[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Proposed Rules]
[Pages 43350-43357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17613]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0821; FRL-9910-53]
Fragrance Components; Proposed Exemption From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to establishes an exemption from the
requirement of a tolerance for residues of various fragrance component
substances (when used as inert ingredients) in antimicrobial pesticide
formulations for use on food contact surfaces in public eating places,
dairy processing equipment, and food processing equipment and utensils.
DATES: Comments must be received on or before September 23, 2014.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2013-0821, 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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the
[[Page 43351]]
disk or CD-ROM as CBI and then identify electronically within the disk
or CD-ROM the specific information that is claimed as CBI. In addition
to one complete version of the comment that includes information
claimed as CBI, a copy of the comment that does not contain the
information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. This Proposal
EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C.
346a(e), is proposing to establish an exemption from the requirement of
a tolerance for residues of acetaldehyde (CAS Reg. No. 75-07-0), acetic
acid (CAS Reg. No. 64-19-7), allyl cyclohexyl propionate (CAS Reg. No.
2705-87-5), butryic acid (CAS Reg. No. 107-92-6), butyl alcohol (CAS
Reg. No. 71-36-3), citral (CAS Reg. No. 5392-40-5), citronellol (CAS
Reg. No. 106-22-9), citronellyl acetate (CAS Reg. No. 150-84-5),
[beta]-damascone, (Z)- (CAS Reg. No. 23726-92-3), decanal (CAS Reg. No.
112-31-2), (E)-4-decenal (CAS Reg. No. 65405-70-1), decanoic acid (CAS
Reg. No. 334-48-5), 1-decanol (CAS Reg. No. 112-30-1), 2,6-dimethyl-5-
heptanal (CAS Reg. No. 106-72-9), 2-dodecanol, (2E)- (CAS Reg. No.
20407-84-5), d-limonene (CAS Reg. No. 5989-27-5), ethyl 2-
methylbutyrate (CAS Reg. No. 452-79-1), (E)-geraniol (CAS Reg. No. 106-
24-1), (E)-geraniol acetate (CAS Reg. No. 105-87-3), heptanal (CAS Reg.
No. 111-71-7), heptanoic acid (CAS Reg. No. 111-14-8), heptyl alcohol
(CAS Reg. No. 111-70-6), hexanal (CAS Reg. No. 66-25-1), hexanoic acid
(CAS Reg. No. 142-62-1), (Z)-3-hexenol (CAS Reg. No. 928-96-1), (Z)-3-
hexenol acetate (CAS Reg. No. 3681-71-8), hexyl acetate (CAS Reg. No.
142-92-7), hexyl alcohol (CAS Reg. No. 111-27-3), lauric acid (CAS Reg.
No. 143-07-7), lauric aldehyde (CAS Reg. No. 112-54-9), lauryl alcohol
(CAS Reg. No. 112-53-8), methyl-[alpha]-ionone (CAS Reg. No. 127-42-4),
3-methyl-2-butenyl acetate (CAS Reg. No. 1191-16-8), 2-methylundecanal
(CAS Reg. No. 110-41-8), myristaldehyde (CAS Reg. No. 124-25-4),
myristic acid (CAS Reg. No. 544-63-8), neryl acetate (CAS Reg. No. 141-
12-8), n-hexanol (CAS Reg. No. 111-27-3), nonanal (CAS Reg. No. 124-19-
6), nonanoic acid (CAS Reg. No. 112-05-0), nonyl alcohol (CAS Reg. No.
143-08-8), octanal (CAS Reg. No. 124-13-0), octanoic acid (CAS Reg. No.
124-07-2), 1-octanol (CAS Reg. No. 111-87-5), palmitic acid (CAS Reg.
No. 57-10-3), propionic acid (CAS Reg. No. 79-09-4), stearic acid (CAS
Reg. No. 57-11-4), 2-tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-
trimethylhexanal (CAS Reg. No. 5435-64-3), undecanal (CAS Reg. No. 112-
44-7), undecyl alcohol (CAS Reg. No. 112-42-5), valeraldehyde (CAS Reg.
No. 110-62-3), and valeric acid (CAS Reg. No. 109-52-4) when used as
fragrance components (i.e., inert ingredients) in antimicrobial
pesticide formulations for use on food contact surfaces in public
eating places, dairy processing equipment, and food processing
equipment and utensils at end-use concentrations not to exceed 100
parts per million (ppm).
