Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various Food and Feed Commodities, 46106-46110 [E6-13082]
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Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Rules and Regulations
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because it is not
economically significant. In addition,
this rule does not involve technical
standards, thus the requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not
apply. This rule also does not impose an
information collection burden under the
provisions of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
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).
Under section 307(b)(1) of the Clean
Air Act (CAA), petitions for judicial
review of this action must be filed in the
United States Court of Appeals for the
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4).
This rule also does not have tribal
implications because it will not have a
substantial direct effect on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes,
as specified by Executive Order 13175
(65 FR 67249, November 9, 2000). This
rule also does not have Federalism
implications because it does 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 (64 FR 43255,
August 10, 1999). This rule merely
corrects an inadvertent error by
conforming the effective date of the 8hour ozone attainment redesignation for
Montgomery County, Tennessee to the
effective date of EPA’s rulemaking
approving the redesignation, and does
not alter the relationship or the
distribution of power and
responsibilities established in the Clean
Air Act. This rule also is not subject to
Executive Order 13045 ‘‘Protection of
Children from Environmental Health
appropriate circuit by October 10, 2006.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See CAA
section 307(b)(2).)
List of Subjects in 40 CFR Part 81
Environmental protection, Air
pollution control, National parks,
Wilderness areas.
Dated: July 20, 2006.
A. Stanley Meiburg,
Acting, Regional Administrator, Region 4.
I
40 CFR part 81 is amended as follows:
PART 81—[CORRECTED]
1. The authority citation for part 81
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
2. In § 81.343, the table entitled
‘‘Tennessee_Ozone (8–Hour Standard)’’
is amended by revising the entry for
‘‘Clarksville-Hopkinsville, TN-KY:
Montgomery County’’ to read as follows:
I
§ 81.343
*
Tennessee.
*
*
*
*
TENNESSEE—OZONE (8–HOUR STANDARD)
Designationa
Category/classification
Designated area
Date 1
*
*
*
*
Clarksville-Hopkinsville, TN-KY Area:
Montgomery County ......................................................................................
*
*
*
*
11/ 21/05
*
Date 1
Type
Type
*
*
*
*
Attainment
*
a Includes
1 This
*
Indian Country located in each county or area, except as otherwise specified.
date is June 15, 2004, unless otherwise noted.
*
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*
*
ACTION:
178 (see also Unit I.C. of the
Final rule.
SUPPLEMENTARY INFORMATION.
[FR Doc. E6–13161 Filed 8–10–06; 8:45 am]
SUMMARY: This regulation establishes a
tolerance exemption for residues of
copper sulfate pentahydrate when
applied in or on meat, fat and meat byproducts of cattle, sheep, hogs, goats,
horses, poultry, milk and eggs when
applied as a bactericide/fungicide to
animal premises and bedding.
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2005–0314; FRL–8085–3]
Copper Sulfate Pentahydrate;
Tolerance Exemption in or on Various
Food and Feed Commodities
Environmental Protection
Agency (EPA).
AGENCY:
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This regulation is effective
August 11, 2006. Objections and
requests for hearings must be received
on or before October 10, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
DATES:
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0314. All documents in the
docket are listed on the regulations.gov
Web site. Although listed in the index,
some information is not publicly
available, e.g., 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.
ADDRESSES:
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Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Rules and Regulations
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Marshall Swindell,
AntimicrobialsDivision (7510C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
6341; e-mail:
swindell.marshall@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
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Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0314 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before October 10, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0314, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of December
21, 2005 (70 FR 75807) (FRL–7748–3),
EPA issued a notice pursuant to section
408(d)(2) of Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a,
as amended by the Food Quality
Protection Act (FQPA) (Public Law 104–
107) announcing the filing of a pesticide
petition (PP 5F6982), by ArchAngel,
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LLC, 636 Hampshire St., Suite 208,
Quincy, IL 62301. EPA did not receive
any public comments in response to this
petition. The petition requested that 40
CFR part 180 be amended to exempt
from the requirement of a tolerance
residues of the bactericide/fungicide
copper sulfate pentahydrate when
applied as a bactericide/fungicide in or
on meat, fat and meat by-products of
cattle, sheep, hogs, goats, horses,
poultry, milk and eggs when applied as
a bactericide/fungicide to animal
premises and bedding. Various copper
containing substances, including copper
sulfate pentahydrate, have been
exempted from tolerance requirements
for numerous uses. 40 CFR 180.1021
exempts the listed copper compounds
when applied, among other things, to
growing crops as well as shellfish, meat,
milk, poultry, eggs, and irrigated crops.
