[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Rules and Regulations]
[Pages 18398-18403]
[FR Doc No: 2019-08785]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0476; FRL-9991-75]

Bentazon; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
bentazon in or on pea, dry, seed. Interregional Project Number 4 (IR-4)
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective May 1, 2019. Objections and
requests for hearings must be received on or before July 1, 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-2017-0476, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing 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-2017-0476 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
July 1, 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-2017-0476, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8597) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.355 be amended by increasing the existing
tolerance for residues of the herbicide bentazon, (3-isopropyl-1H-
2,1,3-benzothiadiazin-4(3H)-one-2,2-dioxide) and its 6- and 8-hydroxy
metabolites, in or on Pea, dry, seed to 3.0 parts per million (ppm).
That document referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is now available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

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. . .
.''.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 for bentazon including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with bentazon follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database and considered
its 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.
    Bentazon elicits low acute lethality by the oral, inhalation, and
dermal routes of exposure. It is moderately irritating to the eye,
slightly irritating to the skin and is also a dermal sensitizer. In a
21-day dermal toxicity study of bentazon, no effects were observed up
to 1,000 mg/kg/day.
    In the acute neurotoxicity study, a clear NOAEL was established for
the effect observed in decreased motor activity at the mid- and high-
dose groups in males on day 0. There were no effects in the subchronic
neurotoxicity study, and no evidence of neurotoxicity observed in the
rest of the toxicology database.
    In subchronic studies in rats and dogs and in chronic studies in
all species, the most toxicologically significant effects were changes
in hematological/coagulation parameters following oral administration
of bentazon. In rats, subchronic oral exposure caused increased
thromboplastin and prothrombin times (PT). In dogs, hemoglobin,
hematocrit, and erythrocyte counts were significantly reduced in
animals at both 6 weeks and at term. PT and reticulocytes were also
elevated.
    The effects in the chronic studies in rats, mice and dogs were
similar to those in subchronic studies. In a chronic/oncogenicity study
in mice, PT were elevated. In addition, the incidence of hemorrhage in
liver and heart was increased. In a chronic/oncogenicity study in rats,
partial thromboplastin times (PTT) were elevated. In a one-year feeding
study in dogs, at the highest dose tested, there were clinical signs
(emaciation, dehydration, bloody stool, pale mucous membranes,
moderated activity) and a slight to severe anemia (decreased
hemoglobin, hematocrit, and erythrocyte count, decreased reticulocytes,
platelets, leukocytes, PTT, and abnormal red cell morphology) during
the first 13 weeks.
    In the rat developmental toxicity study, maternal effects consisted
of increased post-implantation loss and fetal resorptions, and
developmental effects consisted of skeletal variations and reduced
fetal weights. In the rabbit developmental toxicity study, at the
highest dose tested, maternal effects consisted of partial abortions
with resorptions, and developmental effects consisted of an increased
incidence of no living fetuses. In the two-generation reproductive
toxicity study in rats, there was an increased quantitative offspring
susceptibility. Offspring toxicity manifested as reduced absolute pup
weights during lactation at a dose lower than where parental systemic
toxicity was observed. The sole parental effect was an increased
incidence of kidney mineralization and liver microgranuloma. In rats
and rabbits, fetal effects occurred at doses that caused maternal
toxicity.
    Bentazon was found not to be mutagenic. It is classified as a Group
``E'' chemical (evidence of non-carcinogenicity for humans) based upon
lack of evidence of carcinogenicity in rats and mice.
    Specific information on the studies received and the nature of the
adverse effects caused by bentazon as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document SUBJECT: Sodium Bentazon--Preliminary
Human Health Risk Assessment for Registration Review at page 32 in
docket ID number EPA-HQ-OPP-2017-0476.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for bentazon used for
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Bentazon for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General             NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Acute neurotoxicity-Rat.
 population, including infants     UFA = 10x...........   kg/day.             LOAEL = 150 mg/kg/day based on
 and children).                    UFH = 10x...........  aPAD = 0.05 mg/kg/    decreased motor activity in males
                                   FQPA SF = 1x........   day.                 on study day 0.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 15 mg/kg/day.  Chronic RfD = 0.15   Reproduction and fertility
                                   UFA = 10x...........   mg/kg/day.           effects--Rat Offspring LOAEL = 62
                                   UFH = 10x...........  cPAD = 0.15 mg/kg/    mg/kg/day based on decreased
                                   FQPA SF = 1x........   day.                 absolute pup body weights during
                                                                               lactation.
----------------------------------------------------------------------------------------------------------------
Incidental oral short- (1-30       NOAEL= 15 mg/kg/day.  Residential LOC for  Reproduction and fertility
 days) and Intermediate--term (1-  UFA = 10X...........   MOE = 100.           effects--Rat Offspring LOAEL = 62
 6 months).                        UFH = 10X...........                        mg/kg/day based on decreased
                                   FQPA SF= 1X.........                        absolute pup body weights during
                                                                               lactation.
----------------------------------------------------------------------------------------------------------------
Inhalation short- (1-30 days) and  NOAEL= 15 mg/kg/day.  Residential LOC for  Reproduction and fertility
 Intermediate-term (1-6 months).   UFA = 10x...........   MOE = 100.           effects--Rat Offspring LOAEL = 62
                                   UFH = 10x...........                        mg/kg/day based on decreased
                                   FQPA SF = 1x........                        absolute pup body weights during
                                                                               lactation.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Bentazon is classified as a Group ``E'' chemical (evidence of non-
                                    carcinogenicity for humans) based upon lack of evidence of carcinogenicity
                                    in rats and mice
----------------------------------------------------------------------------------------------------------------
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). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. 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 bentazon, EPA considered exposure under the petitioned-for
tolerances as well as all existing bentazon tolerances in 40 CFR
180.355. EPA assessed dietary exposures from bentazon in food as
follows:
    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.
    Such effects were identified for bentazon. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the United States Department of Agriculture (USDA) National Health and
Nutrition Survey/What We Eat in America (NHANES/WWEIA). The acute
dietary (food and drinking water) exposure assessment was conducted
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all existing and proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption information from the
USDA NHANES/WWEIA. The chronic dietary (food and drinking water)
exposure assessment was conducted using DEEM-FCID, Version 3.16. As to
residue levels in food, EPA assumed 100 PCT and tolerance-level
residues for all existing and proposed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that bentazon does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for bentazon. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for bentazon in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of bentazon. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model and application rate of two
applications of 1.1 pounds (lbs) active ingredient (ai) per acre for a
total application of 2.2 lbs ai/acre/year and a soil adsorption
coefficient of 0.898, the estimated drinking water concentrations
(EDWCs) of bentazon for acute and chronic exposures are estimated to be
2,112

