[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]]
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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.
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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