Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82939 

PART 131—WATER QUALITY 

STANDARDS 

■ 1. The authority citation for part 131 

continues to read as follows: 

Authority: 33 U.S.C. 1251 et seq. 

Subpart D—Federally Promulgated 

Water Quality Standards 

§ 131.43 [Amended] 

■ 2. Amend § 131.43 by removing 

paragraphs (a) and (j) and redesignating 

paragraphs (b) through (i) as paragraphs 

(a) through (h). 

[FR Doc. 2020–26998 Filed 12–18–20; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2019–0233; FRL–10017–30] 

2,4-D; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 2,4-D in or on 

intermediate wheatgrass bran, forage, 

grain, and straw and sesame seed. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2020. Objections and 

requests for hearings must be received 

on or before February 19, 2021, 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–2019–0233, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: 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 Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2019–0233 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 February 19, 2021. 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– 

2019–0233, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

30, 2020 (85 FR 61681) (FRL–10014–74), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (an amended PP 

9E8745 and PP 0E8848) by IR–4, IR–4 

Project Headquarters, Rutgers, The State 

University of New Jersey, 500 College 

Road East, Suite 201W, Princeton, NJ 

08540. This September 30, 2020 Notice 

supersedes the previous document the 

Agency published notifying the public 

of the filing of the IR–4 petition 

PP9E8745 in the Federal Register of 

August 30, 2019 (84 FR 45702) (FRL– 

9998–15). 

The petitions requested that 40 CFR 

part 180 be amended by establishing 

tolerances for residues of 2,4-D in or on 

the raw agricultural commodities 

wheatgrass, intermediate, bran at 4 parts 

per million (ppm); wheatgrass, 

intermediate, grain at 2 ppm; 

wheatgrass, intermediate, straw at 50 

ppm, and wheatgrass, intermediate, 

forage at 25 ppm (PP 9E8745) and 

sesame, seed at 0.05 ppm (PP 0E8848). 

That document referenced summaries of 

the petitions prepared by Nufarm and 

PBI Gordon, the registrants, which are 

82940 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

available in the docket, http://

www.regulations.gov. There was one 

comment received in response to the 

notice of filing and it was in support of 

the petition. Although the petitioner 

requested a tolerance for wheatgrass, 

intermediate, forage at 25 ppm, the 

available data indicate that a tolerance 

of 30 ppm is appropriate; therefore, EPA 

is establishing that tolerance at 30 ppm. 

The remaining tolerances are being 

established as requested. 

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 2,4-D including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 2,4-D 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 toxicity profile of 2,4-D shows 

that the principal toxic effects are 

changes in the kidney, thyroid, liver, 

adrenal, eye, and ovaries/testes in the 

rat following exposure to 2,4-D via the 

oral route at dose levels above the 

threshold of saturation of renal 

clearance; below that level, the kidneys 

rapidly excrete the chemical before it 

has any toxic effects on the body. No 

systemic toxicity was observed in 

rabbits following repeated exposure via 

the dermal route at dose levels up to the 

limit dose. Neurotoxicity was observed 

in the acute neurotoxicity study in rats 

at the high dose. In an extended 1- 

generation reproductive toxicity study 

in rats, reproductive toxicity, 

developmental neurotoxicity, and 

immunotoxicity were not observed, and 

the thyroid effects observed at dose 

levels up to/approaching renal 

saturation were considered treatmentrelated, although not adverse. Maternal 

and developmental toxicities were 

observed only at high dose levels 

exceeding the threshold of saturation of 

renal clearance. Regarding 

carcinogenicity, available data showed 

no statistically significant tumor 

response in rats and mice. Moreover, 

EPA’s literature review found that, 

overall, there was little substantive 

evidence to suggest a clear associative or 

causal relationship between exposure to 

2,4-D and cancer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by 2,4-D 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 http:// 

www.regulations.gov in the document 

titled ‘‘2,4-D. Second Revision: Human 

Health Risk Assessment for Registration 

Review’’ (hereinafter ‘‘2,4-D Human 

Health Risk Assessment for Registration 

Review’’) in docket ID number EPA– 

HQ–OPP–2019–0233. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. 