parts per billion (ppb) for surface water which represents ``worst
case''. The Agency believes all of the other uses of bentazon would
produce EDWCs lower than this conservative value for both surface and
groundwater because the Tier 1 Rice Model does not consider degradation
in the rice paddy and EDWCs will not be adjusted by the percent crop
adjustment (PCA) factors.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 2,112 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 2,112 ppb was used to
assess the contribution to 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,
termiticides, and flea and tick control on pets).
    Bentazon is currently registered for the following uses that could
result in residential exposures: Turf and ornamentals. EPA developed a
quantitative exposure assessment for adult residential handlers and
post-application exposure to children, based on the following
scenarios.
    For adult residential handler exposure estimates, these three
scenarios were assessed: (1) Mixing/loading/applying liquids to turf
and gardens/trees with manually-pressurized handwand; (2) mixing/
loading/applying liquids to turf and gardens/trees with hose-end
sprayer; and (3) mixing/loading/applying liquids turf and gardens/trees
with backpack.
    Since there is no dermal hazard, a quantitative residential handler
dermal assessment was not conducted. The inhalation exposure risk
estimates for residential handlers at baseline for all scenarios
resulted in all MOEs >=75,000. EPA's level of concern for bentazon is
an MOE <100.
    The quantitative exposure assessment for residential post-
application exposures, i.e., hand-to-mouth; object to mouth; and short-
and intermediate-term incidental soil ingestion, is based on the
scenario of physical activities on turf for children 1 to <2 years old
(incidental oral).
    The lifestages selected for each post-application scenario are
based on an analysis provided in EPA's 2012 Residential Standard
Operating Procedures (SOPs). While not the only lifestage potentially
exposed for these post-application scenarios, the lifestage that is
included in the quantitative assessment is health protective for the
exposures estimates for any other potentially exposed lifestage. All
risk estimates for post-application exposure resulted in MOEs >=1,000
for children.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 bentazon to share a common mechanism of toxicity
with any other substances, and bentazon does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that bentazon 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. In the rat developmental
toxicity study, skeletal variations and reduced fetal weights were
observed. In the two-generation reproductive toxicity study in rats,
there was evidence of increased quantitative offspring susceptibility
based on low pup weights. In the rabbit developmental toxicity study,
developmental effects resulted in an increased incidence of no living
fetuses at the highest dose tested. Offspring toxicity manifested as
reduced absolute pup weights during lactation at a dose lower than
where parental systemic toxicity was observed. In rats and rabbits,
fetal effects occurred at doses that caused maternal toxicity.
    3. Conclusion. EPA has concluded 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 available toxicity database for bentazon is complete for
FQPA evaluation. Developmental toxicity studies in rats and rabbits, a
2-generation reproduction study in rats, and neurotoxicity studies in
rats are available for FQPA consideration.
    ii. There is no indication that bentazon should be classified as a
neurotoxic chemical. The acute neurotoxicity study established a clear
NOAEL for the observed effect (decreased motor activity). However, no
evidence of neurotoxicity was observed in the remaining toxicology
database, including the subchronic neurotoxicity study. There is no
need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    iii. There is evidence of increased quantitative offspring
susceptibility. However, the concern is low because of (1) a clear
NOAEL is established in the offspring; (2) the dose-response for these
effects are well defined and characterized; and (3) endpoints selected
for risk assessment are protective of the observed offspring and
developmental effects. There are no residual uncertainties for pre- and
post-natal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. The residential exposure
assessment is considered health-protective. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to bentazon in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure. These assessments will
not underestimate the exposure and risks posed by bentazon.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to bentazon will occupy 73% of the aPAD for all infants less than one
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
bentazon from food and water will utilize 78% of the cPAD for all
infants less than one year old, the population group receiving the
greatest exposure. None of the residential exposure scenarios described
in Unit III.C.3 result in long-term exposure. Therefore, the chronic
risk aggregate risk assessment is equivalent to the chronic dietary
risk assessment.
    3. Short- and Intermediate-term risk. Short-and intermediate-term
aggregate exposure takes into account short- and intermediate-term
aggregate residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Bentazon is currently registered for uses on turf and ornamentals
that could result in short-term residential exposures only, as
