80 FR 37547 - Cuprous Oxide; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 126 (July 1, 2015)

This regulation amends the tolerance exemption for copper in/ on meat, milk, poultry, eggs, fish, shellfish, and irrigated crops when it results from the use of cuprous oxide embedded in polymer emitter heads used in irrigation systems for root incursion prevention. This regulation eliminates the need to establish a maximum permissible level for residues of copper resulting from this use of cuprous oxide.

[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Rules and Regulations]
[Pages 37547-37551]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16224]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0865; FRL-9929-51]


Cuprous Oxide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerance exemption for copper in/
on meat, milk, poultry, eggs, fish, shellfish, and irrigated crops when 
it results from the use of cuprous oxide embedded in polymer emitter 
heads used in irrigation systems for root incursion prevention. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of copper resulting from this use of cuprous oxide.

DATES: This regulation is effective July 1, 2015. Objections and 
requests for hearings must be received on or before August 31, 2015, 
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: The docket for this action, identified by docket 
identification (ID)

[[Page 37548]]

number EPA-HQ-OPP-2014-0865, is available at http://www.regulations.gov 
or at the Office of Pesticide Programs Regulatory Public Docket (OPP 
Docket) in the Environmental Protection Agency Docket Center (EPA/DC), 
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. 
NW., Washington, DC 20460-0001. The Public Reading Room is open from 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jennifer McLain, Antimicrobials 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 308-0293; email 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under Federal Food, Drug and Cosmetic Act (FFDCA) section 408(g), 
21 U.S.C. 346a, any person may file an objection to any aspect of this 
regulation and may also request a hearing on those objections. 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-
2014-0865 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before August 31, 2015. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0865, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of April 22, 2015 (80 FR 22466) (FRL-9925-
79), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 4F8324) by Cupron, Inc., 800 East Leigh St., Richmond, VA 
23219. The petition requested that 40 CFR 180.1021 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of copper in/on meat, milk, poultry, eggs, fish, shellfish, 
and irrigated crops by including the use of cuprous oxide (also 
referred to as copper oxide) embedded in polymer emitter heads used in 
irrigation systems for agricultural crops or residential food 
commodities for algicidal or root incursion prevention. That document 
referenced a summary of the petition prepared by Cupron, Inc., which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Section 408(c)(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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA 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 FFDCA 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 
FFDCA 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 FFDCA section 408(b)(2)(D), 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 cuprous 
oxide are discussed in this unit.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of

[[Page 37549]]

the studies 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. 
Specific information on the studies received and the nature of the 
adverse effects caused by cuprous oxide, as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed adverse effect-
level (LOAEL) from the toxicity studies, are discussed in the final 
rule published in the Federal Register of August 11, 2006 (71 FR 46106) 
(FRL-8085-3). 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 humans such 
as mining and smelting of the natural ore. It is one of the elements 
found essential to life. 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.
    The 2006 Reregistration Eligibility Decision for Copper compounds 
reviewed and summarized all toxicity studies submitted for copper and 
has determined that the toxicological database is sufficient to assess 
the hazard from pesticides containing copper. Copper generally has 
moderate to low acute toxicity based on acute oral, dermal, and 
inhalation studies in animals. All effects resulting from acute 
exposure to copper containing pesticides are due to acute body 
responses to minimize excessive absorption or exposure to copper. 
Current available data in animals do not show any evidence of upper 
limit toxicity level that warrant determining acute toxicity end 
points.
    Based on available data summarized in the ``2006 Reregistration 
Eligibility Decision for Coppers'', there is no evidence of any 
dietary, oral, and dermal or inhalation adverse effects warranting 
quantitative assessment of sub-chronic or chronic risk. Available 
short-term feeding studies with rats and mice indicate decreased food 
and water intake with increasing oral concentrations of copper. 
Irritation of the stomach was seen at higher copper concentrations. 
Longer-term feeding studies indicate decreased feed intake with 
reductions in body weight gains, and increased copper concentration of 
the liver. Available reproductive and developmental studies by the oral 
route of exposure generally indicate that the main concern in animals 
for reproductive and teratogenic effects of copper has usually been 
associated with the deficiency rather than the excess of copper.
    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 
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 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.