A summary of the toxicological 

endpoints for 2,4-D used for human risk 

assessment can be found in the 2,4-D 

Human Health Risk Assessment for 

Registration Review. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 2,4-D, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 2,4-D 

tolerances in 40 CFR 180.142. EPA 

assessed dietary exposures from 2,4-D 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 2,4-D. 

In estimating acute dietary exposure, 

EPA used 2003–2008 food consumption 

information from the United States 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 

tolerance-level residues, except for 

transgenic soybeans and cotton (for 

which a value higher than the tolerance 

was used to account for the 2,4-DCP 

metabolite), and 100 percent crop 

treated (PCT) for all commodities, as 

well as empirical and default processing 

factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the USDA’s 

NHANES/WWEIA. As to residue levels 

in food, EPA assumed tolerance-level 

residues, except for transgenic soybeans 

and cotton (for which a value higher 

than the tolerance was used to account 

for the 2,4-DCP metabolite), and 100 

percent crop treated (PCT) for all 

commodities, as well as empirical and 

default processing factors. 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82941 

iii. Cancer. Based on the data 

summarized in the 2,4-D Human Health 

Risk Assessment for Registration Review 

in docket ID number EPA–HQ–OPP– 

2019–0233, EPA has concluded that 2,4- 

D is not expected to 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. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 2,4-D. 

Tolerance-level residues (except for 

transgenic soybeans and cotton, for 

which a value higher than the tolerance 

was used to account for the 2,4-DCP 

metabolite) and 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 2,4-D in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 2,4-D. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Surface Water 

Concentration Calculator (SWCC), 

Pesticide Root Zone Model Ground 

Water (PRZM GW) model, and 

monitoring data, the estimated drinking 

water concentrations (EDWCs) of 2,4-D 

for acute exposures are estimated to be 

298 parts per billion (ppb) for surface 

water and 14.89 ppb for ground water, 

and for chronic exposures are estimated 

to be 34.5 ppb for surface water and 

14.89 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 298 ppb was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment, the water concentration 

of value 34.5 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

2,4-D is currently registered for the 

following uses that could result in 

residential exposures: Ornamental turf, 

including lawns, parks, sports fields, 

and golf courses, as well as aquatic uses. 

EPA assessed residential exposure using 

the following assumptions: There is no 

potential hazard via the dermal route for 

2,4-D; therefore, the handler assessment 

included only the inhalation route of 

exposure. There are registered 2,4-D 

products for use in residential sites (e.g., 

lawns and turf) that have been 

considered in the short-term residential 

handler assessment for 2,4-D. As the 

aquatic use product labels include PPE 

requirements, and state that 

coordination and approval of local and 

state authorities and/or permits may be 

required prior to application, those 

applications are assumed to be made 

only by occupational applicators. 

There is potential for short-term postapplication exposure for individuals as 

a result of being in an environment that 

has been previously treated with 2,4-D. 

The quantitative exposure/risk 

assessment for residential postapplication exposures is based on the 

following scenarios: 

• Incidental ingestion (i.e., hand-tomouth, object-to-mouth, soil ingestion 

exposure) from contact with treated turf 

(children 1 to less than 2 years old 

only), 

• Episodic granular ingestion on 

treated turf (children 1 to less than 2 

years old only), and 

• Incidental ingestion of water during 

recreational swimming (both adults and 

children 3 to less than 6 years old). 

The residential exposure scenario 

used in the adult and children 3 to less 

than 6 years aggregate assessments 

reflects short-term incidental oral 

exposure from post-application 

exposure swimmer scenario. 

The residential exposure scenario 

used in the children 1 to less than 2 

years old aggregate assessment reflects 

short-term hand-to-mouth exposures 

from post-application turf scenario (i.e., 

post-application exposure to turf 

applications). 

These scenarios are considered worstcase and are protective of all other 

exposure scenarios. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-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.’’ 

