FD&C Red No. 40; Exemption From the Requirement of a Tolerance, 66308-66312 [2014-26526]
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‘‘Creating a Federal Strategy to Promote
the Health of Honey Bees and Other
Pollinators’’ which directs EPA to assess
the effect of pesticides on bee and other
pollinator health and take action as
appropriate. This exemption from the
requirement of a tolerance is for a
substance used as an inert ingredient in
a pesticide formulation and as such is
not itself a pesticide. However, under
the strategy, the Agency will consider
any available product specific data on
bee toxicity during the product
registration process.
Dated: October 30, 2014.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
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).
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
XI. Congressional Review Act
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, alphabetically add the
following polymer to the table to read as
follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
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Polymer
CAS No.
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2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated, compounds with diethanolamine, minimum number average molecular weight (in amu), 2,000 ........
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[FR Doc. 2014–26529 Filed 11–6–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0572; FRL–9917–14]
FD&C Red No. 40; 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 FD&C Red No.
40 when used as an inert ingredient as
colorant in antimicrobial pesticide
formulation in food-contact surface
sanitizer products at a maximum level
in the end-use concentration of 20 parts
per million (ppm). Diversey 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 FD&C
Red No. 40.
DATES: This regulation is effective
November 7, 2014. Objections and
requests for hearings must be received
on or before January 6, 2015, and must
be filed in accordance with the
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SUMMARY:
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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–2012–0572, 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), 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan T. Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main 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
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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://
www.ecfr.gov/cgi-bin/textidx?&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–2012–0572 in the subject line on
the first page of your submission. All
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objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before January 6, 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–
2012–0572, 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.
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II. Petition for Exemption
In the Federal Register of August 22,
2012 (77 FR 50664) (FRL–9358–9), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
1E7843) by Diversey Inc., 8310 16th
Street, Sturtevant, Wisconsin 53177.
The petition requested that 40 CFR
180.940(a) be amended by establishing
an exemption from the requirement of a
tolerance for residues of FD&C Red No.
40 (CAS No. 25956–17–6) when used as
an inert ingredient (colorant) in foodcontact surface sanitizing solutions at a
maximum level in the end-use
concentration of 20 parts per million
(ppm). That document referenced a
summary of the petition prepared by
Diversey Inc., the petitioner, which is
available in the docket, EPA–HQ–OPP–
2012–0572, at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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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 nontoxicity; 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. In
order 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
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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
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 FD&C Red No. 40
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with FD&C Red No. 40 is
detailed in a May 9, 2014 Memorandum
entitled ‘‘Decision Document for
Petition Number 1E7843: FD&C Red No.
40 (CAS Reg. No. 25956–17–6); Human
Health Risk Assessment and Ecological
Effects Assessment for Proposed
Exemption from the Requirement of a
Tolerance When Used as an Inert
Ingredient in Pesticide Formulations’’
which is available in the docket for this
rule, EPA–HQ–OPP–2012–0572. A
summary of that assessment 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 is
discussed in this unit.
The European Food Safety Authority
(EFSA) has conducted the most recent
(2009) full review of the toxicology of
FD&C Red No. 40. This document relied
heavily on the earlier reviews (1980),
conducted by the Joint FAO/WHO
Expert Committee on Food Additives
(JECFA) and the European Union
Scientific Committee for Food (SCF) in
1984 and 1989. These evaluations of
FD&C Red No. 40 included reviews of
an extensive set of toxicological data
including genotoxicity, chronic toxicity,
carcinogenicity, reproductive and
developmental toxicity and metabolism.
The available data demonstrated that no
adverse effects were seen in studies at
limit dose levels.
Briefly, no compound related clinical
signs of toxicity were observed when
FD&C Red No. 40 (Allura Red AC) was
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given to rats by gavage at doses varying
from 215 to 10,000 milligrams/kilogram
(mg/kg). It was not irritating to the skin
of rabbits. Repeated dose toxicity
studies were conducted in rats, dogs
and pigs. No evidence of systemic
toxicity was observed in rats fed FD&C
Red No. 40 in the diet for six weeks at
doses up to 2,595 mg/kg/day. The dog
studies (two) were determined to be too
limited to derive a NOAEL. No
compound related effects were reported
in pigs given gavage dose of 1,000 mg/
kg/day for 21 days and then increased
to 1,500 mg/kg/day for an additional 54
days.
