[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Rules and Regulations]
[Pages 57621-57627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20438]



[[Page 57621]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0498; FRL-9521-01-OCSPP]


Glufosinate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
glufosinate in or on multiple commodities that are identified and 
discussed later in this document. Interregional Project Number 4 (IR-4) 
and BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 21, 2022. Objections and 
requests for hearings must be received on or before November 21, 2022, 
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-2020-0498, is available online at 
https://www.regulations.gov or in-person 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 and the OPP Docket is (202) 566-
1744.
    For the latest status information on EPA/DC services, docket 
access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505T), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-1030; 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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2020-0498 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 21, 2022. 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-2020-0498, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-
10016-93), 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 
0E8859) by IR-4, NC State University, 1730 Varsity Drive, Venture IV, 
Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 
180.473 be amended to establish tolerances for residues of the 
herbicide glufosinate-ammonium, determined by measuring the sum of 
glufosinate-ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl) monoammonium salt, and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl)butanoic acid, and 3-
(hydroxymethylphosphinyl)propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents in or on avocado at 
0.03 parts per million (ppm); bushberry subgroup 13-07B at 0.15 ppm; 
cottonseed subgroup 20C at 4 ppm; fig at 0.07 ppm; fig, dried at 0.2 
ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 0.05 ppm; hop, dried cones at 0.9 ppm; melon subgroup 9A at 0.08 
ppm; pepper/eggplant subgroup 8-10B at 0.08 ppm; rapeseed, subgroup 20A 
at 0.4 ppm; squash/cucumber subgroup 9B at 0.15 ppm; tomato, paste at 
0.11 ppm; tomato, subgroup 8-10A at 0.06 ppm; tropical and subtropical, 
small fruit, edible peel, subgroup 23A at 0.5 ppm; and vegetable, 
tuberous and corm, subgroup 1C at 0.8 ppm. Upon the establishment of 
those tolerances, the petition also requested that EPA remove the 
following tolerances from 40 CFR 180.473: apple at 0.05 ppm; bushberry 
subgroup 13B at 0.15 ppm; canola, seed at 0.40 ppm; cotton, undelinted 
seed at 4.0 ppm; grape at 0.05 ppm; juneberry at 0.10 ppm; lingonberry 
at 0.10 ppm; olive at 0.50 ppm; pistachio at 0.10 ppm; potato at 0.80 
ppm; and salal at 0.10 ppm. That document referenced a summary of the 
petition prepared by IR-4, the petitioner, and is available in the 
docket, https://www.regulations.gov.

[[Page 57622]]

Two comments were received on the notice of filing. EPA's response to 
these comments is discussed in Unit IV.C.
    In the Federal Register of August 24, 2021 (86 FR 47275) (FRL-8792-
02-OCSPP), 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 
0F8865) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.473 be amended to 
establish or revise tolerances for residues of the herbicide 
glufosinate-ammonium, determined by measuring the sum of glufosinate-
ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl) 
monoammonium salt, and its metabolites, 2-(acetylamino)-4-
(hydroxymethyl phosphinyl)butanoic acid, and 3-
(hydroxymethylphosphinyl)propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents in or on oilseed, 
cottonseed subgroup 20C at 15 ppm and cotton gin byproducts at 50 ppm. 
That document referenced a summary of the petition prepared by BASF, 
the registrant, and is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing some tolerances at different levels than the petitioner 
requested. The reasons for these changes are explained in Unit IV.D.