2,4-D is a member of the 

alkylphenoxy herbicide class of 

pesticides. This class also includes 

MCPA, 2,4-DB, and 2,4-DP. 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 2,4-D and any 

other substances. For the purposes of 

this action, therefore, EPA has not 

assumed that 2,4-D 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 the policy 

statements released by EPA’s Office of 

Pesticide Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

2,4-D has been evaluated for potential 

developmental effects in the rat and 

rabbit. There is no evidence of increased 

susceptibility following in utero 

exposure to 2,4-D in the rabbit 

developmental toxicity study or 

following in utero and/or pre-/post-natal 

exposure in the rat extended 1- 

generation reproduction toxicity study. 

Maternal toxicity in the rabbit included 

decreased body weight gain, clinical 

signs of toxicity (decreased motor 

activity, ataxia, loss of righting reflex, 

extremities cold to the touch) and 

developmental toxicity includes 

abortions. 

The rat developmental toxicity study 

and the rat 2-generation reproductive 

study indicate increased susceptibility 

82942 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

following in utero exposure to 2,4-D in 

the rat developmental toxicity study 

and/or pre-/post-natal exposure in the 

reproductive study. In the former, 

maternal toxicity included decreased 

body weight gains at the same dose level 

where developmental effects 

(occurrence of skeletal malformations) 

occurred; in the latter, maternal toxicity 

included decreased body weight gains at 

the same dose level where reduced 

viability of the F1 pups was observed. 

In both the rat developmental study and 

the rat 2-generation reproduction study, 

the toxicity was observed at dose levels 

that exceed renal saturation. Because 

the toxicity was observed at those 

levels, EPA expects that had an 

examination of the kidney been done on 

the maternal animals in these studies, 

kidney effects would have been revealed 

at doses lower than where the 

developmental effects had occurred; 

therefore, the study findings are not 

considered evidence of real 

susceptibility. 

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. That decision is 

based on the following findings: 

i. The toxicity database for 2,4-D is 

complete. 

ii. Evidence of neurotoxicity was 

observed in the acute neurotoxicity 

study in rats, as evidenced by an 

increase in the incidence of incoordination and slight gait 

abnormalities (forepaw flexing or 

knuckling) during the Functional 

Operational Battery assessment at the 

high dose in both sexes. In the 

subchronic neurotoxicity study, relative 

forelimb grip strength was significantly 

increased in rats of both sexes at the 

high-dose level, although there was no 

treatment-related change in absolute 

grip strength. Clinical signs of 

neurotoxicity (decreased motor activity, 

ataxia, loss of righting reflex, extremities 

cold to the touch) were observed in 

maternal rabbits in the developmental 

toxicity study. Developmental 

neurotoxicity was not observed in the 

developmental neurotoxicity cohort of 

the Extended One Generation 

Reproductive Toxicity study in rats. 

Neuropathological effects were not 

observed in any study. 

iii. There is evidence of increased 

susceptibility following in utero 

exposure to 2,4-D in the rat 

developmental toxicity study and 

following in utero and/or pre-/post-natal 

exposure in the rat 2-generation 

reproduction study at dose levels that 

exceed renal saturation. There is no 

evidence of increased susceptibility 

following in utero exposure to 2,4-D in 

the rabbit developmental toxicity study 

or following in utero and/or pre-/postnatal exposure in the rat extended 1- 

generation reproduction toxicity study. 

Despite this conclusion, there is no 

residual uncertainty concerning the 

potential susceptibility of infants and 

children to effects of 2,4-D necessitating 

the retention of the 10X FQPA safety 

factor. There are no data gaps in the 

toxicology database, and the available 

reliable data provide clearly established 

NOAELs and LOAELs for the 

population of concern and the points of 

departure (POD) that are protective of 

susceptibility. Consequently, there is no 

need to retain the 10X FQPA safety 

factor to protect infants and children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary exposure estimates are 

unrefined and reflect primarily 

tolerance-level residues in food and 100 

PCT. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to 2,4-D in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by 2,4-D. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 2,4-D 

will occupy 23% of the aPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 2,4-D from food 

and water will utilize 20% of the cPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of 2,4-D 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). 