Section 408(c)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(2)(A)(ii) defines ‘‘safe’’ to
mean that ‘‘there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue, including all
anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take into account the factors set
forth in section 408(b)(2)(C), which
requires EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
residue in establishing a tolerance and
to ‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
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completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. The
nature of the toxic effects caused by
copper sulfate pentahydrate are
discussed in this unit.
There is adequate information
available to characterize the toxicity of
the copper ion. Copper is ubiquitous in
nature and is a necessary nutritional
element for both animals (including
humans) and plants. Copper is found
naturally in the food we eat including
fruits, vegetables, meats and seafood. It
is found in the water we drink, the air
we breathe and in our bodies
themselves. Some of the environmental
copper is due to direct modification of
the environment by man such as mining
and smelting of the natural ore. It is one
of the elements found essential to life.
The National Academy of Science
establishes recommended daily
allowances (RDAs) of vitamins and
minerals for the diet. The RDA for
copper ranges from approximately 400
micrograms per day (µg/d) in young
children to 900 µg/d in adults.
Additionally, over-the-counter dietary
supplements containing copper at levels
ranging from 0.33 milligram (mg) to 3
mg are available for individuals with
low levels of copper. The copper ion is
present in the adult human body with
nearly two-thirds of the body copper
content located in the skeleton and
muscle. The liver is the primary organ
for the maintenance of plasma copper
concentrations.
Oral ingestion of excessive amounts of
the copper ion from pesticidal uses
including the proposed use is unlikely.
Copper compounds are irritating to the
gastric mucosa. Ingestion of large
amounts of copper results in prompt
emesis. This protective reflex reduces
the amount of copper ion available for
absorption into the human body.
Additionally, at high levels humans are
also sensitive to the taste of copper.
Because of this organoleptic property,
oral ingestions would also serve to limit
high doses.
Only a small percentage of ingested
copper is absorbed, and most of the
absorbed copper is excreted. The human
body appears to have efficient
mechanisms in place to regulate total
body copper. The copper ion occurs
naturally in food and the metabolism of
copper is well understood. The Agency
has conducted a risk assessment in
connection with the development and
issuance of the Reregistration Eligibility
Decision Document for Copper (EPA–
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HQ–OPP–2005–0558; Human Health
Chapter). No endpoints of toxicology
concern were identified for risk
assessment purposes for a number of
reasons. One of the foremost of these is
the fact that copper is a required
nutritional element for both plants and
animals. Indeed, current available data
and literature studies indicate that there
is a greater risk from the deficiency of
copper intake than from excess intake.
Copper also occurs naturally in a
number of food items including fruits,
vegetables, meats and seafood. Although
there is little known about the minimum
levels of dietary copper necessary to
cause evidence of adverse effect, this
situation is likely due to the existence
of an effective homeostatic mechanism
that is involved in the dietary intake of
copper and that protects man from
excess body copper. Given that copper
is ubiquitous and is routinely consumed
as part of the daily diet, it is unlikely
that with the current exposure pattern
there would be any long term adverse
effects.
Finally, sulfate has little toxic effect
and is routinely used in medicine as a
cathartic when combined with
magnesium or sodium, the only adverse
manifestation from this use being
dehydration if water intake is
concurrently limited.
IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide
chemicals, the Agency considers the
toxicity of the chemical in conjunction
with possible exposure to residues of
the chemical through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure, an
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exemption from the requirement of a
tolerance may be established.
A. Dietary Exposure
Copper is ubiquitous in nature and is
a necessary nutritional element for both
animals (including humans) and plants.
It is one of several elements found
essential to life. The human body must
have copper to stay healthy. In fact, for
a variety of biochemical processes in the
body to operate normally, copper must
be part of our daily diet. Copper is
needed for certain critical enzymes to
function in the body. Actually, too little
copper in the body can actually lead to
disease.
1. Food. The main source of copper
for infants, children, and adults,
regardless of age, is the diet. Copper is
typically present in mineral rich foods
like vegetables (potato, legumes (beans
and peas), nuts (peanuts and pecans),
grains (wheat and rye), fruits (peaches
and raisins), and chocolate in levels that
range from 0.3 to 3.9 ppm. A single
day’s diet may contain 10 mg or more
of copper. The daily recommended
allowance of copper for adult
nutritional needs is 2 mg. It is not likely
that the approval of this petition would
significantly increase exposure over that
of the existing levels of copper.