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of FFDCA section 408 and a complete description
of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
Consistent with FFDCA section 408(b)(2)(D), 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, consistent with FFDCA
section 408(b)(2), for an exemption from tolerance for residues of
fragrance components listed in Unit II. used as inert ingredients in
antimicrobial pesticide formulations for use on food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils at end-use concentrations not to
exceed 100 ppm. EPA's assessment of exposures and risks associated with
establishing the exemptions from tolerance for the fragrance components
listed in Unit II. follows:
A. Toxicological Profile
In the case of the fragrance components listed in Unit II. above,
each of these substances has been approved for use as a synthetic
flavoring substance in food under 21 CFR 172.515 based on a substance-
specific evaluation conducted by the U.S. Food and Drug Administration
(FDA). Additionally, the fragrance components listed in Unit II. above
have been evaluated and approved for use as food flavoring agents by
the Joint Food and Agricultural Organization of the United Nations/
World Health Organization Expert Committee on Food Additives (JECFA)
and the European Food Safety Agency (EFSA) as part of their assessment
of more than 2,800 food flavoring substances. The EFSA and JECFA food
flavoring substance were conducted under an approach titled the
Threshold of Toxicological Concern (TTC). Under this approach, generic
human exposure threshold values for both non-cancer and cancer
endpoints are set at a level below which there would be no appreciable
risk to human health. These generic values allow for the safety
assessment of substances even
[[Page 43352]]
in the absence of substance-specific hazard data.
The derivation of TTC human exposure threshold values for non-
cancer endpoints is based on an extensive reference database compiled
by Munro, (Ref. 1) which included data on chronic, subchronic,
reproductive and developmental toxicity studies primarily derived from
the reports of the US National Toxicology Program (NTP), the
toxicological monographs of JECFA, the EPA Integrated Risk Information
System (IRIS), and the Developmental and Reproductive Toxicology (DART)
database compiled by the US National Library of Medicine. These sources
were considered to contain well-validated toxicological data for well-
defined chemical structures, covering pesticides, food additives,
industrial and other types of chemicals. Only studies using the oral
route of administration (gavage, diet, drinking water, or capsule) were
included. In all, the reference database contained 2941 no-observed-
adverse-effect levels (NOAELs) from studies conducted on 613
substances, and from these the most conservative (lowest) NOAEL for
each substance was entered on the published database. The NOAELs in the
reference database were those selected by the original authors of each
study, apart from the studies in the IRIS database, for which the
NOAELs were selected by the EPA. Munro commented that some authors were
highly conservative in their selection of a NOAEL, but such NOAELs were
still used for the database to maintain a conservative approach. Munro
also stated that, in the calculation of the TTC values, NOAELs from
subchronic studies were divided by a factor of 3 to approximate the
NOAELs that are likely to be derived from a chronic study.
The chemicals in the Munro database were divided into three
structural classes, based on a ``decision tree'' developed earlier by
Cramer et al. (Ref. 2) Cramer Class I are chemicals of simple
structure, with efficient modes of metabolism, suggesting low oral
toxicity; Cramer Class III are chemicals with structures suggesting
significant toxicity or which did not permit any strong initial
presumption of safety, and Cramer Class II are chemicals with
structures that were less innocuous than Cramer Class I but without
features suggesting significant toxicity. Human exposure threshold
values were derived by taking the lower 5th percentile value of the
distribution of NOAELs for the substances in each of the three Cramer
structural classes, multiplying by 60 to convert the values expressed
as milligrams/kilograms (mg/kg) of body weight (bw) per day into mg/
person per day, and then dividing by a factor of 100 to ensure a margin
of safety.
For substances without structural alerts for cancer, the TTC human
exposure values for non-cancer risks are considered protective of any
potential cancer risk. For substances with a structural alert for
cancer, a separate TTC value has been derived. Originally, FDA
developed human exposure threshold values to protect against all
chronic risks, including the endpoint of cancer, without regard to
whether the substance had a structural alert for carcinogenicity (Ref.