2,4-D is currently 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 2,4-D. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2000 for adults and 280 for 

children. Because EPA’s level of 

concern for 2,4-D is a MOE of 100 or 

below, these MOEs 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, 2,4-D is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm 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 

2,4-D. 

5. Aggregate cancer risk for U.S. 

population. As discussed above, EPA 

has concluded that 2,4-D will not pose 

a cancer risk. 

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 2,4-D 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate analytical methods are 

available for data collection and the 

enforcement of plant commodity 

tolerances. An adequate Gas 

Chromatography/Electron Capture 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82943 

Detector (GC/ECD) enforcement method 

for plants (designated as EN–CAS 

Method No. ENC–2/93) was submitted, 

which has been independently 

validated and radiovalidated. An 

enforcement method was submitted for 

determination of 2,4-D in livestock 

commodities, which has been 

adequately radiovalidated. The methods 

have been submitted to FDA for 

inclusion in PAM II. The 10/1997 

edition of FDA PAM Volume I, 

Appendix I indicates that 2,4-D is 

partially recovered (50–80%) using 

Multiresidue Methods Section 402 E1 

and 402 E2. 

For multiresidue method analysis, 

2,4-D is documented to be wellrecovered through the QuEChERS 

(Quick, Easy, Cheap, Effective, Rugged, 

and Safe) streamlined extraction 

method. 

The methods 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 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex has not established any 

MRLs for 2,4-D on intermediate 

wheatgrass raw agricultural 

commodities or sesame seed. 

C. Response to Comments 

There was one comment received in 

response to the notice of filing and it 

was in support of the petition. 

V. Conclusion 

Therefore, tolerances are established 

for residues of 2,4-D, in or on sesame, 

seed at 0.05 ppm; wheatgrass, 

intermediate, bran at 4 ppm; wheatgrass, 

intermediate, forage at 30 ppm; 

wheatgrass, intermediate, grain at 2 

ppm; and wheatgrass, intermediate, 

straw at 50 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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). This action 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), nor does 

it require any special considerations 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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: December 4, 2020. 

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 § 180.142 amend paragraph (a) 

by designating the table and adding, in 

alphabetical order, in newly designated 

Table 1 to paragraph (a) the entries 

‘‘Sesame, seed’’; ‘‘Wheatgrass, 

intermediate, bran’’; ‘‘Wheatgrass, 

intermediate, forage’’; ‘‘Wheatgrass, 

intermediate, grain’’; and ‘‘Wheatgrass, 

intermediate, straw’’ to read as follows: 

§ 180.142 2,4-D; tolerances for residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Sesame, seed ....................... 0.05 

* * * * * 

Wheatgrass, intermediate, 

bran ................................... 4 

Wheatgrass, intermediate, 

forage ................................ 30 

Wheatgrass, intermediate, 

grain .................................. 2 

82944 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

TABLE 1 TO PARAGRAPH (a)— 

Continued 

Commodity Parts per 

million 

Wheatgrass, intermediate, 

straw .................................. 50 

* * * * * 

[FR Doc. 2020–28128 Filed 12–17–20; 11:15 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 201214–0337] 

RIN 0648–BJ98 

Fisheries of the Northeastern United 

States; Golden Tilefish Fishery; Final 

2021 and Projected 2022 Specifications 

and Emergency Action 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS announces final 

specifications for the 2021 commercial 

golden tilefish fishery and projected 

specifications for 2022. This action also 

implements temporary emergency 

measures for the golden tilefish fishery 

at the request of the Mid-Atlantic 

Fishery Management Council. This 

action establishes allowable harvest 

levels and other management measures 

to prevent overfishing while allowing 

optimum yield, consistent with the 

Magnuson-Stevens Fishery 

Conservation and Management Act and 

the Tilefish Fishery Management Plan. 

The emergency measures allow a 

limited one-time carryover of up to 5 

percent of unharvested fishing quota 

from the 2020 fishing year into the 2021 

fishing year. 

DATES: This rule is effective December 

21, 2020. Emergency action measures 

expire June 19, 2021. The 2021 

specification measures expire November 

1, 2021. 

