EPA EXEMPTION: Copper (II) Hydroxide; Exemption from the Requirement of a Tolerance
-------------------------
FREQUENT SYMPTOMS AND SIGNS OF COPPER HYDROXIDE POISONING
All of these salts (including copper hydroxide) irritate the skin and eyes and damage mucous membranes. When ingested, they are powerfully emetic: the stomach usually empties promptly and automatically in fully conscious individuals. When retained and absorbed, toxic injury affects the gastrointestinal lining, capillaries, brain, liver, kidney, and formed elements of the blood. Copper salts are hemolytic.
Manifestations of poisoning include burning in the chest and abdomen, intense nausea, vomiting, diarrhea, headache, sweating and shock. Later, the liver is enlarged. Jaundice may reflect hemolysis or liver damage or both. Anuria indicates kidney injury by copper and/or free hemoglobin. Death may occur from convulsions, coma, or hepatorenal failure. Elevated serum copper levels (maximum normal level is 125 ug per 100 ml) indicate severity of poisoning (25).
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[Federal Register: January 28, 2004 (Volume 69, Number 18)]
[Rules and Regulations]
[Page 4065-4069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja04-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0356; FRL-7341-1]
Copper (II) Hydroxide; Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of copper (II) hydroxide on raw
agricultural commodities when used as an inert ingredient (for pH
control) in pesticide products. Syngenta Crop Protection submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of copper (II) hydroxide.
DATES: This regulation is effective January 28, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0356,
must be received on or before March 29, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address:
campbell.princess@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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0356. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2,
1921 Jefferson Davis Hwy., Arlington, VA. This 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.
2. 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/ A frequently updated electronic version of 40 CFR part 180 is available at
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of July 2, 2003 (68 FR 39554) (FRL-7315-2),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA (Public Law 104-170), announcing the filing of a
pesticide tolerance petition (PP 2E6471) by Syngenta Crop Protection,
P.O. Box 18300, Greensboro, North Carolina 27419-8300. The notice
included a summary of the petition prepared by the petitioner Syngenta
Crop Protection. There were no comments received in response to the
notice of filing.
The petition requested that 40 CFR 180.1021 be amended by
establishing an exemption from the requirement of a tolerance for
residues of copper (II) hydroxide (CAS Reg. No. 20427-59-2).
Section 408(b)(2)(A)(i) of 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(b)(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. Section 408(b)(2)(C) 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. Human Health Assessment
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, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the
[[Page 4066]]
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children. The nature of the toxic
effects caused by copper (II) hydroxide are discussed in this unit.
However, for copper (II) hydroxide, toxicity has not been assessed
based on the results of animal toxicity data. As discussed below the
toxicity is characterized by a discussion of the use of an hydroxide as
a neutralizing agent, the natural occurrence of copper, and the highly
reactive nature of any hydroxide.
In formulating a pesticide product, a basic chemical such as copper
(II) hydroxide serves a specific purpose, that of a neutralizing agent
or a pH adjuster. During the manufacture of a pesticide product (or, in
fact, many industrial chemicals), it may be necessary to adjust the pH
of the product. A base functions as a neutralizing agent when the
hydroxyl ion combines with the H+ in an acidic solution to
form a molecule of water. Small amounts of the hydroxide would be added
to the solution until a neutral pH is reached. After the pH adjustment
is performed and the neutralization reaction occurs, copper (II)
hydroxide is no longer present. The reaction products that are then
present are the copper (II) positively charged ion and water.
Alternatively, it might be necessary to have a pesticide product
maintain a basic pH; thus, the copper hydroxide would be added during
the manufacturing process to deliberately raise the pH, which would
mean an excess of the hydroxyl ion. Such products are not likely to be
sold to the residential market.
On November 15, 2000, the Agency published in the Federal Register
(65 FR 68908) (FRL-6747-3) a final rule establishing a tolerance
exemption for copper sulfate pentahydrate. That final rule discussed
the Agency's evaluation of the toxicity of copper which is also
applicable to copper (II) hydroxide. As stated in that final rule,
copper is a naturally-occurring material, i.e. ubiquitous in nature, is
a necessary nutritional element, and is found naturally in the food we
consume for nutrition. Oral ingestion of excessive amounts of the
copper ion from pesticidal use is very unlikely. In fact, if large
amounts of copper are ingested prompt emesis will occur. This is the
body's protective reflex.