2. Drinking water exposure. Copper is
a natural element found in the earth’s
crust. As a result, most of the world’s
surface water and ground water that is
used for drinking purposes contains
copper. The actual amount varies from
region to region, depending on how
much is present in the earth, but in
almost all cases the amount of copper in
water is extremely low. Naturally
occurring copper in drinking water is
safe for human consumption, even in
rare instances where it is at levels high
enough to impart a metallic taste to the
water. Residues of copper in drinking
water are regulated under the Safe
Drinking Water Act. A Maximum
Contaminant Level Goal of 1.3 ppm has
been set by the Agency for copper.
According to the National Research
Council’s Committee on Copper in
Drinking Water, this level is ‘‘set at a
concentration at which no known or
expected adverse health effects occur
and for which there is an adequate
margin of safety.’’ The Agency believes
that this level of protection would not
cause any potential health problems, i.e.
stomach and intestinal distress, liver
and kidney damage and anemia. It is not
likely that the approval of this petition
would significantly increase exposure
over that of the existing levels of copper.
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B. Other Non-Occupational Exposure
Copper compounds have many uses
on crops (food as well as non-food) and
ornamentals as a fungicide.
Dermal exposure. Given the
prevalence of copper in the
environment, no significant dermal
exposure increase above current levels
would be expected from the nonoccupational use of copper sulfate
pentahydrate.
Inhalation exposure. Air
concentrations of copper are relatively
low. A study based on several thousand
samples assembled by EPA’s
Environmental Monitoring Systems
Laboratory showed copper levels
ranging from 0.003 to 7.32 micrograms
per cubic meter. Other studies indicated
that air levels of copper are much lower.
The Agency does not expect the air
concentrations of copper to be
significantly affected by the use of
copper sulfate pentahydrate.
V. Cumulative Effects
The Agency believes that copper has
no significant toxicity to humans and
that no cumulative adverse effects are
expected from long-term exposure to
copper salts including copper sulfate
pentahydrate. For the purposes of this
tolerance action, EPA has not assumed
that copper compounds have a common
mechanism of toxicity with other
substances.
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VI. Determination of Safety for U.S.
Population, Infants and Children
Copper sulfate pentahydrate is
considered as Generally Recognized as
Safe (GRAS) by the Food and Drug
Administration (FDA). EPA has also
exempted various copper compounds
from the requirement of a tolerance
when used as aquatic herbicides (40
CFR 180.1021). Copper compounds,
including copper sulfate pentahydrate,
are also exempt from the requirements
of a tolerance when applied to growing
crops when used as a plant fungicide in
accordance with good agricultural
practices (40 CFR 180.1021).
1. U.S. population. Copper is a
component of the human diet and an
essential element. In addition, no acute
or chronic dietary end points were
selected because no endpoints of
toxicological concerns have been
identified for risk assessment purposes.
Use of copper sulfate pentahydrate is
not expected to increase the amount of
copper in the diet as a result of its use
on growing crops and post harvest use.
2. Infants and children. Copper is also
a component of the diet of infants and
children and also an essential element
of their diet. Since no endpoints of
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concern have been identified, EPA has
not conducted a quantitative risk
assessment for copper sulfate
pentahydrate. The Agency has also
determined that the special FQPA safety
factor to protect infants and children
was not needed since there are no
toxicity endpoints or uncertainty
surrounding exposure.
Based on the information in this
preamble, EPA concludes that there is a
reasonable certainty of no harm to the
general population, including infants
and children, from aggregate exposure
to copper sulfate pentahydrate residues.
VII. Other Considerations
A. Analytical Method
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. Existing Tolerance Exemptions
Copper sulfate pentahydrate has been
exempted from the requirement of a
tolerance under 40 CFR 180.1021 (c)
when applied to growing crops or to raw
agricultural commodities after harvest.
C. International Tolerances
The Agency is not aware of any
country requiring a tolerance for copper
sulfate pentahydrate nor have any
CODEX Maximum Residue Levels
(MRLs) been established for any food
crops at this time.
VIII. Conclusions
Based on the information contained in
the document, EPA concludes that there
is a reasonable certainty of no harm
from aggregate exposure to residues of
copper sulfate pentahydrate. According,
EPA finds that the exemption for
residues in or on meat, fat and meat byproducts of cattle, sheep, hogs, goats,
horses and poultry, milk and eggs when
applied as a bactericide/fungicide to
animal premises and bedding will be
safe.