3, 4, 5). FDA derived these threshold values using mathematical
modeling of risks from animal bioassay data on over 500 known genotoxic
and non-genotoxic carcinogens, based on their carcinogenic potency. In
1995, FDA incorporated the threshold value in its threshold of
regulation (TOR) policy for substances present in food contact
materials. (Ref 6). Under the TOR, substances used in food contact
materials that are present in the diet at concentrations below the
threshold level are exempted from regulation as food additives.
Subsequently, FDA modified this approach by adopting lower threshold
values for substances with a structural alert for carcinogenicity.
Kroes et al. (Ref. 7) This FDA approach as to substances with
structural alerts for carcinogenicity was further refined and adopted
by EFSA and JEFCA for use in the TTC approach.
The TTC approach has been incorporated in the evaluations made by
JECFA and EFSA in which the organizations both concluded that the each
of the substances listed in Unit II. were safe for use as flavoring
agents in foods. Under 21 CFR 170.39 Threshold of regulation for
substances used in food-contact articles, FDA has issued exemptions
from regulation as food additives for a number of substances based on
human exposure threshold values.
B. Toxicological Points of Departure/Levels of Concern
The human exposure threshold value for threshold (i.e., noncancer)
risks is based upon Cramer structural class. In the case of the
fragrance components listed in Unit II., all of the substances are
included in the Cramer Class I category, which is defined as chemicals
of simple structure and efficient modes of metabolism, suggesting low
oral toxicity. An EFSA Scientific Committee critical evaluation of the
human threshold values for threshold risks concluded that ``the use of
the 5th percentile No-observed-adverse-effect-level (NOAEL) and an
uncertainty factor of 100 to derive the TTC value gives a very low
probability (somewhere between 0-5%) of any appreciable non-cancer risk
to human health from exposures to substances below the Cramer Class I
TTC value of 30 [mu]g/kg/day'' (Ref. 8)
Use of TTC values for risk assessment of the fragrance components
listed in Unit II. is a more conservative alternative to the chemical-
specific Population Adjusted Dose (PAD) or Reference Dose (RfD)
approach typically used in Agency risk assessments. For example, in the
case of substances having chemical structures described by Cramer Class
I for which chemical-specific risk assessments have been performed,
these substances have PAD/RfD values which are often orders of
magnitude greater than the corresponding TTC values (Ref 9). A summary
of the safe exposure levels corresponding to each of the exposure
scenarios considered the aggregate exposure assessment of the fragrance
components listed in Unit II. is given below:
1. Acute dietary (all populations). There were no effects that
could be attributed to a single dose in the database. Therefore, a
quantitative acute dietary assessment is not necessary.
2. Chronic dietary (all populations). Concerns for chronic dietary
exposures exceeding the TTC value of 30 [micro]g/kg/day.
3. Incidental oral short-term (1 to 30 days). Concerns for
incidental oral short-term exposures exceeding the TTC value of 30
[micro]g/kg/day.
4. Dermal short-term (1 to 30 days) and intermediate-term (1 to 6
months). Concern for dermal exposures exceeding the TTC value of 30
[micro]g/kg/day based on oral toxicity data and conservative assumption
of 100% dermal absorption.
5. Inhalation short-term (1 to 30 days) and intermediate-term (1 to
6 months). Concern for inhalation exposures exceeding the TTC value of
30 [micro]g/kg/day based on oral toxicity data. Based on subchronic
inhalation data for a number of fragrance substances, including some of
fragrance components listed in Unit II., in which no adverse effects
were noted at exposure levels up to 1% of ambient air (Ref. 10), it is
reasonable to assume that in the case of the fragrance components
listed in Unit II. inhalation toxicity would not be observed at doses
below which oral toxicity is observed.
6. Cancer (Oral, dermal, inhalation). The Agency used a qualitative
structure activity relationship (SAR) database, DEREK11, to determine
if there were structural alerts for potential genotoxicity/
carcinogenicity for any of
[[Page 43353]]
the fragrance components. No structural alerts for genotoxicity/
carcinogenicity relevant to human exposure to these substances as
flavoring agents/fragrance components were identified, therefore the
use of the TTC human exposure threshold for non-threshold risks for
these fragrance components is not applicable. In these circumstances,
assessment under the TTC value for non-cancer risks is protective for
all risks, including carcinogenicity.