intermediate-term residential exposures are not expected from
registered uses. Therefore, EPA determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to bentazon.
    For short-term exposures, incidental oral and inhalation exposure
risk assessments are appropriate to aggregate since the PODs for these
routes are based on the same study/effects. The short-term incidental
oral and inhalation exposures are combined (where appropriate) with
chronic dietary (food and water) exposure for determination of
aggregate short-term exposures.
    Adults are potentially exposed to bentazon through dermal,
inhalation, and dietary (food and drinking water) routes. However,
dermal hazard was not identified, so dermal risk estimates were not
assessed and are not included in the aggregate. Adult handler
inhalation exposures have been aggregated with dietary (food and water)
exposures for the short-term duration. The backpack scenario for mixing
and loading liquids is the exposure scenario with the greatest
exposure; therefore, the exposure estimates for this scenario are
protective of other exposure scenarios.
    For young children, due primarily to their hand-to-mouth
activities, short-term oral (non-dietary) exposures are expected along
with dermal and dietary (food and drinking water) exposures. Only the
incidental oral exposures have been aggregated with dietary exposures
since a dermal hazard was not identified. The non-dietary residential
exposures for children 1-2 years old are included in the aggregate
assessment and are considered health protective for exposures and risk
estimates for other potentially exposed lifestages.
    The short-term aggregate risk estimates for children 1-2 years old
and adults are aggregate MOEs of 180 and 330, respectively, and
therefore, not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, bentazon is not expected to pose a cancer risk to humans.
    5. 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 bentazon residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for the determination of
residues of bentazon and its 6- and 8-hydroxy metabolites in/on plant
commodities. The Pesticide Analytical Method Volume II (PAM II) lists
Method II, a gas liquid chromatography (GLC) method with flame
photometric detection for the determination of bentazon and its hydroxy
metabolites in/on corn, rice, and soybeans; the limit of detection
(LOD) for each compound is 0.05 ppm. Method III, modified from Method
II, is available for the determination of bentazon and its hydroxy
metabolites in/on peanuts and seed and pod vegetables with a LOD of
0.05 ppm for each compound. A validated analytical method for
enforcement of the residue definition is also available, with a
combined limit of quantitation (LOQ) of 0.03 ppm in high water content,
high oil content, acidic, and dry commodities (http://www.efsa.europa.eu/en/efsajournal/doc/2822.pdf).
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The current U.S. tolerance of 1.0 ppm for sodium bentazon on pea,
dry, seed is harmonized with the current Codex MRL, including having
identical residue expressions. However, in 2018, the Joint FAO/WHO
Meeting on Pesticide Residues (JMPR) recommended that Codex revise the
tolerance expression for sodium bentazon to include only the parent
chemical and to decrease the MRL for pea, dry, seed to 0.5 ppm. These
changes are expected to be finalized during 2019. Since the metabolite
residues included in the U.S. tolerance expression are the major
residues in some commodities, EPA concluded that it is not appropriate
to eliminate these compounds from the U.S. tolerance expression to
harmonize with Codex. Because the new dry pea data resulted in residues
greater than the current tolerance, EPA is increasing the pea, dry,
seed tolerance from 1 ppm to 3 ppm. The new tolerance level and
tolerance expression are harmonized with Canada.

V. Conclusion

    Therefore, tolerances are established for residues of bentazon,
including its metabolites and degradates, in or on Pea, dry, seed at 3
ppm.

    In addition to establishing the requested tolerance, EPA is
revising the tolerance expression to clarify (1) that, as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of bentazon not specifically mentioned; and (2) that
compliance with the specified tolerance levels is to be determined by
measuring only the specific compounds mentioned in the tolerance
expression. EPA has determined that it is reasonable to make this
change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 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).

VII. 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: April 24, 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.  180.355(a)(1):
0
a. Revise the introductory text.
0
b. Revise the entry for ``Pea, dry, seed'' in the table.
    The revisions read as follows:

Sec.  180.355  Bentazon; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
bentazon, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring for only the sum of
bentazon (3-(1-methylethyl)-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-
dioxide), 6-hydroxy-3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-
dioxide, and 8-hydroxy-3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one
2,2-dioxide calculated as the stoichiometric equivalent of bentazon.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Pea, dry, seed..........................................               3

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-08785 Filed 4-30-19; 8:45 am]
BILLING CODE 6560-50-P