Document ID: EPA-HQ-OPP-2005-0314-0007
Agency: epa
Document Type: Rule
Title: Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various Food and Feed Commodities
Posted Date: 2006-08-11T12:51:41Z

[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Rules and Regulations]               
[Page 46106-46110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0314; FRL-8085-3]

 
Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various 
Food and Feed Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance exemption for residues 
of copper sulfate pentahydrate when applied in or on meat, fat and meat 
by-products of cattle, sheep, hogs, goats, horses, poultry, milk and 
eggs when applied as a bactericide/fungicide to animal premises and 
bedding.

DATES: This regulation is effective August 11, 2006. Objections and 
requests for hearings must be received on or before October 10, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0314. All documents in the 
docket are listed on the regulations.gov Web site. Although listed in 
the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form.

[[Page 46107]]

Publicly available docket materials are available either in the 
electronic docket at http://www.regulations.gov, or, if only available 

in hard copy, at the Office of Pesticide Programs (OPP) Regulatory 
Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA. The hours of operation of this Docket 
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Marshall Swindell, 
AntimicrobialsDivision (7510C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6341; e-mail: 
swindell.marshall@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0314 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before October 10, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0314, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 21, 2005 (70 FR 75807) (FRL-
7748-3), EPA issued a notice pursuant to section 408(d)(2) of Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-107) announcing the 
filing of a pesticide petition (PP 5F6982), by ArchAngel, LLC, 636 
Hampshire St., Suite 208, Quincy, IL 62301. EPA did not receive any 
public comments in response to this petition. The petition requested 
that 40 CFR part 180 be amended to exempt from the requirement of a 
tolerance residues of the bactericide/fungicide copper sulfate 
pentahydrate when applied as a bactericide/fungicide in or on meat, fat 
and meat by-products of cattle, sheep, hogs, goats, horses, poultry, 
milk and eggs when applied as a bactericide/fungicide to animal 
premises and bedding. Various copper containing substances, including 
copper sulfate pentahydrate, have been exempted from tolerance 
requirements for numerous uses. 40 CFR 180.1021 exempts the listed 
copper compounds when applied, among other things, to growing crops as 
well as shellfish, meat, milk, poultry, eggs, and irrigated crops.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity,

[[Page 46108]]

completeness and reliability and the relationship of this information 
to human risk. EPA has also considered available information concerning 
the variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children. The nature of the toxic 
effects caused by copper sulfate pentahydrate are discussed in this 
unit.
    There is adequate information available to characterize the 
toxicity of the copper ion. Copper is ubiquitous in nature and is a 
necessary nutritional element for both animals (including humans) and 
plants. Copper is found naturally in the food we eat including fruits, 
vegetables, meats and seafood. It is found in the water we drink, the 
air we breathe and in our bodies themselves. Some of the environmental 
copper is due to direct modification of the environment by man such as 
mining and smelting of the natural ore. It is one of the elements found 
essential to life. The National Academy of Science establishes 
recommended daily allowances (RDAs) of vitamins and minerals for the 
diet. The RDA for copper ranges from approximately 400 micrograms per 
day ([mu]g/d) in young children to 900 [mu]g/d in adults. Additionally, 
over-the-counter dietary supplements containing copper at levels 
ranging from 0.33 milligram (mg) to 3 mg are available for individuals 
with low levels of copper. The copper ion is present in the adult human 
body with nearly two-thirds of the body copper content located in the 
skeleton and muscle. The liver is the primary organ for the maintenance 
of plasma copper concentrations.
    Oral ingestion of excessive amounts of the copper ion from 
pesticidal uses including the proposed use is unlikely. Copper 
compounds are irritating to the gastric mucosa. Ingestion of large 
amounts of copper results in prompt emesis. This protective reflex 
reduces the amount of copper ion available for absorption into the 
human body. Additionally, at high levels humans are also sensitive to 
the taste of copper. Because of this organoleptic property, oral 
ingestions would also serve to limit high doses.
    Only a small percentage of ingested copper is absorbed, and most of 
the absorbed copper is excreted. The human body appears to have 
efficient mechanisms in place to regulate total body copper. The copper 
ion occurs naturally in food and the metabolism of copper is well 
understood. The Agency has conducted a risk assessment in connection 
with the development and issuance of the Reregistration Eligibility 
Decision Document for Copper (EPA-HQ-OPP-2005-0558; Human Health 
Chapter). No endpoints of toxicology concern were identified for risk 
assessment purposes for a number of reasons. One of the foremost of 
these is the fact that copper is a required nutritional element for 
both plants and animals. Indeed, current available data and literature 
studies indicate that there is a greater risk from the deficiency of 
copper intake than from excess intake. Copper also occurs naturally in 
a number of food items including fruits, vegetables, meats and seafood. 
Although there is little known about the minimum levels of dietary 
copper necessary to cause evidence of adverse effect, this situation is 
likely due to the existence of an effective homeostatic mechanism that 
is involved in the dietary intake of copper and that protects man from 
excess body copper. Given that copper is ubiquitous and is routinely 
consumed as part of the daily diet, it is unlikely that with the 
current exposure pattern there would be any long term adverse effects.
    Finally, sulfate has little toxic effect and is routinely used in 
medicine as a cathartic when combined with magnesium or sodium, the 
only adverse manifestation from this use being dehydration if water 
intake is concurrently limited.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide chemicals, the Agency considers the toxicity of the chemical 
in conjunction with possible exposure to residues of the chemical 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure, an exemption from the requirement of a tolerance may be 
established.

