteria. The Federal 
Register notice for the proposed rule focused more on those studies 
that, at first, appeared to meet the listing criteria. As EPA explained 
in the notice for the proposal, other acute toxicity studies indicate 
that phosmet does not meet the listing criteria. These studies are 
summarized and discussed in the technical background document; and 
available for review in the public docket. EPA did take into 
consideration the many results of these other acute oral toxicity 
studies when making its decision to delist phosmet.
    EPA also reviewed the 17 technical references and reports submitted 
by the Working Group on Community Right-to-Know, in July 2002. These 
references primarily contained information on phosmet's acute and 
chronic toxicity, human health effects and risks. EPA carefully 
reviewed the submitted information and saw no new data or studies on 
acute toxicity that had not already been reviewed and considered in the 
decision. The EHS listing criteria is based on specific LC50 
or LD50 acute toxicity testing results in mammals and does 
not rely on chronic, long-term health effects.

V. Regulatory Impacts of This Rule

    As a result of this final rule, phosmet will no longer be an EHS 
listed under section 302 of EPCRA. As a result, facilities that have 
phosmet on-site will no longer be required to (1) notify their SERCs 
and LEPCs that they are subject to the emergency planning provisions of 
EPCRA section 302 for the chemical phosmet; (2) provide to their LEPC a 
facility emergency coordinator (unless other listed EHS chemicals are 
present at the facility) and information about phosmet for developing 
and implementing the emergency plan; and (3) notify SERCs and LEPCs of 
accidental releases of phosmet under the requirements of EPCRA Section 
304. Releases from application of a pesticide were already exempted 
from Section 304 reporting. LEPCs would no longer be required to 
include phosmet as part of a local emergency plan for responding to a 
chemical emergency at a facility.
    Phosmet is still a `` hazardous chemical'' under Section 311 and 
312 requirements, except when it is used in routine agricultural 
operations, such as a pesticide applied on crops. According to 29 CFR 
1900.1200(c), phosmet is considered a ``toxic'' health hazard because 
it has an oral rat acute toxicity LD50 of less than 200 mg/
kg. Facilities that process or distribute phosmet, such as phosmet 
product manufacturers and agricultural chemical distributors would 
still be subject to EPCRA section 311 and 312 reporting requirements 
for phosmet if they have phosmet present in amounts equal to or greater 
than 10,000 pounds, as provided in 40 CFR 370.20(b)(4).

[[Page 68813]]

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, (October 4, 1993)), 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. 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 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. 1395.05). 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 e-mail 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 rule will relieve burden for facilities that have phosmet on-site. 
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 in 40 CFR are listed in 40 CFR part 9.

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 is 
defined by the Small Business Administration by category of business 
using North America Industrial Classification System (NAICS) and 
codified at 13 CFR 121.201; (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 the final rule on small 
entities, we have concluded that this action will not have a 
significant economic impact on a substantial number of small entities. 
This action would remove requirements for reporting and emergency 
planning for small entities with phosmet on site, and thus relieves 
regulatory burden.

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 statement, 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 and timely input in the development of EPA 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 rule will 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. The rule will provide burden relief to regulated entities.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an

[[Page 68814]]

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.''
    Under Executive Order 13132, EPA may not issue a regulation that 
has federalism implications, that imposes substantial direct compliance 
costs, and that is not required by statute, unless the Federal 
Government provides the funds necessary to pay the direct compliance 
costs incurred by State and local governments, or EPA consults with 
State and local officials early in the process of developing the 
regulation.
    This final rule 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 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 rule.
    Because this rule deletes phosmet from the list of EHS chemicals, 
it relieves some burden on local governments for preparing emergency 
response plans because fewer facilities will be subject to reporting 
requirements. This action does not prevent any State government from 
enforcing more stringent standards for this chemical.

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 final rule does not have tribal implications, as specified in 
Executive Order 13175. It 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.

G. Executive Order 13045: Protection of Children From Environmental 
Health 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 (1) is determined to be ``economically 
significant'' as defined under Executive Order 12866, and (2) concerns 
an environmental health or safety risk that EPA has reason to believe 
may have 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 final rule 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 action present a 
disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution or Use

    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a 
significant regulatory action defined under Executive Order 12866.

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 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 
final rule does not involve technical standards. Therefore, EPA is not 
considering the use of any voluntary consensus standards.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A Major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). The rule will be effective December 27, 2004.

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 18, 2004.
Michael O. Leavitt,
Administrator.


0
For the reasons set out in the preamble, part 355 of title 40 of the 
Code of Federal Regulations is amended as follows:

PART 355--EMERGENCY PLANNING AND NOTIFICATION

0
1. The authority citation for part 355 continues to read as follows:

    Authority: 42 U.S.C. 11002, 11004, and 11048.

[[Page 68815]]

Appendices A and B--[Amended]

0
2. Appendices A and B to part 355 are amended by removing the entry for 
CAS No. 732-11-6 for the Chemical Name Phosmet.

[FR Doc. 04-26162 Filed 11-24-04; 8:45 am]
BILLING CODE 6560-50-P