[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Rules and Regulations]
[Pages 51060-51066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20529]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0651; FRL-9996-66]
2-Phenoxyethanol; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-
[[Page 51061]]
phenoxyethanol when used as an inert ingredient (solvent or cosolvent)
limited to 0.2% by weight in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest. The Dow Chemical
Company 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 2-phenoxyethanol
when used in accordance with the terms of the exemption.
DATES: This regulation is effective September 27, 2019. Objections and
requests for hearings must be received on or before November 26, 2019,
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-2017-0651, 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: Michael Goodis, Director, 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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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-2017-0651 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
November 26, 2019. 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-2017-0651, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of June 14, 2018 (83 FR 27743) (FRL-9978-
41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11069) by
The Dow Chemical Company, 1803 Building, Washington Street, Midland, MI
48764. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of 2-phenoxyethanol (CAS Reg. No. 122-99-6) when used as an
inert ingredient (solvent or co-solvent) in pesticide formulations
applied to growing crops and raw agricultural commodities after
harvest. That document referenced a summary of the petition prepared by
The Dow Chemical Company, the petitioner, which is available in the
docket, http://www.regulations.gov. One comment was received on the
notice of filing. EPA's response is discussed in Unit V.C.
Based upon review of the data supporting the petition, EPA has
limited the maximum end-use concentration of 2-phenoxyethanol as not to
exceed 0.2% by weight in pesticide formulations, when ready for use.
The reason for this change is explained in Unit V.B.
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
[[Page 51062]]
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 2-phenoxyethanol including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with 2-phenoxyethanol
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.
Single and repeat-dose studies in rats indicated that 2-
phenoxyethanol is rapidly and nearly completely absorbed after oral
administration and more than 90% of the administered dose is excreted
in urine within 24 hours of exposure. Following oral and dermal
exposure the terminal hydroxyl group of 2-phenoxyethanol is
metabolized, mainly in the liver, by alcohol dehydrogenase (ADH) to 2-
phenoxyacetaldehyde and then by aldehyde dehydrogenase (ALDH) to 2-
phenoxyacetic acid (PhAA).
2-Phenoxyethanol exhibits low levels of acute toxicity. Acute
studies in rats showed oral LD50 ranging from 1,260 to more
than 2,500 mg/kg. The dermal LD50 in two rabbit studies were
more than 2,200 and more than 3,653 mg/kg and 14391 mg/kg in a rat
study. The inhalation LC50 in the rat was more than 1,000
mg/m\3\. 2-Phenoxyethanol is considered to be an eye irritant and a
mild skin irritant. However, it was not found to be a dermal
sensitizer.
Studies on 2-phenoxyethanol show that the target organ in rats and
mice is the kidney, most likely due to an extensive first-pass
metabolism and formation of high amounts/concentrations of 2-
phenoxyacetic acid in systemic circulation. Following oral and dermal
exposure the terminal hydroxyl group of 2-phenoxyethanol is
metabolized, mainly in the liver, to 2-phenoxyacetic acid (PhAA). Data
suggest that mice are somewhat more resistant to the toxic effects of
2-phenoxyethanol and its main metabolite 2-phenoxyacetic acid than
rats.
In addition to the effects on the kidney, hematotoxicity was also
observed. This appears to be the result of exposure to the parent
compound. Although hemotoxic effects of 2-phenoxyethanol were observed
in repeat dose studies, the available repeat dose dataset indicates
that the rabbit is the most sensitive species. The hemolysis was less
pronounced in rats and mice. Based on differences in metabolism, humans
are expected to be the least susceptible to RBC hemolysis.
In developmental toxicity studies in rats and rabbits, no evidence
of developmental toxicity was observed. In a two-generation
reproductive toxicity study in mice, an effect on fertility was
observed but only at a dose level above limit dose values. Offspring
toxicity was observed, but only in the presence of maternal toxicity
(i.e., decreased body weight and increased liver weight).