The risk assessment and use of human threshold values for
evaluation of food flavoring agents by JECFA and EFSA has focused on
oral toxicity and dietary exposure to substances via food and feed.
However, the applicability of the TTC approach to substance exposure by
routes other than the oral route has been considered by the ESFA
Scientific Committee. The Scientific Committee determined that when
several routes of exposure are to be taken into account they should be
reflected in the exposure assessment used in the application of the TTC
approach and that ``the application of the TTC approach to routes of
exposure other than oral can be done via route-to-route extrapolation,
as is often done in conventional risk assessment in cases where only
oral toxicity data are available.''
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the fragrance components listed in Unit II., EPA considered
exposure under the proposed tolerance exemptions at a concentration not
to exceed 100 ppm for each of the fragrance components listed in Unit
II. as well as any other sources of dietary exposure. The use
limitation of 100 ppm was incorporated by the Agency to reflect maximum
concentrations of these fragrance components in antimicrobial pesticide
formulations as well as to ensure that exposures to these fragrance
components will be below levels of concern. In conducting the dietary
exposure assessment for the fragrance components listed in Unit II.,
EPA considered dietary exposure from potential residues in or on food
resulting from the use as inert ingredients in antimicrobial pesticide
product formulations from treated food contact surfaces; and from food
that contains the fragrance components as flavoring agents. As to the
residue levels in or food resulting from the inert ingredient uses, in
the absence of actual dietary exposure data resulting from this use,
the EPA has utilized a conservative, health-protective method of
estimating dietary intake that is based upon conservative assumptions
related to the amount of residues that can be transferred to foods as a
result of the proposed use of the fragrance components in food contact
sanitizing antimicrobial pesticide products. This same methodology has
been utilized by EPA in estimating dietary exposures to antimicrobial
pesticides used in food-handling settings. A complete description of
the approach used to assess dietary exposures resulting from food
contact sanitizing solution uses of the fragrance components can be
found at http://www.regulations.gov in document; ``Various Fragrance
Components: Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations,''
pp. 5-8 in docket ID number EPA-HQ-OPP-2013-0821.
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicity database for the fragrance components listed
in Unit II., therefore a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, the Agency believes the assumptions used to estimate
chronic dietary exposures lead to an extremely conservative assessment
of chronic dietary risk due to a series of compounded conservatisms.
First, when a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface (residual solution). In the absence
of any other data, EPA has used an estimated worst-case concentration
of 1 mg of solution per square centimeter (cm) of treated surface area
for this quantity. Second, the conservatism of this methodology is
compounded by EPA's decision to assume a worst case scenario that all
food that an individual consumes will come into contact with 4,000 cm
\2\ of sanitized non-porous food-contact surfaces. This contact area
represents all the surface area from silverware, china, and glass used
by a person who regularly eats three meals per day at an institutional
or public facility. The surface area of counter tops that comes in
contact with food is expected to be smaller than the surface area for
food utensils. As a conservative estimate, EPA assumed that 2,000 cm
\2\ of treated counter top surface area, comes into contact with an
individual's food per day. Third, EPA assumes that 100% of the material
present on food contact surfaces will migrate to food (Ref 11).
iii. Cancer. Based on the data summarized in Unit III. A., EPA has
concluded that the fragrance components listed in Unit II. are not
expected to be carcinogenic to humans. Therefore, a dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
2. Dietary exposure from drinking water. The proposed use of the
fragrance components listed in Unit II. in antimicrobial pesticide
products has only a limited opportunity to result in contamination of
drinking water because these types of products are used inside of
structures. There is the possibility of exposure to drinking water
sources via down-the-drain releases and discharges to waste water
treatment plants; however, based on the extremely low concentrations of
the fragrance components in pesticide formulations, combined with the
biodegradability of the fragrance components, there would be at most a
negligible exposure to surface water or ground water. Therefore, the
use of these fragrance components as inert ingredients is not expected
to contribute to dietary exposure from drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticide, and flea and tick control on pets).