In chronic studies, no dye-related
anomalies were noted in terms of
survival, or gross and histopathology of
major organs and the skin in mice
treated dermally with FD&C Red No. 40
with a 5% test solution twice weekly for
20 months. A moderate growth
depression was observed in both sexes
of rat fed at the highest dose level of
2,595 mg/kg/day for 92 weeks. No
compound-related effects were observed
regarding appearance, behavior,
survival, organ weights, clinical
laboratory studies, or gross and
histopathology in rats.
FD&C Red No. 40 was evaluated for
its mutagenic activity in adequate range
of in vivo and in vitro mutagenicity
assays. Overall, it gave a negative
response for mutagenicity in in vivo and
in vitro assays except Comet assay.
EFSA Panel considered this finding in
the light of negative carcinogenicity
studies, and determined that the
biological significance of the Comet
assay results is uncertain.
As summarized by EFSA, no evidence
of carcinogenicity was observed in male
rats at doses up to 2,595 mg/kg/day and
2,829 mg/kg/day in female rats; and in
mice at dose levels up to 7,422 mg/kg/
day in males and 8,304 mg/kg/day in
females.
Relevant reproductive and
developmental toxicity studies are
summarized in the EFSA document. In
a multi-generation reproduction study
in rats at a dietary levels of 0, 0.37, 0.72,
1.39 or 5.19% (equivalent to 0, 185, 360,
695 and 2,595 mg/kg bw/day), no
treatment related adverse effects were
observed in the parental animals. Only
slight growth retardation was observed
at the high dose levels in F1 and F2
pups. The NOAEL for offspring toxicity
was 695 mg/kg/day and the LOAEL was
2,595 mg/kg/day. No reproductive or
developmental toxicity was seen at high
doses in three chronic studies in rats
and mice in which these parameters
were evaluated concurrently. Rats
(group number not reported) were
exposed up to 10% of FD&C Red No. 40
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in the diet (calculated doses of 0, 1,250,
2,500 and 5,000 mg/kg/day). Litter
mortality was increased between 22–24
days of age at a concentration of 10% in
the diet. Significantly decreased
running wheel activity was observed in
all exposed groups. Increased open-field
rearing was observed in the two highest
dose groups. The LOAEL was
determined to be 1,250 mg/kg/day; a
NOAEL could not be determined from
this study. No neurobehavioral effects
were observed in mice administered
1.68% FD&C Red No. 40 via diet
(equivalent to 2,400 mg/kg/day) for 2generations. Teratology studies in rats
and rabbits showed no evidence of
adverse effects at doses up to 200 mg/
kg/day administered via gavage during
gestation days (GD) 0–19 in rats, and at
doses up to 700 mg/kg/day administered
via gavage during GD 6–18 in rabbits. In
rats (group number not reported) dosed
with FD&C Red No. 40 up to 0.7% in
drinking water (equivalent to 939 mg/kg
bw/day) during GDs, on GD 0–20 a
significant increase in the incidence of
fetuses with reduced ossification of the
hyoid was observed at the highest dose
level. No other fetal malformations were
observed. The NOAEL from this study
was determined to be 546 mg/kg/day.
In rats fed 5.19% FD&C Red No. 40 in
the diet, only 0.1% and 29% of the
unmetabolized dye was found to be
excreted in the urine and feces,
respectively. Several metabolites,
possibly resulting from azo-reduction in
the gastrointestinal tract (two identified
as aromatic amines, p-cresidine sulfnic
acid being the major one), were also
found in the feces and urine. Finally,
significant retention in the washed
intestines of rat was observed, probably
due to adhesion to the intestinal wall.
B. Toxicological Points of Departure/
Levels of Concern
Based on the low potential hazard,
toxicological endpoints of concern have
not been identified for FD&C Red No.