ADDRESSES: Copies of the Supplemental 

Information Report prepared for this 

action are available from Dr. 

Christopher M. Moore, Executive 

Director, Mid-Atlantic Fishery 

Management Council, 800 North State 

Street, Suite 201, Dover, DE 19901. 

These documents are also accessible via 

the internet at http://www.mafmc.org. 

FOR FURTHER INFORMATION CONTACT: 

Douglas Potts, Fishery Policy Analyst, 

(978) 281–9341. 

SUPPLEMENTARY INFORMATION: 

Background 

The Mid-Atlantic Fishery 

Management Council manages the 

golden tilefish fishery under the Tilefish 

Fishery Management Plan (FMP), which 

outlines the Council’s process for 

establishing annual specifications. The 

FMP requires the Council to recommend 

acceptable biological catch (ABC), 

annual catch limit (ACL), annual catch 

target (ACT), total allowable landings 

(TAL), and other management measures, 

for up to 3 years at a time. The directed 

fishery is managed under an individual 

fishing quota (IFQ) program, with small 

amounts of non-IFQ catch allowed 

under an incidental permit. Detailed 

background information regarding the 

development of the 2021–2022 

specifications for this fishery was 

provided in the specifications proposed 

rule (85 FR 72616; November 13, 2020). 

That information is not repeated here. 

Specifications 

The table below shows the 2021 and 

projected 2022 specifications including 

the ABC, ACL, ACT, and TAL for the 

commercial Mid-Atlantic golden tilefish 

fishery. NMFS will publish a notice in 

the Federal Register before the 2022 

fishing year notifying the public of the 

final specifications. 

TABLE 1—2021 AND PROJECTED 2022 GOLDEN TILEFISH SPECIFICATIONS

2021 Projected 2022 

million lb mt million lb mt 

ABC ................................................................................................................................. 1.636 742 1.636 742 

ACL ................................................................................................................................. 1.636 742 1.636 742 

IFQ ACT .......................................................................................................................... 1.554 705 1.554 705 

Incidental ACT ................................................................................................................. 0.082 37 0.082 37 

IFQ TAL ........................................................................................................................... 1.554 705 1.554 705 

Incidental TAL ................................................................................................................. 0.070 32 0.070 32 

Under the FMP, 95 percent of the ACL 

is allocated for the IFQ fishery, and the 

remaining 5 percent is allocated for the 

incidental fishery. This results in the 

ACT for each. The TAL for each of these 

sectors of the fishery is derived by 

deducting anticipated discards of 

tilefish from the ACT. 

This action makes no changes to 

possession limits in the golden tilefish 

fishery. The incidental trip limit 

remains 500 lb (226.8 kg) (live weight), 

or 50 percent of the weight of all fish 

being landed, whichever is less, and the 

recreational catch limit remains eight 

fish per angler per trip. 

Emergency Action 

At its April 2020 meeting, the Council 

requested that NMFS take emergency 

action to allow a 5 percent carryover of 

unharvested IFQ quota from fishing year 

2020 to 2021. The tilefish IFQ program 

does not normally allow any carryover 

of unharvested allocation from one 

fishing year into the next. Unforeseen 

changes in the market for seafood 

resulting from the COVID–19 pandemic, 

particularly the loss of restaurant sales 

due to local closure orders, have 

substantially reduced demand for 

golden tilefish. A review of golden 

tilefish IFQ landings from November 1, 

2019, through June 30, 2020, shows that 

landings were approximately 18.5- 

percent below the same date in 2018 

and 2019. Because of this 

unprecedented impact on the fishery, 

we are implementing this one-time carry 

over under our emergency rulemaking 

authority specified in section 305(c) of 

the Magnuson-Stevens Act. 

Each IFQ quota shareholder will be 

able to carry over 2020 IFQ quota 

pounds that are not used to land tilefish 

before the end of the fishing year, up to 

a maximum amount of 5 percent of their 

initial 2020 IFQ quota pounds. Final 

IFQ accounting is normally completed 

in December or January, after all 

landings data has been submitted and 

undergone normal reviews for quality 

control and quality assurance. 

Following that accounting, IFQ quota