There is no evidence that exposure to 2-phenoxyethanol suppresses
or otherwise harms immune function in humans. No signs of neurotoxicity
were reported in acute or repeat-dose oral studies. There were also no
signs of carcinogenicity in the database including the 2-year feeding
studies. Similarly, all tests were negative for genotoxicity and
mutagenicity. The available data suggests that 2-phenoxyethanol is not
carcinogenic.
Specific information on the studies received and the nature of the
adverse effects caused by 2-phenoxyethanol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) identified from the toxicity studies can be found at
http://www.regulations.gov in the document ``IN-11069; 2-
Phenoxyethanol: Human Health Risk and Ecological Effects--Assessment of
a Food Use Pesticide Inert Ingredient'' at pages 9-32 in docket ID
number EPA-HQ-OPP-2017-0651.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for 2-phenoxyethanol used
[[Page 51063]]
for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for 2-Phenoxyethanol for Use in Human Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Chronic dietary (All populations) NOAEL = 369 mg/kg/ Chronic RfD = 3.69 90-Day Drinking Water Toxicity
day. mg/kg/day. (rat).
UFA = 10x........... cPAD = 3.69 mg/kg/ LOAEL = 10,000 mg/L (687 mg/kg/day
UFH = 10x........... day. in males and 1,000 mg/kg/day in
FQPA SF = 1x........ females) based on hematotoxicity
and histopathological changes in
the kidney and bladder.
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Incidental oral short-term (1 to NOAEL = 369 mg/kg/ LOC for MOE = 100.. 90-Day Drinking Water Toxicity
30 days). day. (rat).
UFA = 10x........... LOAEL = 10,000 mg/L (687 mg/kg/day
UFH = 10x........... in males and 1,000 mg/kg/day in
FQPA SF = 1x........ females) based on hematotoxicity
and histopathological changes in
the kidney and bladder.
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Dermal short-term (1 to 30 days) Dermal study NOAEL = LOC for MOE = 100.. 90-Day Dermal Toxicity Study
and intermediate-term (1 to 6 500 mg/kg/day. (rabbit).
months). UFA = 10x........... LOAEL = 600 mg/kg/day from
UFH = 10x........... hemolysis and death seen in the
FQPA SF = 1x........ Developmental Toxicity-Dermal
(rabbit).
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Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 100.. 14-Day Inhalation Toxicity Study
days). NOAEL = ~12.7 mg/kg/ (rat).
day (inhalation LOAEL = ~65 mg/kg/day based on
absorption rate = respiratory effects (i.e.,
100%). degeneration/squamous metaplasia
UFA = 100x.......... of respiratory epithelium in the
UFH = 10x........... nasal cavity, hyperplasia of the
FQPA SF = 1x........ respiratory epithelium in the
nasal cavity of all males and
females, inflammatory cell
infiltrates in the nasal cavity,
and statistically significant
increased absolute lung weights
in males).
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Inhalation (1 to 6 months)....... Inhalation study LOC for MOE = 1,000 14-Day Inhalation Toxicity Study
NOAEL = 12.7 mg/kg/ (rat).
day (inhalation LOAEL = ~65 mg/kg/day based on
absorption rate = respiratory effects (i.e.,
100%). degeneration/squamous metaplasia
UFA = 10x........... of respiratory epithelium in the
UFH = 10x........... nasal cavity, hyperplasia of the
UFS = 10x........... respiratory epithelium in the
FQPA SF = 1x........ nasal cavity of all males and
females, inflammatory cell
infiltrates in the nasal cavity,
and statistically significant
increased absolute lung weights
in males).
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Cancer (Oral, dermal, inhalation) No evidence of carcinogenicity in the available database.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day (= milligram/kilogram/day). MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). UFS = use of a short-term study for long-term risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2-phenoxyethanol, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from 2-phenoxyethanol in food as follows:
Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary. In conducting the
chronic dietary exposure assessment using the Dietary Exposure
Evaluation Model DEEM- FCID\TM\, Version 3.16, EPA used food
consumption information from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What we eat in
America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to
2008. The Inert Dietary Exposure Evaluation Model (I-DEEM) is a highly
conservative model with the assumption that the residue level of the
inert ingredient would be no higher than the highest tolerance for a
given commodity. Implicit in this assumption is that there would be
similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. In the case of 2-
phenoxyethanol, a 0.2% by weight limitation in formulation was
incorporated into the model.