40. Thus, due to its low potential hazard
and lack of hazard endpoint, the Agency
has determined that a quantitative risk
assessment using safety factors applied
to a point of departure protective of an
identified hazard endpoint is not
appropriate. JEFCA and EFSA
established the acceptable daily intake
(ADI) of 0–7 mg/kg/day based on the
NOAEL of 695 mg/kg/day derived from
a reproductive toxicity study in rats,
which revealed slight growth
suppression observed mainly at the high
test levels of 2,595 mg/kg/day in F1 and
F2 pups and from a teratogenicity study
in rats which revealed lower body
weights and growth rates at the highest
dose level of 2,595 mg/kg/day but not at
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695 mg/kg bw/day. Since adverse effects
in these two studies were observed at
2.5 times the limit dose of 1,000 mg/kg/
day; EPA concluded that it is not
warranted to conduct a quantitative risk
assessment.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses and drinking water. Dietary
exposure (food and drinking water) to
FD&C Red No. 40 can occur following
ingestion of foods with residues from
food-contact surface sanitizing solutions
for public eating places, treated dairyand food-processing equipment and
utensils; pre- and post-harvest crop uses
and as a direct food additives. In
addition, dietary exposures to FD&C
Red No. 40 can occur as a result of its
use as a color additive in foods.
However, EPA did not conduct a
quantitative dietary exposure
assessment since no endpoint of
concern for risk assessment has been
identified.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
FD&C Red No. 40 is used as an inert
ingredient in agricultural pesticide
products that could result in short- and
intermediate-term residential exposure.
Residential exposure can occur via
dermal and inhalation routes of
exposure to residential applicator.
Dermal and inhalation exposure can
occur from the use of consumer
products and foods/food additives
containing FD&C Red No. 40. Since an
endpoint for risk assessment was not
identified, a quantitative residential
exposure assessment for FD&C Red No.
40 was not conducted.
3. 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 FD&C Red No. 40
to share a common mechanism of
toxicity with any other substances, and
FD&C Red No. 40 does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that FD&C Red No. 40 does not
have a common mechanism of toxicity
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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.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
At this time, there is no concern for
potential sensitivity to infants and
children resulting from exposures to
FD&C Red No. 40. There is no reported
quantitative or qualitative evidence of
increased susceptibility of rat fetuses to
in utero exposure to FD&C Red No. 40
in developmental toxicity studies in
rats. No quantitative or qualitative
evidence of increased susceptibility has
been reported following the pre/
postnatal exposure to rats in 2generation reproduction toxicity studies
in rats. Given the lack of adverse
toxicological effects at limit dose levels,
a safety factor analysis has not been
used to assess the risk. For these reasons
the additional tenfold safety factor is
unnecessary.
E. Aggregate Risks and Determination of
Safety
In examining aggregate exposure, EPA
takes into account the available and
reliable information concerning
exposures to pesticide residues in food
and drinking water, and nonoccupational pesticide exposures.
Dietary (food and drinking water) and
non-dietary (residential) exposures of
concern are not anticipated for FD&C
Red No. 40 because of its low toxicity
based on animal studies showing
toxicity at or above the limit dose of
1,000 mg/kg/day. Taking into
consideration all available information
on FD&C Red No. 40, EPA has
determined that there is a reasonable
certainty that no harm to any population
subgroup, including infants and
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children, will result from aggregate
exposure to FD&C Red No. 40 under
reasonably foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance under 40 CFR
180.940(a) for residues of FD&C Red No.
40 when used as an inert ingredient
(colorant) in pesticide formulations
applied to food contact surfaces in
public eating places, dairy processing
equipment and food processing
equipment and utensils up to 20 ppm in
antimicrobial pesticide formulations 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 establishing an exemption
from the requirement of a tolerance
without any numerical limitation. EPA
is establishing a limitation on the
amount of FD&C Red No. 40 that may
be used in pesticide formulations.
The limitation will be 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 food-contact surface
antimicrobial pesticide for sale or
distribution with concentrations of
FD&C Red No. 40 exceeding 20 ppm in
the end use formulation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.940(a) for FD&C Red
No. 40 (CAS No. 25956–17–6) when
used as an inert ingredient (colorant) in
pesticide formulations applied to foodcontact surfaces in public eating places,
dairy-processing equipment and foodprocessing equipment and utensils up to
20 ppm in end use formulation.
VII. Statutory and Executive Order
Reviews
This final rule 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 final rule has been exempted from
review under Executive Order 12866,
this final rule 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,
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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 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.
