[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26526]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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.
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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
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: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. 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
http://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
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
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
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
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
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
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
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
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
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
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
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
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
Dated: October 30, 2014.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
* * * * *
(a) * * *
Pesticide chemical CAS Reg. No. Limits
* * * * * * *
FD&C Red No. 40................... 25956-17-6 When ready for use,
not to exceed 20
* * * * * * *
* * * * *
[FR Doc. 2014-26526 Filed 11-6-14; 8:45 am]
BILLING CODE 6560-50-P