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 glufosinate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with glufosinate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data 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.
    The toxicology database for glufosinate is complete. A primary 
effect associated with glufosinate is inhibition of glutamine 
synthetase in the brain, which may be of significant concern for 
possible neurotoxicity and/or expression of clinical signs. Clinical 
signs of neurotoxicity were seen in several studies, including the 
subchronic, developmental, and chronic studies in rats and dogs. In 
addition to a variety of clinical signs, retinal atrophy was also 
observed in the subchronic and chronic rat studies. The rat 
developmental neurotoxicity (DNT) study demonstrated altered brain 
morphometrics.
    There was evidence of both qualitative (rabbit developmental study) 
and quantitative (rat reproductive toxicity study; DNT study) 
susceptibility following glufosinate exposure. A 28-day inhalation 
toxicity study demonstrated toxicity at the lowest dose tested as 
indicated by lung and bronchial congestion. Glufosinate ammonium is 
classified as Toxicity Category III or IV for acute oral, dermal, and 
inhalation toxicity; and is not a dermal or eye irritant, nor a dermal 
sensitizer. Glufosinate was classified as ``not likely to be a human 
carcinogen.'' There was no evidence of a treatment-related increase in 
tumors in either rats or mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by glufosinate 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 https://www.regulations.gov in the document titled ``Glufosinate. Human Health 
Risk Assessment for the Proposed Use of Glufosinate on tomato subgroup 
8-10A; pepper/eggplant subgroup 8-10B; melon subgroup 9A; squash/
cucumber subgroup 9B; fig; avocado; hops: and crop group expansions for 
rapeseed subgroup 20A; cottonseed subgroup 20C; fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F; tropical and 
subtropical, small fruit, edible peel, subgroup 23A; vegetable, 
tuberous and corm, subgroup 1C; and a crop group conversion for 
bushberry subgroup 13-07B: an amended application rate for cotton: and 
revised restricted entry intervals for cotton, field corn, sweet corn, 
soybean, and canola'' (hereinafter ``Glufosinate Human Health Risk 
Assessment'') on pages 43-52 in docket ID number EPA-HQ-OPP-2020-0498.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    A summary of the toxicological endpoints for glufosinate used for 
human risk assessment can be found in the Glufosinate Human Health Risk 
Assessment on page 23-26.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

[[Page 57623]]

exposure to glufosinate, EPA considered exposure under the petitioned-
for tolerances as well as all existing glufosinate tolerances in 40 CFR 
180.473. EPA assessed dietary exposures from glufosinate 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 glufosinate.
    In conducting the acute dietary exposure assessment, EPA used the 
2003-2008 food consumption data from the U.S. Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). The acute dietary 
exposure assessment is unrefined, assuming tolerance level residues and 
100% crop treated (100 PCT) for all crop and livestock commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the 2003-2008 food consumption data from the 
NHANES/WWEIA. EPA used anticipated residues based on average field 
trial residue levels for plant raw agricultural commodities, PCT 
information where available, and experimentally-determined processing 
factors where available. Anticipated residues for livestock commodities 
were also calculated and incorporated into the assessment.
    iii. Cancer. EPA has concluded that glufosinate 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 PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    For the chronic dietary assessment, the following PCT assumptions 
were made: almonds: 25%; apples: 5%; apricots: 15%; blueberries: 20%; 
canola: 55%; cherries: 5%; corn: 2.5%; cotton: 20%; grapes: 20%; 
hazelnuts: 40%; peaches:10%; pears: 10%; pecans: 1%; pistachios: 35%; 
plums/prunes: 15%; potatoes: 15%; rice: 1%; soybeans: 10%; sweet corn: 
1%; and walnuts: 20%. In the acute analysis, the Agency made the 
conservative assumption of 100 PCT.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5% except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which glufosinate may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for glufosinate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of glufosinate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the Pesticides in Water Calculator (PWC; version 1.52), 
the estimated drinking water concentrations (EDWCs) of glufosinate are 
estimated to be 201 ppb for acute dietary exposures and 24.4 ppb parts 
per billion (ppb) for chronic dietary exposures. Surface water 
simulations resulted in the highest EDWCs.
    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). Glufosinate is 
currently registered for uses that could result in residential handler 
and post-application exposures including use on lawn and turf as well 
as recreational sites such as golf courses. The current action does not 
add any new uses with residential exposures.
    For assessing aggregate exposure to adults, the Agency used 
exposures from the dermal exposure scenario from high

[[Page 57624]]

