Copper Sulfate Pentahydrate; Exemption From the Requirement of a Tolerance, 78727-78731 [2013-31101]
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Dated: December 6, 2013.
Susan Hedman,
Regional Administrator, Region 5.
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Ozone, Reporting and recordkeeping
requirements, Volatile organic
compounds.
Authority: 42 U.S.C. 7401 et seq.
2. In § 52.770 the table in paragraph
(c) is amended by adding a new entry
in ‘‘Article 8. Volatile Organic
Compound Rules’’ for ‘‘Rule 17.
Industrial Solvent Cleaning Operations’’
in numerical order to read as follows:
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40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
§ 52.770
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1. The authority citation for part 52
continues to read as follows:
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EPA-APPROVED INDIANA REGULATIONS
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Indiana
effective date
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EPA approval date
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Notes
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Article 8. Volatile Organic Compound Rules
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Rule 17. Industrial Solvent Cleaning Operations
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defined.
VOC emissions control requirements.
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Reporting requirements for monitoring and recordkeeping information.
Requirements on compliance certification.
Recordkeeping requirements for
exempt sources.
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[FR Doc. 2013–30543 Filed 12–26–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0286; FRL–9904–30]
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Copper Sulfate Pentahydrate;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of copper sulfate
SUMMARY:
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2/24/2010, 75 FR 8246 ...................
12/27/2013, [INSERT PAGE NUMBER WHERE THE DOCUMENT
BEGINS].
2/24/2010, 75 FR 8246 ...................
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pentahydrate when applied to all food
contact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment at a maximum
level in the end use concentration of 80
parts per million (ppm). Toxcel on
behalf of OhSo Clean, Inc., submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting establishment of 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.
DATES: This regulation is effective
December 27, 2013. Objections and
requests for hearings must be received
on or before February 25, 2014, and
must be filed in accordance with the
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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)
number EPA–HQ–OPP–2013–0286, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
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
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the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@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. 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 https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under 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–2013–0286 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 February 25, 2014. 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
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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–
2013–0286, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of July 19,
2013 (78 FR 43115) (FRL–9392–9), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
2E8116) by Toxcel, P.O. Box 363, 7140
Heritage Village Plaza, Gainesville, VA
20156, on behalf of OhSo Clean, Inc.,
315 Pacific Ave., San Francisco, CA
94111. The petition requested that 40
CFR 180.940 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of copper sulfate pentahydrate
(Chemical Abstracts Service Registry
Number (CAS Reg. No.) 7758–99–8)
when used as an inert ingredient
(emulsion stabilizer) in antimicrobial
pesticide formulations (food contact
surface sanitizing solutions) not to
exceed 80 ppm. That document
referenced a summary of the petition
prepared by Toxcel LLC., 7140 Heritage
Village Plaza, Gainesville, VA 20155,
the petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
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pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply non-toxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
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 tolerance is ‘‘safe.’’
Section 408(b)(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. Section
408(b)(2)(C) of FFDCA 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 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. To
determine the risks from aggregate
exposure to pesticide inert ingredients,
the Agency considers the toxicity of the
inert in conjunction with possible
exposure to residues of the inert
ingredient 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 to the inert
ingredient, an exemption from the
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requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for copper sulfate
pentahydrate including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with copper sulfate
pentahydrate follows.
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
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 copper sulfate pentahydrate, as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-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 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
(mg/d) in young children to 900 mg/d in
adults. Additionally, over the counter
dietary supplements containing copper
at level 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.
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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. However, copper sulfate
pentahydrate specifically has a been
classified as moderate for acute oral
toxicity, low for acute dermal toxicity
and dermal irritation, and high for
primary eye irritation. All effects
resulting from acute exposure to coppercontaining 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 endpoints.
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
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naturally in food and the metabolism of
copper is well understood.
Finally, sulfate has little toxic effect
and is routinely used in medicine as a
cathartic when combined with
magnesium or sodium; the only adverse
manifestations from this use being
dehydration if water intake is
concurrently limited.
