[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Rules and Regulations]
[Pages 4065-4069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1376]


-----------------------------------------------------------------------

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: 
[email protected].

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 [email protected], 
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: [email protected]. 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