[Federal Register: November 26, 2004 (Volume 69, Number 227)]
[Rules and Regulations]
[Page 68809-68815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no04-24]
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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: franklin.kathy@epa.gov
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
auby.susan@epa.gov, or by calling 202-566-1672. A copy may also be
downloaded off the Internet at http://www.epa.gov/icr. Include the ICR
and/or OMB number in any correspondence.
This action does not impose any new information collection burden.
This 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]
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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