B. Toxicological Points of Departure/
Levels of Concern
No endpoints of toxicological concern
were identified for risk assessment
purposes for copper sulfate
pentahydrate. Copper sulfate
pentahydrate readily hydrolyzes into
the copper cation and the sulfate 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 sulfate
pentahydrate as a pesticide chemical
would not be of toxicological concern.
Further, the sulfate anion is also
ubiquitous; it is the substrate in a
number of normal human biosynthetic
reactions. Following ingestion, sulfate is
poorly absorbed via the gastrointestinal
tract and is excreted in the urine. Other
than a slight laxative effect at extremely
high doses, sulfate has no known
adverse toxic effects.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to copper sulfate
pentahydrate, EPA considered exposure
under the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from copper
sulfate pentahydrate in food as follows:
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 chocolate,
fruits (peaches and raisins), grains
(wheat and rye), nuts (peanuts and
pecans), and vegetables (potatoes and
legumes (beans and peas)) in levels that
range from 0.3 to 3.9 ppm. It is not
likely that the approval of this petition
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would significantly increase exposure
over that of the existing levels of copper.
2. Dietary exposure from drinking
water. 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.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., carpets; hard surface disinfection
on walls, floors, and tables; swimming
pools; and textiles (clothing and
diapers)).
Residential (oral, dermal, and
inhalation) exposure to copper sulfate
pentahydrate from its use as an inert
ingredient in food-contact surface
sanitizing solutions for public eating
places, dairy processing equipment, and
food-processing equipment and utensils
is possible. However, since there are no
toxicological effects of concern
identified in the available database, it is
not necessary to conduct a quantitative
assessment of residential (nonoccupational) exposures.
4. 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 copper sulfate pentahydrate to
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share a common mechanism of toxicity
with any other substances, and copper
sulfate pentahydrate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that copper sulfate
pentahydrate 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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
FFDCA, as amended by the Food
Quality Protection Act (FQPA), directs
the Agency to use an additional 10X
safety factor (SF), to account for
potential pre- and postnatal toxicity and
completeness of the data with respect to
exposure and toxicity to infants and
children. FQPA authorizes the Agency
to modify the 10X FQPA SF only if
reliable data demonstrate that the
resulting level of exposure would be
safe for infants and children. Since
copper is an essential trace element,
with copper deficiency more common
in humans than toxicity from the excess,
a quantitative assessment using safety
factors was not conducted for potential
human health exposure to copper
sulfate pentahydrate. For the same
reason the 10X FQPA SF was not
retained.
E. Aggregate Risks and Determination of
Safety
Taking into consideration the
information discussed on copper sulfate
pentahydrate, EPA has determined that
there is a reasonable certainty that no
harm to any population subgroup,
including infants and children, will
result from aggregate exposure to copper
sulfate pentahydrate under reasonable
foreseeable circumstances. Therefore,
the establishment of an exemption from
tolerance under 40 CFR 180.940(a) for
residues of copper sulfate pentahydrate
when used as an inert ingredient in
pesticide formulations applied to foodcontact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment and utensils at a
limit of 80 ppm is safe under FFDCA
section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
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tolerance for residues of copper sulfate
pentahydrate in or on any food
commodities. EPA is establishing a
limitation on the amount of copper
sulfate pentahydrate that may be used in
pesticide formulations.
The limitation is enforced through the
pesticide registration process under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136
et seq.). EPA will not register any
pesticide for sale or distribution that
contains greater than 80 ppm of copper
sulfate pentahydrate in the pesticide
formulation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nation Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established a MRL for copper sulfate
pentahydrate.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.940(a) for copper
sulfate pentahydrate (CAS Reg. No.
7758–99–8) when used in antimicrobial
pesticide formulations applied to all
food contact surfaces in public eating
places, dairy-processing equipment, and
food-processing equipment and utensils
at a maximum level in the end use
concentration of 80 ppm.
VII. Statutory and Executive Order
Reviews
This final rule establishes 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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
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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 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.), 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 tolerance 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.