contact lawn activity on treated lawns and turf. For assessing 
aggregate exposure to children 1 to less than 2 years old, the 
conservative exposure assessment for dermal plus incidental oral (hand-
to-mouth and object-to-mouth) exposure from high contact lawn activity 
on lawns and turf treated with glufosinate was assumed. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at https://www.epa.gov/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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to glufosinate and any other 
substances, and glufosinate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that glufosinate has 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 https://www.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 Food Quality 
Protection Act (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 are available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Quantitative susceptibility 
was seen in the rat developmental neurotoxicity (DNT) study for 
glufosinate which demonstrated alterations in brain morphometrics in 
the adult offspring exposed in utero and/or during lactation at dose 
levels not associated with maternal toxicity. The reproductive toxicity 
study in rats also showed evidence of quantitative susceptibility 
indicated by an increase in pup mortality in the absence of parental 
toxicity. In rabbits, decreased fetal body weight and increased 
mortality were observed. Since increased fetal mortality was observed 
in the presence of less severe maternal toxicity (decreased food 
consumption, body weight, and body weight gain), there is evidence of 
qualitative susceptibility in the fetuses. The developmental toxicity 
study in the rat revealed dilated renal pelvis and/or hydroureter in 
the fetuses at the same dose level that produced significant increases 
in hyperactivity and vaginal bleeding in the dams indicating no 
qualitative or quantitative sensitivity.
    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 for acute dietary exposure. For all other 
exposure scenarios where the DNT study or the 28-day inhalation study 
is used as an endpoint for risk assessment (i.e., short-term incidental 
oral, short- and intermediate-term dermal, and chronic dietary), EPA is 
retaining a 10X FQPA SF as a LOAEL to NOAEL extrapolation factor since 
NOAELs were not observed in those studies. The decision to reduce the 
FQPA SF to 1X for acute dietary exposure is based on the following 
findings:
    i. The toxicity database for glufosinate is complete.
    ii. A number of clinical signs indicative of neurotoxicity were 
noted in rat and dog studies. A critical indication of neurotoxicity 
was also evident in the DNT study where alterations in brain 
morphometrics in the adult offspring were demonstrated. However, 
concern is low since the selected points of departure are protective of 
observed neurotoxic effects.
    iii. Quantitative evidence of increased in utero and post-natal 
susceptibility was identified in rats. However, concern for the 
observed susceptibility is low as all selected endpoints are protective 
of these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues for all crops and 
livestock commodities. With limited monitoring data available, upper-
bound assumptions were used to determine exposure through drinking 
water sources. These assessments will not underestimate the exposure 
and risks posed by glufosinate.

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. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to 
glufosinate from food and water will utilize 27% of the aPAD with the 
females 13 to 49 years old population subgroup, the only population 
group of concern because no appropriate toxicological effect 
attributable to a single dose was observed for the general U.S. 
population or any other population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
glufosinate from food and water will utilize 37% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Chronic residential exposure to residues of glufosinate is 
not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Glufosinate 
is 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 glufosinate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and

[[Page 57625]]

residential exposures result in a short-term aggregate MOE 5,100 for 
adults. Likewise, for children 1 to less than 2 years old, the short-
term aggregate risk estimates are not of concern. The short-term 
aggregate MOE is 1,100 and the Agency's level of concern is 1,000 for 
the particular exposures discussed in this section. Because EPA's level 
of concern for glufosinate is 1,000 or below, these risks are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
glufosinate is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately-protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
glufosinate.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, glufosinate 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 glufosinate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two analytical methods have been validated by EPA for enforcement 
of the currently established tolerances: (1) Method HRAV-5A for the 
determination of glufosinate and glufosinate propanoic acid in/on 
almond, apple, corn forage, corn grain, grape, and soybean seed; and, 
(2) Method BK/01/99 used for the determination of glufosinate, N-
acetyl-glufosinate, and glufosinate propanoic acid in/on canola seed 
and sugar beet root.
    Based on the results of the crop field trials validating a method 
similar to Method BK/01/99, EPA concludes that Method BK/01/99 is a 
suitable method for enforcement of tolerances on avocado, fig, hops, 
melon, pepper, squash/cucumber and tomato.

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). 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.
    Codex has not established MRLs for glufosinate in/on cotton, gin 
byproducts; fig, dried; hop, dried cones; melon, subgroup 9A; pepper/
eggplant 8-10B; squash/cucumber subgroup 9B; or tomato, paste.
    The U.S. tolerances for avocado and fig are harmonized with the 
Codex MRLs of 0.1 ppm for avocado and 0.1 ppm for fig. The U.S. 
tolerance for tomato subgroup 8-10A is harmonized with Codex MRLs of 
0.1 ppm on naranjilla and tree tomato.
    Tolerances for bushberry subgroup 13-07B; tropical and subtropical, 
small fruit, edible peel, subgroup 23A; vegetable, tuberous and corm, 
subgroup 1C; and cottonseed subgroup 20C are not harmonized with the 
corresponding Codex MRLs because the residue data based on approved 
application rates indicates that residues of glufosinate would be 
higher than the Codex MRL. Decreasing the U.S. tolerances would put 
U.S. growers at risk of having violative residues despite legal use of 
glufosinate according to the label. The tolerance for rapeseed subgroup 
20A at 0.4 ppm is not harmonized with the Codex MRL on rapeseed at 1.5 
ppm because the Codex MRL is based on an obsolete use and because 
available data indicate that 0.4 ppm is sufficient for glufosinate 
residues from use on rapeseed subgroup 20A. EPA is not harmonizing the 
U.S. tolerance for fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.05 ppm with the Codex MRLs of 0.15 ppm for table 
and wine grape because the Codex MRLs are based on obsolete data and 
there are no registered uses in the European Union.

