31738 Federal Register / Vol. 87, No. 101 / Wednesday, May 25, 2022 / Rules and Regulations 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969(42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting 3.5 hours that will prohibit 

entry between 2 bridges within 

approximately 500 yards near a 

fireworks barge. It is categorically 

excluded from further review under 

paragraph L60(a) of Appendix A, Table 

1 of DHS Instruction Manual 023–01– 

001–01, Rev. 1. A Record of 

Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T13–0269 to read as 

follows: 

§ 165.T13–0269 Safety Zone; Fireworks 

Display, Willamette River, Portland, OR. 

(a) Location. The following area is a 

safety zone: All navigable waters of the 

Willamette River, surface to bottom, 

between the Hawthorne and Marquam 

Bridges, Portland, OR. The fireworks 

barge location will be at the 

approximate point of 45°30′37.61′′ N/ 

122°40′11.81′′ W. 

(b) Definitions. As used in this 

section— 

Designated representative means a 

Coast Guard Patrol Commander, 

including a Coast Guard coxswain, petty 

officer, or other officer operating a Coast 

Guard vessel and a Federal, State, and 

local officer designated by or assisting 

the Captain of the Port Columbia River 

(COTP) in the enforcement of the safety 

zone. 

Participant means all persons and 

vessels registered with the event 

sponsor as a participant in the race. 

(c) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by calling (503) 209–2468 

or the Sector Columbia River Command 

Center on Channel 16 VHF–FM. Those 

in the safety zone must comply with all 

lawful orders or directions given to 

them by the COTP or the COTP’s 

designated representative. 

(3) The COTP will provide notice of 

the regulated area through advanced 

notice via broadcast notice to mariners 

and by on-scene designated 

representatives. 

(d) Enforcement period. This section 

will be enforced from 8:30 p.m. on 27 

May, 2022 to 12:00 a.m. on May 28, 

2022. It will be subject to enforcement 

this entire period unless the COTP 

determines it is no longer needed, in 

which case the Coast Guard will inform 

mariners via Notice to Mariners. 

Dated: May 19, 2022. 

G.M. Bailey, 

Captain, U.S. Coast Guard, Alternate Captain 

of the Port Sector Columbia River. 

[FR Doc. 2022–11187 Filed 5–24–22; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0339; FRL–9298–02– 

OCSPP] 

Pyridate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyridate in or 

on lentil, dry, seed and rapeseed 

subgroup 20A. Belchim Crop 

Production US Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

25, 2022. Objections and requests for 

hearings must be received on or before 

July 25, 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). 


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ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2021–0339, 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. Please review 

the visitor instructions and additional 

information about the docket available 

at 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: RDFRNotices@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Office of the Federal Register’s eCFR 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–2021–0339 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before July 

25, 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– 

2021–0339, 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/contacts.html. 

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 June 28, 

2021 (86 FR 33922) (FRL–10025–08), 

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 0F8885) by 

Belchim Crop Protection N.V./S.A., c/o 

Belchim Crop Protection US 

Corporation, 2751 Centreville Rd., Suite 

100, Wilmington, DE 19808. The 

petition requested that 40 CFR 180.462 

be amended to establish tolerances for 

residues of the herbicide pyridate 

calculated as the stoichiometric 

equivalent of pyridate, in or on the 

commodities lentils at 0.40 parts per 

million (ppm) and Rapeseed Subgroup 

(Crop Subgroup 20A) at 0.015 ppm. 

That document referenced a summary of 

the petitioned prepared by Belchim 

Crop Protection, the registrant, which is 

available in the docket, https:// 

www.regulations.gov. There were no 

comments received in response to the 

Notice of Filing. 

Based upon review of the data 

supporting the petition and in 

accordance with its authority under 

FFDCA section 408(d)(4)(A)(i), EPA is 

establishing the tolerance for rapeseed 

crop subgroup 20A at a different level 

than petitioned-for and is revising the 

commodity definition. The reasons for 

these changes are explained in Unit 

IV.C. 

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 in 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 pyridate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyridate 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 


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subgroups of consumers, including 

infants and children. 