This final rule 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 final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(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 of 1995
(NTTAA) (15 U.S.C. 272 note).
VIII. 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
Pesticide chemical
7758–99–8
*
*
*
*
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 20, 2013.
Lois Rossi,
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), 346a and 371.
2. In § 180.940, alphabetically add the
following inert ingredient to the table in
paragraph (a) to read as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
*
*
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0420; FRL–9903–92]
Indoxacarb; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of indoxacarb in
or on multiple commodities and
removes previously established
commodities that will be superseded by
tolerances established in this action,
SUMMARY:
VerDate Mar<15>2010
18:49 Dec 26, 2013
Jkt 232001
*
Frm 00039
*
*
*
*
When ready for use, the end-use concentration is not to exceed 80
ppm
*
which are identified and discussed later
in this document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 27, 2013. Objections and
requests for hearings must be received
on or before February 25, 2014, 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)
number EPA–HQ–OPP–2012–0420, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
PO 00000
*
Limits
*
*
[FR Doc. 2013–31101 Filed 12–26–13; 8:45 am]
tkelley on DSK3SPTVN1PROD with RULES
List of Subjects in 40 CFR Part 180
CAS reg. no.
*
*
*
Copper sulfate pentahydrate ........................................
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).
Fmt 4700
Sfmt 4700
*
*
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 https://www.epa.gov/dockets.
Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27DER1.SGM
27DER1
Agencies
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78727-78731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31101]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0286; FRL-9904-30]
Copper Sulfate Pentahydrate; 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 sulfate pentahydrate when applied
to all food contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment at a maximum level in the end
use concentration of 80 parts per million (ppm). Toxcel on behalf of
OhSo Clean, Inc., submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of 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.
DATES: This regulation is effective December 27, 2013. Objections and
requests for hearings must be received on or before February 25, 2014,
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) number EPA-HQ-OPP-2013-0286, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West 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
[[Page 78728]]
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@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.
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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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-2013-0286 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
February 25, 2014. 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-2013-0286, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E8116) by
Toxcel, P.O. Box 363, 7140 Heritage Village Plaza, Gainesville, VA
20156, on behalf of OhSo Clean, Inc., 315 Pacific Ave., San Francisco,
CA 94111. The petition requested that 40 CFR 180.940 be amended by
establishing an exemption from the requirement of a tolerance for
residues of copper sulfate pentahydrate (Chemical Abstracts Service
Registry Number (CAS Reg. No.) 7758-99-8) when used as an inert
ingredient (emulsion stabilizer) in antimicrobial pesticide
formulations (food contact surface sanitizing solutions) not to exceed
80 ppm. That document referenced a summary of the petition prepared by
Toxcel LLC., 7140 Heritage Village Plaza, Gainesville, VA 20155, the
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply non-
toxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA 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 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. To determine the risks from aggregate exposure to pesticide
inert ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
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 to the inert ingredient, an exemption from the
[[Page 78729]]
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for copper sulfate pentahydrate
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with copper
sulfate pentahydrate follows.
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 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 copper sulfate pentahydrate, 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 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 ([micro]g/d) in
young children to 900 [micro]g/d in adults. Additionally, over the
counter dietary supplements containing copper at level 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.
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. However, copper sulfate pentahydrate
specifically has a been classified as moderate for acute oral toxicity,
low for acute dermal toxicity and dermal irritation, and high for
primary eye irritation. 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 endpoints.
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.
Finally, sulfate has little toxic effect and is routinely used in
medicine as a cathartic when combined with magnesium or sodium; the
only adverse manifestations from this use being dehydration if water
intake is concurrently limited.