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
E:\FR\FM\07NOR1.SGM
07NOR1
66312
Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Rules and Regulations
Dated: October 30, 2014.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
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.
2. In § 180.940, the table in paragraph
(a) is amended by alphabetically adding
an entry for ‘‘FD&C Red No. 40’’ before
the entry for ‘‘FD&C Yellow No. 5’’ to
read as follows:
■
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
■
Authority: 21 U.S.C. 321(q), 346a and 371.
Pesticide chemical
CAS Reg. No.
*
*
*
FD&C Red No. 40 ......................................................................
*
*
*
*
*
*
*
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 15
[DA 14–1507]
Unlicensed Personal Communications
Services Devices in the 1920–1930
MHz Band
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this document, the
Commission revises its rules. The
practical effect of this decision is that
applicants for certification of
Unlicensed Personal Communications
Service (UPCS) devices will no longer
be required to be members of UTAM,
Inc. (UTAM).
DATES: Effective November 7, 2014.
FOR FURTHER INFORMATION CONTACT:
Patrick Forster, Senior Engineer, (202)
418–7061, Policy and Rules Division,
Office of Engineering and Technology,
(202) 418–2290, Patrick.Forster@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order
adopted October 20, 2014, and released
October 20, 2014, DA 14–1507. The full
text of this document is available on the
Commission’s Internet site at
www.fcc.gov. It is also available for
inspection and copying during regular
business hours in the FCC Reference
Center (Room CY–A257), 445 12th
Street SW., Washington, DC 20554. The
full text of this document also may be
purchased from the Commission’s
rmajette on DSK2VPTVN1PROD with RULES
VerDate Sep<11>2014
14:20 Nov 06, 2014
Jkt 235001
*
25956–17–6
*
Frm 00046
Fmt 4700
*
Sfmt 4700
*
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*
*
When ready for use, the end-use concentration is not to exceed 20 ppm.
Summary of the Order
1. The Order revises part 15 subpart
D of the Commission’s rules to remove
and reserve § 15.307. As a result of this
decision, applicants for certification of
Unlicensed Personal Communications
Service (UPCS) devices will no longer
be required to be members of UTAM,
Inc. (UTAM). The Commission took the
action to eliminate the rule without
notice and comment procedures
pursuant to section 553(b)(b) of the
Administrative Procedures Act (5 U.S.C.
553(b)(B)).
2. Section 15.307 has served, along
with other Commission actions, to
ensure that UTAM is reimbursed for the
costs it incurred in clearing the 1910–
1930 MHz band of incumbent
microwave licensees. In a letter
submitted to the Commission, UTAM
indicated that this objective had been
met. The Commission agreed, and
concluded that the rule no longer served
its intended purpose. Moreover, because
UTAM’s board of directors had
proposed to its membership a plan of
dissolution and cessation of all
corporate activities, the Commission
anticipated that it would soon become
impossible for UPCS device
manufacturers to satisfy § 15.307’s
membership requirement.
3. In 1993, the Commission
reallocated the 1910–1930 MHz band
from the Private Operational Fixed
Microwave Service (POFS) to UPCS use.
As part of this reallocation, the
Commission designated UTAM to
PO 00000
*
Limits
duplication contractor, Best Copy and
Printing Inc., Portals II, 445 12th St.
SW., Room CY–B402, Washington, DC
20554; telephone (202) 488–5300; fax
(202) 488–5563; email FCC@
BCPIWEB.COM.
*
[FR Doc. 2014–26526 Filed 11–6–14; 8:45 am]
SUMMARY:
*
*
(a) * * *
*
*
manage the transition of the 1910–1930
MHz band from POFS to UPCS use.
Under the relocation funding plan
approved by the Commission, UTAM
would pay to relocate or agree to share
the costs to relocate incumbent services
in the band, and future UPCS device
manufacturers would reimburse UTAM
for their share of the incurred costs. The
UPCS device manufacturers would
reimburse UTAM via a fee for each
device sold (which UTAM subsequently
eliminated), as well as a membership fee
set by UTAM. To ensure that UTAM
received this reimbursement, the
Commission required—via § 15.307—
that each application for certification of
UPCS equipment be accompanied by an
affidavit from UTAM certifying that the
applicant was a member of UTAM.
