[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: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at 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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  No evidence of carcinogenicity in the available database.
----------------------------------------------------------------------------------------------------------------
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.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-20529 Filed 9-26-19; 8:45 am]
 BILLING CODE 6560-50-P