B. Toxicological Points of Departure/Levels of Concern

    No endpoints of toxicological concern were identified for risk 
assessment purposes for copper oxide. Cuprous oxide readily hydrolyzes 
into the copper cation and oxygen anion. Copper is a required essential 
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, meats, seafood, and vegetables. In humans, as part of the 
utilization of copper as an essential nutrient, there is an effective 
homeostatic mechanism that is involved in the dietary intake of copper 
and that protects humans from excess body copper. Given that copper is 
ubiquitous, is an essential nutrient, and is routinely consumed as part 
of the daily diet, exposure to copper as a result of the use of copper 
oxide as a pesticide chemical would not be of toxicological concern.

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

    Copper is ubiquitous in nature and is 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 parts per 
million (ppm). A single day's diet may contain 10 milligram (mg) or 
more of copper. It is not likely that the approval of this petition 
would significantly increase exposure over that of existing levels of 
copper. In any event, given the lack of toxicity of copper, EPA does 
not expect any increased exposure resulting from approval of this 
petition to be unsafe.
    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. In any event, given the lack of toxicity

[[Page 37550]]

of copper, EPA does not expect any increased exposure resulting from 
approval of this petition to be unsafe.

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 dermal exposure increase above current 
levels would be expected from this non-occupational use of cuprous 
oxide. In any event, given the lack of toxicity of copper, EPA does not 
expect any increased exposure resulting from approval of this petition 
to be unsafe.
    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 
indicated that air levels of copper are much lower. The Agency does not 
expect the air concentrations of copper to be significantly affected by 
this use of cuprous oxide. In any event, given the lack of toxicity of 
copper, EPA does not expect any increased exposure resulting from 
approval of this petition to be unsafe.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of 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 has not found cuprous oxide to share a common mechanism of 
toxicity with any other substances, and cuprous oxide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cuprous oxide does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

    Cuprous oxide is considered 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 
herbicide and algicide (40 CFR 180.1021), including cuprous oxide when 
contained in antifouling coatings on submerged concrete or other 
(irrigation) structures (40 CFR 180.1021(a)(4)). Copper compounds 
including cuprous oxide 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(b)).
    1. U.S. population. Copper is a component of the human diet and an 
essential element. In addition, no acute or chronic dietary endpoints 
were selected because no endpoints of toxicological concern have been 
identified for risk assessment purposes. Use of cuprous oxide 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 component of the diet of 
infants and children as is also an essential element of their diet. 
Since no endpoints have been identified, EPA has not conducted a 
quantitative risk assessment for cuprous oxide. The Agency has also 
determined that the special Food Quality Protection Act safety factor 
(FQPA SF) 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 from aggregate exposure to 
residues. Accordingly, EPA finds that exempting residues of cuprous 
oxide from the requirement of a tolerance will be safe.

VII. Other Considerations

A. Analytical Enforcement Methodology

    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. Revisions to Petitioned-For Tolerances

    The Agency is establishing an exemption for cuprous oxide that 
differs slightly from the exemption that was requested. First, the 
Agency has removed the phrase ``for agricultural crops or residential 
food commodities'' because the current structure of section 180.1021(a) 
makes that language duplicative and potentially confusing. With today's 
exemption, residues of copper on any irrigated crop that result from 
uses of cuprous oxide in polymer emitter heads for irrigation are 
exempt from the requirement of a tolerance; it is not necessary to 
further clarify where the irrigation heads are intended to be used. 
Also, the term algaecidal was deleted from the proposed tolerance 
exemption expression because the product is not intended to act as an 
algaecide.

VIII. Conclusion

    Based on the information contained in the document, EPA concludes 
that there is no reasonable certainty of harm from aggregate exposure 
to residues of cuprous oxide. Accordingly, EPA finds that the exemption 
for residues of copper in or on meat, milk, poultry, egg, fish, 
shellfish, and irrigated crops from use of cuprous oxide embedded in 
polymer emitter heads used in irrigation systems for root incursion 
prevention will be safe. Therefore, an exemption is established for 
residues of copper oxide embedded in polymer emitter heads used in 
irrigation systems for root incursion prevention.

IX. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance 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 action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), 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).
    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,

[[Page 37551]]

the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action 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, Cuprous oxide.

    Dated: June 18, 2015.
Jennifer L. McClain,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.

    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. Add paragraph (a)(5) to Sec.  180.1021 to read as follows:


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

    (a) * * *
    (5) Copper oxide embedded in polymer emitter heads used in 
irrigation systems for root incursion prevention.
* * * * *
[FR Doc. 2015-16224 Filed 6-30-15; 8:45 am]
 BILLING CODE 6560-50-P