4. In 2004, the Commission redesignated the 1910–1915 MHz and
1915–1920 MHz bands from UPCS use
to Broadband PCS and Advanced
Wireless Service (AWS) operations,
respectively. As part of the 1910–1915
MHz band re-designation, the
Commission determined that UTAM
was entitled to a reimbursement from
Nextel Communications, Inc. (the 1910–
1915 MHz band licensee) for 25
percent—on a pro rata basis—of the
total relocation costs it had incurred in
clearing the 1910–1930 MHz band of
incumbent microwave stations. In 2007,
Sprint Nextel Corp. (successor to
Nextel), reimbursed UTAM for these
costs.
5. Similarly, as part of the 1915–1920
MHz band re-designation, the
Commission determined that UTAM
was entitled to a reimbursement from
the future AWS licensee(s) in the 1915–
1920 MHz AWS–2 band for 25
percent—on a pro rata basis—of the
total relocation costs it had incurred in
E:\FR\FM\07NOR1.SGM
07NOR1
Agencies
[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Rules and Regulations]
[Pages 66308-66312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26526]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0572; FRL-9917-14]
FD&C Red No. 40; 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 FD&C Red No. 40 when used as an inert
ingredient as colorant in antimicrobial pesticide formulation in food-
contact surface sanitizer products at a maximum level in the end-use
concentration of 20 parts per million (ppm). Diversey 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 FD&C Red No. 40.
DATES: This regulation is effective November 7, 2014. Objections and
requests for hearings must be received on or before January 6, 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) number EPA-HQ-OPP-2012-0572, 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), 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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://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 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-2012-0572 in the subject line on the first
page of your submission. All
[[Page 66309]]
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before January 6, 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-2012-0572, 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 August 22, 2012 (77 FR 50664) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 1E7843) by
Diversey Inc., 8310 16th Street, Sturtevant, Wisconsin 53177. The
petition requested that 40 CFR 180.940(a) be amended by establishing an
exemption from the requirement of a tolerance for residues of FD&C Red
No. 40 (CAS No. 25956-17-6) when used as an inert ingredient (colorant)
in food-contact surface sanitizing solutions at a maximum level in the
end-use concentration of 20 parts per million (ppm). That document
referenced a summary of the petition prepared by Diversey Inc., the
petitioner, which is available in the docket, EPA-HQ-OPP-2012-0572, at
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
nontoxicity; 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. In order 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
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 FD&C Red No. 40 including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with FD&C Red No. 40 is
detailed in a May 9, 2014 Memorandum entitled ``Decision Document for
Petition Number 1E7843: FD&C Red No. 40 (CAS Reg. No. 25956-17-6);
Human Health Risk Assessment and Ecological Effects Assessment for
Proposed Exemption from the Requirement of a Tolerance When Used as an
Inert Ingredient in Pesticide Formulations'' which is available in the
docket for this rule, EPA-HQ-OPP-2012-0572. A summary of that
assessment 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 is discussed in
this unit.
The European Food Safety Authority (EFSA) has conducted the most
recent (2009) full review of the toxicology of FD&C Red No. 40. This
document relied heavily on the earlier reviews (1980), conducted by the
Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the
European Union Scientific Committee for Food (SCF) in 1984 and 1989.
These evaluations of FD&C Red No. 40 included reviews of an extensive
set of toxicological data including genotoxicity, chronic toxicity,
carcinogenicity, reproductive and developmental toxicity and
metabolism. The available data demonstrated that no adverse effects
were seen in studies at limit dose levels.
Briefly, no compound related clinical signs of toxicity were
observed when FD&C Red No. 40 (Allura Red AC) was
[[Page 66310]]
given to rats by gavage at doses varying from 215 to 10,000 milligrams/
kilogram (mg/kg). It was not irritating to the skin of rabbits.
Repeated dose toxicity studies were conducted in rats, dogs and pigs.
No evidence of systemic toxicity was observed in rats fed FD&C Red No.
40 in the diet for six weeks at doses up to 2,595 mg/kg/day. The dog
studies (two) were determined to be too limited to derive a NOAEL. No
compound related effects were reported in pigs given gavage dose of
1,000 mg/kg/day for 21 days and then increased to 1,500 mg/kg/day for
an additional 54 days.