C. Response to Comments

    The same two comments were received to both the registrant's and 
IR-4's notice of filing. Both comments stated in part that the Agency 
should ``deny this profiteering exemption for rutgers.'' 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 FFDCA authorizes EPA to establish tolerances when 
it determines that the tolerances are 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 the glufosinate tolerances are safe. The commenter has provided no 
information indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-for Tolerances

    EPA is establishing the tolerances for avocado, fig, and tomato 
subgroup 8-10A at different levels than requested to harmonize with the 
Codex MRL.
    For cottonseed, subgroup 20C, IR-4 requested a tolerance of 4 ppm 
based on the existing tolerance of 4 ppm on cotton, undelinted seed; 
however, BASF also petitioned for a new tolerance on cottonseed 
subgroup 20C at 15 ppm. EPA is establishing the tolerance at 15 ppm 
based on the new cotton field trial data. For cotton, gin byproducts, 
the already established tolerance of 15 ppm is being changed to 30 ppm 
rather than 50 ppm requested by BASF based on the new field trial data 
provided for cotton gin byproducts. The tolerance of 30 ppm for cotton 
gin byproducts is based on the field trials most reflective of the 
label use pattern on cotton (2 applications of ~0.8 lb ai/A), rather 
than using field trials that exceed the maximum single application 
rate.
    IR-4 requested a tolerance of 0.2 ppm for fig, dried. EPA is 
establishing the tolerance for fig, dried at 0.15 ppm to reflect the 
correct theoretical processing factor. The tolerance level for fig, 
dried was derived using the combined glufosinate, 3-
(hydroxymethylphosphinyl) propanoic acid (MPP), and 2-(acetylamino)-4-
(hydroxymethyl phosphinyl) butanoic acid (NAG) highest average field 
trials (HAFTs) of the fig field trials in combination with the 
theoretical processing factor of 3.5X rather than 4.8X.
    EPA is establishing the tolerance for pepper/eggplant subgroup 8-
10B at 0.15 ppm rather than at 0.08 ppm as requested by IR-4. As the 
representative crops for the subgroup, the field trial data for bell 
and nonbell peppers were analyzed separately, which resulted in a 
higher tolerance of 0.15 ppm for nonbell

[[Page 57626]]

pepper. EPA is using that value to establish the tolerance for the 
subgroup.
    IR-4 requested a tolerance of 0.11 ppm for tomato, paste but EPA is 
establishing the tolerance at 0.15 ppm. The tolerance level of 0.15 ppm 
was derived using the glufosinate and 3-(hydroxymethylphosphinyl) 
propanoic acid HAFTs from the tomato field trials in combination with 
the empirically-determined processing factors for glufosinate and 3-
(hydroxymethylphosphinyl) propanoic acid.

V. Conclusion

    Therefore, tolerances are established for residues of glufosinate, 
including its metabolites and degradates, in or on avocado at 0.1 ppm; 
bushberry subgroup 13-07B at 0.15 ppm; cottonseed subgroup 20C at 15 
ppm; fig at 0.1 ppm; fig, dried at 0.15 ppm; fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.05 ppm; hop, 
dried cones at 0.9 ppm; melon subgroup 9A at 0.08 ppm; pepper/eggplant 
subgroup 8-10B at 0.15 ppm; rapeseed subgroup 20A at 0.4 ppm; squash/
cucumber subgroup 9B at 0.15 ppm; tomato, paste at 0.15 ppm; tomato 
subgroup 8-10A at 0.1 ppm; tropical and subtropical, small fruit, 
edible peel, subgroup 23A at 0.5 ppm; and vegetable, tuberous and corm, 
subgroup 1C at 0.8 ppm. EPA is also revising the tolerance for cotton, 
gin byproducts from 15 ppm to 30 ppm.
    Tolerances are also removed for the following commodities due to 
the establishment of tolerances for the above commodities or previously 
established tolerances: apple at 0.05 ppm; bushberry subgroup 13B at 
0.15 ppm; canola, seed at 0.40 ppm; cotton, undelinted seed at 4.0 ppm; 
grape at 0.05 ppm; juneberry at 0.10 ppm; lingonberry at 0.10 ppm; 
olive at 0.50 ppm; pistachio at 0.10 ppm; potato at 0.80 ppm; and salal 
at 0.10 ppm.
    Finally, EPA is revising the title of Sec.  180.473 from 
``Glufosinate Ammonium; tolerances for residues'' to ``Glufosinate; 
tolerances for residues'' and revising the tolerance expression for 
glufosinate in 40 CFR 180.473(a) and (d) to clarify that the tolerance 
for the active ingredient will be referred to as glufosinate (i.e., the 
racemic mixture). Glufosinate is a racemic mixture of the D- and L-
enantiomers; with the L-enantiomer being responsible for its herbicidal 
activity. Glufosinate can exist in multiple forms, including the acid, 
ammonium, and sodium forms; other salt forms of glufosinate may be 
possible as well. While there are presently only registrations for the 
ammonium form of glufosinate, future registration requests may be 
submitted for the acid, sodium, or other forms. This change to the 
tolerance expression will cover the particular form (e.g., acid or 
ammonium) that may be in any particular pesticide product in the 
future. 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 because ammonium is the only form currently 
registered.