IX. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the tolerance
requirement under FFDCA section
408(d) in response to a petition
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted
from review under Executive Order
12866 due to its lack of significance,
this rule is not subject to Executive
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Order 13211, Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001). This final rule
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to 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). Since
tolerances and exemptions that are
established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby
certifies that this rule will not have
significant negative economic impact on
a substantial number of small entities.
In addition, the Agency has determined
that this action will not have a
substantial direct effect on 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, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 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 final rule
directly regulates growers, food
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processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has
determined that this rule does not have
any ‘‘tribal implications’’ as described
in Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, 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.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
Dated: August 3, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1021 is amended by
revising paragraph (c) to read as follows:
I
§ 180.1021 Copper; exemption from the
requirement of a tolerance.
*
*
*
*
*
(c) Copper sulfate pentahydrate (CAS
Reg. No. 7758–99–8) is exempt from the
requirement of a tolerance when applied
as a fungicide to growing crops or to raw
agricultural commodities after harvest,
and as a bactericide/fungicide in or on
meat, fat and meat by-products of cattle,
sheep, hogs, goats, horses and poultry,
milk and eggs when applied as a
bactericide/fungicide to animal
premises and bedding.
*
*
*
*
*
[FR Doc. E6–13082 Filed 8–10–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
X. Congressional Review Act
[EPA–HQ–OPP–2005–0542; FRL–8081–8]
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 this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
Imidacloprid; Pesticide Tolerances
rwilkins on PROD1PC63 with RULES
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements, copper sulfate
pentahydrate.
VerDate Aug<31>2005
16:23 Aug 10, 2006
Jkt 208001
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
imidacloprid and its metabolites
containing the 6-chloropyridinyl
moiety, all expressed as the parent in or
on caneberry subgroup 13A; coffee,
green bean; seed of: Black mustard,
borage, crambe, field mustard, flax,
Indian mustard, Indian rapeseed,
rapeseed, safflower, and sunflower;
atemoya, biriba, cherimoya, custard
apple, ilama, soursop, and sugar apple;
almond hulls, pistachio and tree nut
group 14; pomegranate; banana; herbs
subgroup 19A dried; and herbs
subgroup 19A fresh. Interregional
Research Project No. 4 (IR–4), requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
This regulation is effective
August 11, 2006. Objections and
requests for hearings must be received
on or before October 10, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0542. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., 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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov..
SUPPLEMENTARY INFORMATION:
DATES:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
E:\FR\FM\11AUR1.SGM
11AUR1
]]>Agencies
[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Rules and Regulations]
[Pages 46106-46110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13082]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0314; FRL-8085-3]
Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various
Food and Feed Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance exemption for residues
of copper sulfate pentahydrate when applied in or on meat, fat and meat
by-products of cattle, sheep, hogs, goats, horses, poultry, milk and
eggs when applied as a bactericide/fungicide to animal premises and
bedding.
DATES: This regulation is effective August 11, 2006. Objections and
requests for hearings must be received on or before October 10, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0314. All documents in the
docket are listed on the regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
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.
[[Page 46107]]
Publicly available docket materials are available either in the
electronic docket at https://www.regulations.gov, or, if only available
in hard copy, at the Office of Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Marshall Swindell,
AntimicrobialsDivision (7510C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-6341; e-mail:
swindell.marshall@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0314 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 10, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0314, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 21, 2005 (70 FR 75807) (FRL-
7748-3), EPA issued a notice pursuant to section 408(d)(2) of Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the
Food Quality Protection Act (FQPA) (Public Law 104-107) announcing the
filing of a pesticide petition (PP 5F6982), by ArchAngel, LLC, 636
Hampshire St., Suite 208, Quincy, IL 62301. EPA did not receive any
public comments in response to this petition. The petition requested
that 40 CFR part 180 be amended to exempt from the requirement of a
tolerance residues of the bactericide/fungicide copper sulfate
pentahydrate when applied as a bactericide/fungicide in or on meat, fat
and meat by-products of cattle, sheep, hogs, goats, horses, poultry,
milk and eggs when applied as a bactericide/fungicide to animal
premises and bedding. Various copper containing substances, including
copper sulfate pentahydrate, have been exempted from tolerance
requirements for numerous uses. 40 CFR 180.1021 exempts the listed
copper compounds when applied, among other things, to growing crops as
well as shellfish, meat, milk, poultry, eggs, and irrigated crops.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which requires EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity,
[[Page 46108]]
completeness and reliability and the relationship of this information
to human risk. EPA has also considered available information concerning
the variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children. The nature of the toxic
effects caused by copper sulfate pentahydrate are discussed in this
unit.
