[Federal Register Volume 65, Number 221 (Wednesday, November 15, 2000)]
[Rules and Regulations]
[Pages 68908-68912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28715]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301060; FRL-6747-3]
RIN 2070-AB78


Copper Sulfate Pentahydrate; Exemption from the Requirement of a 
Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes an exemption from the requirement 
of a tolerance for residues of copper sulfate pentahydrate when applied 
as a fungicide to raw agricultural commodities after harvest. Magna Bon 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act of 1996 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of copper sulfate pentahydrate. In this final rule, the 
Agency is also reordering the structure of 40 CFR 180.1001(b)(1) and 
180.1021 to group most of the copper exemptions together. The 
reordering does not change the regulatory status of these chemicals.

DATES:  This regulation is effective November 15, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301060 
must be received by EPA on or before January 16, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301060 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8373; and e-mail address: 
<a href="/cdn-cgi/l/email-protection#76171a050219185802041300173613061758111900"><span class="__cf_email__" data-cfemail="98f9f4ebecf7f6b6eceafdeef9d8fde8f9b6fff7ee">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                      Affected  Entities
------------------------------------------------------------------------
Industry........................  111                 Crop production
  ..............................  112                 Animal production
  ..............................  311                 Food manufacturing
  ..............................  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 68909]]

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301060. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 14, 1999 (64 FR 37972) (FRL -6085-
5), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide petition (PP 8F4982) by Magna Bon Corporation, 
3213 Ocean Drive, Vero Beach, Florida 32963. This notice included a 
summary of the petition prepared by the petitioner. There were no 
comments received in response to the notice of filing. Various copper 
containing substances have been exempted from tolerance requirements 
for numerous uses. 40 CFR 180.1001 (b) (1) exempts the listed copper 
compounds when applied to growing crops. However, these substances are 
not exempted from the requirement of a tolerance when applied to a crop 
at the time of or after harvest. Other exempted uses of copper include 
harvested fish and shellfish, meat, milk, poultry, eggs, and irrigated 
crops as specified in 40 CFR 180.1021. The petition requested that 
copper sulfate pentahydrate be exempted from the requirement of a 
tolerance when applied to raw agricultural commodities at 0.050 ppm. 
The Agency does not generally grant an exemption from the requirement 
of tolerance with a numerical limitation.
    Section 408(b)(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(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. 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, 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, in the water we 
drink, in 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 26 
elements found essential to life. The copper ion is present in the 
adult human body at levels of 80-150 mg.
    Oral ingestion of excessive amounts of the copper ion from 
pesticidal uses 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 ingestion 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 copper ion occurs naturally in 
many foods and the metabolism of copper is well understood. The Agency 
published a registration standard for copper sulfate in 1985. As 
indicated in the registration standard, there are several factors 
unique to copper which indicate that specific studies to fulfill the 
usual data requirements are not necessary to regulate copper sulfate as 
a pesticide. One of the foremost of these is the fact that copper is a 
required nutritional element for both plants and animals. It appears 
that more evidence is available to define the adverse effects of a 
deficiency in the diet than to show the toxic effects of an excess 
intake; in fact, no account has been found in the literature reviewed 
which describes a toxic effect to normal humans from ingestion of 
common foodstuffs containing copper. Because copper toxicity to man 
through the diet has not been shown in normal persons, little is known 
about the minimum levels of dietary copper necessary to cause evidence 
of adverse effects. This situation is likely due, to an effective 
homeostatic mechanism that is involved in the dietary intake of copper 
and that protects man from excess body copper. This complex mechanism 
integrates absorption, retention, and excretion to stabilize the copper 
body burden. Given that copper is ubiquitous and is routinely consumed 
as part of the daily diet, it is unlikely that with current exposure 
patterns there would be any long term adverse effects.

[[Page 68910]]

    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 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 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.
    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 (peach and 
raisins), and chocolate in levels ranging 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 adults 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. The Agency 
has set a maximum contaminant level for copper at 1.3 ppm because 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.

B. Other Non-Occupational Exposure

    Copper compounds have many uses on crops (food as well as non food) 
and ornamentals as a fungicide.
    1. Dermal exposure. Given the prevalence of copper in the 
environment, no significant increase above current levels would be 
expected from the dermal non-occupational use of copper sulfate 
pentahydrate.
    2. 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 
indicate that air levels of copper are much lower. The Agency does not 
expect the air concentration 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. 
EPA does not have, at this time, available data to determine whether 
copper compounds have a common mechanism of toxicity with other 
substances or how to include this inert ingredient in a cumulative risk 
assessment. 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. EPA has exempted 
various copper compounds from the requirement of a tolerance when used 
as aquatic herbicides (40 CFR 180.1021). Copper compounds 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 180.1001 (b)(1)).
    1. U.S. population. Copper is a component of the human diet and an 
essential element. 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. 
Because of copper's low toxicity, EPA has not used a safety factor 
approach to analyze the safety of copper sulfate pentahydrate used in 
growing crops as well as post harvest. For similar reasons, an 
additional ten-fold margin of safety is not necessary for the 
protection of infants and children.
    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(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.