The use of the fragrance components in food contact surface
antimicrobial pesticide products could result in short- and
intermediate-term residential exposures, adult handler dermal and
inhalation exposure; post-application dermal and inhalation exposure
and child's post- application dermal and incidental oral exposure. In
addition, non pesticidal uses of these substances as fragrance
components in consumer products may also result in residential dermal
and inhalation exposure. However, these pesticidal and non pesticidal
non-dietary exposures would be negligible in comparison to the highly
conservative estimates of dietary exposure as discussed in Unit
III.C.1. above. Further information regarding EPA standard assumptions
and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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
[[Page 43354]]
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
EPA has not found the fragrance components listed in Unit II. to
share a common mechanism of toxicity with any other substances, and
these fragrance components do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that these fragrance components do
not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
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.
The use of a threshold exposure level as described in Unit II.
above is health protective of any toxicity to infants and children and
the exposure assumptions utilized in the risk assessment of the
fragrance components are highly conservative (protective). These
assessments will not underestimate the exposure and risks posed by
these fragrance components and no additional safety factor is needed
for assessing risk to infants and
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
the fragrance components are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
each of the fragrance components listed in Unit II. from food and water
will utilize 23% of the safe exposure level for the U.S. population and
all subpopulations.
3. From non-dietary exposure. The fragrance components listed in
Unit II. may be utilized in antimicrobial pesticide products with uses
that could result in residential exposure such as hard surface cleaning
products. For residential handler exposure, the Agency assumed that
most residential use will result in short-term (1 to 30 days) dermal
and inhalation exposures.
The Agency assumed that post-application exposure in residential
settings is expected to be short-term in duration only but
antimicrobial products used as cleaning agents may be used in
facilities where cleaning activities can occur on an intermediate-term
basis. Therefore, these post-application scenarios were included in the
intermediate-term aggregate assessment. The scenarios evaluated were
short- and intermediate term post-application dermal and inhalation
(indoor), short- and intermediate-term incidental oral ingestion from
treated indoor surfaces (hand-to-mouth vinyl/hard surfaces).
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
4. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
These fragrance components may be utilized as inert ingredients in
pesticide formulations registered for uses that could result in short-
term residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to the fragrance components listed in
Unit II.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate exposures for each of the
individual fragrance components listed in Unit II. do not exceed 24% of
the safe exposure level (i.e., a level equivalent to a PAD or RfD) and
therefore are not of concern.
5. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate exposures that do not exceed 24% of the safe exposure level
for each of the fragrance components listed in Unit II. and not of
concern.
6. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity and the lack of exceedance of the
chronic TTC value, the fragrance components listed in Unit II. are not
expected to pose a cancer risk to humans.
7. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of each of the fragrance components listed in Unit
II. Therefore EPA is proposing to exempt from the requirement of a
tolerance under 40 CFR 180.940(a) the residues of acetaldehyde, acetic
acid, allyl cyclohexyl propionate, butryic acid, butyl alcohol, citral,
citronellol, citronellyl acetate, [beta]-damascone, (Z)-, decanal, (E)-
4-decenal, decanoic acid, 1-decanol, 2,6-dimethyl-5-heptanal, 2-
dodecanol, (2E)-, d-limonene, ethyl 2-methylbutyrate, (E)-geraniol,
(E)-geraniol acetate, heptanal), heptanoic acid, heptyl alcohol,
hexanal, hexanoic acid, (Z)-3-hexenol, (Z)-3-hexenol acetate, hexyl
acetate, hexyl alcohol, lauric acid, lauric aldehyde, lauryl alcohol),
methyl-[alpha]-ionone, 3-methyl-2-butenyl acetate, 2-methylundecanal,
myristaldehyde, myristic acid, neryl acetate, n-hexanol, nonanal,
nonanoic acid, nonyl alcohol, octanal, octanoic acid, 1-octanol,
palmitic acid, propionic acid, stearic acid, 2-tridecanal, 3,5,5-
trimethylhexanal, undecanal, undecyl alcohol, valeraldehyde, and
valeric acid.
[[Page 43355]]
IV. 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. The use limitation of 100
ppm will be enforced through the pesticide registration process under
the FIFRA, 7 U.S.C. 136 et seq. EPA will not register any food-contact
use antimicrobial pesticide for sale or distribution containing any of
the fragrance components listed in Unit II. at concentrations exceeding
100 ppm.