In chronic studies, no dye-related anomalies were noted in terms of
survival, or gross and histopathology of major organs and the skin in
mice treated dermally with FD&C Red No. 40 with a 5% test solution
twice weekly for 20 months. A moderate growth depression was observed
in both sexes of rat fed at the highest dose level of 2,595 mg/kg/day
for 92 weeks. No compound-related effects were observed regarding
appearance, behavior, survival, organ weights, clinical laboratory
studies, or gross and histopathology in rats.
FD&C Red No. 40 was evaluated for its mutagenic activity in
adequate range of in vivo and in vitro mutagenicity assays. Overall, it
gave a negative response for mutagenicity in in vivo and in vitro
assays except Comet assay. EFSA Panel considered this finding in the
light of negative carcinogenicity studies, and determined that the
biological significance of the Comet assay results is uncertain.
As summarized by EFSA, no evidence of carcinogenicity was observed
in male rats at doses up to 2,595 mg/kg/day and 2,829 mg/kg/day in
female rats; and in mice at dose levels up to 7,422 mg/kg/day in males
and 8,304 mg/kg/day in females.
Relevant reproductive and developmental toxicity studies are
summarized in the EFSA document. In a multi-generation reproduction
study in rats at a dietary levels of 0, 0.37, 0.72, 1.39 or 5.19%
(equivalent to 0, 185, 360, 695 and 2,595 mg/kg bw/day), no treatment
related adverse effects were observed in the parental animals. Only
slight growth retardation was observed at the high dose levels in
F1 and F2 pups. The NOAEL for offspring toxicity
was 695 mg/kg/day and the LOAEL was 2,595 mg/kg/day. No reproductive or
developmental toxicity was seen at high doses in three chronic studies
in rats and mice in which these parameters were evaluated concurrently.
Rats (group number not reported) were exposed up to 10% of FD&C Red No.
40 in the diet (calculated doses of 0, 1,250, 2,500 and 5,000 mg/kg/
day). Litter mortality was increased between 22-24 days of age at a
concentration of 10% in the diet. Significantly decreased running wheel
activity was observed in all exposed groups. Increased open-field
rearing was observed in the two highest dose groups. The LOAEL was
determined to be 1,250 mg/kg/day; a NOAEL could not be determined from
this study. No neurobehavioral effects were observed in mice
administered 1.68% FD&C Red No. 40 via diet (equivalent to 2,400 mg/kg/
day) for 2-generations. Teratology studies in rats and rabbits showed
no evidence of adverse effects at doses up to 200 mg/kg/day
administered via gavage during gestation days (GD) 0-19 in rats, and at
doses up to 700 mg/kg/day administered via gavage during GD 6-18 in
rabbits. In rats (group number not reported) dosed with FD&C Red No. 40
up to 0.7% in drinking water (equivalent to 939 mg/kg bw/day) during
GDs, on GD 0-20 a significant increase in the incidence of fetuses with
reduced ossification of the hyoid was observed at the highest dose
level. No other fetal malformations were observed. The NOAEL from this
study was determined to be 546 mg/kg/day.
In rats fed 5.19% FD&C Red No. 40 in the diet, only 0.1% and 29% of
the unmetabolized dye was found to be excreted in the urine and feces,
respectively. Several metabolites, possibly resulting from azo-
reduction in the gastrointestinal tract (two identified as aromatic
amines, p-cresidine sulfnic acid being the major one), were also found
in the feces and urine. Finally, significant retention in the washed
intestines of rat was observed, probably due to adhesion to the
intestinal wall.
B. Toxicological Points of Departure/Levels of Concern
Based on the low potential hazard, toxicological endpoints of
concern have not been identified for FD&C Red No. 40. Thus, due to its
low potential hazard and lack of hazard endpoint, the Agency has
determined that a quantitative risk assessment using safety factors
applied to a point of departure protective of an identified hazard
endpoint is not appropriate. JEFCA and EFSA established the acceptable
daily intake (ADI) of 0-7 mg/kg/day based on the NOAEL of 695 mg/kg/day
derived from a reproductive toxicity study in rats, which revealed
slight growth suppression observed mainly at the high test levels of
2,595 mg/kg/day in F1 and F2 pups and from a
teratogenicity study in rats which revealed lower body weights and
growth rates at the highest dose level of 2,595 mg/kg/day but not at
695 mg/kg bw/day. Since adverse effects in these two studies were
observed at 2.5 times the limit dose of 1,000 mg/kg/day; EPA concluded
that it is not warranted to conduct a quantitative risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses and drinking water.