As a chemical class, hydroxides are significantly different from
many of the chemicals regulated as inert ingredients in pesticide
products. First, hydroxides are highly corrosive. Due to this property,
toxicity testing can only be performed on very diluted solutions.
Therefore, toxicity studies performed with undiluted copper (II)
hydroxide are not available. Second, hydroxides are highly reactive,
and therefore are not expected to be persistent in the food supply, the
environment, or in water resources. Copper (II) hydroxide would be
expected to dissociate and immediately react with both plant and animal
materials.
Chemically, an hydroxide is known as a base, a substance that when
dissolved in water yields hydroxyl (OH-1) ions. The increase
of the concentration of the OH-1 ion raises the pH. It is
the hydroxyl ion that is highly reactive, thus displaying the corrosive
characteristic. The consequences of acute exposure to hydroxides are
well understood: They are corrosive to the eyes, the skin, and the
respiratory tract. The hazard of any hydroxide chemical derives
directly from and is due to these irritation and caustic effects.
Copper (II) hydroxide is not considered to be a strong base. The
strongest bases (the most reactive) are those of the alkali metal and
alkali earth groups, such as sodium, potassium, calcium, and magnesium.
Even the strongest base hydroxides, however, have been approved by the
Food and Drug Administration (FDA) for many uses including direct use
in the food supply. In fact FDA has evaluated the following hydroxides
and determined that the following substances are GRAS (generally
recognized as safe) when used as direct food additives.
------------------------------------------------------------------------
Chemical FDA GRAS Citation GRAS Use Pattern
------------------------------------------------------------------------
Ammonium hydroxide.............. 21 CFR 184.1139... Leavening agent,
pH control agent,
surface-finishing
agent, boiler
water additive
------------------------------------------------------
Calcium hydroxide............... 21 CFR 184.1205... (No limitations
specified)
------------------------------------------------------
Magnesium hydroxide............. 21 CFR 184.1428... Nutrient
supplement, pH
control agent,
processing aid
------------------------------------------------------
Potassium hydroxide............. 21 CFR 184.1631... Formulation aid,
pH control agent,
processing aid,
stabilizer and
thickener
------------------------------------------------------
Sodium hydroxide................ 21 CFR 184.1763... pH control agent,
processing aid
------------------------------------------------------------------------
There is no available information on any hydroxide chemical
indicative of a human health hazard from the ingestion of food directly
treated with these hydroxides resulting from the FDA GRAS uses.
According to FDA, no data were found ``. . . suggesting that the use of
sodium or potassium hydroxides, as currently practiced in food
processing, is hazardous to consumers. The corrosive effect of
ingestion of large amounts of strong alkalis such as sodium and
potassium hydroxides has been amply demonstrated. However, these
alkalis are not present as such in foods as consumed. The small amounts
added for pH adjustment during food processing react rapidly with food
acids to form neutral salts. Moreover, any free alkali that might be
present in food . . . is converted to neutral salts in the stomach.''
Given the structural similarities of copper (II) hydroxide and the
stronger bases evaluated in the FDA GRAS evaluation, there is no
expectation that copper (II) hydroxide would react in a different
manner. Thus, the likelihood of any unreacted copper (II) hydroxide
being available in the food supply is extremely unlikely.
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).
A. Dietary Exposure
1. Food. Copper is ubiquitous in nature and is a necessary
nutritional element for both animals (including
[[Page 4067]]
humans) and plants. It is 1 of 26 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 diet. Copper is needed for certain critical enzymes to
function in the body. Too little copper in the body can actually lead
to disease.
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 (peach and
raisins), and chocolate in levels ranging from 0.3 to 3.9 parts per
million (ppm). A single day's diet may contain 10 milligrams (mg) or
more of copper. The daily recommended allowance of copper for adults'
nutritional needs ranges from 2 to 3 mg/day.
Given the widespread occurrence of copper and hydroxides in the
existing food supply, the amount of copper (II) hydroxide that can be
applied to food as a result of a use in a pesticide product would not
be expected to significantly increase the existing amounts of either
copper or hydroxide in the food supply. The EPA-regulated uses as an
inert ingredient in a pesticide product would be considerably less than
all of the FDA GRAS uses of hydroxides. More importantly, generally all
of hydroxide used as an inert ingredient would either be neutralized in
the pesticide solution or in the environment prior to any human
exposure.