A complete description of the general approach taken to assess
inert ingredient risks in the absence of residue data is contained in
the memorandum entitled ``Alkyl Amines Polyalkoxylates (Cluster 4):
Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure
and Risk
[[Page 51064]]
Assessments for the Inerts.'' (D361707, S. Piper, 2/25/09) and can be
found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2008-0738.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for 2-phenoxyethanol, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. 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). 2-
Phenoxyethanol is currently approved as a nonfood use inert ingredient.
A review of residential products containing this inert ingredient
revealed that it is currently used in antimicrobial cleaning products
and in pet spot-on treatment products. There is also a potential for
outdoor uses in pesticides applied to residential lawns and turf. In a
conservative effort to assess exposure, the EPA has conducted a
screening level assessment using high-end exposure scenarios for
pesticidal use on lawns/turf, in antimicrobial spray cleaning products,
and in pet spot-on application.
In addition to the proposed and current pesticidal uses of 2-
phenoxyethanol, 2-phenoxyethanol is also used in various non-pesticidal
products such as paints and coatings, personal care/cosmetic products,
and cleaning products. The Agency incorporated known non-pesticidal
background exposure to 2-phenoxyethanol used in latex paint, cosmetic
products, and cleaning products into this risk assessment.
For each residential scenario, short-term exposure for both the
handler (adult) and post-application exposure (adult and child) is
expected. Based on the proposed use pattern, intermediate-term and
long-term pesticidal exposures from residential uses are not expected.
Non-pesticidal use in cosmetics can result in short-term, intermediate-
term, and long-term exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found 2-phenoxyethanol to share a common mechanism of
toxicity with any other substances, and 2-phenoxyethanol does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
2-phenoxyethanol 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 website 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.
2. Prenatal and postnatal sensitivity. A reproductive toxicity
study showed effects on reproductive parameters of fertility at doses
of 4,000 mg/kg/day. These effects were not seen in animals dosed with
2,000 mg/kg/day which is above the limit dose of 1,000 mg/kg/day.
Although evidence of adverse effects were observed in the offspring
(i.e., decreased pup weight), this effect was only seen in the presence
of maternal toxicity. In addition, two developmental studies showed no
effect on offspring at the limit dose of 1,000 mg/kg/day.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for 2-phenoxyethanol is complete.
ii. There is no indication that 2-phenoxyethanol is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that 2-phenoxyethanol results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. All evidence of toxicity was seen in the presence of maternal
toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and incorporated a limitation of 0.2% by weight in pesticide
formulation. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to 2-
phenoxyethanol in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by 2-phenoxyethanol.
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,
2-phenoxyethanol is 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
2-phenoxyethanol from food and water will utilize 0.00007% of the cPAD
for children 1 to 2 years of age, the population group receiving the
greatest exposure. Based on the explanation in this unit, regarding
residential use patterns, chronic residential exposure to residues of
2-phenoxyethanol is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus
[[Page 51065]]
chronic exposure to food and water (considered to be a background
exposure level). 2-Phenoxyethanol is currently used as an inert
ingredient in pesticide products that are 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 2-
phenoxyethanol. However, the mode of action of the toxicological effect
must be the same across routes of exposure in order to aggregate the
exposure. In this case, the toxic effects are different by one route
and duration from those produced by a different route and duration. To
produce an aggregate risk estimate in situations in which it is not
appropriate to aggregate exposures due to differing toxicological
effects, risk measures are calculated separately for each route and
duration for a given toxic effect for each hypothetical ``individual.''