B. Toxicological Points of Departure/Levels of Concern
No endpoints of toxicological concern were identified for risk
assessment purposes for copper sulfate pentahydrate. Copper sulfate
pentahydrate readily hydrolyzes into the copper cation and the sulfate
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 sulfate pentahydrate as a
pesticide chemical would not be of toxicological concern. Further, the
sulfate anion is also ubiquitous; it is the substrate in a number of
normal human biosynthetic reactions. Following ingestion, sulfate is
poorly absorbed via the gastrointestinal tract and is excreted in the
urine. Other than a slight laxative effect at extremely high doses,
sulfate has no known adverse toxic effects.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to copper sulfate pentahydrate, EPA considered exposure under
the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from copper sulfate pentahydrate in food as
follows:
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 chocolate, fruits (peaches and raisins), grains (wheat
and rye), nuts (peanuts and pecans), and vegetables (potatoes and
legumes (beans and peas)) in levels that range from 0.3 to 3.9 ppm. It
is not likely that the approval of this petition
[[Page 78730]]
would significantly increase exposure over that of the existing levels
of copper.
2. Dietary exposure from drinking water. 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.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., carpets; hard surface disinfection on walls, floors,
and tables; swimming pools; and textiles (clothing and diapers)).
Residential (oral, dermal, and inhalation) exposure to copper
sulfate pentahydrate from its use as an inert ingredient in food-
contact surface sanitizing solutions for public eating places, dairy
processing equipment, and food-processing equipment and utensils is
possible. However, since there are no toxicological effects of concern
identified in the available database, it is not necessary to conduct a
quantitative assessment of residential (non-occupational) exposures.
4. 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 copper
sulfate pentahydrate to share a common mechanism of toxicity with any
other substances, and copper sulfate pentahydrate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
copper sulfate pentahydrate 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
FFDCA, as amended by the Food Quality Protection Act (FQPA),
directs the Agency to use an additional 10X safety factor (SF), to
account for potential pre- and postnatal toxicity and completeness of
the data with respect to exposure and toxicity to infants and children.
FQPA authorizes the Agency to modify the 10X FQPA SF only if reliable
data demonstrate that the resulting level of exposure would be safe for
infants and children. Since copper is an essential trace element, with
copper deficiency more common in humans than toxicity from the excess,
a quantitative assessment using safety factors was not conducted for
potential human health exposure to copper sulfate pentahydrate. For the
same reason the 10X FQPA SF was not retained.
E. Aggregate Risks and Determination of Safety
Taking into consideration the information discussed on copper
sulfate pentahydrate, EPA has determined that there is a reasonable
certainty that no harm to any population subgroup, including infants
and children, will result from aggregate exposure to copper sulfate
pentahydrate under reasonable foreseeable circumstances. Therefore, the
establishment of an exemption from tolerance under 40 CFR 180.940(a)
for residues of copper sulfate pentahydrate when used as an inert
ingredient in pesticide formulations applied to food-contact surfaces
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at a limit of 80 ppm is safe under
FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
copper sulfate pentahydrate in or on any food commodities. EPA is
establishing a limitation on the amount of copper sulfate pentahydrate
that may be used in pesticide formulations.
The limitation is enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136 et seq.). EPA will not register any pesticide for
sale or distribution that contains greater than 80 ppm of copper
sulfate pentahydrate in the pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for copper sulfate pentahydrate.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for copper sulfate pentahydrate
(CAS Reg. No. 7758-99-8) when used in antimicrobial pesticide
formulations applied to all food contact surfaces in public eating
places, dairy-processing equipment, and food-processing equipment and
utensils at a maximum level in the end use concentration of 80 ppm.
VII. Statutory and Executive Order Reviews
This final rule establishes 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is
[[Page 78731]]
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 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.), 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 tolerance 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.
This final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. 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.
Dated: December 20, 2013.
Lois Rossi,
Director, Registration 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. In Sec. 180.940, alphabetically add the following inert ingredient
to the table in paragraph (a) to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
------------------------------------------------------------------------
Pesticide chemical CAS reg. no. Limits
------------------------------------------------------------------------
* * * * * * *
Copper sulfate pentahydrate.... 7758-99-8 When ready for use,
the end-use
concentration is not
to exceed 80 ppm
* * * * * * *
------------------------------------------------------------------------
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[FR Doc. 2013-31101 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P