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.
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. The Agency has set a maximum
contaminant level (MCL) for copper in drinking water at 1.3 ppm.
As previously stated, hydroxides, including copper (II) hydroxide,
are not expected to be persistent in the environment, or in water
resources. Copper (II) hydroxide would be expected to dissociate, react
with organic or inorganic materials, and complex with ionic substrates.
B. Other Non-Occupational Exposure
Copper is a naturally occurring element present in the earth's
crust, and it is therefore naturally occurring in soil, water, and air.
Soils would be considered copper deficient if they contain less than 1
to 2 ppm available copper in the context of plant health. 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.
As a group, hydroxides constitute a group of chemicals with many
industrial uses. However, considering the reactivity and corrosivity of
any hydroxide, there are few uses of even diluted solutions of
hydroxides in and around the home.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA does not have, at this
time, available data to determine whether copper (II) hydroxide has a
common mechanism of toxicity with other substances. Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to copper (II) hydroxide and any other
substances, and copper (II) hydroxide does not appear to produce toxic
metabolites produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that copper (II)
hydroxide has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.
VI. Determination of Safety for U.S. Population, Infants and Children
Copper is a naturally occurring element present in the earth's
crust, and it is therefore naturally occurring in soil, water, and air.
Copper is a component of the diet of all humans (including infants and
children). Copper is an essential trace element for which the National
Academy of Sciences has issued a recommended daily allowance (RDA)
ranging from 2 to 3 mg/day for adults. The RDA reflects a level needed
to avoid nutritional deficiencies, not an upper limit. The Agency
believes that copper has no significant toxicity to humans. Given the
ubiquitous nature of copper, there is reasonable certainty that no harm
will result from the aggregate exposure of the U.S. population to
copper.
Given the ubiquitous nature of copper, there is reasonable
certainty that no harm will result from the aggregate exposure of
infants and children to copper. A safety factor analysis has not been
used to assess the risk. The additional tenfold safety factor for the
protection of infants and children is unnecessary.
Hydroxide chemicals have been used in the food supply for a number
of years. Use of various hydroxides as direct food additives has been
reviewed by FDA and granted GRAS status. Given the structural
similarities of copper (II) hydroxide and the stronger bases evaluated
in the FDA GRAS evaluations, it is expected that copper (II) hydroxide
would react in a similar manner. No significant exposure to copper (II)
hydroxide is expected from use of copper hydroxide as an inert
ingredient in pesticide products. It is extremely unlikely that use of
copper (II) hydroxide in pesticide products will lead to any unreacted
copper (II) hydroxide in the food supply.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. . . .'' EPA has been working with
interested stakeholders to develop a screening and testing program as
well as a priority setting scheme. As the Agency proceeds with
implementation of this program, further testing of products containing
copper (II) hydroxide (for endocrine effects) may be required.
B. Analytical Method(s)
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.
C. Existing Tolerances
Copper (II) hydroxide has been exempted from the requirement of a
tolerance under 40 CFR 180.1021(b)
[[Page 4068]]
when applied (primarily) as a fungicide to growing crops.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
copper (II) hydroxide, and no CODEX maximum residue levels have been
established for any food crops at this time.
VIII. Conclusions
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
copper (II) hydroxide. Accordingly, EPA finds that exempting copper
(II) hydroxide (CAS Reg. No. 20427-59-2) from the requirement of a
tolerance will be safe.
IX. Objections and Hearing Requests
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. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d), as
was provided in the old FFDCA sections 408 and 409. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0356 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 March 29,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall
2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0356, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.1. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. 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
[[Page 4069]]
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.
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
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.
XI. 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.
Dated: January 12, 2004.
Lois Rossi,
Director, Registration 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), 346(a) and 371.
0
2. Section 180.1021 is amended by adding paragraph (d) to read as
follows:
Sec. 180.1021 Copper; exemption from the requirement of a tolerance.
* * * * *
(d) Copper (II) hydroxide (CAS Reg. No. 20427-59-2) is exempt from
the requirement of a tolerance when applied to growing crops or to raw
agricultural commodities as an inert ingredient (for pH control) in
pesticide products.
[FR Doc. 04-1376 Filed 1-27-04; 8:45 am]
BILLING CODE 6560-50-S