V. Conclusion
An exemption from the requirement for a tolerance is proposed for
residues of acetaldehyde, acetic acid, allyl cyclohexyl propionate,
butryic acid, butyl alcohol, citral, citronellol, citronellyl acetate,
[beta]-damascone, (Z)-, decanal, (E)-4-decenal, decanoic acid, 1-
decanol, 2,6-dimethyl-5-heptanal, 2-dodecanol, (2E)-, d-limonene, ethyl
2-methylbutyrate, (E)-geraniol, (E)-geraniol acetate, heptanal),
heptanoic acid, heptyl alcohol, hexanal, hexanoic acid, (Z)-3-hexenol,
(Z)-3-hexenol acetate, hexyl acetate, hexyl alcohol, lauric acid,
lauric aldehyde, lauryl alcohol), methyl-[alpha]-ionone, 3-methyl-2-
butenyl acetate, 2-methylundecanal, myristaldehyde, myristic acid,
neryl acetate, n-hexanol, nonanal, nonanoic acid, nonyl alcohol,
octanal, octanoic acid, 1-octanol, palmitic acid, propionic acid,
stearic acid, 2-tridecanal, 3,5,5-trimethylhexanal, undecanal, undecyl
alcohol, valeraldehyde, and valeric acid when used as inert ingredients
(fragrance components) in antimicrobial pesticide formulations for use
on food contact surfaces in public eating places, dairy processing
equipment, and food processing equipment and utensils at end-use
concentrations not to exceed 100 ppm.
VI. Statutory and Executive Order Reviews
This document proposes to establish exemptions from tolerances
under FFDCA section 408(d). 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 proposed rule has been exempted from
review under Executive Order 12866 due to its lack of significance,
this proposed 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). This
proposed rule does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), or impose any enforceable duty or contain any unfunded mandate
as described under Title II. of the Unfunded Mandates Reform Act of
1995 (UMRA) (2 U.S.C. 1501 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); or OMB review or any
Agency action under Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272
note). The Agency hereby certifies under the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) that this proposed action will not have
significant negative economic impact on a substantial number of small
entities. Establishing an a pesticide tolerance or an exemption from
the requirement of a pesticide tolerance is, in effect, the removal of
a regulatory restriction on pesticide residues in food and thus such an
action will not have any negative economic impact on any entities,
including small entities.
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999). Executive Order 13132 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
VII. References
1. Munro, I.C. A Procedure for the Safety Evaluation of Flavouring
Substances. Toxicological evaluation of certain food additives and
contaminants. Joint FAO/WHO Expert Committee on Food Additives. WHO
Food Additive Series 35, Annex 5. 1996. http://www.inchem.org/documents/jecfa/jecmono/v35je21.htm.
2. Cramer, G. M., Ford, R. A., Hall, R. L. Estimation of Toxic
Hazard--A Decision Tree Approach. Food and Cosmetic Toxicology. Vol.
16 pp. 255-276. 1978
3. Rulis, A.M. De minimis and the Threshold of Regulation. Food
Protection Technology Proceedings of the 1986 Conference for Food
Protection. Eds Felix, C.W. Lewis Publishing, Inc. Chelsea,
Michigan. pp. 29-37. 1986.
4. Rulis, A.M. Establishing a Threshold of Regulation. Risk
Assessment in Setting National Priorities. Eds Bonin, J.J.,
Stevenson, D.E. Plenum Publishing Corporation, New York. pp. 271-
278. 1989.
5. Rulis, AM. Threshold of Regulation: Options for Handling Minimal
Risk Situations. Food Safety Assessment, Chapter 14, Eds Finlay,
J.W., Robinson, S.F., Armstrong, D.J. American Chemical Society
Symposium Series No. 484.
[[Page 43356]]
American Chemical Society, Washington, DC. pp 132-139. 1992.
6. U.S. Food and Drug Administration (FDA). Food Additives:
Threshold of Regulation for Substances Used in Food-Contact
Articles. Federal Register (60 FR 36582-36596, Monday, July 17,
1995).
7. Kroes, R., Renwick, A. G., Cheeseman, et al. Structure-based
Thresholds of Toxicological Concern (TTC): Guidance for Application
to Substances Present at Low Levels in the Diet. Food and Chemical
Toxicology. Vol. 42 pp. 65-83. 2004.