B. Existing Tolerance Exemptions

    Copper sulfate pentahydrate has been exempted from the requirement 
of a tolerance under 40 CFR 180.1001(b)(1) when applied to growing 
crops.

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 in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from

[[Page 68911]]

aggregate exposure to residues of copper sulfate pentahydrate. 
Accordingly, EPA finds that exempting post harvest uses of copper 
sulfate pentahydrate from the requirement of a tolerance will be safe. 
Although the petitioner requested an exemption with a maximum residue 
limit, the Agency does not generally grant an exemption from the 
requirement of a tolerance with a numerical limitation. Given the lack 
of toxicity of this compound, EPA is following its general practice of 
not establishing a numerical limitation with this exemption.
    In examining the existing tolerance exemptions for copper 
compounds, it was observed that the exemptions from the requirement of 
a tolerance are in two places in the Code of Federal Regulations, 40 
CFR 180.1001 (b)(1) and 40 CFR 180.1021. For ease of use, all of these 
exemptions from the requirement of a tolerance are being placed in 
180.1021. While reordering of the structure of the CFR is occurring, 
there have not been any changes with respect to the exemptions from the 
requirement of a tolerance of these copper compounds. However, copper 
sulfate pentahydrate is now exempt from the requirement of a tolerance 
when applied as a fungicide to growing crops or to raw agricultural 
commodities after harvest.

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 of 1996, 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 control number OPP-301060 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 January 
16, 2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
    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 email at <a href="/cdn-cgi/l/email-protection#e4908b89948f8d8a97ca8e8d89a4819485ca838b92"><span class="__cf_email__" data-cfemail="b2c6dddfc2d9dbdcc19cd8dbdff2d7c2d39cd5ddc4">[email protected]</span></a>, 
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.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.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.2. Mail 
your copies, identified by docket control number OPP-301060, 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.2. You may also send an electronic copy of your 
request via e-mail to: <a href="/cdn-cgi/l/email-protection#f19e8181dc959e929a9485b1948190df969e87"><span class="__cf_email__" data-cfemail="d4bba4a4f9b0bbb7bfb1a094b1a4b5fab3bba2">[email protected]</span></a>. 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 file format 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. Regulatory Assessment Requirements

    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). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork

[[Page 68912]]

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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low Income 
Populations (59 FR 7629, February 16, 1994); or require 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).

XI. Submission to Congress and the Comptroller General

    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:October 31, 2000.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


Sec. 180.1001  [Amended]

    2. Section 180.1001 is amended by removing and reserving the text 
of paragraph (b)(1).
    3. Section 180.1021 is revised to read as follows:


Sec. 180.1021  Copper; exemption from the requirement of a tolerance.

    (a) Copper is exempted from the requirement of a tolerance in meat, 
milk, poultry, eggs, fish, shellfish, and irrigated crops when it 
results from the use of:
    (1) Copper sulfate as an algicide or herbicide in irrigation 
conveyance systems and lakes, ponds, reservoirs, or bodies of water in 
which fish or shellfish are cultivated.
    (2) Basic copper carbonate (malachite) as an algicide or herbicide 
in impounded and stagnant bodies of water
    (3) Copper triethanolamine and copper monoethanolamine as an 
algicide or herbicide in fish hatcheries, lakes, ponds, and reservoirs
    (4) Cuprous oxide bearing antifouling coatings for control of algae 
or other coatings for control of algae or other organisms on submerged 
concrete or other (irrigation) structures.
    (b) The following copper compounds are exempt from the requirement 
of a tolerance when applied (primarily) as a fungicide to growing crops 
using good agricultural practices: Bordeaux mixture, basic copper 
carbonate (malachite) (CAS Reg. No. 1184-64-1), copper ethylenediamine 
complex, copper hydroxide (CAS Reg. No. 20427-59-2), copper lime 
mixtures, copper linoleate (CAS Reg. No. 7721-15-5), copper octanoate 
(CAS Reg. No. 20543-04-8), copper oleate (CAS Reg. No. 10402-16-1), 
copper oxychloride (CAS Reg. No. 1332-40-7), copper sulfate basic (CAS 
Reg. No. 1344-73-6), cupric oxide (CAS Reg. No. 1317-38-0), and cuprous 
oxide (CAS Reg. No. 1317-19-1).
    (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.
[FR Doc. 00-28715 Filed 11-14-00; 8:45 am]
BILLING CODE 6560-50-S


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