[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Rules and Regulations]
[Pages 18398-18403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (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, 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 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.

[[Page 18399]]

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

[[Page 18400]]

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

[[Page 18401]]

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.

[[Page 18402]]

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: (410) 305-2905; email address: 
[email protected].

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.

[[Page 18403]]

    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