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). 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 tolerances 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: September 15, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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. Amend Sec.  180.473 by:
0
a. Revising the section heading.
0
b. In paragraph (a):
0
i. Revising the introductory text.
0
ii. Adding a table heading;
0
iii. Removing the entry for ``Apple'';
0
iv. Adding in alphabetical order the entry ``Avocado'';

[[Page 57627]]

0
v. Removing the entry for ``Bushberry subgroup 13B'';
0
vi. Adding in alphabetical order the entry ``Bushberry subgroup 13-
07B'';
0
vii. Removing the entry for ``Canola, seed'';
0
viii. Revising the entry for ``Cotton, gin byproducts'';
0
ix. Removing the entry for ``Cotton, undelinted seed'';
0
x. Adding in alphabetical order the entries ``Cottonseed subgroup 
20C''; ``Fig''; ``Fig, dried''; and ``Fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F'';
0
xi. Removing the entry for ``Grape'';
0
xii. Adding in alphabetical order the entry ``Hop, dried cones'';
0
xiii. Removing the entries for ``Juneberry'' and ``Lingonberry'';
0
xiv. Adding in alphabetical order the entry ``Melon subgroup 9A'';
0
xv. Removing the entry for ``Olive'';
0
xvi. Adding in alphabetical order the entry ``Pepper/eggplant subgroup 
8-10B'';
0
xvii. Removing the entries for ``Pistachio'' and ``Potato'';
0
xviii. Adding in alphabetical order the entry ``Rapeseed subgroup 
20A'';
0
xix. Removing the entry for ``Salal''; and
0
xx. Adding in alphabetical order the entries ``Squash/cucumber subgroup 
9B''; ``Tomato, paste''; ``Tomato subgroup 8-10A''; ``Tropical and 
subtropical, small fruit, edible peel, subgroup 23A''; and ``Vegetable, 
tuberous and corm, subgroup 1C''.
0
c. In paragraph (d):
0
i. Revising the introductory text; and
0
ii. Adding a table heading.
    The additions and revisions read as follows:


Sec.  180.473  Glufosinate; tolerances for residues.

    (a) General. Tolerances are established for residues of 
glufosinate, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring the sum of glufosinate (2-amino-4-
(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado......................................................        0.1
 
                                * * * * *
Bushberry subgroup 13-07B....................................       0.15
 
                                * * * * *
Cotton, gin byproducts.......................................         30
Cottonseed subgroup 20C......................................         15
 
                                * * * * *
Fig..........................................................        0.1
Fig, dried...................................................       0.15
 
                                * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup       0.05
 13-07F......................................................
 
                                * * * * *
Hop, dried cones.............................................        0.9
 
                                * * * * *
Melon subgroup 9A............................................       0.08
 
                                * * * * *
Pepper/eggplant subgroup 8-10B...............................       0.15
 
                                * * * * *
Rapeseed subgroup 20A........................................        0.4
 
                                * * * * *
Squash/cucumber subgroup 9B..................................       0.15
Tomato, paste................................................       0.15
Tomato subgroup 8-10A........................................        0.1
Tropical and subtropical, small fruit, edible peel, subgroup         0.5
 23A.........................................................
Vegetable, tuberous and corm, subgroup 1C....................        0.8
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of glufosinate, including its 
metabolites and degradates, in or on the commodities in the following 
table, as a result of the application of glufosinate to crops listed in 
paragraph (a) of this section. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring the 
sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl) butanoic acid) 
and its metabolite, 3-(hydroxymethylphosphinyl) propanoic acid, 
expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid 
equivalents.

 Table 2 to Paragraph (d)
* * * * *
[FR Doc. 2022-20438 Filed 9-20-22; 8:45 am]
BILLING CODE 6560-50-P