There is adequate information available to characterize the
toxicity of the copper ion. Copper is ubiquitous in nature and is a
necessary nutritional element for both animals (including humans) and
plants. Copper is found naturally in the food we eat including fruits,
vegetables, meats and seafood. It is found in the water we drink, the
air we breathe and in our bodies themselves. Some of the environmental
copper is due to direct modification of the environment by man such as
mining and smelting of the natural ore. It is one of the elements found
essential to life. The National Academy of Science establishes
recommended daily allowances (RDAs) of vitamins and minerals for the
diet. The RDA for copper ranges from approximately 400 micrograms per
day ([mu]g/d) in young children to 900 [mu]g/d in adults. Additionally,
over-the-counter dietary supplements containing copper at levels
ranging from 0.33 milligram (mg) to 3 mg are available for individuals
with low levels of copper. The copper ion is present in the adult human
body with nearly two-thirds of the body copper content located in the
skeleton and muscle. The liver is the primary organ for the maintenance
of plasma copper concentrations.
Oral ingestion of excessive amounts of the copper ion from
pesticidal uses including the proposed use is unlikely. Copper
compounds are irritating to the gastric mucosa. Ingestion of large
amounts of copper results in prompt emesis. This protective reflex
reduces the amount of copper ion available for absorption into the
human body. Additionally, at high levels humans are also sensitive to
the taste of copper. Because of this organoleptic property, oral
ingestions would also serve to limit high doses.
Only a small percentage of ingested copper is absorbed, and most of
the absorbed copper is excreted. The human body appears to have
efficient mechanisms in place to regulate total body copper. The copper
ion occurs naturally in food and the metabolism of copper is well
understood. The Agency has conducted a risk assessment in connection
with the development and issuance of the Reregistration Eligibility
Decision Document for Copper (EPA-HQ-OPP-2005-0558; Human Health
Chapter). No endpoints of toxicology concern were identified for risk
assessment purposes for a number of reasons. One of the foremost of
these is the fact that copper is a required nutritional element for
both plants and animals. Indeed, current available data and literature
studies indicate that there is a greater risk from the deficiency of
copper intake than from excess intake. Copper also occurs naturally in
a number of food items including fruits, vegetables, meats and seafood.
Although there is little known about the minimum levels of dietary
copper necessary to cause evidence of adverse effect, this situation is
likely due to the existence of an effective homeostatic mechanism that
is involved in the dietary intake of copper and that protects man from
excess body copper. Given that copper is ubiquitous and is routinely
consumed as part of the daily diet, it is unlikely that with the
current exposure pattern there would be any long term adverse effects.
Finally, sulfate has little toxic effect and is routinely used in
medicine as a cathartic when combined with magnesium or sodium, the
only adverse manifestation from this use being dehydration if water
intake is concurrently limited.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide chemicals, the Agency considers the toxicity of the chemical
in conjunction with possible exposure to residues of the chemical
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure, an exemption from the requirement of a tolerance may be
established.
A. Dietary Exposure
Copper is ubiquitous in nature and is a necessary nutritional
element for both animals (including humans) and plants. It is one of
several elements found essential to life. The human body must have
copper to stay healthy. In fact, for a variety of biochemical processes
in the body to operate normally, copper must be part of our daily diet.
Copper is needed for certain critical enzymes to function in the body.
Actually, too little copper in the body can actually lead to disease.
1. Food. The main source of copper for infants, children, and
adults, regardless of age, is the diet. Copper is typically present in
mineral rich foods like vegetables (potato, legumes (beans and peas),
nuts (peanuts and pecans), grains (wheat and rye), fruits (peaches and
raisins), and chocolate in levels that range from 0.3 to 3.9 ppm. A
single day's diet may contain 10 mg or more of copper. The daily
recommended allowance of copper for adult nutritional needs is 2 mg. It
is not likely that the approval of this petition would significantly
increase exposure over that of the existing levels of copper.