Dietary exposure (food and drinking water) to FD&C Red No. 40 can occur
following ingestion of foods with residues from food-contact surface
sanitizing solutions for public eating places, treated dairy- and food-
processing equipment and utensils; pre- and post-harvest crop uses and
as a direct food additives. In addition, dietary exposures to FD&C Red
No. 40 can occur as a result of its use as a color additive in foods.
However, EPA did not conduct a quantitative dietary exposure assessment
since no endpoint of concern for risk assessment has been identified.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
FD&C Red No. 40 is used as an inert ingredient in agricultural
pesticide products that could result in short- and intermediate-term
residential exposure. Residential exposure can occur via dermal and
inhalation routes of exposure to residential applicator. Dermal and
inhalation exposure can occur from the use of consumer products and
foods/food additives containing FD&C Red No. 40. Since an endpoint for
risk assessment was not identified, a quantitative residential exposure
assessment for FD&C Red No. 40 was not conducted.
3. 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 FD&C Red No. 40 to share a common mechanism of
toxicity with any other substances, and FD&C Red No. 40 does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that FD&C
Red No. 40 does not have a common mechanism of toxicity
[[Page 66311]]
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
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
At this time, there is no concern for potential sensitivity to
infants and children resulting from exposures to FD&C Red No. 40. There
is no reported quantitative or qualitative evidence of increased
susceptibility of rat fetuses to in utero exposure to FD&C Red No. 40
in developmental toxicity studies in rats. No quantitative or
qualitative evidence of increased susceptibility has been reported
following the pre/postnatal exposure to rats in 2-generation
reproduction toxicity studies in rats. Given the lack of adverse
toxicological effects at limit dose levels, a safety factor analysis
has not been used to assess the risk. For these reasons the additional
tenfold safety factor is unnecessary.
E. Aggregate Risks and Determination of Safety
In examining aggregate exposure, EPA takes into account the
available and reliable information concerning exposures to pesticide
residues in food and drinking water, and non-occupational pesticide
exposures. Dietary (food and drinking water) and non-dietary
(residential) exposures of concern are not anticipated for FD&C Red No.
40 because of its low toxicity based on animal studies showing toxicity
at or above the limit dose of 1,000 mg/kg/day. Taking into
consideration all available information on FD&C Red No. 40, 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 FD&C Red No. 40 under reasonably foreseeable
circumstances. Therefore, the establishment of an exemption from
tolerance under 40 CFR 180.940(a) for residues of FD&C Red No. 40 when
used as an inert ingredient (colorant) in pesticide formulations
applied to food contact surfaces in public eating places, dairy
processing equipment and food processing equipment and utensils up to
20 ppm in antimicrobial pesticide formulations 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 establishing an exemption from the requirement of a
tolerance without any numerical limitation. EPA is establishing a
limitation on the amount of FD&C Red No. 40 that may be used in
pesticide formulations.
The limitation will be 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 food-contact
surface antimicrobial pesticide for sale or distribution with
concentrations of FD&C Red No. 40 exceeding 20 ppm in the end use
formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for FD&C Red No. 40 (CAS No. 25956-
17-6) when used as an inert ingredient (colorant) in pesticide
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment and food-processing equipment and utensils
up to 20 ppm in end use formulation.
VII. Statutory and Executive Order Reviews
This final rule 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 final rule has been exempted from review
under Executive Order 12866, this final rule 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 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 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.
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
[[Page 66312]]
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: October 30, 2014.
Susan Lewis,
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, the table in paragraph (a) is amended by
alphabetically adding an entry for ``FD&C Red No. 40'' before the entry
for ``FD&C Yellow No. 5'' 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
------------------------------------------------------------------------
* * * * * * *
FD&C Red No. 40................... 25956-17-6 When ready for use,
the end-use
concentration is
not to exceed 20
ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2014-26526 Filed 11-6-14; 8:45 am]
BILLING CODE 6560-50-P