In these situations, multiple aggregate assessments are performed for a
single chemical of interest if the relevant toxicological endpoints for
all routes/pathways are not the same. When that is the case, a separate
aggregate assessment is then performed for each toxic effect of
concern.
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 MOEs above the Agency's
level of concern. Aggregate dermal exposures resulted in a MOE of 114
for adults and a MOE of 165 in children. Because EPA's level of concern
for 2-phenoxyethanol is a MOE of 100 or below, these MOEs are not of
concern.
4. Intermediate-term and long-term risk. Intermediate- and long-
term aggregate exposure takes into account intermediate- or long-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). An intermediate-term
and long-term adverse effect was identified; however, 2-phenoxyethanol
is not currently used as an inert ingredient in pesticide products that
are registered for any use patterns that would result in intermediate-
or long-term residential exposure. Intermediate-term risk is assessed
based on intermediate-term residential exposure plus chronic dietary
exposure. Long-term risk is assessed based on long-term residential
exposure plus chronic dietary exposure. Although intermediate- and
long- term residential pesticidal uses of 2-phenoxyethanol are not
expected, because 2-phenoxyethanol is used in cosmetics, intermediate-
and long-term residential exposure is possible. However, in this case,
the relevant toxicological endpoints resulting from intermediate- and
long-term exposure from cosmetic use and chronic dietary exposures from
pesticidal uses are not the same; therefore, an intermediate- and long-
term aggregate risk assessment was not conducted.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, 2-phenoxyethanol is not expected to pose a cancer risk to
humans.
6. 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 2-phenoxyethanol residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of 2-
phenoxyethanol in or on any food commodities. EPA is establishing
limitations on the amount of 2-phenoxyethanol that may be used in
pesticide formulations applied pre- and post-harvest. These limitations
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 pesticide formulation for
food use that exceeds 0.2% by weight of 2-phenoxyethanol in the final
pesticide formulation.
B. Revisions to Petitioned for Tolerances
Although the petition did not specify a limitation on concentration
of this inert ingredient in end-use pesticide formulations, the Agency
is establishing this exemption with the limitation of 0.2% by weight in
pesticide formulations. Based upon an evaluation of the data included
in the petition, as well as publicly available literature, it was
determined that 2-phenoxyethanol has biocidal properties; therefore,
EPA is establishing a limitation in formulation, when ready for use,
(i.e., the end-use concentration is not to exceed 0.2% by weight). This
limitation is being placed to ensure that the chemical is functioning
as an inert ingredient and not a biocide. This limitation is explained
in the Agency's risk assessment which can be found at http://www.regulations.gov in document IN-11069; 2-Phenoxyethanol: Human
Health Risk and Ecological Effects Assessment of a Food Use Pesticide
Inert Ingredient in docket ID number EPA-HQ-OPP-2017-0651.
C. Response to Comments
One comment was submitted generally opposing the establishment of
tolerance exemptions. Although the Agency recognizes that some
individuals believe that pesticides should be banned on agricultural
crops, the existing legal framework provided by section 408 of the
Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish
tolerances when it determines that the tolerance is safe. Upon
consideration of the validity, completeness, and reliability of the
available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that this exemption from the requirement
of a tolerance is safe. The commenter provided no information to
support a conclusion that the exemption was not safe.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for 2-phenoxyethanol (CAS Reg. No.
122-99-6) when used as an inert ingredient (solvent or co-solvent)
limited to 0.2% by weight in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does
[[Page 51066]]
it require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 16, 2019.
Michael Goodis,
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. 180.910, add a heading to the table and alphanumerically
add inert ingredient ``2-phenoxyethanol (CAS Reg. No. 122-99-6)'' to
read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Table 1 to 180.910
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
2-Phenoxyethanol (CAS Reg. No. 122-99- 0.2% by weight in pesticide Solvent or co-solvent.
6). formulation.
* * * * * * *
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[FR Doc. 2019-20529 Filed 9-26-19; 8:45 am]
BILLING CODE 6560-50-P