2. Drinking water exposure. Copper is a natural element found in
the earth's crust. As a result, most of the world's surface water and
ground water that is used for drinking purposes contains copper. The
actual amount varies from region to region, depending on how much is
present in the earth, but in almost all cases the amount of copper in
water is extremely low. Naturally occurring copper in drinking water is
safe for human consumption, even in rare instances where it is at
levels high enough to impart a metallic taste to the water. Residues of
copper in drinking water are regulated under the Safe Drinking Water
Act. A Maximum Contaminant Level Goal of 1.3 ppm has been set by the
Agency for copper. According to the National Research Council's
Committee on Copper in Drinking Water, this level is ``set at a
concentration at which no known or expected adverse health effects
occur and for which there is an adequate margin of safety.'' The Agency
believes that this level of protection would not cause any potential
health problems, i.e. stomach and intestinal distress, liver and kidney
damage and anemia. It is not likely that the approval of this petition
would significantly increase exposure over that of the existing levels
of copper.
[[Page 46109]]
B. Other Non-Occupational Exposure
Copper compounds have many uses on crops (food as well as non-food)
and ornamentals as a fungicide.
Dermal exposure. Given the prevalence of copper in the environment,
no significant dermal exposure increase above current levels would be
expected from the non-occupational use of copper sulfate pentahydrate.
Inhalation exposure. Air concentrations of copper are relatively
low. A study based on several thousand samples assembled by EPA's
Environmental Monitoring Systems Laboratory showed copper levels
ranging from 0.003 to 7.32 micrograms per cubic meter. Other studies
indicated that air levels of copper are much lower. The Agency does not
expect the air concentrations of copper to be significantly affected by
the use of copper sulfate pentahydrate.
V. Cumulative Effects
The Agency believes that copper has no significant toxicity to
humans and that no cumulative adverse effects are expected from long-
term exposure to copper salts including copper sulfate pentahydrate.
For the purposes of this tolerance action, EPA has not assumed that
copper compounds have a common mechanism of toxicity with other
substances.
VI. Determination of Safety for U.S. Population, Infants and Children
Copper sulfate pentahydrate is considered as Generally Recognized
as Safe (GRAS) by the Food and Drug Administration (FDA). EPA has also
exempted various copper compounds from the requirement of a tolerance
when used as aquatic herbicides (40 CFR 180.1021). Copper compounds,
including copper sulfate pentahydrate, are also exempt from the
requirements of a tolerance when applied to growing crops when used as
a plant fungicide in accordance with good agricultural practices (40
CFR 180.1021).
1. U.S. population. Copper is a component of the human diet and an
essential element. In addition, no acute or chronic dietary end points
were selected because no endpoints of toxicological concerns have been
identified for risk assessment purposes. Use of copper sulfate
pentahydrate is not expected to increase the amount of copper in the
diet as a result of its use on growing crops and post harvest use.
2. Infants and children. Copper is also a component of the diet of
infants and children and also an essential element of their diet. Since
no endpoints of concern have been identified, EPA has not conducted a
quantitative risk assessment for copper sulfate pentahydrate. The
Agency has also determined that the special FQPA safety factor to
protect infants and children was not needed since there are no toxicity
endpoints or uncertainty surrounding exposure.
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to copper
sulfate pentahydrate residues.
VII. Other Considerations
A. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Existing Tolerance Exemptions
Copper sulfate pentahydrate has been exempted from the requirement
of a tolerance under 40 CFR 180.1021 (c) when applied to growing crops
or to raw agricultural commodities after harvest.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
copper sulfate pentahydrate nor have any CODEX Maximum Residue Levels
(MRLs) been established for any food crops at this time.
VIII. Conclusions
Based on the information contained in the document, EPA concludes
that there is a reasonable certainty of no harm from aggregate exposure
to residues of copper sulfate pentahydrate. According, EPA finds that
the exemption for residues in or on meat, fat and meat by-products of
cattle, sheep, hogs, goats, horses and poultry, milk and eggs when
applied as a bactericide/fungicide to animal premises and bedding will
be safe.
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, 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). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to 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). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. In addition, the Agency has determined that this action
will not have a substantial direct effect on 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, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 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 final rule directly regulates growers, food
[[Page 46110]]
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, 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.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
X. 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 this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements, copper sulfate pentahydrate.
Dated: August 3, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1021 is amended by revising paragraph (c) to read as
follows:
Sec. 180.1021 Copper; exemption from the requirement of a tolerance.
* * * * *
(c) Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt
from the requirement of a tolerance when applied as a fungicide to
growing crops or to raw agricultural commodities after harvest, and as
a bactericide/fungicide in or on meat, fat and meat by-products of
cattle, sheep, hogs, goats, horses and poultry, milk and eggs when
applied as a bactericide/fungicide to animal premises and bedding.
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[FR Doc. E6-13082 Filed 8-10-06; 8:45 am]
BILLING CODE 6560-50-S