The toxicological database for 

pyridate is adequate for hazard 

characterization, toxicity endpoint 

selection, and Food Quality Protection 

Act (FQPA) Safety Factor (SF) 

consideration. The available toxicity 

database for pyridate indicates that the 

nervous system is the toxicological 

target in studies where pyridate was 

administered via gavage or capsules, 

with the dog and the rat showing similar 

levels of sensitivity once bodyweight 

scaling is considered. The neurotoxic 

effects were associated with the peak 

plasma concentrations, occurred within 

a few hours of treatment, and resolved 

in less than 24 hours of the bolus dose 

from gavage or capsule administration. 

The neurobehavioral effects do not 

appear to be accumulative or 

progressive since the effects in the 

subchronic dog study occurred at 

approximately the same dose where 

effects were seen in the chronic dog 

study and were generally resolved 

within 6 hours of treatment. No 

evidence of neurotoxicity was observed 

in the studies where pyridate was 

administered via the diet (feed) 

following subchronic or chronic dietary 

exposure. Effects observed following 

dietary (feed) exposure were generally 

limited to systemic toxicity, primarily 

reductions in bodyweight. Additionally, 

there were no effects seen at the limit 

dose in the dermal toxicity study. 

There was no evidence of increased 

susceptibility to the fetus or offspring in 

the available developmental and 

reproduction toxicity studies. 

Developmental (missing and unossified 

sternebrae and decreased bodyweight in 

fetuses) and offspring effects (decreased 

bodyweights) were seen in the presence 

of maternal toxicity in rats. An 

increased incidence of abortions was 

also noted in the developmental toxicity 

study in rabbits at the highest dose 

tested. 

Pyridate is classified as ‘‘Not Likely to 

be Carcinogenic to Humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyridate as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at https:// 

www.regulations.gov in the document 

titled ‘‘Pyridate. Human Health Risk 

Assessment for the Proposed New 

Section 3 Registration on Lentils, 

Rapeseed Subgroup 20A, Popcorn, and 

Seed Corn.’’ (hereinafter referred to as 

‘‘Pyridate Human Health Risk 

Assessment’’) on pages 25–27 in docket 

ID number EPA–HQ–OPP–2021–0339. 

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-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

A summary of the toxicological 

endpoints for pyridate used for human 

risk assessment can be found in the 

Pyridate Human Health Risk 

Assessment on pages 13–16. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyridate, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

pyridate tolerances in 40 CFR 180.462. 

EPA assessed dietary exposures from 

pyridate 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 pyridate. 

In conducting the acute dietary 

exposure assessment, EPA used the 

2005–2010 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, 100% crop treated (100 PCT) 

for all commodities, and default 

processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2005–2010 food 

consumption data from the NHANES/ 

WWEIA. The chronic dietary exposure 

assessment is unrefined, assuming 

tolerance-level residues, 100 PCT for all 

commodities, and default processing 

factors. 

iii. Cancer. EPA has classified 

pyridate as ‘‘Not Likely to be 

Carcinogenic to Humans’’ as there was 

no evidence carcinogenicity in either of 

the rodent cancer studies; therefore, a 

cancer dietary assessment was not 

performed. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyridate in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of pyridate. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-medels-used-pesticide. 

Based on the Pesticides in Water 

Calculator (PWC; version 1.52), the 

estimated drinking water concentrations 

(EDWCs) of pyridate are estimated to be 

363 parts per billion (ppb) for acute 

dietary exposures and 256 ppb for 

chronic dietary exposures. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). Pyridate 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

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 


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mechanism of toxicity finding as to 

pyridate and any other substances and 

pyridate does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

action, therefore, EPA has not assumed 

that pyridate has a common mechanism 

of toxicity with other substances. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility to the fetus or offspring in 

the available developmental and 

reproduction toxicity studies. 

Developmental (missing and unossified 

sternebrae and decreased bodyweight in 

fetuses) and offspring effects (decreased 

bodyweights) were seen in the presence 

of maternal toxicity in rats. An 

increased incidence of abortions was 

also noted in the developmental toxicity 

study in rabbits at the highest dose 

tested. Since these effects occurred in 

the presence of comparable or more 

severe maternal toxicity, they were not 

considered evidence of qualitative 

susceptibility. Furthermore, the selected 

points of departure are protective of 

these effects. 