A. Dietary Exposure

    Copper is ubiquitous in nature and is a necessary nutritional 
element for both animals (including humans) and plants. It is one of 
several elements found essential to life. The human body must have 
copper to stay healthy. In fact, for a variety of biochemical processes 
in the body to operate normally, copper must be part of our daily diet. 
Copper is needed for certain critical enzymes to function in the body. 
Actually, too little copper in the body can actually lead to disease.
    1. Food. The main source of copper for infants, children, and 
adults, regardless of age, is the diet. Copper is typically present in 
mineral rich foods like vegetables (potato, legumes (beans and peas), 
nuts (peanuts and pecans), grains (wheat and rye), fruits (peaches and 
raisins), and chocolate in levels that range from 0.3 to 3.9 ppm. A 
single day's diet may contain 10 mg or more of copper. The daily 
recommended allowance of copper for adult nutritional needs is 2 mg. It 
is not likely that the approval of this petition would significantly 
increase exposure over that of the existing levels of copper.
    2. Drinking water exposure. Copper is a natural element found in 
the earth's crust. As a result, most of the world's surface water and 
ground water that is used for drinking purposes contains copper. The 
actual amount varies from region to region, depending on how much is 
present in the earth, but in almost all cases the amount of copper in 
water is extremely low. Naturally occurring copper in drinking water is 
safe for human consumption, even in rare instances where it is at 
levels high enough to impart a metallic taste to the water. Residues of 
copper in drinking water are regulated under the Safe Drinking Water 
Act. A Maximum Contaminant Level Goal of 1.3 ppm has been set by the 
Agency for copper. According to the National Research Council's 
Committee on Copper in Drinking Water, this level is ``set at a 
concentration at which no known or expected adverse health effects 
occur and for which there is an adequate margin of safety.'' The Agency 
believes that this level of protection would not cause any potential 
health problems, i.e. stomach and intestinal distress, liver and kidney 
damage and anemia. It is not likely that the approval of this petition 
would significantly increase exposure over that of the existing levels 
of copper.

[[Page 46109]]

B. Other Non-Occupational Exposure

    Copper compounds have many uses on crops (food as well as non-food) 
and ornamentals as a fungicide.
    Dermal exposure. Given the prevalence of copper in the environment, 
no significant dermal exposure increase above current levels would be 
expected from the non-occupational use of copper sulfate pentahydrate.
    Inhalation exposure. Air concentrations of copper are relatively 
low. A study based on several thousand samples assembled by EPA's 
Environmental Monitoring Systems Laboratory showed copper levels 
ranging from 0.003 to 7.32 micrograms per cubic meter. Other studies 
indicated that air levels of copper are much lower. The Agency does not 
expect the air concentrations of copper to be significantly affected by 
the use of copper sulfate pentahydrate.

V. Cumulative Effects

    The Agency believes that copper has no significant toxicity to 
humans and that no cumulative adverse effects are expected from long-
term exposure to copper salts including copper sulfate pentahydrate. 
For the purposes of this tolerance action, EPA has not assumed that 
copper compounds have a common mechanism of toxicity with other 
substances.

VI. Determination of Safety for U.S. Population, Infants and Children

    Copper sulfate pentahydrate is considered as Generally Recognized 
as Safe (GRAS) by the Food and Drug Administration (FDA). EPA has also 
exempted various copper compounds from the requirement of a tolerance 
when used as aquatic herbicides (40 CFR 180.1021). Copper compounds, 
including copper sulfate pentahydrate, are also exempt from the 
requirements of a tolerance when applied to growing crops when used as 
a plant fungicide in accordance with good agricultural practices (40 
CFR 180.1021).
    1. U.S. population. Copper is a component of the human diet and an 
essential element. In addition, no acute or chronic dietary end points 
were selected because no endpoints of toxicological concerns have been 
identified for risk assessment purposes. Use of copper sulfate 
pentahydrate is not expected to increase the amount of copper in the 
diet as a result of its use on growing crops and post harvest use.
    2. Infants and children. Copper is also a component of the diet of 
infants and children and also an essential element of their diet. Since 
no endpoints of concern have been identified, EPA has not conducted a 
quantitative risk assessment for copper sulfate pentahydrate. The 
Agency has also determined that the special FQPA safety factor to 
protect infants and children was not needed since there are no toxicity 
endpoints or uncertainty surrounding exposure.
    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm to the general population, 
including infants and children, from aggregate exposure to copper 
sulfate pentahydrate residues.

VII. Other Considerations

A. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. Existing Tolerance Exemptions

    Copper sulfate pentahydrate has been exempted from the requirement 
of a tolerance under 40 CFR 180.1021 (c) when applied to growing crops 
or to raw agricultural commodities after harvest.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
copper sulfate pentahydrate nor have any CODEX Maximum Residue Levels 
(MRLs) been established for any food crops at this time.

VIII. Conclusions

    Based on the information contained in the document, EPA concludes 
that there is a reasonable certainty of no harm from aggregate exposure 
to residues of copper sulfate pentahydrate. According, EPA finds that 
the exemption for residues in or on meat, fat and meat by-products of 
cattle, sheep, hogs, goats, horses and poultry, milk and eggs when 
applied as a bactericide/fungicide to animal premises and bedding will 
be safe.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. The Agency hereby certifies that this rule will not 
have significant negative economic impact on a substantial number of 
small entities. In addition, the Agency has determined that this action 
will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food

[[Page 46110]]

processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements, copper sulfate pentahydrate.

    Dated: August 3, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1021 is amended by revising paragraph (c) to read as 
follows:

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

* * * * *
    (c) Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt 
from the requirement of a tolerance when applied as a fungicide to 
growing crops or to raw agricultural commodities after harvest, and as 
a bactericide/fungicide in or on meat, fat and meat by-products of 
cattle, sheep, hogs, goats, horses and poultry, milk and eggs when 
applied as a bactericide/fungicide to animal premises and bedding.
* * * * *
[FR Doc. E6-13082 Filed 8-10-06; 8:45 am]

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