8. EFSA Scientific Committee. Scientific Opinion on Exploring
Options for Providing Advice About Possible Human Health Risks Based
on the Concept of Threshold of Toxicological Concern (TTC). EFSA
Journal 2012;10 (7):2750 103 pp. doi:10.2903/j.efsa.2012.2750.
www.efsa.europa.eu/efsajournal.
9. European Food Safety Authority. Scientific Opinion on Flavouring
Group Evaluation 95 (FGE.95): Consideration of aliphatic, linear or
branched-chain saturated and unsaturated alcohols, aldehydes, acids
and related esters evaluated by JECFA (69th meeting) structurally
related to esters of branched- and straight-chain aliphatic
saturated primary alcohols and of one secondary alcohol, and
branched- and straight-chain unsaturated carboxylic acids evaluated
by EFSA in FGE.05Rev1 (2008). EFSA Journal 2010; 8(11):1207. 51 pp.
doi:10.2903/j.efsa.2010.1207. http://www.efsa.europa.eu/en/efsajournal/doc/1207.pdf.
10. Fukayama, M.Y., Easterday, O.D., Serafino, P.A., et al.
Subchronic Inhalation Studies of Complex Fragrance Mixtures in Rats
and Hamsters. Toxicol Lett. 20;111(1-2). pp. 175-187. 1999.
11. U.S. Environmental Protection Agency. Reregistration Eligibility
Decision for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC). pp.
15-16. 2006. http://www.epa.gov/pesticides/reregistration/REDs/adbac_red.pdf.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 14, 2014.
Jack Housenger,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be 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, add alphabetically the following inert ingredients
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
------------------------------------------------------------------------
Acetaldehyde................... 75-07-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Acetic acid.................... 64-19-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Allyl cyclohexyl propionate.... 2705-87-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Butryic acid................... 107-92-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Butyl alcohol.................. 71-36-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Citral......................... 5392-40-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Citronellol.................... 106-22-9 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Citronellyl acetate............ 150-84-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
[beta]-Damascone, (Z)-......... 23726-92-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Decanal........................ 112-31-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
(E)-4-Decenal.................. 65405-70-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Decanoic acid.................. 334-48-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
1-Decanol...................... 112-30-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2,6-Dimethyl-5-heptanal........ 106-72-9 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
2-Dodecanol, (2E)-............. 20407-84-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Ethyl 2-methylbutyrate......... 452-79-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
(E)-Geraniol................... 106-24-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
(E)-Geraniol acetate........... 105-87-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Heptanal....................... 111-71-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Heptanoic acid................. 111-14-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Heptyl alcohol................. 111-70-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Hexanal........................ 66-25-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Hexanoic acid.................. 142-62-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
n-Hexanol...................... 111-27-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
(Z)-3-Hexenol.................. 928-96-1 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
(Z)-3-Hexenol acetate.......... 3681-71-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Hexyl acetate.................. 142-92-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Hexyl alcohol.................. 111-27-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
[[Page 43357]]
* * * * * * *
Lauric acid.................... 143-07-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Lauric aldehyde................ 112-54-9 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Lauryl alcohol................. 112-53-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
d-Limonene..................... 5989-27-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Methyl-[alpha]-ionone.......... 127-42-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
3-Methyl-2-butenyl acetate..... 1191-16-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2-Methylundecanal.............. 110-41-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Myristaldehyde................. 124-25-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Myristic acid.................. 544-63-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Neryl acetate.................. 141-12-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Nonanal........................ 124-19-6 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Nonanoic acid.................. 112-05-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Nonyl alcohol.................. 143-08-8 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Octanal........................ 124-13-0 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Octanoic acid.................. 124-07-2 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
1-Octanol...................... 111-87-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Palmitic acid.................. 57-10-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Propionic acid................. 79-09-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
Stearic acid................... 57-11-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
2-Tridecanal................... 7774-82-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
3,5,5-Trimethylhexanal......... 5435-64-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Undecanal...................... 112-44-7 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Undecyl alcohol................ 112-42-5 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Valeraldehyde.................. 110-62-3 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
Valeric acid................... 109-52-4 When ready for use, the
end-use concentration
is not to exceed 100
ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2014-17613 Filed 7-24-14; 8:45 am]
BILLING CODE 6560-50-P