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 all exposure 

scenarios. That decision is based on the 

following findings: 

i. The toxicology database for pyridate 

is complete and includes acceptable 

developmental and reproductive 

toxicity studies for evaluating 

sensitivity for infants and children. 

ii. There are adverse neurotoxic 

effects observed in the database for 

pyridate both in the acute neurotoxicity 

(ACN) and in other studies, including 

the subchronic rat and chronic and 

subchronic dog, with effects such as 

emesis, ataxia, salivation, dyspnea, 

tremors, and prostration in dogs; and 

hypoactivity and excessive salivation in 

rats. However, these effects were only 

observed in studies where the test 

animals were exposed to a concentrated 

bolus of the chemical (gavage/capsule) 

and not in studies in which animals 

were exposed through the diet. These 

neurotoxic effects increased rapidly in 

incidence within 1–3 hours after dosing 

and gradually resolved over the next 8– 

12 hours and do not show progression 

in chronic studies. EPA concluded 

based upon a weight-of-evidence 

approach that the subchronic 

neurotoxicity study was not required for 

risk assessment at this time. Although 

there is evidence of neurotoxicity, 

concern is low since the selected 

endpoints for this chemical are 

protective of these effects. 

iii. There was no evidence of 

increased quantitative or qualitative 

susceptibility in the developmental 

toxicity studies in rabbits or rats or the 

reproduction toxicity study in rats. 

iv. There is no residual uncertainty in 

the exposure database. The dietary 

assessment is based on high-end 

assumptions such as modeled, high-end 

estimates of residues in drinking water, 

assuming 100 PCT and tolerance-level 

residues. In addition, there are no 

residential uses proposed for pyridate at 

this time. These assessments will not 

underestimate the exposure and risks 

posed by pyridate. 

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 estimates 

from dietary consumption of food and 

drinking water, EPA has concluded that 

acute exposure to pyridate from food 

and water will utilize 33% of the aPAD 

for all infants less than 1-year old, the 

most highly exposed population 

subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure of pyridate from 

food and water will utilize 18% of the 

cPAD for all infants less than 1-year old, 

the population group receiving the 

greatest exposure. 

3. Short- and intermediate-term risks. 

Short- and intermediate-term exposure 

takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). A short-term adverse 

effect and an intermediate-term adverse 

effect were identified; however, pyridate 

is not registered for any use patterns 

that would result in short- or 

intermediate-term residential exposure. 

Short- and intermediate-term risk is 

assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or 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 short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for pyridate. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyridate is not expected to pose a cancer 

risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to pyridate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography with ultraviolet 

detection (UV–HPLC)) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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 


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(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

Codex has not established an MRL for 

pyridate in/on lentils or rapeseed 

subgroup 20A. 

C. Revisions to Petitioned-For 

Tolerances 

For rapeseed subgroup 20A, the 

registrant proposed a tolerance of 0.015 

ppm, which is less than the limit of 

quantitation (LOQ) of the enforcement 

method. Therefore, EPA is establishing 

a tolerance of 0.05 ppm for rapeseed 

subgroup 20A, which is the LOQ of the 

method employed in the crop field 

trials. EPA also adjusted the commodity 

definition for rapeseed subgroup 20A to 

use standard terminology. In addition, 

EPA dropped the trailing zero from the 

lentil tolerance value to be consistent 

with current Agency rounding practices. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyridate, in or on lentil, 

dry, seed at 0.4 ppm and rapeseed 

subgroup 20A at 0.05 ppm. 

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: May 19, 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.462, the table in paragraph 

(a) is amended by: 

■ a. Adding a table heading; and 

■ b. Adding the commodities ‘‘Lentil, 

dry, seed’’ and ‘‘Rapeseed subgroup 

20A’’ to the table in alphabetical order. 

The additions read as follows: 

§ 180.462 Pyridate; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity 

Parts 

per 

million 

* * * * * 

Lentil, dry, seed .............................. 0.4 

* * * * * 

Rapeseed subgroup 20A ................ 0.05 

* * * * * 

* * * * * 

[FR Doc. 2022–11173 Filed 5–24–22; 8:45 am] 

BILLING CODE 6560–50–P 


lotter on DSK11XQN23PROD with RULES1